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Sample records for united states fda

  1. Single Cigarette Sales: State Differences in FDA Advertising and Labeling Violations, 2014, United States.

    Science.gov (United States)

    Baker, Hannah M; Lee, Joseph G L; Ranney, Leah M; Goldstein, Adam O

    2016-02-01

    Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. All 50 states and the District of Columbia. Tobacco retailer inspections conducted by FDA (n = 33 543). State cigarette tax, youth smoking prevalence, poverty, and tobacco production. State proportion of FDA warning letters issued for single cigarette violations. There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  2. Smokers' reactions to FDA regulation of tobacco products: Findings from the 2009 ITC United States survey

    Directory of Open Access Journals (Sweden)

    Fix Brian V

    2011-12-01

    Full Text Available Abstract Background On June 22, 2009, the US FDA was granted the authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act (FSPTCA. The intent is to improve public health through regulations on tobacco product marketing and tobacco products themselves. This manuscript reports baseline data on smokers' attitudes and beliefs on specific issues relevant to the FSPTCA. Method Between November 2009 and January 2010, a telephone survey among a nationally representative sample of n = 678 smokers in the US was performed as part of the International Tobacco Control (ITC United States Survey. Participants answered a battery of questions on their attitudes and beliefs about aspects of the FSPTCA. Results Most smokers were unaware of the new FDA tobacco regulations. Smokers indicated support for banning cigarette promotion and nearly a quarter supported requiring tobacco companies to sell cigarettes in plain packaging. Seventy two percent of smokers supported reducing nicotine levels to make cigarettes less addictive if nicotine was made easily available in non-cigarette form. Conclusion Most smokers were limited in their understanding of efforts to regulate tobacco products in general. Smokers were supportive of efforts to better inform the public about health risks, restrict advertising, and make tobacco products less addictive.

  3. The use of the United States FDA programs as a strategy to advance the development of drug products for neglected tropical diseases.

    Science.gov (United States)

    Sachs-Barrable, Kristina; Conway, Jocelyn; Gershkovich, Pavel; Ibrahim, Fady; Wasan, Kishor M

    2014-11-01

    Neglected tropical diseases (NTDs) are infections which are endemic in poor populations in lower- and middle-income countries (LMIC). Approximately one billion people have now or are at risk of getting an NTD and yet less than 5% of research dollars are focused on providing treatments and prevention of these highly debilitating and deadly conditions. The United States Food and Drug Administration (FDA) Orphan Drug Designation program (ODDP) provides orphan status to drugs and biologics, defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and/or disorders that affect fewer than 200 000 people in the United States, or that affect more than 200 000 persons but are not expected to recover the costs of developing and marketing a treatment drug. These regulations have led to the translation of rare disease knowledge into innovative rare disease therapies. The FDA Guidance for Industry on developing drugs for the treatment and prevention of NTDs describes the following regulatory strategies: Orphan Product Designation, Fast Track Designation, Priority Review Designation, Accelerated Approval and Tropical Disease Priority Review Voucher. This paper will discuss how these regulations and especially the ODDP can improve the clinical development and accessibility of drug products for NTDs.

  4. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.

    Science.gov (United States)

    Gupta, Ravi; Dhruva, Sanket S; Fox, Erin R; Ross, Joseph S

    2017-10-01

    Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. To examine the clinical evidence for approval and association with prices and shortages of previously unapproved prescription drugs after being addressed by the UDI. Previously unapproved prescription drugs that faced UDI regulatory action or with at least 1 product that received FDA approval through manufacturers' voluntary compliance with the UDI between 2006 and 2015 were identified. The clinical evidence was categorized as either newly conducted clinical trials or use of previously published literature and/or bioequivalence studies to demonstrate safety and efficacy. We determined the change in average wholesale price, presence of shortage, and duration of shortage for each drug during the 2 years before and after UDI regulatory action or approval through voluntary compliance. Between 2006 and 2015, 34 previously unapproved prescription drugs were addressed by the UDI. Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. Among the 26 drugs with available pricing data, average wholesale price during the 2 years before and after voluntary approval or UDI action increased by a median of 37% (interquartile range [IQR] = 23%-204%; P Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to

  5. Medical Device Regulation: A Comparison of the United States and the European Union.

    Science.gov (United States)

    Maak, Travis G; Wylie, James D

    2016-08-01

    Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported. However, after recent high-profile device failures, political pressure in both the United States and the European Union has favored more restrictive approval processes. Substantial reforms of the European Union process within the next 5 to 10 years will result in a more stringent approach to device regulation, similar to that of the FDA. Changes in the FDA regulatory process have been suggested but are not imminent.

  6. 77 FR 2492 - United States Pharmacopeial Convention; Filing of Food Additive Petition; Amendment

    Science.gov (United States)

    2012-01-18

    ..., and 180 [Docket No. FDA-2010-F-0320] United States Pharmacopeial Convention; Filing of Food Additive... Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by the U.S. Pharmacopeial Convention requesting that the food additive regulations that incorporate by...

  7. Update of food irradiation in the united states

    Energy Technology Data Exchange (ETDEWEB)

    Engel, R E

    1986-12-31

    The Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA) has the responsibility of assuring consumers that meat and poultry products sold in interstate commerce within the United States are safe, wholesome, and accurately labelled. An important aspect of this charge involves the study and evaluation of promising innovations in food technology. The Agency is now focusing closely on food irradiation as a possible technique for meat and poultry production that would offer advantages to producers and consumers beyond those of traditional methods. Radiation treatment of food in the United States is regulated by the Food and Drug Administration (FDA), which proposed in February 1984 to allow the use of low levels of ionizing radiation for preserving food products and higher levels for disinfesting spices. Meat and poultry products were not included in the proposal, but FDA has recently entered that area by approving, on July 22, 1985, the use of ionizing radiation to control trichina in pork carcasses or fresh, non-heat processed cuts of pork. Other applications may be approved in the near future. The use of radiation for food production would have important implications for public health protection. The FDA approval of irradiated pork has brought food irradiation to the forefront of FSIS attention

  8. Update of food irradiation in the united states

    International Nuclear Information System (INIS)

    Engel, R. E.

    1985-01-01

    The Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA) has the responsibility of assuring consumers that meat and poultry products sold in interstate commerce within the United States are safe, wholesome, and accurately labelled. An important aspect of this charge involves the study and evaluation of promising innovations in food technology. The Agency is now focusing closely on food irradiation as a possible technique for meat and poultry production that would offer advantages to producers and consumers beyond those of traditional methods. Radiation treatment of food in the United States is regulated by the Food and Drug Administration (FDA), which proposed in February 1984 to allow the use of low levels of ionizing radiation for preserving food products and higher levels for disinfesting spices. Meat and poultry products were not included in the proposal, but FDA has recently entered that area by approving, on July 22, 1985, the use of ionizing radiation to control trichina in pork carcasses or fresh, non-heat processed cuts of pork. Other applications may be approved in the near future. The use of radiation for food production would have important implications for public health protection. The FDA approval of irradiated pork has brought food irradiation to the forefront of FSIS attention

  9. Product quality of parenteral vancomycin products in the United States.

    Science.gov (United States)

    Nambiar, S; Madurawe, R D; Zuk, S M; Khan, S R; Ellison, C D; Faustino, P J; Mans, D J; Trehy, M L; Hadwiger, M E; Boyne, M T; Biswas, K; Cox, E M

    2012-06-01

    In response to concerns raised about the quality of parenteral vancomycin products, the U.S. Food and Drug Administration (FDA) is investigating the product quality of all FDA-approved parenteral vancomycin products available in the United States. Product quality was evaluated independently at two FDA Office of Testing and Research (FDA-OTR) sites. In the next phase of the investigation, being done in collaboration with the National Institute of Allergy and Infectious Diseases, the in vivo activity of these products will be evaluated in an appropriate animal model. This paper summarizes results of the FDA investigation completed thus far. One site used a validated ultrahigh-pressure liquid chromatography method (OTR-UPLC), and the second site used the high-performance liquid chromatography (HPLC) method for related substances provided in the British Pharmacopeia (BP) monograph for vancomycin intravenous infusion. Similar results were obtained by the two FDA-OTR laboratories using two different analytical methods. The products tested had 90 to 95% vancomycin B (active component of vancomycin) by the BP-HPLC method and 89 to 94% vancomycin by OTR-UPLC methods. Total impurities were 5 to 10% by BP-HPLC and 6 to 11% by OTR-UPLC methods. No single impurity was >2.0%, and the CDP-1 level was ≤ 2.0% across all products. Some variability in impurity profiles of the various products was observed. No adverse product quality issues were identified with the six U.S. vancomycin parenteral products. The quality parameters of all parenteral vancomycin products tested surpassed the United States Pharmacopeia acceptance criteria. Additional testing will characterize in vivo performance characteristics of these products.

  10. Drugs@FDA: FDA Approved Drug Products

    Science.gov (United States)

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  11. Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands

    NARCIS (Netherlands)

    Bastiaans, D.E.T.; Forcat, S.; Lyall, H.; Cressey, T.R.; Hansudewechakul, R.; Kanjanavanit, S.; Noguera-Julian, A.; Konigs, C.; Inshaw, J.R.; Chalermpantmetagul, S.; Saidi, Y.; Compagnucci, A.; Harper, L.M.; Giaquinto, C.; Colbers, A.P.; Burger, D.M.

    2014-01-01

    BACKGROUND: Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval

  12. Small Area Estimate Maps: Does the FDA Regulate Tobacco? - Small Area Estimates

    Science.gov (United States)

    This metric is defined as a person 18 years of age or older who must have reported that he/she believes that the United States Food and Drug Administration (FDA) regulates tobacco products in the U.S.

  13. A United States regulator's perspective on the ongoing chlorofluorocarbon transition.

    Science.gov (United States)

    Meyer, R J

    1999-12-01

    The Food and Drug Administration (FDA) put in place a general ban on the use of chlorofluorocarbons for the products it regulates (medical devices, drugs, and foods) in 1978, exempting those products where chlorofluorocarbon use was determined to be essential for the public health. In the intervening years, as the international commitment to a full transition away from all chlorofluorocarbon use took shape under the Montreal Protocol, the FDA has worked with industry to facilitate the development and testing of alternative technologies and products for inhalation drug products. As these alternative products begin to move from testing through the approval process and into marketing, the FDA is working collaboratively with the Environmental Protection Agency, other governmental agencies, and nongovernmental stakeholders to develop a transition policy for the United States. The transition policy for metered dose inhalers must be one that achieves the dual aims of first protecting the patients who rely on these vital medical products, while also achieving the public health need of protecting the ozone layer. As a part of developing such a transition strategy, the FDA published an advance notice of proposed rulemaking (ANPRM) in March 1997. The ANPRM proposed mechanisms by which the FDA could determine when chlorofluorocarbon use in a drug product could no longer be considered essential. The ANPRM resulted in a large amount of valuable public debate and input. The FDA is now working to incorporate the knowledge gained from these public comments as it continues the rule-making process.

  14. Medical abortion practices : a survey of National Abortion Federation members in the United States

    NARCIS (Netherlands)

    Wiegerinck, Melanie M. J.; Jones, Heidi E.; O'Connell, Katharine; Lichtenberg, E. Steve; Paul, Maureen; Westhoff, Carolyn L.

    2008-01-01

    Background: Little is known about clinical implementation of medical abortion in the United States following approval of mifepristone as an abortifacient by the Food and Drug Administration (FDA) in 2000. We collected information regarding medical abortion practices of National Abortion Federation

  15. Medical abortion practices: a survey of National Abortion Federation members in the United States

    NARCIS (Netherlands)

    Wiegerinck, Melanie M. J.; Jones, Heidi E.; O'Connell, Katharine; Lichtenberg, E. Steve; Paul, Maureen; Westhoff, Carolyn L.

    2008-01-01

    Little is known about clinical implementation of medical abortion in the United States following approval of mifepristone as an abortifacient by the Food and Drug Administration (FDA) in 2000. We collected information regarding medical abortion practices of National Abortion Federation (NAF) members

  16. Addressing a Yellow Fever Vaccine Shortage - United States, 2016-2017.

    Science.gov (United States)

    Gershman, Mark D; Angelo, Kristina M; Ritchey, Julian; Greenberg, David P; Muhammad, Riyadh D; Brunette, Gary; Cetron, Martin S; Sotir, Mark J

    2017-05-05

    Recent manufacturing problems resulted in a shortage of the only U.S.-licensed yellow fever vaccine. This shortage is expected to lead to a complete depletion of yellow fever vaccine available for the immunization of U.S. travelers by mid-2017. CDC, the Food and Drug Administration (FDA), and Sanofi Pasteur are collaborating to ensure a continuous yellow fever vaccine supply in the United States. As part of this collaboration, Sanofi Pasteur submitted an expanded access investigational new drug (eIND) application to FDA in September 2016 to allow for the importation and use of an alternative yellow fever vaccine manufactured by Sanofi Pasteur France, with safety and efficacy comparable to the U.S.-licensed vaccine; the eIND was accepted by FDA in October 2016. The implementation of this eIND protocol included developing a systematic process for selecting a limited number of clinic sites to provide the vaccine. CDC and Sanofi Pasteur will continue to communicate with the public and other stakeholders, and CDC will provide a list of locations that will be administering the replacement vaccine at a later date.

  17. Data gaps in toxicity testing of chemicals allowed in food in the United States.

    Science.gov (United States)

    Neltner, Thomas G; Alger, Heather M; Leonard, Jack E; Maffini, Maricel V

    2013-12-01

    In the United States, chemical additives cannot be used in food without an affirmative determination that their use is safe by FDA or additive manufacturer. Feeding toxicology studies designed to estimate the amount of a chemical additive that can be eaten safely provide the most relevant information. We analyze how many chemical additives allowed in human food have feeding toxicology studies in three toxicological information sources including the U.S. Food and Drug Administration's (FDA) database. Less than 38% of FDA-regulated additives have a published feeding study. For chemicals directly added to food, 21.6% have feeding studies necessary to estimate a safe level of exposure and 6.7% have reproductive or developmental toxicity data in FDA's database. A program is needed to fill these significant knowledge gaps by using in vitro and in silico methods complemented with targeted in vivo studies to ensure public health is protected. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

  18. Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines.

    Science.gov (United States)

    Klara, Kristina; Kim, Jeanie; Ross, Joseph S

    2018-05-01

    Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.

  19. FDA direct-to-consumer advertising for prescription drugs: what are consumer preferences and response tendencies?

    Science.gov (United States)

    Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza

    2007-01-01

    The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources.

  20. Awareness and trust of the FDA and CDC: Results from a national sample of US adults and adolescents.

    Directory of Open Access Journals (Sweden)

    Sarah D Kowitt

    Full Text Available Trust in government agencies plays a key role in advancing these organizations' agendas, influencing behaviors, and effectively implementing policies. However, few studies have examined the extent to which individuals are aware of and trust the leading United States agencies devoted to protecting the public's health. Using two national samples of adolescents (N = 1,125 and adults (N = 5,014, we examined demographic factors, with a focus on vulnerable groups, as correlates of awareness of and trust in the Centers for Disease Control and Prevention (CDC, Food and Drug Administration (FDA, and the federal government. From nine different weighted and adjusted logistic regression models, we found high levels of awareness of the existence of the FDA and CDC (ranging from 55.7% for adolescents' awareness of the CDC to 94.3% for adults' awareness of the FDA and moderate levels of trust (ranging from a low of 41.8% for adults' trust in the federal government and a high of 78.8% for adolescents' trust of the FDA. In the adolescent and adult samples, awareness was higher among non-Hispanic Blacks and respondents with low numeracy. With respect to trust, few consistent demographic differences emerged. Our findings provide novel insights regarding awareness and trust in the federal government and specific United States public health agencies. Our findings suggest groups to whom these agencies may want to selectively communicate to enhance trust and thus facilitate their communication and regulatory agendas.

  1. United States v. Caronia: The increasing strength of commercial free speech and potential new emphasis on classifying off-label promotion as "false and misleading".

    Science.gov (United States)

    Scheineson, Marc J; Cuevas, Guillermo

    2013-01-01

    The authority of the United States Food and Drug Administration (FDA) to prohibit off-label promotion of drug products suffered another serious setback in United States v. Caronia. Viewing a legal system where physicians can prescribe prescription pharmaceuticals for unapproved uses legally in their practice of medicine, the Federal appeals court affirmed the commercial free speech rights of manufacturers to use truthful, non-misleading speech about lawfully marketed products. As a result of this case, and others upon which the decision is based, FDA is likely to challenge manufacturer promotion more carefully, and only if it can demonstrate that claims are not truthful, but are false or misleading, or otherwise deprive the prescriber of adequate directions for use.

  2. Progress of food irradiation in the United States

    International Nuclear Information System (INIS)

    Derr, D.D.; Engeljohn, D.L.; Griffin, R.L.

    1995-01-01

    Irradiated foods have not yet made a significant impact in the United States marketplace. What progress has occurred to facilitate their commercialization? Irradiated produce has been sold in small quantities since 1992 and irradiated poultry was introduced in the marketplace in 1993. Federal inspection of irradiated commodities has settled into a regular routine. What must occur to further expand irradiated foods in the marketplace? Petitions to permit irradiation of red meats and seafood are being considered by the Food and Drug Administration (FDA) and a petition to permit the irradiation of shell eggs is being prepared for submission to FDA. In addition, the U.S. Department of Agriculture (USDA) has accelerated efforts to develop the policies and regulatory structure needed to facilitate the approval of new irradiation treatments for imported plant products regulated by quarantine. When will greater commercialization occur? More positive coverage to food irradiation in recent months by both the trade and popular press indicates a change in attitude towards irradiated foods by both consumers and the food industry. Finally, actual consumer response to available irradiated foods casts a favorable light on the potential for increased marketing of value-added irradiated foods. (Author)

  3. Stem-cell-derived products: an FDA update.

    Science.gov (United States)

    Moos, Malcolm

    2008-12-01

    The therapeutic potential of products derived from stem cells of various types has prompted increasing research and development and public attention. Initiation of human clinical trials in the not-too-distant future is now a realistic possibility. It is, therefore, important to weigh the potential benefits against known, theoretical and totally unsuspected risks in light of current knowledge to ensure that subjects participating in these trials are afforded the most reasonable balance possible between potential risks and potential benefits. There are no apparent differences in fundamental, qualitative biological characteristics between stem-cell-derived products and other cellular therapies regulated by the United States Food and Drug Administration (FDA). Existing authorities can, therefore, be applied. Nevertheless, these products do have properties that require careful evaluation.

  4. Changes In Growth Culture FDA Activity Under Changing Growth Conditions

    DEFF Research Database (Denmark)

    Jørgensen, Per Elberg; Eriksen, Thomas Juul; Jensen, Bjørn K.

    1992-01-01

    The FDA hydrolysis capacities and bacterial biomass concentrations (estimated by determination of ATP content) of growth cultures prepared from activated sludge and wastewater, were measured to find out whether the FDA activity would reflect bacterial biomass under different physiological states...... of the bacteria. The FDA activity/ATP ratio was calculated for different concentrations of autoclaved sludge. A faster decay rate of ATP relative to FDA hydrolysis activity was observed, thus causing changes in the ratio. Furthermore, comparison between values obtained from pure cultures and different soils...... revealed differences up to two orders of magnitude of the ratio. Based on these results it was concluded that the FDA activity should not be applied for measurements of viable biomass in environments in which different physiological conditions occur....

  5. Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

    Science.gov (United States)

    Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S

    2011-01-01

    Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Few physician-directed print pharmaceutical advertisements

  6. Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

    Directory of Open Access Journals (Sweden)

    Deborah Korenstein

    Full Text Available Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA; adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14. Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1% adhered to all FDA guidelines, 41 (49.4% were non-adherent with at least one form of FDA-described bias, and 27 (32.5% were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.Few physician-directed print pharmaceutical

  7. Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?

    Science.gov (United States)

    Rosania, Larry

    2010-01-01

    Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.

  8. Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.

    Science.gov (United States)

    KuKanich, Butch; Warner, Matt; Hahn, Kevin

    2017-02-01

    OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.

  9. 31 CFR 515.321 - United States; continental United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States; continental United... General Definitions § 515.321 United States; continental United States. The term United States means the United States and all areas under the jurisdiction or authority thereof, including the Trust Territory of...

  10. 31 CFR 500.321 - United States; continental United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States; continental United... General Definitions § 500.321 United States; continental United States. The term United States means the United States and all areas under the jurisdiction or authority thereof, including U.S. trust territories...

  11. 31 CFR 535.321 - United States; continental United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States; continental United... General Definitions § 535.321 United States; continental United States. The term United States means the United States and all areas under the jurisdiction or authority thereof including the Trust Territory of...

  12. Drugs@FDA Database

    Data.gov (United States)

    U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...

  13. Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review

    Directory of Open Access Journals (Sweden)

    Juan Carlos Martínez-Aguayo

    2016-06-01

    Full Text Available ABSTRACT Background The United States Food and Drug Administration (FDA has warned about the increased suicidality risk associated with the use of selective serotonin reuptake inhibitors (SSRI and venlafaxine in children and adolescents. Objectives To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents. Methods A critical review of articles in Medline/PubMed and SciELO databases regarding the FDA Black box warning for antidepressants, and the impact of FDA warnings on antidepressant prescriptions and suicide rates. Results The warning was based on surveys that did not report either cases of suicide nor a significant difference supporting an increased suicidality rate. The concept was defined in an ambiguous way and there is currently more available evidence to support such definition. The use of SSRI and venlafaxine has been associated to lower suicidality rates, but the prescription fall due to the warning increased suicide rates. Discussion Suicidality is an inherent feature of depressive disorders so it would be desirable to consider how much of the phenomenon may be attributed to antidepressants per se. It would be appropriate to consider that suicide rates might increase also as a consequence of the warning.

  14. Rapanos v. United States & Carabell v. United States

    Science.gov (United States)

    Documents associated with guidance for implementing the definition of waters of the United States under the Clean Water Act following the Rapanos v. United States, and Carabell v. United States Supreme Court decision.

  15. U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States.

    Science.gov (United States)

    Wing, Deborah A; Powers, Barbara; Hickok, Durlin

    2010-04-01

    The process for drug approval in the United States is complex and time-consuming. There are comparatively few drugs with U.S. Food and Drug Administration (FDA)-approved indications for obstetric use in this country at this time; however, several are under development. We review the process for drug approval and recount the approval histories of obstetric drugs reviewed in the recent past. We also outline the current status of two progestational agents that are under development. For a variety of reasons, including a small market compared with others such as cardiology or oncology, and the potential of being drawn into medical-legal litigation, sponsors are disinclined to pursue drug development for obstetric purposes in this country. We compare the procedures for review and approval of drugs in the United States with those in Europe, and note that recent changes within the FDA may result in not only more drugs being approved but also changes in labeling of already approved drugs. Special programs to facilitate drug development and reforms to modernize the process and improve safety are discussed. These may result in changes in labeling of already approved drugs. Obstacles such as funding and liability are also discussed.

  16. Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry.

    Science.gov (United States)

    Ciavarella, Anthony B; Khan, Mansoor A; Gupta, Abhay; Faustino, Patrick J

    This U.S. Food and Drug Administration (FDA) laboratory study examines the impact of tablet splitting, the effect of tablet splitters, and the presence of a tablet score on the dose uniformity of two model drugs. Whole tablets were purchased from five manufacturers for amlodipine and six for gabapentin. Two splitters were used for each drug product, and the gabapentin tablets were also split by hand. Whole and split amlodipine tablets were tested for content uniformity following the general chapter of the United States Pharmacopeia (USP) Uniformity of Dosage Units , which is a requirement of the new FDA Guidance for Industry on tablet scoring. The USP weight variation method was used for gabapentin split tablets based on the recommendation of the guidance. All whole tablets met the USP acceptance criteria for the Uniformity of Dosage Units. Variation in whole tablet content ranged from 0.5 to 2.1 standard deviation (SD) of the percent label claim. Splitting the unscored amlodipine tablets resulted in a significant increase in dose variability of 6.5-25.4 SD when compared to whole tablets. Split tablets from all amlodipine drug products did not meet the USP acceptance criteria for content uniformity. Variation in the weight for gabapentin split tablets was greater than the whole tablets, ranging from 1.3 to 9.3 SD. All fully scored gabapentin products met the USP acceptance criteria for weight variation. Size, shape, and the presence or absence of a tablet score can affect the content uniformity and weight variation of amlodipine and gabapentin tablets. Tablet splitting produced higher variability. Differences in dose variability and fragmentation were observed between tablet splitters and hand splitting. These results are consistent with the FDA's concerns that tablet splitting can have an effect on the amount of drug present in a split tablet and available for absorption. Tablet splitting has become a very common practice in the United States and throughout the

  17. First Zika-positive donations in the continental United States.

    Science.gov (United States)

    Galel, Susan A; Williamson, Phillip C; Busch, Michael P; Stanek, Danielle; Bakkour, Sonia; Stone, Mars; Lu, Kai; Jones, Scott; Rossmann, Susan N; Pate, Lisa Lee

    2017-03-01

    Zika virus (ZIKV) has spread in the Americas, including parts of the southern United States, and infection can be associated with serious complications, including congenital brain abnormalities. Probable transfusion transmission of ZIKV has been documented in Brazil. Preemptive testing of blood donations for ZIKV RNA was implemented in southern US states at risk of local transmission using a test approved under a Food and Drug Administration (FDA) investigational new drug application, cobas Zika. Screening was expanded after issuance of an updated FDA guidance. Donations reactive on initial screening were further tested by nucleic acid and antibody tests to determine the donor status. Of 358,786 donations from US states screened by individual donation testing, 23 were initially reactive on cobas Zika. Fourteen of these represented probable ZIKV infection based on reactivity on additional nucleic acid testing or anti-Zika immunoglobulin M. Ten of the 14 donors reported travel to an identified ZIKV-active area within 90 days before donation (median time from end of travel to donation, 25 days; range, 6-71 days). Three donors with travel history also had a potential sexual exposure. Only seven of the 14 donations with probable ZIKV infection were detectable upon 1:6 dilution to simulate minipool testing. The estimated specificity of the cobas Zika test was 99.997%. Screening of donations for ZIKV RNA can interdict ZIKV-infected donors. Donor risk factors include travel more than 4 weeks before donation and sexual exposure. Minipool screening would have detected only 50% of the RNA-positive donations. © 2017 The Authors Transfusion published by Wiley Periodicals, Inc. on behalf of AABB.

  18. Access to benznidazole for Chagas disease in the United States-Cautious optimism?

    Directory of Open Access Journals (Sweden)

    Jonathan D Alpern

    2017-09-01

    Full Text Available Drugs for neglected tropical diseases (NTD are being excessively priced in the United States. Benznidazole, the first-line drug for Chagas disease, may become approved by the Food and Drug Administration (FDA and manufactured by a private company in the US, thus placing it at risk of similar pricing. Chagas disease is an NTD caused by Trypanosoma cruzi; it is endemic to Latin America, infecting 8 million individuals. Human migration has changed the epidemiology causing nonendemic countries to face increased challenges in diagnosing and managing patients with Chagas disease. Only 2 drugs exist with proven efficacy: benznidazole and nifurtimox. Benznidazole has historically faced supply problems and drug shortages, limiting accessibility. In the US, it is currently only available under an investigational new drug (IND protocol from the CDC and is provided free of charge to patients. However, 2 companies have stated that they intend to submit a New Drug Application (NDA for FDA approval. Based on recent history of companies acquiring licensing rights for NTD drugs in the US with limited availability, it is likely that benznidazole will become excessively priced by the manufacturer-paradoxically making it less accessible. However, if the companies can be taken at their word, there may be reason for optimism.

  19. Access to benznidazole for Chagas disease in the United States-Cautious optimism?

    Science.gov (United States)

    Alpern, Jonathan D; Lopez-Velez, Rogelio; Stauffer, William M

    2017-09-01

    Drugs for neglected tropical diseases (NTD) are being excessively priced in the United States. Benznidazole, the first-line drug for Chagas disease, may become approved by the Food and Drug Administration (FDA) and manufactured by a private company in the US, thus placing it at risk of similar pricing. Chagas disease is an NTD caused by Trypanosoma cruzi; it is endemic to Latin America, infecting 8 million individuals. Human migration has changed the epidemiology causing nonendemic countries to face increased challenges in diagnosing and managing patients with Chagas disease. Only 2 drugs exist with proven efficacy: benznidazole and nifurtimox. Benznidazole has historically faced supply problems and drug shortages, limiting accessibility. In the US, it is currently only available under an investigational new drug (IND) protocol from the CDC and is provided free of charge to patients. However, 2 companies have stated that they intend to submit a New Drug Application (NDA) for FDA approval. Based on recent history of companies acquiring licensing rights for NTD drugs in the US with limited availability, it is likely that benznidazole will become excessively priced by the manufacturer-paradoxically making it less accessible. However, if the companies can be taken at their word, there may be reason for optimism.

  20. Retail Deli Slicer Cleaning Frequency--Six Selected Sites, United States, 2012.

    Science.gov (United States)

    Brown, Laura G; Hoover, E Rickamer; Ripley, Danny; Matis, Bailey; Nicholas, David; Hedeen, Nicole; Faw, Brenda

    2016-04-01

    Listeria monocytogenes (Listeria) causes the third highest number of foodborne illness deaths (an estimated 255) in the United States annually, after nontyphoidal Salmonella species and Toxoplasma gondii (1). Deli meats are a major source of listeriosis illnesses, and meats sliced and packaged at retail delis are the major source of listeriosis illnesses attributed to deli meat (4). Mechanical slicers pose cross-contamination risks in delis and are an important source of Listeria cross-contamination. Reducing Listeria contamination of sliced meats in delis will likely reduce Listeria illnesses and outbreaks. Good slicer cleaning practices can reduce this foodborne illness risk. CDC's Environmental Health Specialists Network (EHS-Net) studied how often retail deli slicers were fully cleaned (disassembled, cleaned, and sanitized) at the Food and Drug Administration (FDA) Food Code-specified minimum frequency of every 4 hours and examined deli and staff characteristics related to slicer cleaning frequency. Interviews with staff members in 298 randomly-selected delis in six EHS-Net sites showed that approximately half of delis fully cleaned their slicers less often than FDA's specified minimum frequency. Chain-owned delis and delis with more customers, more slicers, required manager food safety training, food safety-knowledgeable workers, written slicer-cleaning policies, and food safety-certified managers fully cleaned their slicers more frequently than did other types of delis, according to deli managers or workers. States and localities should require deli manager training and certification, as specified in the FDA Food Code. They should also consider encouraging or requiring delis to have written slicer-cleaning policies. Retail food industry leaders can also implement these prevention efforts to reduce risk in their establishments. Because independent and smaller delis had lower frequencies of slicer cleaning, prevention efforts should focus on these types of

  1. FDA regulation of tobacco: blessing or curse for FDA professionals?

    Science.gov (United States)

    O'Reilly, James T

    2009-01-01

    Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.

  2. FDA Acronyms and Abbreviations

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities

  3. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Science.gov (United States)

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

  4. FDA Warns About Stem Cell Therapies

    Science.gov (United States)

    ... Home For Consumers Consumer Updates FDA Warns About Stem Cell Therapies Share Tweet Linkedin Pin it More sharing ... see the boxed section below for more advice. Stem Cell Uses and FDA Regulation The FDA has the ...

  5. High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

    Science.gov (United States)

    Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

    2007-01-01

    Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

  6. Current and future state of FDA-CMS parallel reviews.

    Science.gov (United States)

    Messner, D A; Tunis, S R

    2012-03-01

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians.

  7. Comparison of the FDA and ASCO/CAP Criteria for HER2 Immunohistochemistry in Upper Urinary Tract Urothelial Carcinoma

    Directory of Open Access Journals (Sweden)

    Gilhyang Kim

    2016-11-01

    Full Text Available Background Human epidermal growth factor receptor 2 (HER2 is one of the known oncogenes in urothelial carcinoma. However, the association between HER2 and the prognosis of upper urinary tract urothelial carcinoma (UUTUC has not yet been fully clarified. The aim of this study was to evaluate HER2 expression using the United States Food and Drug Administration (FDA criteria and American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP criteria and compare their prognostic significance in UUTUC. Methods HER2 expression was evaluated in 144 cases of UUTUC by immunohistochemistry (IHC using tissue microarrays. We separately analyzed HER2 expression using the FDA and ASCO/CAP criteria. The IHC results were categorized into low (0, 1+ and high (2+, 3+ groups. Results Using the FDA criteria, 94 cases were negative, 38 cases were 1+, nine cases were 2+, and three cases were 3+. Using the ASCO/CAP criteria, 94 cases were negative, 34 cases were 1+, 13 cases were 2+, and three cases were 3+. Four cases showing 2+ according to the ASCO/CAP criteria were reclassified as 1+ by the FDA criteria. High HER2 expression by both the FDA criteria and ASCO/CAP criteria was significantly associated with International Society of Urological Pathology high grade (p = .001 and p < .001. The high HER2 expression group classified with the FDA criteria showed significantly shorter cancer-specific survival (p = .004, but the HER2 high and low expression groups classified with the ASCO/CAP criteria did not show significant differences (p = .161 in cancer-specific survival. Conclusions HER2 high expression groups were significantly associated with shorter cancer-specific survival, and our study revealed that the FDA criteria are more suitable for determining HER2 expression in UUTUC.

  8. 78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Science.gov (United States)

    2013-03-05

    ... FDA's Product Tracing Web page at http://www.fda.gov/Food/FoodSafety/FSMA/ucm270851.htm . This... Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Request for Comments and... Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food...

  9. Impact of the FDA warning of potential ceftriaxone and calcium interactions on drug use policy in clinical practice.

    Science.gov (United States)

    Esterly, John S; Steadman, Emily; Scheetz, Marc H

    2011-06-01

    In September 2007, the FDA issued an alert recommending that ceftriaxone and calcium-containing solutions should not be administered to any patient within 48 h of each other. Due to the widespread use of ceftriaxone, significant concern was expressed by the greater healthcare community about the warning, which the FDA eventually retracted in April of 2009. We sought to quantify the impact of the warning on healthcare institutions. A survey was administered to the membership of the Society of Infectious Diseases Pharmacists to quantify perceived changes in ceftriaxone use among healthcare institutions across the United States. A survey of Infectious Diseases experts was conducted. Participants were queried for hospital policies/drug use statistics during two times: immediately after the FDA warning and approximately 13 months post warning (preceding the FDA retraction). Related changes in formulary, drug-use policy, and the number of employee hours that were devoted to addressing the FDA warning were assessed. Ninety-four surveys representing 94 hospital systems were included in the analysis. Approximately half (n = 49, 52%) of respondent institutions enacted at least one drug-use policy change based on the warning; one institution removed ceftriaxone from a clinical protocol. Institutions' final interpretations of the warning differed slightly from initial understanding of the warning, and there was an overall minor decrease in the perceived use of ceftriaxone. The majority of those surveyed (n = 70, 74%) estimated that their respective institutions devoted between 1 and 49 employee hours to address the warning. Hospitals with ID pharmacists had minimal changes to ceftriaxone use after the 2007 FDA warning. Specialized pharmacists may be uniquely situated to help hospitals interpret global recommendations locally.

  10. FDA Peanut-Containing Product Recall

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...

  11. The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s.

    Science.gov (United States)

    Shorter, Edward

    2008-01-01

    The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.

  12. Radiation processing in the United States

    International Nuclear Information System (INIS)

    Brynjolfsson, A.

    1986-01-01

    In animal feeding studies, including the huge animal feeding studies on radiation sterilized poultry products irradiated with sterilizing dose of 58 kGy revealed no harmful effects. This finding is corroborated by the very extensive analysis of the radiolytic products, which indicated that the radiolytic products could not in the quantity found in the food be expected to produce any toxic effect. It thus appears to be proven with reasonable certainty that no harm will result from the proposed use of the process. Accordingly, FDA is moving forward with approvals while allowing the required time for hearings and objection. On July 5, 1983 FDA permitted gamma irradiation for control of microbial contamination in dried spices and dehydrated vegetable seasoning at doses up to 10 kGy; on June 19, 1984 the approval was expanded to cover insect infection; and additional seasonings and irradiation of dry or dehydrated enzyme preparations were approved on February 12 and June 4, respectively, 1985. In addition, in July 1985, FDA cleared irradiation of pork products with doses of 0.3 to 1 kGy for eliminating trichinosis. Approvals of other agencies, including Food and Drug Administration, Department of Agriculture, the Nuclear Regulatory Commission, Occupational Safety and Health Administration, Department of Transportation, Environmental Protection Agency, and States and local communities, are usually of a technological nature and can then be obtained if the process is technologically feasible. (Namekawa, K.)

  13. FDA-CDC Antimicrobial Resistance Isolate Bank: a Publicly Available Resource To Support Research, Development, and Regulatory Requirements.

    Science.gov (United States)

    Lutgring, Joseph D; Machado, María-José; Benahmed, Faiza H; Conville, Patricia; Shawar, Ribhi M; Patel, Jean; Brown, Allison C

    2018-02-01

    The FDA-CDC Antimicrobial Resistance Isolate Bank was created in July 2015 as a publicly available resource to combat antimicrobial resistance. It is a curated repository of bacterial isolates with an assortment of clinically important resistance mechanisms that have been phenotypically and genotypically characterized. In the first 2 years of operation, the bank offered 14 panels comprising 496 unique isolates and had filled 486 orders from 394 institutions throughout the United States. New panels are being added. Copyright © 2018 American Society for Microbiology.

  14. 7 CFR 1220.615 - State and United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false State and United States. 1220.615 Section 1220.615... CONSUMER INFORMATION Procedures To Request a Referendum Definitions § 1220.615 State and United States. State and United States include the 50 States of the United States of America, the District of Columbia...

  15. 7 CFR 1220.129 - State and United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false State and United States. 1220.129 Section 1220.129... CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.129 State and United States. The terms State and United States include the 50 States of the United States of America, the District...

  16. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

    Science.gov (United States)

    Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

    2013-01-22

    The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5

  17. Can claims, misleading information, and manufacturing issues regarding dietary supplements be improved in the United States?

    Science.gov (United States)

    Gibson, James E; Taylor, David A

    2005-09-01

    The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

  18. Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

    Science.gov (United States)

    Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E

    2015-10-01

    The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.

  19. Trends in utilization of smoking cessation agents before and after the passage of FDA boxed warning in the United States.

    Science.gov (United States)

    Shah, Drishti; Shah, Anuj; Tan, Xi; Sambamoorthi, Usha

    2017-08-01

    In 2009, the FDA required a black box warning (BBW) on bupropion and varenicline, the two commonly prescribed smoking cessation agents due to reports of adverse neuropsychiatric events. We investigated if there was a decline in use of bupropion and varenicline after the BBW by comparing the percent using these medications before and after BBW. We conducted a retrospective observational study using data from the Medical Expenditure Panel Survey from 2007 to 2014. The study sample consisted of adult smokers, who were advised by their physicians to quit smoking. We divided the time period into "pre-warning", "post-warning: immediate", and "post-warning: late." Unadjusted analysis using chi-square tests and adjusted analyses using logistic regressions were conducted to evaluate the change in bupropion and varenicline use before and after the BBW. Secondary analyses using piecewise regression were also conducted. On an average, 49.04% of smokers were advised by their physicians to quit smoking. We observed a statistically significant decline in varenicline use from 22.1% in year 2007 to 9.23% in 2014 (p valuesmoking by their physicians were less likely to use varenicline in the immediate post-BBW period as compared to pre-BBW period. While the use of varenicline continued to be significantly low in the late post-BBW period (AOR=0.45, 95% CI=0.31-0.64) as compared to the pre-BBW period, the trend in use as seen in piecewise regression remained stable (OR=0.90, 95% CI=0.75-1.06). We did not observe significant differences in bupropion use between the pre- and post-BBW periods. The passage of the FDA boxed warning was associated with a significant decline in the use of varenicline, but not in the use of bupropion. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Regulatory alerts for dietary supplements in Canada and the United States, 2005-13.

    Science.gov (United States)

    Abe, Andrew M; Hein, Darren J; Gregory, Philip J

    2015-06-01

    Dietary supplement regulatory alerts published by the Food and Drug Administration (FDA) and Health Canada were evaluated and characterized. FDA MedWatch and Health Canada websites were reviewed to identify regulatory alerts regarding dietary supplements from January 1, 2005, through December 31, 2013. Alerts were analyzed to identify product characteristics that may be predictive of product quality issues and potential patient harm. A total of 1560 dietary supplement-related regulatory alerts were identified. Of those, 1287 (83%) were identified through Health Canada, and 273 (18%) were identified through FDA MedWatch. The country of origin of dietary supplements associated with regulatory alerts was not provided in most regulatory alerts; however, when their origin was provided, the United States was the most common. Dietary supplements intended for sexual enhancement were the subject of 33% of all regulatory alerts identified. Products purchased online were the most likely to be associated with a regulatory alert. Dietary supplements intended for sexual enhancement, weight loss, and bodybuilding or athletic performance appeared to pose the greatest risk for patient harm due to product contamination with a pharmaceutical such as a phosphodiesterase-5 inhibitor or sibutramine. Analysis of Canadian and U.S. regulatory alerts concerning dietary supplements revealed that more than 80% of the composite alerts were issued by Health Canada. The most common intended uses of supplements for which alerts were issued were sexual enhancement, weight loss, and bodybuilding or athletic performance. The most common reason for alerts was the presence of a pharmaceutical contaminant. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  1. 7 CFR 1209.21 - State and United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false State and United States. 1209.21 Section 1209.21... Definitions § 1209.21 State and United States. (a) State means any of the several States, the District of Columbia, and the Commonwealth of Puerto Rico. (b) United States means collectively the several States of...

  2. The future of food irradiation in the United States

    Energy Technology Data Exchange (ETDEWEB)

    Durante, R W [Food Safeguards Council Inc., Arlington, VA (United States)

    1997-12-01

    According to statistics released by the U.S. Public Health Service, between 50 and 80 million cases of foodbome diseases will be contracted by American consumers every year and as many as 10,000 of those will die as a consequence. The World Health Organization and the Commission on World Hunger have estimated that 25 percent of the world`s food supply is lost to spoilage and infestation. The solution for the twin problems of foodbome disease and hunger is food irradiation. Many food when exposed to ionizing radiation produced by radionuclides or electron beam machines will not only experience extended shelf life but most of the harmful pathogens contained on those foods will be destroyed. Food irradiation has been researched and developed for more than 50 years and this technology has been approved by almost every major government agency, including the FDA, the American Medical Association, and the World Health Organization. Irradiated food has been consumed by military personnel, hospital patients and astronauts in space with absolutely no ill effects. Scientists from every technological discipline have endorsed the safety and reliability of this technology and it is currently being utilized in more than 37 countries. Yet it is not used in the United States and food producers who even think about using it are severely criticized and boycotted by anti-nuclear organizations. What do we see as the future of food irradiation in the United States? Will this technology ever be used here? Will there be a time when consumers can feel confident that all the data and facts have been carefully presented on this important and beneficial technology. This paper discusses some of the history of food irradiation and explores problems facing the food industry and the difficulty getting the right message to the public. It also looks at the industry`s efforts to promote food irradiation commerce in the United States, and examines the role government has played in the development of

  3. The future of food irradiation in the United States

    International Nuclear Information System (INIS)

    Durante, R.W.

    1997-01-01

    According to statistics released by the U.S. Public Health Service, between 50 and 80 million cases of foodbome diseases will be contracted by American consumers every year and as many as 10,000 of those will die as a consequence. The World Health Organization and the Commission on World Hunger have estimated that 25 percent of the world's food supply is lost to spoilage and infestation. The solution for the twin problems of foodbome disease and hunger is food irradiation. Many food when exposed to ionizing radiation produced by radionuclides or electron beam machines will not only experience extended shelf life but most of the harmful pathogens contained on those foods will be destroyed. Food irradiation has been researched and developed for more than 50 years and this technology has been approved by almost every major government agency, including the FDA, the American Medical Association, and the World Health Organization. Irradiated food has been consumed by military personnel, hospital patients and astronauts in space with absolutely no ill effects. Scientists from every technological discipline have endorsed the safety and reliability of this technology and it is currently being utilized in more than 37 countries. Yet it is not used in the United States and food producers who even think about using it are severely criticized and boycotted by anti-nuclear organizations. What do we see as the future of food irradiation in the United States? Will this technology ever be used here? Will there be a time when consumers can feel confident that all the data and facts have been carefully presented on this important and beneficial technology. This paper discusses some of the history of food irradiation and explores problems facing the food industry and the difficulty getting the right message to the public. It also looks at the industry's efforts to promote food irradiation commerce in the United States, and examines the role government has played in the development of

  4. Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

    Science.gov (United States)

    Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.

    2015-01-01

    Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691

  5. 7 CFR 1160.104 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 9 2010-01-01 2009-01-01 true United States. 1160.104 Section 1160.104 Agriculture... Definitions § 1160.104 United States. United States means the 48 contiguous states in the continental United States and the District of Columbia, except that United States means the 50 states of the United States...

  6. 21 CFR 60.34 - FDA action on petitions.

    Science.gov (United States)

    2010-04-01

    ... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... this section or investigate and determine under § 60.36 whether the applicant acted with due diligence during the regulatory review period. FDA will publish its due diligence determination in the Federal...

  7. Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States

    Directory of Open Access Journals (Sweden)

    Mark I. Avigan

    2016-03-01

    Full Text Available In the United States (US, the risk of hepatotoxicity linked to the widespread use of certain herbal products has gained increased attention among regulatory scientists. Based on current US law, all dietary supplements sold domestically, including botanical supplements, are regulated by the Food and Drug Administration (FDA as a special category of foods. Under this designation, regulatory scientists do not routinely evaluate the efficacy of these products prior to their marketing, despite the content variability and phytochemical complexity that often characterizes them. Nonetheless, there has been notable progress in the development of advanced scientific methods to qualitatively and quantitatively measure ingredients and screen for contaminants and adulterants in botanical products when hepatotoxicity is recognized.

  8. State Medicaid Coverage for Tobacco Cessation Treatments and Barriers to Accessing Treatments - United States, 2015-2017.

    Science.gov (United States)

    DiGiulio, Anne; Jump, Zach; Yu, Annie; Babb, Stephen; Schecter, Anna; Williams, Kisha-Ann S; Yembra, Debbie; Armour, Brian S

    2018-04-06

    Cigarette smoking prevalence among Medicaid enrollees (25.3%) is approximately twice that of privately insured Americans (11.8%), placing Medicaid enrollees at increased risk for smoking-related disease and death (1). Medicaid spends approximately $39 billion annually on treating smoking-related diseases (2). Individual, group, and telephone counseling and seven Food and Drug Administration (FDA)-approved medications* are effective in helping tobacco users quit (3). Although state Medicaid coverage of tobacco cessation treatments improved during 2014-2015, coverage was still limited in most states (4). To monitor recent changes in state Medicaid cessation coverage for traditional (i.e., nonexpansion) Medicaid enrollees, the American Lung Association collected data on coverage of a total of nine cessation treatments: individual counseling, group counseling, and seven FDA-approved cessation medications † in state Medicaid programs during July 1, 2015-June 30, 2017. The American Lung Association also collected data on seven barriers to accessing covered treatments, such as copayments and prior authorization. As of June 30, 2017, 10 states covered all nine of these treatments for all enrollees, up from nine states as of June 30, 2015; of these 10 states, Missouri was the only state to have removed all seven barriers to accessing these cessation treatments. State Medicaid programs that cover all evidence-based cessation treatments, remove barriers to accessing these treatments, and promote covered treatments to Medicaid enrollees and health care providers would be expected to reduce smoking, smoking-related disease, and smoking-attributable federal and state health care expenditures (5-7).

  9. The "natural" aversion: the FDA's reluctance to define a leading food-industry marketing claim, and the pressing need for a workable rule.

    Science.gov (United States)

    Farris, April L

    2010-01-01

    As of 2009, the "natural foods" industry has become a 22.3 billion dollar giant and "all-natural" is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term "natural" through rulemaking. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term "natural," and FDA has abandoned efforts to define "natural" through rulemaking in the face of more pressing priorities. In absence of any governing federal standard, consumer advocacy groups and warring food industries have attempted to define "natural" to fit their preferences through high-stakes litigation of state law claims, leaving courts free to apply diverging standards without the expertise of FDA. Recent case law from federal district courts and the Supreme Court leaves little hope that FDA's current policy statement will preempt state law causes of action. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rulemaking to define the term "natural." This paper concludes by sketching potential formulations for such a rule based on FDA's previous successful rule-making ventures and standards used by natural foods retailers.

  10. Real-World Evidence, Public Participation, and the FDA.

    Science.gov (United States)

    Schwartz, Jason L

    2017-11-01

    For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.

  11. Tobacco Product Use Among Adults - United States, 2015.

    Science.gov (United States)

    Phillips, Elyse; Wang, Teresa W; Husten, Corinne G; Corey, Catherine G; Apelberg, Benjamin J; Jamal, Ahmed; Homa, David M; King, Brian A

    2017-11-10

    Tobacco use remains the leading cause of preventable disease and death in the United States (1). Despite declining cigarette smoking prevalence among U.S. adults, shifts in the tobacco product landscape have occurred in recent years (2,3). Previous estimates of tobacco product use among U.S. adults were obtained from the National Adult Tobacco Survey, which ended after the 2013-2014 cycle. This year, CDC and the Food and Drug Administration (FDA) assessed the most recent national estimates of tobacco product use among adults aged ≥18 years using, for the first time, data from the 2015 National Health Interview Survey (NHIS), an annual, nationally representative, in-person survey of the noninstitutionalized U.S. civilian population. The 2015 NHIS adult core questionnaire included 33,672 adults aged ≥18 years, reflecting a 55.2% response rate. Data were weighted to adjust for differences in selection probability and nonresponse, and to provide nationally representative estimates. In 2015, 20.1 % of U.S. adults currently (every day or some days) used any tobacco product, 17.6% used any combustible tobacco product, and 3.9% used ≥2 tobacco products. By product, 15.1% of adults used cigarettes; 3.5% used electronic cigarettes (e-cigarettes); 3.4% used cigars, cigarillos, or filtered little cigars; 2.3% used smokeless tobacco; and 1.2% used regular pipes, water pipes, or hookahs.* Current use of any tobacco product was higher among males; persons aged product was 47.2% among adults with serious psychological distress compared with 19.2% among those without serious psychological distress. Proven population-level interventions that focus on the diversity of tobacco product use are important to reducing tobacco-related disease and death in the United States (1).

  12. 31 CFR 800.225 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 800.225 Section 800... TAKEOVERS BY FOREIGN PERSONS Definitions § 800.225 United States. The term United States or U.S. means the United States of America, the States of the United States, the District of Columbia, and any commonwealth...

  13. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

    Directory of Open Access Journals (Sweden)

    Nguyen Diane

    2013-01-01

    Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by

  14. 7 CFR 1150.106 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 9 2010-01-01 2009-01-01 true United States. 1150.106 Section 1150.106 Agriculture... Order Definitions § 1150.106 United States. United States means the 48 contiguous States in the continental United States. ...

  15. Malaria Treatment (United States)

    Science.gov (United States)

    ... Providers, Emergency Consultations, and General Public. Contact Us Malaria Treatment (United States) Recommend on Facebook Tweet Share Compartir Treatment of Malaria: Guidelines For Clinicians (United States) Download PDF version ...

  16. Lessons to be Learned from Recent Biosafety Incidents in the United States.

    Science.gov (United States)

    Weiss, Shay; Yitzhaki, Shmuel; Shapira, Shmuel C

    2015-05-01

    During recent months, the Centers for Disease Control and Prevention (CDC) announced the occurrence of three major biosafety incidents, raising serious concern about biosafety and biosecurity guideline implementation in the most prestigious agencies in the United States: the CDC, the National Institutes of Health (NIH) and the Federal Drug Administration (FDA). These lapses included: a) the mishandling of Bacillus anthracis spores potentially exposing dozens of employees to anthrax; b) the shipment of low pathogenic influenza virus unknowingly cross-contaminated with a highly pathogenic strain; and c) an inventory lapse of hundreds of samples of biological agents, including six vials of variola virus kept in a cold storage room for decades, unnoticed. In this review we present the published data on these events, report the CDC inquiry's main findings, and discuss the key lessons to be learnt to ensure safer scientific practice in biomedical and microbiological service and research laboratories.

  17. EVA geen FDA

    NARCIS (Netherlands)

    Folbert, J.P.; Dagevos, J.C.

    2001-01-01

    De oprichting van een Europese Voedselautoriteit die in 2002 operationeel moet zijn. Velen zien hierin een evenbeeld van de Amerikaanse FDA (Food and Drug Administration). Deze instantie werkt echter niet zo ideaal als vaak wordt voorgesteld. Het belangrijkste verschil tussen beide instanties is de

  18. 7 CFR 65.255 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false United States. 65.255 Section 65.255 Agriculture..., PEANUTS, AND GINSENG General Provisions Definitions § 65.255 United States. United States means the 50... United States. ...

  19. 7 CFR 1250.308 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1250.308 Section 1250.308 Agriculture... Research and Promotion Order Definitions § 1250.308 United States. United States means the 48 contiguous States of the United States of America and the District of Columbia. ...

  20. 7 CFR 1205.23 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1205.23 Section 1205.23 Agriculture... Procedures for Conduct of Sign-up Period Definitions § 1205.23 United States. The term United States means the 50 states of the United States of America. Procedures ...

  1. 31 CFR 597.318 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 597.318 Section 597... General Definitions § 597.318 United States. The term United States means the United States, its territories, states, commonwealths, districts, and possessions, and all areas under the jurisdiction or...

  2. 7 CFR 1219.26 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1219.26 Section 1219.26 Agriculture..., AND INFORMATION Hass Avocado Promotion, Research, and Information Order Definitions § 1219.26 United States. United States means collectively the several 50 States of the United States, the District of...

  3. 7 CFR 1212.31 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1212.31 Section 1212.31 Agriculture..., Consumer Education, and Industry Information Order Definitions § 1212.31 United States. “United States... territories and possessions of the United States. ...

  4. 22 CFR 120.13 - United States.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false United States. 120.13 Section 120.13 Foreign... United States. United States, when used in the geographical sense, includes the several states, the Commonwealth of Puerto Rico, the insular possessions of the United States, the District of Columbia, the...

  5. 31 CFR 592.311 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 592.311 Section 592... § 592.311 United States. The term United States, when used in the geographic sense, means the several States, the District of Columbia, and any commonwealth, territory, or possession of the United States. ...

  6. FDA Drug Label Data

    Data.gov (United States)

    U.S. Department of Health & Human Services — This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number...

  7. FDA and the Chemical Brain Drainers

    DEFF Research Database (Denmark)

    Grandjean, Philippe

    2017-01-01

    Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907......Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907...

  8. 7 CFR 1205.313 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1205.313 Section 1205.313 Agriculture... Research and Promotion Order Definitions § 1205.313 United States. United States means the 50 States of the United States of America. [31 FR 16758, Dec. 31, 1966. Redesignated at 56 FR 64472, Dec. 10, 1991] ...

  9. 31 CFR 542.310 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 542.310 Section 542.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF....310 United States. The term United States means the United States, its territories and possessions...

  10. 31 CFR 548.310 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 548.310 Section 548.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF....310 United States. The term United States means the United States, its territories and possessions...

  11. 31 CFR 546.310 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 546.310 Section 546.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF....310 United States. The term United States means the United States, its territories and possessions...

  12. 31 CFR 586.318 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 586.318 Section 586...) KOSOVO SANCTIONS REGULATIONS General Definitions § 586.318 United States. The term United States means the United States, its territories and possessions, and all areas under the jurisdiction or authority...

  13. 31 CFR 537.318 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 537.318 Section 537.318 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF....318 United States. The term United States means the United States, its territories and possessions...

  14. 31 CFR 585.316 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 585.316 Section 585.316 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... General Definitions § 585.316 United States. The term United States means the United States, its...

  15. 31 CFR 575.319 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 575.319 Section 575.319 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF....319 United States. The term United States means the United States, its territories and possessions...

  16. 31 CFR 539.312 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 539.312 Section 539.312 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... General Definitions § 539.312 United States. The term United States means the United States, its...

  17. 31 CFR 551.309 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 551.309 Section 551.309 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF....309 United States. The term United States means the United States, its territories and possessions...

  18. 31 CFR 587.310 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 587.310 Section 587...) MILOSEVIC SANCTIONS REGULATIONS General Definitions § 587.310 United States. The term United States means the United States, its territories and possessions, and all areas under the jurisdiction or authority...

  19. 31 CFR 547.310 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 547.310 Section 547.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... General Definitions § 547.310 United States. The term United States means the United States, its...

  20. FDA Recognized Consensus Standards

    Data.gov (United States)

    U.S. Department of Health & Human Services — This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information...

  1. 31 CFR 598.317 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 598.317 Section 598.317 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... Definitions § 598.317 United States. The term United States means the United States, its territories and...

  2. 31 CFR 596.312 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 596.312 Section 596.312 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... General Definitions § 596.312 United States. The term United States means the United States, including its...

  3. 31 CFR 538.314 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 538.314 Section 538.314 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... § 538.314 United States. The term United States means the United States, its territories and possessions...

  4. 31 CFR 543.310 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 543.310 Section 543.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... Definitions § 543.310 United States. The term United States means the United States, its territories and...

  5. 31 CFR 594.313 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 594.313 Section 594.313 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... Definitions § 594.313 United States. The term United States means the United States, its territories and...

  6. 31 CFR 588.310 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 588.310 Section 588.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... Definitions § 588.310 United States. The term United States means the United States, its territories and...

  7. 31 CFR 536.315 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 536.315 Section 536.315 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... Definitions § 536.315 United States. The term United States means the United States, its territories and...

  8. 31 CFR 544.310 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 544.310 Section 544.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... REGULATIONS General Definitions § 544.310 United States. The term United States means the United States, its...

  9. 31 CFR 545.313 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 545.313 Section 545.313 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... Definitions § 545.313 United States. The term United States means the United States, its territories and...

  10. 31 CFR 595.314 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 595.314 Section 595.314 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... § 595.314 United States. The term United States means the United States, its territories and possessions...

  11. 31 CFR 560.307 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 560.307 Section 560.307 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... § 560.307 United States. The term United States means the United States, including its territories and...

  12. 31 CFR 593.311 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 593.311 Section 593.311 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... REGULATIONS General Definitions § 593.311 United States. The term United States means the United States, its...

  13. 31 CFR 541.310 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 541.310 Section 541.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... § 541.310 United States. The term United States means the United States, its territories and possessions...

  14. 31 CFR 540.313 - United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 540.313 Section 540.313 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... REGULATIONS General Definitions § 540.313 United States. The term United States means the United States, its...

  15. A regulatory perspective on the abuse potential evaluation of novel stimulant drugs in the United States.

    Science.gov (United States)

    Calderon, Silvia N; Klein, Michael

    2014-12-01

    In the United States of America (USA), the abuse potential assessment of a drug is performed as part of the safety evaluation of a drug under development, and to evaluate if the drug needs to be subject to controls that would minimize the abuse of the drug once on the market. The assessment of the abuse potential of new drugs consists of a scientific and medical evaluation of all data related to abuse of the drug. This paper describes the regulatory framework for evaluating the abuse potential of new drugs, in general, including novel stimulants. The role of the United States Food and Drug Administration (FDA) in the evaluation of the abuse potential of drugs, and its role in drug control are also discussed. A definition of abuse potential, an overview of the currently accepted approaches to evaluating the abuse potential of a drug, as well as a description of the criteria that applies when recommending a specific level of control (i.e., a Schedule) for a drug under the Controlled Substances Act (CSA). This article is part of the Special Issue entitled 'CNS Stimulants'. Published by Elsevier Ltd.

  16. 21 CFR 60.10 - FDA assistance on eligibility.

    Science.gov (United States)

    2010-04-01

    ... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in... in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852...

  17. 7 CFR 1206.23 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1206.23 Section 1206.23 Agriculture... INFORMATION Mango Promotion, Research, and Information Order Definitions § 1206.23 United States. United... Rico, and the territories and possessions of the United States. ...

  18. 7 CFR 1215.20 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1215.20 Section 1215.20 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... United States. United States means all of the States. Popcorn Board ...

  19. FDA: polyurethane condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.

    Science.gov (United States)

    1995-02-01

    The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.

  20. 7 CFR 1280.127 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1280.127 Section 1280.127 Agriculture... INFORMATION ORDER Lamb Promotion, Research, and Information Order Definitions § 1280.127 United States. United States means collectively the 50 States and the District of Columbia. ...

  1. Challenging the FDA's authority to regulate autologous adult stem cells for therapeutic use: Celltex therapeutics' partnership with RNL Bio, substantial medical risks, and the implications of United States v. Regenerative Sciences.

    Science.gov (United States)

    Drabiak-Syed, Katherine

    2013-01-01

    This Article examines the convergence of three corporations that have attempted to capitalize on translating emerging research into clinical procedures by manufacturing and facilitating the process for patients to obtain mesenchymal stem cell (MSC) injections. Although the Food and Drug Administration (FDA) has asserted its authority to regulate somatic cell therapy products like MSCs under the Public Health Service Act and the Food, Drug, and Cosmetic Act, some manufacturers have attempted to circumvent FDA regulation through various mechanisms and argue that their products do not fall within the definition of a biological product or drug. However, scientific knowledge of using MSCs for clinical therapy remains in its infancy, and MSCs pose a number of serious risks to patients. This Article focuses on the development of Celltex, a company based in Sugar Land, Texas that manufactures and facilitates the injection of autologous MSCs; RNL Bio, a company that licenses its operations technology to Celltex; and Regenerative Sciences, a company based in Broomfield, Colorado that was recently involved in litigation with the FDA. Corporate circumvention of intended regulatory oversight exposes patients to potentially inefficacious products that could contribute to serious medical injuries such as viruses, myocardial infarction, cancer, or death.

  2. Subarray-based FDA radar to counteract deceptive ECM signals

    Science.gov (United States)

    Abdalla, Ahmed; Wang, Wen-Qin; Yuan, Zhao; Mohamed, Suhad; Bin, Tang

    2016-12-01

    In recent years, the frequency diverse array (FDA) radar concept has attracted extensive attention, as it may benefit from a small frequency increment, compared to the carrier frequency across the array elements and thereby achieve an array factor that is a function of the angle, the time, and the range which is superior to the conventional phase array radar (PAR). However, limited effort on the subject of FDA in electronic countermeasure scenarios, especially in the presence of mainbeam deceptive jamming, has been published. Basic FDA is not desirable for anti-jamming applications, due to the range-angle coupling response of targets. In this paper, a novel method based on subarrayed FDA signal processing is proposed to counteract deceptive ECM signals. We divide the FDA array into multiple subarrays, each of which employs a distinct frequency increment. As a result, in the subarray-based FDA, the desired target can be distinguished at subarray level in joint range-angle-Doppler domain by utilizing the fact that the jammer generates false targets with the same ranges to each subarray without reparations. The performance assessment shows that the proposed solution is effective for deceptive ECM targets suppression. The effectiveness is verified by simulation results.

  3. 7 CFR 1260.108 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1260.108 Section 1260.108 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... Promotion and Research Order Definitions § 1260.108 United States. United States means the 50 States and the...

  4. 7 CFR 1221.32 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1221.32 Section 1221.32 Agriculture... INFORMATION ORDER Sorghum Promotion, Research, and Information Order Definitions § 1221.32 United States. United States or U.S. means collectively the 50 States, the District of Columbia, the Commonwealth of...

  5. 7 CFR 1216.30 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1216.30 Section 1216.30 Agriculture... INFORMATION ORDER Peanut Promotion, Research, and Information Order Definitions § 1216.30 United States. United States means collectively the 50 states, the District of Columbia, the Commonwealth of Puerto Rico...

  6. 7 CFR 1218.22 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1218.22 Section 1218.22 Agriculture... INFORMATION ORDER Blueberry Promotion, Research, and Information Order Definitions § 1218.22 United States. United States means collectively the 50 states, the District of Columbia, the Commonwealth of Puerto Rico...

  7. 7 CFR 1210.315 - United States.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1210.315 Section 1210.315 Agriculture... PLAN Watermelon Research and Promotion Plan Definitions § 1210.315 United States. United States means each of the several States and the District of Columbia. [60 FR 10797, Feb. 28, 1995] National...

  8. Regulating nanomedicine - can the FDA handle it?

    Science.gov (United States)

    Bawa, Raj

    2011-05-01

    There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle

  9. 76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

    Science.gov (United States)

    2011-01-07

    ...] FDA Transparency Initiative: Improving Transparency to Regulated Industry AGENCY: Food and Drug... the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The...

  10. Biosimilars: A consideration of the regulations in the United States and European union.

    Science.gov (United States)

    Daller, Justin

    2016-04-01

    Biosimilars are defined as biological products that are highly similar to a reference product, notwithstanding minor differences in clinically inactive components. Biosimilars show no clinically meaningful differences in safety, purity, and potency of the product in comparison to the reference product. With the ever looming patent expiry of some major high cost biologics, biosimilar production is becoming ever more lucrative to companies. Europe (EU) set the precedent, followed by the United States (US) in early 2012, for the approval process for biosimilars. Therefore, the purpose of this paper is to explore the nature of the regulatory processes in the US and EU and to determine the requirements of each in the approval process of a biosimilar. The current Food and Drug Administration (FDA) and European Medicines Agency's (EMA) guidance documents for biosimilars were reviewed revealing a need for further clarifications, as well as specifically addressing Celltrion's and Sandoz's application for approval for the biosimilars infliximab and filgrastim, respectively. Currently, the FDA and EMA focus on comparability in terms of the clinical, pharmacokinetic (PK)/pharmacodynamic (PD), preclinical, biological activity, and physiochemical characterization results, as well as requiring a robust and consistent manufacturing process. Both the EU and US have prepared guidance documents for biosimilars that will result in biotherapeutics that are as safe and efficacious as the innovator product but the necessity exists to globally harmonize international nonproprietary naming nomenclature and clarify how the concept of pharmacovigilance, extrapolation, and interchangeability will be handled and regulated in the future. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. 21 CFR 312.86 - Focused FDA regulatory research.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency...

  12. Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.

    Science.gov (United States)

    Sage, Adam; Blalock, Susan J; Carpenter, Delesha

    This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. A Hypothetical Case: UNITED STATES v. Clonaid

    OpenAIRE

    Wu, Chun-Ying

    2003-01-01

    The government took the place of FDA to bring a suit against Clonaid Company to grant preliminary injunction to enjoin defendant Clonaid Company from cloning human beings and using human embryos in SCNT research in violation of the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. In response to government¡¦s motion for injunction, the defendant, Clonaid, first challenges the statutory authority of FDA to regulate human cloning. Then Clonaid ass...

  14. Toll Facilities in the United States - Toll Facilities in the United States

    Data.gov (United States)

    Department of Transportation — Biennial report containing selected information on toll facilities in the United States that has been provided to FHWA by the States and/or various toll authorities...

  15. Oil Vulnerabilities and United States Strategy

    Science.gov (United States)

    2007-02-08

    Mazda, Mercedes - Benz , Ford, Mercury, and Nissan offer flexible fuel vehicles in the United States. Ethanol is currently produced in the United States...USAWC STRATEGY RESEARCH PROJECT OIL VULNERABILITIES AND UNITED STATES STRATEGY by Colonel Shawn P. Walsh...Colleges and Schools, 3624 Market Street, Philadelphia, PA 19104, (215) 662-5606. The Commission on Higher Education is an institutional accrediting

  16. Gottlieb, the FDA and dumbing down medicine

    OpenAIRE

    Robbins RA

    2017-01-01

    No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some wh...

  17. 31 CFR 596.313 - United States person.

    Science.gov (United States)

    2010-07-01

    ... FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY TERRORISM LIST GOVERNMENTS SANCTIONS REGULATIONS General Definitions § 596.313 United States person. The term United States person means any United States...

  18. Nuclear development in the United States

    International Nuclear Information System (INIS)

    Brewer, S.

    1983-01-01

    The history of the nuclear development in the United States has been one of international cooperation relations so far. The United States is to offer the technical information on atomic energy utilization to foreign countries in exchange for the guarantee that they never attempt to have or develop nuclear weapons. Actually, the United States has supplied the technologies on nuclear fuel cycle and other related fields to enable other countries to achieve economical and social progress. The Department of Energy clarified the public promise of the United States regarding the idea of international energy community. The ratio of nuclear power generation to total electric power supply in the United States exceeded 12%, and will exceed 20% by 1990. Since 1978, new nuclear power station has not been ordered, and some of the contracted power stations were canceled. The atomic energy industry in the United States prospered at the beginning of 1970s, but lost the spirit now, mainly due to the institutional problems rather than the technical ones. As the policy of the government to eliminate the obstacles, the improvement of the procedure for the permission and approval, the establishment of waste disposal capability, the verification of fast breeder reactor technology and the promotion of commercial fuel reprocessing were proposed. The re-establishment of the United States as the reliable supplier of atomic energy service is the final aim. (Kako, I.)

  19. 78 FR 70274 - United States Travel and Tourism Advisory Board: Meeting of the United States Travel and Tourism...

    Science.gov (United States)

    2013-11-25

    ... DEPARTMENT OF COMMERCE International Trade Administration United States Travel and Tourism Advisory Board: Meeting of the United States Travel and Tourism Advisory Board AGENCY: International Trade... the schedule and agenda for an open meeting of the United States Travel and Tourism Advisory Board...

  20. 78 FR 3398 - United States Travel and Tourism Advisory Board: Meeting of the United States Travel and Tourism...

    Science.gov (United States)

    2013-01-16

    ... DEPARTMENT OF COMMERCE International Trade Administration United States Travel and Tourism Advisory Board: Meeting of the United States Travel and Tourism Advisory Board AGENCY: International Trade... the schedule and agenda for an open meeting of the United States Travel and Tourism Advisory Board...

  1. 78 FR 18234 - Service of Process on Manufacturers; Manufacturers Importing Electronic Products Into the United...

    Science.gov (United States)

    2013-03-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1005 [Docket No. FDA-2007-N-0091; (formerly 2007N-0104)] Service of Process on Manufacturers; Manufacturers Importing Electronic Products Into the United States; Agent Designation; Change of Address AGENCY: Food and Drug...

  2. United States Food and Drug Administration and Department of Defense shelf-life extension program of pharmaceutical products: progress and promise.

    Science.gov (United States)

    Khan, Saeed R; Kona, Ravikanth; Faustino, Patrick J; Gupta, Abhay; Taylor, Jeb S; Porter, Donna A; Khan, Mansoor

    2014-05-01

    The Department of Defense (DoD)-United States Food and Drug Administration (FDA) shelf-life extension program (SLEP) was established in 1986 through an intra-agency agreement between the DoD and the FDA to extend the shelf life of product nearing expiry. During the early stages of development, special attention was paid to program operation, labeling requirements, and the cost benefits associated with this program. In addition to the substantial cost benefits, the program also provides the FDA's Center for Drug Evaluation and Research with significant scientific understanding and pharmaceutical resource. As a result of this unique resource, numerous regulatory research opportunities to improve public health present themselves from this distinctive scientific database, which includes examples of products shelf life, their long-term stability issues, and various physical and chemical tests to identify such failures. The database also serves as a scientific resource for mechanistic understanding and identification of test failures leading to the development of new formulations or more robust packaging. It has been recognized that SLEP is very important in maintaining both national security and public welfare by confirming that the stockpiled pharmaceutical products meet quality standards after the "expiration date" assigned by the sponsor. SLEP research is an example of regulatory science that is needed to best ensure product performance past the original shelf life. The objective of this article is to provide a brief history and background and most importantly the public health benefits of the SLEP. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  3. Gottlieb, the FDA and dumbing down medicine

    Directory of Open Access Journals (Sweden)

    Robbins RA

    2017-04-01

    Full Text Available No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1. Others praised Gottlieb as the right man to lead the FDA. As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2. Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight …

  4. United States housing, 2012

    Science.gov (United States)

    Delton Alderman

    2013-01-01

    Provides current and historical information on housing market in the United States. Information includes trends for housing permits and starts, housing completions for single and multifamily units, and sales and construction. This report will be updated annually.

  5. 42 CFR 405.203 - FDA categorization of investigational devices.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational.../investigational (Category A) or non-experimental/investigational (Category B). (c) CMS uses the categorization of...

  6. FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...

  7. 31 CFR 500.520 - Payments from accounts of United States citizens in employ of United States in foreign countries...

    Science.gov (United States)

    2010-07-01

    ... States citizens in employ of United States in foreign countries and certain other persons. 500.520..., Authorizations and Statements of Licensing Policy § 500.520 Payments from accounts of United States citizens in employ of United States in foreign countries and certain other persons. (a) Banking institutions within...

  8. 31 CFR 515.520 - Payments from accounts of United States citizens in employ of United States in foreign countries...

    Science.gov (United States)

    2010-07-01

    ... States citizens in employ of United States in foreign countries and certain other persons. 515.520..., Authorizations, and Statements of Licensing Policy § 515.520 Payments from accounts of United States citizens in employ of United States in foreign countries and certain other persons. (a) Banking institutions within...

  9. Understanding the role of the news media in HPV vaccine uptake in the United States: Synthesis and commentary.

    Science.gov (United States)

    Gollust, Sarah E; LoRusso, Susan M; Nagler, Rebekah H; Fowler, Erika Franklin

    2016-06-02

    Vaccination rates for the human papillomavirus (HPV) vaccine fall below targets and only 2 states and the District of Columbia require the vaccine for middle school-age children. Messages conveyed through news media-to parents, providers, policymakers, and the general public-may contribute to sluggish vaccination rates and policy action. In this commentary, we review the findings from 13 published studies of news media coverage of the HPV vaccine in the United States since FDA licensure in 2006. We find 2 important themes in news coverage: a rising focus on political controversy and a consistent emphasis on the vaccine as for girls, even beyond the point when the vaccine was recommended for boys. These political and gendered messages have consequences for public understanding of the vaccine. Future research should continue to monitor news media depictions of the HPV vaccine to assess whether political controversy will remain a pronounced theme of coverage or whether the media ultimately depict the vaccine as a routine public health service.

  10. TRAINING OF THE STATE PRESIDENT'S UNIT

    African Journals Online (AJOL)

    The primary function of the State President's Unit is to protect the head of state - not his person as is generally believed, but his authority over the state. Ironically, the ceremonial performances of the State President's Unit lead people to believe that they are only capable of doing drill exer- cises. However, upon investigating.

  11. Healthy public relations: the FDA's 1930s legislative campaign.

    Science.gov (United States)

    Kay, G

    2001-01-01

    In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more.

  12. Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models.

    Science.gov (United States)

    Uebbing, Lukas; Klumpp, Lukas; Webster, Gregory K; Löbenberg, Raimar

    2017-01-01

    Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR) formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP) were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning) impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is DPP controlled, disintegration, intrinsic dissolution and dissolution testing were performed in conventional and disintegration impacting media (DIM). Tablet disintegration was affected by DIM and model fitting to the Korsmeyer-Peppas equation showed a growing effect of the formulation in DIM. DDDPlus was able to predict tablet dissolution and the intrinsic dissolution profiles in conventional media and DIM. The study showed that disintegration has to occur before DPP-dependent dissolution can happen. The study suggests that

  13. Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.

    Science.gov (United States)

    Ronquillo, Jay G; Zuckerman, Diana M

    2017-09-01

    Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review

  14. 31 CFR 515.334 - United States national.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States national. 515.334 Section 515.334 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE... of the United States, and which has its principal place of business in the United States. [61 FR...

  15. 7 CFR 1212.32 - United States Customs Service.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States Customs Service. 1212.32 Section 1212... § 1212.32 United States Customs Service. “United States Customs Service” or “Customs” means the United States Customs and Border Protection, an agency of the Department of Homeland Security. Honey Packers and...

  16. First use of halothane in the United States, C. Ronald Stephen, M.D. (1916-2006).

    Science.gov (United States)

    Giesecke, Adolph H

    2008-01-01

    Anesthesia is one of the most valued discoveries in all of history. Almost immediately after the first public demonstration of ether anesthesia, a search for a better drug began. Ether, despite its flammability, persisted as the primary inhalation agent for over a hundred years. The breakthrough came with the introduction of a non-flammable volatile anesthetic called halothane in 1955. The drug was approved by the FDA in 1958 and quickly became the most commonly used agent in the United States. It was a quantum leap forward in the safety of anesthetic drugs. It became obsolete in 1988 because of hepatotoxicity. Three eminent anesthesiologists: Drs. Abajian of Vermont, Siker of Pittsburgh and Stephen of Duke could have been the first to use halothane in the USA. My review of the documents and writings of the three confirm that Dr. C. Ronald Stephen of Duke University was indeed the first to use and publish on halothane anesthesia in the USA.

  17. Incentives for orphan drug research and development in the United States.

    Science.gov (United States)

    Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Szeinbach, Sheryl L; Visaria, Jay

    2008-12-16

    The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during the study period. The FDA listed 1,793 orphan designations and 322 approvals between 1983 and 2007. Cancer was the main group of diseases targeted for orphan approvals. Eighty-three companies concentrated 67.7% of the total orphan NMEs approvals. The average time from orphan designation to FDA approval was 4.0 +/- 3.3 years (mean +/- standard deviation). The average maximum effective patent and market exclusivity life was 11.7 +/- 5.0 years for orphan NME. OD market exclusivity increased the average maximum effective patent and market exclusivity life of ODs by 0.8 years. Public programs, federal regulations, and policies support orphan drugs R&D. Grants, research design support, FDA fee waivers, tax incentives, and orphan drug market exclusivity are the main incentives for orphan drug R&D. Although the 7-year orphan drug market exclusivity provision had a positive yet relatively modest overall effect on effective patent and market exclusivity life, economic incentives and public support mechanisms provide a platform for continued orphan drug development for a highly specialized market.

  18. Nuclear power in the United States

    International Nuclear Information System (INIS)

    Johnston, J.B.

    1985-01-01

    All over the world except in the United States, nuclear energy is a low cost, secure, environmentally acceptable form of energy. In the United States, civilian nuclear power is dead. 112 nuclear power plants have been abandoned or cancelled in the last decade, and there has been no new order for nuclear plants since 1978. It will be fortunate to have 125 operating nuclear plants in the United States in the year 2000. There are almost 90 completed nuclear power plants and about 45 under construction in the United States, but several of those under construction will eventually be abandoned. About 20 % of the electricity in the United States will be generated by nuclear plants in 2000 as compared with 13 % supplied in the last year. Under the present regulatory and institutional arrangement, American electric utilities would not consider to order a new nuclear power plant. Post-TMI nuclear plants became very expensive, and there is also ideological opposition to nuclear power. Coal-firing plants are also in the similar situation. The uncertainty about electric power demand, the cost of money, the inflation of construction cost and regulation caused the situation. (Kako, I.)

  19. Teen Pregnancy in the United States

    Science.gov (United States)

    ... United States: the contribution of abstinence and improved contraceptive use. Am J Public Health. 2007;97(1):150-6. Lindberg LD, Santelli JS, Desai, S. Understanding the Decline in Adolescent Fertility in the United States, 2007–2012. J ...

  20. Immigration Enforcement Within the United States

    Science.gov (United States)

    2006-04-06

    Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Policy Issues...Remained in the United States, (Washington: Center for Immigration Studies, May 2002). Immigration Enforcement Within the United States Introduction ...interior enforcement lack a border component. For example, fugitive taskforces, investigations of alien slavery and sweatshops , and employer sanctions do

  1. Tobacco use among middle and high school students - United States, 2011-2014.

    Science.gov (United States)

    Arrazola, René A; Singh, Tushar; Corey, Catherine G; Husten, Corinne G; Neff, Linda J; Apelberg, Benjamin J; Bunnell, Rebecca E; Choiniere, Conrad J; King, Brian A; Cox, Shanna; McAfee, Tim; Caraballo, Ralph S

    2015-04-17

    Tobacco use and addiction most often begin during youth and young adulthood. Youth use of tobacco in any form is unsafe. To determine the prevalence and trends of current (past 30-day) use of nine tobacco products (cigarettes, cigars, smokeless tobacco, e-cigarettes, hookahs, tobacco pipes, snus, dissolvable tobacco, and bidis) among U.S. middle (grades 6-8) and high school (grades 9-12) students, CDC and the Food and Drug Administration (FDA) analyzed data from the 2011-2014 National Youth Tobacco Surveys (NYTS). In 2014, e-cigarettes were the most commonly used tobacco product among middle (3.9%) and high (13.4%) school students. Between 2011 and 2014, statistically significant increases were observed among these students for current use of both e-cigarettes and hookahs (pstudents continue to be exposed to harmful tobacco product constituents, including nicotine. Nicotine exposure during adolescence, a critical window for brain development, might have lasting adverse consequences for brain development, causes addiction, and might lead to sustained tobacco use. For this reason, comprehensive and sustained strategies are needed to prevent and reduce the use of all tobacco products among youths in the United States.

  2. United States advanced technologies

    International Nuclear Information System (INIS)

    Longenecker, J.R.

    1985-01-01

    In the United States, the advanced technologies have been applied to uranium enrichment as a means by which it can be assured that nuclear fuel cost will remain competitive in the future. The United States is strongly committed to the development of advanced enrichment technology, and has brought both advanced gas centrifuge (AGC) and atomic vapor laser isotope separation (AVLIS) programs to a point of significant technical refinement. The ability to deploy advanced technologies is the basis for the confidence in competitive future price. Unfortunately, the development of advanced technologies is capital intensive. The year 1985 is the key year for advanced technology development in the United States, since the decision on the primary enrichment technology for the future, AGC or AVLIS, will be made shortly. The background on the technology selection process, the highlights of AGC and AVLIS programs and the way to proceed after the process selection are described. The key objective is to maximize the sales volume and minimize the operating cost. This will help the utilities in other countries supply low cost energy on a reliable, long term basis. (Kako, I.)

  3. The United States and the Arab Gulf Monarchies

    International Nuclear Information System (INIS)

    Kechichian, J.A.

    1999-01-01

    The United States has enduring strategic interests in the Persian Gulf region. To understand these interests and the Usa policy towards the Arab Gulf Monarchies, the french institute of international relations (IFRI) proposes this document. The following chapters are detailed: the United States and the Arab Gulf Monarchies, overview, Chief Unites States Objective: Access to oil, re-evaluating United States Foreign Policy in the Gulf, the second term (Usa strategy). (A.L.B.)

  4. FDA Approves First Therapeutic Cancer Vaccine

    Science.gov (United States)

    Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.

  5. Mining FDA drug labels for medical conditions.

    Science.gov (United States)

    Li, Qi; Deleger, Louise; Lingren, Todd; Zhai, Haijun; Kaiser, Megan; Stoutenborough, Laura; Jegga, Anil G; Cohen, Kevin Bretonnel; Solti, Imre

    2013-04-24

    Cincinnati Children's Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration's (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system.

  6. Environmental assessments and findings of no significant impact--FDA. Notice.

    Science.gov (United States)

    1998-05-18

    The Food and Drug Administration (FDA) is announcing that it has reviewed environmental assessments (EA's) and issued findings of no significant impact (FONSI's) relating to the 167 new drug applications (NDA's) and supplemental applications listed in this document. FDA is publishing this notice because Federal regulations require public notice of the availability of environmental documents.

  7. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive...

  8. 78 FR 46686 - Privacy Act of 1974; Treasury/United States Mint .013-United States Mint National Electronic...

    Science.gov (United States)

    2013-08-01

    ... available publicly. FOR FURTHER INFORMATION CONTACT: For general questions and privacy issues, please... DEPARTMENT OF THE TREASURY Privacy Act of 1974; Treasury/United States Mint .013--United States... Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Department of the Treasury (``Treasury'') and the...

  9. 39 CFR 221.1 - The United States Postal Service.

    Science.gov (United States)

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false The United States Postal Service. 221.1 Section 221.1 Postal Service UNITED STATES POSTAL SERVICE ORGANIZATION AND ADMINISTRATION GENERAL ORGANIZATION § 221.1 The United States Postal Service. The United States Postal Service was established as an...

  10. UNITED STATES DURING THE COLD WAR 1945-1990

    Directory of Open Access Journals (Sweden)

    Novita Mujiyati

    2016-02-01

    Full Text Available United States and the Soviet Union is a country on the part of allies who emerged as the winner during World War II. However, after reaching the Allied victory in the situation soon changed, man has become an opponent. United States and the Soviet Union are competing to expand the influence and power. To compete the United States strive continuously strengthen itself both in the economic and military by establishing a defense pact and aid agencies in the field of economy. During the Cold War the two are not fighting directly in one of the countries of the former Soviet Union and the United States. However, if understood, teradinya the Korean War and the Vietnam War is a result of tensions between the two countries and is a direct warfare conducted by the United States and the Soviet Union. Cold War ended in conflict with the collapse of the Soviet Union and the United States emerged as the winner of the country.

  11. Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations

    KAUST Repository

    Xu, Liren; Zhang, Chen; Rungta, Meha; Qiu, Wulin; Liu, Junqiang; Koros, William J.

    2014-01-01

    This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family

  12. Gas separation performance of 6FDA-based polyimides with different chemical structures

    KAUST Repository

    Qiu, Wulin

    2013-10-01

    This work reports the gas separation performance of several 6FDA-based polyimides with different chemical structures, to correlate chemical structure with gas transport properties with a special focus on CO2 and CH 4 transport and plasticization stability of the polyimides membranes relevant to natural gas purification. The consideration of the other gases (He, O2 and N2) provided additional insights regarding effects of backbone structure on detailed penetrant properties. The polyimides studied include 6FDA-DAM, 6FDA-mPDA, 6FDA-DABA, 6FDA-DAM:DABA (3:2), 6FDA-DAM:mPDA (3:2) and 6FDA-mPDA:DABA (3:2). Both pure and binary gas permeation were investigated. The packing density, which is tunable by adjusting monomer type and composition of the various samples, correlated with transport permeability and selectivity. The separation performance of the polyimides for various gas pairs were also plotted for comparison to the upper bound curves, and it was found that this family of materials shows attractive performance. The CO 2 plasticization responses for the un-cross-linked polyimides showed good plasticization resistance to CO2/CH4 mixed gas with 10% CO2; however, only the cross-linked polyimides showed good plasticization resistance under aggressive gas feed conditions (CO 2/CH4 mixed gas with 50% CO2 or pure CO 2). For future work, asymmetric hollow fibers and carbon molecular sieve membranes based on the most attractive members of the family will be considered. © 2013 Elsevier Ltd. All rights reserved.

  13. 78 FR 27857 - United States Standards for Wheat

    Science.gov (United States)

    2013-05-13

    ... RIN 0580-AB12 United States Standards for Wheat AGENCY: Grain Inspection, Packers and Stockyards... (GIPSA) is revising the United States Standards for Wheat under the United States Grain Standards Act (USGSA) to change the definition of Contrasting classes (CCL) in the class Hard White wheat. This change...

  14. Tuberculosis along the United States-Mexico border, 1993-2001.

    Science.gov (United States)

    Schneider, Eileen; Laserson, Kayla F; Wells, Charles D; Moore, Marisa

    2004-07-01

    Tuberculosis (TB) is a leading public health problem and a recognized priority for the federal Governments of both Mexico and the United States of America. The objectives of this research, primarily for the four states in the United States that are along the border with Mexico, were to: (1) describe the epidemiological situation of TB, (2) identify TB risk factors, and (3) discuss tuberculosis program strategies. We analyzed tuberculosis case reports collected from 1993 through 2001 by the tuberculosis surveillance system of the United States. We used those data to compare TB cases mainly among three groups: (1) Mexican-born persons in the four United States border states (Arizona, California, New Mexico, and Texas), (2) persons in those four border states who had been born in the United States, and (3) Mexican-born persons in the 46 other states of the United States, which do not border Mexico. For the period from 1993 through 2001, of the 16 223 TB cases reported for Mexican-born persons in the United States, 12 450 of them (76.7%) were reported by Arizona, California, New Mexico, and Texas. In those four border states overall in 2001, tuberculosis case rates for Mexican-born persons were 5.0 times as high as the rates for persons born in the United States; those four states have 23 counties that directly border on Mexico, and the ratio in those counties was 5.8. HIV seropositivity, drug and alcohol use, unemployment, and incarceration were significantly less likely to be reported in Mexican-born TB patients from the four border states and the nonborder states than in patients born in the United States from the four border states (P pulmonary tuberculosis patients who were 18-64 years of age and residing in the four border states, the Mexican-born patients were 3.6 times as likely as the United States-born patients were to have resistance to at least isoniazid and rifampin (i. e., to have multidrug-resistant TB) and twice as likely to have isoniazid resistance

  15. Global Entrepreneurship and the United States

    Science.gov (United States)

    2010-09-01

    Global Entrepreneurship and the United States by Zoltan J. Acs Laszlo Szerb Ruxton, MD 21204 for under contract number SBAHQ-09...SUBTITLE Global Entrepreneurship and the United States 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT...3 2.1. Assessing Entrepreneurship ..................................................................................4 2.2. Stages of Development

  16. 75 FR 25925 - United States Mint

    Science.gov (United States)

    2010-05-10

    ... Committee May 25, 2010 Public Meeting. SUMMARY: Pursuant to United States Code, Title 31, section 5135(b)(8... scheduled for May 25, 2010. Date: May 25, 2010. Time: 9 a.m. to 12 p.m. Location: 8th Floor Board Room, United States Mint, 801 9th Street, NW., Washington, DC 20220. Subject: Review and discuss obverse and...

  17. 31 CFR 515.330 - Person within the United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Person within the United States. 515... Definitions § 515.330 Person within the United States. (a) The term person within the United States, includes: (1) Any person, wheresoever located, who is a resident of the United States; (2) Any person actually...

  18. Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations

    KAUST Repository

    Xu, Liren

    2014-06-01

    This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family with attractive dense film properties for several potential applications. The work reported here for the 6FDA-DAM polyimide provides insight for the challenging fabrication of defect-free asymmetric hollow fiber membranes for this class of 6FDA-polyimides, which behave rather different from lower free volume polymers. Specifically, the 6FDA based materials show relatively slow phase separation rate in water quench baths, which presents a challenge for fiber spinning. For convenience, we refer to the behavior as more "non-solvent resistant" in comparison to other lower free volume polymers, since the binodal phase boundary is displaced further from the conventional position near the pure polymer-solvent axis on a ternary phase diagram in conventional polymers like Matrimid® and Ultem®. The addition of lithium nitrate to promote phase separation has a useful impact on 6FDA-DAM asymmetric hollow fiber formation. 6FDA-DAM phase diagrams using ethanol and water as non-solvent are reported, and it was found that water is less desirable as a non-solvent dope additive for defect-free fiber spinning. Phase diagrams are also reported for 6FDA-DAM dope formulation with and without the addition of lithium nitrate, and defect-free asymmetric hollow fiber membranes are reported for both cases. The effect of polymer molecular weight on defect-free fiber spinning was also investigated. Gas transport properties and morphology of hollow fibers were characterized. With several thorough case studies, this work provides a systematic guideline for defect-free fiber formation from 6FDA-polymers. © 2014 Elsevier B.V.

  19. 45 CFR 212.7 - Repayment to the United States.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 2 2010-10-01 2010-10-01 false Repayment to the United States. 212.7 Section 212... UNITED STATES CITIZENS RETURNED FROM FOREIGN COUNTRIES § 212.7 Repayment to the United States. (a) An..., any or all of the cost of such assistance to the United States, except insofar as it is determined...

  20. 20 CFR 416.215 - You leave the United States.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false You leave the United States. 416.215 Section... Eligible § 416.215 You leave the United States. You lose your eligibility for SSI benefits for any month during all of which you are outside of the United States. If you are outside of the United States for 30...

  1. 37 CFR 1.412 - The United States Receiving Office.

    Science.gov (United States)

    2010-07-01

    ... Information § 1.412 The United States Receiving Office. (a) The United States Patent and Trademark Office is a Receiving Office only for applicants who are residents or nationals of the United States of America. (b) The... “United States Receiving Office” or by the abbreviation “RO/US.” (c) The major functions of the Receiving...

  2. Network-Based Real-time Integrated Fire Detection and Alarm (FDA) System with Building Automation

    Science.gov (United States)

    Anwar, F.; Boby, R. I.; Rashid, M. M.; Alam, M. M.; Shaikh, Z.

    2017-11-01

    Fire alarm systems have become increasingly an important lifesaving technology in many aspects, such as applications to detect, monitor and control any fire hazard. A large sum of money is being spent annually to install and maintain the fire alarm systems in buildings to protect property and lives from the unexpected spread of fire. Several methods are already developed and it is improving on a daily basis to reduce the cost as well as increase quality. An integrated Fire Detection and Alarm (FDA) systems with building automation was studied, to reduce cost and improve their reliability by preventing false alarm. This work proposes an improved framework for FDA system to ensure a robust intelligent network of FDA control panels in real-time. A shortest path algorithmic was chosen for series of buildings connected by fiber optic network. The framework shares information and communicates with each fire alarm panels connected in peer to peer configuration and declare the network state using network address declaration from any building connected in network. The fiber-optic connection was proposed to reduce signal noises, thus increasing large area coverage, real-time communication and long-term safety. Based on this proposed method an experimental setup was designed and a prototype system was developed to validate the performance in practice. Also, the distributed network system was proposed to connect with an optional remote monitoring terminal panel to validate proposed network performance and ensure fire survivability where the information is sequentially transmitted. The proposed FDA system is different from traditional fire alarm and detection system in terms of topology as it manages group of buildings in an optimal and efficient manner.Introduction

  3. Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.

    Science.gov (United States)

    Yu, Lawrence X; Baker, Jeffrey; Berlam, Susan C; Boam, Ashley; Brandreth, E J; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M V; Mullin, Theresa; Raju, G K; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar

    2015-07-01

    On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.

  4. FDA-approved small-molecule kinase inhibitors

    DEFF Research Database (Denmark)

    Wu, Peng; Nielsen, Thomas E.; Clausen, Mads Hartvig

    2015-01-01

    Kinases have emerged as one of the most intensivelypursued targets in current pharmacological research,especially for cancer, due to their critical roles in cellularsignaling. To date, the US FDA has approved 28 smallmoleculekinase inhibitors, half of which were approvedin the past 3 years. While...

  5. Awareness and knowledge of methylmercury in fish in the United States

    Energy Technology Data Exchange (ETDEWEB)

    Lando, Amy M., E-mail: amy.lando@fda.hhs.gov [Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740 (United States); Zhang, Yuanting [Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740 (United States)

    2011-04-15

    In the 1970s several states in the Great Lakes region became concerned about mercury contamination in lakes and rivers and were the first to issue local fish consumption advisories. In 2001, the Food and Drug Administration (FDA) advised pregnant women, nursing mothers, young children, and women who may become pregnant not to consume shark, swordfish, king mackerel, and tilefish and recommended that these women not exceed 12 ounces of other fish per week. In 2004, FDA reissued this advice jointly with the U.S. Environmental Protection Agency (EPA) and modified it slightly to provide information about consumption of canned tuna and more details about consumption of recreationally caught fish. Though several studies have examined consumers' awareness of the joint FDA and EPA advisory as well as different state advisories, few used representative data. We examined the changes in awareness and knowledge of mercury as a problem in fish using the pooled nationally representative 2001 and 2006 Food Safety Surveys (FSS) with sample sizes of 4482 in 2001 and 2275 in 2006. Our results indicated an increase in consumers' awareness of mercury as a problem in fish (69% in 2001 to 80% in 2006, p<.001). In our regression models, we found that in both years, parents having children less than 5 years of age were more aware of mercury in fish and knowledgeable about the information contained in the national advisories about mercury in fish (p<.01) than other adults. In both 2001 and 2006, women of childbearing age (aged 18-45) were less aware and knowledgeable about this information than other women. However, women of all age groups had larger gains in awareness and knowledge than their male counterparts during this time. Participants' race, education, income, region, fish preparation experiences, having a foodborne illness in the past year, and risk perceptions about the safety of food were significant predictors of their awareness and knowledge. - Research

  6. Awareness and knowledge of methylmercury in fish in the United States

    International Nuclear Information System (INIS)

    Lando, Amy M.; Zhang, Yuanting

    2011-01-01

    In the 1970s several states in the Great Lakes region became concerned about mercury contamination in lakes and rivers and were the first to issue local fish consumption advisories. In 2001, the Food and Drug Administration (FDA) advised pregnant women, nursing mothers, young children, and women who may become pregnant not to consume shark, swordfish, king mackerel, and tilefish and recommended that these women not exceed 12 ounces of other fish per week. In 2004, FDA reissued this advice jointly with the U.S. Environmental Protection Agency (EPA) and modified it slightly to provide information about consumption of canned tuna and more details about consumption of recreationally caught fish. Though several studies have examined consumers' awareness of the joint FDA and EPA advisory as well as different state advisories, few used representative data. We examined the changes in awareness and knowledge of mercury as a problem in fish using the pooled nationally representative 2001 and 2006 Food Safety Surveys (FSS) with sample sizes of 4482 in 2001 and 2275 in 2006. Our results indicated an increase in consumers' awareness of mercury as a problem in fish (69% in 2001 to 80% in 2006, p<.001). In our regression models, we found that in both years, parents having children less than 5 years of age were more aware of mercury in fish and knowledgeable about the information contained in the national advisories about mercury in fish (p<.01) than other adults. In both 2001 and 2006, women of childbearing age (aged 18-45) were less aware and knowledgeable about this information than other women. However, women of all age groups had larger gains in awareness and knowledge than their male counterparts during this time. Participants' race, education, income, region, fish preparation experiences, having a foodborne illness in the past year, and risk perceptions about the safety of food were significant predictors of their awareness and knowledge. - Research highlights: → We

  7. The United States and the Kurds: Case Studies in United States Engagement

    National Research Council Canada - National Science Library

    Lambert, Peter

    1997-01-01

    ..., between 1969- 1975, and 1990-1996. Both eras saw the United States able to influence events relating to the Kurds in support of a larger regional policy, only to find no easy solution to the Kurdish quest for autonomy...

  8. Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men.

    Science.gov (United States)

    Underhill, Kristen; Morrow, Kathleen M; Operario, Don; Mayer, Kenneth H

    2014-02-01

    The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while others perceived approval as irrelevant or less significant than other sources of information. Our results suggest that FDA approval sends a signal that directly shapes PrEP acceptability among some MSM, while indirect influences of approval may affect uptake by others. Efforts to educate MSM about PrEP can increase acceptability by incorporating information about FDA approval, and outreach strategies should consider how this information may factor into personal decisions about PrEP use.

  9. Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.

    Science.gov (United States)

    McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D

    2017-01-01

    Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.

  10. United States rejoin ITER

    International Nuclear Information System (INIS)

    Roberts, M.

    2003-01-01

    Upon pressure from the United States Congress, the US Department of Energy had to withdraw from further American participation in the ITER Engineering Design Activities after the end of its commitment to the EDA in July 1998. In the years since that time, changes have taken place in both the ITER activity and the US fusion community's position on burning plasma physics. Reflecting the interest in the United States in pursuing burning plasma physics, the DOE's Office of Science commissioned three studies as part of its examination of the option of entering the Negotiations on the Agreement on the Establishment of the International Fusion Energy Organization for the Joint Implementation of the ITER Project. These were a National Academy Review Panel Report supporting the burning plasma mission; a Fusion Energy Sciences Advisory Committee (FESAC) report confirming the role of ITER in achieving fusion power production, and The Lehman Review of the ITER project costing and project management processes (for the latter one, see ITER CTA Newsletter, no. 15, December 2002). All three studies have endorsed the US return to the ITER activities. This historical decision was announced by DOE Secretary Abraham during his remarks to employees of the Department's Princeton Plasma Physics Laboratory. The United States will be working with the other Participants in the ITER Negotiations on the Agreement and is preparing to participate in the ITA

  11. United States Stateplane Zones - NAD83

    Data.gov (United States)

    Earth Data Analysis Center, University of New Mexico — U.S. State Plane Zones (NAD 1983) represents the State Plane Coordinate System (SPCS) Zones for the 1983 North American Datum within United States.

  12. United States Stateplane Zones - NAD27

    Data.gov (United States)

    Earth Data Analysis Center, University of New Mexico — U.S. State Plane Zones (NAD 1927) represents the State Plane Coordinate System (SPCS) Zones for the 1927 North American Datum within United States.

  13. Present state of electric power business in United States and Europe

    International Nuclear Information System (INIS)

    Onishi, Kenichi

    2011-01-01

    This article reported present state of nuclear power and electric power business in United States and Europe after Fukushima Daiichi Accident. As for the trend of demand and supply of electric power and policy, the accident forced Germany possibly to proceed with phase-out of nuclear power, but France and United States to sustain nuclear power with no great change of energy policy at this moment. As for the trend of electric power market, there was not state in United States with liberalized retail market of electric power after rolling blackouts occurred in California State in the early 2000s. In Germany proceeding with renewable energy introduction, renewable electricity fed into the grid was paid for by the network operators at fixed tariffs and the costs passed on to electricity consumers were increasing. Renewable Portfolio Standards (RPS) in United States forced the state to introduction of renewable energy to some ratio, and Feed-in Tariff (FIT) introduced in EU in 1990s lead to introduction of a large amount of renewable electricity targeted in 2020. Huge amount of wind power introduction brought about several problems to solve such that excess electric power above domestic demand had bad effects on grids in neighboring region. Enforcement of power transmission lines was also needed with increase of maximum electric power as well as introduction of a large amount of renewable electricity. (T. Tanaka)

  14. Death in the United States, 2011

    Science.gov (United States)

    ... Order from the National Technical Information Service NCHS Death in the United States, 2011 Recommend on Facebook ... 2011 SOURCE: National Vital Statistics System, Mortality. Do death rates vary by state? States experience different mortality ...

  15. 31 CFR 103.39 - Person outside the United States.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Person outside the United States. 103... Person outside the United States. For the purposes of this subpart, a remittance or transfer of funds, or... the United States, shall be deemed to be a remittance or transfer to a person outside the United...

  16. Evaluating eating behavior treatments by FDA standards

    Directory of Open Access Journals (Sweden)

    A. Janet eTomiyama

    2014-01-01

    Full Text Available Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require the patients’ time and investment, and may have risks. The Food and Drug Administration (FDA has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1 Is the treatment safe? (2 How dangerous is the condition the intervention is treating? (3 Is the treatment effective? (4 Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine.

  17. Energy problems of the United States

    International Nuclear Information System (INIS)

    Pertuzio, A.

    2006-01-01

    The united states are the third world producer of oil which accounts for 440% of world production and 20 million barrels/day of which 60% are imported. That dependence on imports is likely to increase in the next decades. Such supplies and their security are therefore a fundamental factor of the United States foreign policy in combination with their political, economic and strategic objectives in a world both unsure and dangerous

  18. Household pesticide usage in the United States.

    Science.gov (United States)

    Savage, E P; Keefe, T J; Wheeler, H W; Mounce, L; Helwic, L; Applehans, F; Goes, E; Goes, T; Mihlan, G; Rench, J; Taylor, D K

    1981-01-01

    A total of 10,000 U.S. households in 25 standard metropolitan statistical areas and 25 counties were included in the United States. More than 8,200 households granted an interview. Nine of every ten households in the United States used some types of pesticide in their house, garden, or yard. Households in the southeastern United States used the most pesticides. Although more than 500 different pesticide formulations were used by the sampled households, 15 pesticides accounted for 65.5% of all pesticides reported in this study. Thirteen of these 15 pesticides were insecticides, one was a herbicide, and one was a rodenticide.

  19. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Science.gov (United States)

    2011-05-24

    ... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...

  20. 75 FR 13345 - Pricing for Certain United States Mint Products

    Science.gov (United States)

    2010-03-19

    ... DEPARTMENT OF THE TREASURY United States Mint Pricing for Certain United States Mint Products AGENCY: United States Mint, Department of the Treasury. ACTION: Notice. SUMMARY: The United States Mint is announcing the price of First Spouse Bronze Medals and 2010 First Spouse Bronze Medal Series: Four...

  1. 22 CFR 22.3 - Remittances in the United States.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Remittances in the United States. 22.3 Section...-DEPARTMENT OF STATE AND FOREIGN SERVICE § 22.3 Remittances in the United States. (a) Type of remittance. Remittances shall be in the form of: (1) Check or bank draft drawn on a bank in the United States; (2) money...

  2. FDA actions against health economic promotions, 2002-2011.

    Science.gov (United States)

    Neumann, Peter J; Bliss, Sarah K

    2012-01-01

    To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading. We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act. Of 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114. The FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  3. The United Kingdom: Issues for the United States

    National Research Council Canada - National Science Library

    Archick, Kristin

    2007-01-01

    ...; and more recently, from the UK's strong support in countering terrorism and confronting Iraq. The United States and Britain also share a mutually beneficial trade and economic relationship, and are each other's biggest foreign direct investors...

  4. Radiation therapy facilities in the United States

    International Nuclear Information System (INIS)

    Ballas, Leslie K.; Elkin, Elena B.; Schrag, Deborah; Minsky, Bruce D.; Bach, Peter B.

    2006-01-01

    Purpose: About half of all cancer patients in the United States receive radiation therapy as a part of their cancer treatment. Little is known, however, about the facilities that currently deliver external beam radiation. Our goal was to construct a comprehensive database of all radiation therapy facilities in the United States that can be used for future health services research in radiation oncology. Methods and Materials: From each state's health department we obtained a list of all facilities that have a linear accelerator or provide radiation therapy. We merged these state lists with information from the American Hospital Association (AHA), as well as 2 organizations that audit the accuracy of radiation machines: the Radiologic Physics Center (RPC) and Radiation Dosimetry Services (RDS). The comprehensive database included all unique facilities listed in 1 or more of the 4 sources. Results: We identified 2,246 radiation therapy facilities operating in the United States as of 2004-2005. Of these, 448 (20%) facilities were identified through state health department records alone and were not listed in any other data source. Conclusions: Determining the location of the 2,246 radiation facilities in the United States is a first step in providing important information to radiation oncologists and policymakers concerned with access to radiation therapy services, the distribution of health care resources, and the quality of cancer care

  5. 75 FR 13345 - Pricing for Certain 2010 United States Mint Products

    Science.gov (United States)

    2010-03-19

    ... DEPARTMENT OF THE TREASURY United States Mint Pricing for Certain 2010 United States Mint Products AGENCY: United States Mint, Department of the Treasury. ACTION: Notice. SUMMARY: The United States Mint is announcing the price of the 2010 United States Mint Presidential $1 Coin and First Spouse Medal...

  6. Intergenerational educational mobility in Denmark and the United States

    DEFF Research Database (Denmark)

    Andrade, Stefan Bastholm; Thomsen, Jens-Peter

    2018-01-01

    An overall finding in comparative mobility studies is that intergenerational mobility is greater in Scandinavia than in liberal welfare-state countries like the United States and United Kingdom. However, in a recent study, Landersø and Heckman (L & H) (2017) argue that intergenerational educational...... mobility in Denmark and the United States is remarkably similar. L & H’s findings run contrary to widespread beliefs and have been echoed in academia and mass media on both sides of the Atlantic Ocean. In this article, we reanalyze educational mobility in Denmark and the United States using the same data...... sources as L & H. We apply several different methodological approaches from economics and sociology, and we consistently find that educational mobility is higher in Denmark than in the United States....

  7. Toll Facilities in the United States

    Data.gov (United States)

    Department of Transportation — Biennial report containing selected information on toll facilities in the United States that has been provided to FHWA by the States and/or various toll authorities...

  8. State nuclear initiatives in the United States

    International Nuclear Information System (INIS)

    Strauss, P.L.; Stoiber, C.R.

    1977-01-01

    The paper deals with State nuclear initiatives regarding the role of nuclear power in the energy future of the United States. The question of whether and under what circumstances nuclear facilities should be used to generate electricity was put to the popular vote in several States in 1976. Some general principles of Federal-State relations are discussed with specific reference to nuclear regulations. The initiative mechanism itself is described as well as its legal form and background. The parallel developments in the State and Federal legislative consideration of nuclear issues is reviewed and the suggested reasons for the defeat of the proposals in the seven States concerned are discussed. Finally, the author draws some conclusions on the effects of the 1976 initiatives on future decision-making in the US on energy policy in general and nuclear power in particular. (NEA) [fr

  9. 27 CFR 479.89 - Transfers to the United States.

    Science.gov (United States)

    2010-04-01

    ... Transfers to the United States. A firearm may be transferred to the United States or any department... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Transfers to the United States. 479.89 Section 479.89 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO...

  10. 32 CFR 516.54 - Witnesses for the United States.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Witnesses for the United States. 516.54 Section..., Travel, and Expenses of Witnesses § 516.54 Witnesses for the United States. (a) Status of witness. A military member authorized to appear as a witness for the United States, including those authorized to...

  11. 32 CFR 150.21 - Appeals by the United States.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 1 2010-07-01 2010-07-01 false Appeals by the United States. 150.21 Section 150... the United States. (a) Restricted filing. Only a representative of the government designated by the Judge Advocate General of the respective service may file an appeal by the United States under Article...

  12. United States housing, first quarter 2013

    Science.gov (United States)

    Delton Alderman

    2014-01-01

    Provides current and historical information on housing market in the United States. Information includes trends for housing permits and starts, housing under construction, and housing completions for single and multifamily units, and sales and construction. This report will be updated regularly.

  13. FDA regulations for commercial food irradiation

    International Nuclear Information System (INIS)

    Takeguchi, C.A.

    1985-01-01

    The Food and Drug Administration published an Advance Notice of Proposed Rulemaking (ANPR) on food irradiation on March 27, 1981 (FDA, 1981). The next step in the rulemaking process is a proposed rule that will deal with low-dose irradiation of certain foods and high-dose irradiation of spices. The status of the proposed regulation is discussed

  14. Arsenic in Ground Water of the United States

    Science.gov (United States)

    ... Team More Information Arsenic in groundwater of the United States Arsenic in groundwater is largely the result of ... Gronberg (2011) for updated arsenic map. Featured publications United States Effects of human-induced alteration of groundwater flow ...

  15. Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models

    Directory of Open Access Journals (Sweden)

    Uebbing L

    2017-04-01

    Full Text Available Lukas Uebbing,1,2,* Lukas Klumpp,1,3,* Gregory K Webster,4 Raimar Löbenberg1 1Faculty of Pharmacy and Pharmaceutical Sciences, Katz Group-Rexall Centre for Pharmacy and Health Research, University of Alberta, Edmonton, Canada; 2Institute of Pharmacy and Biochemistry, Johannes Gutenberg University, Mainz, 3Institute of Pharmaceutical Technology, Goethe University Frankfurt, Frankfurt, Germany; 4Global Research and Development, AbbVie Inc., North Chicago, IL, USA *These authors contributed equally to this work Abstract: Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is

  16. FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology.

    Science.gov (United States)

    Grant, Evita V

    Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.

  17. Enrichment situation outside the United States

    International Nuclear Information System (INIS)

    Anon.

    1979-01-01

    Different enrichment technologies are briefly characterized which include gaseous diffusion, which is presently the production mainstay of the United States and France; the gaseous centrifuge which is the production plant for Urenco and the technology for future United States enrichment expansion; the aero-dynamic processes which include the jet nozzle (also known as the Becker process) and the fixed-wall centrifuge (also known as the Helikon process); chemical processes; laser isotope separation processes (also referred to in the literature as LIS); and plasma technology

  18. Leading Causes of Death in Females United States

    Science.gov (United States)

    ... and Health Issues at Work Health Equity Leading Causes of Death in Females, United States Recommend on Facebook Tweet ... to current and previous listings for the leading causes of death in females in the United States. Please note ...

  19. 33 CFR 2.38 - Waters subject to the jurisdiction of the United States; waters over which the United States has...

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Waters subject to the jurisdiction of the United States; waters over which the United States has jurisdiction. 2.38 Section 2.38 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY GENERAL JURISDICTION...

  20. Unites States and the oil of the Middle-East

    International Nuclear Information System (INIS)

    Noel, P.

    2005-08-01

    The author discusses different aspects of the United States intervention and behavior in the Middle-East petroleum management. The Iraq and Iran potentials are largely under used. The Saudi Arabia defines its own oil policy, but benefits of the Unites States military help. The United States intervention is in the domain of the security of flux on the world market. (A.L.B.)

  1. Small-molecule kinase inhibitors: an analysis of FDA-approved drugs

    DEFF Research Database (Denmark)

    Wu, Peng; Nielsen, Thomas Eiland; Clausen, Mads Hartvig

    2016-01-01

    Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther......Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function...

  2. Food irradiation in the United States

    International Nuclear Information System (INIS)

    Pauli, G.H.

    1991-01-01

    Since 1963, some irradiated foods have been permitted for sale in the United States. Yet, at this time, commercial application has been limited to irradiation of a relatively small fraction of the spices and seasonings used as ingredients in other foods. The current situation regarding irradiated foods in the United States and how it developed is discussed. The author writes from experience gained as a Government regulator concerned primarily with ensuring safety of food and therefore this is stressed together with the crucial role played by consumers and industry. (author)

  3. FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.

    Science.gov (United States)

    Wilson, Carolyn A; Simonyan, Vahan

    2014-01-01

    Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and

  4. TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

    International Nuclear Information System (INIS)

    2016-01-01

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  5. TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2016-06-15

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  6. The State Geologic Map Compilation (SGMC) geodatabase of the conterminous United States

    Science.gov (United States)

    Horton, John D.; San Juan, Carma A.; Stoeser, Douglas B.

    2017-06-30

    The State Geologic Map Compilation (SGMC) geodatabase of the conterminous United States (https://doi. org/10.5066/F7WH2N65) represents a seamless, spatial database of 48 State geologic maps that range from 1:50,000 to 1:1,000,000 scale. A national digital geologic map database is essential in interpreting other datasets that support numerous types of national-scale studies and assessments, such as those that provide geochemistry, remote sensing, or geophysical data. The SGMC is a compilation of the individual U.S. Geological Survey releases of the Preliminary Integrated Geologic Map Databases for the United States. The SGMC geodatabase also contains updated data for seven States and seven entirely new State geologic maps that have been added since the preliminary databases were published. Numerous errors have been corrected and enhancements added to the preliminary datasets using thorough quality assurance/quality control procedures. The SGMC is not a truly integrated geologic map database because geologic units have not been reconciled across State boundaries. However, the geologic data contained in each State geologic map have been standardized to allow spatial analyses of lithology, age, and stratigraphy at a national scale.

  7. Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.

    Science.gov (United States)

    Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen

    2014-01-01

    The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications. © 2013 Pharmacotherapy Publications, Inc.

  8. Exporting Rambutan to United States: One Reality?

    International Nuclear Information System (INIS)

    Ahmad Zainuri Mohd Dzomir; Zainon Othman; Mohd Sidek Othman

    2011-01-01

    Rambutan is a one of commodity that are passed by United States of America authority to be market in that states. The main condition for the approval is the exporter must use irradiation technology as quarantine treatment to monitor the insects in there. United States of America's Agriculture Department (USDA-APHIS) has make early survey to the facilities involved in exporting process chain to overview Malaysia preparedness for this purpose. This paper work will discussed the possibility of this exporting implemented based on conditions rule by the USDA. (author)

  9. FDA publishes checklist of Y2K high-risk devices.

    Science.gov (United States)

    1999-09-01

    Key points. The federal Food and Drug Administration (FDA) has developed a list of types of medical devices that have the potential for the most serious consequences for patients should they fail because of Y2K-related problems. This list of computer-controlled potentially high-risk devices can provide a guide to health care facilities regarding the types of devices that should receive priority in their assessment and remediation of medical devices. The list may change as the FDA receives comments on the types of devices included in the list.

  10. Wheat rusts in the United States in 2016

    Science.gov (United States)

    In 2016, wheat stripe rust caused by Puccinia striiformis f. sp. graminis was widespread throughout the United States. Cool temperatures and abundant rainfall in the southern Great Plains allowed stripe rust to become widely established and spread throughout the Great Plains and eastern United State...

  11. High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations

    KAUST Repository

    Zhang, Chen; Dai, Ying; Johnson, Justin R.; Karvan, Oguz; Koros, William J.

    2012-01-01

    We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.

  12. High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations

    KAUST Repository

    Zhang, Chen

    2012-02-01

    We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.

  13. United States National Seismographic Network

    International Nuclear Information System (INIS)

    Buland, R.

    1993-09-01

    The concept of a United States National Seismograph Network (USNSN) dates back nearly 30 years. The idea was revived several times over the decades. but never funded. For, example, a national network was proposed and discussed at great length in the so called Bolt Report (U. S. Earthquake Observatories: Recommendations for a New National Network, National Academy Press, Washington, D.C., 1980, 122 pp). From the beginning, a national network was viewed as augmenting and complementing the relatively dense, predominantly short-period vertical coverage of selected areas provided by the Regional Seismograph Networks (RSN's) with a sparse, well-distributed network of three-component, observatory quality, permanent stations. The opportunity finally to begin developing a national network arose in 1986 with discussions between the US Geological Survey (USGS) and the Nuclear Regulatory Commission (NRC). Under the agreement signed in 1987, the NRC has provided $5 M in new funding for capital equipment (over the period 1987-1992) and the USGS has provided personnel and facilities to develop. deploy, and operate the network. Because the NRC funding was earmarked for the eastern United States, new USNSN station deployments are mostly east of 105 degree W longitude while the network in the western United States is mostly made up of cooperating stations (stations meeting USNSN design goals, but deployed and operated by other institutions which provide a logical extension to the USNSN)

  14. 37 CFR 1.413 - The United States International Searching Authority.

    Science.gov (United States)

    2010-07-01

    ... Processing Provisions General Information § 1.413 The United States International Searching Authority. (a... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false The United States International Searching Authority. 1.413 Section 1.413 Patents, Trademarks, and Copyrights UNITED STATES PATENT...

  15. United States Attorney Prosecutions

    Science.gov (United States)

    1993-10-01

    property of CocaCola Bottling Company, Fayetteville, North Carolina, of a value in excess of $100.00, in violation of Title 18 United States Code, Section...another, to-wit: a Cocacola soft drink machine, the amount of damage to said personal property being more than $200.00, in violation of North Carolina

  16. 77 FR 48542 - United States

    Science.gov (United States)

    2012-08-14

    ... litigation.'' United States v. Armour and Co., 402 U.S. 673, 681 (1971). Section 5 of the Clayton Act... relief in consent judgment that contained recitals in which defendants asserted their innocence); Armour...

  17. United States Strategy for Mexico

    National Research Council Canada - National Science Library

    Centner, Robert C

    2005-01-01

    The security and stability of Mexico is of national interest to the United States, and a strong, effective alliance between the two countries is pivotal to our national defense strategy and economic prosperity...

  18. NCHS - Injury Mortality: United States

    Data.gov (United States)

    U.S. Department of Health & Human Services — This dataset describes injury mortality in the United States beginning in 1999. Two concepts are included in the circumstances of an injury death: intent of injury...

  19. Dose Matters: FDA's Guidance on Children's X-rays

    Science.gov (United States)

    ... Consumer Updates Dose Matters: FDA's Guidance on Children's X-rays Share Tweet Linkedin Pin it More sharing options ... exposure during medical procedures. The level of ionizing radiation from X-ray imaging is generally very low, but can ...

  20. Both Europe's and the United States' electrification

    International Nuclear Information System (INIS)

    Matly, M.

    2006-01-01

    While the United States quickly had the largest electrical indus in the world, electrification in rural areas ended about thirty years after most European countries. Public intervention is a deciding factor in completing electrification, and the late involvement by the American authorities explains the gap. However it would be wrong to oppose in Europe and in the United States a motivated public sector and little involved private companies. In both continents indeed, major private and public urban distributors were almost not involved in rural electrification processes, where local players prevailed: local communities around Europe, small and medium size business in some European countries such as France, co-operative companies in the United States. Additionally, there is an essential difference between electrification in Europe and in the United States. The former does not provide much more than lighting and its success leaves few traces in popular memories; the latter includes many facilities and services, changes the lives of rural populations and is celebrated a such. Whereas the colonial venture keep European economies away from their domestic markets, while in the United States the urban market growth contents large companies, the American co-operative movement is right to believe in the existence of a large electrical equipment market among farmers then considered poor and behind. It even uses the market to complete a more profitable and less costly electrification. Electricity stories that offer food for the thoughts of Third World decision makers and power companies, when they entrust most rural electrification to their large urban companies and deny the existence of a real equipment market in their own rural world. (author)

  1. Asian Immigration: The View from the United States.

    Science.gov (United States)

    Gardner, Robert W.

    1992-01-01

    Examines contemporary Asian immigration to the United States from a U.S. perspective. Analyzes immigration policies and data on recent immigration from Asia. Discusses impacts concerning the United States and the immigrants themselves and speculates on future immigration. The composition of Asian immigration might change, and the number might…

  2. 26 CFR 1.956-2 - Definition of United States property.

    Science.gov (United States)

    2010-04-01

    ..., which is— (i) Tangible property (real or personal) located in the United States; (ii) Stock of a... year ending June 30, 1964, R Corporation's increase in earnings invested in United States property for... United States property during its taxable year 1965, S Corporation's increase in earnings invested in...

  3. Licensed pertussis vaccines in the United States: History and current state

    OpenAIRE

    Klein, Nicola P

    2014-01-01

    The United States switched from whole cell to acellular pertussis vaccines in the 1990s following global concerns with the safety of the whole cell vaccines. Despite high levels of acellular pertussis vaccine coverage, the United States and other countries are experiencing large pertussis outbreaks. The aim of this article is to describe the historical context which led to acellular pertussis vaccine development, focusing on vaccines currently licensed in the US, and to review evidence that w...

  4. Tobacco Advertising and Promotional Expenditures in Sports and Sporting Events - United States, 1992-2013.

    Science.gov (United States)

    Agaku, Israel T; Odani, Satomi; Sturgis, Stephanie; Harless, Charles; Glover-Kudon, Rebecca

    2016-08-19

    Smokeless tobacco has been actively promoted by tobacco companies using endorsements by major sport figures, and research indicates that tobacco advertising can lead to youth initiation of tobacco use (1,2). Television and radio advertisements for cigarettes and smokeless tobacco have been prohibited since 1969,* and the 1998 Master Settlement Agreement(†) further prohibited tobacco companies from targeting youths with tobacco product advertisements in specified areas. In 2010, the Food and Drug Administration (FDA), under authority of the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), prohibited tobacco-brand sponsorship (i.e., sponsorship of sports and entertainment events or other social or cultural events using the tobacco brand name or anything identifiable with any brand of cigarettes or smokeless tobacco).(§) However, corporate-name tobacco sponsorship (i.e., sponsorship using the name of the corporation that manufactures regulated tobacco products) is still permitted under certain conditions.(¶) To monitor tobacco advertising and promotional activities in sports in the United States, CDC analyzed trends in sports-related marketing expenditures for cigarettes and smokeless tobacco during 1992-2013 using data from the Federal Trade Commission (FTC). During 1992-2013, sports-related marketing expenditures, adjusted by the consumer price index to constant 2013 dollars, decreased significantly for both cigarettes (from $136 million in 1992 to $0 in 2013) and smokeless tobacco (from $34.8 million in 1992 to $2.1 million in 2013). During 2010-2013, after the prohibition of tobacco-brand sponsorship in sports under the FSPTCA, cigarette manufacturers reported no spending (i.e., $0) on sports-related advertising and promotional activities; in contrast, smokeless tobacco manufacturers reported expenditures of $16.3 million on advertising and promoting smokeless tobacco in sports during 2010-2013. These findings indicate that despite prohibitions

  5. Nations United: The United Nations, the United States, and the Global Campaign Against Terrorism. A Curriculum Unit & Video for Secondary Schools.

    Science.gov (United States)

    Houlihan, Christina; McLeod, Shannon

    This curriculum unit and 1-hour videotape are designed to help students understand the purpose and functions of the United Nations (UN) and explore the relationship between the United Nations and the United States. The UN's role in the global counterterrorism campaign serves as a case study for the unit. The students are asked to develop a basic…

  6. Estimated United States Transportation Energy Use 2005

    Energy Technology Data Exchange (ETDEWEB)

    Smith, C A; Simon, A J; Belles, R D

    2011-11-09

    A flow chart depicting energy flow in the transportation sector of the United States economy in 2005 has been constructed from publicly available data and estimates of national energy use patterns. Approximately 31,000 trillion British Thermal Units (trBTUs) of energy were used throughout the United States in transportation activities. Vehicles used in these activities include automobiles, motorcycles, trucks, buses, airplanes, rail, and ships. The transportation sector is powered primarily by petroleum-derived fuels (gasoline, diesel and jet fuel). Biomass-derived fuels, electricity and natural gas-derived fuels are also used. The flow patterns represent a comprehensive systems view of energy used within the transportation sector.

  7. United States of America National Report

    International Nuclear Information System (INIS)

    1992-01-01

    The United States has produced this report as part of the preparations for the United Nations Conference on Environment and Development (UNCED) to be held in Brazil in June 1992. It summarizes this nation's efforts to protect and enhance the quality of the human environment in concert with its efforts to provide economic well-being during the two decades since the United Nations Conference on the Human Environment was held in Stockholm. The information presented in this report is primarily and deliberately retrospective. It is an attempt to portray the many human, economic and natural resources of the United States, to describe resource use and the principal national laws and programs established to protect these resources, and to analyze key issues on the agenda of UNCED. This analysis is presented in terms of past and present conditions and trends, measures of progress made in responding to the key issues, and a summary of government activities, underway or pending, to address ongoing or newly emerging national environmental and resource management problems

  8. African Journals Online: United States Minor Outlying Islands

    African Journals Online (AJOL)

    African Journals Online: United States Minor Outlying Islands. Home > African Journals Online: United States Minor Outlying Islands. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register · Browse By Category · Browse Alphabetically · Browse By Country · List All Titles ...

  9. Refugee Status Required for Resettlement in the United States

    Science.gov (United States)

    2017-06-09

    STATES REFUGEE ADMISSIONS PROGRAM FLOWCHART ...the American public’s concerns. 50 APPENDIX A UNITED STATES REFUGEE ADMISSIONS PROGRAM FLOWCHART Source: US Citizenship and Immigration...TITLE AND SUBTITLE Refugee Status Required for Resettlement in the United States 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT

  10. Latin America and the United States: What Do United States History Textbooks Tell Us?

    Science.gov (United States)

    Fleming, Dan B.

    1982-01-01

    Evaluates how U.S.-Latin American relations are presented in high school U.S. history textbooks. An examination of 10 textbooks published between 1977-81 revealed inadequate coverage of Latin American cultural diversity and United States foreign policy from the Latin American perspective. (AM)

  11. Preparation of School Psychologists in the United States

    Science.gov (United States)

    Joyce-Beaulieu, Diana; Rossen, Eric

    2014-01-01

    School psychology in the United States continues to evolve in response to shifts in the country's demographic characteristics, an increasing focus on the importance of child mental health, together with health and education reforms. The landscape of school psychological services in the United States also is shaped through the changing roles and…

  12. Agreements and Discrepancies between FDA Reports and Journal Papers on Biologic Agents Approved for Rheumatoid Arthritis

    DEFF Research Database (Denmark)

    Amarilyo, Gil; Furst, Daniel E; Woo, Jennifer M P

    2016-01-01

    BACKGROUND: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. OBJECTIVES: This study sought to determine if there are differences between the FDA assessments and journal...... reports on biologic agents developed for the treatment of rheumatoid arthritis. METHODS: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American...... College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report...

  13. United States position on severe accidents

    International Nuclear Information System (INIS)

    Ross, D.F.

    1988-01-01

    The United States policy on severe accidents was published in 1985 for both new plant applications and for existing plants. Implementation of this policy is in progress. This policy, aided by a related safety goal policy and by analysis capabilities emerging from improved understanding of accident phenomenology, is viewed as a logical development from the pioneering work in the WASH-1400 Reactor Safety Study published by the United States Nuclear Regulatory Commission (NRC) in 1975. This work provided an estimate of the probability and consequences of severe accidents which, prior to that time, had been mostly evaluated by somewhat arbitrary assumptions dating back 30 years. The early history of severe accident evaluation is briefly summarized for the period 1957-1979. Then, the galvanizing action of Three Mile Island Unit 2 (TMI-2) on severe accident analysis, experimentation and regulation is reviewed. Expressions of US policy in the form of rulemaking, severe accident policy, safety research, safety goal policy and court decisions (on adequacy of safety) are discussed. Finally, the NRC policy as of March 1988 is stated, along with a prospective look at the next few years. (author). 19 refs

  14. Understanding human trafficking in the United States.

    Science.gov (United States)

    Logan, T K; Walker, Robert; Hunt, Gretchen

    2009-01-01

    The topic of modern-day slavery or human trafficking has received increased media and national attention. However, to date there has been limited research on the nature and scope of human trafficking in the United States. This article describes and synthesizes nine reports that assess the U.S. service organizations' legal representative knowledge of, and experience with, human trafficking cases, as well as information from actual cases and media reports. This article has five main goals: (a) to define what human trafficking is, and is not; (b) to describe factors identified as contributing to vulnerability to being trafficked and keeping a person entrapped in the situation; (c) to examine how the crime of human trafficking differs from other kinds of crimes in the United States; (d) to explore how human trafficking victims are identified; and, (e) to provide recommendations to better address human trafficking in the United States.

  15. Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain.

    Science.gov (United States)

    Chambers, James D; May, Katherine E; Neumann, Peter J

    2013-06-01

    The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.

  16. 42 CFR 410.175 - Alien absent from the United States.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Alien absent from the United States. 410.175... Alien absent from the United States. (a) Medicare does not pay Part B benefits for services furnished to... during the first full calendar month the alien is back in the United States. [53 FR 6634, Mar. 2, 1988] ...

  17. Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.

    Science.gov (United States)

    Sarapa, Nenad

    2007-09-01

    The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.

  18. Inventory of power plants in the United States. [By state within standard Federal Regions, using county codes

    Energy Technology Data Exchange (ETDEWEB)

    None

    1977-12-01

    The purpose of this inventory of power plants is to provide a ready reference for planners whose focus is on the state, standard Federal region, and/or national level. Thus the inventory is compiled alphabetically by state within standard Federal regions. The units are listed alphabetically within electric utility systems which in turn are listed alphabetically within states. The locations are identified to county level according to the Federal Information Processing Standards Publication Counties and County Equivalents of the States of the United States. Data compiled include existing and projected electrical generation units, jointly owned units, and projected construction units.

  19. Norovirus in the United States

    Centers for Disease Control (CDC) Podcasts

    2013-09-09

    Dr. Aron Hall, a CDC epidemiologist specializing in norovirus, discusses the impact of norovirus in the United States.  Created: 9/9/2013 by National Center for Emerging and Zoonotic Infectious Diseases (NCEZID).   Date Released: 9/17/2013.

  20. Fragmentation of Continental United States Forests

    Science.gov (United States)

    Kurt H. Riitters; James D. Wickham; Robert V. O' Neill; K. Bruce Jones; Elizabeth R. Smith; John W. Coulston; Timothy G. Wade; Jonathan H. Smith

    2002-01-01

    We report a multiple-scale analysis of forest fragmentation based on 30-m (0.09 ha pixel-1) land- cover maps for the conterminous United States. Each 0.09-ha unit of forest was classified according to fragmentation indexes measured within the surrounding landscape, for five landscape sizes including 2.25, 7.29, 65.61, 590.49, and 5314.41 ha....

  1. Trial by jury in the United States

    Directory of Open Access Journals (Sweden)

    Lochhead Robert

    2015-10-01

    Full Text Available Th e Republic of Moldova is considering the adoption of trial by jury in select criminal cases. Th e following article is intended to contribute to the discussion of that proposal. Th e article will briefl y describe the history of juries under the English common law and as adopted by the United States. It will then outline some of the basic procedures in trials by jury as currently practiced in the United States federal court system.

  2. CEDAW in the Eyes of the United States

    Directory of Open Access Journals (Sweden)

    Al Shraideh Saleh

    2017-12-01

    Full Text Available Despite the large number of reservations registered by Member countries, making it one of the, if not the, most heavily reserved human rights treaties; the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW has managed to achieve a very high rate of states’ membership [1]. Currently, 187 countries out of the 193 United Nations Members are parties to CEDAW [2]. What is strange to digest, however, is the fact that the United States is one of the seven countries that are yet to ratify the Convention [3]. This article provides an insight into the position of the United States from the ratification of CEDAW. It examines the merits of arguments made for and against the ratification and their rationale to provide a better understanding that explains what is considered by many as a buzzling stand of the United States from the Convention.

  3. Global context for the United States Forest Sector in 2030

    Science.gov (United States)

    James Turner; Joseph Buongiorno; Shushuai Zhu; Jeffrey P. Prestemon

    2005-01-01

    The purpose of this study was to identify markets for, and competitors to, the United States forest industries in the next 30 years. The Global Forest Products Model was used to make predictions of international demand, supply, trade, and prices, conditional on the last RPA Timber Assessment projections for the United States. It was found that the United States, Japan...

  4. No sisyphean task: how the FDA can regulate electronic cigarettes.

    Science.gov (United States)

    Paradise, Jordan

    2013-01-01

    The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

  5. A functional intranet for the United States Coast Guard Unit

    OpenAIRE

    Hannah, Robert Todd.

    1998-01-01

    Approved for public release; distribution in unlimited. This thesis describes the complete development process of a friendly functional Intranet for an operational United States Coast Guard (USCG) electronic Support Unit (ESU) in Alameda, California. The final product is suitable for immediate use. It may also be used as a prototype for future Intranet development efforts. The methodology used to develop a finished, working product provides the core subject matter for this thesis. The disc...

  6. Residency training in the United States: What foreign medical ...

    African Journals Online (AJOL)

    FMGs) planning to pursue post-graduate residency training in the United States of America (USA). While the number of residency training positions is shrinking, and the number of United States graduates has steadily declined over the past ...

  7. The state of amphibians in the United States

    Science.gov (United States)

    Muths, E.; Adams, M.J.; Grant, E.H.C.; Miller, D.; Corn, P.S.; Ball, L.C.

    2012-01-01

    More than 25 years ago, scientists began to identify unexplained declines in amphibian populations around the world. Much has been learned since then, but amphibian declines have not abated and the interactions among the various threats to amphibians are not clear. Amphibian decline is a problem of local, national, and international scope that can affect ecosystem function, biodiversity, and commerce. This fact sheet provides a snapshot of the state of the amphibians and introduces examples to illustrate the range of issues in the United States.

  8. Inventory of power plants in the United States, 1993

    International Nuclear Information System (INIS)

    1994-12-01

    The Inventory of Power Plants in the United States is prepared annually by the Survey Management Division, Office of Coal, Nuclear, Electric and Alternate Fuels, Energy Information Administration (EIA), U.S. Department of Energy (DOE). The purpose of this publication is to provide year-end statistics about electric generating units operated by electric utilities in the United States (the 50 States and the District of Columbia). The publication also provides a 10-year outlook of future generating unit additions. Data summarized in this report are useful to a wide audience including Congress, Federal and State agencies, the electric utility industry, and the general public. Data presented in this report were assembled and published by the EIA to fulfill its data collection and dissemination responsibilities as specified in the Federal Energy Administration Act of 1974 (Public Law 93-275) as amended

  9. Inventory of power plants in the United States, 1993

    Energy Technology Data Exchange (ETDEWEB)

    1994-12-01

    The Inventory of Power Plants in the United States is prepared annually by the Survey Management Division, Office of Coal, Nuclear, Electric and Alternate Fuels, Energy Information Administration (EIA), U.S. Department of Energy (DOE). The purpose of this publication is to provide year-end statistics about electric generating units operated by electric utilities in the United States (the 50 States and the District of Columbia). The publication also provides a 10-year outlook of future generating unit additions. Data summarized in this report are useful to a wide audience including Congress, Federal and State agencies, the electric utility industry, and the general public. Data presented in this report were assembled and published by the EIA to fulfill its data collection and dissemination responsibilities as specified in the Federal Energy Administration Act of 1974 (Public Law 93-275) as amended.

  10. Use of Internet Search Data to Monitor Rotavirus Vaccine Impact in the United States, United Kingdom, and Mexico.

    Science.gov (United States)

    Shah, Minesh P; Lopman, Benjamin A; Tate, Jacqueline E; Harris, John; Esparza-Aguilar, Marcelino; Sanchez-Uribe, Edgar; Richardson, Vesta; Steiner, Claudia A; Parashar, Umesh D

    2018-02-19

    Previous studies have found a strong correlation between internet search and public health surveillance data. Less is known about how search data respond to public health interventions, such as vaccination, and the consistency of responses in different countries. In this study, we aimed to study the correlation between internet searches for "rotavirus" and rotavirus disease activity in the United States, United Kingdom, and Mexico before and after introduction of rotavirus vaccine. We compared time series of internet searches for "rotavirus" from Google Trends with rotavirus laboratory reports from the United States and United Kingdom and with hospitalizations for acute gastroenteritis in the United States and Mexico. Using time and location parameters, Google quantifies an internet query share (IQS) to measure the relative search volume for specific terms. We analyzed the correlation between IQS and laboratory and hospitalization data before and after national vaccine introductions. There was a strong positive correlation between the rotavirus IQS and laboratory reports in the United States (R2 = 0.79) and United Kingdom (R2 = 0.60) and between the rotavirus IQS and acute gastroenteritis hospitalizations in the United States (R2 = 0.87) and Mexico (R2 = 0.69) (P United States and by 70% (95% CI, 55%-86%) in Mexico. In the United Kingdom, there was a loss of seasonal variation after vaccine introduction. Rotavirus internet search data trends mirrored national rotavirus laboratory trends in the United States and United Kingdom and gastroenteritis-hospitalization data in the United States and Mexico; lower correlations were found after rotavirus vaccine introduction. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  11. Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men

    OpenAIRE

    Underhill, Kristen; Morrow, Kathleen M.; Operario, Don; Mayer, Kenneth H.

    2014-01-01

    The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while o...

  12. Licensed pertussis vaccines in the United States. History and current state.

    Science.gov (United States)

    Klein, Nicola P

    2014-01-01

    The United States switched from whole cell to acellular pertussis vaccines in the 1990s following global concerns with the safety of the whole cell vaccines. Despite high levels of acellular pertussis vaccine coverage, the United States and other countries are experiencing large pertussis outbreaks. The aim of this article is to describe the historical context which led to acellular pertussis vaccine development, focusing on vaccines currently licensed in the US, and to review evidence that waning protection following licensed acellular pertussis vaccines have been significant factors in the widespread reappearance of pertussis.

  13. The United States initiative for international radioactive source management (ISRM)

    International Nuclear Information System (INIS)

    Naraine, N.; Karhnak, J.

    1999-01-01

    The United States takes seriously the potential problems from uncontrolled radioactive sources. To address these problems, the United States Department of State is leading the development of an initiative for International Radioactive Source Management (ISRM). The Department of State, through a number of Federal and state agencies, regulatory bodies and private industry, will endeavor to provide coordinated support to the international community, particularly through IAEA, to assist in the development and implementation of risk-based clearance levels to support import/export of radioactive contaminated metals and the tracking, management, identification, remediation, and disposition of 'lost sources' entering nation states and targeted industries. The United States believes that the international control of radioactive sources is critical in avoiding wide-spread contamination of the world metal supply. Thus the initiative has four objectives: (1) Protect sources from becoming lost (Tracking management); (2) Identify primary locations where sources have been lost (Stop future losses); (3) Locate lost sources (monitor and retrieve); and (4) Educate and train (deploy knowledge and technology). A number of efforts already underway in the United States support the overall initiative. The EPA has provided a grant to the Conference of Radiation Program Control Directors (CRCPD) to develop a nation-wide program for the disposition of orphaned radioactive sources. This program now has internet visibility and a toll-free telephone number to call for assistance in the disposal of sources. The Nuclear Regulatory Commission (NRC), the Department of Energy (DOE), and other government agencies as well as private companies are assisting CRCPD in this program. The NRC has begun a program to improve control of radioactive sources in the United States, and also intends to promulgate a regulation defining conditions for the release of materials from licensed facilities. The DOE is

  14. Antiabortion violence in the United States.

    Science.gov (United States)

    Russo, Jennefer A; Schumacher, Kristin L; Creinin, Mitchell D

    2012-11-01

    This study was conducted to determine if an association exists between the amount of harassment and violence directed against abortion providers and the restrictiveness of state laws relating to family planning. We used responses from a July 2010 survey of 357 abortion providers in 50 states to determine their experience of antiabortion harassment and violence. Their responses were grouped and analyzed in relation to a published grading of state laws in the United States (A, B, C, D and F) as they relate to restrictions on family planning services. Group by group comparison of respondents illustrates that the difference in the number of reported incidents of minor vandalism by group is statistically significant (A vs. C, p=.07; A vs. D, p=.017; A vs. F, p=.0002). Incidents of harassment follow a similar pattern. There were no differences noted overall for violence or major vandalism. Major violence, including eight murders, is a new occurrence in the last two decades. Harassment of abortion providers in the United States has an association with the restrictiveness of state abortion laws. In the last two decades, murder of abortion providers has become an unfortunate part of the violence. Copyright © 2012 Elsevier Inc. All rights reserved.

  15. Masturbation in the United States.

    Science.gov (United States)

    Das, Aniruddha

    2007-01-01

    Using data from the nationally representative National Health and Social Life Survey, this study queried the correlates of masturbation in the United States in 1992. Among those aged 18-60, 38% (CI, 35-41) of women and 61% (CI, 57-65) of men reported any masturbation over the preceding year. The system of factors underlying masturbation was similar for both genders, consistent with a convergence in gender patterns of sexual expression in the United States. Among both women and men, masturbation responded to a stable sexualized personality pattern, catalyzed by early-life factors and manifested in current sexual traits. Strikingly, the masturbation-partnered sex linkage, often conceptualized either as compensating for unsatisfying sex or complementing a satisfactory sex life, appeared to be bimodal for both genders. For some, masturbation complemented an active and pleasurable sex life, while among others, it compensated for a lack of partnered sex or satisfaction in sex.

  16. Research on Anoplophora glabripennis in the United States

    Science.gov (United States)

    Robert A. Haack

    2003-01-01

    In the mid-1990s it was estimated that more than 400 exotic (non-native) forest insects had already become established in the United States (HAACK and BYLER, 1993; MATTSON et al., 1994; NIEMELA and MATTSON, 1996). This number has continued to grow with new exotics discovered annually in the United States (HAACK, 2002; HAACK and POLAND, 2001; HAACK et al., 2002). One...

  17. Leading Causes of Death in Males United States, 2010

    Science.gov (United States)

    ... What’s this? Submit What’s this? Submit Button Leading Causes of Death in Males and Females, United States Recommend on ... to current and previous listings for the leading causes of death for males and females in the United States. ...

  18. 76 FR 18198 - European Union-United States Atlantis Program

    Science.gov (United States)

    2011-04-01

    ... DEPARTMENT OF EDUCATION European Union-United States Atlantis Program AGENCY: Office of...)--Special Focus Competition: European Union-(EU) United States (U.S.) Atlantis Program Notice inviting... and Culture, European Commission for funding under a separate but parallel EU competition. Within this...

  19. Development of Water Quality Modeling in the United States

    Science.gov (United States)

    This presentation describes historical trends in water quality model development in the United States, reviews current efforts, and projects promising future directions. Water quality modeling has a relatively long history in the United States. While its origins lie in the work...

  20. Solar energy in the United States

    International Nuclear Information System (INIS)

    Ochoa, D.; Slaoui, A.; Soler, R.; Bermudez, V.

    2009-01-01

    Written by a group of five French experts who visited several research centres, innovating companies and solar power stations in the United States, this report first proposes an overview of solar energy in the United States, indicating and commenting the respective shares of different renewable energies in the production, focusing on the photovoltaic energy production and its RD sector. The second part presents industrial and research activities in the solar sector, and more specifically photovoltaic technologies (silicon and thin layer technology) and solar concentrators (thermal solar concentrators, photovoltaic concentrators). The last chapter presents the academic research activities in different universities (California Tech Beckman Institute, Stanford, National Renewable Energy Laboratory, Colorado School of Mines)

  1. 75 FR 22551 - United States Standards for Grades of Frozen Blueberries

    Science.gov (United States)

    2010-04-29

    ...] United States Standards for Grades of Frozen Blueberries AGENCY: Agricultural Marketing Service, USDA... United States Standards for Grades of Frozen Blueberries. After considering the comments received... . The United States Standards for Grades of Frozen Blueberries are available by accessing the AMS Web...

  2. Concentration of Selected Anions in Bottled Water in the United Arab Emirates

    Directory of Open Access Journals (Sweden)

    Mohamed Yehia Z. Abouleish

    2012-05-01

    Full Text Available Several studies have shown concern over nitrate and nitrite contamination of prepared infant formula used by infants less than six months old, as it may lead to methemoglobinemia and death. One possible source of contamination is through the use of improperly treated drinking water. Contamination of water could result from fertilizers and manure runoff, not fully treated and released human and industrial waste, or from disinfection processes. In the United Arab Emirates (UAE, bottled water is the major source of drinking water and may be used for the preparation of infant formula. Therefore, in this study, several bottled water brands that are sold on the UAE market, and could be used for preparation of infant formula, were tested for nitrate and nitrite and other anions to show their compatibility with the permissible levels of the United States Environmental Protection Agency (U.S. EPA, United States Food and Drug Administration/Code of Federal Regulations (U.S. FDA/CFR, and other international organizations. All the bottled water samples demonstrated nitrate, nitrite, and other anions levels below the permissible levels accepted by U.S. EPA, U.S. FDA/CFR, and other international organizations, except for one sample that showed nitrite levels exceeding the European Commission and Drinking Water Directive (EC/DWD permissible levels. Such study sheds light on the quality of bottled water sold not only in the UAE and the region, but also in other countries, such as France, since some of them are imported. In addition, the results shed light on the effectiveness of the treatment processes and possible sources of infant formula contamination that can affect the health of infants.

  3. Customizable orthopaedic oncology implants: one institution's experience with meeting current IRB and FDA requirements.

    Science.gov (United States)

    Willis, Alexander R; Ippolito, Joseph A; Patterson, Francis R; Benevenia, Joseph; Beebe, Kathleen S

    2016-01-01

    Customizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Currently, obtaining customizable orthopaedic implants for orthopaedic oncology patients can be an arduous task involving submitting approval requests to the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). There is great potential for the delay of a patient's surgery and unnecessary paperwork if the submission pathways are misunderstood or a streamlined protocol is not in place. The objective of this study was to review the existing FDA custom implant approval pathways and to determine whether this process was improved with an institutional protocol. An institutional protocol for obtaining IRB and FDA approval for customizable orthopaedic implants was established with the IRB at our institution in 2013. This protocol was approved by the IRB, such that new patients only require submission of a modification to the existing protocol with individualized patient information. During the two-year period of 2013-2014, eight patients were retrospectively identified as having required customizable implants for various orthopaedic oncology surgeries. The dates of request for IRB approval, request for FDA approval, and total time to surgery were recorded, along with the specific pathway utilized for FDA approval. The average patient age was 12 years old (7-21 years old). The average time to IRB approval of a modification to the pre-approved protocol was 14 days (7-21 days). Average time to FDA approval after submission of the IRB approval to the manufacturer was 12.5 days (7-19 days). FDA approval was obtained for all implants as compassionate use requests in accordance with Section 561 of the Federal Food Drug and Cosmetic Act's expanded access provisions. Establishment of an institutional protocol with pre-approval by the IRB can expedite the otherwise time-consuming and complicated

  4. 77 FR 64031 - United States-Peru Trade Promotion Agreement

    Science.gov (United States)

    2012-10-18

    ... Trade Promotion Agreement AGENCIES: U.S. Customs and Border Protection, Department of Homeland Security... tariff treatment and other customs-related provisions of the United States-Peru Trade Promotion Agreement... other customs-related provisions of the United States-Peru Trade Promotion Agreement (PTPA). Please...

  5. Inching toward incrementalism: federalism, devolution, and health policy in the United States and the United Kingdom.

    Science.gov (United States)

    Sparer, Michael S; France, George; Clinton, Chelsea

    2011-02-01

    In the United States, the recently enacted Patient Protection and Affordable Care Act of 2010 envisions a significant increase in federal oversight over the nation's health care system. At the same time, however, the legislation requires the states to play key roles in every aspect of the reform agenda (such as expanding Medicaid programs, creating insurance exchanges, and working with providers on delivery system reforms). The complicated intergovernmental partnerships that govern the nation's fragmented and decentralized system are likely to continue, albeit with greater federal oversight and control. But what about intergovernmental relations in the United Kingdom? What impact did the formal devolution of power in 1999 to Scotland, Wales, and Northern Ireland have on health policy in those nations, and in the United Kingdom more generally? Has devolution begun a political process in which health policy in the United Kingdom will, over time, become increasingly decentralized and fragmented, or will this "state of unions" retain its long-standing reputation as perhaps the most centralized of the European nations? In this article, we explore the federalist and intergovernmental implications of recent reforms in the United States and the United Kingdom, and we put forward the argument that political fragmentation (long-standing in the United States and just emerging in the United Kingdom) produces new intergovernmental partnerships that, in turn, produce incremental growth in overall government involvement in the health care arena. This is the impact of what can be called catalytic federalism.

  6. Changes in the utilization of osteoporosis drugs after the 2010 FDA bisphosphonate drug safety communication

    Directory of Open Access Journals (Sweden)

    Bander Balkhi

    2018-02-01

    Conclusions: The 2010 FDA bisphosphonates safety communication appeared to have influenced Osteoporosis utilization in Medicaid recipients. The 2010 FDA bisphosphonates safety communication was associated with a significant reduction in the utilization of bisphosphonates in the Medicaid program.

  7. THE UNITED STATES EDUCATIONAL SYSTEM

    OpenAIRE

    David Suriñach Fernández

    2017-01-01

    The United States educational system is very complex. Due to the fact a big number of agents take play of its regulation, the differences between the education from one State compared to the education from another, or even between school districts, might be considerable. The last two largest federal education initiatives, No Child Left Behind and Race to the Top, have had a huge impact on the American education system. The escalation of the standardized test throughout the whole country as a ...

  8. Inventory of Power Plants in the United States, October 1992

    Energy Technology Data Exchange (ETDEWEB)

    1993-10-27

    The Inventory of Power Plants in the United States is prepared annually by the Survey Management Division, Office of Coal, Nuclear, Electric and Alternate Fuels, Energy Information Administration (EIA), US Department of Energy (DOE). The purpose of this publication is to provide year-end statistics about electric generating units operated by electric utilities in the United States (the 50 States and the District of Columbia). The publication also provides a 10-year outlook of future generating unit additions. Data summarized in this report are useful to a wide audience including Congress, Federal and State agencies, the electric utility industry, and the general public. Data presented in this report were assembled and published by the EIA to fulfill its data collection and dissemination responsibilities as specified in the Federal Energy Administration Act of 1974 (Public Law 93-275) as amended. The report is organized into the following chapters: Year in Review, Operable Electric Generating Units, and Projected Electric Generating Unit Additions. Statistics presented in these chapters reflect the status of electric generating units as of December 31, 1992.

  9. 78 FR 63052 - United States-Panama Trade Promotion Agreement

    Science.gov (United States)

    2013-10-23

    ...-Panama Trade Promotion Agreement AGENCY: U.S. Customs and Border Protection, Department of Homeland... Trade Promotion Agreement entered into by the United States and the Republic of Panama. DATES: Interim... and the Republic of Panama (the ``Parties'') signed the United States-Panama Trade Promotion Agreement...

  10. United States Military in Central Asia: Beyond Operation Enduring Freedom

    Science.gov (United States)

    2009-10-23

    Malinowski , advocacy director for Human Rights Watch, stated, “the United States is most effective in promoting liberty around the world when people...26 U.S. President, The National Security Strategy of the United States of America, page? 27 Thomas Malinowski , “Testimony

  11. 31 CFR Appendix D to Subpart A of... - United States Secret Service

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false United States Secret Service D...—United States Secret Service 1. In general. This appendix applies to the United States Secret Service. 2. Public reading room. The United States Secret Service will provide a room on an ad hoc basis when...

  12. 76 FR 68271 - To Modify the Harmonized Tariff Schedule of the United States

    Science.gov (United States)

    2011-11-03

    ... the Convention and do not run counter to the national economic interest of the United States. I have... United States obligations under the Convention and do not run counter to the national economic interest of the United States. 7. On June 6, 2003, the United States and Chile entered into the United States...

  13. Human prion diseases in the United States.

    Directory of Open Access Journals (Sweden)

    Robert C Holman

    Full Text Available BACKGROUND: Prion diseases are a family of rare, progressive, neurodegenerative disorders that affect humans and animals. The most common form of human prion disease, Creutzfeldt-Jakob disease (CJD, occurs worldwide. Variant CJD (vCJD, a recently emerged human prion disease, is a zoonotic foodborne disorder that occurs almost exclusively in countries with outbreaks of bovine spongiform encephalopathy. This study describes the occurrence and epidemiology of CJD and vCJD in the United States. METHODOLOGY/PRINCIPAL FINDINGS: Analysis of CJD and vCJD deaths using death certificates of US residents for 1979-2006, and those identified through other surveillance mechanisms during 1996-2008. Since CJD is invariably fatal and illness duration is usually less than one year, the CJD incidence is estimated as the death rate. During 1979 through 2006, an estimated 6,917 deaths with CJD as a cause of death were reported in the United States, an annual average of approximately 247 deaths (range 172-304 deaths. The average annual age-adjusted incidence for CJD was 0.97 per 1,000,000 persons. Most (61.8% of the CJD deaths occurred among persons >or=65 years of age for an average annual incidence of 4.8 per 1,000,000 persons in this population. Most deaths were among whites (94.6%; the age-adjusted incidence for whites was 2.7 times higher than that for blacks (1.04 and 0.40, respectively. Three patients who died since 2004 were reported with vCJD; epidemiologic evidence indicated that their infection was acquired outside of the United States. CONCLUSION/SIGNIFICANCE: Surveillance continues to show an annual CJD incidence rate of about 1 case per 1,000,000 persons and marked differences in CJD rates by age and race in the United States. Ongoing surveillance remains important for monitoring the stability of the CJD incidence rates, and detecting occurrences of vCJD and possibly other novel prion diseases in the United States.

  14. Competitive Electricity Market Regulation in the United States: A Primer

    Energy Technology Data Exchange (ETDEWEB)

    Flores-Espino, Francisco [National Renewable Energy Lab. (NREL), Golden, CO (United States); Tian, Tian [National Renewable Energy Lab. (NREL), Golden, CO (United States); Chernyakhovskiy, Ilya [National Renewable Energy Lab. (NREL), Golden, CO (United States); Chernyakhovskiy, Ilya [National Renewable Energy Lab. (NREL), Golden, CO (United States); Miller, Mackay [National Grid, Warwick (United Kingdom)

    2016-12-01

    The electricity system in the United States is a complex mechanism where different technologies, jurisdictions and regulatory designs interact. Today, two major models for electricity commercialization operate in the United States. One is the regulated monopoly model, in which vertically integrated electricity providers are regulated by state commissions. The other is the competitive model, in which power producers can openly access transmission infrastructure and participate in wholesale electricity markets. This paper describes the origins, evolution, and current status of the regulations that enable competitive markets in the United States.

  15. Health, United States, 2012: Men's Health

    Science.gov (United States)

    ... Mailing List Previous Reports Suggested Citation Related Sites Purchase Health, United States Behavioral Health Report Children’s ... with Internet Explorer may experience difficulties in directly accessing links to Excel files ...

  16. Dengue Fever in the United States

    Centers for Disease Control (CDC) Podcasts

    Dr. Amesh Adalja, an associate at the Center for Biosecurity and clinical assistant professor at the University of Pittsburgh School, of Medicine, discusses dengue fever outbreaks in the United States.

  17. 15 CFR 971.209 - Processing outside the United States.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Processing outside the United States... THE ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR COMMERCIAL RECOVERY PERMITS Applications Contents § 971.209 Processing outside the United States. (a) Except as provided in this section...

  18. Obesity: A United States Strategic Imperative

    Science.gov (United States)

    2013-04-01

    States Department of Veterans Affairs 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) Dr. Thomas ...Army Ms. Karen Malebranche United States Department of Veterans Affairs Project Adviser Dr. Thomas Williams U.S. Army War...per American has increased by 57 pounds per year ( poultry representing 46 pounds).86 Surprisingly however, the percentage of calories from meat

  19. Cholera in the United States

    Centers for Disease Control (CDC) Podcasts

    2011-11-08

    Anna Newton, Surveillance Epidemiologist at CDC, discusses cholera that was brought to the United States during an outbreak in Haiti and the Dominican Republic (Hispaniola).  Created: 11/8/2011 by National Center for Emerging and Zoonotic Infectious Diseases (NCEZID).   Date Released: 11/8/2011.

  20. The United States

    International Nuclear Information System (INIS)

    Art, R.J.

    1991-01-01

    This paper reports that at least in the national security arena, the outcomes of bureaucratic infighting and domestic political struggles are not determined wholly by what goes on with the state. Rather struggles among contending groups are greatly affected by what is perceived to be happening outside the nation. Because external conditions give greater potency to some domestic forces over other, the external environment is never neutral in its domestic impact. The decisions of the period 1950-53 discussed above illustrate the point. But so too do the decisions of 1947, 1960-61 and 1969-72. In the 1947 case, Soviet intransigence provoked US nuclear rearmament. In the 1960-61 case, extended deterrent considerations pushed the United States to preserve its again newly discovered nuclear superiority. In the 1969-72 case, a Soviet determination to remain equal forced US acceptance of nuclear equality. And perhaps the best evidence of all, the perpetuation of parity ended the US inclination to resort to nuclear brinkmanship. In each instance, concerns about relative position heavily affected nuclear choice. Finally, the events of the past three years testify to the effects of international events on domestic choice. Under the terms of the 1987 INF Treaty, the two superpowers decided to dismantle and destroy an entire class of missiles of intermediate range (500-3000 kilometers) that both had deployed in Europe in the 1970s and 1980s, and in their June 1990 joint statement on strategic nuclear weapons, President Gorbachev and Brush agreed to cut the number of Soviet and US long range nuclear forces by 30 per cent. This agreement marks a watershed in US-Soviet strategic arm negotiations because for the first time the United States and the Soviet Union agreed in principals to reduce the number of weapons aimed at one another. Between 1985 and 1990 the cold war was brought to a close

  1. Malaria Surveillance - United States, 2015.

    Science.gov (United States)

    Mace, Kimberly E; Arguin, Paul M; Tan, Kathrine R

    2018-05-04

    Malaria in humans is caused by intraerythrocytic protozoa of the genus Plasmodium. These parasites are transmitted by the bite of an infective female Anopheles species mosquito. The majority of malaria infections in the United States occur among persons who have traveled to regions with ongoing malaria transmission. However, malaria is occasionally acquired by persons who have not traveled out of the country through exposure to infected blood products, congenital transmission, laboratory exposure, or local mosquitoborne transmission. Malaria surveillance in the United States is conducted to provide information on its occurrence (e.g., temporal, geographic, and demographic), guide prevention and treatment recommendations for travelers and patients, and facilitate transmission control measures if locally acquired cases are identified. This report summarizes confirmed malaria cases in persons with onset of illness in 2015 and summarizes trends in previous years. Malaria cases diagnosed by blood film microscopy, polymerase chain reaction, or rapid diagnostic tests are reported to local and state health departments by health care providers or laboratory staff members. Case investigations are conducted by local and state health departments, and reports are transmitted to CDC through the National Malaria Surveillance System (NMSS), the National Notifiable Diseases Surveillance System (NNDSS), or direct CDC consultations. CDC reference laboratories provide diagnostic assistance and conduct antimalarial drug resistance marker testing on blood samples submitted by health care providers or local or state health departments. This report summarizes data from the integration of all NMSS and NNDSS cases, CDC reference laboratory reports, and CDC clinical consultations. CDC received reports of 1,517 confirmed malaria cases, including one congenital case, with an onset of symptoms in 2015 among persons who received their diagnoses in the United States. Although the number of

  2. Malaria Surveillance - United States, 2014.

    Science.gov (United States)

    Mace, Kimberly E; Arguin, Paul M

    2017-05-26

    Malaria in humans is caused by intraerythrocytic protozoa of the genus Plasmodium. These parasites are transmitted by the bite of an infective female Anopheles mosquito. The majority of malaria infections in the United States occur among persons who have traveled to regions with ongoing malaria transmission. However, malaria is occasionally acquired by persons who have not traveled out of the country through exposure to infected blood products, congenital transmission, laboratory exposure, or local mosquitoborne transmission. Malaria surveillance in the United States is conducted to identify episodes of local transmission and to guide prevention recommendations for travelers. This report summarizes cases in persons with onset of illness in 2014 and trends during previous years. Malaria cases diagnosed by blood film, polymerase chain reaction, or rapid diagnostic tests are reported to local and state health departments by health care providers or laboratory staff. Case investigations are conducted by local and state health departments, and reports are transmitted to CDC through the National Malaria Surveillance System, National Notifiable Diseases Surveillance System, or direct CDC consultations. CDC conducts antimalarial drug resistance marker testing on blood samples submitted by health care providers or local or state health departments. Data from these reporting systems serve as the basis for this report. CDC received reports of 1,724 confirmed malaria cases, including one congenital case and two cryptic cases, with onset of symptoms in 2014 among persons in the United States. The number of confirmed cases in 2014 is consistent with the number of confirmed cases reported in 2013 (n = 1,741; this number has been updated from a previous publication to account for delayed reporting for persons with symptom onset occurring in late 2013). Plasmodium falciparum, P. vivax, P. ovale, and P. malariae were identified in 66.1%, 13.3%, 5.2%, and 2.7% of cases, respectively

  3. 26 CFR 1.993-7 - Definition of United States.

    Science.gov (United States)

    2010-04-01

    ... 26 Internal Revenue 10 2010-04-01 2010-04-01 false Definition of United States. 1.993-7 Section 1.993-7 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES Domestic International Sales Corporations § 1.993-7 Definition of United States...

  4. Price, performance, and the FDA approval process: the example of home HIV testing.

    Science.gov (United States)

    Paltiel, A David; Pollack, Harold A

    2010-01-01

    The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process.

  5. 26 CFR 49.4261-5 - Payments made outside the United States.

    Science.gov (United States)

    2010-04-01

    ... travel under section 4262(b), the tax imposed by section 4261(b), shall not apply unless the... made outside the United States for one-way or round-trip transportation between a point within the United States and a point outside the United States. (b) Transportation between two or more points in the...

  6. 42 CFR 455.21 - Cooperation with State Medicaid fraud control units.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Cooperation with State Medicaid fraud control units... Detection and Investigation Program § 455.21 Cooperation with State Medicaid fraud control units. In a State with a Medicaid fraud control unit established and certified under subpart C of this part, (a) The...

  7. Regulating (for the benefit of) future persons: a different perspective on the FDA's jurisdiction to regulate human reproductive cloning.

    Science.gov (United States)

    Javitt, Gail H; Hudson, Kathy

    2003-01-01

    The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.

  8. Low birth weight in the United States.

    Science.gov (United States)

    Goldenberg, Robert L; Culhane, Jennifer F

    2007-02-01

    Pregnancy outcomes in the United States and other developed countries are considerably better than those in many developing countries. However, adverse pregnancy outcomes are generally more common in the United States than in other developed countries. Low-birth-weight infants, born after a preterm birth or secondary to intrauterine growth restriction, account for much of the increased morbidity, mortality, and cost. Wide disparities exist in both preterm birth and growth restriction among different population groups. Poor and black women, for example, have twice the preterm birth rate and higher rates of growth restriction than do most other women. Low birth weight in general is thought to place the infant at greater risk of later adult chronic medical conditions, such as diabetes, hypertension, and heart disease. Of interest, maternal thinness is a strong predictor of both preterm birth and fetal growth restriction. However, in the United States, several nutritional interventions, including high-protein diets, caloric supplementation, calcium and iron supplementation, and various other vitamin and mineral supplementations, have not generally reduced preterm birth or growth restriction. Bacterial intrauterine infections play an important role in the etiology of the earliest preterm births, but, at least to date, antibiotic treatment either before labor for risk factors such as bacterial vaginosis or during preterm labor have not consistently reduced the preterm birth rate. Most interventions have failed to reduce preterm birth or growth restriction. The substantial improvement in newborn survival in the United States over the past several decades is mostly due to better access to improved neonatal care for low-birth-weight infants.

  9. 31 CFR 594.315 - United States person; U.S. person.

    Science.gov (United States)

    2010-07-01

    ... (Continued) OFFICE OF FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY GLOBAL TERRORISM SANCTIONS REGULATIONS General Definitions § 594.315 United States person; U.S. person. The term United States person or...

  10. New FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis.

    Science.gov (United States)

    English, Clayton; Aloi, Joseph J

    2015-04-01

    Interferon injectables and glatiramer acetate have served as the primary disease-modifying treatments for multiple sclerosis (MS) since their introduction in the 1990s and are first-line treatments for relapsing-remitting forms of MS (RRMS). Many new drug therapies were launched since early 2010, expanding the drug treatment options considerably in a disease state that once had a limited treatment portfolio. The purpose of this review is to critically evaluate the safety profile and efficacy data of disease-modifying agents for MS approved by the US Food and Drug Administration (FDA) from 2010 to the present and provide cost and available pharmacoeconomic data about each new treatment. Peer-reviewed clinical trials, pharmacoeconomic studies, and relevant pharmacokinetic/pharmacologic studies were identified from MEDLINE (January 2000-December 2014) by using the search terms multiple sclerosis, fingolimod, teriflunomide, alemtuzumab, dimethyl fumarate, pegylated interferon, peginterferon beta-1a, glatiramer 3 times weekly, and pharmacoeconomics. Citations from available articles were also reviewed for additional references. The databases publically available at www.clinicaltrials.gov and www.fda.gov were searched for unpublished studies or studies currently in progress. A total of 5 new agents and 1 new dosage formulation were approved by the FDA for the treatment of RRMS since 2010. Peginterferon beta-1a and high-dose glatiramer acetate represent 2 new effective injectable options for MS that reduce burden of administration seen with traditional interferon and low-dose glatiramer acetate. Fingolimod, teriflunomide, and dimethyl fumarate represent new oral agents available for MS, and their efficacy in reducing annualized relapse rates is 48% to 55%, 22% to 36.3%, and 44% to 53%, respectively, compared with placebo. Alemtuzumab is a biologic given over a 2-year span that reduced annualized relapse rates by 55% in treatment-naive patients and by 49% in patients

  11. Stigma and abortion complications in the United States.

    Science.gov (United States)

    Harris, Lisa H

    2012-12-01

    Abortion is highly stigmatized in the United States and elsewhere. As a result, many women who seek or undergo abortion keep their decision a secret. In many regions of the world, stigma is a recognized contributor to maternal morbidity and mortality from unsafe abortion, even when abortion is legal. Women may self-induce abortion in ways that are dangerous, or seek unsafe clandestine abortion from inadequately trained health care providers out of fear that their sexual activity, pregnancy, or abortion will be exposed if they present to a safe, licensed facility. However, unsafe abortion rarely occurs in the United States, and accordingly, stigma as a cause of unsafe abortion in the United States context has not been described. I consider the relationship of stigma to two serious abortion complications experienced by U.S. patients. Both patients wished to keep their abortion decision a secret from family and friends, and in both cases, their inability to disclose their abortion contributed to life-threatening complications. The experiences of these patients suggest that availability of legal abortion services in the United States may not be enough to keep all women safe. The cases also challenge the rhetoric that "abortion hurts women," suggesting instead that abortion stigma hurts women.

  12. Vanadium recycling in the United States in 2004

    Science.gov (United States)

    Goonan, Thomas G.

    2011-01-01

    As one of a series of reports that describe the recycling of metal commodities in the United States, this report discusses the flow of vanadium in the U.S. economy in 2004. This report includes a description of vanadium supply and demand in the United States and illustrates the extent of vanadium recycling and recycling trends. In 2004, apparent vanadium consumption, by end use, in the United States was 3,820 metric tons (t) in steelmaking and 232 t in manufacturing, of which 17 t was for the production of superalloys and 215 t was for the production of other alloys, cast iron, catalysts, and chemicals. Vanadium use in steel is almost entirely dissipative because recovery of vanadium from steel scrap is chemically impeded under the oxidizing conditions in steelmaking furnaces. The greatest amount of vanadium recycling is in the superalloy, other-alloy, and catalyst sectors of the vanadium market. Vanadium-bearing catalysts are associated with hydrocarbon recovery and refining in the oil industry. In 2004, 2,850 t of vanadium contained in alloy scrap and spent catalysts was recycled, which amounted to about 44 percent of U.S. domestic production. About 94 percent of vanadium use in the United States was dissipative (3,820 t in steel/4,050 t in steel+fabricated products).

  13. The voluntary safeguards offer of the United States

    International Nuclear Information System (INIS)

    Houck, F.S.

    1985-01-01

    During negotiations of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) concerns were expressed by non-nuclear-weapon States that their acceptance of Agency safeguards would put them at a disadvantage vis-a-vis the nuclear-weapon States. To allay these concerns, the United States and the United Kingdom in December 1967 made voluntary offers to accept Agency safeguards on their peaceful nuclear activities. Subsequently, France made a voluntary offer, the safeguards agreement for which was approved by the IAEA Board of Governors in February 1978, with a view to encouraging acceptance of Agency safeguards by additional States. More recently, in February 1985 the Board approved the safeguards agreement for the voluntary offer of the USSR, made inter alia to encourage further acceptance of Agency safeguards. These safeguards agreements with nuclear-weapon-States have two important features in common: Namely, they result from voluntary offers to accept safeguards rather than from multilateral or bilateral undertakings, and they give the Agency the right but generally not an obligation to apply its safeguards. The agreements differ in certain respects, the most noteworthy of which is the scope of the nuclear activities covered by each offer. The agreements of the United States and United Kingdom are the broadest, covering all peaceful nuclear activities in each country. The safeguards agreement for the US voluntary offer has been in force since December 1980. Now is an appropriate time to review the experience with the agreement's implementation during its first four years, as well as its history and salient features

  14. United States Navy DL Perspective

    Science.gov (United States)

    2010-08-10

    United States Navy DL Perspective CAPT Hank Reeves Navy eLearning Project Director 10 August 2010 Report Documentation Page Form ApprovedOMB No...Marine Corps (USMC) Navy eLearning Ongoing Shared with USMC, Coast Guard 9 NeL Help Site https://ile-help.nko.navy.mil/ile/ https://s-ile

  15. A study to evaluate the levels of dioxin-like compounds in dairy feeds in the United States

    Energy Technology Data Exchange (ETDEWEB)

    Lorber, M.; Ferrario, J.; Byrne, C. [United States Environmental Protection Agency, WA, DC (United States); Greene, C.; Cyrus, A. [Versar, Inc., Springfield, VA (United States)

    2004-09-15

    The primary route for general population exposure to dioxin-like compounds is through the consumption of animal fats, with bovine-derived meat, milk and dairy products comprising over 50% of total exposure in the United States. The primary route of exposure hypothesized for cattle is airborne deposition of dioxins onto the leaves of feed crops. Over the last few years additional pathways of exposure have been identified associated with contaminated feed additives such as ball clay, mineral supplements, and animal byproducts. Studies by the United States Department of Agriculture (USDA) have shown that incidental contact with pentachlorophenol (PCP)-treated wood by cattle have resulted in elevated tissue levels. Although the air-to-leaf pathway is still considered by most researchers to be the dominant pathway of exposure, the lack of any systematic examination of animal feeds to quantify the contribution of the air-to-leaf pathway has been a major gap in our empirical understanding of dioxin exposure. The Environmental Protection Agency (EPA), in cooperation with USDA and the US Food and Drug Administration (FDA), has undertaken a program to study the presence of dioxin-like compounds in animal feeds. Two phases of this program have been completed, and this paper reports on the third phase. The first phase was a study on the mass balance of dioxins in lactating cows. The objective of that study was to quantify the role feeds play in total dairy cow exposure. The second phase of the program involved the collection and measurement of dioxins in minor feed components. Dioxins in specific targeted animal feed components of interest, including animal byproducts (beef, pork, poultry by-products, fish meal) and plant byproducts (deodorizer distillates from corn, soybean, peanut, cottonseed, and canola processers; cane and beet molasses), were measured. The third phase of the project, reported here, involved component sampling of dairy feeds around the US.

  16. 26 CFR 1.953-2 - Actual United States risks.

    Science.gov (United States)

    2010-04-01

    ... being the promotion of such sales to United States retail outlets by advertising in trade publications... 26 Internal Revenue 10 2010-04-01 2010-04-01 false Actual United States risks. 1.953-2 Section 1.953-2 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX...

  17. 31 CFR 595.315 - United States person; U.S. person.

    Science.gov (United States)

    2010-07-01

    ... (Continued) OFFICE OF FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY TERRORISM SANCTIONS REGULATIONS General Definitions § 595.315 United States person; U.S. person. The term United States person or U.S...

  18. United States Interagency Elevation Inventory (USIEI)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The U.S. Interagency Elevation Inventory displays high-accuracy topographic and bathymetric data for the United States and its territories. The project is a...

  19. China's international trade and air pollution in the United States.

    Science.gov (United States)

    Lin, Jintai; Pan, Da; Davis, Steven J; Zhang, Qiang; He, Kebin; Wang, Can; Streets, David G; Wuebbles, Donald J; Guan, Dabo

    2014-02-04

    China is the world's largest emitter of anthropogenic air pollutants, and measurable amounts of Chinese pollution are transported via the atmosphere to other countries, including the United States. However, a large fraction of Chinese emissions is due to manufacture of goods for foreign consumption. Here, we analyze the impacts of trade-related Chinese air pollutant emissions on the global atmospheric environment, linking an economic-emission analysis and atmospheric chemical transport modeling. We find that in 2006, 36% of anthropogenic sulfur dioxide, 27% of nitrogen oxides, 22% of carbon monoxide, and 17% of black carbon emitted in China were associated with production of goods for export. For each of these pollutants, about 21% of export-related Chinese emissions were attributed to China-to-US export. Atmospheric modeling shows that transport of the export-related Chinese pollution contributed 3-10% of annual mean surface sulfate concentrations and 0.5-1.5% of ozone over the western United States in 2006. This Chinese pollution also resulted in one extra day or more of noncompliance with the US ozone standard in 2006 over the Los Angeles area and many regions in the eastern United States. On a daily basis, the export-related Chinese pollution contributed, at a maximum, 12-24% of sulfate concentrations over the western United States. As the United States outsourced manufacturing to China, sulfate pollution in 2006 increased in the western United States but decreased in the eastern United States, reflecting the competing effect between enhanced transport of Chinese pollution and reduced US emissions. Our findings are relevant to international efforts to reduce transboundary air pollution.

  20. Comparison of Plastic Surgery Residency Training in United States and China.

    Science.gov (United States)

    Zheng, Jianmin; Zhang, Boheng; Yin, Yiqing; Fang, Taolin; Wei, Ning; Lineaweaver, William C; Zhang, Feng

    2015-12-01

    Residency training is internationally recognized as the only way for the physicians to be qualified to practice independently. China has instituted a new residency training program for the specialty of plastic surgery. Meanwhile, plastic surgery residency training programs in the United States are presently in a transition because of restricted work hours. The purpose of this study is to compare the current characteristics of plastic surgery residency training in 2 countries. Flow path, structure, curriculum, operative experience, research, and evaluation of training in 2 countries were measured. The number of required cases was compared quantitatively whereas other aspects were compared qualitatively. Plastic surgery residency training programs in 2 countries differ regarding specific characteristics. Requirements to become a plastic surgery resident in the United States are more rigorous. Ownership structure of the regulatory agency for residency training in 2 countries is diverse. Training duration in the United States is more flexible. Clinical and research training is more practical and the method of evaluation of residency training is more reasonable in the United States. The job opportunities after residency differ substantially between 2 countries. Not every resident has a chance to be an independent surgeon and would require much more training time in China than it does in the United States. Plastic surgery residency training programs in the United States and China have their unique characteristics. The training programs in the United States are more standardized. Both the United States and China may complement each other to create training programs that will ultimately provide high-quality care for all people.

  1. 19 CFR 10.46 - Articles for the United States.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false Articles for the United States. 10.46 Section 10... THE TREASURY ARTICLES CONDITIONALLY FREE, SUBJECT TO A REDUCED RATE, ETC. General Provisions Articles for Institutions § 10.46 Articles for the United States. Pursuant to subheadings 9808.00.10 and 9808...

  2. 21 CFR 5.1110 - FDA public information offices.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...) Press Relations Staff. Press offices are located in White Oak Bldg. 1, 10903 New Hampshire Ave., Silver...

  3. 26 CFR 1.864-2 - Trade or business within the United States.

    Science.gov (United States)

    2010-04-01

    ... States, as his agent to effect transactions in the United States in stocks and securities for the account... A ordinarily effects transactions in the United States in stocks or securities. Under the agency..., effects transactions in the United States in stocks or securities for the partnership's own account or...

  4. Taxation of United States general aviation

    Science.gov (United States)

    Sobieralski, Joseph Bernard

    General aviation in the United States has been an important part of the economy and American life. General aviation is defined as all flying excluding military and scheduled airline operations, and is utilized in many areas of our society. The majority of aircraft operations and airports in the United States are categorized as general aviation, and general aviation contributes more than one percent to the United States gross domestic product each year. Despite the many benefits of general aviation, the lead emissions from aviation gasoline consumption are of great concern. General aviation emits over half the lead emissions in the United States or over 630 tons in 2005. The other significant negative externality attributed to general aviation usage is aircraft accidents. General aviation accidents have caused over 8000 fatalities over the period 1994-2006. A recent Federal Aviation Administration proposed increase in the aviation gasoline tax from 19.4 to 70.1 cents per gallon has renewed interest in better understanding the implications of such a tax increase as well as the possible optimal rate of taxation. Few studies have examined aviation fuel elasticities and all have failed to study general aviation fuel elasticities. Chapter one fills that gap and examines the elasticity of aviation gasoline consumption in United States general aviation. Utilizing aggregate time series and dynamic panel data, the price and income elasticities of demand are estimated. The price elasticity of demand for aviation gasoline is estimated to range from -0.093 to -0.185 in the short-run and from -0.132 to -0.303 in the long-run. These results prove to be similar in magnitude to automobile gasoline elasticities and therefore tax policies could more closely mirror those of automobile tax policies. The second chapter examines the costs associated with general aviation accidents. Given the large number of general aviation operations as well as the large number of fatalities and

  5. Analysis of United States' Broadband Policy

    National Research Council Canada - National Science Library

    Uzarski, Joel S

    2007-01-01

    .... With every month that passes, the United States fails to close the gap in the digital divide both inside its borders as well as among the other countries that lead the world in broadband penetration...

  6. Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

    Science.gov (United States)

    Caliendo, Angela M; Hanson, Kimberly E

    2016-04-01

    Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  7. One and done: Reasons principal investigators conduct only one FDA-regulated drug trial

    Directory of Open Access Journals (Sweden)

    Amy Corneli, PhD, MPH

    2017-06-01

    Full Text Available Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as “one-and-done.” Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1 workload balance (balancing trial implementation with other work obligations and opportunities (63.8%; 2 time requirements (time to initiate and implement trial; investigator and staff time (63.4%; and 3 data and safety reporting (56.5%. Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly “one-and-done.” Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.

  8. Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.

    Science.gov (United States)

    Deyo, Richard A

    2004-01-01

    Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.

  9. State of the Art in the Cramer Classification Scheme and ...

    Science.gov (United States)

    Slide presentation at the SOT FDA Colloquium on State of the Art in the Cramer Classification Scheme and Threshold of Toxicological Concern in College Park, MD. Slide presentation at the SOT FDA Colloquium on State of the Art in the Cramer Classification Scheme and Threshold of Toxicological Concern in College Park, MD.

  10. Regulations in the United States for cell transplantation clinical trials in neurological diseases

    Institute of Scientific and Technical Information of China (English)

    He Zhu; Yuanqing Tan; Qi Gu; Weifang Han; Zhongwen Li; Jason S Meyer; Baoyang Hu

    2015-01-01

    Objective: This study aimed to use a systematic approach to evaluate the current utilization, safety, and effectiveness of cell therapies for neurological diseases in human. And review the present regulations, considering United States (US) as a representative country, for cell transplantation in neurological disease and discuss the challenges facing the field of neurology in the coming decades. Methods:A detailed search was performed in systematic literature reviews of cellular‐based therapies in neurological diseases, using PubMed, web of science, and clinical trials. Regulations of cell therapy products used for clinical trials were searched from the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). Results: Seven most common types of cell therapies for neurological diseases have been reported to be relatively safe with varying degrees of neurological recovery. And a series of regulations in US for cellular therapy was summarized including preclinical evaluations, sourcing material, stem cell manufacturing and characterization, cell therapy product, and clinical trials. Conclusions:Stem cell‐based therapy holds great promise for a cure of such diseases and will value a growing population of patients. However, regulatory permitting activity of the US in the sphere of stem cells, technologies of regenerative medicine and substitutive cell therapy are selective, theoretical and does not fit the existing norm and rules. Compiled well‐defined regulations to guide the application of stem cell products for clinical trials should be formulated.

  11. Anti-Terrorism Authority Under the Laws of the United Kingdom and the United States

    National Research Council Canada - National Science Library

    Feikert, Clare; Doyle, Charles

    2006-01-01

    This is a comparison of the laws of the United Kingdom and of the United States that govern criminal and intelligence investigations of terrorist activities Both systems rely upon a series of statutory authorizations...

  12. 76 FR 38700 - United States, et al.

    Science.gov (United States)

    2011-07-01

    ... prices in advertisements, in-store displays, and online. Consumer World believes these rules should be... has ruled on that motion. I. Procedural History The United States and seven Plaintiff States filed the... Restraints result in higher merchant costs, and merchants generally pass costs on to consumers, retail prices...

  13. We really need to talk: adapting FDA processes to rapid change.

    Science.gov (United States)

    Lykken, Sara

    2013-01-01

    The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.

  14. THPdb: Database of FDA-approved peptide and protein therapeutics.

    Directory of Open Access Journals (Sweden)

    Salman Sadullah Usmani

    Full Text Available THPdb (http://crdd.osdd.net/raghava/thpdb/ is a manually curated repository of Food and Drug Administration (FDA approved therapeutic peptides and proteins. The information in THPdb has been compiled from 985 research publications, 70 patents and other resources like DrugBank. The current version of the database holds a total of 852 entries, providing comprehensive information on 239 US-FDA approved therapeutic peptides and proteins and their 380 drug variants. The information on each peptide and protein includes their sequences, chemical properties, composition, disease area, mode of activity, physical appearance, category or pharmacological class, pharmacodynamics, route of administration, toxicity, target of activity, etc. In addition, we have annotated the structure of most of the protein and peptides. A number of user-friendly tools have been integrated to facilitate easy browsing and data analysis. To assist scientific community, a web interface and mobile App have also been developed.

  15. 75 FR 10561 - Pricing for 2010 United States Mint America the Beautiful QuartersTM

    Science.gov (United States)

    2010-03-08

    ... DEPARTMENT OF THE TREASURY United States Mint Pricing for 2010 United States Mint America the Beautiful Quarters\\TM\\ Two-Roll Set, etc. AGENCY: United States Mint, Department of the Treasury. ACTION: Notice. SUMMARY: The United States Mint is announcing the price of the 2010 United States Mint America...

  16. 78 FR 77103 - United States Travel and Tourism Advisory Board

    Science.gov (United States)

    2013-12-20

    ... DEPARTMENT OF COMMERCE International Trade Administration United States Travel and Tourism... extended deadline for application for membership on the United States Travel and Tourism Advisory Board... Travel and Tourism Advisory Board (Board). The November 25, 2013 notice provided that all applications...

  17. State of pine decline in the southeastern United States

    Science.gov (United States)

    Lori Eckhardt; Mary Anne Sword Sayer; Don Imm

    2010-01-01

    Pine decline is an emerging forest health issue in the southeastern United States. Observations suggest pine decline is caused by environmental stress arising from competition, weather, insects and fungi, anthropogenic disturbances, and previous management. The problem is most severe for loblolly pine on sites that historically supported longleaf pine, are highly...

  18. 78 FR 53426 - United States Travel and Tourism Advisory Board Charter Renewal

    Science.gov (United States)

    2013-08-29

    ... DEPARTMENT OF COMMERCE International Trade Administration United States Travel and Tourism... for the United States Travel and Tourism Advisory Board on August 19, 2013. DATES: The Charter for the United States Travel and Tourism Advisory Board was renewed on August 19, 2013. FOR FURTHER INFORMATION...

  19. Summary of Notifiable Diseases, United States. Volume 45, Number 53.

    Science.gov (United States)

    1997-10-31

    Trichinosis Tuberculosis Typhoid fever Yellow fever NOTE: Although varicella is not a nationally notifiable disease, the Council of State and...plague among humans, two of which were fatal, were re- ported in the United States (two cases in Arizona, one in Colorado, and two in New Mexico ). Both...13 cases per year) were reported in the United States. Of these cases, 80% occurred in the southwestern states of New Mexico , Arizona, and

  20. Forest carbon management in the United States: 1600-2100

    Science.gov (United States)

    Richard A. Birdsey; Kurt Pregitzer; Alan Lucier

    2006-01-01

    This paper reviews the effects of past forest management on carbon stocks in the United States, and the challenges for managing forest carbon resources in the 21st century. Forests in the United States were in approximate carbon balance with the atmosphere from 1600-1800. Utilization and land clearing caused a large pulse of forest carbon emissions during the 19th...

  1. NCHS - Births and General Fertility Rates: United States

    Data.gov (United States)

    U.S. Department of Health & Human Services — This dataset includes crude birth rates and general fertility rates in the United States since 1909. The number of states in the reporting area differ historically....

  2. Genetic Characterization of Fungi Isolated from the Environmental Swabs collected from a Compounding Center Known to Cause Multistate Meningitis Outbreak in United States Using ITS Sequencing

    Directory of Open Access Journals (Sweden)

    Irshad M. Sulaiman

    2014-08-01

    Full Text Available A multistate fungal meningitis outbreak started in September of 2012 which spread in 20 states of the United States. The outbreak has been fatal so far, and has affected 751 individuals with 64 deaths among those who received contaminated spinal injections manufactured by a Compounding Center located in Massachusetts. In a preliminary study, Food and Drug Administration (FDA investigated the outbreak in collaboration with Centers for Disease Control and Prevention (CDC, state and local health departments, and identified four fungal and several bacterial contaminations in the recalled unopened injection vials. This follow-up study was carried out to assess DNA sequencing of the ITS1 region of rRNA gene for rapid identification of fungal pathogens during public health outbreak investigations. A total of 26 environmental swabs were collected from several locations at the manufacturing premises of the Compounding Center known to have caused the outbreak. The swab samples were initially examined by conventional microbiologic protocols and a wide range of fungal species were recovered. Species-identification of these microorganisms was accomplished by nucleotide sequencing of ITS1 region of rRNA gene. Analysis of data confirmed 14 additional fungal species in the swabs analyzed.

  3. Green electricity policies in the United States: case study

    International Nuclear Information System (INIS)

    Menz, Fredric C.

    2005-01-01

    While there has been interest in promoting the use of renewable energy in electricity production for a number of years in the United States, the market share of non-hydro renewable energy sources in electricity production has remained at about 2 percent over the past decade. The paper reviews the principal energy resources used for electricity production, considers the changing regulatory environment for the electricity industry, and describes government policies that have been used to promote green electricity in the United States, with an emphasis on measures adopted by state governments. Factors influencing the development of green power markets are also discussed, including underlying economic issues, public policy measures, the regulatory environment, external costs, and subsidies. Without significant increases in fossil fuel prices, much more stringent environmental regulations, or significant changes in electricity customer preferences, green electricity markets are likely to develop slowly in the United States

  4. 78 FR 70275 - United States Travel and Tourism Advisory Board

    Science.gov (United States)

    2013-11-25

    ... DEPARTMENT OF COMMERCE International Trade Administration United States Travel and Tourism... an opportunity to apply for membership on the United States Travel and Tourism Advisory Board... Travel and Tourism Advisory Board (Board). The purpose of the Board is to advise the Secretary of...

  5. Veterinary Fusarioses within the United States

    Science.gov (United States)

    Multilocus DNA sequence data was used to retrospectively assess the genetic diversity and evolutionary relationships of 67 Fusarium strains from veterinary sources, most of which were from the United States. Molecular phylogenetic analyses revealed that the strains comprised 23 phylogenetically dist...

  6. Low-level radioactive waste disposal technologies used outside the United States

    International Nuclear Information System (INIS)

    Templeton, K.J.; Mitchell, S.J.; Molton, P.M.; Leigh, I.W.

    1994-01-01

    Low-level radioactive waste (LLW) disposal technologies are an integral part of the waste management process. In the United States, commercial LLW disposal is the responsibility of the State or groups of States (compact regions). The United States defines LLW as all radioactive waste that is not classified as spent nuclear fuel, high- level radioactive waste, transuranic waste, or by-product material as defined in Section II(e)(2) of the Atomic Energy Act. LLW may contain some long-lived components in very low concentrations. Countries outside the United States, however, may define LLW differently and may use different disposal technologies. This paper outlines the LLW disposal technologies that are planned or being used in Canada, China, Finland, France, Germany, Japan, Sweden, Taiwan, and the United Kingdom (UK)

  7. Understanding how perceptions of tobacco constituents and the FDA relate to effective and credible tobacco risk messaging: A national phone survey of U.S. adults, 2014–2015

    Directory of Open Access Journals (Sweden)

    Marcella H. Boynton

    2016-06-01

    Full Text Available Abstract Background The passage of the 2009 Family Smoking Prevention and Tobacco Control Act has necessitated the execution of timely, innovative, and policy-relevant tobacco control research to inform Food and Drug Administration (FDA regulatory and messaging efforts. With recent dramatic changes to tobacco product availability and patterns of use, nationally representative data on tobacco-related perceptions and behaviors are vital, especially for vulnerable populations. Methods The UNC Center for Regulatory Research on Tobacco Communication conducted a telephone survey with a national sample of adults ages 18 and older living in the United States (U.S.. The survey assessed regulatory relevant factors such as tobacco product use, tobacco constituent perceptions, and tobacco regulatory agency credibility. The study oversampled high smoking/low income areas as well as cell phone numbers to ensure adequate representation among smokers and young adults, respectively. Coverage extended to approximately 98 % of U.S. households. Results The final dataset (N = 5,014 generated weighted estimates that were largely comparable to other national demographic and tobacco use estimates. Results revealed that over one quarter of U.S. adults, and over one third of smokers, reported having looked for information about tobacco constituents in cigarette smoke; however, the vast majority was unaware of what constituents might actually be present. Although only a minority of people reported trust in the federal government, two thirds felt that the FDA can effectively regulate tobacco products. Conclusions As the FDA continues their regulatory and messaging activities, they should expand both the breadth and availability of constituent-related information, targeting these efforts to reach all segments of the U.S. population, especially those disproportionately vulnerable to tobacco product use and its associated negative health outcomes.

  8. Pakistan: Can the United States Secure an Insecure State?

    Science.gov (United States)

    2010-01-01

    do not have female staff; the male-to-female staff ratio in the health field is 7 to 1.130 More nurses and female staff are needed, especially to...exercise was rescheduled for 2009. 9 Interview with Ninth Air Force personnel, September 12, 2008. 200 Pakistan: Can the United States Secure an Insecure

  9. The hydroelectric power market in the United States

    International Nuclear Information System (INIS)

    2002-01-01

    The second-largest producer of hydroelectric power in the world is the United States, right after Canada. In the United States, 7.1 per cent of net electricity generation was attributed to hydroelectric power in 2000, which totalled 269 terawatt hours (TWh). Aging facilities, outdated technology in some facilities, a cumbersome licensing process, and increasing environmental demands from interest groups for the preservation of river systems and surrounding wildlife challenge the industry. Pacific Coast states, especially California, were faced with electric power shortages during the summer of 2001, due to low market prices, high power usage among consumers and drought. The problems with the deregulation of the electricity market were brought to light by these shortages. Legislation to restructure the electric power industry in 25 states had not been enacted as of January 2002. The purchase of more power from both Canada and the Mexico is being considered by the government of the United States, as is the creation of a national power grid to allow for power transmission throughout the country. The Canada-United States energy trade might be affected by such a move, and result in project construction opportunities for Canadian companies. Renewable energy sources must be responsible for the generation of 10 per cent of power generation levels by 2020, on a gradual basis as mandated by law. By 2005, New York City must purchase 10 per cent of its power from renewable energy sources, reaching 20 per cent by 2010. The repair and replacement of aging dam equipment, the development of advanced turbine technology to protect fish stocks and water quality, dam removal, the construction of power lines are all opportunities open to Canadian companies. 60 refs., 5 tabs

  10. Research and photovoltaic industry at the United States

    International Nuclear Information System (INIS)

    Lerouge, Ch.; Herino, R.; Delville, R.; Allegre, R.

    2006-06-01

    For a big country as the United States, the solar energy can be a solution for the air quality improvement, the greenhouse gases fight and the reduction of the dependence to the imported petroleum and also for the economic growth by the increase of the employment in the solar industry sector. This document takes stock on the photovoltaic in the United States in the industrial and research domains. The american photovoltaic industry is the third behind the Japan and the Germany. (A.L.B.)

  11. Usefulness of [18F]-DA and [18F]-DOPA for PET imaging in a mouse model of pheochromocytoma

    International Nuclear Information System (INIS)

    Martiniova, Lucia; Cleary, Susannah; Lai, Edwin W.; Kiesewetter, Dale O.; Seidel, Jurgen; Dawson, Linda F.; Phillips, Jacqueline K.; Thomasson, David; Chen Xiaoyuan; Eisenhofer, Graeme; Powers, James F.; Kvetnansky, Richard

    2012-01-01

    Purpose: To evaluate the usefulness of [ 18 F]-6-fluorodopamine ([ 18 F]-DA) and [ 18 F]-L-6-fluoro-3,4-dihydroxyphenylalanine ([ 18 F]-DOPA) positron emission tomography (PET) in the detection of subcutaneous (s.c.) and metastatic pheochromocytoma in mice; to assess the expression of the norepinephrine transporter (NET) and vesicular monoamine transporters 1 and 2 (VMAT1 and VMAT2), all important for [ 18 F]-DA and [ 18 F]-DOPA uptake. Furthermore, to compare tumor detection by micro-computed tomography (microCT) to magnetic resonance imaging (MRI) in individual mouse. Methods: SUV max values were calculated from [ 18 F]-DA and [ 18 F]-DOPA PET, tumor-to-liver ratios (TLR) were obtained and expression of NET, VMAT1 and VMAT2 was evaluated. Results: [ 18 F]-DA detected less metastatic lesions compared to [ 18 F]-DOPA. TLR values for liver metastases were 2.26–2.71 for [ 18 F]-DOPA and 1.83–2.83 for [ 18 F]-DA. A limited uptake of [ 18 F]-DA was found in s.c. tumors (TLR=0.22-0.27) compared to [ 18 F]-DOPA (TLR=1.56-2.24). Overall, NET and VMAT2 were expressed in all organ and s.c. tumors. However, s.c. tumors lacked expression of VMAT1. We confirmed [ 18 F]-DA's high affinity for the NET for its uptake and VMAT1 and VMAT2 for its storage and retention in pheochromocytoma cell vesicles. In contrast, [ 18 F]-DOPA was found to utilize only VMAT2. Conclusion: MRI was superior in the detection of all organ tumors compared to microCT and PET. [ 18 F]-DOPA had overall better sensitivity than [ 18 F]-DA for the detection of metastases. Subcutaneous tumors were localized only with [ 18 F]-DOPA, a finding that may reflect differences in expression of VMAT1 and VMAT2, perhaps similar to some patients with pheochromocytoma where [ 18 F]-DOPA provides better visualization of lesions than [ 18 F]-DA.

  12. The Food and Drug Administration and Drug Legalization: A Brief Model of Regulation

    OpenAIRE

    Kalam, Murad

    2002-01-01

    This paper offers a brief model of FDA regulation of currently illegal narcotics in the United States. Given that nearly three out of four Americans believe that the drug war has failed, recent calls from prominent liberal and conservative thinkers to legalize drugs, and state “compassionate use†ballot initiatives, future drug legalization is at least conceivable in the United States. Yet, how would the FDA regulate NLD’s under its current st...

  13. State cigarette minimum price laws - United States, 2009.

    Science.gov (United States)

    2010-04-09

    Cigarette price increases reduce the demand for cigarettes and thereby reduce smoking prevalence, cigarette consumption, and youth initiation of smoking. Excise tax increases are the most effective government intervention to increase the price of cigarettes, but cigarette manufacturers use trade discounts, coupons, and other promotions to counteract the effects of these tax increases and appeal to price-sensitive smokers. State cigarette minimum price laws, initiated by states in the 1940s and 1950s to protect tobacco retailers from predatory business practices, typically require a minimum percentage markup to be added to the wholesale and/or retail price. If a statute prohibits trade discounts from the minimum price calculation, these laws have the potential to counteract discounting by cigarette manufacturers. To assess the status of cigarette minimum price laws in the United States, CDC surveyed state statutes and identified those states with minimum price laws in effect as of December 31, 2009. This report summarizes the results of that survey, which determined that 25 states had minimum price laws for cigarettes (median wholesale markup: 4.00%; median retail markup: 8.00%), and seven of those states also expressly prohibited the use of trade discounts in the minimum retail price calculation. Minimum price laws can help prevent trade discounting from eroding the positive effects of state excise tax increases and higher cigarette prices on public health.

  14. 75 FR 78338 - Meeting of the United States-Oman Joint Forum on Environmental Cooperation Pursuant to the United...

    Science.gov (United States)

    2010-12-15

    ... DEPARTMENT OF STATE [Public Notice 7261] Meeting of the United States-Oman Joint Forum on Environmental Cooperation Pursuant to the United States-Oman Memorandum of Understanding on Environmental Cooperation ACTION: Notice of the meeting of the U.S.-Oman Joint Forum on Environmental Cooperation and...

  15. 77 FR 27669 - Modifications to Definition of United States Property

    Science.gov (United States)

    2012-05-11

    ... contracts. The temporary regulations provide that certain obligations of United States persons arising from upfront payments made by controlled foreign corporations pursuant to contracts that are cleared by a... the meaning of section 956(c)) for obligations of United States persons arising from certain upfront...

  16. Contemporary United States Foreign Policy Towards Indonesia

    National Research Council Canada - National Science Library

    McAslan, Hugh

    2004-01-01

    United States national interests in Indonesia have traditionally being based on strategic security requirements given Indonesia's geographic location between the Indian and Pacific Oceans, and strong...

  17. Employers mexican migrants in the United States

    Directory of Open Access Journals (Sweden)

    Eduardo Fernández Guzmán

    2013-09-01

    Full Text Available You might think that by definition the migrant labor plays in less profitable niches and meager social mobility. However, a large group of migrants in different economically developed countries have successfully launched businesses of diverse nature and volume. This is why entrepreneurship of migrants is an issue that has received increasing attention in recent years. Compared to other immigrant groups in the United States, Mexicans show low levels of entrepreneurial activity. The aim of this paper is to, through a general literature review of official statistical data, a preliminary analysis of mexican migrant entrepreneurship in the United States, that is to say in recent years has been growing in importance.

  18. Motorcycle trends in the United States

    Science.gov (United States)

    2009-05-01

    During the last decade there has been a significant increase in the number of motorcycle sales and registrations in the United States. At the same time there has been a shift in the demographics of motorcycle users and increased focus on motorcycle s...

  19. THE UNITED STATES AND NIGERIAN RELATIONS:

    African Journals Online (AJOL)

    Mrs. I.D

    2009-12-25

    Dec 25, 2009 ... response from the Nigerian government. ... domestic crises that negatively impacts state stability, the US government ... Harrison C. Ajebon, Department of Political Science, University of Calabar, ..... Sweden. United Kingdom. Switzerland. Asia & far East. Japan ..... case Study of Nigeria, in Ikonnechidi and.

  20. 37 CFR 1.416 - The United States International Preliminary Examining Authority.

    Science.gov (United States)

    2010-07-01

    ... STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES International Processing Provisions General Information § 1.416 The United States International Preliminary... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false The United States...

  1. 31 CFR Appendix C to Subpart C of... - United States Customs Service

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false United States Customs Service C... Customs Service 1. In general. This appendix applies to the United States Customs Service. It sets forth... records and accounting of disclosures. (a) For records which are maintained at the United States Customs...

  2. FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.

    Science.gov (United States)

    James, J S

    1998-03-06

    The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.

  3. The State of Homeless Children in the United States

    Science.gov (United States)

    Kabler, Brenda; Weinstein, Elana

    2009-01-01

    Across America, the numbers of homeless children and families are growing as a result of many factors including the recent economic crisis, home foreclosures, and natural disasters. Because of an increase in the number of homeless children throughout the United States, this population has unmet needs that can be targeted in school settings under…

  4. 78 FR 53478 - Proposed Information Collection; United States Park Police Personal History Statement

    Science.gov (United States)

    2013-08-29

    ...] Proposed Information Collection; United States Park Police Personal History Statement AGENCY: National Park... about this IC, contact Major Scott Fear, United States Park Police, 1100 Ohio Drive SW., Washington, DC... INFORMATION: I. Abstract The United States Park Police (USPP) is a unit of the National Park Service...

  5. 44 CFR 351.26 - The United States Department of Agriculture.

    Science.gov (United States)

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false The United States Department of Agriculture. 351.26 Section 351.26 Emergency Management and Assistance FEDERAL EMERGENCY... PREPAREDNESS Interagency Assignments § 351.26 The United States Department of Agriculture. (a) Assist FEMA in...

  6. Fragmented patterns of flood change across the United States

    Science.gov (United States)

    Archfield, Stacey A.; Hirsch, Robert M.; Viglione, A.; Blöschl, G.

    2016-01-01

    Trends in the peak magnitude, frequency, duration, and volume of frequent floods (floods occurring at an average of two events per year relative to a base period) across the United States show large changes; however, few trends are found to be statistically significant. The multidimensional behavior of flood change across the United States can be described by four distinct groups, with streamgages experiencing (1) minimal change, (2) increasing frequency, (3) decreasing frequency, or (4) increases in all flood properties. Yet group membership shows only weak geographic cohesion. Lack of geographic cohesion is further demonstrated by weak correlations between the temporal patterns of flood change and large-scale climate indices. These findings reveal a complex, fragmented pattern of flood change that, therefore, clouds the ability to make meaningful generalizations about flood change across the United States.

  7. Media Education in the United States: A Check under the "Gestalt" Hood.

    Science.gov (United States)

    Phillips, Melissa

    1998-01-01

    Examines four commonalities of media education in the United States. Outlines the four ideological perspectives that in fact guide media education in the United States: celebration, protectionism, cultural criticism, and educated consumerism. Suggests what all of this means for the future of media education in the United States and what will be…

  8. Prevalence, level and distribution of Salmonella in shipments of imported capsicum and sesame seed spice offered for entry to the United States: observations and modeling results.

    Science.gov (United States)

    Van Doren, Jane M; Blodgett, Robert J; Pouillot, Régis; Westerman, Ann; Kleinmeier, Daria; Ziobro, George C; Ma, Yinqing; Hammack, Thomas S; Gill, Vikas; Muckenfuss, Martin F; Fabbri, Linda

    2013-12-01

    In response to increased concerns about spice safety, the United States Food and Drug Administration (FDA) initiated research to characterize the prevalence and levels of Salmonella in imported spices. 299 imported dried capsicum shipments and 233 imported sesame seed shipments offered for entry to the United States were sampled. Observed Salmonella shipment prevalence was 3.3% (1500 g examined; 95% CI 1.6-6.1%) for capsicum and 9.9% (1500 g; 95% Confidence Interval (CI) 6.3-14%) for sesame seed. Within shipment contamination was not inconsistent with a Poisson distribution. Shipment mean Salmonella level estimates among contaminated shipments ranged from 6 × 10(-4) to 0.09 (capsicum) or 6 × 10(-4) to 0.04 (sesame seed) MPN/g. A gamma-Poisson model provided the best fit to observed data for both imported shipments of capsicum and imported shipments of sesame seed sampled in this study among the six parametric models considered. Shipment mean levels of Salmonella vary widely between shipments; many contaminated shipments contain low levels of contamination. Examination of sampling plan efficacy for identifying contaminated spice shipments from these distributions indicates that sample size of spice examined is critical. Sampling protocols examining 25 g samples are predicted to be able to identify a small fraction of contaminated shipments of imported capsicum or sesame seeds. Published by Elsevier Ltd.

  9. 7 CFR 58.2825 - United States Standard for ice cream.

    Science.gov (United States)

    2010-01-01

    ... AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT... DAIRY PRODUCTS 1 United States Department of Agriculture Standard for Ice Cream § 58.2825 United States... from the use of bulky optional ingredients, chocolate and cocoa solids used shall be considered the...

  10. 22 CFR 61.8 - Coordination with United States Customs Service.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Coordination with United States Customs Service... FREE FLOW OF AUDIO-VISUAL MATERIALS § 61.8 Coordination with United States Customs Service. (a) Nothing in this part shall preclude examination of imported materials pursuant to the Customs laws and...

  11. 49 CFR 24.208 - Aliens not lawfully present in the United States.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Aliens not lawfully present in the United States... Requirements § 24.208 Aliens not lawfully present in the United States. (a) Each person seeking relocation... of an individual, that he or she is either a citizen or national of the United States, or an alien...

  12. Environmental performance reviews: United States

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2006-01-15

    This book presents OECD assessments and recommendations regarding the United States' effort to manage its environment including air, water nature, and biodiversity to do this in a sustainable manner; and to do this in co-operation with its global neighbours. In particular, it assesses progress made since 1996, when OECD's previous review on the US was done. 40 figs., 21 tabs.

  13. Consumer bankruptcy law for Ethiopia: Lessons from United States ...

    African Journals Online (AJOL)

    After deregulation of consumer credit and resultant availability, ... Germany, United States, United Kingdom and France are some of the countries ... social insurance, development policy and rehabilitative function of discharge and fresh start.

  14. United States - Japanese nuclear relations: implications for the pacific region

    International Nuclear Information System (INIS)

    Suttmeier, R.P.

    1980-01-01

    The initiation of a new approach to non-proliferation policy by the United States in 1977 was the most upsetting development in the history of US-Japanese nuclear relations. The policy has seemingly altered Japanese views of its own nuclear future very little, yet it has altered the tone of the nuclear relationship with the United States. Recent Japanese nuclear power developments, both technical and administrative, are outlined and the prospects for the future of the United States-Japanese nuclear relationship and for Pacific regional cooperation assessed. Issues of importance in the relationship include reprocessing - enrichment, plutonium management, spent fuel and waste management and uranium supplies

  15. 46 CFR 153.12 - IMO Certificates for United States Ships.

    Science.gov (United States)

    2010-10-01

    ... 8, or the Officer in Charge, Marine Inspection, issues a United States ship an IMO Certificate... 46 Shipping 5 2010-10-01 2010-10-01 false IMO Certificates for United States Ships. 153.12 Section... CARGOES SHIPS CARRYING BULK LIQUID, LIQUEFIED GAS, OR COMPRESSED GAS HAZARDOUS MATERIALS General § 153.12...

  16. Fisher, Neyman, and Bayes at FDA.

    Science.gov (United States)

    Rubin, Donald B

    2016-01-01

    The wise use of statistical ideas in practice essentially requires some Bayesian thinking, in contrast to the classical rigid frequentist dogma. This dogma too often has seemed to influence the applications of statistics, even at agencies like the FDA. Greg Campbell was one of the most important advocates there for more nuanced modes of thought, especially Bayesian statistics. Because two brilliant statisticians, Ronald Fisher and Jerzy Neyman, are often credited with instilling the traditional frequentist approach in current practice, I argue that both men were actually seeking very Bayesian answers, and neither would have endorsed the rigid application of their ideas.

  17. China’s international trade and air pollution in the United States

    Science.gov (United States)

    Lin, Jintai; Pan, Da; Davis, Steven J.; Zhang, Qiang; He, Kebin; Wang, Can; Streets, David G.; Wuebbles, Donald J.; Guan, Dabo

    2014-01-01

    China is the world’s largest emitter of anthropogenic air pollutants, and measurable amounts of Chinese pollution are transported via the atmosphere to other countries, including the United States. However, a large fraction of Chinese emissions is due to manufacture of goods for foreign consumption. Here, we analyze the impacts of trade-related Chinese air pollutant emissions on the global atmospheric environment, linking an economic-emission analysis and atmospheric chemical transport modeling. We find that in 2006, 36% of anthropogenic sulfur dioxide, 27% of nitrogen oxides, 22% of carbon monoxide, and 17% of black carbon emitted in China were associated with production of goods for export. For each of these pollutants, about 21% of export-related Chinese emissions were attributed to China-to-US export. Atmospheric modeling shows that transport of the export-related Chinese pollution contributed 3–10% of annual mean surface sulfate concentrations and 0.5–1.5% of ozone over the western United States in 2006. This Chinese pollution also resulted in one extra day or more of noncompliance with the US ozone standard in 2006 over the Los Angeles area and many regions in the eastern United States. On a daily basis, the export-related Chinese pollution contributed, at a maximum, 12–24% of sulfate concentrations over the western United States. As the United States outsourced manufacturing to China, sulfate pollution in 2006 increased in the western United States but decreased in the eastern United States, reflecting the competing effect between enhanced transport of Chinese pollution and reduced US emissions. Our findings are relevant to international efforts to reduce transboundary air pollution. PMID:24449863

  18. The United States and world energy markets

    International Nuclear Information System (INIS)

    Ramsay, W.C.

    1992-01-01

    The United States, dominating the world's energy markets as a producer and consumer, is sensitive to changes in this market and intends to influence the development of global energy policy. Supply will be increased by nations such as Venezuela, Indonesia and perhaps in the future a United Yemen and the Commonwealth of Independent States, moving to freer market economies which will allow investment opportunities previously inaccessible to foreign companies. Although world energy demand will grow, little of this will be in the US where, under the National Energy Strategy, comprehensive measures are being introduced to improve energy efficiency. The US energy security will be further improved by such measures as diversification of supply, larger domestic production and increasing interdependence between suppliers, traders and consumers. (author)

  19. The financial burden of out-of-pocket expenses in the United States and Canada: How different is the United States?

    Directory of Open Access Journals (Sweden)

    Katherine E Baird

    2016-01-01

    Full Text Available Background: This article compares the burden that medical cost-sharing requirements place on households in the United States and Canada. It estimates the probability that individuals with similar demographic features in the two countries have large medical expenses relative to income. Method: The study uses 2010 nationally representative household survey data harmonized for cross-national comparisons to identify individuals with high medical expenses relative to income. Using logistic regression, it estimates the probability of high expenses occurring among 10 different demographic groups in the two countries. Results: The results show the risk of large medical expenses in the United States is 1.5–4 times higher than it is in Canada, depending on the demographic group and spending threshold used. The United States compares least favorably when evaluating poorer citizens and when using a higher spending threshold. Conclusion: Recent health care reforms can be expected to reduce Americans’ catastrophic health expenses, but it will take very large reductions in out-of-pocket expenditures—larger than can be expected—if poorer and middle-class families are to have the financial protection from high health care costs that their counterparts in Canada have.

  20. GEOPOLITICS AND TRANSPORTATION. UNITED STATES AND PANAMA CANAL

    Directory of Open Access Journals (Sweden)

    Benea Ciprian Beniamin

    2009-05-01

    Full Text Available This article presents the great connection which exists between the realization of Panama Canal and the rising power on United States; and how this state, after the construction of this canal, could promote efficiently at global level its interests.

  1. A Descriptive Longitudinal Study of Changes in Vape Shop Characteristics and Store Policies in Anticipation of the 2016 FDA Regulations of Tobacco Products, Including E-Cigarettes.

    Science.gov (United States)

    Yu, Sheila; Escobedo, Patricia; Garcia, Robert; Cruz, Tess Boley; Unger, Jennifer B; Baezconde-Garbanati, Lourdes; Meza, Leah; Sussman, Steve

    2018-02-11

    After proposing the "Deeming Rule" in 2014, the U.S. Food and Drug Administration (FDA) began regulating the manufacturing, marketing, and sales of electronic cigarette (e-cigarette) products as tobacco products in 2016. The current study conducted vape shop store observations and surveyed Los Angeles-area shop employees (assessing their beliefs, awareness, and perceptions of e-cigarettes and related FDA regulations) at two time points one year apart to better understand what vape shop retailers would do given FDA's soon-to-be-enacted Deeming Rule. The study also compared retailer beliefs/awareness/actions and store characteristics immediately after the Deeming Rule proposal versus a year after the Rule had been proposed, right before its enactment. Two data collection waves occurred before the Deeming Rule enactment, with Year 1 surveying 77 shops (2014) and Year 2 surveying 61 shops (2015-2016). Between the data collection points, 16 shops had closed. Among the shops that were open at both time points, the majority (95% in Year 1; 74% in Year 2) were aware of some FDA regulations or other policies applying to vape shops. However, overall awareness of FDA regulations and state/local policies governing e-cigarettes significantly decreased from Year 1 to Year 2. At both time points, all shops offered customers free puffs of nicotine-containing e-liquids (prohibited by the then upcoming Deeming Rule). Perceptions of e-cigarette safety also significantly decreased between the years. Exploring vape shop retailer perceptions and store policies (i.e., free puffs/samples displays, perceptions of e-cigarette safety, etc.) over time will help the FDA assess the needs of the vape shop community and develop more effective retailer education campaigns and materials targeted to increase compliance with the newly enacted regulations.

  2. Improving the United States' Strategic Communication Strategy

    National Research Council Canada - National Science Library

    Risberg, Robert H

    2008-01-01

    ...? Much of the answer to this question is the failure of the United States Government to effectively use strategic communication to inform and influence populations to recognize the value of American...

  3. Nickel recycling in the United States in 2004

    Science.gov (United States)

    Goonan, Thomas G.

    2009-01-01

    As one of a series of reports that describe the recycling of metal commodities in the United States, this report discusses the flow of nickel from production through distribution and use, with particular emphasis on the recycling of industrial scrap (new scrap) and used products (old scrap) in 2004. This materials flow study includes a description of nickel supply and demand for the United States to illustrate the extent of nickel recycling and to identify recycling trends. Understanding how materials flow from a source through disposition can aid in improving the management of natural resource delivery systems. In 2004, the old scrap recycling efficiency for nickel was estimated to be 56.2 percent. In 2004, nickel scrap consumption in the United States was as follows: new scrap containing 13,000 metric tons (t) of nickel (produced during the manufacture of products), 12 percent; and old scrap containing 95,000 t of nickel (articles discarded after serving a useful purpose), 88 percent. The recycling rate for nickel in 2004 was 40.9 percent, and the percentage of nickel in products attributed to nickel recovered from nickel-containing scrap was 51.6 percent. Furthermore, U.S. nickel scrap theoretically generated in 2004 had the following distribution: scrap to landfills, 24 percent; recovered and used scrap, 50 percent; and unaccounted for scrap, 26 percent. Of the 50 percent of old scrap generated in the United States that was recovered and then used in 2004, about one-third was exported and two-thirds was consumed in the domestic production of nickel-containing products.

  4. Three Drugs Approved for Urothelial Carcinoma by FDA.

    Science.gov (United States)

    2017-07-01

    The FDA has approved one PD-1 checkpoint inhibitor, pembrolizumab, and two PD-L1 checkpoint inhibitors, avelumab and durvalumab, to treat metastatic urothelial carcinoma in patients whose disease continues to progress despite platinum-based chemotherapy. This brings the total number of checkpoint inhibitors for the disease to five, prompting questions about how best to use them. ©2017 American Association for Cancer Research.

  5. School Autonomy: A Comparison between China and the United States

    Science.gov (United States)

    Xia, Jiangang; Gao, Xingyuan; Shen, Jianping

    2017-01-01

    This study examined and compared school autonomy in China and the United States. Based on the international PISA 2012 school data, the authors examined three aspects of school autonomy. We found that in comparison with the United States, (1) principals from China were less likely to have responsibility over eleven school decisions (hiring…

  6. 6 CFR 13.45 - Deposit in Treasury of United States.

    Science.gov (United States)

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Deposit in Treasury of United States. 13.45 Section 13.45 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY PROGRAM FRAUD CIVIL REMEDIES § 13.45 Deposit in Treasury of United States. All amounts collected pursuant to this part...

  7. 14 CFR 47.7 - United States citizens and resident aliens.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false United States citizens and resident aliens... AIRCRAFT AIRCRAFT REGISTRATION General § 47.7 United States citizens and resident aliens. (a) U.S. citizens... the application. (b) Resident aliens. An applicant for aircraft registration under 49 U.S.C. 44102 who...

  8. Promoting "Academic Entrepreneurship" in Europe and the United States

    DEFF Research Database (Denmark)

    Tvarnø, Christina D.; Bagley, Constance E.

    2016-01-01

    and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the European Union (“EU”) needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies...... States (“U.S.”). Our comparative analysis of the EU and U.S. approaches to translational medicine shows that there are lessons to be shared. The EU can apply the experiences from the U.S. Bayh-Dole Act and PPPPs in the United States, and the United States can emulate certain of the open innovation...

  9. The Energy Puzzle Between the United States and China

    Science.gov (United States)

    2013-03-01

    securing China’s status as a great power.2 As of 2011, China is the second largest consumer of natural resources (oil, liquefied petroleum gas ( LPG ...pursuit of natural resources, (oil, natural gas , coal or renewable energy sources) is reshaping the world’s energy security. The United States is...pursuit of natural resources, (oil, natural gas , coal or renewable energy sources) is reshaping the world’s energy security. The United States is

  10. Assisted Reproductive Technology Surveillance - United States, 2015.

    Science.gov (United States)

    Sunderam, Saswati; Kissin, Dmitry M; Crawford, Sara B; Folger, Suzanne G; Boulet, Sheree L; Warner, Lee; Barfield, Wanda D

    2018-02-16

    Since the first U.S. infant conceived with assisted reproductive technology (ART) was born in 1981, both the use of ART and the number of fertility clinics providing ART services have increased steadily in the United States. ART includes fertility treatments in which eggs or embryos are handled in the laboratory (i.e., in vitro fertilization [IVF] and related procedures). Although the majority of infants conceived through ART are singletons, women who undergo ART procedures are more likely than women who conceive naturally to deliver multiple-birth infants. Multiple births pose substantial risks for both mothers and infants, including obstetric complications, preterm delivery (state-specific information for the United States (including the District of Columbia and Puerto Rico) on ART procedures performed in 2015 and compares birth outcomes that occurred in 2015 (resulting from ART procedures performed in 2014 and 2015) with outcomes for all infants born in the United States in 2015. 2015. In 1995, CDC began collecting data on ART procedures performed in fertility clinics in the United States as mandated by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA) (Public Law 102-493 [October 24, 1992]). Data are collected through the National ART Surveillance System, a web-based data collection system developed by CDC. This report includes data from 52 reporting areas (the 50 states, the District of Columbia, and Puerto Rico). In 2015, a total of 182,111 ART procedures (range: 135 in Alaska to 23,198 in California) with the intent to transfer at least one embryo were performed in 464 U.S. fertility clinics and reported to CDC. These procedures resulted in 59,334 live-birth deliveries (range: 55 in Wyoming to 7,802 in California) and 71,152 infants born (range: 68 in Wyoming to 9,176 in California). Nationally, the number of ART procedures performed per 1 million women of reproductive age (15-44 years), a proxy measure of the ART utilization rate, was

  11. Chapter 16. Conservation status of great gray owls in the United States

    Science.gov (United States)

    Gregory D. Hayward

    1994-01-01

    Previous chapters outlined the biology and ecology of great gray owls as well as the ecology of this species in the western United States. That technical review provides the basis to assess the current conservation status of great gray owls in the United States. Are populations of great gray owls in the United States currently threatened? Are current land management...

  12. Outbreak of Salmonella Oslo Infections Linked to Persian Cucumbers - United States, 2016.

    Science.gov (United States)

    Bottichio, Lyndsay; Medus, Carlota; Sorenson, Alida; Donovan, Danielle; Sharma, Reeti; Dowell, Natasha; Williams, Ian; Wellman, Allison; Jackson, Alikeh; Tolar, Beth; Griswold, Taylor; Basler, Colin

    2016-12-30

    In April 2016, PulseNet, the national molecular subtyping network for foodborne disease surveillance, detected a multistate cluster of Salmonella enterica serotype Oslo infections with an indistinguishable pulsed-field gel electrophoresis (PFGE) pattern (XbaI PFGE pattern OSLX01.0090).* This PFGE pattern was new in the database; no previous infections or outbreaks have been identified. CDC, state and local health and agriculture departments and laboratories, and the Food and Drug Administration (FDA) conducted epidemiologic, traceback, and laboratory investigations to identify the source of this outbreak. A total of 14 patients in eight states were identified, with illness onsets occurring during March 21-April 9, 2016. Whole genome sequencing, a highly discriminating subtyping method, was used to further characterize PFGE pattern OSLX01.0090 isolates. Epidemiologic evidence indicates Persian cucumbers as the source of Salmonella Oslo infections in this outbreak. This is the fourth identified multistate outbreak of salmonellosis associated with cucumbers since 2013. Further research is needed to understand the mechanism and factors that contribute to contamination of cucumbers during growth, harvesting, and processing to prevent future outbreaks.

  13. Regulations for radiochemical facilities in the United States

    International Nuclear Information System (INIS)

    Emeigh, Ch; Smith, B.; Williams, T

    1999-01-01

    Material control and accounting is implemented to provide assurance that physical protection measures have been effective, and in case they fail, to provide delayed detection of the loss. Regulations in the United States have been developed that include both performance and compliance requirements to provide a defence in depth approach addressing the unique characteristics of each facility. Regulations address administrative controls, material control and material accounting. Nuclear materials control and accounting plans are negotiated between regulatory agencies and facilities to develop a site-specific approach. An overview of the regulations and their implementation in the United State is provided [ru

  14. Platinum recycling in the United States in 1998

    Science.gov (United States)

    Hilliard, Henry E.

    2001-01-01

    In the United States, catalytic converters are the major source of secondary platinum for recycling. Other sources of platinum scrap include reforming and chemical process catalysts. The glass industry is a small but significant source of platinum scrap. In North America, it has been estimated that in 1998 more than 20,000 kilograms per year of platinum-group metals from automobile catalysts were available for recycling. In 1998, an estimated 7,690 kilograms of platinum were recycled in the United States. U.S. recycling efficiency was calculated to have been 76 percent in 1998; the recycling rate was estimated at 16 percent.

  15. 78 FR 46958 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

    Science.gov (United States)

    2013-08-02

    ... send a check by a courier such as Federal Express or United Parcel Service, the courier may deliver the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0007... of the Treasury notifies FDA of payment. U.S. Bank and the United States Treasury are required to...

  16. The independent nuclear state. The United States, Britain and the military atom

    International Nuclear Information System (INIS)

    Simpson, J.

    1983-01-01

    A chronological account and overview are presented of the 40-year history of British military research, development and production work in atomic energy. The United Kingdom's efforts in this field have always had close links with equivalent activities in the United States, and have often been conducted on a mutually co-operative basis. This book contains descriptions of the technical evolution of British nuclear weapon designs and production models, estimates of annual output figures for fissile material and weapon types, and indications of the nature of the weapon-testing programme. Decision-points are charted. The impact of the agreements with the United States, both upon weapon development and production programmes and upon stockpiling, is analysed, as well as their effects upon the nuclear submarine programme. The impact of later events upon Anglo-American relations is identified, together with the recent British attempts to move to a closer political association with Europe. The study concludes by evaluating the essential nature of four decades of United Kingdom military nuclear development, and identifying the practical limits imposed by past policies upon any attempt by a British government to implement a policy of unilateral nuclear disarmament. (author)

  17. Income Distribution Policy in the United States [and] Discussion Paper.

    Science.gov (United States)

    Okner, Benjamin A.; Rivlin, Alice M.

    The focus of this paper is inequality - primarily, income - inequality - in the United States and the historical-political context in which policies that affect inequality are being discussed. The first section gives a brief description of recent trends in the distribution of income in the United States, a picture whose most remarkable feature is…

  18. IAEA Completes Nuclear Security Review Mission in United States

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: A team of nuclear security experts led by the International Atomic Energy Agency (IAEA) today completed a mission to review nuclear security practices of civil nuclear facilities licensed by the United States Nuclear Regulatory Commission (NRC). Conducted at the U.S. Government's request, the two-week International Physical Protection Advisory Service (IPPAS) mission reviewed the United States' nuclear security-related legislative and regulatory framework. As part of this work, the IPPAS team, led by John O'Dacre of Canada and comprising nine experts from eight IAEA Member States, met with NRC officials and reviewed the physical protection systems at the Center for Neutron Research (NCNR) at the National Institute of Standards and Technology. The IPPAS team concluded that nuclear security within the U.S. civil nuclear sector is robust and sustainable and has been significantly enhanced in recent years. The team identified a number of good practices in the nation's nuclear security regime and at the NCNR. The IPPAS team also made a recommendation and some suggestions for the continuing improvement of nuclear security overall. The mission in the United States was the 60th IPPAS mission organized by the IAEA. 'Independent international peer reviews such as IAEA IPPAS missions are increasingly being recognized for their value as a key component for exchanges of views and advice on nuclear security measures', said Khammar Mrabit, Director of the IAEA Office of Nuclear Security. 'The good practices identified during this mission will contribute to the continuous improvements of nuclear security in other Member States'. The IPPAS team provided a draft report to the NRC and will submit a final report soon. Because it contains security-related information about a specific nuclear site, IPPAS reports are not made public. 'The IPPAS programme gives us a chance to learn from the experience and perspective of our international partners', said NRC Chairman Allison M

  19. 2009 United States Automatic Identification System Database

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The 2009 United States Automatic Identification System Database contains vessel traffic data for planning purposes within the U.S. coastal waters. The database is...

  20. 2014 United States Automatic Identification System Database

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The 2014 United States Automatic Identification System Database contains vessel traffic data for planning purposes within the U.S. coastal waters. The database is...

  1. 2012 United States Automatic Identification System Database

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The 2012 United States Automatic Identification System Database contains vessel traffic data for planning purposes within the U.S. coastal waters. The database is...

  2. 2010 United States Automatic Identification System Database

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The 2010 United States Automatic Identification System Database contains vessel traffic data for planning purposes within the U.S. coastal waters. The database is...

  3. 2011 United States Automatic Identification System Database

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The 2011 United States Automatic Identification System Database contains vessel traffic data for planning purposes within the U.S. coastal waters. The database is...

  4. Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.

    Science.gov (United States)

    Chen, Brian K; Yang, Y Tony; Cheng, Xi; Bian, John; Bennett, Charles L

    2016-01-01

    The United States Constitution protects the right of citizens to petition the government for "a redress of grievances." This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10-13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to "redress grievances."

  5. United Kingdom and United States Tourism Demand for Malaysia:A Cointegration Analysis

    OpenAIRE

    Habibi, Fateh; Abdul Rahim, Khalid; Chin, Lee

    2008-01-01

    Tourism industry has been an important contributor to the Malaysia economy. In this paper we inspect variations in the long run demand for tourism from United Kingdom and United States to Malaysia. The demand for tourism has been explained by macroeconomic variables, including income in origin countries, tourism prices in Malaysia, and travel cost between the two countries. Annual data from 1972 to 2006 are used for the analysis. Augmented Dickey-Fuller and Johansen’s maximum likelihood tests...

  6. Status of nuclear engineering education in the United States

    International Nuclear Information System (INIS)

    Brown, G.J.

    2000-01-01

    Nuclear engineering education in the United States is reflective of the perceived health of the nuclear electric power industry within the country. Just as new commercial reactor orders have vanished and some power plants have shut down, so too have university enrollments shrunk and research reactors closed. This decline in nuclear trained specialists and the disappearance of the nuclear infrastructure is a trend that must be arrested and reversed if the United States is to have a workforce capable of caring for a nuclear power industry to not only meet future electric demand but to ensure that the over 100 existing plants, their supporting facilities and their legacy in the form of high level waste and facility clean-up are addressed. Additionally, the United States has an obligation to support and maintain its nuclear navy and other defence needs. And, lastly, if the United States is to have a meaningful role in the international use of nuclear power with regard to safety, non-proliferation and the environment, then it is imperative that the country continues to produce world-class nuclear engineers and scientists by supporting nuclear engineering education at its universities. The continued support of the federal government. and industry for university nuclear engineering and nuclear energy research and development is essential to sustain the nuclear infrastructure in the United States. Even with this support, and the continued excellent operation of the existing fleet of nuclear electric power plants, it is conceivable that nuclear engineering as an academic discipline may fall victim to poor communications and a tarnished public image. What is needed is a combination of federal and industrial support along with the creativity of the universities to expand their offerings to include more than power production. The objective is a positive message on careers in nuclear related fields, and recognition of the important role of nuclear energy in meeting the country

  7. Aerosol container-related eye injuries in the United States: 1997-2009.

    Science.gov (United States)

    Seidman, Carly J; Linakis, James G; Mello, Michael J; Greenberg, Paul B

    2011-06-01

    To quantify and characterize eye injuries related to aerosol container consumer products treated in United States hospital emergency departments (EDs) from 1997 through 2009. Retrospective study. Descriptive analysis of aerosol container-related eye injury data derived from the National Electronic Injury Surveillance System, a stratified probability sample of hospital-affiliated United States EDs. Data collected included demographic variables (gender and age), locale, diagnoses, and hospital disposition associated with aerosol container-related eye injuries treated in United States EDs from 1997 through 2009. Products associated with injury and mechanisms of injury also were extracted and analyzed. There were an estimated 10 765 (95% confidence interval [CI], 9842 to 11 688) visits to United States EDs for aerosol container-related eye injuries during the study period; 6756 (95% CI, 5771 to 7742; 63%) patients were male; 5927 (95% CI, 4956 to 6897; 55%) injuries occurred in children (age container-related eye injuries in the United States occur in men and children and that self-inflicted spray to the eye is the most common mechanism of injury. Further research is needed to devise effective prevention strategies for these types of injuries. Published by Elsevier Inc.

  8. Right to experimental treatment: FDA new drug approval, constitutional rights, and the public's health.

    Science.gov (United States)

    Leonard, Elizabeth Weeks

    2009-01-01

    On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.

  9. Critical Concerns for Oral Communication Education in the United States and the United Kingdom

    Science.gov (United States)

    Emanuel, Richard

    2011-01-01

    An examination of oral communication education in the United States (U.S.) and United Kingdom (U.K.) identified four critical concerns: (1) Today's college students are not getting adequate oral communication education; (2) Oral communication education is being relegated to a "module" in another discipline-specific course; (3) When an…

  10. Forest management and water in the United States [Chapter 13

    Science.gov (United States)

    Daniel G. Neary

    2017-01-01

    This chapter outlines a brief history of the United States native forests and forest plantations. It describes the past and current natural and plantation forest distribution (map, area, main species), as well as main products produced (timber, pulp, furniture, etc.). Integrated into this discussion is a characterization of the water resources of the United States and...

  11. Continental integration and energy demand in the United States

    International Nuclear Information System (INIS)

    Manning, D.J.

    2004-01-01

    This presentation highlighted some of the major issues regarding energy demand in the United States and continental integration. The energy markets in Canada and the United States are economically integrated with large cross-border investment. Therefore, the energy infrastructure can be significantly affected by inconsistencies between the two countries in policy, regulatory processes and fiscal regimes. The author discussed the inelasticity in the natural gas demand in the United States in the near-term, and how natural gas consumption, particularly for power generation, is greater than North America's supply capacity. New supplies such as liquefied natural gas and arctic gas are needed to meet growing demands. The role of renewable energy technologies and energy efficiency was also discussed. It was emphasized that imbalances in supply and demand inevitably lead to price volatility and that high prices are a major obstacle to economic growth. tabs., figs

  12. Radioactive waste management in the United States

    International Nuclear Information System (INIS)

    Smiley, J.L.

    1985-01-01

    In the United States, efforts to dispose of the nation's high- and low-level radioactive wastes are based on somewhat different approaches.The individual States are responsible for disposing of low-level wastes with the Federal Government providing technical and financial support to help the States in the early phases of their efforts. The Federal Government has responsibility for developing facilities for the disposal of high-level waste. However, both efforts show a common need to meet national objectives while satisfying the concerns of the public. (author)

  13. The United States and Europe: Current Issues

    National Research Council Canada - National Science Library

    Archick, Kristin; Morelli, Vince L

    2006-01-01

    The United States and Europe share a long and intertwined history. Both sides of the Atlantic face a common set of international concerns, have few other comparable partners, and share a deep economic relationship...

  14. Policies Supporting Local Food in the United States

    Directory of Open Access Journals (Sweden)

    Steve W. Martinez

    2016-08-01

    Full Text Available Local food has been the subject of federal, state, and local government policies in recent years throughout the United States as consumer demand has grown. Local foods have been linked to several government priorities—including enhancing the rural economy, the environment, and supporting agricultural producers. This article provides an overview of U.S. Federal, State and regional policies designed to support local food systems. It details the latest economic information on policy, relying on findings from several national surveys and a synthesis of recent literature. Federal policies related to local food systems were greatly expanded by the 2008 Farm Bill, and are further expanded in the Agricultural Act of 2014. United States policies address several barriers to the further expansion of local food markets, including scaling up output of small farms to address the needs of larger commercial outlets, lack of infrastructure for increasing local food sales, ability to trace product source, and producer education regarding local food expansion.

  15. 21 CFR 1.101 - Notification and recordkeeping.

    Science.gov (United States)

    2010-04-01

    ..., during an inspection for review and copying by FDA. (1) Records demonstrating that the product meets the... sale in the United States: This may consist of production and shipping records for the exported product... product, and make available to FDA, upon request, during an inspection for review and copying by FDA, the...

  16. Dengue Fever in the United States

    Centers for Disease Control (CDC) Podcasts

    2012-04-09

    Dr. Amesh Adalja, an associate at the Center for Biosecurity and clinical assistant professor at the University of Pittsburgh School, of Medicine, discusses dengue fever outbreaks in the United States.  Created: 4/9/2012 by National Center for Emerging and Zoonotic Infectious Diseases (NCEZID).   Date Released: 4/16/2012.

  17. Addressing Child Poverty: How Does the United States Compare With Other Nations?

    Science.gov (United States)

    Smeeding, Timothy; Thévenot, Céline

    2016-04-01

    Poverty during childhood raises a number of policy challenges. The earliest years are critical in terms of future cognitive and emotional development and early health outcomes, and have long-lasting consequences on future health. In this article child poverty in the United States is compared with a set of other developed countries. To the surprise of few, results show that child poverty is high in the United States. But why is poverty so much higher in the United States than in other rich nations? Among child poverty drivers, household composition and parent's labor market participation matter a great deal. But these are not insurmountable problems. Many of these disadvantages can be overcome by appropriate public policies. For example, single mothers have a very high probability of poverty in the United States, but this is not the case in other countries where the provision of work support increases mothers' labor earnings and together with strong public cash support effectively reduces child poverty. In this article we focus on the role and design of public expenditure to understand the functioning of the different national systems and highlight ways for improvements to reduce child poverty in the United States. We compare relative child poverty in the United States with poverty in a set of selected countries. The takeaway is that the United States underinvests in its children and their families and in so doing this leads to high child poverty and poor health and educational outcomes. If a nation like the United States wants to decrease poverty and improve health and life chances for poor children, it must support parental employment and incomes, and invest in children's futures as do other similar nations with less child poverty. Copyright © 2016 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  18. Dynamics of Pertussis Transmission in the United States

    Science.gov (United States)

    Magpantay, F. M. G.; Rohani, P.

    2015-01-01

    Past patterns of infectious disease transmission set the stage on which modern epidemiologic dynamics are played out. Here, we present a comprehensive account of pertussis (whooping cough) transmission in the United States during the early vaccine era. We analyzed recently digitized weekly incidence records from Morbidity and Mortality Weekly Reports from 1938 to 1955, when the whole-cell pertussis vaccine was rolled out, and related them to contemporary patterns of transmission and resurgence documented in monthly incidence data from the National Notifiable Diseases Surveillance System. We found that, during the early vaccine era, pertussis epidemics in US states could be categorized as 1) annual, 2) initially annual and later multiennial, or 3) multiennial. States with predominantly annual cycles tended to have higher per capita birth rates, more household crowding, more children per family, and lower rates of school attendance than the states with multiennial cycles. Additionally, states that exhibited annual epidemics during 1938–1955 have had the highest recent (2001–2010) incidence, while those states that transitioned from annual cycles to multiennial cycles have had relatively low recent incidence. Our study provides an extensive picture of pertussis epidemiology in the United States dating back to the onset of vaccination, a back-story that could aid epidemiologists in understanding contemporary transmission patterns. PMID:26022662

  19. 31 CFR 540.705 - Administrative collection; referral to United States Department of Justice.

    Science.gov (United States)

    2010-07-01

    ... to United States Department of Justice. 540.705 Section 540.705 Money and Finance: Treasury... Administrative collection; referral to United States Department of Justice. In the event that the respondent does... Treasury or to the United States Department of Justice for appropriate action to recover the penalty in a...

  20. 31 CFR 586.705 - Administrative collection; referral to United States Department of Justice.

    Science.gov (United States)

    2010-07-01

    ... to United States Department of Justice. 586.705 Section 586.705 Money and Finance: Treasury....705 Administrative collection; referral to United States Department of Justice. In the event that the... Treasury or to the United States Department of Justice for appropriate action to recover the penalty in a...

  1. 31 CFR 597.705 - Administrative collection; referral to United States Department of Justice.

    Science.gov (United States)

    2010-07-01

    ... to United States Department of Justice. 597.705 Section 597.705 Money and Finance: Treasury... collection; referral to United States Department of Justice. In the event that the respondent does not pay... Department of the Treasury or to the United States Department of Justice for appropriate action to recover...

  2. 31 CFR 587.705 - Administrative collection; referral to United States Department of Justice.

    Science.gov (United States)

    2010-07-01

    ... to United States Department of Justice. 587.705 Section 587.705 Money and Finance: Treasury... § 587.705 Administrative collection; referral to United States Department of Justice. In the event that... Department of the Treasury or to the United States Department of Justice for appropriate action to recover...

  3. United States Earthquake Intensity Database, 1638-1985

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The United States Earthquake Intensity Database is a collection of damage and felt reports for over 23,000 U.S. earthquakes from 1638-1985. The majority of...

  4. Healthcare Needs of Homeless Youth in the United States

    OpenAIRE

    TERRY, Marisa J; BEDI, Gurpreet; PATEL, Neil

    2010-01-01

    Approximately 1.6 - 2.8 million youth at any given time in the United States are considered homeless and at high risk for poor social and health outcomes. It is estimated that in the United States homelessness overall is expected to rise 10 -20 percent in the next year. While governmental and private programs exist to address the tribulations faced by homeless persons, youth continue to be underserved. The 2009, $787 billion economic stimulus package includes $1.5 billion to address issues...

  5. 77 FR 56811 - United States Travel and Tourism Advisory Board; Meeting

    Science.gov (United States)

    2012-09-14

    ... DEPARTMENT OF COMMERCE International Trade Administration United States Travel and Tourism... the United States Travel and Tourism Advisory Board (Board). The Board will meet to present updates on... implementation of the National Travel and Tourism Strategy and the progress on implementing the President's...

  6. 75 FR 51978 - United States Standards for Grades of Pineapple Juice

    Science.gov (United States)

    2010-08-24

    ...-327] United States Standards for Grades of Pineapple Juice AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice; correction. SUMMARY: The United States Standards for Grades of Pineapple Juice... e-mail [email protected] . Corrected copies of the U.S. Standards for Grades of Pineapple...

  7. 75 FR 31465 - United States, State of Illinois, State of Colorado, and State of Indiana

    Science.gov (United States)

    2010-06-03

    ..., and often offer full-service restaurants or in-service dining. Premiere theatres also differ from... selection is deemed not to be a suitable alternative, the United States shall in its sole discretion select... suitable alternative pursuant to Section VI(A). If AMC's selection is deemed not to be a suitable...

  8. Framework for Naval Cooperation between Vietnam and the United States

    Science.gov (United States)

    2017-06-09

    the Vietnam-United States relationship has taken giant steps forward in virtually every aspect, especially solidified by a Comprehensive Partnership...United States relationship has taken giant steps forward in virtually every aspect, especially solidified by a Comprehensive Partnership Agreement signed...Economic Zone FTA Free Trade Agreement GDP Gross Domestic Product IMET International Military Education and Training MIA Missing in Action

  9. Performance of diagnostic mammography differs in the United States and Denmark

    DEFF Research Database (Denmark)

    Jensen, Allan; Geller, Berta M; Gard, Charlotte C

    2010-01-01

    in the United States and Denmark. The performance of 93,585 diagnostic mammograms from 180 facilities contributing data to the US Breast Cancer Surveillance Consortium (BCSC) from 1999 to 2001 was compared to that of all 51,313 diagnostic mammograms performed at Danish clinics in 2000. We used the imaging...... workup's final assessment to determine sensitivity, specificity and an estimate of accuracy: area under the receiver-operating characteristics (ROCs) curve (AUC). Diagnostic mammography had slightly higher sensitivity in the United States (85%) than in Denmark (82%). In contrast, it had higher...... specificity in Denmark (99%) than in the United States (93%). The AUC was high in both countries: 0.91 in United States and 0.95 in Denmark. Denmark's higher accuracy may result from supplementary ultrasound examinations, which are provided to 74% of Danish women but only 37% to 52% of US women. In addition...

  10. Estimating annualized earthquake losses for the conterminous United States

    Science.gov (United States)

    Jaiswal, Kishor S.; Bausch, Douglas; Chen, Rui; Bouabid, Jawhar; Seligson, Hope

    2015-01-01

    We make use of the most recent National Seismic Hazard Maps (the years 2008 and 2014 cycles), updated census data on population, and economic exposure estimates of general building stock to quantify annualized earthquake loss (AEL) for the conterminous United States. The AEL analyses were performed using the Federal Emergency Management Agency's (FEMA) Hazus software, which facilitated a systematic comparison of the influence of the 2014 National Seismic Hazard Maps in terms of annualized loss estimates in different parts of the country. The losses from an individual earthquake could easily exceed many tens of billions of dollars, and the long-term averaged value of losses from all earthquakes within the conterminous U.S. has been estimated to be a few billion dollars per year. This study estimated nationwide losses to be approximately $4.5 billion per year (in 2012$), roughly 80% of which can be attributed to the States of California, Oregon and Washington. We document the change in estimated AELs arising solely from the change in the assumed hazard map. The change from the 2008 map to the 2014 map results in a 10 to 20% reduction in AELs for the highly seismic States of the Western United States, whereas the reduction is even more significant for Central and Eastern United States.

  11. 76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

    Science.gov (United States)

    2011-10-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  12. [Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].

    Science.gov (United States)

    Huang, Fanghua

    2010-04-01

    Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine.

  13. 31 CFR 593.705 - Administrative collection; referral to United States Department of Justice.

    Science.gov (United States)

    2010-07-01

    ... to United States Department of Justice. 593.705 Section 593.705 Money and Finance: Treasury... collection; referral to United States Department of Justice. In the event that the respondent does not pay... United States Department of Justice for appropriate action to recover the penalty in a civil suit in a...

  14. 31 CFR 539.705 - Administrative collection; referral to United States Department of Justice.

    Science.gov (United States)

    2010-07-01

    ... to United States Department of Justice. 539.705 Section 539.705 Money and Finance: Treasury... collection; referral to United States Department of Justice. In the event that the respondent does not pay... United States Department of Justice for appropriate action to recover the penalty in a civil suit in a...

  15. Radioactive residues at nuclear sites in the United States of America

    International Nuclear Information System (INIS)

    Fiore, J.; Rampertaap, A.; Greeves, J.; MacKinney, J.; Raguso, M.; Selstrom, J.

    2000-01-01

    The United States of America has a large number of sites where radioactive materials have been mined, processed, produced, or used. Upon completion of activities at these sites, some will be cleaned up completely and released for unrestricted future use. However, at other sites, contamination will remain on the site following cleanup, requiring long term institutional controls. Depending on the purpose or the activity conducted at a specific site, these locations are generally under the jurisdiction of a federal agency: the United States Department of Energy, the United States Nuclear Regulatory Commission, the United States Environmental Protection Agency, or the United States Department of Defense. However, under certain conditions, the Nuclear Regulatory Commission relinquishes regulatory authority to individual states to regulate the commercial uses of radioactive materials (except for nuclear reactors), so some locations with radioactive materials are under the jurisdiction of individual states. Other sites with naturally occurring radioactive contamination may also be controlled by individual states. One or two sites under the jurisdiction of each agency are discussed where radioactive materials either existed in the past or exist today, and the source of contamination, the anticipated end state, and the process by which the responsible agency did or will conduct cleanup and site closure are described. Several issues are reviewed that must be addressed in order to design and implement remediations that will ensure long term protection for the environment and future inhabitants. The role of citizens in environmental cleanups is examined, and how institutional controls may be applied to ensure long term protection of remediations that leave some contaminants in place. (author)

  16. NCHS - Leading Causes of Death: United States

    Data.gov (United States)

    U.S. Department of Health & Human Services — This dataset presents the age-adjusted death rates for the 10 leading causes of death in the United States beginning in 1999. Data are based on information from all...

  17. Climate change indicators in the United States

    Science.gov (United States)

    2010-04-01

    The U.S. Environmental Protection Agency (EPA) has published this report, Climate Change Indicators in the United States, to help readers interpret a set of important indicators to better understand climate change. The report presents 24 indicators, ...

  18. Surveillance for Viral Hepatitis - United States, 2014

    Science.gov (United States)

    ... Resource Center Anonymous Feedback Viral Hepatitis Surveillance for Viral Hepatitis – United States, 2014 Recommend on Facebook Tweet Share ... Cases Hepatitis A Hepatitis B Hepatitis C Discussion Hepatitis A virus Index PAGE DESCRIPTION Table 2.1 Reported ...

  19. United States extension of indemnification to utilities and contractors

    International Nuclear Information System (INIS)

    Cunningham, G.H.

    1988-01-01

    The status of legislation in the United States, usually known as the Price-Anderson Act, provides an assured source and means of compensation for members of the public who may be injured as a result of a nuclear accident at a licensed commercial nuclear power plant or at a facility of the United States Government operated by a contractor. First a brief overview of the Act and its history is given, then the course of legislation to extend the Price-Anderson Act through the United States Congress is charted with comments made on the major issues of the debate. The Act requires that a least $560 million in insurance and/or Government indemnity is available to cover public liability claims arising out of an accident at a nuclear power plant. The Act also limits the total liability of all persons for any nuclear incident to a predetermined amount and this is one issue discussed. Final action on the legal situation should be taken in 1988. (U.K.)

  20. Some Spatial Aspects of Southeastern United States Climatology.

    Science.gov (United States)

    Soule, Peter T.

    1998-01-01

    Focuses on the climatology of an eight-state region in the southern and southeastern United States. Discusses general controls of climate and spatial patterns of various climatic averages. Examines mapped extremes as a means of fostering increased awareness of the variability that exists for climatic conditions in the region. (CMK)

  1. MedWatch, the FDA Safety Information and Adverse Event Reporting Program

    Science.gov (United States)

    ... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it ... approved information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety ...

  2. Travel to the United States under the Visa Waiver Program

    CERN Multimedia

    2003-01-01

    The following information has been taken from the Web site of the United States Embassy in Paris, which shall be the only authentic text in the matter: http://www.amb-usa.fr/consul/niv_vwpfr.htm With effect from 15 May 2003, Belgian citizens wishing to travel to the United States (for business or pleasure for a maximum of 90 days) shall be eligible for admission without a visa only if they are in possession of a valid MACHINE-READABLE passport. However, they may still travel to the United States with a valid old-style passport after this date provided that they obtain a visa. This visa waiver for those holding a valid MACHINE-READABLE passport will also apply to the citizens of the following countries with effect from 1st October 2003: Andorra, Australia, Austria, Brunei, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Liechtenstein, Luxemburg, Monaco, Netherlands, New Zealand, Norway, Portugal, San Marino, Singapore, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Citizens not in poss...

  3. Energy policy in the United States

    Energy Technology Data Exchange (ETDEWEB)

    McCormack, M

    1978-06-01

    Energy policy in the United States is examined with particular regard to the nuclear power industry. The advantages of nuclear power over conventional and other sources are presented and the vigorous expansion of research and development is advocated. Future energy supplies are discussed and the author stresses the necessity for continued research into breeder technology.

  4. 76 FR 21786 - Meetings of The United States-Peru Environmental Affairs Council, Environmental Cooperation...

    Science.gov (United States)

    2011-04-18

    ... DEPARTMENT OF STATE [Public Notice: 7417] Meetings of The United States-Peru Environmental Affairs... of meetings of the United States-Peru Environmental Affairs Council, Environmental Cooperation... notice that the United States and Peru intend to hold the third meeting of the Sub-Committee on Forest...

  5. 77 FR 28419 - Meetings of the United States-Peru Environmental Affairs Council, Environmental Cooperation...

    Science.gov (United States)

    2012-05-14

    ... DEPARTMENT OF STATE [Public Notice: 7873] Meetings of the United States-Peru Environmental Affairs... of meetings of the United States-Peru Environmental Affairs Council, Environmental Cooperation... the United States and Peru intend to hold the fifth meeting of the Sub-Committee on Forest Sector...

  6. Immigrants to the United States and Adult Education Services

    Science.gov (United States)

    Larrotta, Clarena

    2017-01-01

    This chapter describes documented and undocumented immigrant populations in the United States. It discusses salient factors influencing their status as immigrants as well as adult education services available to them through publicly funded programs, social units, and community centers, especially churches and libraries.

  7. Drone Warfare: Is the United States Violating the Law of Armed Conflict

    Science.gov (United States)

    2011-02-16

    NOTE AIR WAR COLLEGE AIR UNIVERSITY DRONE WARFARE: IS THE UNITED STATES VIOLATING THE LAW OF ARMED CONFLICT? by Barbara E. Shestko, Col...Base, Alabama. 1 Introduction The United States has become increasingly dependent upon the use of unmanned aircraft systems (UASs) or “ drones ” to...kill targeted members of al-Qaeda and the Taliban.1 Due to the success of drone warfare, we can expect the United States to continue its current

  8. 31 CFR 560.406 - Transshipment or transit through United States prohibited.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Transshipment or transit through United States prohibited. 560.406 Section 560.406 Money and Finance: Treasury Regulations Relating to... TRANSACTIONS REGULATIONS Interpretations § 560.406 Transshipment or transit through United States prohibited...

  9. Public and nonprofit funding for research on mental disorders in France, the United Kingdom, and the United States.

    Science.gov (United States)

    Chevreul, Karine; McDaid, David; Farmer, Carrie M; Prigent, Amélie; Park, A-La; Leboyer, Marion; Kupfer, David J; Durand-Zaleski, Isabelle

    2012-07-01

    To document the investments made in research on mental disorders by both government and nonprofit nongovernmental organizations in France, the United Kingdom, and the United States. An exhaustive survey was conducted of primary sources of public and nonprofit organization funding for mental health research for the year 2007 in France and the United Kingdom and for fiscal year 2007-2008 in the United States, augmented with an examination of relevant Web sites and publications. In France, all universities and research institutions were identified using the Public Finance Act. In the United Kingdom, we scrutinized Web sites and hand searched annual reports and grant lists for the public sector and nonprofit charitable medical research awarding bodies. In the United States, we included the following sources: the National Institutes of Health, other administrative entities within the Department of Health and Human Services (eg, Centers for Disease Control and Prevention), the Department of Education, the Department of Veterans Affairs, the Department of Defense, and the National Science Foundation and, for nonprofit funding, The Foundation Center. We included research on all mental disorders and substance-related disorders using the same keywords. We excluded research on mental retardation and dementia and on the promotion of mental well-being. We used the same algorithm in each country to obtain data for only mental health funding in situations in which funding had a broader scope. France spent $27.6 million (2%) of its health research budget on mental disorders, the United Kingdom spent $172.6 million (7%), and the United States spent $5.2 billion (16%). Nongovernmental funding ranged from 1% of total funding for mental health research in France and the United States to 14% in the United Kingdom. Funding for research on mental disorders accounts for low proportions of research budgets compared with funding levels for research on other major health problems, whereas

  10. Agreements and Discrepancies between FDA Reports and Journal Papers on Biologic Agents Approved for Rheumatoid Arthritis: A Meta-Research Project.

    Directory of Open Access Journals (Sweden)

    Gil Amarilyo

    Full Text Available Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA which independently analyzes the raw data and reports the results on its website.This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis.Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy and withdrawal due to adverse events (safety. As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report, followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy.FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34 except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61 pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55 pairwise comparisons and were statistically significant in 5. The "signal" in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical.There was no empirical evidence to suggest biased estimates between the two

  11. United States Department of Energy radiological emergency response programme - a national capability

    International Nuclear Information System (INIS)

    Gordon-Hagerty, L.E.

    1993-01-01

    In order to respond to a radiological emergency, the United States Department of Energy (USDOE) maintains seven emergency response assets and capabilities in support of a radiological emergency of any proportion within the continental United States and abroad. The seven emergency response assets and capabilities include: Accident Response Group; Aerial Measuring Systems; Atmospheric Release Advisory Capability; Federal Radiological Monitoring and Assessment Center; Nuclear Emergency Search Team; Radiation Emergency Assistance Center/Training Site; and Radiological Assistance Program. Presently, USDOE maintains the most comprehensive national radiological emergency response assets in the United States, capable of dealing with any type of emergency involving nuclear materials. In all, the Department's assets are available to support any type of accident/incident involving radioactive materials in coordination with other United States Federal agencies, as well as state and local governments, as required. (author)

  12. The work-family interface in the United States and Singapore: conflict across cultures.

    Science.gov (United States)

    Galovan, Adam M; Fackrell, Tamara; Buswell, Lydia; Jones, Blake L; Hill, E Jeffrey; Carroll, Sarah June

    2010-10-01

    This article examines the work-family interface in a cross-cultural comparison between two nationally representative samples from the United States (n = 1,860) and Singapore (n = 1,035) with emphasis on work-family conflict. Family-to-work conflict was negatively related to marital satisfaction in both Singapore and the United States, although the effect was stronger in the United States. Similarly, family-to-work conflict was positively related to job satisfaction in the United States but was negatively related in Singapore. As expected, schedule flexibility was negatively related to depression in the United States, but in Singapore the relationship was positive. These findings suggest that theoretical relationships in the work-family interface developed in the more culturally individualistic West may need to be adapted when studying populations in the more collectivist East.

  13. State laws on tobacco control--United States, 1998.

    Science.gov (United States)

    Fishman, J A; Allison, H; Knowles, S B; Fishburn, B A; Woollery, T A; Marx, W T; Shelton, D M; Husten, C G; Eriksen, M P

    1999-06-25

    State laws addressing tobacco use, the leading preventable cause of death in the United States, are summarized. Laws address smoke-free indoor air, minors' access to tobacco products, advertising of tobacco products, and excise taxes on tobacco products. Legislation effective through December 31, 1998. CDC identified laws addressing tobacco control by using an on-line legal research database. CDC's findings were verified with the National Cancer Institute's State Cancer Legislative Database. Since a previous surveillance summary on state tobacco-control laws published in November 1995 (covering legislation effective through June 30, 1995), several states have enacted new restrictions or strengthened existing legislation that addresses smoke-free indoor air, minors' access to tobacco, tobacco advertising, and tobacco taxes. Five states strengthened their smoke-free indoor air legislation. All states and Washington, D.C., continued to prohibit the sale and distribution of tobacco products to minors; however, 21 states expanded minors' access laws by designating enforcement authorities, adding license suspension or revocation for sale to minors, or requiring signage. Since the 1995 report, eight additional states (a total of 19 states and Washington, D.C.) now ban vending machines from areas accessible to minors. Thirteen states restrict advertising of tobacco products, an increase of four states since the 1995 report. Although the number of states that tax cigarettes and smokeless tobacco did not change, 13 states increased excise taxes on cigarettes, and five states increased excise taxes on smokeless tobacco products. The average state excise tax on cigarettes is 38.9 cents per pack, an increase of 7.4 cents compared with the average tax in the 1995 report. State laws addressing tobacco control vary in relation to restrictiveness, enforcement and penalties, preemptions, and exceptions. The data summarizing state tobacco-control laws are available through CDC

  14. Timelines of translational science: From technology initiation to FDA approval.

    Directory of Open Access Journals (Sweden)

    Laura M McNamee

    Full Text Available While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p<0.0005. Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.

  15. FDA, CE mark or something else?-Thinking fast and slow.

    Science.gov (United States)

    Mishra, Sundeep

    There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  16. Enabling Housing Cooperatives: policy lessons from Sweden, India and the United States.

    Science.gov (United States)

    Ganapati, Sukumar

    2010-01-01

    Housing cooperatives became active in urban areas in Sweden, India and the United States during the interwar period. Yet, after the second world war, while housing cooperatives grew phenomenally nationwide in Sweden and India, they did not do so in the United States. This article makes a comparative institutional analysis of the evolution of housing cooperatives in these three countries. The analysis reveals that housing cooperatives' relationship with the state and the consequent support structures explain the divergent evolution. Although the relationships between cooperatives and the state evolved over time, they can be characterized as embedded autonomy, overembeddedness and disembeddedness in Sweden, India and the United States respectively. Whereas the consequent support structures for housing cooperatives became well developed in Sweden and India, such structures have been weak in the United States. The article highlights the need for embedded autonomy and the need for supportive structures to enable the growth of housing cooperatives.

  17. 75 FR 43142 - United States Standards for Grades of Refried Beans

    Science.gov (United States)

    2010-07-23

    ...] United States Standards for Grades of Refried Beans AGENCY: Agricultural Marketing Service, USDA. ACTION... comments on the possible establishment of voluntary United States Standards for Grades of Refried Beans... industry requested that USDA develop grade standards for canned refried beans to be used by the industry...

  18. Complexity Leadership Theory: A United States Marine Corps Historical Overlay

    Science.gov (United States)

    2017-05-25

    DD-MM-YYYY) 23-04-2017 2. REPORT TYPE Master’s Thesis 3. DATES COVERED (From - To) JUN 2016 – MAY 2017 4. TITLE AND SUBTITLE Complexity...Monograph Title : Complexity Leadership Theory : A United States Marine Corps Historical Overlay Approved by...General Ridgway’s Success in Korea.” Master’s thesis , United States Army Command and General Staff College, 2010. Diana, Gabriel. “Vision, Education

  19. Declining urban and community tree cover in the United States

    Science.gov (United States)

    David J. Nowak; Eric J. Greenfield

    2018-01-01

    Paired aerial photographs were interpreted to assess recent changes (c. 2009–2014) in tree, impervious and other cover types within urban/community and urban land in all 50 United States and the District of Columbia. National results indicate that tree cover in urban/community areas of the United States is on the decline at a rate of about 175,000 acres per year, which...

  20. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

    Science.gov (United States)

    Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

    2015-06-01

    Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.

  1. 75 FR 10345 - Pricing for 2010 United States Mint America the Beautiful Quarters Proof Set, etc.

    Science.gov (United States)

    2010-03-05

    ... DEPARTMENT OF THE TREASURY United States Mint Pricing for 2010 United States Mint America the Beautiful Quarters Proof Set, etc. AGENCY: United States Mint, Department of the Treasury. ACTION: Notice. SUMMARY: The United States Mint is announcing the prices of the 2010 United States Mint America the...

  2. Economic opportunity in Mexico and return migration from the United States.

    Science.gov (United States)

    Lindstrom, D P

    1996-08-01

    I analyze the influence of the economic characteristics of origin area on trip duration for Mexican migrants in the United States. I argue that migrants from economically dynamic areas in Mexico with favorable opportunities for employment and small capital investment have a larger incentive to stay in the United States longer and to withstand the psychic costs of separation from family and friends than do migrants from economically stagnant areas in Mexico, where the productive uses of savings are severely limited. In line with this argument we should expect investment opportunities in migrants' origin areas to be associated positively with migrants' trip duration in the United States. To test this hypothesis I use individual- and household-level data on U.S. migration experience collected in 13 Mexican communities. Evidence from parametric hazards models supports the idea that economic characteristics of origin areas influence the motivations and strategies of Mexican migrants in the United States.

  3. The FDA's failure to address the lack of generalisability of antidepressant efficacy trials in product labelling.

    Science.gov (United States)

    Zimmerman, Mark

    2016-06-01

    According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored. © The Royal College of Psychiatrists 2016.

  4. The Development Strategies of Electronic Records: United States, Canada, United Kingdom and Australia as Examples

    Directory of Open Access Journals (Sweden)

    Chiao-Min Lin

    2004-09-01

    Full Text Available The development of electronic records have been an indicator of modern government all over the world. The format of public records of government agencies have been gradually transformed to digitalform. How to manage the life cycle of electronic records have became an important issue. In this paper, the development strategies in electronic records of the United States, Canada, United Kingdom and Australia are taken as examples to explain their state-of-the-art. Several suggestions are proposed as the reference for Taiwan’s government. [Article content in Chinese

  5. 78 FR 70414 - Pricing for the 2013 United States Mint Limited Edition Silver Proof SetTM

    Science.gov (United States)

    2013-11-25

    ... DEPARTMENT OF THE TREASURY United States Mint Pricing for the 2013 United States Mint Limited Edition Silver Proof Set TM AGENCY: United States Mint, Department of the Treasury. ACTION: Notice. SUMMARY: The United States Mint is announcing a price of $139.95 for the 2013 United States Mint Limited...

  6. 75 FR 5836 - Meeting of the United States-Peru Environmental Affairs Council

    Science.gov (United States)

    2010-02-04

    ... DEPARTMENT OF STATE [Public Notice: 6889] Meeting of the United States-Peru Environmental Affairs Council ACTION: Notice of the meeting of the U.S.-Peru Environmental Affairs Council and request for...) are providing notice that the United States and Peru intend to hold the first meeting of the...

  7. Cancer insurance policies in Japan and the United States.

    Science.gov (United States)

    Bennett, C L; Weinberg, P D; Lieberman, J J

    1998-01-01

    Cancer care in the United States often results in financial hardship for patients and their families. Standard health insurance covers most medical costs, but nonmedical costs (such as lost wages, deductibles, copayments, and travel to and from caregivers) are paid out of pocket. Over the course of treatment, these costs can become substantial. Insurance companies have addressed the burden of these out-of-pocket costs by offering supplemental cancer insurance policies that, upon diagnosis of cancer, pay cash benefits for items that usually require out-of-pocket expenditures and are distinct from reimbursements made by traditional health insurance. Limitations associated with managed care have fostered increased consumer awareness and interest in the United States for cancer insurance and its ability to defray treatment expenditures that usually require out-of-pocket payments. Marketing campaigns are becoming more aggressive, and the number of cancer insurance policies sold has been steadily rising. While cancer insurance is only recently gaining popularity in the United States, it has been a successful product in Japan for over twenty years. In Japan, approximately one-quarter of the population own cancer insurance, and ten-year retention rates are estimated at 75%. As a result, individuals are afforded good access to nonmedical cancer services. Understanding the factors that led to the success of cancer insurance in Japan may assist policymakers in evaluating cancer insurance policies as they become more prevalent in the United States.

  8. Nuclear accidents. Three mile Island (United States)

    International Nuclear Information System (INIS)

    Duco, J.

    2004-01-01

    This paper describes the accident of Three Miles Island power plant which occurred the 28 march 1979 in the United States. The accident scenario, the consequences and the reactor core and vessel, after the accident, are analyzed. (A.L.B.)

  9. United States home births increase 20 percent from 2004 to 2008.

    Science.gov (United States)

    MacDorman, Marian F; Declercq, Eugene; Mathews, T J

    2011-09-01

    After a gradual decline from 1990 to 2004, the percentage of births occurring at home increased from 2004 to 2008 in the United States. The objective of this report was to examine the recent increase in home births and the factors associated with this increase from 2004 to 2008. United States birth certificate data on home births were analyzed by maternal demographic and medical characteristics. In 2008, there were 28,357 home births in the United States. From 2004 to 2008, the percentage of births occurring at home increased by 20 percent from 0.56 percent to 0.67 percent of United States births. This rise was largely driven by a 28 percent increase in the percentage of home births for non-Hispanic white women, for whom more than 1 percent of births occur at home. At the same time, the risk profile for home births has been lowered, with substantial drops in the percentage of home births of infants who are born preterm or at low birthweight, and declines in the percentage of home births that occur to teen and unmarried mothers. Twenty-seven states had statistically significant increases in the percentage of home births from 2004 to 2008; only four states had declines. The 20 percent increase in United States home births from 2004 to 2008 is a notable development that will be of interest to practitioners and policymakers. (BIRTH 38:3 September 2011). © 2011, Copyright the Authors. Journal compilation © 2011, Wiley Periodicals, Inc.

  10. The United States and the European Community, 1969-1974: an uneasy partnership

    Directory of Open Access Journals (Sweden)

    Thi Thuy Hang NGUYEN

    2016-06-01

    Full Text Available The relations between the United States and the European Community under the Nixon Administration (1969-1974 were considerably changing. Post-1945 cooperation and dependence increasingly gave way to economic competition and division in military and foreign policies. Yet, the United States and the European Community knew that they were strategically important to each other, thus they had to continue cooperation and coordination to defend and advance their economic and strategic interests. With a documentary research approach, this paper aims to examine how the United States and the European Community their partnership evolved between 1969 and 1974. It explores the ties that the Nixon Administration designed to bind the European Community and the European Community’s responses. It also puts forth that despite their efforts to continue cooperation; the relations between the United States and the European Community were on a downward course. It will be concluded that the United States and the European Community experienced a difficult time in their relations between 1969 and 1974, but both sides showed certain efforts to maintain the partnership.

  11. 49 CFR 565.14 - Motor vehicles imported into the United States.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 6 2010-10-01 2010-10-01 false Motor vehicles imported into the United States...) REQUIREMENTS VIN Requirements § 565.14 Motor vehicles imported into the United States. (a) Importers shall utilize the VIN assigned by the original manufacturer of the motor vehicle. (b) All passenger cars...

  12. Distribution of specialized care centers in the United States.

    Science.gov (United States)

    Wang, Henry E; Yealy, Donald M

    2012-11-01

    As a recommended strategy for optimally managing critical illness, regionalization of care involves matching the needs of the target population with available hospital resources. The national supply and characteristics of hospitals providing specialized critical care services is currently unknown. We seek to characterize the current distribution of specialized care centers in the United States. Using public data linked with the American Hospital Association directory and US Census, we identified US general acute hospitals providing specialized care for ST-segment elevation myocardial infarction (STEMI) (≥40 annual primary percutaneous coronary interventions reported in Medicare Hospital Compare), stroke (The Joint Commission certified stroke centers), trauma (American College of Surgeons or state-designated, adult or pediatric, level I or II), and pediatric critical care (presence of a pediatric ICU) services. We determined the characteristics and state-level distribution and density of specialized care centers (centers per state and centers per state population). Among 4,931 acute care hospitals in the United States, 1,325 (26.9%) provided one of the 4 defined specialized care services, including 574 STEMI, 763 stroke, 508 trauma, and 457 pediatric critical care centers. Approximately half of the 1,325 hospitals provided 2 or more specialized services, and one fifth provided 3 or 4 specialized services. There was variation in the number of each type of specialized care center in each state: STEMI median 7 interquartile range (IQR 2 to 14), stroke 8 (IQR 3 to 17), trauma 6 (IQR 3 to 11), pediatric specialized care 6 (IQR 3 to 11). Similarly, there was variation in the number of each type of specialized care center per population: STEMI median 1 center per 585,135 persons (IQR 418,729 to 696,143), stroke 1 center per 412,188 persons (IQR 321,604 to 572,387), trauma 1 center per 610,589 persons (IQR 406,192 to 917,588), and pediatric critical care 1 center per 665

  13. Executive Summary: Forests of the Northern United States

    Science.gov (United States)

    Stephen R. Shifley; Francisco X. Aguilar; Nianfu Song; Susan I. Stewart; David J. Nowak; Dale D. Gormanson; W. Keith Moser; Sherri Wormstead; Eric J. Greenfield

    2012-01-01

    This executive summary provides an overview of the 200-page report, Forests of the Northern United States, which covers in detail current forest conditions, recent trends, issues, threats and opportunities in the forests in the 20 Northern States. It provides a context for subsequent Northern Forest Futures Project analyses that will forecast alternative future...

  14. 78 FR 32356 - United States-Korea Free Trade Agreement

    Science.gov (United States)

    2013-05-30

    ...-Korea Free Trade Agreement AGENCIES: U.S. Customs and Border Protection, Department of Homeland Security... treatment and other customs-related provisions of the United States-Korea Free Trade Agreement entered into...-Korea Free Trade Agreement (hereinafter ``UKFTA'' or the ``Agreement''). On December 3, 2010, the United...

  15. Inventory of power plants in the United States 1989. [Contains glossary

    Energy Technology Data Exchange (ETDEWEB)

    1990-09-21

    This document is prepared annually by the Electric Power Division, Office of Coal, Nuclear, Electric and Alternate Fuels, Energy Information Administration (EIA), US Department of Energy (DOE). The purpose of this publication is to provide year-end statistics about electric generating units in operation and to provide a 10-year outlook of future generating unit additions by electric utilities in the United States (the 50 states and the District of Columbia). Data summarized in this report are useful to a wide audience including Congress, federal and state agencies, the electric utility industry, and the general public. The data presented in this report were assembled and published by the EIA, to fulfill its data collection and dissemination responsibilities as specified in the Federal Energy Administration Act of 1974 (Public Law 93-275) as amended. The report is organized into the following chapters: Summary Statistics; Operable Electric Generating Units; and Projected Electric Generating Unit Additions.

  16. Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.

    Science.gov (United States)

    Bradford, W David; Kleit, Andrew N

    2015-07-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. Copyright © 2014 John Wiley & Sons, Ltd.

  17. Academic Library Consortia in the United States: An Introduction

    Directory of Open Access Journals (Sweden)

    Sharon L. Bostick

    2001-07-01

    Full Text Available Library consortia in the United States arose from a need for sharing when resources or funding for those resources were scarce. This is as true today as it was over 100 years ago when the first American consortia were formed. Consortia continue to be a growing and important part of the library profession. This article will give an overview of academic library consortia, with special emphasis on the history and modern developments in the United States and provide a general introduction to the concept of library cooperation.

  18. The Physical Economy of the United States of America.

    Science.gov (United States)

    Gierlinger, Sylvia; Krausmann, Fridolin

    2012-06-01

    The United States is not only the world's largest economy, but it is also one of the world's largest consumers of natural resources. The country, which is inhabited by some 5% of the world's population, uses roughly one-fifth of the global primary energy supply and 15% of all extracted materials. This article explores long-term trends and patterns of material use in the United States. Based on a material flow account (MFA) that is fully consistent with current standards of economy-wide MFAs and covers domestic extraction, imports, and exports of materials for a 135-year period, we investigated the evolution of the U.S. industrial metabolism. This process was characterized by an 18-fold increase in material consumption, a multiplication of material use per capita, and a shift from renewable biomass toward mineral and fossil resources. In spite of considerable improvements in material intensity, no dematerialization has happened so far; in contrast to other high-income countries, material use has not stabilized since the 1970s, but has continued to grow. This article compares patterns and trends of material use in the United States with those in Japan and the United Kingdom and discusses the factors underlying the disproportionately high level of U.S. per capita resource consumption.

  19. Populations of Phytophthora rubi Show Little Differentiation and High Rates of Migration Among States in the Western United States.

    Science.gov (United States)

    Tabima, Javier F; Coffey, Michael D; Zazada, Inga A; Grünwald, Niklaus J

    2018-04-11

    Population genetics is a powerful tool to understand patterns and evolutionary processes that are involved in plant-pathogen emergence and adaptation to agricultural ecosystems. We are interested in studying the population dynamics of Phytophthora rubi, the causal agent of Phytophthora root rot in raspberry. P. rubi is found in the western United States, where most of the fresh and processed raspberries are produced. We used genotyping-by-sequencing to characterize genetic diversity in populations of P. rubi sampled in the United States and other countries. Our results confirm that P. rubi is a monophyletic species with complete lineage sorting from its sister taxon P. fragariae. Overall, populations of P. rubi show low genetic diversity across the western United States. Demographic analyses suggest that populations of P. rubi from the western United States are the source of pathogen migration to Europe. We found no evidence for population differentiation at a global or regional (western United States) level. Finally, our results provide evidence of migration from California and Oregon into Washington. This report provides new insights into the evolution and structure of global and western United States populations of the raspberry pathogen P. rubi, indicating that human activity might be involved in moving the pathogen among regions and fields.

  20. The contemporary cement cycle of the United States

    Science.gov (United States)

    Kapur, A.; Van Oss, H. G.; Keoleian, G.; Kesler, S.E.; Kendall, A.

    2009-01-01

    A country-level stock and flow model for cement, an important construction material, was developed based on a material flow analysis framework. Using this model, the contemporary cement cycle of the United States was constructed by analyzing production, import, and export data for different stages of the cement cycle. The United States currently supplies approximately 80% of its cement consumption through domestic production and the rest is imported. The average annual net addition of in-use new cement stock over the period 2000-2004 was approximately 83 million metric tons and amounts to 2.3 tons per capita of concrete. Nonfuel carbon dioxide emissions (42 million metric tons per year) from the calcination phase of cement manufacture account for 62% of the total 68 million tons per year of cement production residues. The end-of-life cement discards are estimated to be 33 million metric tons per year, of which between 30% and 80% is recycled. A significant portion of the infrastructure in the United States is reaching the end of its useful life and will need to be replaced or rehabilitated; this could require far more cement than might be expected from economic forecasts of demand for cement. ?? 2009 Springer Japan.

  1. 26 CFR 1.953-3 - Risks deemed to be United States risks.

    Science.gov (United States)

    2010-04-01

    ... 26 Internal Revenue 10 2010-04-01 2010-04-01 false Risks deemed to be United States risks. 1.953-3... TAX (CONTINUED) INCOME TAXES Controlled Foreign Corporations § 1.953-3 Risks deemed to be United States risks. (a) Artificial arrangements. For purposes of paragraph (a) of § 1.953-1, the term “United...

  2. Nightmares in United States Military Personnel With Sleep Disturbances

    Science.gov (United States)

    Creamer, Jennifer L.; Brock, Matthew S.; Matsangas, Panagiotis; Motamedi, Vida; Mysliwiec, Vincent

    2018-01-01

    Study Objectives: Sleep disturbances are common in United States military personnel. Despite their exposure to combat and trauma, little is known about nightmares in this population. The purpose of this study was to describe the prevalence and associated clinical and polysomnographic characteristics of nightmares in United States military personnel with sleep disturbances. Methods: Retrospective review of 500 active duty United States military personnel who underwent a sleep medicine evaluation and polysomnography at our sleep center. The Pittsburgh Sleep Quality Index and the Pittsburgh Sleep Quality Index-Addendum were used to characterize clinically significant nightmares. Subjective and objective sleep attributes were compared between groups. Results: At least weekly nightmares were present in 31.2%; yet, only 3.9% reported nightmares as a reason for evaluation. Trauma-related nightmares occurred in 60% of those patients with nightmares. Patients with nightmares had increased sleep onset latency (SOL) and rapid eye movement (REM) sleep latency (mean SOL/REM sleep latency 16.6/145 minutes, P = .02 and P = .01 respectively) compared to those without (mean SOL/REM sleep latency 12.5/126 minutes). The comorbid disorders of depression (P ≤ .01, relative risk [RR] 3.55 [95% CI, 2.52–4.98]), anxiety (P ≤ .01, RR 2.57 [95% CI, 1.93–3.44]), posttraumatic stress disorder (P ≤ .01, RR 5.11 [95% CI, 3.43–7.62]), and insomnia (P ≤ .01, RR 1.59 [95% CI, 1.42–1.79]) were all associated with nightmares. Conclusions: Clinically significant nightmares are highly prevalent in United States military personnel with sleep disturbances. Nightmares are associated with both subjective and objective sleep disturbances and are frequently comorbid with other sleep and mental health disorders. Commentary: A commentary on this article appears in this issue on page 303. Citation: Creamer JL, Brock MS, Matsangas P, Motamedi V, Mysliwiec V. Nightmares in United States military

  3. Need for Subsidized Family Planning Services: United States, Each State and County, 1968.

    Science.gov (United States)

    Planned Parenthood--World Population, New York, NY.

    To provide federal, state, and local health agencies with information needed to achieve the national objectives of improving health, assisting families to escape poverty, and providing parents with freedom of choice in determining the number and spacing of their children, information was collected from 3,072 United States counties. Data from a…

  4. The US Opioid Crisis: Current Federal and State Legal Issues.

    Science.gov (United States)

    Soelberg, Cobin D; Brown, Raeford E; Du Vivier, Derick; Meyer, John E; Ramachandran, Banu K

    2017-11-01

    The United States is in the midst of a devastating opioid misuse epidemic leading to over 33,000 deaths per year from both prescription and illegal opioids. Roughly half of these deaths are attributable to prescription opioids. Federal and state governments have only recently begun to grasp the magnitude of this public health crisis. In 2016, the Centers for Disease Control and Prevention released their Guidelines for Prescribing Opioids for Chronic Pain. While not comprehensive in scope, these guidelines attempt to control and regulate opioid prescribing. Other federal agencies involved with the federal regulatory effort include the Food and Drug Administration (FDA), the Drug Enforcement Agency (DEA), and the Department of Justice. Each federal agency has a unique role in helping to stem the burgeoning opioid misuse epidemic. The DEA, working with the Department of Justice, has enforcement power to prosecute pill mills and physicians for illegal prescribing. The DEA could also implement use of prescription drug monitoring programs (PDMPs), currently administered at the state level, and use of electronic prescribing for schedule II and III medications. The FDA has authority to approve new and safer formulations of immediate- and long-acting opioid medications. More importantly, the FDA can also ask pharmaceutical companies to cease manufacturing a drug. Additionally, state agencies play a critical role in reducing overdose deaths, protecting the public safety, and promoting the medically appropriate treatment of pain. One of the states' primary roles is the regulation of practice of medicine and the insurance industry within their borders. Utilizing this authority, states can both educate physicians about the dangers of opioids and make physician licensure dependent on registering and using PDMPs when prescribing controlled substances. Almost every state has implemented a PDMP to some degree; however, in addition to mandating their use, increased interstate

  5. FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR

    Science.gov (United States)

    An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing.  Br

  6. Supporting Young English Learners in the United States

    Science.gov (United States)

    Barrow, Lisa; Markman-Pithers, Lisa

    2016-01-01

    Simply put, children with poor English skills are less likely to succeed in school and beyond. What's the best way to teach English to young children who aren't native English speakers? In this article, Lisa Barrow and Lisa Markman-Pithers examine the state of English learner education in the United States and review the evidence behind different…

  7. Analysis of elder abuse statutes across the United States, 2011-2012.

    Science.gov (United States)

    Jirik, Stacey; Sanders, Sara

    2014-01-01

    The purpose of this article is to describe the state elder abuse statutes in the United States and Washington DC during 2011-2012. The last review of elder abuse statutes occurred in 2001; thus, a reexamination is warranted given the increased awareness of elder abuse at the state and national level and the growing number of older adults in the United States. This descriptive study analyzed the following components of elder or dependent abuse statutes: definitions, reporting requirements, training, and consequences for failure to report. It was determined that differences remain in how states respond to elder abuse at the community-based level.

  8. 3 CFR - Designation of Officers of the United States Section, International Boundary and Water Commission...

    Science.gov (United States)

    2010-01-01

    ... 3 The President 1 2010-01-01 2010-01-01 false Designation of Officers of the United States Section, International Boundary and Water Commission, United States and Mexico To Act as the Commissioner of the United... States and Mexico To Act as the Commissioner of the United States Section Memorandum for the Commissioner...

  9. Continuing education requirements among State Occupational Therapy Regulatory Boards in the United States of America

    Directory of Open Access Journals (Sweden)

    Savannah R. Hall

    2016-10-01

    Full Text Available Purpose The purpose of this study is to compare and contrast the contents of each state’s occupational therapy (OT regulatory board requirements regarding licensees’ acquisition of continuing education units in the United States of America. Methods Data related to continuing education requirements from each OT regulatory board of all 50 states and the District of Columbia in the United States were reviewed and categorized by two reviewers. Analysis was conducted based on the categorization of the continuing education requirements and activities required, allowed, and not allowed/not mentioned for continuing education units. Results Findings revealed non-uniformity and inconsistency of continuing education requirements for licensure renewal between OT regulatory boards and was coupled with lack of specific criteria for various continuing education activities. Continuing education requirements were not tailored to meet the needs of individual licensee’s current and anticipated professional role and job responsibilities, with a negative bias towards presentation and publication allowed for continuing education units. Few boards mandated continuing education topics on ethics related to OT practice within each renewal cycle. Conclusion OT regulatory boards should move towards unifying the reporting format of continuing education requirements across all states to reduce ambiguity and to ensure licensees are equipped to provide ethical and competent practice. Efforts could be made to enact continuing education requirements specific to the primary role of a particular licensee. Finally, assigning the amount of continuing education credits to be awarded for different activities should be based on research evidence rather than arbitrary determination.

  10. Maternal characteristics associated with pregnancy exposure to FDA category C, D, and X drugs in a Canadian population.

    Science.gov (United States)

    Yang, Tubao; Walker, Mark C; Krewski, Daniel; Yang, Qiuying; Nimrod, Carl; Garner, Peter; Fraser, William; Olatunbosun, Olufemi; Wen, Shi Wu

    2008-03-01

    To estimate the frequency of exposure to prescription Food and Drug Administration (FDA) category C, D, and X drugs in pregnant women, and to analyze the maternal characteristics associated with such an exposure. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 was chosen for the study. The rate of exposure to FDA category C, D, or X drugs recorded in the pharmacist database was estimated. Associations of exposure to FDA category C, D, and X drugs with maternal characteristics were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 575 women were included in this study. Among them, 3604 (19.4%) had exposure to one or more FDA category C, D, and X drugs during pregnancy. Category C drugs were the most frequently used drugs (15.8%), followed by D drugs (5.2%), and X drugs (3.9%). Women with chronic health conditions had fourfold at increased risk of exposure than women without. Regardless of health status, women who were or =3, and who were on social assistance plan were at increased risk of pregnancy exposure to these drugs. About 19.4% pregnant women are exposed to FDA C, D or X drugs during pregnancy. Women with chronic diseases, younger age, increased parity, and under social assistance are at increased risk of exposure to FDA C, D, or X drugs. Copyright 2008 John Wiley & Sons, Ltd.

  11. FDA Developments: Food Code 2013 and Proposed Trans Fat Determination

    NARCIS (Netherlands)

    Grossman, M.R.

    2014-01-01

    268 Reports EFFL 4|2014 USA FDA Developments: Food Code 2013 and Proposed Trans Fat Determination Margaret Rosso Grossman* I. Food Code 2013 and Food Code Reference System Since 1993, the US Food and Drug Administration has published a Food Code, now updated every four years. In November 2013, the

  12. Caveat oncologist: clinical findings and consequences of distributing counterfeit erythropoietin in the United States.

    Science.gov (United States)

    Qureshi, Zaina P; Norris, Leann; Sartor, Oliver; McKoy, June M; Armstrong, John; Raisch, Dennis W; Garg, Vishvas; Stafkey-Mailey, Dana; Bennett, Charles Lee

    2012-03-01

    Counterfeit pharmaceuticals pose risks domestically. Because of their cost, cancer pharmaceuticals are vulnerable. We review findings from a domestic counterfeiting episode involving erythropoietin and outline anticounterfeiting recommendations for policy makers, patients, and health care professionals. Information was obtained on patients who received counterfeit erythropoietin, its distribution, and criminal investigations into counterfeiting networks. Interview sources included a physician, an attorney, employees of the Florida Department of Health and Human Services and the US Food and Drug Administration's (FDA) Office of Criminal Investigation, manufacturers, and wholesalers. Other sources included the book "Dangerous Doses," LexisNexis (search terms "counterfeit" and "erythropoietin") and the FDA database. Counterfeit product consisted of 2,000 U vials with counterfeit labels denoting 40,000 U. The counterfeiters, in collaboration with a Miami pharmacy, purchased 110,000 erythropoietin 2,000 U vials and affixed counterfeit labels to each vial. Products were then sold via the pharmaceutical "gray market" to wholesalers, then pharmacy chains. Investigations by Florida government officials implicated 17 persons, all of whom were found guilty of trafficking in counterfeit pharmaceuticals. Despite the large size of the operation, the FDA received reports of only 12 patients who had received counterfeit erythropoietin and detailed information for only two individuals. A 17-year-old liver transplant recipient and a 61-year-old patient with breast cancer experienced loss of efficacy after receiving counterfeit erythropoietin. Wider use of FDA anticounterfeit initiatives, limiting pharmaceutical suppliers to reputable distributors, and educating providers and patients about signs of counterfeit drugs can improve the safety of cancer pharmaceuticals.

  13. Racial Conflict in the United States: What Should Be Done? Grade Twelve. [Resource Unit V.] Project Social Studies.

    Science.gov (United States)

    Minnesota Univ., Minneapolis. Project Social Studies Curriculum Center.

    This is the fifth of seven resource units for a twelfth grade course on value conflicts and policy decisions. The topic for this unit is racial conflict in the United States. The introduction explains how this unit coincides with other units of the K-12 series which have treated intergroup relations. The objectives are listed as to…

  14. Cigarette Smoking among Korean International College Students in the United States

    Science.gov (United States)

    Sa, Jaesin; Seo, Dong-Chul; Nelson, Toben F.; Lohrmann, David K.

    2013-01-01

    Objective and Participants: This study explored (1) the prevalence of cigarette smoking among South Korean international college students in the United States, (2) differences in smoking between on- and off-campus living arrangements, and (3) predictors of an increase in smoking over time in the United States Methods: An online survey was…

  15. 8 CFR 1212.5 - Parole of aliens into the United States.

    Science.gov (United States)

    2010-01-01

    ... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Parole of aliens into the United States. 1212.5 Section 1212.5 Aliens and Nationality EXECUTIVE OFFICE FOR IMMIGRATION REVIEW, DEPARTMENT OF... INADMISSIBLE ALIENS; PAROLE § 1212.5 Parole of aliens into the United States. Procedures and standards for the...

  16. Advanced Reactor Development in the United States

    Energy Technology Data Exchange (ETDEWEB)

    Giessing, D. F.; Griffith, J. D.; McGoff, D. J.; Rosen, Sol [U. S. Department of Energy, Texas (United States)

    1990-04-15

    In the United States, three technologies are employed for the new generation of advanced reactors. These technologies are Advanced Light Water Reactors (A LWRs) for the 1990s and beyond, the Modular High Temperature Gas Reactor (M HTGR) for commercial use after the turn of the century, and Liquid Metal Reactors (LWRs) to provide energy production and to convert reactor fission waste to a more manageable waste product. Each technology contributes to the energy solution. Light Water Reactors For The 1990s And Beyond--The U. S. Program The economic and national security of the United States requires a diversified energy supply base built primarily upon adequate, domestic resources that are relatively free from international pressures. Nuclear energy is a vital component of this supply and is essential to meet current and future national energy demands. It is a safe, economically continues to contribute to national energy stability, and strength. The Light Water Reactor (LWR) has been a major and successful contributor to the electrical generating needs of many nations throughout the world. It is being counted upon in the United States as a key to revitalizing nuclear energy option in the 1990s. In recent years, DOE joined with the industry to ensure the availability and future viability of the LWR option. This national program has the participation of the Nation's utility industry, the Electric Power Research Institute (EPRI), and several of the major reactor manufacturers and architect-engineers. Separate but coordinated parts of this program are managed by EPRI and DOE.

  17. The Caspian energy game: views from the United States and United Kingdom

    International Nuclear Information System (INIS)

    Bird, H.

    2003-01-01

    The importance of the Caspian Sea region to energy production is increasing and the forces influencing it are changing. The attention on this region focuses on its oil and natural gas reserves. A series of interviews with Western experts mainly from the United States and United Kingdom, including those in international organizations, academia, policy institutions, and government and industry officials identified key trends and issues that are important to their future policies and the significance of the Caspian oil and gas to the world energy market. The overriding issues are: The influence of Russia on regional security, stability, and the transportation of oil and gas products in the Caspian region. The outcome of the test between the United States and Iraq and the major effects it could have on commercial interests in the region and on who will be the major actors. Tensions caused by Iran refusal to settle the international demarcation of the Caspian Sea. Turkey position as a player, the affect of its new islamic-dominated government and its energy policies. Europe need to import gas and to diversify its supply. The construction of a pipeline to China. The impact of September 11, 2001 and terrorism on the Caspian region issues. The stability of the former Soviet Republics in the region. (author)

  18. The Caspian energy game: views from the United States and United Kingdom

    Energy Technology Data Exchange (ETDEWEB)

    Bird, H

    2003-07-01

    The importance of the Caspian Sea region to energy production is increasing and the forces influencing it are changing. The attention on this region focuses on its oil and natural gas reserves. A series of interviews with Western experts mainly from the United States and United Kingdom, including those in international organizations, academia, policy institutions, and government and industry officials identified key trends and issues that are important to their future policies and the significance of the Caspian oil and gas to the world energy market. The overriding issues are: The influence of Russia on regional security, stability, and the transportation of oil and gas products in the Caspian region. The outcome of the test between the United States and Iraq and the major effects it could have on commercial interests in the region and on who will be the major actors. Tensions caused by Iran refusal to settle the international demarcation of the Caspian Sea. Turkey position as a player, the affect of its new islamic-dominated government and its energy policies. Europe need to import gas and to diversify its supply. The construction of a pipeline to China. The impact of September 11, 2001 and terrorism on the Caspian region issues. The stability of the former Soviet Republics in the region. (author)

  19. America, you are digging your grave with your spoon--should the FDA tell you that on food labels?

    Science.gov (United States)

    Card, Melissa M

    2013-01-01

    R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.

  20. Experience with HEPA filters at United States nuclear installations

    International Nuclear Information System (INIS)

    Bellamy, R.R.

    1977-01-01

    Part 50 of Title 10 of the United States Code of Federal Regulations requires that a number of atmosphere cleanup systems be included in the design of commercial nuclear power plants to be licensed in the United States. These filtering systems are to contain high efficiency particulate air (HEPA) filters for removal of radioactive particulate matter generated during normal and accident conditions. Recommendations for the design, testing and maintenance of the filtering systems and HEPA filter components are contained in a number of United States Nuclear Regulatory Commission documents and industry standards. This paper will discuss this published guidance available to designers of filtering systems and the plant operators of U.S. commercial nuclear power plants. The paper will also present a survey of published reports of experience with HEPA filters, failures and possible causes for the failures, and other abnormal occurrences pertaining to HEPA filters installed in U.S. nuclear power installations. A discussion will be included of U.S. practices for qualification of HEPA filters before installation, and verification of continued performance capability at scheduled intervals during operation

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