77 FR 65237 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Science.gov (United States)

2012-10-25

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...Tree Trust October 19, 2012. I. Introduction On August 15, 2012, The NASDAQ Stock Market LLC (``Nasdaq... temporary defensive strategies that are inconsistent with its investment strategies, the Fund's ability to...

77 FR 49034 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Science.gov (United States)

2012-08-15

... entering new orders at inferior prices. This occurs because the current process directs the order to NASDAQ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Amend Rule... June 14, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange''), filed with the Securities and...

76 FR 21085 - Self-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To...

Science.gov (United States)

2011-04-14

...-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To Amend The NASDAQ OMX Group, Inc. By- Laws April 8, 2011. I. Introduction On February 8, 2011, The NASDAQ Stock Market... vote cast either ``for'' or ``against'' that director's election. In its filing, NASDAQ noted that...

Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.

Science.gov (United States)

2008-07-10

The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.

77 FR 37762 - Domestic Dates Produced or Packed in Riverside County, CA; Order Amending Marketing Order 987

Science.gov (United States)

2012-06-25

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 987 [Doc. No. AMS-FV-10-0025; FV10-987-1 FR] Domestic Dates Produced or Packed in Riverside County, CA; Order Amending Marketing Order 987 AGENCY: Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: This final rule...

75 FR 28231 - Cotton Classification and Market News Service: Notice of Request for an Extension and Revision of...

Science.gov (United States)

2010-05-20

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [AMS-CN-10-0037; CN-10-003] Cotton....regulations.gov. All comments should reference the docket number and page number of this issue of the Federal... and Market News Service. OMB Number: 0581-0009. Expiration Date of Approval: December 30, 2010. Type...

Effect of edible co-polymers coatings using γ-irradiation on Hyani date fruit behavior during marketing.

Science.gov (United States)

El-Dein, Asmaa Ezz; Khozemy, Ehab E; Farag, Serag A; Abd El-Hamed, N; Dosoukey, I M

2018-05-24

The present work introduces a preparation of coating fruits film from natural biodegradable materials with evaluation of its efficiency in keeping the quality of fresh date fruits. Triple blend (Tb) which involved PVA, chitosan (Cs) and tannic (TA) acids was studied in preservation of Rutab (Hyani) date. Antimicrobial characters besides decay of fruits during a cold storage were determined. The blend solutions were exposed to the γ-irradiation (5.0 to 20 kGy) before casting or use. The effects of polymer composition and irradiation dose on the mechanical and thermo-mechanical properties were studied. The obtained results showed that γ-irradiation and the addition of tannic acid (TA) increased the mechanical properties of the films and the shelf-life of Rutab (Hyani) date during the marketing period (12 ± 2 °C, 98%, RH) from one week to one month of marketing period for consumers with accepted freshness and quality. Copyright © 2018 Elsevier B.V. All rights reserved.

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

Science.gov (United States)

Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

2018-05-02

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

17 CFR 248.128 - Effective date, compliance date, and prospective application.

Science.gov (United States)

2010-04-01

... Affiliate Marketing § 248.128 Effective date, compliance date, and prospective application. (a) Effective date. This subpart is effective September 10, 2009. (b) Mandatory compliance date. Compliance with this... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Effective date, compliance...

76 FR 45308 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Science.gov (United States)

2011-07-28

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change To... change should provide NOM Participants assistance in effectively managing their quotations. \\6\\ 15 U.S.C...,\\2\\ a proposed rule change to adopt a new risk monitor mechanism. The proposed rule change was...

78 FR 62834 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Science.gov (United States)

2013-10-22

... Fund of First Trust Exchange-Traded Fund VII October 9, 2013. I. Introduction On August 16, 2013, The... for the provision of custody, transfer agency, and accounting agent services with the same or with...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...

Internet dating as a project: the commodification and rationalisation of online dating

Directory of Open Access Journals (Sweden)

Tjaša Žakelj

2015-04-01

Full Text Available Based on qualitative empirical data from two studies on Internet dating in Slovenia, this paper discusses the social contexts of the Internet dating of heterosexual men and women and homosexual men. Special attention is given to different aspects of the commodification and rationalisation of dating in the process of forming potential (romantic partnerships. First, we discuss our respondents’ reasons for using the Internet to get in touch with potential (romantic partners. Second, we focus on the demands and strategies of targeted market- ing in personal profile writing and, finally, on the process of selecting potential partners. Our study shows that the primary understanding of Internet dating among people who engage in it is its economic nature. Together with targeted marketing and the predeter- mined criteria for choosing interesting others, Internet dating can thus be understood as a market that encourages rationalisation and commodification in the process of forming intimate relationships.

7 CFR 1421.101 - Maturity dates.

Science.gov (United States)

2010-01-01

... filed and disbursed except, for transferred marketing assistance loan collateral. The maturity date for transferred marketing assistance loan collateral will be the maturity date applicable to the original loan... AGRICULTURE LOANS, PURCHASES, AND OTHER OPERATIONS GRAINS AND SIMILARLY HANDLED COMMODITIES-MARKETING...

Current Status & Development Trend of VSAT Market in China

Institute of Scientific and Technical Information of China (English)

Xu Nutu

2006-01-01

@@ 1. General Status of VSAT Market Development in China 1)Development History Development in China The history of the application of satellite communication in China is not too long and it was dated from the early seventies of the 20th century. In 1973, approved by Chinese government,Ministry of Posts and Telecommunications purchased satellite earth equipment from foreign country and constructed 3 stations in Shanghai and Beijing.

12 CFR 41.28 - Effective date, compliance date, and prospective application.

Science.gov (United States)

2010-01-01

... TREASURY FAIR CREDIT REPORTING Affiliate Marketing § 41.28 Effective date, compliance date, and prospective... an affiliate to make solicitations to a consumer if the bank receives such information prior to...

16 CFR 680.28 - Effective date, compliance date, and prospective application.

Science.gov (United States)

2010-01-01

... REPORTING ACT AFFILIATE MARKETING § 680.28 Effective date, compliance date, and prospective application. (a... part shall not prohibit you from using eligibility information that you receive from an affiliate to...

12 CFR 571.28 - Effective date, compliance date, and prospective application.

Science.gov (United States)

2010-01-01

... THE TREASURY FAIR CREDIT REPORTING Affiliate Marketing § 571.28 Effective date, compliance date, and... receive from an affiliate to make solicitations to a consumer if you receive such information prior to...

Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use; delay of compliance dates. Final rule; delay of compliance dates; request for comments.

Science.gov (United States)

2012-05-11

The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.

Policy plan for the early approval for irradiated meat products and the promotion of irradiated meats in market

Energy Technology Data Exchange (ETDEWEB)

Lee, Ju Woon [Team for Radiation Food Science and Biotechnology, Advanced Radiation Technology Institute, Korea Atomic Energy Research Institute, Jeongeup (Korea, Republic of); Kim, Wang Geun [Ministry of Education, Science and Technology, Seoul (Korea, Republic of); Kim, Kyong Su [Dept. of Food and Nutrition, Chosun University, Gwangju (Korea, Republic of); Yook, Hong Sun [Dept. of Food and Nutrition, Chungnam National University, Daejeon (Korea, Republic of); Kim, Cheon Jei [Division of Animal Life Science, Konkuk University, Seoul (Korea, Republic of)

2008-11-15

The consumption of meat products is gradually being increased by the development of livestock raising technology, industrialized farm management and international trade. This increased consumption also created new market for ready-to-eat and ready-to-cook meat products. However, these convenience meat products can be easily contaminated during the processing and storage by pathogens, and there have been many reported cases of food borne illness by meats. One of the most effective methods for the decontamination of meat products is the radiation technology. Food irradiation was the established, well-recognized and safe sterilization method. Many other countries researched the effect of irradiation on the meat products and approved the irradiation. In this article, the effectiveness, the international acceptance, the economics and the research trend of irradiation on meat products have been reviewed. Also, the policy plans for the early approval of the irradiated meat products in Korea and the promotion policy of irradiated meats in market were discussed.

Policy plan for the early approval for irradiated meat products and the promotion of irradiated meats in market

International Nuclear Information System (INIS)

Lee, Ju Woon; Kim, Wang Geun; Kim, Kyong Su; Yook, Hong Sun; Kim, Cheon Jei

2008-01-01

The consumption of meat products is gradually being increased by the development of livestock raising technology, industrialized farm management and international trade. This increased consumption also created new market for ready-to-eat and ready-to-cook meat products. However, these convenience meat products can be easily contaminated during the processing and storage by pathogens, and there have been many reported cases of food borne illness by meats. One of the most effective methods for the decontamination of meat products is the radiation technology. Food irradiation was the established, well-recognized and safe sterilization method. Many other countries researched the effect of irradiation on the meat products and approved the irradiation. In this article, the effectiveness, the international acceptance, the economics and the research trend of irradiation on meat products have been reviewed. Also, the policy plans for the early approval of the irradiated meat products in Korea and the promotion policy of irradiated meats in market were discussed

78 FR 55057 - Authority To Manufacture Carbon Fiber for the U.S. Market Not Approved; Foreign-Trade Subzone...

Science.gov (United States)

2013-09-09

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1914] Authority To Manufacture Carbon... behalf of Toho Tenax America, Inc. (TTA), to manufacture carbon fiber under zone procedures for the U.S... approve the application requesting authority to manufacture carbon fiber for the U.S. market under zone...

Trial endpoints for drug approval in oncology: Chemoprevention.

Science.gov (United States)

Beitz, J

2001-04-01

As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

Science.gov (United States)

Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

2017-06-01

An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post-marketing

Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Qualification & Approval Bodies

Science.gov (United States)

Wheelahan, Leesa; Buchanan, John; Yu, Serena

2015-01-01

This summary pulls together the relevant key findings for qualification and approval bodies from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education…

76 FR 77998 - Market Access Agreement

Science.gov (United States)

2011-12-15

... FARM CREDIT ADMINISTRATION Market Access Agreement AGENCY: Farm Credit Administration. ACTION: Notice of approval of the Draft Second Amended and Restated Market Access Agreement. SUMMARY: The Farm Credit Administration (FCA) announces that it has approved the Draft Second Amended and Restated Market...

30 CFR 14.7 - Approval marking and distribution records.

Science.gov (United States)

2010-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.7 Approval marking and distribution records. (a) An approved conveyor belt must be marketed only under the name specified in the approval. (b) Approved conveyor belt must be legibly and...

The Evolution of Approval Services.

Science.gov (United States)

Warzala, Martin

1994-01-01

Describes major developments in book approval plans used by academic libraries for acquisition and for information dissemination and document distribution services based on approval-like concepts. Topics addressed include publishers; marketing; the impact of library automation; value-added services; the economic climate; the influence of…

Pharmaceutical market access in emerging markets: concepts, components, and future.

Science.gov (United States)

Kumar, Anuj; Juluru, Karthaveerya; Thimmaraju, Phani Kishore; Reddy, Jayachandra; Patil, Anand

2014-01-01

This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities.

17 CFR 1.54 - Contract market rules submitted to and approved or not disapproved by the Secretary of Agriculture.

Science.gov (United States)

2010-04-01

... submitted to and approved or not disapproved by the Secretary of Agriculture. 1.54 Section 1.54 Commodity... Secretary of Agriculture. Notwithstanding any provision of these rules, any bylaw, rule, regulation, or resolution of a contract market that was submitted to the Secretary of Agriculture pursuant or § 1.38(a) or...

75 FR 31508 - Notice of Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2010-06-03

... County, Pa.; Approval Date: April 13, 2010. 23. Chesapeake Appalachia, LLC, Pad ID: Henry, ABR-20100423..., Susquehanna County, Pa.; Approval Date: April 14, 2010. 26. EOG Resources, Inc., Pad ID: JENKINS 1H, ABR...

7 CFR 900.14 - Execution and issuance of marketing agreements and marketing orders.

Science.gov (United States)

2010-01-01

... Register. The marketing agreement shall not become effective less than 30 days after its publication in the... earlier effective date therefor: Provided, That no marketing agreement shall become effective as to any... effective date of the marketing agreement. (b) Issuance of marketing order with marketing agreement...

7 CFR 996.22 - USDA-approved laboratory.

Science.gov (United States)

2010-01-01

..., Agricultural Marketing Service, USDA, that chemically analyze peanuts for aflatoxin content. Quality and... 7 Agriculture 8 2010-01-01 2010-01-01 false USDA-approved laboratory. 996.22 Section 996.22 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing...

7 CFR 1425.4 - Approval.

Science.gov (United States)

2010-01-01

... AGRICULTURE LOANS, PURCHASES, AND OTHER OPERATIONS COOPERATIVE MARKETING ASSOCIATIONS § 1425.4 Approval. (a) For a cooperative to gain CMA status to participate in a marketing assistance loan or Loan deficiency... prepared in accordance with generally accepted accounting principles; (3) A copy of the articles of...

42 CFR 8.13 - Revocation of accreditation and accreditation body approval.

Science.gov (United States)

2010-10-01

... GENERAL PROVISIONS CERTIFICATION OF OPIOID TREATMENT PROGRAMS Certification and Treatment Standards § 8.13... period of 1 year after the date of withdrawal of approval of the accreditation body, unless SAMHSA.... (2) Within 1 year from the date of withdrawal of approval of an accreditation body, or within any...

7 CFR 966.124 - Approved receiver.

Science.gov (United States)

2010-01-01

... limited to, the following information: (1) Name, address, contact person, telephone number, and e-mail... 7 Agriculture 8 2010-01-01 2010-01-01 false Approved receiver. 966.124 Section 966.124 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements...

12 CFR 717.28 - Effective date, compliance date, and prospective application.

Science.gov (United States)

2010-01-01

... REGULATIONS AFFECTING CREDIT UNIONS FAIR CREDIT REPORTING Affiliate Marketing § 717.28 Effective date... eligibility information that you receive from an affiliate to make solicitations to a consumer if you receive...

Marketing Sustainable Retail Development

Directory of Open Access Journals (Sweden)

Dragan Ilić

2013-06-01

Full Text Available One of the primary benefits of sustainable retail over the long run has to be the marketing gain from having something other competitors do not: lower operating costs, a more socially responsible public profile, ease of gaining planning approval for new projects, better access to certain investment pools, higher rents (in the case of developers, ease of recruiting and retaining key people. Each of these benefits needs marketing and public relations support; each benefits from a clear and consistent corporate message that promotes sustainable retail. To date, there are very few retailers or developers who have championed sustainability long enough, consistently enough and with enough actual demonstration of changes in standard operations to gain the benefits of green marketing, but the very paucity of examples serves to underscore the point: the green marketing space is wide open for large retailers and developers. What would be the marketing steps that a company could take to benefit from its “sustainability focus?” The key to any marketing program is to differentiate a company’s actions from those of competitors and to do it along lines that its various stakeholders care about. This practice of differentiation is often expressed as “finding a difference that makes a difference, to someone who makes difference to you.” For retail developers, the first differentiator should be to attract more and better tenants to all of their centers, tenants who value lower operating costs and the developer’s program of sustainable development and corporate social responsibility.

Heterogeneity of Clinical Trials for Antihypertensive Drugs in Japan: Exploratory Analysis of Confirmatory Phase III Trials Used for Marketing Approval.

Science.gov (United States)

Kaneko, Reina; Sano, Kota; Ono, Shunsuke

2018-07-01

The results of pivotal trials, which provide a rationale for marketing approval decisions for new drugs, are considered for various comparative purposes in postmarketing analyses. Using meta-regression analysis of 91 randomized controlled trials of 61 approved antihypertensive drugs in Japan, we show that mean baseline blood pressure (BP) of each arm was associated with predetermined entry criteria (EC), age, and trial start year (TSY). BP changes following treatment were associated with EC, subject characteristics (e.g., age, complications, baseline BP), study design (e.g., concomitant drug use), and TSY. Effect sizes were generally larger in trials for the first and second drugs in the same class than in trials for follow-on drugs. Results of pivotal trials may vary depending on many factors, suggesting possible challenges associated with the comparison of these results indirectly. Due to the heterogeneity in pivotal trials, caution should be exercised when comparing approved drugs and conducting meta-analyses retrospectively. © 2017, The American Society for Clinical Pharmacology and Therapeutics.

12 CFR 334.28 - Effective date, compliance date, and prospective application.

Science.gov (United States)

2010-01-01

... REGULATIONS AND STATEMENTS OF GENERAL POLICY FAIR CREDIT REPORTING Affiliate Marketing § 334.28 Effective date... eligibility information that you receive from an affiliate to make solicitations to a consumer if you receive...

Approval plans issues and innovations

CERN Document Server

Katz, Linda S

2013-01-01

How can you, as an acquisition librarians, keep current on the output of hundreds of publishers? The answer, of course, is that you cannot. For over 30 years, approval plans have been used by librarians to acquire current titles, save staff time, and build core collections. Even today, these reasons seem appropriate, as libraries try to maintain up-to-date collections and control personnel and operating budgets. However, as shown in Approval Plans: Issues and Innovations, the use of approval plans is not so simple and straightforward; their use is subject to complex procedures and policies--an

24 CFR 886.107 - Approval of applications.

Science.gov (United States)

2010-04-01

...) The Owner's Affirmative Fair Housing Marketing Plan is approvable. (b) The HUD-approved unit rents are... climatic or geological conditions or local codes are examples which may justify such variations. (d) A... neighborhood in a substantially adverse manner. Examples of such adverse effects are (1) substantial move-outs...

Linaclotide: first global approval.

Science.gov (United States)

McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

2012-11-12

Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

Accelerated approval of oncology products: the food and drug administration experience.

Science.gov (United States)

Johnson, John R; Ning, Yang-Min; Farrell, Ann; Justice, Robert; Keegan, Patricia; Pazdur, Richard

2011-04-20

We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations allowed accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. Failure to complete postapproval trials to confirm clinical benefit with due diligence could result in removal of the accelerated approval indication from the market. From December 11, 1992, to July 1, 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in postapproval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8-12.6 years) and the mean time was 4.7 years, representing a substantial time savings in terms of earlier availability of drugs to cancer patients. Three new indications did not show clinical benefit when confirmatory postapproval trials were completed and were subsequently removed from the market or had restricted distribution plans implemented. Confirmatory trials were not completed for 14 new indications. The five longest intervals from receipt of accelerated approval to July 1, 2010, without completion of trials to confirm clinical benefit were 10.5, 6.4, 5.5, 5.5, and 4.7 years. The five longest intervals between accelerated approval and successful conversion to regular approval were 12.6, 9.7, 8.1, 7.5, and 7.4 years. Trials to confirm clinical benefit should be part of the drug development plan and should be in progress at the time of an application seeking accelerated approval to prevent an ineffective drug from remaining on the market for an unacceptable time.

77 FR 7166 - Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late...

Science.gov (United States)

2012-02-10

... late in the development of a drug for marketing approval or after approval based on what is already... investigational drugs to support marketing approval (premarket) and trials conducted after approval (postmarket... assessment without compromising the integrity of the trial results. DATES: Although you can comment on any...

Is It Really FDA Approved?

Science.gov (United States)

... satisfaction before companies can market them in interstate commerce. Some examples of biologics that require approval are ... it means the agency has determined that the benefits of the product outweigh the known risks for ...

24 CFR 886.321 - Marketing.

Science.gov (United States)

2010-04-01

... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Marketing. 886.321 Section 886.321... the Disposition of HUD-Owned Projects § 886.321 Marketing. (a) Marketing in accordance with HUD-Approved Plan. Marketing of units and selection of families by the owner shall be in accordance with the...

75 FR 36058 - Notice of Request for Extension and Revision of a Currently Approved Information Collection

Science.gov (United States)

2010-06-24

... Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and...: Extension and revision of a currently approved information collection. Abstract: Marketing order programs... / Thursday, June 24, 2010 / Notices#0;#0; [[Page 36058

7 CFR 999.1 - Regulation governing the importation of dates.

Science.gov (United States)

2010-01-01

... SERVICE (Marketing Agreements and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE SPECIALTY...) Dates in retail packages means whole or pitted dates, other than dates prepared or preserved, wrapped or... includes dates coated with a substance materially altering their color. (5) Dates prepared or preserved...

Forecasting Housing Approvals in Australia: Do Forecasters Herd?

DEFF Research Database (Denmark)

Stadtmann, Georg; Pierdzioch; Rülke

2012-01-01

Price trends in housing markets may reflect herding of market participants. A natural question is whether such herding, to the extent that it occurred, reflects herding in forecasts of professional forecasters. Using more than 6,000 forecasts of housing approvals for Australia, we did not find...

Marketing reporting system

OpenAIRE

Hanić Hasan M.

2004-01-01

The main components of a developed and good organized marketing information system are: internal reporting system, marketing reporting system, market research system and analytical marketing system. Marketing reporting system provides data and information about changes in business and micro marketing environment. This component of MIS ensures that marketing managers are up-to-date with what is going on, and to be informed about changes in company marketing environment.

Marketing reporting system

Directory of Open Access Journals (Sweden)

Hanić Hasan M.

2004-01-01

Full Text Available The main components of a developed and good organized marketing information system are: internal reporting system, marketing reporting system, market research system and analytical marketing system. Marketing reporting system provides data and information about changes in business and micro marketing environment. This component of MIS ensures that marketing managers are up-to-date with what is going on, and to be informed about changes in company marketing environment.

18 CFR 300.10 - Application for confirmation and approval.

Science.gov (United States)

2010-04-01

... REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS FOR FEDERAL POWER MARKETING ADMINISTRATIONS CONFIRMATION AND APPROVAL OF THE RATES OF FEDERAL POWER MARKETING ADMINISTRATIONS Filing Requirements § 300.10... with applicable laws and that it is the lowest possible rate consistent with sound business principles...

MODEL OF MARKETING COMMUNICATIONS EFFECTIVENESS IN THE BUSINESS-TO-BUSINESS MARKETS

OpenAIRE

Jerman, Damjana; Završnik, Bruno

2012-01-01

Much of the research into marketing communications has focused on the consumer market with little regard to date for the business-to-business market. This paper focuses on a development and testing of a model of marketing communication effectiveness in the business-to-business market. Building on past research from the marketing communications and business-to-business marketing literature, the model (which incorporates facets of the marketing communication objectives, bidirectional communicat...

A drug's life: the pathway to drug approval.

Science.gov (United States)

Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

2013-10-01

In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

77 FR 24677 - Notice of Intent To Seek Approval to Revise and Extend a Currently Approved Information Collection

Science.gov (United States)

2012-04-25

... target population, sampling design, and/or questionnaire length. DATES: Comments on this notice must be..., feed dealers, and others in the marketing and supply channels as a basis for production and marketing...

MARKET WATCH

Institute of Scientific and Technical Information of China (English)

无

2010-01-01

TO THE POINT:The government vows to control the real estate market after a year of robust growth.To diversify financial investment tools,the regulatory authorities approved the launch of stock index futures,and short selling and margin trading to allow investors to hedge against risks.China overtakes the United States to become the world’s biggest auto market in2009.The country is also expected to become the largest consumer market in the world by2020.Google threatens to halt its China operations if it cannot reach a censorship agreement with the government.

78 FR 17890 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.

Science.gov (United States)

2013-03-25

... requiring this device to meet the statute's premarket approval requirements and the benefits to the public... requiring the device to have an approved PMA or a declared completed PDP and the benefit to the public from... consider exercising enforcement discretion for devices lawfully distributed before the requirement to have...

78 FR 76383 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

Science.gov (United States)

2013-12-17

... purchase. Decision Date: April 5, 2013. FOR FURTHER INFORMATION CONTACT: Trang Tran, Seattle Airports... Approved in This Decision: $121,393,042. Earliest Charge Effective Date: August 1, 2014. Estimated Charge... planning and program administration. Decision Date: March 8, 2013. FOR FURTHER INFORMATION CONTACT: Steve...

75 FR 76729 - Market Access Agreement

Science.gov (United States)

2010-12-09

... FARM CREDIT ADMINISTRATION Market Access Agreement AGENCY: Farm Credit Administration. ACTION: Notice of approval of the draft amendment to the amended and restated market access agreement. SUMMARY... Credit Bank of Wichita and the Western Farm Credit Bank under Section 7.12 of the Market Access Agreement...

Number of patients studied prior to approval of new medicines

DEFF Research Database (Denmark)

Duijnhoven, Ruben G; Straus, Sabine M J M; Raine, June M

2013-01-01

length of time), whereas 67 (79.8%) of the medicines met the criteria for 12-mo patient exposure (at least 100 participants studied for 12 mo). CONCLUSIONS: For medicines intended for chronic use, the number of patients studied before marketing is insufficient to evaluate safety and long-term efficacy....... Both safety and efficacy require continued study after approval. New epidemiologic tools and legislative actions necessitate a review of the requirements for the number of patients studied prior to approval, particularly for chronic use, and adequate use of post-marketing studies. Please see later...

75 FR 29306 - Notice of Request for Extension of a Currently Approved Information Collection

Science.gov (United States)

2010-05-25

... Market News Branch, Livestock and Seed Program, Agricultural Marketing Service, U.S. Department of... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No. AMS-LS-10-0035] Notice of Request for Extension of a Currently Approved Information Collection AGENCY: Agricultural Marketing...

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...

Reactions to Participating in Dating Violence Research: Are Our Questions Distressing Participants?

Science.gov (United States)

Shorey, Ryan C.; Cornelius, Tara L.; Bell, Kathryn M.

2011-01-01

In recent years, there has been increased research focus on dating violence, producing important information for reducing these violent relationships. Yet Institutional Review Boards (IRBs) are often hesitant to approve research on dating violence, citing emotional distress of participants as a possible risk of participation. However, no known…

A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds.

Science.gov (United States)

DiMasi, J A; Hermann, J C; Twyman, K; Kondru, R K; Stergiopoulos, S; Getz, K A; Rackoff, W

2015-11-01

We developed an algorithm (ANDI) for predicting regulatory marketing approval for new cancer drugs after phase II testing has been conducted, with the objective of providing a tool to improve drug portfolio decision-making. We examined 98 oncology drugs from the top 50 pharmaceutical companies (2006 sales) that first entered clinical development from 1999 to 2007, had been taken to at least phase II development, and had a known final outcome (research abandonment or regulatory marketing approval). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Logistic regression and machine-learning methods were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors. We found that a simple four-factor model (activity, number of patients in the pivotal phase II trial, phase II duration, and a prevalence-related measure) had high sensitivity and specificity for predicting regulatory marketing approval. © 2015 American Society for Clinical Pharmacology and Therapeutics.

Use of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Metformin, or Psychotropic Drugs

Science.gov (United States)

McGettigan, Patricia; Roderick, Peter; Mahajan, Rushikesh; Kadam, Abhay; Pollock, Allyson M.

2015-01-01

; anti-psychotics: ten formulations, three (30%) approved, seven (70%) unapproved. After 1 May 2002, the proportions of approved FDC formulations increased for NSAIDs (26%/28%) and anti-psychotics (0%/38%) and decreased for metformin (100%/75%) and anti-depressants/benzodiazepines (20%/18%), and the overall proportion approved remained similar before and after that date. FDC formulations gave rise to multiple branded products, ranging from 211 anti-psychotic FDC products from ten formulations to 2,739 NSAID FDC products from 124 formulations. The proportions of FDC sales volumes arising from unapproved formulations were as follows: anti-depressants/benzodiazepines, 69%; anti-psychotics, 43%; NSAIDs, 28%; and metformin, 0.4%. Formulations including drugs banned/restricted internationally comprised over 12% of NSAID FDC sales and 53% of anti-psychotic FDC sales. Across the four therapeutic areas, 14 FDC formulations were approved in the UK and 22 in the US. Conclusions There was evidence supporting concerns about FDCs. Metformin excepted, substantial numbers of centrally unapproved formulations for NSAID, anti-depressant/benzodiazepine, and anti-psychotic FDCs were marketed; sales volumes were high. The legal need for central approval of new drugs before manufacture has been in place continuously since 1961, including for FDCs meeting the applicable legal test. Proportions of centrally unapproved formulations after 1 May 2002 did not decrease overall, and no ambiguity was found about states’ licensing powers. Unapproved formulations should be banned immediately, prioritising those withdrawn/banned internationally and undertaking a review of benefits and risks for patients in ceasing or switching to other medicines. Drug laws need to be amended to ensure the safety and effectiveness of medicines marketed in India. PMID:25965416

40 CFR 52.1605 - EPA-approved New Jersey regulations.

Science.gov (United States)

2010-07-01

... of “large zone 3 coal conversions” must be provided to EPA (40 CFR 52.1601(b)). Subchapter 11... Subchapter 16 is approved into the SIP except for Open Market Emissions Trading (OMET) provisions at 16.1A(g... into the SIP except for the following provisions: (1) Open Market Emissions Trading (OMET) provisions...

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures; delay of effective date. Final rule; delay of effective date.

Science.gov (United States)

2004-02-23

The Food and Drug Administration (FDA) is further delaying, until December 1, 2006, the effective date of certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). In the Federal Register of May 3, 2000 (65 FR 25639), the agency delayed until October 1, 2001, the effective date of certain requirements in the final rule relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record, and distribution of blood derivatives by entities that meet the definition of a "health care entity" in the final rule. The agency further delayed the effective date of these requirements in three subsequent Federal Register notices. Most recently, in the Federal Register of January 31, 2003 (68 FR 4912), FDA delayed the effective date until April 1, 2004. This action further delays the effective date of these requirements until December 1, 2006. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The agency is taking this action to address concerns about the requirements in the final rule raised by affected parties. As explained in the SUPPLEMENTARY INFORMATION section, FDA is working with stakeholders through its counterfeit drug initiative to facilitate widespread, voluntary adoption of track and trace technologies that will generate a de facto electronic pedigree, including prior transaction history back to the original manufacturer, as a routine course of business. If this technology is widely adopted, it is expected to help fulfill the pedigree requirements of the PDMA and obviate or resolve many of the concerns that have been raised with respect to the final rule by ensuring that an electronic pedigree travels with a drug product at all times. Therefore, it is necessary to delay the effective date of Sec

Analysis of the Risks and Benefits of New Chemical Entities Approved by the US Food and Drug Administration (FDA) and Subsequently Withdrawn From the US Market.

Science.gov (United States)

Patriarca, Peter A; Van Auken, R Michael; Kebschull, Scott A

2018-01-01

Benefit-risk evaluations of drugs have been conducted since the introduction of modern regulatory systems more than 50 years ago. Such judgments are typically made on the basis of qualitative or semiquantitative approaches, often without the aid of quantitative assessment methods, the latter having often been applied asymmetrically to place emphasis on benefit more so than harm. In an effort to preliminarily evaluate the utility of lives lost or saved, or quality-adjusted life-years (QALY) lost and gained as a means of quantitatively assessing the potential benefits and risks of a new chemical entity, we focused our attention on the unique scenario in which a drug was initially approved based on one set of data, but later withdrawn from the market based on a second set of data. In this analysis, a dimensionless risk to benefit ratio was calculated in each instance, based on the risk and benefit quantified in similar units. The results indicated that FDA decisions to approve the drug corresponded to risk to benefit ratios less than or equal to 0.136, and that decisions to withdraw the drug from the US market corresponded to risk to benefit ratios greater than or equal to 0.092. The probability of FDA approval was then estimated using logistic regression analysis. The results of this analysis indicated that there was a 50% probability of FDA approval if the risk to benefit ratio was 0.121, and that the probability approaches 100% for values much less than 0.121, and the probability approaches 0% for values much greater than 0.121. The large uncertainty in these estimates due to the small sample size and overlapping data may be addressed in the future by applying the methodology to other drugs.

7 CFR 905.54 - Marketing, research and development.

Science.gov (United States)

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Marketing, research and development. 905.54 Section... Marketing, research and development. The committee may, with the approval of the Secretary, establish, or provide for the establishment of, projects including production research, marketing research and...

Streptomyces phaeopurpureus Shinobu 1957 (Approved Lists 1980) and Streptomyces griseorubiginosus (Ryabova and Preobrazhenskaya 1957) Pridham et al. 1958 (Approved Lists 1980) are heterotypic subjective synonyms.

Science.gov (United States)

Kämpfer, Peter; Rückert, Christian; Blom, Jochen; Goesmann, Alexander; Wink, Joachim; Kalinowski, Jörn; Glaeser, Stefanie P

2017-08-01

On the basis of whole genome comparisons of Streptomyces griseorubiginosus and Streptomyces phaeopurpureus it could by shown that these two species are subjective synonyms. The names of both species have been published in the Approved Lists of Bacterial Names and, in such a case, normally Rule 24b (1) of the Prokaryotic Code applies, which reads: 'If two names compete for priority and if both names date from 1 January 1980 on an Approved List, the priority shall be determined by the date of the original publication of the name before 1 January 1980'. Streptomyces griseorubiginosus and Streptomyces phaeopurpureus were both effectively published in 1957, and for both publications, the exact date cannot be obtained. In this case a further statement of Rule 24 applies, which reads: 'If the names or epithets are of the same date, the author who first unites the taxa has the right to choose one of them, and his choice must be followed.' Hence we propose that Streptomyces phaeopurpureus is a later heterotypic subjective synonym of Streptomyces griseorubiginosus.

Using microwaves in Disinsection of dates

International Nuclear Information System (INIS)

Zouba, Anis

2008-01-01

The date palm plays a very significant role in Tunisia in term of culture as well as social, economic and ecological aspects. The production of the dates which is estimated to 120.000 tons/year ensures the principal income for the majority of the oasis population of the South of Tunisia and constitutes the basis for agricultural, industrial, commercial and tourist activities, offering million of working days. The date palm is cultivated mainly for the production of dates which are consumed locally or also exported abroad but for its by-products (food of the cattle, wind breaks, fuel, construction) which are marketed and/ or used in the everyday life thus taking part in the sedentarisation of the populations and the maintenance of a fragile socio-economic balance. The date moth, Ectomyelois ceratoniae Zell. ( L will epidoptera, Pyralidae) is without question the most significant problem of the Tunisian date palm. The infestation of dates in the field and in the storage and packing houses enormously depreciates the marketable quality of dates and risk to compromise exports in particular those of the variety Deglet Nour. rates of infestations of about 20% are often recorded in Tunisia where as the European standards require rates lower than 5%. In Tunisia the desinsectisation of dates is done until now by the use of methyl bromide, its high toxicity substantially reduces the duration of date treatment, and consequently the treated volumes. The replacement of this product becomes an urgent need its use will not be authorized by 2015. Within the framework of a agreement between the Regional Research Center in Oasis Agriculture (CRRAO), The Interprofessional Grouping of Fruits (GIF), and the Italian Company IMETEC, the use one of micro-waves as a desinsectisation method of dates was evaluated. The results of this present work showed that total desinsectisation of dates by microwaves can be obtained only with homogeneous dates in term of water content. Total

78 FR 38912 - Notice of Request for Revision of a Currently Approved Information Collection

Science.gov (United States)

2013-06-28

... immediate production and marketing decisions and as a guide to the amount of product in the supply channel... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Document No. AMS-FV-13-0022] Notice of Request for Revision of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service...

76 FR 64868 - Orphan Drug Regulations

Science.gov (United States)

2011-10-19

...: Pharmacological Property: The mechanism of action is a common principle for limiting the investigation and use of... drug, even in the face of a holder's exclusive marketing rights, if the subsequent sponsor advances a... appropriate, for those additional subsets from the date of such additional marketing approval(s). Before...

78 FR 23883 - Marketing Orders for Fruit Crops; Notice of Request for Extension and Revision of a Currently...

Science.gov (United States)

2013-04-23

... Extension and Revision of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service... submitted through the Internet at http://www.regulations.gov . SUPPLEMENTARY INFORMATION: Title: Marketing... Request: Extension and Revision of a currently approved information collection. Abstract: Marketing orders...

7 CFR 3565.353 - Affirmative fair housing marketing.

Science.gov (United States)

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Affirmative fair housing marketing. 3565.353 Section... fair housing marketing. As a condition of the guarantee, the lender must ensure that the lender and borrower are in compliance with the approved Affirmative Fair Housing Marketing Plan. This plan must be...

7 CFR 1427.10 - Approved storage.

Science.gov (United States)

2010-01-01

... § 1427.10 Approved storage. (a) Eligible cotton may be pledged as collateral for loans only if stored at... receipt for any bale or bales of cotton pledged as collateral for a CCC loan must include the dates that... cotton pledged as collateral for a CCC loan that are stored outside, and (ii) Through their electronic...

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

Science.gov (United States)

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

B2B marketing communications in emerging markets : content marketing in digital channels: a case study of the United Arab Emirates

OpenAIRE

Banjo, Olugbenga

2013-01-01

With the ever increasing online community and opportunities, digital marketing is fast becoming the mainstream in the field of marketing. At the same time marketers have to be up-to-date with the current digital trends in order to be able to improve themselves and make valuable contributions to their organisations. The significance of digital marketing thus should make any thoughtful organisation want to plan for, perform, evaluate and improve its digital marketing endeavours where necessary,...

7 CFR 930.48 - Research, market development and promotion.

Science.gov (United States)

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Research, market development and promotion. 930.48... Order Regulating Handling Research, Market Development and Promotion § 930.48 Research, market development and promotion. The Board, with the approval of the Secretary, may establish or provide for the...

77 FR 5028 - Withdrawal of Approval of New Animal Drug Applications

Science.gov (United States)

2012-02-01

.... DATES: Withdrawal of approval is effective February 13, 2012. FOR FURTHER INFORMATION CONTACT: John...- 3115. NADA 100-689 DIFIL Syrup (diethylcarbamazine Evsco Pharmaceuticals, an Affiliate of citrate). IGI...

7 CFR 915.45 - Production research, marketing research and development.

Science.gov (United States)

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Production research, marketing research and... Production research, marketing research and development. The committee may, with the approval of the Secretary, establish or provide for the establishment of production research, marketing research and...

76 FR 68811 - Notice of Request for the Revision of Currently Approved Information Collection

Science.gov (United States)

2011-11-07

... operating information from the nation's public transportation systems. Congress created the NTD to be the... request the Office of Management and Budget (OMB) to approve the revision of the currently approved information collection: 49 U.S.C. 5335(a) and (b) National Transit Database (NTD). DATES: Comments must be...

21 CFR 314.81 - Other postmarketing reports.

Science.gov (United States)

2010-04-01

... FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.81 Other... date each authorized generic drug (as defined in § 314.3) entered the market, the date each authorized... process, review, and archive. FDA will periodically issue guidance on how to provide the electronic...

[Marketing approval and market surveillance of medical devices in Germany: Where does policy integration take place?].

Science.gov (United States)

Lang, Achim

2014-01-01

Since 2011 new regulatory measures regarding medical devices have been set up with the aim to eliminate obstacles to innovations and to find more coordinated ways to marketing authorisation and market surveillance. This essay investigates whether these new and existing coordination mechanisms build up to a Joined-up Government approach. The analysis shows that the regulatory process should be adjusted along several dimensions. First, many organisations lack awareness regarding their stakeholders and focus solely on their immediate organisational activities. Second, the regulatory process (marketing authorisation and market surveillance) is too fragmented for an effective communication to take place. Finally, the underlying strategy process is an ad-hoc approach lacking continuity and continued involvement of, in particular, the responsible federal ministries. Copyright © 2013. Published by Elsevier GmbH.

75 FR 36059 - Notice of Request for Extension and Revision of a Currently Approved Information Collection

Science.gov (United States)

2010-06-24

... Internet at http://www.regulations.gov . SUPPLEMENTARY INFORMATION: Title: Marketing Orders for Fruit Crops... Revision of a currently approved information collection. Abstract: Marketing order programs provide an... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No. AMS-FV-10-0033; FV10-902-1NC...

76 FR 66682 - Request for an Extension to a Currently Approved Information Collection for the Regulations...

Science.gov (United States)

2011-10-27

... Marketing Service's (AMS) intention to request approval from the Office of Management and Budget, for an... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No.: AMS-DA-11-0087; DA-11-05] RIN...) AGENCY: Agricultural Marketing Service, USDA. ACTION: Request for comments. SUMMARY: In accordance with...

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

Directory of Open Access Journals (Sweden)

Ross JS

2015-05-01

Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

78 FR 2878 - Approval and Promulgation of Implementation Plans; Georgia: New Source Review-Prevention of...

Science.gov (United States)

2013-01-14

... incorrect version of the proposed rulemaking. DATES: The proposed rule published January 2, 2013, is... Deterioration'' to approve changes to Georgia's SIP-approved regulations entitled ``Air Quality Control Rule 391-3-.1.'' The proposed rule version published in the Federal Register on January 2, 2013, was an...

Avelumab: First Global Approval.

Science.gov (United States)

Kim, Esther S

2017-05-01

Avelumab (Bavencio ® ) is an intravenously administered programmed cell death ligand-1-blocking human antibody initially developed by EMD Serono Inc. (the biopharmaceutical division of Merck KGaA, Darmstadt, Germany) [now jointly developed and commercialized by EMD Serono Inc. and Pfizer] for the treatment of various tumours. It has received accelerated approval in the USA for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults and paediatric patients aged ≥12 years. The marketing authorization application for avelumab in the treatment of mMCC is undergoing regulatory review in the EU, the biologics license application for avelumab in the treatment of urothelial carcinoma is undergoing priority review by the FDA, and avelumab is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of avelumab leading to this first approval for mMCC.

77 FR 56241 - Notice of Withdrawal of Final Design Approval; Westinghouse Electric Company; Advanced Passive 1000

Science.gov (United States)

2012-09-12

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0131] Notice of Withdrawal of Final Design Approval; Westinghouse Electric Company; Advanced Passive 1000 By letter dated December 10, 2010, Westinghouse Electric... final design approval (FDA) for the Advanced Passive 1000 (AP1000) design upon the completion of...

75 FR 1543 - Approval and Promulgation of Implementation Plans; Puerto Rico; Guaynabo PM10

Science.gov (United States)

2010-01-12

... Control of Atmospheric Pollution. On July 15, 2009, the Puerto Rico Environmental Quality Board submitted... Control of Atmospheric Pollution Commonwealth Puerto Rico regulations effective date EPA approval date... analysis and revisions to Rules 102 and 423 of the Puerto Rico Regulation for the Control of Atmospheric...

76 FR 33285 - Filing Dates for the Nevada Special Election in the 2nd Congressional District

Science.gov (United States)

2011-06-08

... 2nd Congressional District AGENCY: Federal Election Commission. ACTION: Notice of filing dates for... members of major or minor political parties on the special general election ballot until candidates are... INFORMATION: On May 12, 2011, the Commission approved the filing dates for the Special General Election in the...

75 FR 44934 - Notice of Request for Extension and Revision of a Currently Approved Information Collection

Science.gov (United States)

2010-07-30

... Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request... information collection. Abstract: Federal milk marketing order regulations authorized under the Agricultural... / Friday, July 30, 2010 / Notices#0;#0; [[Page 44934

75 FR 25120 - List of Approved Spent Fuel Storage Casks: NUHOMS® HD System Revision 1

Science.gov (United States)

2010-05-07

...] RIN 3150-AI75 List of Approved Spent Fuel Storage Casks: NUHOMS[supreg] HD System Revision 1 AGENCY...), NUHOMS[supreg] HD System listing within the ``List of Approved Spent Fuel Storage Casks'' to include... Modular Storage System for Irradiated Nuclear Fuel. Docket Number: 72-1030. Certificate Expiration Date...

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures; delay of effective date; reopening of administrative record. Food and Drug Administration, HHS. Final rule; delay of effective date; reopening of administrative record.

Science.gov (United States)

2000-05-03

The Food and Drug Administration (FDA) is delaying until October 1, 2001, the effective date and reopening the administrative record to receive additional comments regarding certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). The other provisions of the final rule become effective on December 4, 2000. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (the Modernization Act). FDA is delaying the effective date for certain requirements relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record. FDA is also delaying the effective date of another requirement that would prohibit blood centers functioning as "health care entities" to act as wholesale distributors of blood derivatives. The agency is taking this action to address numerous concerns about the provisions raised by affected parties.

21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

Science.gov (United States)

2010-04-01

... based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Approval based on evidence of effectiveness from... the effectiveness of these products only when: (1) There is a reasonably well-understood...

48 CFR 245.7305 - Sale approval and award.

Science.gov (United States)

2010-10-01

... that the sale price is fair and reasonable, taking into consideration— (i) Knowledge or tests of the market; (ii) Current published prices for the property; (iii) The nature, condition, quantity, and...) Approve award to the responsible bidder whose bid is most advantageous to the Government, price and other...

75 FR 51437 - Notice of Request for Extension of a Currently Approved Information Collection (Advanced Meat...

Science.gov (United States)

2010-08-20

... Request for Extension of a Currently Approved Information Collection (Advanced Meat Recovery) AGENCY: Food... information collection regarding the regulatory requirements associated with the production of meat from Advanced Meat Recovery systems because the OMB approval will expire on January 31, 2011. DATES: Comments on...

75 FR 63717 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Amendment to...

Science.gov (United States)

2010-10-18

... clarity, style, format, and consistency with the Ozone Transport Commission Model Rule and Federal... authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 et seq. Subpart NN... State citation Title/subject State EPA approval date explanation/Sec. effective date 52.2063 citation...

75 FR 81632 - Australia Beef Imports Approved for the Electronic Certification System (eCERT)

Science.gov (United States)

2010-12-28

... for the Electronic Certification System (eCERT) AGENCY: Customs and Border Protection, Department of... restraints will be accomplished through the Electronic Certification System (eCERT). Beginning on that date... Fisheries and with the approval of the United States Government. DATES: The use of the eCERT process for all...

76 FR 47085 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

Science.gov (United States)

2011-08-04

... manufacturers take action to prevent the further use of devices for which no PMA or PDP has been filed and may... completion of a product development protocol (PDP) for the class III preamendments device pacemaker... injury designed to be eliminated or reduced by requiring this device to meet the statute's approval...

Effect of gamma rays on fruit storage of some date palm cultivars

International Nuclear Information System (INIS)

El Salhy, F.T.A.

1998-01-01

This investigation wa conducted on two date groups: Semi-dry date (Amry cultivar) and dry date (Sackoti and Bartamoda cultivars) dates, at the National Center for Radiation Research and Technology (NCRRT), in Cairo, during two successive seasons, 1992 and 1993. The aim of this study is to find out the best alternative method for improving fruit quality as well as prolonging the marketable period of date fruits. Semi-dry date (Amry) fruits were obtained from El-Kourain region, brought from Aswan Governorate. Two hundred and twenty kilograms of fruits from each date group were collected to be used for the different postharvest experiments

Utility-Marketer Partnerships. An Effective Strategy for Marketing Green Power?

Energy Technology Data Exchange (ETDEWEB)

Bird, L. A. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Brown, E. S. [National Renewable Energy Lab. (NREL), Golden, CO (United States)

2006-04-01

This paper explores whether partnerships between utilities and independent marketers are an effective strategy for marketing green power. We present case studies of voluntary and mandatory partnerships covering green power program design and implementation in both regulated and restructured electricity markets. We also include perspectives (based on interviews) from utilities, marketers, and regulators involved in developing and implementing these partnerships. From these case studies and interviews, we describe lessons learned about developing effective partnerships, including such issues as respective roles in marketing and administration, product branding, and contract and incentive structures. Based on experience to date, strategic partnerships between utilities and marketers can be an effective approach to marketing green power. Partnerships leverage the sales and resource procurement experience of marketers and the utility’s reputation and access to customers. Further, partnerships can create greater incentives for success because marketers have a vested financial interest in maximizing customer participation and green power sales.

Utility-Marketing Partnerships: An Effective Strategy for Marketing Green Power?

Energy Technology Data Exchange (ETDEWEB)

Bird, L. A.; Brown, E. S.

2006-04-01

This paper explores whether partnerships between utilities and independent marketers are an effective strategy for marketing green power. We present case studies of voluntary and mandatory partnerships covering green power program design and implementation in both regulated and restructured electricity markets. We also include perspectives (based on interviews) from utilities, marketers, and regulators involved in developing and implementing these partnerships. From these case studies and interviews, we describe lessons learned about developing effective partnerships, including such issues as respective roles in marketing and administration, product branding, and contract and incentive structures. Based on experience to date, strategic partnerships between utilities and marketers can be an effective approach to marketing green power. Partnerships leverage the sales and resource procurement experience of marketers and the utility?s reputation and access to customers. Further, partnerships can create greater incentives for success because marketers have a vested financial interest in maximizing customer participation and green power sales.

7 CFR 1717.608 - RUS approval of contracts.

Science.gov (United States)

2010-01-01

... the contracts or arrangements, and regardless of whether or not a Federal power marketing agency is a party to any of them. (d) System management and maintenance contracts. RUS approval of contracts for the management and operation of a borrower's electric system or for the maintenance of the electric system is...

78 FR 38913 - National Organic Program: Request for an Extension of a Currently Approved Information Collection

Science.gov (United States)

2013-06-28

... essential to the integrity of the organic certification system. They create a paper trail that is a critical... States to establish their own organic certification programs after the programs are approved by the... date, one State organic certification program is approved by USDA. Certifying agents. Certifying agents...

76 FR 28727 - Child Nutrition (CN) Labeling Program; Request for Extension and Revision of a Currently Approved...

Science.gov (United States)

2011-05-18

... (CN) Labeling Program; Request for Extension and Revision of a Currently Approved Information... INFORMATION: Title: Child Nutrition Labeling Program. OMB Number: 0581-0261 . Expiration Date of Approval: 3... collection. Abstract: The Child Nutrition (CN) Labeling Program is a voluntary technical assistance service...

78 FR 23884 - Seed Testing Service Program; Request for an Extension of and Revision to a Currently Approved...

Science.gov (United States)

2013-04-23

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No. AMS-LS-13-0007] Seed Testing... AGENCY: Agricultural Marketing Service, USDA. ACTION: Request for comments. SUMMARY: In accordance with... Marketing Service's (AMS) intention to request approval from the Office of Management and Budget (OMB), for...

[Management of Chinese materia medica market based on information asymmetry].

Science.gov (United States)

Yang, Guang; Wang, Nuo; Guo, Lan-Ping; Wang, Yong-Yan; Huang, Lu-Qi; Liu, Jin-Xin

2013-12-01

Pharmaceutical market is a typical market with information asymmetry, and which can lead to "lemons" problem. In all developed countries, firms must receive regulatory approval to market a pharmaceutical product. Such administrative department including SFDA, EMA, FDA and so on. Chinese materia medica is a special part of pharmaceutical market in China. The management of Chinese materia medica is a special challenge in China.

77 FR 32633 - Approval of Test Marketing Exemptions for Certain New Chemicals

Science.gov (United States)

2012-06-01

... of Customers: CBI. Test Marketing Period: CBI days, commencing on first day of commercial manufacture... inorganic pigments and extenders. Production Volume: CBI. Number of Customers: CBI. Test Marketing Period... Customers: CBI. Test Marketing Period: CBI days, commencing on first day of commercial manufacture. TME-11...

75 FR 62176 - Notice of Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2010-10-07

..., Snow Shoe Township, Centre County, Pa.; Consumptive Use of up to 5.000 mgd; Approval Date: August 11.... Chesapeake Appalachia, LLC, Pad ID: Wolf, ABR-201008158, Athens Township, Bradford County, Pa.; Consumptive...

School Principals as Marketing Managers: The Expanding Role of Marketing for School Development

Science.gov (United States)

Anast-May, Linda; Mitchell, Mark; Buckner, Barbara Chesler; Elsberry, Cindy

2012-01-01

This study examined the relative importance that school principals attach to aspects of their role as marketing managers for their schools and their relative satisfaction with their efforts to date. The study included 60 principals from two school districts. Findings suggest that principals are aware of the importance of marketing in today's…

Pharmacovigilance of biologicals : dynamics in post-approval safety learning

NARCIS (Netherlands)

Vermeer, N.S.

2015-01-01

Regulatory decisions to allow new drugs on the market by definition have to accept a certain level of uncertainty about the full benefit-risk balance. Pre-approval studies typically provide information on a limited number of patients over a relative short follow-up period, and handle strict

The competitive advantage of the Tunisian palm date sector in the Mediterranean region

Energy Technology Data Exchange (ETDEWEB)

Ben-Amor, R.; Aguayo, E.; Miguel-Gómez, M. D. de

2015-07-01

In Tunisia, date-palm cultivation and production are of clear strategic importance in terms of economic, social and environmental development. However, the globalization of markets has had a huge impact on the traditional concept of the comparative advantage enjoyed by Tunisia in date exports, highlighting the necessary determinants for competitiveness in the international scenario. In fact, an analysis of the competitive advantage of the Tunisian date industry in the Mediterranean area and Iran over the last 20 years shows that Tunisia is still the main supplier of dates to the EU. The Deglet-Nour variety, in particular, puts Tunisia ahead of traditional competitors such as Algeria and Iran, with average of competitiveness indices as BIS 6405.99, DI 17.38, CMS 41.04 and TBI 99.50 are more stable than those countries during the studied period. But it is currently facing new competitors like Israel and re-exporting countries like France. New business strategies (conditioning, new non-chemical treatments, packing, opening new markets, new distribution channels) would be positive responses to tackle current market limitations, the emergence of new producers and restrictive EU policies. (Author)

The competitive advantage of the Tunisian palm date sector in the Mediterranean region

Directory of Open Access Journals (Sweden)

Rihab Ben-Amor

2015-06-01

Full Text Available In Tunisia, date-palm cultivation and production are of clear strategic importance in terms of economic, social and environmental development. However, the globalization of markets has had a huge impact on the traditional concept of the comparative advantage enjoyed by Tunisia in date exports, highlighting the necessary determinants for competitiveness in the international scenario. In fact, an analysis of the competitive advantage of the Tunisian date industry in the Mediterranean area and Iran over the last 20 years shows that Tunisia is still the main supplier of dates to the EU. The Deglet-Nour variety, in particular, puts Tunisia ahead of traditional competitors such as Algeria and Iran, with average of competitiveness indices as BIS 6405.99, DI 17.38, CMS 41.04 and TBI 99.50 are more stable than those countries during the studied period. But it is currently facing new competitors like Israel and re-exporting countries like France. New business strategies (conditioning, new non-chemical treatments, packing, opening new markets, new distribution channels would be positive responses to tackle current market limitations, the emergence of new producers and restrictive EU policies.

77 FR 3928 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Consumer and Commercial...

Science.gov (United States)

2012-01-26

... Incorporated by Reference, in order to make administrative changes for clarity, style, format, renumbering, and... follows: PART 52--[AMENDED] 0 1. The authority citation for 40 CFR part 52 continues to read as follows... Statutes State State citation Title/subject effective EPA approval date Explanation [former date SIP...

Supply Network Planning for New Product Market Entry in the Pharmaceutical Industry

DEFF Research Database (Denmark)

Hansen, Klaus Reinholdt Nyhuus; Grunow, Martin

2011-01-01

uncertainty and the risk of a forced label change and includes solution robustness. While considering limited shelf life of the drug, the supply of packaging material and outsourcing, the objective of our model is to reduce supply chain cost including lost peak sales from delayed market entry....... planning before and during the market entry of the drug after the drug has been approved. Production of the active pharmaceutical ingredient [API] is characterized by long change-over times due to cleaning requirements. Production planning is long term, multiple batches of each drug are produced...... industry, reimbursement negotiations have to be carried out before a drug can be marketed. These negotiations both necessitate time phasing market entries and introduce a series of uncertainties e.g. varying allowed price and awarded subsidy. Also if the label is not approved for marketing, all packaged...

Eligibility in the electricity and gas retail markets in Spain

International Nuclear Information System (INIS)

Marti, F.

2003-01-01

The true liberalization of the electricity and gas retail markets in Spain was initiated in 1997 and 1998 respectively with the approval of the Electricity Act and the Hydrocarbons Act that set up the regulatory framework for both sectors. The initial eligibility calendars established were speeded up by later legal dispositions which set the full eligibility in January 2003. Therefore in January the number of eligible consumers increased from 65,000 electricity consumers to 22 million and from around 5,000 gas consumers to 4.5 million. In Spain there has been however a coexistence of a liberalized market and a regulated market. While in the liberalized market the consumer will pay a regulated Third Party Access (TPA) tariff for the use of the network and a free price for the energy, in the regulated market the consumer will pay all-inclusive tariffs which are established by the Government in the case of the electricity tariffs and by the Ministry of Economy in the case of the gas tariffs. Today any electricity and gas consumer can choose whether he wants to be supplied through the regulated market or through the liberalized one. Only the electricity HV (High Voltage Supply) all-inclusive tariffs are to disappear in 2007. No date has been set for the others. Also important is to highlight the increase in the consumption of both energy sources. The electricity demand has increased about 38 percent from 1997 (155 TWh/year) to 2002 (214 TWh/year). The gas sector, on the other hand, has increased at a higher rate. From 150 TWh/year in January 1999 to almost 270 TWh/year in July 2003, an 80 percent increase in four and a half years.(author)

Design and analysis of post-marketing research.

Science.gov (United States)

Zhou, Xiao-Hua Andrew; Yang, Wei

2013-07-01

A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

Sales-marketing interfaces within business-firms : Transitions and evolution

NARCIS (Netherlands)

Biemans, W.G.; Makovec Brencic, M.; Malshe, A.

2012-01-01

In these turbulent economic times sales-marketing interfaces in business firms are in the state of flux. Sales-marketing interface researchers have till date characterized marketing within business firms in terms of a marketing department rather than a marketing function thereby ignoring B2B firms

Fitzhenry and Whiteside book of Canadian facts and dates

National Research Council Canada - National Science Library

Pound, Richard W

2005-01-01

... of its kind in the market today. More than 25 researchers, editors and contributors were assigned to research and validate important events and dates in the areas of women's issues, human rights, science and technology...

76 FR 29649 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of Control...

Science.gov (United States)

2011-05-23

... listed in the http://www.regulations.gov website. Although listed in the electronic docket, some... III. 40 CFR part 52 is amended as follows: PART 52--[AMENDED] 0 1. The authority citation for part 52... State citation Title/subject State EPA approval date explanation/Sec. effective date 52.2063 citation...

76 FR 27610 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Control...

Science.gov (United States)

2011-05-12

... or otherwise protected through www.regulations.gov or e-mail. The www.regulations.gov website is an.... The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 et seq... effective EPA approval date Additional explanation/ (COMAR) citation date citation at 40 CFR 52.1100...

76 FR 71491 - Gross Estate; Election to Value on Alternate Valuation Date

Science.gov (United States)

2011-11-18

... 14 may be applicable to determine fair market value for Federal estate tax purposes. (iii... valuation period shall be added to the value of the entity on the alternate valuation date. The sum of the... Gross Estate; Election to Value on Alternate Valuation Date AGENCY: Internal Revenue Service (IRS...

75 FR 44935 - Notice of Request for Extension of Approval of an Information Collection; Certificate for Poultry...

Science.gov (United States)

2010-07-30

...] Notice of Request for Extension of Approval of an Information Collection; Certificate for Poultry and... request an extension of approval of an information collection associated with the export of poultry and poultry hatching eggs from the United States. DATES: We will consider all comments that we receive on or...

Compliance of agrochemical marketers with banned cocoa pesticides in southwest Nigeria

OpenAIRE

Mokwunye Idongesit U.; Babalola Folaranmi D.; Asogwa Uche E.; Idris Ndagi; Aderolu Ismail A.; Mokwunye Francis C.; Idrisu Mohammed

2014-01-01

This study investigated the compliance of marketers of agrochemicals with the approved and banned cocoa pesticides in selected cocoa producing states of southwest Nigeria. Primary data was collected through the use of structured questionnaire administered to randomly selected agrochemical marketers. All the marketers (100%) were aware of the recently banned cocoa pesticides, however, majority still have the pesticides in stock. About 70.6% of the marketers ...

76 FR 9650 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Amendment to the...

Science.gov (United States)

2011-02-22

....regulations.gov or e-mail. The http://www.regulations.gov Website is an ``anonymous access'' system, which... Administrator, Region III. 40 CFR part 52 is amended as follows: PART 52--[AMENDED] 0 1. The authority citation.../ citation at 40 CFR regulations (COMAR) citation Title/subject effective date EPA approval date 52.1100 26...

76 FR 30832 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Permits for...

Science.gov (United States)

2011-05-27

... not a ``significant regulatory action'' subject to review by the Office of Management and Budget under... 0 2. In Sec. 52.2520, the table in paragraph (c) is amended by revising the entries for [45 CSR.../subject effective EPA approval date explanation/citation 45 CSR] date at 40 CFR 52.2565 * * * * * * * [45...

Shippers and Network Capacity Booking in the Dutch Gas Market

NARCIS (Netherlands)

Bucura, C.; Lukszo, Z.

2012-01-01

The main objectives of the Third Gas Directive (2009/73EC) approved by the European Union are: unbundling, creating an independent Transport Service Operator (TSO) and ensuring free access to the market. The separation of gas trading from transportation activities required new market rules and gas

75 FR 4901 - Notice of Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2010-01-29

... 2, 2009. 30. EOG Resources, Inc., Pad ID: Ward M 1H, ABR-20090421.1, Springfield Township, Bradford....; Consumptive Use of up to 4.990 mgd; Approval Date: December 29, 2009. 65. EOG Resources, Inc., Pad ID: Kenyon...

Conditional approval: Japan lowers the bar for regenerative medicine products.

Science.gov (United States)

Sipp, Douglas

2015-04-02

A new system for conditional approval of regenerative medicine products will allow products of undetermined efficacy to enter the Japanese market. The potential scientific, economic, and ethical implications of this program highlight the need for further discussion and refinement. Copyright © 2015 Elsevier Inc. All rights reserved.

13 CFR 120.1716 - Required SBA approval of servicing actions.

Science.gov (United States)

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Required SBA approval of servicing actions. 120.1716 Section 120.1716 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Establishment of SBA Secondary Market Guarantee Program for First Lien Position 504 Loan Pools...

The liberalization of gas markets in Europe

International Nuclear Information System (INIS)

Lecarpentier, A.

2006-01-01

On June 22, 1998 all EU Member States unanimously approved Directive 98/30/EC, the so-called Gas Directive, which paved the way for far-reaching changes in the European gas sector and for the establishment of an internal gas market. Five years have elapsed since it was transposed into national law and although markets have started to open up, their rate of progress varies. The next milestone in achieving a fully competitive European market is July 1, 2007, but there are still many obstacles to overcome. (author)

The liberalization of gas market in Europe

International Nuclear Information System (INIS)

Lecarpentier, Armelle

2006-01-01

On June 22, 1998, all EU Member States unanimously approved Directive 98/30/EC, the so-called Gas Directive, which paved the way for far-reaching changes in the European gas Sector and for the establishment of an internal gas market. Five years have elapsed since it was transposed into national law and although markets have started to open up, their rate of progress varies. The next milestone in achieving a fully competitive European market is July 1, 2007, but there are still many obstacles to overcome [it

76 FR 28121 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

Science.gov (United States)

2011-05-13

... fencing. Acquire radio equipment for emergency operations center. Interactive employee training system... survey and wildlife assessment. Decision Date: March 17, 2011. FOR FURTHER INFORMATION CONTACT: Lori...: Aircraft rescue and firefighting facility. Determination: The approval of this project is limited to the...

21 CFR 312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and...

Science.gov (United States)

2010-04-01

... making the final decision on approvability. As part of this evaluation, consistent with the statement of.... (b) In making decisions on whether to grant marketing approval for products that have been the... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Risk-benefit analysis in review of marketing...

Market-Consistent Valuation of Pension Liabilities

NARCIS (Netherlands)

Pelsser, Antoon; Salahnejhad, Ahmad; van den Akker, Ramon

2016-01-01

Pension funds and life insurance companies have liabilities on their books with extremely long-dated maturities that are exposed to non-hedgeable actuarial risks and also to market risks. In this paper, we show that it is computationally feasible to price pensions contracts in an incomplete market

Wholesale markets. Electricity, Natural Gas and CO2 markets Observatory - 3. Quarter 2015

International Nuclear Information System (INIS)

2015-09-01

The wholesale markets Observatory aims to provide general monitoring indicators of electricity, natural gas and CO 2 markets in France. This Observatory is updated on a Quarterly basis and published on CRE's web site (www.cre.fr). The first part of the report summarises the highlights of the Quarter. The indicators (main dates, key Graphs and graphs) are detailed in the second part

Wholesale markets. Electricity, Natural Gas and CO2 markets Observatory - 1. Quarter 2016

International Nuclear Information System (INIS)

2016-03-01

The wholesale markets Observatory aims to provide general monitoring indicators of electricity, natural gas and CO 2 markets in France. This Observatory is updated on a Quarterly basis and published on CRE's web site (www.cre.fr). The first part of the report summarises the highlights of the Quarter. The indicators (main dates, key figures and graphs) are detailed in the second part

Wholesale markets. Electricity, Natural Gas and CO2 markets Observatory - 1. Quarter 2015

International Nuclear Information System (INIS)

2015-03-01

The wholesale markets Observatory aims to provide general monitoring indicators of electricity, natural gas and CO 2 markets in France. This Observatory is updated on a Quarterly basis and published on CRE's web site (www.cre.fr). The first part of the report summarises the highlights of the Quarter. The indicators (main dates, key Graphs and graphs) are detailed in the second part

Wholesale markets. Electricity, Natural Gas and CO2 markets Observatory - 2. Quarter 2015

International Nuclear Information System (INIS)

2015-06-01

The wholesale markets Observatory aims to provide general monitoring indicators of electricity, natural gas and CO 2 markets in France. This Observatory is updated on a Quarterly basis and published on CRE's web site (www.cre.fr). The first part of the report summarises the highlights of the Quarter. The indicators (main dates, key Graphs and graphs) are detailed in the second part

Wholesale markets. Electricity, Natural Gas and CO2 markets Observatory - 3. Quarter 2014

International Nuclear Information System (INIS)

2014-09-01

The wholesale markets Observatory aims to provide general monitoring indicators of electricity, natural gas and CO 2 markets in France. This Observatory is updated on a Quarterly basis and published on CRE's web site (www.cre.fr). The first part of the report summarises the highlights of the Quarter. The indicators (main dates, key Graphs and graphs) are detailed in the second part

Wholesale markets. Electricity, Natural Gas and CO2 markets Observatory - 2. Quarter 2014

International Nuclear Information System (INIS)

2014-06-01

The wholesale markets Observatory aims to provide general monitoring indicators of electricity, natural gas and CO 2 markets in France. This Observatory is updated on a Quarterly basis and published on CRE's web site (www.cre.fr). The first part of the report summarises the highlights of the Quarter. The indicators (main dates, key Graphs and graphs) are detailed in the second part

Wholesale markets. Electricity, Natural Gas and CO2 markets Observatory - 4. Quarter 2014

International Nuclear Information System (INIS)

2014-12-01

The wholesale markets Observatory aims to provide general monitoring indicators of electricity, natural gas and CO 2 markets in France. This Observatory is updated on a Quarterly basis and published on CRE's web site (www.cre.fr). The first part of the report summarises the highlights of the Quarter. The indicators (main dates, key Graphs and graphs) are detailed in the second part

Wholesale markets. Electricity, Natural Gas and CO2 markets Observatory - 4. Quarter 2015

International Nuclear Information System (INIS)

2015-12-01

The wholesale markets Observatory aims to provide general monitoring indicators of electricity, natural gas and CO 2 markets in France. This Observatory is updated on a Quarterly basis and published on CRE's web site (www.cre.fr). The first part of the report summarises the highlights of the Quarter. The indicators (main dates, key Graphs and graphs) are detailed in the second part

76 FR 11264 - Notice of Realty Action: Proposed Direct Sale of Public Land in Shoshone County, ID

Science.gov (United States)

2011-03-01

..., Inc. (Sunshine) for the appraised fair market value of $280. DATES: Comments regarding the proposed... fair market value is $280 based on an approved BLM appraisal. A copy of the appraisal is available for... the Federal mineral interests with the sale of the land. In addition to the appraised fair market...

Recruiting for Prior Service Market

Science.gov (United States)

2008-06-01

perceptions, expectations and issues for re-enlistment • Develop potential marketing and advertising tactics and strategies targeted to the defined...01 JUN 2008 2. REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE Recruiting for Prior Service Market 5a. CONTRACT NUMBER 5b. GRANT...Command First Handshake to First Unit of Assignment An Army of One Proud to Be e e to Serve Recruiting for Prior Service Market MAJ Eric Givens / MAJ Brian

7 CFR 1486.302 - Can changes be made to a project once it has been approved?

Science.gov (United States)

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false Can changes be made to a project once it has been... MARKETS PROGRAM Program Operations § 1486.302 Can changes be made to a project once it has been approved? (a) Approved projects may be modified if circumstances change in such a way that they would likely...

Short-Term Market Risks Implied by Weekly Options

DEFF Research Database (Denmark)

Andersen, Torben Gustav; Fusari, Nicola; Todorov, Viktor

a direct way to study volatility and jump risks. Unlike longer-dated options, they are largely insensitive to the risk of intertemporal shifts in the economic environment. Adopting a novel semi-nonparametric approach, we uncover variation in the negative jump tail risk which is not spanned by market......We study short-term market risks implied by weekly S&P 500 index options. The introduction of weekly options has dramatically shifted the maturity profile of traded options over the last five years, with a substantial proportion now having expiry within one week. Such short-dated options provide......" by the level of market volatility and elude standard asset pricing models....

76 FR 66602 - Nectarines and Fresh Peaches Grown in California; Termination of Marketing Order 916 and the...

Science.gov (United States)

2011-10-27

... these marketing orders are no longer an effective marketing tool for the handling of nectarines and... while also eliminating the costs associated with the operation of the marketing orders. DATES: Effective... served by delaying the effective date. List of Subjects 7 CFR Part 916 Marketing agreements, Nectarines...

75 FR 64675 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

Science.gov (United States)

2010-10-20

...'s Approval of the El Paso Section 110(a)(1) Maintenance Plan for the 1997 8-Hour Ozone Standard... BPA State Implementation Plan (SIP), a 1997 8-hour ozone maintenance plan that includes a 2021 Motor... the 1997 8-hour ozone standard for the El Paso 1997 8-hour attainment area. DATES: Effective Date...

Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry.

Science.gov (United States)

Beck, Alain; Reichert, Janice M

2013-01-01

In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion's Remsima® and Hospira's Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission's decision on an application is typically issued 67 d after an opinion is provided; thus, decisions are expected in early September 2013. If approved, the products will comprise the first biosimilar antibody made available to patients in a highly regulated market, although launch may be delayed due to an extension of the reference product's (Remicade®) patent in the EU.

75 FR 77611 - Notice of Request for Extension of a Currently Approved Information Collection

Science.gov (United States)

2010-12-13

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No. AMS-TM-10-0106] Notice of... Reduction Act of 1995 (44 U.S.C. chapter 35), this notice announces the Agricultural Marketing Service's... calling the AMS Marketing Services Branch contact listed. DATES: Comments received by February 11, 2011...

Wholesale markets. Electricity, Natural Gas and CO2 markets Observatory - 4. Quarter 2013

International Nuclear Information System (INIS)

2013-12-01

The objective of this wholesale markets Observatory is to provide general monitoring indicators of electricity, natural gas and CO 2 markets in France. This Observatory is updated on a Quarterly basis and published on CRE's web site (www.cre.fr). The first part of the report summarises the highlights of the Quarter. The indicators (main dates, key figures and graphs) are detailed in the second part

Wholesale markets. Electricity, Natural Gas and CO2 markets Observatory - 3. Quarter 2013

International Nuclear Information System (INIS)

2013-09-01

The objective of this wholesale markets Observatory is to provide general monitoring indicators of electricity, natural gas and CO 2 markets in France. This Observatory is updated on a Quarterly basis and published on CRE's web site (www.cre.fr). The first part of the report summarises the highlights of the Quarter. The indicators (main dates, key figures and graphs) are detailed in the second part

Wholesale markets. Electricity, Natural Gas and CO2 markets Observatory - 1. Quarter 2014

International Nuclear Information System (INIS)

2014-03-01

The objective of this wholesale markets Observatory is to provide general monitoring indicators of electricity, natural gas and CO 2 markets in France. This Observatory is updated on a Quarterly basis and published on CRE's web site (www.cre.fr). The first part of the report summarises the highlights of the Quarter. The indicators (main dates, key figures and graphs) are detailed in the second part

77 FR 33394 - Notice of Intent To Request an Extension of a Currently Approved Information Collection

Science.gov (United States)

2012-06-06

... information collection in support of authorizations to use the 4-H Club Name and/or Emblem. DATES: Written... Emblem. OMB Number: 0524-0034. Expiration Date of Current Approval: August 31, 2012. Type of Request.... Abstract: Use of the 4-H Club Name and/or Emblem is authorized by an Act of Congress (18 U.S.C. 707). Use...

77 FR 38879 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

Science.gov (United States)

2012-06-29

... marketable non-displayed interest, the Market Maker would be required to re-enter a quotation for purposes of...-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change Adding New... Securities Exchange Act of 1934 (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to add new...

78 FR 57208 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

Science.gov (United States)

2013-09-17

... notice also includes information on four applications, one approved in July 2012 and the other three... carousel 9 and oversized bag belt TU3. Terminal redevelopment program--design and associated technical.... Rehabilitate terminal access road. Administration fees. DECISION DATE: October 18, 2012. FOR FURTHER...

Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.

Science.gov (United States)

Mattingly, T Joseph; Simoni-Wastila, Linda

2017-10-01

Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential. Although the gold standard for establishing safety and efficacy through randomized controlled trials has been in place for more than 50 years, it poses several limitations for rare disorders where patient recruitment for traditional clinical trials is a major barrier. Organized efforts by patient advocacy groups to help patients with rare diseases access investigational therapy have had a legislative and regulatory effect. After approval by the FDA, patient access to therapy may still be limited by cost. A managed care organization (MCO) with the fiduciary responsibility of managing the health of a population must weigh coverage decisions for costly therapies with questionable effectiveness against alternatives within the constraint of a finite budget. Even when the FDA deems a drug safe and effective, an MCO may determine that the drug should only be made available at a tier level where out-of-pocket costs are still too high for many patients. This limitation of availability may be due to cost, other treatment alternatives, or outcomes from existing clinical evidence. However, if the MCO makes a costly new treatment for a rare disease readily available, it may temporarily satisfy a small contingency at the cost of all of its members. This article examines the risks and benefits of patient-centered drug approval and the potential economic effect of patient-centered drug approval on population health. There is no funding to disclose. Mattingly

Date fruit (Phoenix dactylifera L.: An underutilized food seeking industrial valorization

Directory of Open Access Journals (Sweden)

Sami Ghnimi

2017-03-01

Key findings and conclusions: Date fruits contain 6.5–11.5% total dietary fibers (of which 84–94% insoluble and 6–16% soluble dietary fiber and is very rich in phenolic antioxidants (1–2% especially condensed tannin pigments based on (−-epicatechin oligomers. Date seeds contain about 15% of fiber, characterized by a high level of water-insoluble mannan fibers. Date fruits are widely available in the global market, mainly at mature Tamr stage, but there is still room for improvement. It has been suggested that date fruits and seeds can be exploited in some food applications utilizing their high levels of fiber and antioxidants. The incorporation of date fruits and seeds as food ingredients is still growing with the aim to promote the presence of dates in the modern's consumer shopping basket.

Market Valuation of Accrued Social Security Benefits

OpenAIRE

John Geanakoplos; Stephen P. Zeldes

2009-01-01

One measure of the health of the Social Security system is the difference between the market value of the trust fund and the present value of benefits accrued to date. How should present values be computed for this calculation in light of future uncertainties? We think it is important to use market value. Since claims on accrued benefits are not currently traded in financial markets, we cannot directly observe a market value. In this paper, we use a model to estimate what the market price for...

Intervening in global markets to improve access to HIV/AIDS treatment: an analysis of international policies and the dynamics of global antiretroviral medicines markets.

Science.gov (United States)

Waning, Brenda; Kyle, Margaret; Diedrichsen, Ellen; Soucy, Lyne; Hochstadt, Jenny; Bärnighausen, Till; Moon, Suerie

2010-05-25

Universal access to antiretroviral therapy (ART) in low- and middle-income countries faces numerous challenges: increasing numbers of people needing ART, new guidelines recommending more expensive antiretroviral (ARV) medicines, limited financing, and few fixed-dose combination (FDC) products. Global initiatives aim to promote efficient global ARV markets, yet little is known about market dynamics and the impact of global policy interventions. We utilize several data sources, including 12,958 donor-funded, adult first-line ARV purchase transactions, to describe the market from 2002-2008. We examine relationships between market trends and: World Health Organization (WHO) HIV/AIDS treatment guidelines; WHO Prequalification Programme (WHO Prequal) and United States (US) Food and Drug Administration (FDA) approvals; and procurement policies of the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM), US President's Emergency Plan for AIDS Relief (PEPFAR) and UNITAID. WHO recommended 7, 4, 24, and 6 first-line regimens in 2002, 2003, 2006 and 2009 guidelines, respectively. 2009 guidelines replaced a stavudine-based regimen ($88/person/year) with more expensive zidovudine- ($154-260/person/year) or tenofovir-based ($244-465/person/year) regimens. Purchase volumes for ARVs newly-recommended in 2006 (emtricitabine, tenofovir) increased >15-fold from 2006 to 2008. Twenty-four generic FDCs were quality-approved for older regimens but only four for newer regimens. Generic FDCs were available to GFATM recipients in 2004 but to PEPFAR recipients only after FDA approval in 2006. Price trends for single-component generic medicines mirrored generic FDC prices. Two large-scale purchasers, PEPFAR and UNITAID, together accounted for 53%, 84%, and 77% of market volume for abacavir, emtricitabine, and tenofovir, respectively, in 2008. PEPFAR and UNITAID purchases were often split across two manufacturers. Global initiatives facilitated the creation of fairly efficient markets

Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC approved packages

International Nuclear Information System (INIS)

1988-12-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1988. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Directory of certificates of compliance for radioactive materials packages, Report of NRC approved packages

International Nuclear Information System (INIS)

1990-10-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Materials Packages effective October 1, 1990. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

European Regulatory Framework for Money Market Funds

OpenAIRE

Portuese, Aurelien; MacNeil, Iain

2014-01-01

Money market funds are widely used by all types of investors, including households, corporate treasurers, pension funds, or insurance companies, who regard money market funds as a ‘safe’ short-term liquid asset class for investing cash. In this case they are proxies to cash deposits. Money market funds are themselves key lenders to issuers of short dated high quality money market instruments. They provide an important source of funding for a variety of institutions such as sovereigns, banks, ...

77 FR 23715 - Public Information Collections Approved by the Office of Management and Budget (OMB)

Science.gov (United States)

2012-04-20

... carriers that have market power. Additionally, the information collection is necessary to analyze market...: August 17, 2011. Expiration Date: August 31, 2014. Title: 28 GHz Band Segmentation Plan Amending the... Commission in considering whether FCC rules require modification to accommodate the changing market. The...

The Impact of Marketing Advisory Service Recommendations on Producers' Marketing Decisions

NARCIS (Netherlands)

Pennings, J.M.E.; Isengildina, O.; Irwin, S.H.; Good, D.L.

2004-01-01

Abstract To date, there is only fragmented and anecdotal information about the impact of the recommendations of market advisory services (MAS) on producers¿ decision-making. A conceptual framework is developed in which, among others, producers¿ risk attitudes and risk perceptions; producers¿

75 FR 28004 - Credit Reforms in Organized Wholesale Electric Markets; Notice Establishing Date for Comments

Science.gov (United States)

2010-05-19

... Proposed Rulemaking on Credit Reforms in Organized Wholesale Electric Markets.\\1\\ Specifically, the... counterparty to transactions in their markets \\1\\ Credit Reforms in Organized Wholesale Electric Markets, 130... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM10-13-000] Credit Reforms...

Digital mammography. Why hasn't it been approved for U.S. hospitals?

Science.gov (United States)

2000-01-01

Mammography is the only major imaging technique still unavailable in the United States in digital form. This is because the Food and Drug Administration (FDA) has been unable to devise an effective method for manufacturers to demonstrate the safety and efficacy of digital mammography systems. As a result, the agency has been unable to approve any of those systems for marketing in the United States. In this Regulatory Update, we describe FDA's recent efforts to help manufacturers obtain approval and the reasons those efforts have so far proved ineffective.

78 FR 29770 - Notice of Fund Availability (NOFA) for the Neighborhood Stabilization Program 2 (NSP2) Under the...

Science.gov (United States)

2013-05-21

.... This data is now dated and in many cases it no longer reflects the foreclosure market in NSP2 target... needs index score in selecting geographic target areas. DATES: Effective Date: May 21, 2013. FOR FURTHER... NSP2 NOFA requires grantees to carry out NSP2 activities in a HUD-approved target area. HUD developed a...

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

Science.gov (United States)

Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

2018-02-01

Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue

OIL AND GAS FUTURES AND OPTIONS MARKET

Directory of Open Access Journals (Sweden)

Ante Nosić

2017-01-01

Full Text Available Energy mineral resources markets are represented by complex supply and demand ratios which are depending on different factors such as technical (transport and geopolitical. The main specific of energy markets is represented by an uneven geographic distribution of hydrocarbon reserves and exploration on one hand and energy consumption on the other. World oil markets, although geographically localized, because of specific market trade, represent unique global market with decreasing price difference. Price differences are result of development of a transport possibilities of oil supply. Development of transport routes of natural gas and increasing number of liquefied natural gas terminals in the world give pressure to natural gas market and its integration into global gas market. Integration of regional gas markets into a common European gas market is main energy policy of EU concerning natural gas. On the other hand, there are still significant price differences on some markets (e.g. United States of America - South East Asia. Development of global energy markets is enabled by development of a futures and options contracts of an energy trade which have replaced bilateral contract deals between producers and consumers. Futures contracts are standardized contracts traded on exchanges. Buyer agrees to buy certain quantity of stock for an agreed upon price and with some future delivery date. Option is a contract which gives a buyer the option of the right to buy (or sell, depending on the option an asset at predetermined price and at a later date. Stocks price risk can be managed with the purchase and selling futures and options contracts. This paper deals with futures and options energy markets and their market strategies.

Adverse event reporting patterns of newly approved drugs in the USA in 2006: an analysis of FDA Adverse Event Reporting System data.

Science.gov (United States)

Chhabra, Pankdeep; Chen, Xing; Weiss, Sheila R

2013-11-01

The Weber effect states that adverse event (AE) reporting tends to increase in the first 2 years after a new drug is placed onto the market, peaks at the end of the second year, and then declines. However, since the Weber effect was originally described, there has been improvement in the communication of safety information and new policies regarding the reporting of AEs by healthcare professionals and consumers, prompting reassessment of the existence of the Weber effect in the current AE reporting scenario. To determine the AE reporting patterns for new molecular entity (NME) drugs and biologics approved in 2006 and to examine these patterns for the existence of the Weber effect. Publicly available FDA Adverse Event Reporting System data were used to assess the AE reporting patterns for a 5-year period from the drug’s approval date. The total number of annual reports from all sources, based on the report date, was plotted against time (in years). In the period from 2006 to 2011, a total of 91,187 AE reports were submitted for 19 NMEs approved in 2006. The highest number of AE reports were submitted for varenicline tartrate (N = 47,158) and the lowest number for anidulafungin (N = 161). Anidulafungin was reported to have the highest proportion of death reports (36 %) and varenicline tartrate the lowest proportion (1.7 %). The classic Weber pattern was not observed for any of the 19 NMEs approved in 2006. While there was no one predominant pattern of AE report volume, we grouped the drugs into four general categories; the majority of drugs had either a continued increase in reports (Category A 31.6 %) or an N-pattern with reporting reaching an initial peak in year 2 or 3, declining and then beginning to climb again (Category B 42.1 %). There have been numerous changes in AE reporting, particularly a huge increase in overall annual report volume, since the Weber effect was first reported. Our results suggest that a Weber-type reporting pattern should not be assumed

75 FR 10420 - Approval and Promulgation of Implementation Plans: 1-Hour Ozone Extreme Area Plan for San Joaquin...

Science.gov (United States)

2010-03-08

... Air Pollution Control District's Rule 9310, ``School Bus Fleets.'' DATES: Effective Date: This rule is... Pollution Control District (SJVAPCD or the District) in 2004 and amended in 2005. The 2004 SIP addresses CAA... day (tpd) and nitrogen oxides (NO X ) by 20 tpd and to approve SJVAPCD's Rule 9310, School Bus Fleets...

75 FR 51167 - Bank of Ruston, Ruston, Louisiana; Approval of Conversion Application

Science.gov (United States)

2010-08-18

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-48 OTS Nos. 03912 and H4739] Bank of..., 2010, the Office of Thrift Supervision approved the application of Bank of Ruston, Ruston, Louisiana.... Dated: August 11, 2010. By the Office of Thrift Supervision. Sandra E. Evans, Federal Register Liaison...

Individual Factors Affecting Farmers’ Motivation to Participate in Date Growers’ Organizations in Khuzestan

OpenAIRE

E. Alimirzaei; A. Asady

2011-01-01

Khuzestan Province has a great share in Iran’s date production in which many rural households are directly dependent to dates production. However, small holding system has led to a lot of challenges faced by small scale farmers whereas much potential of date production and marketing lost every year. Despite of strong felt need to social capital development and government’s recent activities in order to help farmers to organize themselves, there is not so much interest in this connection gener...

75 FR 53727 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving Proposed Rule Change, as...

Science.gov (United States)

2010-09-01

... underwritings; (ii) supervision of market making commitments; (iii) final approval of advertisements as these... designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable...

Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers.

Science.gov (United States)

Kesselheim, Aaron S; Rome, Benjamin N; Sarpatwari, Ameet; Avorn, Jerry

2017-02-01

To incentivize pharmaceutical manufacturers to invest in areas of unmet medical need, policy makers frequently propose extending the market exclusivity period of desired drugs. Some such proposals are modeled after the pediatric exclusivity patent extension program, which since 1997 has provided six additional months of market exclusivity for drugs studied in children. The most recent proposal would encourage rare disease research by providing six months of extended exclusivity for any existing drug that is granted subsequent FDA approval for a new rare disease indication. Yet the economic impact of such proposals is rarely addressed. We found that for the thirteen FDA-approved drugs that gained supplemental approval for a rare disease indication from 2005 through 2010, the median projected cost of clinical trials leading to approval was $29.8 million. If the exclusivity extension had been in place, the median discounted financial gain to manufacturers would have been $94.6 million. Median net returns would have been $82.4 million, with higher returns for drugs with higher annual sales. Extending market exclusivity would provide substantial compensation to many manufacturers, particularly for top-selling products, far in excess of the cost of conducting these trials. Alternative strategies to incentivize the study of approved drugs for rare diseases may offer similar benefits at a lower cost. Project HOPE—The People-to-People Health Foundation, Inc.

77 FR 71652 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Order Granting Approval to Proposed Rule...

Science.gov (United States)

2012-12-03

... differently from order flow submitted by other market participants, such segmentation would not be... Markets Association, to Elizabeth M. Murphy, Secretary, Commission, dated September 26, 2012 (``SIFMA... Letter from Eric Swanson, Senior Vice President and General Counsel, BATS Global Markets, to Elizabeth M...

5 CFR 9901.333 - Setting and adjusting local market supplements.

Science.gov (United States)

2010-01-01

... factors. The Secretary may determine the effective date of newly set or adjusted targeted local market... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Setting and adjusting local market... DEFENSE NATIONAL SECURITY PERSONNEL SYSTEM (NSPS) Pay and Pay Administration Local Market Supplements...

78 FR 44922 - Vegetable and Specialty Crop Marketing Orders; Notice of Request for Extension and Revision of a...

Science.gov (United States)

2013-07-25

... Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request... assured of consideration. Additional Information or Comments: Contact Andrew Hatch, Supervisory Marketing....regulations.gov . SUPPLEMENTARY INFORMATION: Title: Vegetable and Specialty Crop Marketing Orders. OMB Number...

MARKET WATCH

Institute of Scientific and Technical Information of China (English)

2009-01-01

Pork prices in Beijing remained relatively stable despite the swine flu outbreak in Mexico. China’s job market is still in the doldrums with the registered urban jobless rising slightly in the first quarter. The government is preparing to issue the third tranche of its stimulus package. China Minmetals Corp. received approval from the Australian Treasury to buy the assets of Oz Minerals Ltd. There were signs that international hot money has started to leave China. Surveys indicate that new Chinese parents are shunning foreign baby-care products.

76 FR 70190 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Science.gov (United States)

2011-11-10

... October 20, 2011 (``Shatto Letter''); letter from Naphtali M. Hamlet, Investor, dated October 21, 2011 (``Hamlet Letter''); letter from Daniel Zinn, General Counsel, OTC Markets Group Inc., dated October 20... reported for public dissemination. \\12\\ See Shatto Letter; Hamlet Letter. \\13\\ See Shatto Letter. \\14\\ See...

76 FR 10555 - Marketing Orders for Nectarines and Peaches Grown in California; Notice of Request for New...

Science.gov (United States)

2011-02-25

... California; Notice of Request for New Information Collection AGENCY: Agricultural Marketing Service, USDA... request approval for new forms to be used to collect information related to Federal marketing orders for... to be assured of consideration. Additional Information: Contact Andrew Hatch, Supervisory Marketing...

Challenges in Albania for improving Labor Market Information System and Labor Market Governance

Directory of Open Access Journals (Sweden)

Neshat Zeneli

2017-07-01

Full Text Available Labour Market Policy of the Republic of Albania in terms of design (preparation, case identification, formulation, and approval, programming and budgeting, implementation, monitoring and evaluation has a short experience (1995-ongoing. The influence and presence of hierarchy model is very high beside the support of different programs and projects through bilateral and EU programs. Still there are a lot of key issues to be addressed. The most important issues to be addressed in this paper are evidence based related to: • The Availability of Labor Market Information and its structure on national, regional and local level in Albania and how much this information is used for -policy making and –monitoring/evaluation in terms of input, output, outcome and impact. • Mode of the governance of the labor market in Albania and challenges to pass from the hierarchy to market and network governance. The main aim of this paper/article is to do a complete and deep analysis of the actual situation of labor market information system and labor market governance in Albania, and to propose conclusions and recommendations that will improve both labor market information system and the labor market governance from hierarchy to market and network governance, because good and standardized labor information system can help towards right policy decisions and good governance of LM policy means more employment, more stability, more social inclusion in the society.

Measuring market performance in restructured electricity markets: An empirical analysis of the PJM energy market

Science.gov (United States)

Tucker, Russell Jay

2002-09-01

Today the electric industry in the U.S. is transitioning to competitive markets for wholesale electricity. Independent system operators (ISOs) now manage broad regional markets for electrical energy in several areas of the U.S. A recent rulemaking by the Federal Energy Regulatory Commission (FERC) encourages the development of regional transmission organizations (RTOs) and restructured competitive wholesale electricity markets nationwide. To date, the transition to competitive wholesale markets has not been easy. The increased reliance on market forces coupled with unusually high electricity demand for some periods have created conditions amenable to market power abuse in many regions throughout the U.S. In the summer of 1999, hot and humid summer conditions in Pennsylvania, New Jersey, Maryland, Delaware, and the District of Columbia pushed peak demand in the PJM Interconnection to record levels. These demand conditions coincided with the introduction of market-based pricing in the wholesale electricity market. Prices for electricity increased on average by 55 percent, and reached the $1,000/MWh range. This study examines the extent to which generator market power raised prices above competitive levels in the PJM Interconnection during the summer of 1999. It simulates hourly market-clearing prices assuming competitive market behavior and compares these prices with observed market prices in computing price markups over the April 1-August 31, 1999 period. The results of the simulation analysis are supported with an examination of actual generator bid data of incumbent generators. Price markups averaged 14.7 percent above expected marginal cost over the 5-month period for all non-transmission-constrained hours. The evidence presented suggests that the June and July monthly markups were strongly influenced by generator market power as price inelastic peak demand approached the electricity generation capacity constraint of the market. While this analysis of the

A Market Analysis of Publications, Trade Conferences, and Key Events for Fleet Readiness Center Southwest

Science.gov (United States)

2007-12-01

Win and Keep Big Customers. Austin: Bard Press, 2005. Kotler , Philip and Kevin Lane Keller. Marketing Management. Upper Saddle River, NJ...NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA MBA PROFESSIONAL REPORT A Market Analysis of Publications, Trade Conferences...AGENCY USE ONLY (Leave blank) 2. REPORT DATE December 2007 3. REPORT TYPE AND DATES COVERED MBA Professional Report 4. TITLE AND SUBTITLE: A Market

Illicit online marketing of lorcaserin before DEA scheduling.

Science.gov (United States)

Liang, Bryan A; Mackey, Tim K; Archer-Hayes, Ashley N; Shinn, Linda M

2013-05-01

Antiobesity drugs have been marketed illicitly by "no prescription" online pharmacies after approval and scheduling by the drug enforcement agency. We assess whether antiobesity drug Belviq® (lorcaserin HCl) was available from illicit online vendors before DEA-scheduling when sales are unauthorized. Online searches of "buy Belviq no prescription" examining first five result pages marketing the drug. Searches were performed from 11/5/2012-12/8/2012, prior to DEA scheduing. Belviq® is actively marketed by "no prescription" online vendors despite official unavailability and prescription requirements. Approaches included direct-to-consumer advertising using descriptive website URLs; linking to illicit marketers; and directing customers to other weight-loss websites for additional marketing. Finally, large quantities were marketed by business-to-business vendors. Illicit online "no prescription" pharmacies are marketing unauthorized, suspect antiobesity drugs before DEA scheduling and permitted marketing. Regulators must legally intercede to ensure patient safety, and providers must educate patients about online-sourcing risks. Copyright © 2013 The Obesity Society.

78 FR 52129 - Cotton Classification and Market News Service: Notice of Request for an Extension and Revision of...

Science.gov (United States)

2013-08-22

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [AMS-CN-13-0045] Cotton Classification... Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request for comments... announces the Agricultural Marketing Service's (AMS) intention to request approval from the Office of...

76 FR 11794 - Drugs for Human Use; Unapproved and Misbranded Oral Drugs Labeled for Prescription Use and...

Science.gov (United States)

2011-03-03

... comply with an FDA over-the-counter (OTC) drug final monograph, before marketing. DATES: This notice is... the drug products covered by this notice contain active ingredients that were introduced into the... the firm marketing the product has received approval for additional indication(s). In the early 1970s...

Review of the timetable for gas and electricity market liberalisation

International Nuclear Information System (INIS)

2000-01-01

The findings of the review undertaken by PA Consulting Group on behalf of the Ministry of Economic Affairs into the feasibility of accelerating electricity and gas market liberalisation in the Netherlands are set out. The main purpose of the review was to assess the technical and organisational requirements for the two markets and to consider the time required to deliver them. The chosen market models for electricity and gas liberalisation, as set out in the Electricity Act and the draft Gas Act, were to be taken as given. A review of the market models chosen and consideration of how the markets should be delivered were excluded from the study. The results of this review have been used by the Ministry of Economic Affairs as input into the decision making process regarding the revised opening dates for the electricity and gas markets for both medium size and small customers. The report includes: A description of the market models for electricity and gas; The technical and organisational requirements and progress to date; The time required to deliver each of the two markets; and The benefits and disadvantages of synchronising gas and electricity market openings and recommended timescales

Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

Science.gov (United States)

Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

2016-01-01

Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

Planning operations before market launch for balancing time-to-market and risks in pharmaceutical supply chains

DEFF Research Database (Denmark)

Hansen, Klaus Reinholdt Nyhuus; Grunow, Martin

2015-01-01

Shorter product life cycles and the resulting increase in new product introductions boost the importance of product launch operations. In the pharmaceutical sector, product launch operations are of particular importance, as companies seek to reduce time-to-market to better exploit patent protection....... Large volumes of product need to be ready to fill the downstream supply chain immediately at market launch. Building up the required inventory is, however, connected to several risks. In addition to the risk associated with the lack of demand information for a new product, there are several risks unique...... to the pharmaceutical sector. After approval by central authorities such as the FDA or EMA, a new drug still needs to receive market authorization, which is in most cases granted by some local authorities – in Europe, for example, by more than 30 national and regional bodies. The duration of these different market...

Directory of Certificates of Compliance for radioactive materials packages: Report of NRC approved packages. Volume 1, Revision 18

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-10-01

The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date.

Directory of Certificates of Compliance for radioactive materials packages: Report of NRC approved packages. Volume 1, Revision 18

International Nuclear Information System (INIS)

1995-10-01

The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date

Where do Electronic Markets Come From?

DEFF Research Database (Denmark)

Castelle, Michael; Millo, Yuval; Beunza, Daniel

2016-01-01

of automated markets was produced through an interweaving of both technological and political change. This processual redefinition of the ‘exchange’, in addition, may provide a suggestive precedent for understanding contemporary regulatory crises generated by other digital marketplace platforms.......The practices of high-frequency trading (HFT) are dependent on automated financial markets, especially those produced by securities exchanges electronically interconnected with competing exchanges. How did this infrastructural and organizational state of affairs come to be? Employing the conceptual...... distinction between fixed-role and switch-role markets, we analyse the discourse surrounding the design and eventual approval of the Securities and Exchange Commission’s Regulation of Exchanges and Alternative Trading Systems (Reg ATS). We find that the disruption of the exchange industry at the hands...

40 Is the New 65? Older Adults and Niche Targeting Strategies in the Online Dating Industry

Directory of Open Access Journals (Sweden)

Derek Blackwell

2016-10-01

Full Text Available Niche dating sites have become a popular trend in the online dating industry; yet, little is known about the specialization strategies these sites use to cater to their users’ needs. Moreover, previous research alludes to the idea that many of these sites may be engaging in pseudo-individualization—a deceptive technique that creates an illusion of specialization. This study focuses on niche dating sites for older adults, one of the fastest growing niches in online dating. Through a qualitative content analysis and close reading of older-adult dating sites, I seek to determine how and to what extent online dating sites that target older adults actually customize their services to benefit this population. Three key findings emerge: (1 the use of mass segmentation, a strategy that combines elements of both mass marketing and market segmentation; (2 a strategic broadening of the boundaries of the older-adult niche; and (3 the use of deceptive advertising to attract users. These findings suggest that older-adult dating sites are, in fact, engaging in pseudo-individualization. They also highlight some of the unique aspects of online media that facilitate this practice. Implications for both online daters and site producers are discussed.

Intervening in global markets to improve access to HIV/AIDS treatment: an analysis of international policies and the dynamics of global antiretroviral medicines markets

Directory of Open Access Journals (Sweden)

Hochstadt Jenny

2010-05-01

Full Text Available Abstract Background Universal access to antiretroviral therapy (ART in low- and middle-income countries faces numerous challenges: increasing numbers of people needing ART, new guidelines recommending more expensive antiretroviral (ARV medicines, limited financing, and few fixed-dose combination (FDC products. Global initiatives aim to promote efficient global ARV markets, yet little is known about market dynamics and the impact of global policy interventions. Methods We utilize several data sources, including 12,958 donor-funded, adult first-line ARV purchase transactions, to describe the market from 2002-2008. We examine relationships between market trends and: World Health Organization (WHO HIV/AIDS treatment guidelines; WHO Prequalification Programme (WHO Prequal and United States (US Food and Drug Administration (FDA approvals; and procurement policies of the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM, US President's Emergency Plan for AIDS Relief (PEPFAR and UNITAID. Results WHO recommended 7, 4, 24, and 6 first-line regimens in 2002, 2003, 2006 and 2009 guidelines, respectively. 2009 guidelines replaced a stavudine-based regimen ($88/person/year with more expensive zidovudine- ($154-260/person/year or tenofovir-based ($244-465/person/year regimens. Purchase volumes for ARVs newly-recommended in 2006 (emtricitabine, tenofovir increased >15-fold from 2006 to 2008. Twenty-four generic FDCs were quality-approved for older regimens but only four for newer regimens. Generic FDCs were available to GFATM recipients in 2004 but to PEPFAR recipients only after FDA approval in 2006. Price trends for single-component generic medicines mirrored generic FDC prices. Two large-scale purchasers, PEPFAR and UNITAID, together accounted for 53%, 84%, and 77% of market volume for abacavir, emtricitabine, and tenofovir, respectively, in 2008. PEPFAR and UNITAID purchases were often split across two manufacturers. Conclusions Global initiatives

Spanish generation market: structure, design and results

International Nuclear Information System (INIS)

Agosti, L.; Padilla, A. J.; Requejo, A.

2007-01-01

This paper provides an overview of the structure, design and outcome of the Spanish generation market from 1998, when the market was liberalised, to date. More precisely, this paper reviews the history of the liberalisation process; describes the structure of the generation market and its evolution over time; analyses the existence of market power; and evaluates the outcome of the liberalisation process from the viewpoint of its impact on al locative efficiency, productive efficiency and dynamic efficiency. The paper concludes with a brief summary of recent regulatory reforms. (Author)

Marketing wholesale electricity in British Columbia

Energy Technology Data Exchange (ETDEWEB)

Moghadam, B. [Powerex, Vancouver, BC (Canada)

2002-03-14

An open access wholesale transmission tariff (WTS) has been in place in British Columbia since 1997, and wholesale electricity can be sold to wholesale purchasers by independent producers located within the province. Customers range from municipalities to British Columbia Hydro (BC Hydro), to Powerex, to UtiliCorp Networks Corporation (UNC). Provided that the necessary approvals and transmission services have been acquired, the energy may be transmitted anywhere in Canada or the United States. The generation and sale of electricity within British Columbia and the United States is subject to government and regulatory approvals. Several buyers and sellers that come together to trade a product are part of a hub. The largest such hub in the Pacific Northwest is called the Mid-Columbia (Mid-C) hub in Washington. The commodity is traded in 25 MW standard blocks. The credit requirements of the purchaser must be satisfied by the generating party. BC Hydro wholesale transmission service can be purchased by any wholesale power marketer or generator to transmit the power to market. It is imperative that scheduling personnel be available at all times. The Western System Coordinating Council (WSCC) insists that an operating reserve of 5 per cent hydro generation and 7 per cent thermal generation to support the electrical system in the face of an emergency be available for the electricity marketed through the hub. Powerex has been successful since 1988 in the marketing of electricity throughout the WSCC. An example was provided to help make the rules a bit easier to comprehend. refs.

Marketing wholesale electricity in British Columbia

International Nuclear Information System (INIS)

Moghadam, B.

2002-01-01

An open access wholesale transmission tariff (WTS) has been in place in British Columbia since 1997, and wholesale electricity can be sold to wholesale purchasers by independent producers located within the province. Customers range from municipalities to British Columbia Hydro (BC Hydro), to Powerex, to UtiliCorp Networks Corporation (UNC). Provided that the necessary approvals and transmission services have been acquired, the energy may be transmitted anywhere in Canada or the United States. The generation and sale of electricity within British Columbia and the United States is subject to government and regulatory approvals. Several buyers and sellers that come together to trade a product are part of a hub. The largest such hub in the Pacific Northwest is called the Mid-Columbia (Mid-C) hub in Washington. The commodity is traded in 25 MW standard blocks. The credit requirements of the purchaser must be satisfied by the generating party. BC Hydro wholesale transmission service can be purchased by any wholesale power marketer or generator to transmit the power to market. It is imperative that scheduling personnel be available at all times. The Western System Coordinating Council (WSCC) insists that an operating reserve of 5 per cent hydro generation and 7 per cent thermal generation to support the electrical system in the face of an emergency be available for the electricity marketed through the hub. Powerex has been successful since 1988 in the marketing of electricity throughout the WSCC. An example was provided to help make the rules a bit easier to comprehend. refs

Isolation and identification of fungal species from dried date palm ...

African Journals Online (AJOL)

A total of 360 dried date palm (Phoenix dactylifera) fruits were collected from hawkers, shops and market places within Maiduguri metropolis for the detection of the presence of fungal species. Investigation was based on cultural, microscopically and biochemical tests. Of the 327 (90.83%) fungal isolates recovered on ...

Mommy markets: Racial differences in lesbians' dating preferences for women with children.

Science.gov (United States)

Rafalow, Matthew H; Kizer, Jessica M

2017-11-22

Recent work shows that race is a critical factor in shaping sexual identities, partner preference, and family formation, suggesting there may be racial differences in whether lesbians already have children at the time that they look for companions. In this study, we draw on a sample of 1,923 lesbians on Match.com to quantitatively test whether there are racial differences in dating preferences for women with children, underscoring implications for family inequality through racial differences in who has children when looking for a partner. We find that Blacks, Latinas, and Asians are more likely than Whites to not only have children but also be open to dating other women with children. This suggests that race differentially structures lesbians' openness to partners with children, and such preferences may be a possible mechanism for racial stratification.

77 FR 32704 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

Science.gov (United States)

2012-06-01

... securities owned or under management by the institutional customer. The MSRB stated that FINRA Rule 2111....19b-4. \\3\\ The implementation date for Financial Industry Regulatory Authority (``FINRA'') Rule 2111... General Counsel, Securities Industry and Financial Markets Association, dated May 4, 2012 (``SIFMA Letter...

75 FR 7561 - Notice of Request for Approval of a New Information Collection

Science.gov (United States)

2010-02-22

..., Alaska Native, Asian Pacific Islanders, persons with disabilities, or women farm and ranch operators will...), and the Risk Management Agency (RMA)], actual program delivery will be reviewed. The activities to be... Management and Budget approval. All comments will become a matter of public record. Dated: February 8, 2010...

78 FR 63394 - Approval and Promulgation of Implementation Plans; Idaho: State Board Requirements

Science.gov (United States)

2013-10-24

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2013-0548, FRL-9901-76-Region 10] Approval and Promulgation of Implementation Plans; Idaho: State Board Requirements AGENCY: Environmental..., dated June 26, 2013, and Idaho Code Sec. Sec. 59-701 through 705, Ethics in Government Act, and...

Directory of Certificates of Compliance for Radioactive-Materials Packages. Summary report of NRC approved packages

International Nuclear Information System (INIS)

1983-01-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume I), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective December 31, 1982. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volumes 1 and 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

The possibility of obtaining marketing authorization of orphan pharmaceutical compounding preparations: 3,4-DAP for Lambert-Eaton Myasthenic Syndrome.

Science.gov (United States)

de Wilde, Sofieke; de Jong, Maria G H; Lipka, Alexander F; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

2018-03-01

Pharmaceutical compounding preparations, produced by (hospital) pharmacies, usually do not have marketing authorization. As a consequence, some of these pharmaceutical compounding preparations can be picked-up by a pharmaceutical company to obtain marketing authorization, often leading to price increases. An example is the 3,4-diaminopyridine slow release (3,4-DAP SR) tablets for Lambert-Eaton Myasthenic Syndrome (LEMS). In 2009 marketing authorization was given for the commercial immediate release phosphate salt of the drug, including a fifty-fold price increase compared to the pharmaceutical compounding preparation. Obtaining marketing authorization for 3,4-DAP SR by academia might have been a solution to prevent this price increase. To determine whether the available data of a pharmaceutical compounding preparation with long-term experience in regular care are adequate to obtain marketing authorization, 3,4-DAP SR is used as a case study. A retrospective qualitative case-study was performed. Initially, document analysis was executed by collecting the required data for marketing authorization in general and whether data of Firdapse® and 3,4-DAP SR met these requirements. Secondly, the (non-) available data of the two formulations were compared with each other to determine the differences in availability. At the time of approval, almost all data were available for both Firdapse® and 3,4-DAP SR. Conversely, much of the data used for the approval of Firdapse® originated from the 3,4-DAP immediate release (3,4-DAP IR) formulation. Only two bioequivalence studies and one pharmacology safety study was performed with Firdapse® before marketing authorization application. In conclusion, at time Firdapse® obtained approval, the data available did not differ substantially from 3,4-DAP SR, indicating that approval with 3,4-DAP SR would have been possible. We make a plea for approval of orphan medicinal products developed and manufactured by academic institutions as to

76 FR 37373 - Notice of Realty Action: Competitive Sale of Public Lands in Colusa, Glenn, and Lake Counties...

Science.gov (United States)

2011-06-27

... federally approved fair market value. Each sealed bid must include a certified check, money order, bank... which interested bidders must submit written sealed bids equal to, or greater than, the appraised fair market value of the land. DATES: Comments regarding the proposed sale must be received by the BLM on or...

The Victorian gas market: debunking the myths

International Nuclear Information System (INIS)

Grimwade, T

2001-01-01

The Victorian wholesale gas spot market has operated effectively and trouble-free for over two years. VENCorp's Executive Manager of Energy Markets, reflects on the market experiences to date, and argues that Victoria's physical pipeline system characteristics require its market to be 'different' from those in the other States in Australia. The Victorian gas transmission system in not predominantly comprised of a single point-to-point pipeline; it is rather a 'meshed' network, with multiple point of supply. Gas flow on substantial sections of the transmission pipeline can be bi-directional, depending on market and demand conditions. Consequently, Victoria's wholesale spot market has been designed to address operational and market issues due to the physical characteristics of the Victorian gas pipeline system

76 FR 2151 - Notice of Intent To Seek Approval To Renew an Information Collection

Science.gov (United States)

2011-01-12

... Measure Customer Service Satisfaction. OMB Number: 3145-0157. Expiration Date of Approval: August 31, 2011...: On September 11, 1993, President Clinton issued Executive Order 12862, ``Setting Customer Service... determine the kind and quality of services they want and their level of satisfaction with existing services...

77 FR 50576 - Damage Tolerance and Fatigue Evaluation of Composite Rotorcraft Structures; OMB Approval of...

Science.gov (United States)

2012-08-22

... Composite Rotorcraft Structures; OMB Approval of Information Collection AGENCY: Federal Aviation... Rotorcraft Structures,'' which was published on December 1, 2011. DATES: The rule published on December 1... and Fatigue Evaluation of Composite Rotorcraft Structures,'' published in the Federal Register (76 FR...

Distribution of blood derivatives by registered blood establishments that qualify as health care entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; delay of applicability date. Final rule; delay of applicability date.

Science.gov (United States)

2006-11-13

The Food and Drug Administration (FDA) is further delaying, until December 1, 2008, the applicability date of a certain requirement of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720) (the final rule). The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The provisions of the final rule became effective on December 4, 2000, except for certain provisions whose effective or applicability dates were delayed in five subsequent Federal Register notices, until December 1, 2006. The provision with the delayed applicability date would prohibit wholesale distribution of blood derivatives by registered blood establishments that meet the definition of a "health care entity." In the Federal Register of February 1, 2006 (71 FR 5200), FDA published a proposed rule specific to the distribution of blood derivatives by registered blood establishments that qualify as health care entities (the proposed rule). The proposed rule would amend certain limited provisions of the final rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. In response to the proposed rule, FDA received substantive comments. As explained in the SUPPLEMENTARY INFORMATION section of this document, further delaying the applicability of Sec. 203.3(q) (21 CFR 203.3(q)) to the wholesale distribution of blood derivatives by health care entities is necessary to give the agency additional time to address comments on the proposed rule, consider whether regulatory changes are appropriate, and, if so, to initiate such changes.

76 FR 51075 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Granting Approval to...

Science.gov (United States)

2011-08-17

... Organizations; International Securities Exchange, LLC; Order Granting Approval to a Proposed Rule Change Relating to Appointments to Competitive Market Makers August 11, 2011. I. Introduction On June 10, 2011, the International Securities Exchange, LLC (the ``Exchange'' or the ``ISE'') filed with the Securities...

75 FR 2915 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

Science.gov (United States)

2010-01-19

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61317; File No. SR-ISE-2009-103] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Market Data Fees January 8, 2010. I. Introduction On November 25, 2009, the International...

75 FR 1437 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a...

Science.gov (United States)

2010-01-11

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61274; File No. SR-CBOE-2009-089] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule... announce to members via Regulatory Circular any determination regarding the routing of market stock-option...

76 FR 34618 - Domestic Dates Produced or Packed in Riverside County, CA; Proposed Amendments to Marketing Order

Science.gov (United States)

2011-06-14

... during that time. AMS's experience with similar marketing programs is that establishing tenure limits is... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 987 [Doc. No. AMS-FV-10-0025... Marketing Order AGENCY: Agricultural Marketing Service, USDA. ACTION: Proposed rule. SUMMARY: Five...

76 FR 69678 - Domestic Dates Produced or Packed in Riverside County, CA; Proposed Amendments to Marketing Order...

Science.gov (United States)

2011-11-09

... an alternate during that time. AMS's experience with similar marketing programs is that establishing... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 987 [Doc. No. AMS-FV-10-0025... Marketing Order 987 and Referendum Order AGENCY: Agricultural Marketing Service, USDA. ACTION: Proposed rule...

Price transparency on the market for automotive fuels. Final report

International Nuclear Information System (INIS)

Meindert, L.; Van Schijndel, M.; Volkerink, B.

2011-05-01

The objective of this study is to answer the main question: which bottlenecks may obstruct the road to up-to-date, reliable and fully market covering price comparison services for the Dutch market for automotive fuels. [nl

Retail experience in the de-regulated market

International Nuclear Information System (INIS)

Cummings, R.

2003-01-01

This paper describes the experience gained to date in the de-regulated electricity market through an examination of the commercial market. In 2001, chaos provided opportunity, while in 2002 the emphasis was on operations. In 2003, the landscape reflected hyper-competition, selling second services, and a changing landscape. A discussion followed on the residential market with a look at market structure, economics, and uncertainty concerning the future. The following components were identified as working well: wholesale market, commercial market, market model/data, and innovation in offerings and green supply. Areas requiring further improvement were also identified. It was suggested that the residential de-regulated roadmap should be clarified and retail friendly transactions should be imposed. Other improvements involve education and operations/system capabilities. The author concluded that the deregulated electricity market is still an immature market, where progress is being made in the commercial market. The residential market is in a critical period, with a market model still evolving. figs

Directory of certificates of compliance for radioactive materials packages: Summary report of NRC approved quality assurance programs for radioactive material packages

International Nuclear Information System (INIS)

1987-11-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1987. This directory makes available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

76 FR 31627 - Notice of Realty Action: Competitive Sale of Public Lands in Lake County, CA

Science.gov (United States)

2011-06-01

... equal to, or greater than, the appraised fair market value of the land. DATES: Comments regarding the... process. Sealed bids must be for not less than the Federally approved fair market value. Each sealed bid... known mineral values in the land. The BLM proposes to reserve oil, gas and geothermal mineral interests...

77 FR 29339 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2012-05-17

... Activities; Submission to OMB for Review and Approval; Comment Request; Foreign Purchaser Acknowledgement... nature of the information collection activity and its expected burden and costs. DATES: Additional...(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires an exporter of any...

77 FR 59544 - New Markets Tax Credit Non-Real Estate Investments

Science.gov (United States)

2012-09-28

... Markets Tax Credit Non-Real Estate Investments AGENCY: Internal Revenue Service (IRS), Treasury. ACTION... communities. The final regulations affect taxpayers claiming the new markets tax credit and businesses in low... 45D(a)(1), a taxpayer may claim a new markets tax credit on certain credit allowance dates described...

Marketing Analysis and Strategy for a Small Business in the Beekeeping Industry.

Science.gov (United States)

1980-08-18

segment has opportunities associated with it that may be profitably 2Philip Kotler , " Marketing Management: Analysis, Planning, and Control," Prentice...I I I162 I I BIBLIOGRAPHY IB Abel, Derek and John Hammond. Strategic Market Planning. Englewood Cliffs, N.J.: Prentice- Hall, Inc., 1979. Kotler ...11I’ISTATIOY I I I I MARKETING ANALYSIS AND STRATEGY FOR A SMALL IBUSINESS IN THE BEEKEEPING INDUSTRY I III APPROVED: Acoession For DDC TABUn mounced or

77 FR 37570 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

Science.gov (United States)

2012-06-22

... 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 directs Agencies to assess all costs and..., and other advantages; distributive impacts; and equity). The Agency believes that this final rule is... fallen into disuse and FDA has concluded that there is little or no interest in marketing these devices...

13 CFR 108.470 - SBA approval of merger, consolidation, or reorganization of NMVC Company.

Science.gov (United States)

2010-01-01

... BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Changes in Ownership, Structure, or Control Change in Structure of Nmvc Company § 108.470 SBA approval of merger, consolidation, or reorganization of NMVC Company. You may not merge, consolidate, change form of organization (corporation or...

Internationalization of IKEA in the Japanese and Chinese markets.

OpenAIRE

Cheancharadpong, Wanee; Chaletanone, Wannapa

2008-01-01

Date: June 4, 2008 Level: Master Thesis EFO705, 10 points (15 credits) Authors: Wannapa Chaletanone (05-11-1982, Thailand) Wanee Cheancharadpong (03-09-1983, Thailand) Title: Internationalization of IKEA in the Japanese and Chinese markets Supervisor: Leif Linnskog Problems: Why did IKEA internationalize into Japanese and Chinese markets? And what factors did influence IKEA’s success in Chinese market but failure in the Japanese market of the first round? Purpose: The aim of thesis is to unde...

78 FR 38070 - 30-Day Notice of Proposed Information Collection: Affirmative Fair Housing Marketing (AFHM) Plan

Science.gov (United States)

2013-06-25

... Information Collection: Affirmative Fair Housing Marketing (AFHM) Plan AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: HUD has submitted the proposed information collection requirement... Title of Information Collection: Affirmative Fair Housing Marketing (AFHM) Plan. OMB Approval Number...

Marketing the professional services of the dietitian.

Science.gov (United States)

Eisenberg, J G

1986-01-01

Professionals are beginning to realize that a good service does not necessarily sell itself and that active strategic marketing is often needed. It is no longer sufficient for a dietitian to be up-to-date and provide high quality services; cost effectiveness of sound nutrition must be demonstrated and the services of the dietitian aggressively marketed. A strategic market plan based on an assessment of opportunities and capabilities should be developed and continuously adjusted. This article discusses the steps in strategic market planning with practical examples for the dietitian. Dietitians should examine the marketing strategies being implemented by other professional groups since many can be adapted to marketing nutrition services. There exists much opportunity and unprecedented challenges for all dietitians, calling for creativity, innovation, and professionalism.

75 FR 82119 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

Science.gov (United States)

2010-12-29

..., the Board's basic fair practice rule, to apply the rules to municipal advisors. The proposed rule... Independent Public Finance Advisors, dated December 9, 2010. This order approves the proposed rule change. II... of which may have a substantial impact on the finances of those municipal entities. In other cases...

[Industry regulation and its relationship to the rapid marketing of medical devices].

Science.gov (United States)

Matsuoka, Atsuko

2012-01-01

In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved packages

International Nuclear Information System (INIS)

1979-10-01

This directory contains a Summary Report of NRC Approved Packages for radioactive material packages effective September 14, 1979. Purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory

Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved packages

Energy Technology Data Exchange (ETDEWEB)

None

1979-10-01

This directory contains a Summary Report of NRC Approved Packages for radioactive material packages effective September 14, 1979. Purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory.

76 FR 81009 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Science.gov (United States)

2011-12-27

... assessment, planning, forecasting, cost/benefit analysis, and to target areas for research. DATES: Written..., forecasting, cost/benefit analysis, and to target areas for research. Respondents: Approximately 83,500 owners... invites public comments about our intention to request the Office of Management and Budget (OMB) approval...

77 FR 16676 - Approval and Promulgation of Implementation Plans and Operating Permits Program; Commonwealth of...

Science.gov (United States)

2012-03-22

... for approval of revisions to the Puerto Rico Regulations for the Control of Atmospheric Pollution... Control of Atmospheric Pollution submitted on July 13, 2011 by the Puerto Rico Environmental Quality Board.... Regulation for the Control of Atmospheric Pollution Commonwealth Puerto Rico regulation effective date EPA...

78 FR 47253 - Approval and Promulgation of Air Quality Implementation Plans; Maine; Oxides of Nitrogen...

Science.gov (United States)

2013-08-05

... Promulgation of Air Quality Implementation Plans; Maine; Oxides of Nitrogen Exemption and Ozone Transport... is proposing to approve Maine's October 13, 2012, request for an exemption from the nitrogen oxides... from Stephen D. Page, Director, OAQPS, dated January 14, 2005, entitled ``Guidance on Limiting Nitrogen...

77 FR 50191 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Instituting Proceedings To...

Science.gov (United States)

2012-08-20

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Instituting Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Change To Establish ``Benchmark Orders'' Under NASDAQ Rule 4751(f) August 14, 2012. I. Introduction On May 1, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange...

77 FR 2265 - Request for Extension and Revision of a Currently Approved Information Collection

Science.gov (United States)

2012-01-17

... extension of and revision to a currently approved information collection of a voluntary customer survey... States Grain Standards Act and the Agricultural Marketing Act of 1946. This voluntary survey gives customers that are primarily in the grain, oilseed, rice, lentil, dry pea, edible bean, and related...

7 CFR 1484.30 - How does FAS formalize its working relationship with approved Cooperators?

Science.gov (United States)

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false How does FAS formalize its working relationship with... FAS formalize its working relationship with approved Cooperators? FAS will notify each applicant in... sign the program agreement and submit the signed agreement to the Director, Marketing Operations Staff...

Petroleum marketing annual 1994

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-08-24

The Petroleum Marketing Annual (PMA) provides information and statistical data on a variety of crude oils and refined petroleum products. The publication presents statistics on crude oil costs and refined petroleum products sales for use by industry, government, private sector analysis, educational institutions, and consumers. Data on crude oil include the domestic first purchase price, the fob and landed cost of imported crude oil, and the refiners` acquisition cost of crude oil. Refined petroleum product sales data include motor gasoline, distillates, residuals, aviation fuels, kerosene, and propane. The Petroleum Marketing Division, Office of Oil and Gas, Energy Information Administration ensures the accuracy, quality, and confidentiality of the published data in the Petroleum Marketing Annual. For this production, all estimates have been recalculated since their earlier publication in the Petroleum Marketing Monthly (PMM). These calculations made use of additional data and corrections that were received after the PMM publication date.

Petroleum marketing annual 1994

International Nuclear Information System (INIS)

1995-01-01

The Petroleum Marketing Annual (PMA) provides information and statistical data on a variety of crude oils and refined petroleum products. The publication presents statistics on crude oil costs and refined petroleum products sales for use by industry, government, private sector analysis, educational institutions, and consumers. Data on crude oil include the domestic first purchase price, the fob and landed cost of imported crude oil, and the refiners' acquisition cost of crude oil. Refined petroleum product sales data include motor gasoline, distillates, residuals, aviation fuels, kerosene, and propane. The Petroleum Marketing Division, Office of Oil and Gas, Energy Information Administration ensures the accuracy, quality, and confidentiality of the published data in the Petroleum Marketing Annual. For this production, all estimates have been recalculated since their earlier publication in the Petroleum Marketing Monthly (PMM). These calculations made use of additional data and corrections that were received after the PMM publication date

Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair. Final order.

Science.gov (United States)

2016-01-05

The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair.

Meeting up-to-date safety requirements in the Russian NPP projects

International Nuclear Information System (INIS)

Tepkyan, G. O.; Yashkin, A. V.

2014-01-01

Safety features in Russian NPP designs are implemented by the combination of active and passive safety systems • Russian NPP designs are in compliance with up-to-date international and European safety requirements and refer to Generation III+ • Russian state-of-the-art designs have already implemented some design solutions, which take into account “post-Fukushima” requirements. Russian NPP design principles have been approved during the European discussions in spring 2012, including the IAEA extraordinary session addressed to Fukushima NPP accident

75 FR 27119 - ViewPoint Financial Group, Inc., Plano, Texas; Approval of Conversion Application

Science.gov (United States)

2010-05-13

..., 2010, the Office of Thrift Supervision approved the application of ViewPoint MHC and ViewPoint Bank... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-37: OTS No. H-47111] ViewPoint... Carpenter Freeway, Suite 500, Irving, Texas 75062-2326. Dated: May 7, 2010. By the Office of Thrift...

78 FR 16783 - Approval and Promulgation of Implementation Plans; Georgia; Control Techniques Guidelines and...

Science.gov (United States)

2013-03-19

... Administrative Procedure Act (APA) which, upon finding ``good cause,'' authorizes agencies to dispense with... action addressing approval of the Georgia RACT rules. EPA also finds that there is good cause under APA.... Section 553(d)(3) of the APA allows an effective date less than 30 days after publication ``as otherwise...

Directory of certificates of compliance for radioactive materials packages; Summary Report of NRC Approved Packages

International Nuclear Information System (INIS)

1980-12-01

This directory contains a Summary Report of NRC approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the U.S. Nuclear Regulatory Commission. To assist in identifying packaging, and index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory. Shipments of radioactive material using these packagings must be in accordance with the provisions of 49 CFR 173.393a and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure them--that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

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.

77 FR 29335 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2012-05-17

... Activities; Submission to OMB for Review and Approval; Comment Request; Application for New and Amended... collection activity and its expected burden and costs. DATES: Additional comments may be submitted on or... a pesticide product as required under Section 3 of the Federal Insecticide, Fungicide, and [[Page...

75 FR 44936 - Notice of Request for Extension of Approval of an Information Collection; Phytophthora Ramorum...

Science.gov (United States)

2010-07-30

...] Notice of Request for Extension of Approval of an Information Collection; Phytophthora Ramorum... interstate movement of regulated articles to prevent the spread of Phytophthora ramorum. DATES: We will... for the interstate movement of regulated articles to prevent the spread of Phytophthora ramorum...

75 FR 43137 - Notice of Request for Revision of a Currently Approved Information Collection (Specified Risk...

Science.gov (United States)

2010-07-23

... via Listserv, a free e-mail subscription service consisting of industry, trade, and farm groups... addition, FSIS offers an e-mail subscription service which provides automatic and customized access to... approved information collection, Specified Risk Materials--Transport. DATES: Comments on this notice must...

Integration of new technology into clinical practice after FDA approval.

Science.gov (United States)

Govil, Ashul; Hao, Steven C

2016-10-01

Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

Estimating long-term volatility parameters for market-consistent models

African Journals Online (AJOL)

Contemporary actuarial and accounting practices (APN 110 in the South African context) require the use of market-consistent models for the valuation of embedded investment derivatives. These models have to be calibrated with accurate and up-to-date market data. Arguably, the most important variable in the valuation of ...

76 FR 16038 - Proposed Collection; Comment Request for Prepaid Card Marketing Customer Survey, CS-10-251.

Science.gov (United States)

2011-03-22

... of social marketing. Social marketing principles and practices apply marketing principles to social... Prepaid Card Marketing Customer Survey, CS-10-251. AGENCY: Internal Revenue Service (IRS), Treasury..., the IRS is soliciting comments concerning Prepaid Card Marketing Customer Survey, CS-10-251 DATES...

78 FR 26258 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Consumer Products and...

Science.gov (United States)

2013-05-06

... adopt these VOC limits to create more consistency in regional and national markets for consumer products... organic compound (VOC) content limits and associated provisions for additional consumer products categories into the state's SIP. Finally, EPA is approving language to clarify VOC limit applicability for...

77 FR 55451 - Notice of Intent To Request an Extension of a Currently Approved Information Collection

Science.gov (United States)

2012-09-10

..., marketing, technical, and financial resources to carry out the submitted plan. Estimate of Burden: Public... DEPARTMENT OF AGRICULTURE Agricultural Research Service Notice of Intent To Request an Extension of a Currently Approved Information Collection AGENCY: Agricultural Research Service, USDA. [[Page...

75 FR 16224 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-03-31

... Proposed Rule Change To Delay the Application of NASDAQ Rule 4611(d) March 24, 2010. Pursuant to Section 19... rule change to delay the application of NASDAQ Rule 4611(d) until 180 days following its approval. The... Market Access Rule. Accordingly, NASDAQ is proposing to delay for 180 days from approval the...

Segmenting the Latin American travel market to South Africa

Directory of Open Access Journals (Sweden)

Martinette Kruger

2017-03-01

Full Text Available Orientation and motive of research: Tourism growth to South Africa is in decline resulting in an emphasis shift to identify new markets to offset the slowdown in tourism growth. Purpose of research: This study identified viable target markets within the Latin America tourist market using market segmentation based on motivations to travel to South Africa. Results and findings: Four viable segments were identified that should be catered for and, based on the distinct characteristics of each market, marketing strategies are proposed. Practical implications: This study makes a valuable contribution to the current tourism literature by expanding current knowledge of the profile and motives of a, to date, relatively unknown tourist market.

77 FR 6549 - Acquisition of Items for Which Federal Prison Industries Has a Significant Market Share

Science.gov (United States)

2012-02-08

... Federal Prison Industries Has a Significant Market Share AGENCY: Department of Defense (DoD). ACTION: Notice. SUMMARY: DoD is issuing this notification to set forth an up-to-date list of product categories for which the Federal Prison Industries' share of the DoD market is greater than five percent. DATES...

Applications of different dose of irradiation on dates followed by quality parameters

International Nuclear Information System (INIS)

Haddad, Sofien

2007-01-01

The objective of this project is to evaluate the effects of radiation on the conservation of dates and the development of micro-organisms. Deglet Nour variety of dates were purchased from local market and irradiated at doses 0, 0.5, 0.75 and 1 kGy and stored at room temperature for 30 days. During storage, we evaluated the effects of radiation on the evolution of fructose, glucose, sucrose, pH, organic acid and moisture which are parameters of quality of dates. We have also checked its effect on the development on micro-organisms. During storage, there has been a change in the chemical composition and microbiological quality. However, these changes are proportional to the radiation doses applied. 1 kGy dose appears to be the best. It completely inhibits the development of micro-organisms and slows senescence dates. (Author)

A History of the Sonocare CST-100: The First FDA-approved HIFU Device

Science.gov (United States)

Muratore, Robert

2006-05-01

The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.

Retail market opening plan : key activities and milestones to market opening on May 1, 2002

International Nuclear Information System (INIS)

2002-01-01

The Ontario Energy Board (OEB) published its Retail Market Readiness Plan in January 2000 with particular focus on what is needed by distributors to become ready for self certification on December 14, 2001. The market opening date has now been set for May 1, 2002 so the framework has been updated to focus on what is needed to open the electricity market to retail competition. This report describes the activities required for the opening of the retail electricity market with reference to the activities that the participants, distributors and retailers need to complete to properly interact at market opening. The measures that other organizations such as EBT hubs should take were also identified for cases where the measures involve cooperation and interaction with distributors and retailers to ensure a smooth transition to competition within the industry. While schedules of individual organizations will vary, market participants should try to align with the overall framework at key milestones. The mandatory requirements associated with milestones were included in Appendix B. These included requirements for: market opening baseline; market readiness activities; participant systems and organizational preparations; loading of new rates into systems; cutover to new systems by market participants; data scrubbing; multiple contract resolution; pre-market processing; distributor-retailer service agreement; retail prudential posting; inter-participant testing; contingency arrangements; stability period; and, market opening. Appendix A includes the Market Opening Gantt Chart. 1 tab

British Columbia natural gas: Core market policy

International Nuclear Information System (INIS)

1988-06-01

The core market for natural gas in British Columbia is defined as all natural gas consumers in the residential, institutional, commercial, and industrial sectors not currently purchasing natural gas directly and not exempted from the core market by the British Columbia Utilities Commission (BCUC). The intent of the definition is to include all customers who must be protected by contracts which ensure long-term security of supply and stable prices. Core market customers are excluded from direct natural gas purchase and will be served by distribution utilities. A customer may apply to BCUC to leave the core market; such an application may be approved if it is demonstrated that the customer has adequate long-term natural gas supplies or alternative fuel supplies to protect him from supply interruptions. The non-core market is defined as all large industrial customers who elect to make their own natural gas supply arrangements and who can demonstrate to the BCUC sufficient long-term natural gas supply protection or alternative fuel capability to ensure security of the industry. Non-core market customers have full and open access to the competitive natural gas market. The British Columbia government will not apply its core market policy to other jurisdictions through Energy Removal Certificates

Retail availability and marketing of electronic cigarettes in Canada.

Science.gov (United States)

Hammond, David; White, Christine M; Czoli, Christine D; Martin, Christina L; Magennis, Paul; Shiplo, Samantha

2015-10-09

Canada is among an increasing number of countries with restrictions on the sale of electronic cigarettes (e-cigarettes). In Canada, e-cigarettes containing nicotine have not been approved for sale; however, e-cigarettes that do not contain nicotine and do not make health claims can be sold. To date, there is little empirical evidence assessing the retail availability and marketing of e-cigarettes in countries such as Canada. Audits were conducted at 59 brick-and-mortar retail outlets (grocery stores, convenience stores, tobacconist shops and vape shops) in four cities (Vancouver, Toronto, Montreal and Halifax) in August-October 2014. In addition, a total of 21 e-cigarette manufacturer/retailer websites were audited, and inquiries were made as to whether the companies sold nicotine-containing products. Overall, 76% of the retail outlets sold e-cigarette products. Of convenience stores, grocery stores and tobacconist shops with e-cigarettes for sale, the vast majority (94%) sold nicotine-free products only; in contrast, all the vape shops sold at least one nicotine-containing e-cigarette product. Front counter displays were the most common form of in-store promotions and were present in virtually all convenience stores, tobacconist shops and vape shops. Nicotine-containing e-cigarettes were available for purchase at approximately half (52%) of the online e-cigarette retailers surveyed. E-cigarettes with and without nicotine are widely available and marketed at a variety of retail outlets in Canada. "Illegal" sales of nicotinecontaining e-cigarettes were predominantly found at vape shops and online outlets, suggesting limited compliance with existing regulations.

75 FR 63506 - Logging Operations; Extension of the Office of Management and Budget's (OMB) Approval of...

Science.gov (United States)

2010-10-15

...] Logging Operations; Extension of the Office of Management and Budget's (OMB) Approval of Information... Logging Operations (29 CFR 1910.266). DATES: Comments must be submitted (postmarked, sent, or received) by... following elements: Safe work practices, including the use, operation, and maintenance of tools, machines...

77 FR 36477 - Notice of Intent To Revise and Extend a Currently Approved Information Collection

Science.gov (United States)

2012-06-19

... Reports. Revision to burden hours will be needed due to changes in the size of the target population... Agriculture to help administer programs; by State agencies to develop, research, and promote the marketing of products; and by producers to find their best market opportunity(s). The current expiration date for this...

Immigrants, Labor Market Performance, and Social Insurance

OpenAIRE

Bratsberg, Bernt; Raaum, Oddbjørn; Røed, Knut

2014-01-01

Using longitudinal data from the date of arrival, we study long- term labor market and social insurance outcomes for all major immigrant cohorts to Norway since 1970. Immigrants from highincome countries performed as natives, while labor migrants from low- income source countries had declining employment rates and increasing disability program participation over the lifecycle. Refugees and family migrants assimilated during the initial period upon arrival, but labor market convergence halted ...

Immigrants, Labour Market Performance, and Social Insurance

OpenAIRE

Bratsberg, Bernt; Raaum, Oddbjørn; Røed, Knut

2014-01-01

Using longitudinal data from the date of arrival, we study long-term labour market and social insurance outcomes for all major immigrant cohorts to Norway since 1970. Immigrants from high-income countries performed as natives, while labour migrants from low-income source countries had declining employment rates and increasing disability programme participation over the lifecycle. Refugees and family migrants assimilated during the initial period upon arrival but labour market convergence halt...

Withdrawal of cerivastatin from the world market

Directory of Open Access Journals (Sweden)

Pitt Bertram

2001-09-01

Full Text Available Abstract Cerivastatin was recently withdrawn from the market because of 52 deaths attributed to drug-related rhabdomyolysis that lead to kidney failure. The risk was found to be higher among patients who received the full dose (0.8 mg/day and those who received gemfibrozil concomitantly. Rhabdomyolysis was 10 times more common with cerivastatin than the other five approved statins. We address three important questions raised by this withdrawal. Should we continue to approve drugs on surrogate efficacy? Are all statins interchangeable? Do the benefits outweigh the risks of statins? We conclude that decisions regarding the use of drugs should be based on direct evidence from long-term clinical outcome trials.

The European Medicines Agency's approval of new medicines for type 2 diabetes.

Science.gov (United States)

Blind, Eberhard; Janssen, Heidi; Dunder, Kristina; de Graeff, Pieter A

2018-05-08

Since 2005, more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consist of 15 new active substances establishing three new classes of non-insulin products, and several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralized procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy. For the majority of these new medicines approved since 2005, cardiovascular outcome trials have now been completed, and have invariably supported the cardiovascular safety of these products. In some of these trials additional important benefits have been observed, for instance, a reduction in major adverse cardiovascular events and improvement of renal outcome. The existing regulatory framework and the continuous adaption of regulatory requirements to emerging developments will continue to guide the approval of new products in the future. © 2018 John Wiley & Sons Ltd.

77 FR 52096 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving a Proposed Rule Change, as...

Science.gov (United States)

2012-08-28

...'s rules, the financial and regulatory risk management controls and supervisory procedures required...-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving a Proposed Rule Change, as Modified by... that broker-dealers appropriately control the risks associated with market access, so as not to...

75 FR 80061 - Abbott Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for MERIDIA

Science.gov (United States)

2010-12-21

... withdrawing approval of a new drug application (NDA) for MERIDIA (sibutramine hydrochloride (HCl)) oral... requested that Abbott voluntarily withdraw MERIDIA (sibutramine HCl) oral capsules from the market, based on FDA's recent analysis of clinical trial data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT...

40 CFR 52.2479 - Contents of the federally approved, State submitted implementation plan.

Science.gov (United States)

2010-07-01

... [09/17/90] 173-430-040 Mobile field burners [09/17/90] 173-430-050 Other approvals [09/17/90] 173-430... General Definitions [12/11/80] Section 1.05 Special Definitions [9/9/99] Article 2—Gasoline Marketing...] Section 3.03 Can and Paper Coating Operations [2/10/94] Section 3.04 Motor Vehicle and Mobile Equipment...

Evolution and perspectives of gas market

International Nuclear Information System (INIS)

Russo, S.

1998-01-01

The gas market in Europe, and thus in Italy, will see great changes as regards the market, the deployment of forces on the ground, the structure of the demand and, in the longer term, that of the offer. It is important to look at the future after having gone through, although in brief, the stages of the development of the gas market in Europe and in Italy, from the origins, in the years 1950-60, up today. It is not difficult to see how the organization of the market, up to now, has been oriented prevailingly at the development and at the security of supplies to the consumer. The future will focus on the improvement of the global efficiency of the gas system with the aim of reducing costs, yet for the final users. The realization of this transition has already begun and it is demonstrated by the evolution of both the institutional and regulatory framework already under way, in Europe with the just approved gas directive, and in Italy with the appointment of the market regulation Authority. It is difficult challenge to which the gas industry will answer adequately [it

75 FR 63229 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-10-14

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on October 1, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed... has received approval to launch NASDAQ OMX PSX (``PSX'') \\3\\ as a new platform for trading NMS stocks...

76 FR 2732 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of Longer...

Science.gov (United States)

2011-01-14

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of Longer Period for Commission.... Introduction On June 18, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or the ``Exchange'') filed with the... change. The Commission may extend the period for issuing an order approving or disapproving the proposed...

Analysis of the domestic pharmaceutical market drugs for the treatment of urolithiasis

Directory of Open Access Journals (Sweden)

V. L. Shevina

2014-12-01

was to identify the value of drugs. In the market of Ukraine manufacturers mainly offer the medicines of natural origin, which is 66.66%. For further study of this segment, the products were subject to analysis regarding their pharmaceutical form. The studies have revealed that in the pharmaceutical market of Ukraine the drugs are presented in the following pharmaceutical forms: tablets - 32%, capsules - 11 %, syrups - 16 %, drops - 17 %, gel, powders, granules and teas - 6 % of each. Thus, the most common dosage form is tablets. It is worth mentioning that to date, in the pharmaceutical market of Ukraine the main portfolio of the medicinal products in tablets is compiled by the medicinal products of foreign origin. The share of registered medicinal products in tablets manufactured by Ukrainian manufacturers versus imported medicines is 33.33 % to 66.66 %. However, only one domestic manufacturer present in the market produces the tablets of plant crude: knotweed extract powder, St. John's wort extract powder, horsetail extract dry, avisan. Conclusions The study of the market of medicinal products used for treatment of urolithiasis approved in Ukraine has been performed. It has been established that the pharmaceutical market of Ukraine presents 21 trade names of drugs used to treat urolithiasis. Preparations are analyzed depending on the origin and content of active components, presentation, type of dosage form. Based on the marketing analysis, it has been established that regardless of the general quantity of medicines of plant origin, in the study group the share of herbal medicines in tablets is insignificant (1 manufacturer. The feasibility of study regarding the development of products of plant origin in tablets for treatment of urolithiasis has been confirmed.

76 FR 43650 - Notice of Request for Extension of Approval of an Information Collection; Infectious Salmon...

Science.gov (United States)

2011-07-21

...] Notice of Request for Extension of Approval of an Information Collection; Infectious Salmon Anemia... of indemnity due to infectious salmon anemia. DATES: We will consider all comments that we receive on... the payment of indemnity due to infectious salmon anemia, contact Dr. William G. Smith, Area...

77 FR 14041 - Major Portion Prices and Due Date for Additional Royalty Payments on Indian Gas Production in...

Science.gov (United States)

2012-03-08

... index zone pricing. We approved the Ute Indian Tribe's request; therefore, you must value production... due date for industry to pay additional royalties based on the major portion prices. This notice... additional royalties based on the major portion prices is May 7, 2012. FOR FURTHER INFORMATION CONTACT: John...

An approved personal dosimetry service based on an electronic dosimeter

International Nuclear Information System (INIS)

Marshall, T.O.; Bartlett, D.T.; Burgess, P.H.; Campbell, J.I.; Hill, C.E.; Pook, E.A.; Sandford, D.J.

1991-01-01

At the Second Conference on Radiation Protection and Dosimetry a paper was presented which, in part, announced the development of an electronic dosimeter to be undertaken in the UK by the National Radiological Protection Board (NRPB) and Siemens Plessey Controls Ltd. This dosimeter was to be of a standard suitable for use as the basis of an approved personal dosimetry service for photon and beta radiations. The project has progressed extremely well and dosimeters and readers are about to become commercially available. The system and the specification of the dosimeter are presented. The NRPB is in the process of applying for approval by the Health and Safety Executive (HSE) to operate as personal monitoring service based on this dosimeter. As part of the approval procedure the dosimeter is being type tested and is also undergoing an HSE performance test and wearer trials. The tests and the wearer trials are described and a summary of the results to date presented. The way in which the service will be organized and operated is described and a comparison is made between the running of the service and others based on passive dosimeters at NRPB

The need for approval and the private versus public disclosure of slef.

Science.gov (United States)

Cravens, R W

1975-09-01

The relationship between need for approval and public and private self-disclosure was evaluated. Sixty female college students discussed their preferences for a steady date with a confederate in confidence or after having given permission for their comments to be cited in lectures or a book. The results showed that high-need-for-approval subjects revealed themselves more intimately in public than in private conditions wheras low- and moderate-need subjects disclosed more intimately in private than in public. The results not only demonstrated the strength of the effect of social evaluation on the behavior of high-need subjects, but also suggested that personality must be accounted for in self-disclosure research before factors influencing self-disclosure may be understood completely.

Impact of monetary policy changes on the Chinese monetary and stock markets

Science.gov (United States)

Tang, Yong; Luo, Yong; Xiong, Jie; Zhao, Fei; Zhang, Yi-Cheng

2013-10-01

The impact of monetary policy changes on the monetary market and stock market in China is investigated in this study. The changes of two major monetary policies, the interest rate and required reserve ratio, are analyzed in a study period covering seven years on the interbank monetary market and Shanghai stock market. We find that the monetary market is related to the macro economy trend and we also find that the monetary change surprises both of lowering and raising bring significant impacts to the two markets and the two markets respond to the changes differently. The results suggest that the impact of fluctuations is much larger for raising policy changes than lowering changes in the monetary market on policy announcing and effective dates. This is consistent with the “sign effect”, i.e. bad news brings a greater impact than good news. By studying the event window of each policy change, we also find that the “sign effect” still exists before and after each change in the monetary market. A relatively larger fluctuation is observed before the event date, which indicates that the monetary market might have a certain ability to predict a potential monetary change, while it is kept secret by the central bank before official announcement. In the stock market, we investigate how the returns and spreads of the Shanghai stock market index respond to the monetary changes. Evidences suggest the stock market is influenced but in a different way than the monetary market. The climbing of returns after the event dates for the lowering policy agrees with the theory that lowering changes can provide a monetary supply to boost the market and drive the stock returns higher but with a delay of 2 to 3 trading days on average. While in the bear market, the lowering policy brings larger volatility to the market on average than the raising ones. These empirical findings are useful for policymakers to understand how monetary policy changes impact the monetary and stock markets

The peak of oil production-Timings and market recognition

International Nuclear Information System (INIS)

Almeida, Pedro de; Silva, Pedro D.

2009-01-01

Energy is essential for present societies. In particular, transportation systems depend on petroleum-based fuels. That world oil production is set to pass a peak is now a reasonably accepted concept, although its date is far from consensual. In this work, we analyze the true expectations of the oil market participants about the future availability of this fundamental energy source. We study the evolution through time of the curves of crude oil futures prices, and we conclude that the market participants, among them the crude oil producers, already expect a near-term peak of oil production. This agrees with many technical predictions for the date of peak production, including our own, that point to peak dates around the end of the present decade. If this scenario is confirmed, it can cause serious social and economical problems because societies will have little time to perform the necessary adjustments

Views on world markets - Canada

Energy Technology Data Exchange (ETDEWEB)

Passmore, J. [Canadian Wind Energy Association, Ottawa, Ontario (Canada)

1996-12-31

If {open_quotes}market{close_quotes} is defined by hardware in the ground (as it should be), then the Canadian wind power market has been virtually non-existent (only 23 MW to date). The potential on the other hand is enormous (6400 MW likely to be developed). This potential has not been pursued because of unregulated electric utility monopolies, lack of political knowledge and interest, and punitive tax treatment for renewables. Recent initiatives including utility restructuring, federal plans for green power procurement, and proposed tax measures suggest that situation has potential for change. Interested parties should start familiarizing themselves with the Canadian players / market now, in order to be ready to move when the time comes (likely in the next three years). 3 tabs.

Excipients and their role in approved injectable products: current usage and future directions.

Science.gov (United States)

Nema, Sandeep; Brendel, Ronald J

2011-01-01

This review article is a current survey of excipients used in approved injectable products. Information provided includes concentration ranges, function, frequency of use, and role in dosage form. This article is an update of a paper published more than a decade ago (reference 11). Since then many new products have been approved. Safety concerning excipients has evolved as the scientific community continues to learn about their usage. New excipients are being used in early phases of clinical trials to support novel therapeutic entities like RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving specific needs that traditional excipients are unable to provide and for which safety studies are necessary to support a novel excipient for marketing applications. Excipients are added to parenteral dosage forms to serve a variety of functions including stabilization and as vehicles. This review article is a survey of excipients used in approved injectable products. Information provided includes excipient concentrations, functional roles, and frequency of use. This article is an update of an article originally published over a decade ago. Since then new products have been approved and safety concerns have evolved as the scientific community has learned about the usage of excipients. In addition, new excipients are being used in early phases of clinical trials to support novel therapeutic entities such as RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving

Analýza učebnice pro odborný předmět Marketing SOŠ

OpenAIRE

Dufek, Ondřej

2015-01-01

This bachelor thesis is focused on evaluation of complexity of a marketing textbook for high school with business focus as a didactic text. In the part Present state of knowledge, the work deals with the importance of performance rating of textbooks and different methodological approaches. In the practical part the market with marketing textbooks for secondary schools with business focus is analysed and an analysis of textbook Marketing by Moudrý, M., which hasn't an approval clause from the ...

Market Reaction to the Approval of Stock Option Plans: an Event Study of Bovespa Listed Companies

Directory of Open Access Journals (Sweden)

Fernanda Finotti Cordeiro Perobelli

2009-07-01

Full Text Available This paper aims to verify market reactions to Employee Stock Options Plans (ESOP proposals and awards in the Brazilian Stock Exchange from July 1994 to March 2007. In order to achieve such objective, event studies methodology was applied and the original sample (comprised by all companies that adopted ESOP during the survey period was divided according to employees’ eligibility to ESOP and CEOs bargain power. Using non-parametric tests (Sign Test e Wilcoxon Rank Sum Test, we could verify that announcements of ESOP proposals and ESOP awards were not related to positive abnormal returns. As the opposite, returns around those announcements dates were negatives, in general. Such pattern could be explained by some theoretical consequences of ESOP plans: increase in the CEOs risky behavior, constrains in the dividend policy and CEOs opportunistic behavior by managing the timing of their voluntary disclosures around stock option awards. We also found evidences suggesting that employees´ eligibility is related to abnormal returns. When all employees are awarded, returns are even more negative. Possible explanations are indirect costs of capital pulverization and increase in the companies cost of capital due to the ESOP. Our findings suggest that an ESOP adoption in a poor governance environment can increase agency problems, instead of aligning CEOs and shareholders interests.

78 FR 15394 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change...

Science.gov (United States)

2013-03-11

...-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change Adopting... paragraph (d) it contains a provision establishing how the transition period from NYSE Rule 477 will work... to announce the effective date of the new rules at least 30 days in advance in an Information...

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.

Science.gov (United States)

Kondo, Hideyuki; Saint-Raymond, Agnès; Yasuda, Naoyuki

2018-03-01

The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-market review periods. In FY 2016 / 2016, 112 and 83 new medicines were approved in Japan and EU, respectively. Out of these medicines, 41 and 27 medicines containing new active ingredients were approved with total pre-market review periods of 209 days and 428 days in Japan and EU, respectively. Approximately one-third of these medicines were reviewed by the Agencies in close timing, within 1 year between pre-market review applications in Japan and in EU. Taking into account the increasing number of global clinical trials and constant number of consultations or scientific advice related to global clinical trials in Japan, it is clear that the importance of the continuous, collaborative relationship between EMA and PMDA is more and more crucial, as it does facilitate close and timely exchange of information and opinions on products and technologies under development. There already are effective collaborative frameworks between PMDA and EMA in addition to daily communication, and our findings support the development and best use of regulatory tools such as consultation services and scientific advice/protocol assistance for the benefit of the pharmaceutical industry but mostly of patients.

First emergency contraceptive product hits U.S. market shelves.

Science.gov (United States)

1998-11-01

The Preven Emergency Contraceptive Kit, a product approved by the US Food and Drug Administration (USFDA) for emergency contraception, is now on the market for sale. Produced by Gynetics of Somerville, NJ, the kit consists of an easy-to-use pregnancy test, patient information guide, and 4 blue pills, each containing 0.05 mg ethinyl estradiol and 0.25 mg levonorgestrel. After a woman determines that she is not pregnant by using the kit's test, she takes 2 pills as soon as possible within 72 hours after having unprotected sexual intercourse. The remaining 2 pills are taken 12 hours later. Although Preven is available now only by prescription, Gynetics will cooperate with the USFDA in assessing whether it should be sold over the counter. One course of Preven costs about $20 at a pharmacy, less than any oral contraceptive pills currently used as emergency contraceptives. The Preven Kit carries Health Care Financing Administration approval for Medicaid reimbursement, and most health maintenance organizations have agreed to cover its costs. Two more progestin-only emergency contraceptive products may enter the US market in 1999. Gynetics is in the advanced stages of developing a levonorgestrel-only emergency contraceptive, while Women's Capital Corp. of Seattle, WA, and Washington, DC, plans to submit its application for product approval to the USFDA for a similar progestin-only product by the end of October.

Competition effects of mergers: An event study of the German electricity market

International Nuclear Information System (INIS)

Keller, Andreas

2010-01-01

This paper investigates the competition effects of the entry of Vattenfall into the German electricity market. While the competition authorities supported the entry by approving Vattenfall's acquisition of three regional utilities, other market participants raised concerns over the emergence of an upcoming oligopoly in the German market for power generation. We contrast the efficiency hypothesis postulating pro-competitive effects of mergers with the market power hypothesis postulating anti-competitive effects. For the analysis of the two opposing hypotheses, we use an event study approach to the stock prices of Vattenfall's competitors in the German market. While we find no empirical evidence for increased market power in the German electricity market due to Vattenfall's mergers, there is some indication for efficiency increases. We therefore cannot oppose the view of the competition authorities predicting an overall positive effect for consumers as a result of Vattenfall's entry into the German electricity market.

76 FR 67004 - Order Approving Filing Fees for Exempt Reporting Advisers and Private Fund Advisers

Science.gov (United States)

2011-10-28

... billion or more in hedge fund assets, combined liquidity fund and registered money market fund assets or...] Order Approving Filing Fees for Exempt Reporting Advisers and Private Fund Advisers Section 204(c) of... funds (a ``private fund adviser'') to file proposed Form PF on a periodic basis.\\2\\ On September 30...

77 FR 52097 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change, as...

Science.gov (United States)

2012-08-28

... financial and regulatory risk management controls and supervisory procedures required by Rule 15c3-5 under...-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change, as Modified by... that broker-dealers appropriately control the risks associated with market access, so as not to...

Spillover effects in energy futures markets

International Nuclear Information System (INIS)

Lin, S.X.; Tamvakis, M.N.

2001-01-01

Price discovery in crude oil and refined oil products has been extensively undertaken in organised futures markets for over a decade now. There are two dominant such markets today: the first one in the New York Mercantile Exchange; and the second in London's International Petroleum Exchange. With the demise of OPEC as the leading price setter for crude and products, NYMEX light sweet crude and Brent crude have usurped the role of benchmark grades for price setting. To date considerable work has been done to scrutinise the degree to which these two markets price efficiently, but little with regard to the way the two markets interact. Participants in these markets move with relative ease from one market to the other and usually take positions in both of them. It is of interest, therefore, to investigate the information transmission mechanism by looking at spillover effects and, perhaps, identify which market is the true price leader. This paper is a first attempt to look at such a problem in the energy market, although similar studies have been done on stock market indices. It is found that substantial spillover effects do exist when both markets are trading simultaneously, although IPE morning prices seem to be considerably affected by the close of the previous day on NYMEX

Study to forecast and determine characteristics of world satellite communications market

Science.gov (United States)

Filep, R. T.; Schnapf, A.; Fordyce, S. W.

1983-01-01

The world commercial communications satellite market during the spring and summer of 1983 was examined and characteristics and forecasts of the market extending to the year 2000 were developed. Past, present and planned satellites were documented in relation to frequencies, procurement and launch dates, costs, transponders, and prime contractor. Characteristics of the market are outlined for the periods 1965 - 1985, 1986 - 1989, and 1990 - 2000. Market share forecasts, discussions of potential competitors in various world markets, and profiles of major communication satellite manufacturing and user countries are documented.

Does Increased Spending on Pharmaceutical Marketing Inhibit Pioneering Innovation?

Science.gov (United States)

Arnold, Denis G; Troyer, Jennifer L

2016-04-01

The pharmaceutical industry has been criticized for developing and aggressively marketing drugs that do not provide significant health benefits relative to existing drugs but retain the benefits of patent protection. Critics argue that drug marketing increases health care expenditures and provides a disincentive for pioneering drug innovation. However, evidence that marketing expenditures have any relationship to new drug approvals has been anecdotal. We hypothesized that, at publicly traded pharmaceutical firms, increased marketing expenditures will result in a reduced volume of pioneering new drugs in comparison to less innovative new drugs. We also hypothesized that additional research and development spending will result in an increased volume of pioneering new drugs in comparison to less innovative drugs. Results confirm our hypotheses. Specific policy recommendations for altering firms' incentives for the development of pioneering drugs are provided. Copyright © 2016 by Duke University Press.

Performance problems of regional labor service market in the context of international integration

OpenAIRE

Karlova, Оlena

2014-01-01

The research examines the current state of the market of legal services (by the example of Kharkiv Region). To date the market of legal services of Kharkiv Region is mature and features high professionalism of its participants, well-shaped market segments and positive market trends.The author highlights some performance problems and development opportunities of the regional market in the context of international integration. They include manifestations of unfair competition, low standards of ...

Inventory of Safety-related Codes and Standards for Energy Storage Systems with some Experiences related to Approval and Acceptance

Energy Technology Data Exchange (ETDEWEB)

Conover, David R.

2014-09-11

The purpose of this document is to identify laws, rules, model codes, codes, standards, regulations, specifications (CSR) related to safety that could apply to stationary energy storage systems (ESS) and experiences to date securing approval of ESS in relation to CSR. This information is intended to assist in securing approval of ESS under current CSR and to identification of new CRS or revisions to existing CRS and necessary supporting research and documentation that can foster the deployment of safe ESS.

Do Internet Credit Markets Improve Access to Credit for Female Business Owners?

OpenAIRE

Barasinska, Nataliya; Schäfer, Dorothea

2010-01-01

Business owners and founders are a minority of any bank's business clients. Scientific studies of traditional credit markets often show a lower probability of loan approval or higher loan costs for female business owners compared to male business owners. With this background the question arises whether female business owners have to struggle with this problem less on Internet credit markets. In this current study, DIW Berlin investigated business loans on the largest German Internet platform,...

The effects of the introduction of market makers in the Brazilian equity market

Directory of Open Access Journals (Sweden)

Marcelo Perlin

2013-07-01

Full Text Available The main objective of this study is to analyze the empirical effects of the introduction of market makers in the Brazilian stock exchange. By aggregating information regarding the dates of the market maker’s contract and the use of a privileged high frequency database, it was possible to execute an event study to check the effect of the introduction of liquidity agents. As expected, the period after the beginning of the market maker’s contract presented a significant increase in the liquidity of the stocks. The study reports an average increase of 31% in the number of trades in the period before and after the start of the contract. Another result is that the work of a liquidity agent can change significantly the autocorrelation of the trade signs in approximately 10%. Such a result is stronger for the stocks with lower liquidity. The investigation also shows heterogeneous results for the performance of the liquidity provision when the analysis based itself on the financial institution of the market maker. Such information is particularly important for companies that are seeking to contract market making services.

76 FR 29680 - Approval and Disapproval and Promulgation of State Implementation Plan Revisions; Infrastructure...

Science.gov (United States)

2011-05-23

..., marketable permits, and auctions of emissions rights), as well as schedules and timetables for compliance as...) program as required by part C of the Act, and the State's minor NSR program as required by 110(a)(2)(C...), respectively. Minor NSR Finally, with regards to minor NSR, in this action EPA is proposing to approve Wyoming...

Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive materials packages

International Nuclear Information System (INIS)

1990-10-01

The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive materials packages

International Nuclear Information System (INIS)

1989-10-01

The purpose of this directory is to make available a convenient source of information on packaging which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

77 FR 49774 - Notice of Request for Extension of a Currently Approved Information Collection; USDA Registration...

Science.gov (United States)

2012-08-17

...Authentication Service (eAuth), located at http://www.eauth.egov.usda.gov . The USDA eAuth service provides the... Electronic Access Code. OMB Number: 0503-0014. Expiration Date of Approval: August 31, 2013. Type of Request... eAuth as a management and technical process that addresses user authentication and authorization...

75 FR 31747 - Notice of Request for Extension of Approval of an Information Collection; Interstate Movement of...

Science.gov (United States)

2010-06-04

...] Notice of Request for Extension of Approval of an Information Collection; Interstate Movement of Certain... interstate movement of certain land tortoises. DATES: We will consider all comments that we receive on or... FURTHER INFORMATION CONTACT: For information on regulations for the interstate movement of certain land...

76 FR 37055 - Notice of Request for Extension of Approval of an Information Collection; Importation of Baby...

Science.gov (United States)

2011-06-24

...] Notice of Request for Extension of Approval of an Information Collection; Importation of Baby Squash and Baby Courgettes From Zambia AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Extension... importation of baby squash and baby courgettes from Zambia. DATES: We will consider all comments that we...

76 FR 45769 - Notice of Request for Extension of Approval of an Information Collection; Pork and Poultry...

Science.gov (United States)

2011-08-01

...] Notice of Request for Extension of Approval of an Information Collection; Pork and Poultry Products From... regulations for pork and poultry products from Mexico transiting the United States. DATES: We will consider... information on pork and poultry products from Mexico transiting the United States, contact Dr. Lynette...

78 FR 8666 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-02-06

... mechanism of a free and open market and a national market system, and, in general, to protect investors and... supports the objectives of perfecting the mechanism of a free and open market and the national market... market-wide circuit breakers pilot until the initial date of operations of the LULD Plan would allow the...

Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive material packages

International Nuclear Information System (INIS)

1988-12-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1988. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

Science.gov (United States)

Lawrence, Dana J

2011-11-01

To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby

Using the Spatial Distribution of Installers to Define Solar Photovoltaic Markets

Energy Technology Data Exchange (ETDEWEB)

O' Shaughnessy, Eric [National Renewable Energy Lab. (NREL), Golden, CO (United States); Nemet, Gregory F. [Univ. of Wisconsin, Madison, WI (United States); Darghouth, Naim [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

2016-09-01

Solar PV market research to date has largely relied on arbitrary jurisdictional boundaries, such as counties, to study solar PV market dynamics. This paper seeks to improve solar PV market research by developing a methodology to define solar PV markets. The methodology is based on the spatial distribution of solar PV installers. An algorithm is developed and applied to a rich dataset of solar PV installations to study the outcomes of the installer-based market definitions. The installer-based approach exhibits several desirable properties. Specifically, the higher market granularity of the installer-based approach will allow future PV market research to study the relationship between market dynamics and pricing with more precision.

75 FR 38072 - Notice of a Request for Extension of a Currently Approved Information Collection

Science.gov (United States)

2010-07-01

... sales transactions, the type and class of commodity, the marketing year of shipment, and the destination... destination or 200,000 tons or more of one commodity during the weekly reporting period. Large sales for... destinations. The estimated total annual burden of 42,947 hours in the OMB inventory for the currently approved...

77 FR 66432 - Request for Extension and Revision of a Currently Approved Information Collection for the...

Science.gov (United States)

2012-11-05

... opportunity to develop a personal relationship with their customers; and cultivate consumer loyalty with the... Management and Budget, for an extension of and revision to the currently approved information collection for... affiliated with a farm where transactions between a farm market operator and customers take place. A farm...

76 FR 38601 - Notice of Request for Extension of Approval of an Information Collection; Self-Certification...

Science.gov (United States)

2011-07-01

... approval of an information collection. Abstract: The Marketing and Regulatory Programs (MRP) agencies of.... agricultural products and protect the health of domestic animal and plant resources. The MRP agencies are the... human resource management, for the three MRP agencies are provided by the MRP Business Services unit of...

Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.

Science.gov (United States)

Avery, Matthew; Liu, Dan

2011-01-01

Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products.

Market Exclusivity Time for Top Selling Originator Drugs in Canada: A Cohort Study.

Science.gov (United States)

Lexchin, Joel

2017-09-01

This study looks at market exclusivity time for the top selling originator drugs in Canada. Total sales for drugs without competition were also calculated. A list of the top selling originator drugs by dollar sales from 2009 to 2015 inclusive, except for 2010, was compiled along with their annual sales. Health Canada databases were used to extract the following information: generic name, date of Notice of Compliance (NOC, date of marketing authorization), whether the product was a small molecule drug or a biologic, and date of NOC for a generic or biosimilar. Market exclusivity time was calculated in days for drugs. A total of 121 drugs were identified. There were 96 small molecule drugs (63 with a generic competitor and 33 with no generic competitor) and 25 biologics (none with a biosimilar competitor). The 63 drugs with a competitor had a mean market exclusivity time of 4478 days (12.3 years) (95% CI 4159-4798). The 58 drugs without competition had total annual sales of Can$8.59 billion and were on the market for a median of 5357 days (14.7 years) (interquartile range 3291-6679) as of January 31, 2017. Top selling originator drugs in Canada have a considerably longer period of market exclusivity than the 8 to 10 years that the research-based pharmaceutical industry claims. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

78 FR 20898 - Agency Information Collection Activities; Notice of Intent to Renew Collection: Market Surveys

Science.gov (United States)

2013-04-08

... prevention of market manipulation. DATES: Comments must be submitted on or before June 7, 2013. ADDRESSES... positions held or introduced by futures commission merchants, members of contract markets, introducing... is designed to assist the Commission in prevention of market manipulation and is promulgated pursuant...

Energy for our future : a plan for British Columbia progress to date

International Nuclear Information System (INIS)

Ostergaard, P.

2004-01-01

This PowerPoint presentation provided a brief overview of British Columbia's electric power system, the policies affecting it, the province's energy plans and support mechanisms to address issues and challenges. In British Columbia, 80 per cent of the electricity is primarily hydro based and is generated by BC Hydro, a public utility. The market structure is regulated and the electricity rates are based on cost of service. The BC market includes western North America with interconnections to Washington State and Alberta. The key issues and challenges facing the electricity sector in the province are meeting domestic demand; adopting clean competitive energy alternatives; export market access and downstream benefits; interest and exchange rates; firming, storage and shaping; transmission upgrades to an aging infrastructure; local governments and First Nations relationships and, permitting and approvals. The transmission system was reviewed with reference to trade with the Pacific Northwest, flexibility and storage. The province's future energy plans are based on low rates and public ownership, secure and reliable supply, more private sector opportunities, and environmental responsibility. figs

76 FR 6794 - 30-Day Submission Period for Requests for ONC-Approved Accreditor (ONC-AA) Status

Science.gov (United States)

2011-02-08

... Accreditor (ONC-AA) Status AGENCY: Office of the National Coordinator for Health Information Technology... submission of requests for ONC-Approved Accreditor (ONC-AA) status. Authority: 42 U.S.C. 300jj-11. DATES: The... for ONC-AA status may be submitted. The 30-day period for submission of requests for ONC-AA status...

76 FR 34033 - Notice of Request for Extension of Approval of an Information Collection; Interstate Movement of...

Science.gov (United States)

2011-06-10

...] Notice of Request for Extension of Approval of an Information Collection; Interstate Movement of Sheep... movement of sheep and goats to control the spread of scrapie. DATES: We will consider all comments that we... . FOR FURTHER INFORMATION CONTACT: For information on regulations for the interstate movement of sheep...

75 FR 20558 - Notice of Request for Extension of Approval of an Information Collection; Plum Pox Compensation

Science.gov (United States)

2010-04-20

...] Notice of Request for Extension of Approval of an Information Collection; Plum Pox Compensation AGENCY... destroyed to eradicate plum pox virus. DATES: We will consider all comments that we receive on or before... FURTHER INFORMATION CONTACT: For information on plum pox compensation, contact Dr. S. Anwar Rizvi, Senior...

The approval process for biosimilar erythropoiesis-stimulating agents.

Science.gov (United States)

Wish, Jay B

2014-09-05

A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage of biosimilar drugs is that they are significantly less expensive than the reference products, allowing for increased accessibility and cost savings. Recognizing these advantages, the US Congress passed the Biologics Price Competition and Innovation Act in 2009 as part of health care reform. The Biologics Price Competition and Innovation Act allows sponsors of biosimilar agents to seek approval by showing structural and functional similarity to the reference agent, with the extent of required clinical studies to be determined on the basis of the degree of biosimilarity with the reference product. The goal is to bring biosimilar agents to the market more efficiently while still protecting the safety of the public. The European Union has had such a process in place for a number of years. Two biosimilar epoetin agents have been approved in the European Union since 2007, and their companies are conducting trials to seek approval in the United States, because Amgen's patent protection for epoetin alfa expires in 2014. Trials completed for European Union approval of both agents showed similar efficacy and safety to the reference epoetin alfa. As with all biologics, immunogenicity concerns may persist because of the fragility of the manufacturing process and the worldwide experience with pure red cell aplasia as a result of epoetin therapy. The uptake of biosimilar epoetins after approval in the United States will depend on the balance of cost advantage against safety concerns. Competition in the marketplace will likely decrease the cost of the reference agent as well. Copyright �

Directory of Certificates of Compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive materials packages. Volume 3, Revision 15

International Nuclear Information System (INIS)

1995-10-01

The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date

75 FR 35452 - Agency Information Collection Activities; Submission To OMB for Review and Approval; Comment...

Science.gov (United States)

2010-06-22

... certain technical, marketing, and health-effects information. The development of health-effects data, as... the number of registered fuels. Dated: June 16, 2010. John Moses, Director, Collection Strategies...

The legal and economic forces that will shape the international market for cybersurgery.

Science.gov (United States)

McLean, Thomas R

2006-12-01

Despite the common use of medical devices most health care providers have little understanding how a device alters medical malpractice litigation. Such knowledge will be increasingly valuable as cybersurgery (i.e. remote robotic surgery) becomes routine. Review of the laws governing products and telecommunication liability. Litigation after cybersurgery will be complex. In addition to being able to sue physicians and hospitals, patients who sustain an adverse outcome after cybersurgery will have the potential to sue the robotic manufacturer and telecommunication company. Robotics manufacturers can obtain virtual immunity from liability if they elected to place their devices on the market after obtaining [see text]360 per-market approval from the FDA. However, because [see text]360 pre-market approval is expensive and time consuming most medical devices on the market (including the robotic surgical instruments) do not have immunity to products liability. Consequently, after an adverse cybersurgical outcome a manufacturer of a robotic surgical instrument faces liability for failure to warn, design defects, and failure to properly manufacture. As for telecommunication providers, existing law provides them with immunity from liability. Litigation following cybersurgery will involve multiple defendants who are likely to use "finger pointing" defenses. Accordingly, there will be liability traps associated with providing cybersurgery. Copyright 2006 John Wiley & Sons, Ltd.

75 FR 45088 - Lamb Promotion, Research, and Information Program; Notice of Request for Extension and Revision...

Science.gov (United States)

2010-08-02

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Document AMS-LS-10-0056] Lamb Promotion... the Lamb Promotion, Research, and Information Program. Once approved, AMS will be requesting OMB merge... INFORMATION: Title: Lamb Promotion, Research, and Information Program. OMB Number: 0581-0198. Expiration Date...

77 FR 35455 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of Proposed...

Science.gov (United States)

2012-06-13

...-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of Proposed Rule Change Amending NYSE Rule 107B To Add a Class of Supplemental Liquidity Providers That Are Registered as Market... proposed rule change to amend NYSE Rule 107B to add a class of Supplemental Liquidity Providers (``SLP...

Impediments to markets for SO2 emission allowances

International Nuclear Information System (INIS)

Walsh, M.; Ramesh, V.C.; Ghosh, K.

1996-01-01

The Clean Air Act (CAA) of 1990 imposed tighter limits on allowed emissions from electric utilities. The CAA also introduced an innovative SO 2 market mechanism to help lower the cost of compliance. The annual Environmental Protection Agency (EPA) auctions of emission allowances intended to help usher in the market mechanisms for trading allowances. In that respect, the results have been mixed. A full fledged market for emission allowances has been slow to emerge. Starting with a detailed study of the EPA auctions to date, this paper analyzes and discusses some of the reasons for this slow development

Chronic Disease Prevalence and Medicare Advantage Market Penetration

OpenAIRE

Steven W. Howard; Stephanie Lazarus Bernell; Faizan M. Casim; Jennifer Wilmott; Lindsey Pearson; Caitlin M. Byler; Zidong Zhang

2015-01-01

By March 2015, 30% of all Medicare beneficiaries were enrolled in Medicare Advantage (MA) plans. Research to date has not explored the impacts of MA market penetration on individual or population health outcomes. The primary objective of this study is to examine the relationships between MA market penetration and the beneficiary?s portfolio of cardiometabolic diagnoses. This study uses 2004 to 2008 Medical Expenditure Panel Survey (MEPS) Household Component data to construct an aggregate inde...

77 FR 37573 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

Science.gov (United States)

2012-06-22

... Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory... (including potential economic, environmental, public health and safety, and other advantages; distributive... of disuse, and FDA has concluded that there is little or no interest in marketing these devices in...

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.

76 FR 81467 - Notice of Request for Extension of Approval of an Information Collection; Importation of Baby...

Science.gov (United States)

2011-12-28

...] Notice of Request for Extension of Approval of an Information Collection; Importation of Baby Corn and Baby Carrots From Zambia AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Extension of... importation of baby corn and baby carrots from Zambia. DATES: We will consider all comments that we receive on...

78 FR 54619 - Notice of Request for Extension of Approval of an Information Collection; Importation of Emerald...

Science.gov (United States)

2013-09-05

...] Notice of Request for Extension of Approval of an Information Collection; Importation of Emerald Ash... for the importation of emerald ash borer host material from Canada to prevent the introduction and spread of emerald ash borer in the United States. DATES: We will consider all comments that we receive on...

Creating marketing strategies for wedding business unit of Amari Atrium Hotel

OpenAIRE

Suvagondha, Apiwat; Soparat, Pattamaporn

2008-01-01

Abstract Date: May 29, 2008 Course: Master Thesis (EFO 705) Authors: Apiwat Suvagondha 790819 Pattamaporn Soparat 840216 Tutor: Tobias Eltebrandt Title: Creating marketing strategies for wedding business unit of Amari Atrium Hotel Problem: What should be marketing strategies for wedding business unit of Amari Atrium Hotel? Purpose: The aim of our thesis is to analyze the wedding market in Bangkok together with consumer purchasing behavior of Thai’s couple regarding to wedding ceremony in orde...

Tuna Park Shopping Centre A comparative study of marketing communication tools

OpenAIRE

Wongrattanavichit, Teewin; Wang, Haiyan

2008-01-01

Date: 2008 June 08 Course: Master thesis Authors: Haiyan Wang, Teewin Wongrattanavichit Tutor: Jan Löwstedt Title: The study of marketing communication effectiveness and customer perception of Tuna Park shopping centre Introduction: The research about the effectiveness of marketing communication tool and customer perception was studied in Tuna Park shopping center, Eskilstuna. The marketing strategy and objective was to compare with the results from the questionnaire in order to measure the e...

The organisation of work and systems of labour market regulation and social protection

DEFF Research Database (Denmark)

Lorenz, Edward; Lundvall, Bengt-Åke

2011-01-01

The paper demonstrates on the basis of date from 15 European countries that there is a close link between the form of labour market regulation and the systems of social protection on the one hand and modes of work organisation and learning on the other hand.......The paper demonstrates on the basis of date from 15 European countries that there is a close link between the form of labour market regulation and the systems of social protection on the one hand and modes of work organisation and learning on the other hand....

Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles

OpenAIRE

Lee, Bruce Y.; Burke, Donald S.

2009-01-01

As history has demonstrated, post-approval obstacles can impede a vaccine’s use and potentially lead to its withdrawal. Addressing these potential obstacles when changes in a vaccine’s technology can still be easily made may improve a vaccine’s chances of success. Augmented vaccine target product profiles (TPPs) can help vaccine scientists better understand and anticipate these obstacles and galvanize conversations among various vaccine stakeholders (e.g., scientists, marketers, business deve...

Lessons for public health campaigns from analysing commercial food marketing success factors: a case study

OpenAIRE

Aschemann-Witzel, Jessica; Perez-Cueto, Federico JA; Niedzwiedzka, Barbara; Verbeke, Wim; Bech-Larsen, Tino

2012-01-01

Abstract Background Commercial food marketing has considerably shaped consumer food choice behaviour. Meanwhile, public health campaigns for healthier eating have had limited impact to date. Social marketing suggests that successful commercial food marketing campaigns can provide useful lessons for public sector activities. The aim of the present study was to empirically identify food marketing success factors that, using the social marketing approach, could help improve public health campaig...

The economics of electricity markets

CERN Document Server

Biggar, Darryl R

2014-01-01

With the transition to liberalized electricity markets in many countries, the shift to more environmentally sustainable forms of power generation and increasing penetration of electric vehicles and smart appliances, a fundamental understanding of the economic principles underpinning the electricity industry is vital. Using clarity and precision, the authors successfully explain economic theory of all liberalized electricity market types from a cross-disciplinary engineering and policy perspective. No prior engineering knowledge or economics expertise is assumed in introducing key ideas such as nodal pricing, optimal dispatch and efficient pricing or in extending those models to areas including investment, risk management and the handling of contingencies. Key features: Comprehensively covers the principles of all liberalized electricity market types, including the US, Europe, New Zealand and Australia. Provides up to date coverage of research and policy iss es, including design of financial transmission rig...

75 FR 500 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule...

Science.gov (United States)

2010-01-05

.... 61043 (November 20, 2009), 74 FR 62612. On January 22, 2009, the Commission approved the formation of... wholly-owned subsidiary, NYSE Market, Inc., owns less than 9% of the aggregate limited partnership... proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f). \\12\\ 15 U.S...

Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

Science.gov (United States)

Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

2015-06-01

All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Belpex and trilateral market coupling

Energy Technology Data Exchange (ETDEWEB)

NONE

2006-01-15

This document describes the operation of Belpex, the Belgian power transmission spot market, and its linking with the French (Powernext) and Dutch (APX) auction-style day-ahead spot markets. A last part deals with the extension of this trilateral market to other European countries. Content: Belpex day-ahead market (DAM) (Goals of the DAM: Provide consumers with a wider choice of electrical energy sources, Enable the ARP's to optimize their portfolio in terms of imbalance costs, Reduce trade and credit risks for market players compared with the risks involved in concluding bilateral contracts, Provide economic players with a transparent price benchmark, Stimulate the opening of the electricity market); Market model Product (description, Contracts, Collateral calculation, From 12 January to launch date Corporate and Legal Aspects, Next developments); Trilateral Market Coupling (What is market coupling and what are the benefits?, Implementation of trilateral market coupling ('TLC') in France/Belgium/Netherlands, From Trilateral to Multilateral, Implementation of Trilateral Market Coupling (TLC) in France/Belgium/Netherlands, Decentralized market coupling mechanism, influence of import and export on area prices); Decentralized market coupling (2 countries Situations: unconstrained/constrained, Decentralized market coupling: 3 countries, High Level Properties of Market Coupling, Maximize flow until prices across link converge (or ATC limit reached), Power flows from low price area to high price area, Implementing a decentralized technical approach, Market Coupling Daily Process, Impact on Existing Exchange Arrangements, Implementing a decentralized contractual approach, TLC Project Process); From Trilateral to Multilateral (Geographic extensions, Towards an Open and Multilateral Market Coupling, Management of Interconnection Capacities, Interconnection Capacities: current situation, TSO Roles and Responsibilities in the TLC, Other Import/Export products

Belpex and trilateral market coupling

International Nuclear Information System (INIS)

2006-01-01

This document describes the operation of Belpex, the Belgian power transmission spot market, and its linking with the French (Powernext) and Dutch (APX) auction-style day-ahead spot markets. A last part deals with the extension of this trilateral market to other European countries. Content: Belpex day-ahead market (DAM) (Goals of the DAM: Provide consumers with a wider choice of electrical energy sources, Enable the ARP's to optimize their portfolio in terms of imbalance costs, Reduce trade and credit risks for market players compared with the risks involved in concluding bilateral contracts, Provide economic players with a transparent price benchmark, Stimulate the opening of the electricity market); Market model Product (description, Contracts, Collateral calculation, From 12 January to launch date Corporate and Legal Aspects, Next developments); Trilateral Market Coupling (What is market coupling and what are the benefits?, Implementation of trilateral market coupling ('TLC') in France/Belgium/Netherlands, From Trilateral to Multilateral, Implementation of Trilateral Market Coupling (TLC) in France/Belgium/Netherlands, Decentralized market coupling mechanism, influence of import and export on area prices); Decentralized market coupling (2 countries Situations: unconstrained/constrained, Decentralized market coupling: 3 countries, High Level Properties of Market Coupling, Maximize flow until prices across link converge (or ATC limit reached), Power flows from low price area to high price area, Implementing a decentralized technical approach, Market Coupling Daily Process, Impact on Existing Exchange Arrangements, Implementing a decentralized contractual approach, TLC Project Process); From Trilateral to Multilateral (Geographic extensions, Towards an Open and Multilateral Market Coupling, Management of Interconnection Capacities, Interconnection Capacities: current situation, TSO Roles and Responsibilities in the TLC, Other Import/Export products on the

76 FR 50663 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices

Science.gov (United States)

2011-08-16

... 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits..., and other advantages; distributive impacts; and equity). The Agency believes that this final rule is... is little or no interest in marketing these devices in the future. Therefore, the Agency certifies...

38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

Science.gov (United States)

2010-07-01

... approvals of community residential care facilities. 17.65 Section 17.65 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Community Residential Care § 17.65 Approvals and provisional approvals of community residential care facilities. (a) An approval of a facility meeting all of...

How much market do market-based instruments create? An analysis for the case of 'white' certificates

International Nuclear Information System (INIS)

Langniss, Ole; Praetorius, Barbara

2006-01-01

Among the diverse economic instruments to foster energy efficiency (EE) and climate protection, tradable certificates have been investigated for renewable energy, and the EU directive on an emissions-trading scheme for CO 2 certificates has been approved in 2003. In contrast, tradable energy efficiency-or 'white'-certificates have only lately been considered as a market-based tool to foster EE as compared with standards and labelling, for example. Theoretically, there is little doubt about the advantages. In practice, however, some fundamental problems arise. Critical issues are the design of an efficient artificial market for white certificates, its compatibility with the European emissions-trading system, the identification of a suitable target group for an EE obligation and the measurement of energy savings as compared with a reference use of energy. We use the theoretical framework of transaction cost economics to elaborate these issues. We conclude that transaction costs and investment specificity will restrict markets for white certificates in practice. Long-term contracts rather than spot trade will be the prevailing form of governance for EE investments. (author)

The comparison of absolute dating (Radiocarbon dating) and relative dating of Pringapus and Gondosuli temples

International Nuclear Information System (INIS)

Faisal, W; Arumbinang, H; Taftazani, A; Widayati, S; Sumiyatno; Suhardi

1996-01-01

The absolute dating (radiocarbon, 14 C dating) and relative dating of Pringapus and Gondosuli temples in Temanggung regency (district) of Central Java Province have been carried out. The field sampling was done especially with the purpose to obtain vertical data, so that excavation method was adopted in the case. The main data were the ecofacts of organic habitation such as bones, woods, charcoals, shells, and paper artefacts. The artefacts data were used as a comparison. The comparative data analysis were conducted at Yogyakarta archaeological Department Laboratory, thus included dating of artefacts which were performed according to archaeological analysis procedures, generally based on the attributes attached to the artefacts, whereas the absolute dating of charcoal samples were performed in the Radiocarbon Dating Laboratory at Yogyakarta Nuclear Research Centre. Based on the relative dating of epigraphy content on the andesit rock from Gondosuli Temple which showed the year of 754 Saka or 832 AD, the Pringapus Temple was estimated to be built in the 850 AD. According to the absolute dating (Radiocarbon Dating with delta 13 C and tree ring corrections) the age for Gondosuli temple based on GDS/LU-2/Spit-7 samples is (384 -602) AD and from GDS/LU-2/Spit-8 = (452 - 652) AD. With these significant differences in the results obtained, it can be concluded that culture environment where the sample were collected already existed before the temple was built. Further investigation is still required

76 FR 65730 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of...

Science.gov (United States)

2011-10-24

...-date information is critical to conducting these activities with efficiency and effectiveness. Under... product is not subject to marketing or licensing approval requirements; and a list of certain drugs or.../DataStandards/StructuredProductLabeling/ default.htm); Obtaining the digital certificate used with FDA...

24 CFR 901.5 - Definitions.

Science.gov (United States)

2010-04-01

... target dates, strategies and incentives for improving management performance; and provides sanctions if... and procurement plan, training, and approved budget. The plan should establish a strategy for meeting... market conditions. Example of units in this category are small PHAs that are located in areas...

Directory of national competent authorities' approval certificates for package design, special form material and shipment of radioactive material. 1998 edition

International Nuclear Information System (INIS)

1998-08-01

The information contained in this report is given in six tables. Tables 1 to 4 present administrative data including issue and expiration dates, package identification, package serial numbers, modes for which the package/shipments approved and the edition of Safety Series No. 6 on which the approval has been based. The technical information on package mass, authorized contents, and detailed and general description of the package are contained in Table 5. Table 6 shows the certificates reported to the IAEA Secretariat by each participating Member State

Applying Russian Search Engines to market Finnish Corporates

OpenAIRE

Pankratovs, Vladimirs

2013-01-01

The goal of this thesis work is to provide basic knowledge of Russia-based Search Engines marketing capabilities. After reading this material, the user is able to diverge different kinds of Search Engine Marketing tools and can perform advertising campaigns. This study includes information about the majority of tools available to the user and provides up to date screenshots of Russian Search engines front-end, which can be useful in further work. Study discusses the main principles and ba...

75 FR 44288 - Overhead and Gantry Cranes; Extension of the Office of Management and Budget's (OMB) Approval of...

Science.gov (United States)

2010-07-28

...] Overhead and Gantry Cranes; Extension of the Office of Management and Budget's (OMB) Approval of... requirements specified in the Standard on Overhead and Gantry Cranes (29 CFR 1910.179). DATES: Comments must be... requirements for: Marking the rated load of cranes; preparing certification records to verify the inspection of...

78 FR 32229 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Virus...

Science.gov (United States)

2013-05-29

...] Notice of Request for Revision to and Extension of Approval of an Information Collection; Virus-Serum... associated with the Virus-Serum-Toxin Act and regulations. DATES: We will consider all comments that we... call (202) 799-7039 before coming. FOR FURTHER INFORMATION CONTACT: For information regarding the Virus...

International coal trade: the evolution of a global market

International Nuclear Information System (INIS)

1998-01-01

The international coal market has developed over the last 25 years to a mature stable market, largely free of government involvement. It is evident, however, that while the coal market is considered widely to be reliable and mature, there is only limited understanding of the way in which the market operates. Understanding energy market mechanisms is fundamental to encourage confidence in the continuing performance of liberalized markets. This publication seeks to address this need by providing a brief descriptive analysis of the operation of the coal market. The report draws attention to the considerable changes that have been experienced to date in the market, where freely operating market mechanisms have coped well. Further change is on the horizon. Coal demand in Europe is stagnating while growing rapidly in Asia. The once-dominant European market remains the region where price is formed but the Asian market is growing rapidly and becoming more flexible. Increasing competition for market share, low margins, and pressure on utilities to reduce costs as electricity markets are liberalized, will continue to stimulate productivity improvement and may lead to innovations in marketing to cope with stable real prices, high transport, and transaction costs

A Comprehensive Review of US FDA-Approved Immune Checkpoint Inhibitors in Urothelial Carcinoma

Directory of Open Access Journals (Sweden)

Fu-Shun Hsu

2017-01-01

Full Text Available Few effective treatment options are available for patients with advanced or metastatic urothelial carcinoma (UC after unsuccessful first-line platinum-based chemotherapy. To date, immune checkpoint inhibitors are novel therapeutic agents for UC treatment. From May 2016 to May 2017, five anti-PD-1/PD-L1 monoclonal antibodies received accelerated or regular approval from the US Food and Drug Administration (FDA for the treatment of patients with locally advanced or metastatic UC. The present comprehensive review presents the background information of these five US FDA-approved anticancer agents to provide a basic but concise understanding of these agents for advanced studies. We summarize their immune checkpoint mechanisms, clinical efficacy, recommended usage protocols, adverse events, and the limitations of the PD-L1 biomarker assays.

Import market penetration in services

OpenAIRE

Langhammer, Rolf J.

1991-01-01

The EC-1992 programme foresees the complete liberalization of trade in services among member countries. To what extent has import market penetration in the Community already begun in selected service industries? Which EC member countries have been the forerunners to date? The following paper uses a new data base released recently by EUROSTAT in an attempt to answer these and other related questions.

Developing strategies to promote the Iranian international film market

Directory of Open Access Journals (Sweden)

Mahmood Mohammadian

2012-04-01

Full Text Available International film market of Iran (IFM is one of the most important presenters of different films and television programs to be sold in the world market especially in Middle East. The primary purpose of this paper is to investigate different methods to promote this market. The study uses a questionnaire and distributes it among buyers and sales agents of IFM. The results of hypothetic tests prove that the socio-cultural factors are the most important reasons for the participants. Another important criterion promoting sales of movies is different awards from various movie festivals dedicated to moviemakers. The opening date and place of market, publication and publicity are other important criteria influencing sales of movies. The paper illustrates film-marketing mix for film marketers. Indicators, which are important for participants in international film festivals, are also illustrated for international film market holders.

Dating Violence

Science.gov (United States)

... for Teens / Dating Violence Bulletins for Teens: Dating Violence What is it? If you are a victim ... often. If You Are a Victim of Dating Violence, You Might… Think it's your fault. Feel angry, ...

Petroleum marketing annual, 1991

International Nuclear Information System (INIS)

1992-08-01

The Petroleum Marketing Annual contains statistical data on a variety of crude oils and refined petroleum products. The publication provides statistics on crude oil costs and refined petroleum products sales for use by industry, government, private sector analysts, educational institutions, and consumers. Data on crude oil include the domestic first purchase price, the free-on-board and landed cost of imported crude oil, and the refiners' acquisition cost of crude oil. Sales data for motor gasoline, distillates, residuals, aviation fuels, kerosene, and propane are presented. For this publication, all estimates have been recalculated since their earlier publication in the Petroleum Marketing Monthly (PMM). These calculations made use of additional data and corrections that were received after the PMM publication dates

Petroleum marketing annual 1993

International Nuclear Information System (INIS)

1995-01-01

The Petroleum Marketing Annual (PMA) contains statistical data on a variety of crude oils and refined petroleum products. The publication provides statistics on crude oil costs and refined petroleum products sales for use by industry, government, private sector analysts, educational institutions, and consumers. Data on crude oil include the domestic first purchase price, the free-on-board (f.o.b.) and landed cost of imported crude oil, and the refiners acquisition cost of crude oil. Sales data for motor gasoline, distillates, residuals, aviation fuels, kerosene, and propane are presented. For this publication, all estimates have been recalculated since their earlier publication in the Petroleum Marketing Monthly (PMM). These calculations made use of additional data and corrections that were received after the PMM publication dates

Petroleum marketing annual 1993

Energy Technology Data Exchange (ETDEWEB)

1995-01-01

The Petroleum Marketing Annual (PMA) contains statistical data on a variety of crude oils and refined petroleum products. The publication provides statistics on crude oil costs and refined petroleum products sales for use by industry, government, private sector analysts, educational institutions, and consumers. Data on crude oil include the domestic first purchase price, the free-on-board (f.o.b.) and landed cost of imported crude oil, and the refiners acquisition cost of crude oil. Sales data for motor gasoline, distillates, residuals, aviation fuels, kerosene, and propane are presented. For this publication, all estimates have been recalculated since their earlier publication in the Petroleum Marketing Monthly (PMM). These calculations made use of additional data and corrections that were received after the PMM publication dates.

Is 137Cs Dating Becoming Obsolete in North America?

Science.gov (United States)

Drexler, J. Z.; Fuller, C.; Salas, A.

2016-12-01

Dating of wetland sediments and peat is routinely carried out using 137Cs and 210Pb analysis. Unlike 210Pb, 137Cs is an anthropogenic radionuclide with a history of fallout from nuclear weapons testing. 137Cs is used as a single time marker; its peak is coincident with the height of atmospheric nuclear testing in 1963/4. During its use in the 1970s-90s, 137Cs peaks were usually highly distinct in wetland sediments (e.g., see 137Cs peaks from Louisiana marshes in Feijtel et al., 1988). This enabled its use as a check for dates assigned to a profile by 210Pb and other methods. However, recently, the efficacy of 137Cs dating in North America has deteriorated. In this presentation, we will provide specific examples of 137Cs as well as 210Pb dating in wetland sediments/peats we collected between 2005 and 2015 in Maine, California, Virginia, North Carolina, South Carolina, and Washington. Two main reasons exist for this decline. First, 137Cs activities in our recent cores are 30-40 % of the original activities in 1963/4 due to decay of the original 137Cs in situ (half-life = 30.17 years) and no major new sources. This manifests in lower signal to noise ratio, with some peaks barely recognizable above the noise. Second, 137Cs peaks are much less distinct due to 137Cs migration through time independent of substrate (or sediment) particles. Migration of peaks has resulted in estimated accretion rates being systematically lower or higher than those derived from 210Pb dating. These issues with 137Cs dating have important implications because 137Cs is used with 210Pb dating or even alone to determine rates of recent wetland carbon accumulation. Such rates are required to enter wetland restoration projects into carbon markets and to document IPCC mandated reductions in carbon pollution. Our analysis shows that, although dating by 137Cs alone has always been highly tenuous, now it is especially contraindicated and should be disallowed for the purposes of carbon accounting.

Type approval and real-world CO_2 and NO_x emissions from EU light commercial vehicles

International Nuclear Information System (INIS)

Zacharof, Nikiforos; Tietge, Uwe; Franco, Vicente; Mock, Peter

2016-01-01

In the European Union, light duty vehicles (LDVs) are subject to emission targets for carbon dioxide (CO_2) and limits for pollutants such as nitrogen oxides (NO_x). CO_2 emissions are regulated for both passenger vehicles (PV) and light commercial vehicles (LCV), as individual manufacturers are required to reach fleet averages of 130 g/km by 2015 and 175 g/km by 2017, respectively. In the case of PVs, it has been found that there is a significant divergence between real-world and type-approval CO_2 emissions, which has been increasing annually, reaching 40% in 2014. On-road exceedances of regulated NO_x emission limits for diesel passenger cars have also been documented. The current study investigated the LCV characteristics and CO_2 and NO_x emissions in the European Union. A vehicle market analysis found that LCVs comprise 17% of the diesel LDV market and while there were some data for CO_2 emissions, there were hardly any data publicly available for NO_x emissions. Monitoring the divergence in CO_2 emissions revealed that it increased from 14% in 2006 to 33% in 2014, posing an additional annual fuel cost from 120€ in 2006 to 305€ in 2014, while a significant percentage of Euro 5 vehicles exceeded NO_x emission standards. - Highlights: • Light commercial vehicles comprise 17% of diesel light duty vehicle market. • On-road CO_2 emissions were found to be on average 33% higher than compared to type approval measurements. • The annual additional fuel cost due to the on-road and type approval divergence is estimated at 400€. • Data indicates exceedances in on-road NO_x emissions. • Little attention has been given to light commercial vehicles compared to passenger vehicles.

The art of designing markets.

Science.gov (United States)

Roth, Alvin E

2007-10-01

Traditionally, markets have been viewed as simply the confluence of supply and demand. But to function properly, they must be able to attract a sufficient number of buyers and sellers, induce participants to make their preferences clear, and overcome congestion by providing both enough time to make choices and a speedy means of registering them. Solutions to these challenges are the province of market design--a blend of game theory and experimental economics. Roth, a professor of both business and economics at Harvard, is a leading market designer. He and his colleagues have rescued failing markets by, for example, designing labor clearinghouses through which U.S. doctors get their first jobs and auctions through which the Federal Communications Commission sells licenses for parts of the radio broadcast spectrum. They have also created marketlike allocation procedures that involve neither prices nor an exchange of money; these include systems for assigning children to schools in Boston and New York and for facilitating exchanges of kidneys. Computers enable the design of "smart markets" that combine the inputs of users in complex ways: In kidney exchange, they run through every possible match of donors and recipients to arrange the greatest possible number of transplants. In the future, computers may make it possible to auction bundled goods, such as airport takeoff and landing slots. As online markets--like those for jobs and dating--proliferate, a growing understanding of markets in general will provide virtually limitless opportunities for market design.

26 CFR 1.430(g)-1 - Valuation date and valuation of plan assets.

Science.gov (United States)

2010-04-01

... the adjusted fair market value of plan assets, assets that are added to a plan as a result of a plan... (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES Certain Stock Options § 1.430(g)-1 Valuation date and.... Paragraph (c) of this section describes rules regarding the determination of the asset value for purposes of...

INSURANCE MARKETING OF INNOVATIONS IN THE REGIONAL MARKET OF SERVICES UNDER PRESENT CONDITIONS: STRATEGIC ASPECTS

Directory of Open Access Journals (Sweden)

A. V. Kovalenko

2012-01-01

Full Text Available Innovative development of insurance activities must be directed towards creation of new insurance products. Up-to-date innovative insurance marketing should be carried out on the basis of an efficient innovative process management system. For a big insurance company with a largeclient base, high service standards may be warranted only through implementation of innovations linked with newest information technologies.

Regulating deregulated energy markets

International Nuclear Information System (INIS)

Jackson, M.

2002-01-01

The North American gas and electricity markets are fast evolving, and regulators are currently faced with a host of issues such as market-based rates, unbundling, stranded costs, open access, and incentive regulation are surfacing as a result of deregulation. The regulatory environment in Ontario was reviewed by the author. Deregulated markets rule, from commodities to gas and electricity. Additionally, there is an evolution of traditional utility regulation. A look at deregulated markets revealed that there are regulations on boundary conditions on the deregulated market. Under the Ontario Energy Board (OEB), all generators, transmitters, distributors, and retailers of electricity must be licensed. The standard supply service (SSS) offered by electricity distributors and system gas which is still being sold by natural gas distributors continues to be regulated by OEB. One issue that was addressed was separation for revenues and costs of the utility's purchase and sale of gas business, at least for accounting purposes. The next issue discussed was cost of system gas and SSS, followed by timely signals and prudent incurred costs. Historical benefits were reviewed, such as historical commitments to low-cost electricity. Pooling transportation costs, transmission pricing continued, market-based rates, unbundling, stranded costs, open access, incentive regulation/ performance based regulation (PBR) were all discussed. Price cap on PBR, both partial and comprehensive were looked at. A requirement to review guidelines on cost of capital and an application to extend blanket approval provisions for gas storage were discussed, as they are amongst some of the challenges of the future. Other challenges include revised rules and practice and procedure; practice directions for cost awards, appeals, and other functions; confidentiality guidelines; and refinements to the role of and approaches to alternative dispute resolution. The future role of regulators was examined in light

Directory of Certificates of Compliance for Radioactive-Materials Packages. Summary report of NRC approved quality assurance programs for radioactive material packages

International Nuclear Information System (INIS)

1983-01-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume I), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective December 31, 1982. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volumes 1 and 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Drug lag and key regulatory barriers in the emerging markets

Directory of Open Access Journals (Sweden)

Harriet Wileman

2010-01-01

This work concludes that the overall relative drug lag in the emerging markets has decreased over time and that there are seven key regulatory barriers which need to be targeted in order to make further improvements; ′Western Approval′, local clinical development (LCD, Certificate of Pharmaceutical Product (CPP, Good Manufacturing Practice (GMP, pricing approval, document authentication and harmonisation.

Setting a date

International Nuclear Information System (INIS)

Moore, Glenis.

1987-01-01

Dating techniques are discussed and explained. The age range and sensitivity of different techniques are given. Potassium/argon dating, amino-acid dating, radiocarbon dating, dendrochronology, thermoluminescence and geomagnetic field dating are all mentioned. Each technique is explained and a brief history given. The techniques and equipment used by the British Museum, and some examples of archaeological articles dated are mentioned. (UK)

78 FR 68477 - Overhead and Gantry Cranes; Extension of the Office of Management and Budget's (OMB) Approval of...

Science.gov (United States)

2013-11-14

...] Overhead and Gantry Cranes; Extension of the Office of Management and Budget's (OMB) Approval of... requirements specified in the Standard on Overhead and Gantry Cranes (29 CFR 1910.179). DATES: Comments must be... information (29 U.S.C. 657). The paperwork provisions of the Standard on Overhead and Gantry Cranes specify...

75 FR 19436 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

Science.gov (United States)

2010-04-14

..., the Commission is not publishing it for comment.\\4\\ This order approves the proposed rule change, as... NASDAQ OMX Corporate Governance Guidelines, however, provide a different standard for uncontested... contained in the Corporate Governance Guidelines; contested elections would remain subject to the plurality...

Opening of the French gas market

International Nuclear Information System (INIS)

Syrota, J.

2002-01-01

A report on the opening of the French gas market has been established, on the request of both the French minister of economy, finances and industry and the state secretary of industry, as expressed in their respective letters addressed to the president of the commission of electric power regulation (CRE). This report follows the step report on the opening of the French gas market published on January 15, 2002. It presents a status of the French gas market since August 2000, date of the enforcement of the European Union directive 98/30/CE, and expresses some recommendations about the main questions that should fall into the field of the future gas regulation. This report was elaborated before the project of law relative to the energy markets and published on October 24, 2002. These recommendations will have to be adapted to the dispositions of the law. This article presents some excerpts of the synthesis report. (J.S.)

19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

Science.gov (United States)

2010-04-01

... after manufacture. 115.41 Section 115.41 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT... PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.41 Certificate of approval for containers approved after manufacture. The Certifying Authority shall...

Radiation vulcanised natural rubber latex (RVNRL) market and challenges

International Nuclear Information System (INIS)

Wan Manshol Wan Zin; Najib Mohamad Zakey; Chai Chee Keong

2000-01-01

RVNRL has the required properties and proven useful for the manufacturing of examination gloves, balloons and finger cots at industrial scale. To date only RVNRL finger cots are available in the market. Problems and challenges for the market of other products are identified. Further success in the on going research activities will be the reference for more applications of RVNRL in the relevant industry to produce natural rubber latex products of more competitive values

Drug-device combination products: regulatory landscape and market growth.

Science.gov (United States)

Bayarri, L

2015-08-01

Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

75 FR 28231 - Cotton Classing, Testing and Standards: Notice of Request for an Extension and Revision to a...

Science.gov (United States)

2010-05-20

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [AMS-CN-10-0038, CN-10-002] Cotton... comments should reference the docket number and page number of this issue of the Federal Register. All... Standards. OMB Number: 0581-0008. Expiration Date of Approval: December 30, 2010. Type of Request: Extension...

From mutation identification to therapy: discovery and origins of the first approved gene therapy in the Western world

NARCIS (Netherlands)

Kastelein, John J. P.; Ross, Colin J. D.; Hayden, Michael R.

2013-01-01

On November 2, 2012, Glybera® (alipogene tipovarvec) was the first human gene therapy to receive long awaited market approval in the Western world. This important milestone is expected to open the door to additional gene therapies for the treatment of many diseases in the future. The development of

The outlook for the freight market in 2002

Energy Technology Data Exchange (ETDEWEB)

Cherrett, D. [H. Clarkson (United Kingdom)

2001-07-01

A series of charts (presented as overheads/slides) show the trends in the Capesize (Richards Bay to Rotterdam), Panamax (Richards Bay to Spain/Mediterranean) and Handymax (Newcastle, Australia to Japan) markets from 1992 to date. Factors affecting the freight rates are discussed.

Moral Behavior in Stock Markets: Islamic finance and socially responsible investment

OpenAIRE

Pitluck, Aaron Z.

2008-01-01

This paper addresses the puzzle of why the inclusion of non-financial social justice or religious criteria by professional fund managers has been so popular in Malaysia and yet has had to date relatively little influence in the United States stock market. Drawing from over 125 ethnographic interviews with financial workers in Malaysia, this paper argues that moral investment behavior in stock markets is shaped primarily by ‘market structure’ rather than by ‘mandates.’ In both countries man...

Market Trials of Irradiated Spices

International Nuclear Information System (INIS)

Charoen, Saovapong; Eemsiri, Jaruratana; Sajjabut, Surasak

2009-07-01

Full text: The objectives of the experiment were to disseminate irradiated retail foods to the domestic publics and to test consumer acceptance on irradiated ground chilli and ground pepper. Market trials of irradiated ground chilli and ground pepper were carried out at 2 local markets and 4 in Bangkok and Nontaburi in 2005-2007. Before the start of the experiment, processing room, gamma irradiation room and labels of the products were approved by Food and Drug Administration, Thailand. 50 grams of irradiated products were packaged in plastic bags for the market trials. 688 and 738 bags of ground chilli and ground pepper were sold, respectively. Questionnaires distributed with the products were commented by 59 consumers and statistically analyzed by experimental data pass program. 88.1 and 91.4 percents of the consumers were satisfied with the quality and the price, respectively. 79.7% of the consumers chose to buy irradiated ground chilli and ground pepper because they believed that the quality of irradiated products were better than that of non-irradiated ones. 91.5% of the consumers would certainly buy irradiated chilli and pepper again. Through these market trials, it was found that all of the products were sold out and the majority of the consumers who returned the questionnaires was satisfied with the irradiated ground chilli and ground pepper and also had good attitude toward irradiated foods

A Study of Marketing Strategy in Chinese Software Marketi : A Case Study of UFIDA Softeare Co., Ltd

OpenAIRE

Zeng, Xiongyu; Du, Yang

2008-01-01

Date: 2008-06-08 Program: International Marketing Course: Master thesis in International Marketing (EF0705) Author: Xiongyu Zeng (780925) Yang Du (820830) Tutor: Jan Löwstedt Title: A Study of Marketing Strategy in Chinese Software Market – A Case Study of UFIDA Software Co., Ltd Strategic Question : What should be an Effective Marketing Strategy for UFIDA in order to Increase its Market Shares and Support its Market Leadership Position? Purpose: The purpose of this study is to investigate an...

The Principal's Role in Marketing the School: Subjective Interpretations and Personal Influences

Science.gov (United States)

Oplatka, Izhar

2007-01-01

The literature on educational marketing to date has been concerned with the ways by which schools market and promote themselves in the community, their strategies to maintain and enhance their image, and the factors affecting parents and children and the processes they undergo when choosing their junior high and high school. Yet, there remains a…

Up-to-date status of food irradiation

Science.gov (United States)

Ahmed, Mainuddin

1993-07-01

The last decade has witnessed significant advancement of the acceptance of food irradiation processing. At present 37 countries have approved one or more food items for human consumption and 25 countries have commercialized this process. More developing countries are showing keen interest to introduce irradiation processing in order to reduce post-harvest food losses, to increase export potentials and to ensure safety of food to their people. Although progress towards acceptance of food irradiation by the industry is slow, actual market trials have shown that once consumers have understood this technology, they are willing to buy irradiated foods. This paper deals with the latest developments in the field of food irradiation with particular reference to legislation, consumer acceptance, commercialization and potential application in developing countries. This paper also deals with the role played by the International Organizations, aimed at facilitating the acceptance of food irradiation.

Use of the conditional marketing authorization pathway for oncology medicines in Europe.

Science.gov (United States)

Hoekman, J; Boon, W P C; Bouvy, J C; Ebbers, H C; de Jong, J P; De Bruin, M L

2015-11-01

Conditional marketing authorization (CMA) in the European Union (EU) is an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. Using a mixed quantitative-qualitative research design, we evaluated how CMA has been used in marketing authorization of oncology medicines in the period 2006 to 2013. We show that compared to full marketing authorization, CMA is granted based on less comprehensive data. However, this is accompanied by significantly longer assessment times and less consensus among regulators about marketing authorization. Moreover, development time from first-in-human testing to marketing authorization did not differ between full marketing authorization and CMA, but was significantly longer for CMA compared to accelerated approved products in the United States (US). Results indicate that CMA is not used by companies as a prospectively planned pathway to obtain early access, but as a "rescue option" when submitted data are not strong enough to justify full marketing authorization. © 2015, The American Society for Clinical Pharmacology and Therapeutics.

Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015.

Science.gov (United States)

Deak, Dalia; Outterson, Kevin; Powers, John H; Kesselheim, Aaron S

2016-09-06

A weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information from company filings, press releases, and media reports. Four antibiotics were approved for acute bacterial skin and skin-structure infection. Seven had similar mechanisms of action to those of previously approved drugs. Six were initially developed by small to midsized companies, and 7 are currently marketed by 1 of 3 large companies. The drugs spent a median of 6.2 years in clinical trials (interquartile range [IQR], 5.4 to 8.8 years) and 8 months in FDA review (IQR, 7.5 to 8 months). The median number of patients enrolled in the pivotal trials was 666 (IQR, 553 to 739 patients; full range, 44 to 1005 patients), and median trial duration was 18 months (IQR, 15 to 22 months). Seven drugs were approved on the basis of pivotal trials evaluating noninferiority. One drug demonstrated superiority on an exploratory secondary end point, 2 showed decreased efficacy in patients with renal insufficiency, and 1 showed increased mortality compared with older drugs. Seven of the drugs are substantially more expensive than their trial comparators. Limitations are that future research may show benefit to patients, new drugs from older classes may show superior effectiveness in specific patient populations, and

Marketing channels of banking products and services in contemporary business environment

OpenAIRE

Rakita Aleksandra

2016-01-01

Marketing application in banking is dating back to the 50s of 20th century, and since then its role is constantly changing. His modern role of synthesis of analysis, planning and control of the bank in the financial markets, achieved by the use of instruments of marketing mix (product, price, distribution and promotion). The paper is an analysis of the distribution function, and is primarily an overview of the modern distribution channels of banking products and services in the US, as the mos...

Steady Increase In Prices For Oral Anticancer Drugs After Market Launch Suggests A Lack Of Competitive Pressure.

Science.gov (United States)

Bennette, Caroline S; Richards, Catherine; Sullivan, Sean D; Ramsey, Scott D

2016-05-01

The cost of treating cancer has risen to unprecedented heights, putting tremendous financial pressure on patients, payers, and society. Previous studies have documented the rising prices of cancer drugs at launch, but less critical attention has been paid to the cost of these drugs after launch. We used pharmacy claims for commercially insured individuals to examine trends in postlaunch prices over time for orally administered anticancer drugs recently approved by the Food and Drug Administration (FDA). In the period 2007-13, inflation-adjusted per patient monthly drug prices increased 5 percent each year. Certain market changes also played a role, with prices rising an additional 10 percent with each supplemental indication approved by the FDA and declining 2 percent with the FDA's approval of a competitor drug. Our findings suggest that there is currently little competitive pressure in the oral anticancer drug market. Policy makers who wish to reduce the costs of anticancer drugs should consider implementing policies that affect prices not only at launch but also later. Project HOPE—The People-to-People Health Foundation, Inc.

The electricity market - wind energy after NFFO and in liberalized markets

International Nuclear Information System (INIS)

Johns, J.H.

1997-01-01

The paper will compare the benefits of leasing and other forms of asset based finance to the wind industry, as compared to conventional sources of finance for both the small and large developer. It will explore the attitudes of specialist and major leasing finance houses to the renewable energy industry in general and wind in particular. To date, leasing has been used more widely in municipal waste projects, although the UK tax regime means that there are also strong advantages to leasing for wind. The paper will examine the sensitivity of sources of leasing and debt finance to possible changes in the electricity markets in the UK, it will identify practical problems to be overcome in applying leasing and provide practical tips to developers. It will also examine some of the issues relevant to firms seeking to participate in overseas markets with the help of UK financiers. (Author)

ONLINE COMMUNICATION IN THE BRICOLAGE MARKET

Directory of Open Access Journals (Sweden)

Mihai-Cosmin FANARU

2016-12-01

Full Text Available In the modern business online marketing communication has become an extremely important phenomenon through its scale and implications on life and society in general. This way the development of the Internet has known a significant worldwide increase in the recent years. Its importance is recognized even by the most approved personalities in literature (Kotler and Keller, 2008, the Internet offering organizations and consumers greater opportunities for interaction and individualization. This article is trying to outline the importance and role of the Internet in communication efforts undertaken by bricolage companies.

NPS-SCAT CONOPS and Radiation Environment

Science.gov (United States)

2012-06-01

flexibility, as well as allows players in the space market who would otherwise not be able to enter due to budgetary limitations. Important to NPS is...commercial market . Although the time frame for completing NPS-SCAT has not been as short as possible due to the nature of the learning environment on its...Program ( STP ) seeks flight opportunities for approved experiments. The current NPS- SCAT launch date offers ample time to finish and test the

Fatigue associated with newly approved vascular endothelial growth factor receptor tyrosine kinase inhibitors in cancer patients: an up-to-date meta-analysis.

Science.gov (United States)

Li, Jing; Gu, Jian

2017-10-01

The fatigue associated with five newly approved vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) (regorafenib, vandetanib, cabozantinib, lenvatinib, axitinib) is poorly understood. We conducted this systematic review to fully investigate the fatigue associated with these VEGFR-TKIs in cancer patients. Relevant studies of randomized controlled trials in cancer patients treated with the five VEGFR-TKIs were retrieved and a systematic evaluation was conducted. EMBASE, MEDLINE, and PubMed were searched for articles published until March 2017. Thirteen randomized controlled trials and 4395 patients were included. The current analysis suggested that the use of five newly approved VEGFR-TKIs increased the risk of all-grade fatigue (1.43; 95% CI 1.23-1.66; p fatigue (1.97; 95% CI1.44-2.70; p fatigue varied significantly within drug type, but high-grade fatigue did not. The RR of all-grade and high-grade fatigue did not vary significantly according to cancer type, treatment line, and treatment duration. The risk of high-grade fatigue may vary with treatment duration, whereas all-grade fatigue may not. The available data suggest that the use of the five newly approved VEGFR-TKIs is associated with a significantly increased risk of fatigue in cancer patients. Physicians should be aware of this adverse effect and should monitor cancer patients receiving these drugs.

Strengthening Building Retrofit Markets

Energy Technology Data Exchange (ETDEWEB)

Templeton, Mary [Michigan Saves; Jackson, Robert [Michigan Energy Office

2014-04-15

The Business Energy Financing (BEF) program offered commercial businesses in Michigan affordable financing options and other incentives designed to support energy efficiency improvements. We worked through partnerships with Michigan utilities, lenders, building contractors, trade associations, and other community organizations to offer competitive interest rates and flexible financing terms to support energy efficiency projects that otherwise would not have happened. The BEF program targeted the retail food market, including restaurants, grocery stores, convenience stores, and wholesale food vendors, with the goal of achieving energy efficiency retrofits for 2 percent of the target market. We offered low interest rates, flexible payments, easy applications and approval processes, and access to other incentives and rebates. Through these efforts, we sought to help customers strive for energy savings retrofits that would save 20 percent or more on their energy use. This program helped Michigan businesses reduce costs by financing energy efficient lighting, heating and cooling systems, insulation, refrigeration, equipment upgrades, and more. Businesses completed the upgrades with the help of our authorized contractors, and, through our lending partners, we provided affordable financing options.

Can the regulated market help foster a free market for wind energy in Brazil?

International Nuclear Information System (INIS)

Dalbem, Marta Corrêa; Brandão, Luiz Eduardo Teixeira; Gomes, Leonardo Lima

2014-01-01

Wind energy has been negotiated in Brazil's regulated market through auctions organized by the government. Bilateral negotiations in the free market have been scarce. In 2011 wind farms were allowed to bid in ‘A minus 5 (A−5)' auctions, for energy with first delivery date 5 years ahead. This new design was expected to stimulate negotiations in the free market, as the 20-year contract in the regulated market eases financing while the 5-year grace period grants wind farms the option to sell whatever energy is generated beforehand in the free market. We modeled bidders' price decision in A−5 auctions as Real Options and concluded that given the low prices averaging USD 50/MW h, winners are tempted to defer investment, expecting more favorable equipment and energy prices, or a better knowledge of the wind site. Construction is likely to begin in 2–3 years, with little time left for the free market. Bidders that consider the option of eventually abandoning the project are more price competitive, increasing chances that some wind farms will never materialize. Therefore, this attempt to foster the free market may not pay-off and, moreover, it may have the unfavorable effect of turning Brazil's energy expansion planning a more difficult task. - Highlights: • Tight auction prices make winners exercise options to defer construction. • Investors that consider the option to abandon the project tend to win the auction. • High chances of default, when investors take abandonment options into account. • Auctioning wind farms for energy delivery 5 yr later will not foster a free market

Factors associated with recognition of the signs of dating violence by Japanese junior high school students.

Science.gov (United States)

Nagamatsu, Miyuki; Hamada, Yukiko; Hara, Kenichi

2016-01-01

This study investigated factors associated with the ability of Japanese junior high school students to recognize the signs of dating violence. During a period of 20 months (from June 2011 to January 2013), a survey was distributed to 3340 students aged 13-15 years in the second and third grades at 18 junior high schools in a Japanese prefecture. The survey examined gender, recognition of the signs of dating violence, knowledge of dating violence, self-esteem, attitudes toward sexual activity, attitudes toward an equal dating relationship, and relationships with school teachers. Multiple linear regression analyses were performed to identify predictors of the ability of boys and girls respondents to recognize the signs of physical and psychological dating violence. Binary multiple logistic regression analysis was also performed to identify predictors of the ability of boys and girls respondents to recognize the sign of sexual dating violence. The Ethics Committee of Saga University Medical School approved the study protocol. A total of 3050 (91.3%) students participated in this study (1547 boys and 1503 girls). Gender differences were noted with regard to the scores for some of the variables measured. The results indicated that boys who had more knowledge of dating violence, who focused on an equal dating relationship, and had a positive relationship with their teachers showed a greater ability to recognize the signs of dating violence. In addition, boys with a conservative attitude toward sexual activity showed a greater ability to recognize the signs of physical and sexual violence. Furthermore, girls with more knowledge of dating violence had a conservative attitude toward sexual activity, and girls who focused on an equal dating relationship showed greater ability to recognize the signs of dating violence. These findings suggest that education programs to prevent dating violence should promote understanding about dating violence with consideration of gender

Marketable pollution permits with uncertainty and transaction costs

International Nuclear Information System (INIS)

Montero, Juan-Pablo

1998-01-01

Increasing interest in the use of marketable permits for pollution control has become evident in recent years. Concern regarding their performance still remains because empirical evidence has shown transaction costs and uncertainty to be significant in past and existing marketable permits programs. In this paper we develop theoretical and numerical models that include transaction costs and uncertainty (in trade approval) to show their effects on market performance (i.e., equilibrium price of permits and trading volume) and aggregate control costs. We also show that in the presence of transaction costs and uncertainty the initial allocation of permits may not be neutral in terms of efficiency. Furthermore, using a numerical model for a hypothetical NO x trading program in which participants have discrete control technology choices, we find that aggregate control costs and the equilibrium price of permits are sensitive to the initial allocation of permits, even for constant marginal transaction costs and certainty

Radiocarbon dates for Rangitoto and Motutapu, a consideration of dating accuracy

International Nuclear Information System (INIS)

Law, R.G.

1975-01-01

The carbon dates for the eruptions of Rangitoto and the occupation of Maori sites on Motutapu contain inconsistencies which are explicable only after the dates have been corrected to allow for the nature of the dating method. The only date which is reasonably established is a 14th or 15th century dating for the ash shower covering Motutapu. (auth.)

The Effect of Attractiveness on Food Sharing Preferences in Human Mating Markets

Directory of Open Access Journals (Sweden)

Michael Stirrat

2011-01-01

Full Text Available The current study explored how physical attractiveness affects food sharing by studying payment preferences for hypothetical romantic dinner dates (a hypothetical mating market. We analyzed payment preferences, self-rated attractiveness, and rated attractiveness for hypothetical dates in 416 participants. We hypothesized that (1 men would be more likely to prefer to pay than would women, (2 attractive individuals of both sexes would be less willing to pay, and (3 preferences to enter an exchange would be influenced by the attractiveness of prospective partners such that (3a men would prefer to pay for attractive women, and (3b women would prefer to be paid for by attractive men. All hypotheses were supported by our results. Individuals with higher self-rated attractiveness were more likely to prefer that their date would pay for the meal, and we found clear sex differences in how the attractiveness of potential dates affected payment preferences. Male participants preferred to pay for dates that had higher facial attractiveness, while female participants preferred that attractive men would pay. Individuals show condition dependent financial preferences consistent with the provisioning hypothesis in this mating market that are adaptive to evaluations of their own quality and that of prospective partners.

Use of target-date funds in 401(k) plans, 2007.

Science.gov (United States)

Copeland, Craig

2009-03-01

WHAT THEY ARE: Target-date funds (also called "life-cycle" funds) are a type of mutual fund that automatically rebalances its asset allocation following a predetermined pattern over time. They typically rebalance to more conservative and income-producing assets as the participant's target date of retirement approaches. WHY THEY'RE IMPORTANT AND GROWING: Of the 401(k) plan participants in the EBRI/ICI 401(k) database who were found to be in plans that offeredtarget-date funds, 37 percent had at least some fraction of their account in target-date funds in 2007. Target-date funds held about 7 percent of total assets in 401(k) plans and the use of these funds is expected to increase in the future. The Pension Protection Act of 2006 made it easier for plan sponsors to automatically enroll new workers in a 401(k) plan, and target-date funds were one of the types of approved funds specified for a "default" investment if the participant does not elect a choice. BRI/ICI 401(K) DATABASE: This study uses the unique richness of the data in the EBRI/ICI Participant-Directed Retirement Plan Data Collection Project, which has almost 22 million participants, to examine the choices and characteristics of participants whose plans offer target-date funds. EFFECT OF AGE, SALARY, JOB TENURE, AND ACCOUNT BALANCE: Younger workers are significantly more likely to invest in target-date funds than are older workers: Almost 44 percent of participants under age 30 had assets in a target-date fund, compared with 27 percent of those 60 or older. Target-date funds appeal to those with lower incomes, little time on the job, and with few assets. On average, target-date fund investors are about 2.5 years younger than those who do not invest in target-date funds, have about 3.5 years less tenure, make about $11,000 less in salary, have $25,000 less in their account, and are in smaller plans. EFFECT OF AUTOMATIC ENROLLMENT: While the EBRI/ICI database does not contain specific information on whether

H2@Scale Resource and Market Analysis

Energy Technology Data Exchange (ETDEWEB)

Ruth, Mark

2017-07-12

This presentation overviews progress to date on the H2@Scale resource and market analysis work. The work finds, for example, that hydrogen demand of 60 MMT/yr is possible when transportation and industry are considered; resources are available to meet that demand; using renewable resources would reduce emissions and fossil use by over 15%; further impacts are possible when considering synergistic benefits; additional analysis is underway to improve understanding of potential markets and synergistic impacts; and further analysis will be necessary to estimate impacts due to spatial characteristics, feedback effects in the economy, and inertia characteristics.

Dating Violence

Science.gov (United States)

Stader, David L.

2011-01-01

Dating violence is a form of student-on-student victimization and is a serious school safety issue. Research indicates that at a minimum, 10 percent of high school students are victims of dating violence in one form or another. Among female high school students that date, some data indicate that as many as 30 percent may be victims of dating…

An analysis of legal warnings after drug approval in Thailand.

Science.gov (United States)

Sriphiromya, Pakawadee; Theeraroungchaisri, Anuchai

2015-02-01

Drug risk management has many tools for minimizing risk and black-boxed warnings (BBWs) are one of those tools. Some serious adverse drug reactions (ADRs) emerge only after a drug is marketed and used in a larger population. In Thailand, additional legal warnings after drug approval, in the form of black-boxed warnings, may be applied. Review of their characteristics can assist in the development of effective risk mitigation. This study was a cross sectional review of all legal warnings imposed in Thailand after drug approval (2003-2012). Any boxed warnings for biological products and revised warnings which were not related to safety were excluded. Nine legal warnings were evaluated. Seven related to drugs classes and two to individual drugs. The warnings involved four main types of predictable ADRs: drug-disease interactions, side effects, overdose and drug-drug interactions. The average time from first ADRs reported to legal warnings implementation was 12 years. The triggers were from both safety signals in Thailand and regulatory measures in other countries outside Thailand. Copyright © 2014 Elsevier Inc. All rights reserved.

New Brunswick Market Design Committee : First interim report

International Nuclear Information System (INIS)

2001-10-01

In June 2001, a Market Design Committee was appointed by the Government of New Brunswick tp provide some advice on the best ways to implement the electricity restructuring initiatives detailed in a White Paper on energy policy in New Brunswick. The Market Design Committee is a very technical committee that was set up with a number of goals in mind: make recommendations concerning all codes and operating protocols, make recommendations on market surveillance and the establishment of a workable competitive market, take into account the reliability of supply for New Brunswick, address ways by which to avoid rate shock to existing self-generators, make recommendations for mitigation of market power in the wholesale and large retail markets, evaluate methods of stranded cost recovery, make recommendations on the requirement for reciprocity in New Brunswick electricity market design, and review the role and treatment of small-scale, on-site electricity generation and make recommendations. The final recommendations are set to be presented in April 2002. This document details the progress realized to date and outlines the plans made for the subsequent phases of the work. The different topics discussed in this document each form the basis for one section of the report. They are: market design committee constitution and process, basic market model, market power issues, transmission issues, environment and renewables, and next steps for the market design committee

A CDO option market model on standardized CDS index tranches

DEFF Research Database (Denmark)

Dorn, Jochen

We provide a market model which implies a dynamic for standardized CDS index tranche spreads. This model is useful for pricing options on tranches with future Issue Dates as well as for modeling emerging options on struc- tured credit derivatives. With the upcoming regulation of the CDS market...... in perspective, the model presented here is also an attempt to face the e ects on pricing approaches provoked by an eventual Clearing Chamber . It becomes also possible to calibrate Index Tranche Options with bespoke tenors/tranche subordination to market data obtained by more liquid Index Tranche Options...

Chronic Disease Prevalence and Medicare Advantage Market Penetration

Science.gov (United States)

Bernell, Stephanie Lazarus; Casim, Faizan M.; Wilmott, Jennifer; Pearson, Lindsey; Byler, Caitlin M.; Zhang, Zidong

2015-01-01

By March 2015, 30% of all Medicare beneficiaries were enrolled in Medicare Advantage (MA) plans. Research to date has not explored the impacts of MA market penetration on individual or population health outcomes. The primary objective of this study is to examine the relationships between MA market penetration and the beneficiary’s portfolio of cardiometabolic diagnoses. This study uses 2004 to 2008 Medical Expenditure Panel Survey (MEPS) Household Component data to construct an aggregate index that captures multiple diagnoses in one outcome measure (Chronic Disease Severity Index [CDSI]). The MEPS data for 8089 Medicare beneficiaries are merged with MA market penetration data from Centers for Medicare and Medicaid Services (CMS). Ordinary least squares regressions are run with SAS 9.3 to model the effects of MA market penetration on CDSI. The results suggest that each percentage increase in MA market penetration is associated with a greater than 2-point decline in CDSI (lower burden of cardiometabolic chronic disease). Spill-over effects may be driving improvements in the cardiometabolic health of beneficiary populations in counties with elevated levels of MA market penetration. PMID:28462266

Blending traditional and digital marketing

Directory of Open Access Journals (Sweden)

Raluca Dania TODOR

2016-07-01

Full Text Available It is a matter of fact that we are in the digital era and internet marketing and social media have a significant impact on the way consumers behave, companies do business and it is a must for companies to adapt to the new reality. Due to the fast evolution of the technology, the continuous increase in demand and supply, the supply chain elongation and the big amount of date, the only solution to face the major changes is the automation of all the processes. But even though the new era of communication is here, specialist suggest that companies should not ignore traditional methods, and to try to blend digital marketing with traditional campaigns in order to achieve their goals.

Luminescence dating

International Nuclear Information System (INIS)

Rieser, U.

2013-01-01

The luminescence techniques have evolved over the last 40 years to a powerful dating instrument in archaeology and geoscience. Depending on how the luminescence is stimulated, one distinguishes the phenomena of thermoluminescence (TL), optically stimulated luminescence (OSL) and infrared stimulated luminescence (IRSL). Each of these phenomena has its specific potential for dating various archaeological materials in the time range from medieval back to palaeolithic periods, or, speaking in geological terms, for dating of Holocene and late Pleistocene objects. The OSL and IRSL techniques are sometimes treated together as 'optical dating'. The luminescence techniques differ from other major dating techniques, such as 14 C, essentially by their applicability to inorganic materials, their wide age-range from about 100 years to more than 100,000 years and the kind of datable events which are the last exposure to heat or to light. (author). 10 refs., 3 figs.

Luminescence dating

International Nuclear Information System (INIS)

Rieser, U.

2009-01-01

The luminescence techniques have evolved over the last 40 years to a powerful dating instrument in archaeology and geoscience. Depending on how the luminescence is stimulated, one distinguishes the phenomena of thermoluminescence (TL), optically stimulated luminescence (OSL) and infrared stimulated luminescence (IRSL). Each of these phenomena has its specific potential for dating various archaeological materals in the time range from medieval back to palaeolithic periods, or, speaking in geological terms, for dating of Holocene and late Pleistocene objects. The OSL and IRSL techniques are sometimes treated together as 'optical dating'. The luminescence techniques differ from other major dating techniques, such as 14 C, essentially by their applicability to inorganic materials, their wide age-range from about 100 years to more than 100,000 years and the kind of datable events which are the last exposure to heat or to light. (author). 10 refs., 3 figs.

Luminescence dating

International Nuclear Information System (INIS)

Rieser, U.

2008-01-01

The luminescence techniques have evolved over the last 40 years to a powerful dating instrument in archaeology and geoscience. Depending on how the luminescence is stimulated, one distinguishes the phenomena of thermoluminescence (TL), optically stimulated luminescence (OSL) and infrared stimulated luminescence (IRSL). Each of these phenomena has its specific potential for dating various archaeological materals in the time range from medieval back to palaeolithic periods, or, speaking in geological terms, for dating of Holocene and late Pleistocene objects. The OSL and IRSL techniques are sometimes treated together as 'optical dating'. The luminescence techniques differ from other major dating techniques, such as 14 C, essentially by their applicability to inorganic materials, their wide age-range from about 100 years to more than 100,000 years and the kind of datable events which are the last exposure to heat or to light. (author). 10 refs., 3 figs

Luminescence dating

International Nuclear Information System (INIS)

Rieser, U.

2012-01-01

The luminescence techniques have evolved over the last 40 years to a powerful dating instrument in archaeology and geoscience. Depending on how the luminescence is stimulated, one distinguishes the phenomena of thermoluminescence (TL), optically stimulated luminescence (OSL) and infrared stimulated luminescence (IRSL). Each of these phenomena has its specific potential for dating various archaeological materials in the time range from medieval back to palaeolithic periods, or, speaking in geological terms, for dating of Holocene and late Pleistocene objects. The OSL and IRSL techniques are sometimes treated together as 'optical dating'. The luminescence techniques differ from other major dating techniques, such as 14 C, essentially by their applicability to inorganic materials, their wide age-range from about 100 years to more than 100,000 years and the kind of datable events which are the last exposure to heat or to light. (author). 10 refs., 3 figs.

Luminescence dating

International Nuclear Information System (INIS)

Rieser, U.

2009-01-01

The luminescence techniques have evolved over the last 40 years to a powerful dating instrument in archaeology and geoscience. Depending on how the luminescence is stimulated, one distinguishes the phenomena of thermoluminescence (TL), optically stimulated luminescence (OSL) and infrared stimulated luminescence (IRSL). Each of these phenomena has its specific potential for dating various archaeological materals in the time range from medieval back to palaeolithic periods, or, speaking in geological terms, for dating of Holocene and late Pleistocene objects. The OSL and IRSL techniques are sometimes treated together as 'optical dating'. The luminescence techniques differ from other major dating techniques, such as 14 C, essentially by their applicability to inorganic materials, their wide age-range from about 100 years to more than 100,000 years and the kind of datable events which are the last exposure to heat or to light. (author). 10 refs., 3 figs

Irradiation of dates

International Nuclear Information System (INIS)

Farkas, J.; Al-Charchafchy, F.; Al-Shaikhaly, M.H.; Mirjan, J.; Auda, H.

1974-01-01

Testing of the technical feasibility of radurization of fresh dates was attempted. In addition preliminary studies were carried out to investigate the applicability of gamma rays to date syrup manufacture. The varieties Zahdi, Lelwi and Tabarzel were studied at different stages of ripening. The eating quality of fresh dates was not affected significantly by irradiation even with doses of 270 and 540 krad. The duration of the softening process, after-ripening, of dates was prolonged by low doses of 10-30 krad in the majority of the experimental batches. The time period of after-ripening was reduced with 270 krad, as well as with 540 krad as a result of shortening of the induction period, i.e. the time after which the date begins to soften. The microbial spoilage of khalaal Lelwi dates was considerably reduced by irradiation with doses above 90 krad. The dibis yield of fully rutab dates was highly increased by the radiation doses of 375 to 2000 krad. The darkness and viable cell count of dibis pressed from irradiated dates were significantly lower than that of untreated dates. (F.J.)

A snapshot of the European energy service market in 2010 and policy recommendations to foster a further market development

International Nuclear Information System (INIS)

Marino, Angelica; Bertoldi, Paolo; Rezessy, Silvia; Boza-Kiss, Benigna

2011-01-01

As of 2010, the energy service market in Europe is still far from utilising its full potential. Wide-scale peer-reviewed studies investigating the development and up-to-date status of the European ESCo market are scarce. This article presents a comprehensive insight of the European ESCo industry based on the results from a large-scale survey carried out 2009-2010 in 39 European countries. The observed market development during the period 2007-2010, trends in business practices, and factors influencing the ESCo industry evolution are described. Finally, having considered the remaining barriers and the supporting factors as well as the successful experiences in Europe, policy measures that could further promote ESCo activities are proposed. - Highlights: → ESCo markets in Europe continue to show diverse stages of development. → Between 2007 and 2010 the European ESCo market underwent a slow growth. → European states have introduced favourable legislative framework for energy conservation. → Loan guarantees recognising the ESCo contractual model increase the access to finance. → Establishment of quality standards and certification schemes for ESCos are essential.

Substitution of Sugar with Dates Powder and Dates Syrup in Cookies Making

OpenAIRE

W.A. Alsenaien; R.A. Alamer; Zhen-Xing Tang; S.A. Albahrani; M.A. Al-Ghannam; S.M. Aleid

2015-01-01

In this study, the effects of dates powder and dates syrup as a sugar substitution, on the physical properties and sensory attributes of cookies were studied. An increase in firmness and moisture content of cookies supplemented with dates was obtained. The diameter and spread ratio of cookies showed a decrease with increasing levels of date powder or date syrup. Partial replacement of sugar with date powder or date syrup produced cookies with more dark and red color. Sensory evaluation result...

75 FR 4692 - Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole, Polymixin B, and Prednisolone...

Science.gov (United States)

2010-01-29

... nitrate, polymixin B sulfate, and prednisolone acetate for the treatment of otitis externa in dogs. DATES... SUROLAN (miconazole nitrate, polymixin B sulfate, and prednisolone acetate) Otic Suspension in dogs for... Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity...

Redfield Energy Approval

Science.gov (United States)

This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-This October 27, 2016 letter from EPA approves the petition from Redfield Energy, LLC, regarding non-grandfathered ethanol produced

Directory of certificates of compliance for radioactive materials packages. Volume 3, revision 1. Summary report of NRC approved quality assurance programs for radioactive material packages

International Nuclear Information System (INIS)

1981-12-01

The directory contains a Summary Report of NRC approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the U.S. Nuclear Regulatory Commission. To assist in identifying packaging, and index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory

Some design lessons from market-based greenhouse gas regulation in the restructured Australian electricity industry

International Nuclear Information System (INIS)

MacGill, Iain; Outhred, Hugh; Nolles, Karel

2006-01-01

There is growing worldwide interest in the use of market-based policy instruments for climate change regulation in the electricity sector. These mechanisms would seem to offer some efficiency and flexibility advantages over more traditional regulatory approaches, while being highly compatible with competitive market-based electricity industries. Australia has been an early and enthusiastic adopter of both electricity industry restructuring and market-based environmental instruments. This paper first outlines some of these recent policy developments. In particular, we describe the objectives, design and outcomes to date of electricity industry restructuring, the Mandatory Renewable Energy Target, the NSW Greenhouse Benchmarks, the Queensland 13% Gas scheme and Government accredited Green Power. From this, we draw some key design lessons for such market-based instruments. These include the perils of abstraction in scheme design, the vital importance of setting appropriate baselines in 'baseline and credit' schemes, the possibility that such measures may interact in ways that reduce their environmental effectiveness, 'market for lemon' risks with tradable instruments that have measurement, verification or 'additionality' difficulties, and the challenges of creating transparent liquid markets for these mechanisms. The mixed performance of these Australian schemes to date illustrates the need for great care in designing such market-based approaches

Some design lessons from market-based greenhouse gas regulation in the restructured Australian electricity industry

Energy Technology Data Exchange (ETDEWEB)

MacGill, Iain [School of Electrical Engineering and Telecommunications, University of New South Wales, Sydney NSW 2052 (Australia)] e-mail: i.macgill@unsw.edu.au; Outhred, Hugh [School of Electrical Engineering and Telecommunications, University of New South Wales, Sydney NSW 2052 (Australia); Nolles, Karel [School of Electrical Engineering and Telecommunications, University of New South Wales, Sydney NSW 2052 (Australia)

2006-01-01

There is growing worldwide interest in the use of market-based policy instruments for climate change regulation in the electricity sector. These mechanisms would seem to offer some efficiency and flexibility advantages over more traditional regulatory approaches, while being highly compatible with competitive market-based electricity industries. Australia has been an early and enthusiastic adopter of both electricity industry restructuring and market-based environmental instruments. This paper first outlines some of these recent policy developments. In particular, we describe the objectives, design and outcomes to date of electricity industry restructuring, the Mandatory Renewable Energy Target, the NSW Greenhouse Benchmarks, the Queensland 13% Gas scheme and Government accredited Green Power. From this, we draw some key design lessons for such market-based instruments. These include the perils of abstraction in scheme design, the vital importance of setting appropriate baselines in 'baseline and credit' schemes, the possibility that such measures may interact in ways that reduce their environmental effectiveness, 'market for lemon' risks with tradable instruments that have measurement, verification or 'additionality' difficulties, and the challenges of creating transparent liquid markets for these mechanisms. The mixed performance of these Australian schemes to date illustrates the need for great care in designing such market-based approaches.

Some design lessons from market-based greenhouse gas regulation in the restructured Australian electricity industry

Energy Technology Data Exchange (ETDEWEB)

Iain MacGill; Hugh Outhred; Karel Nolles [University of New South Wales, Sydney, NSW (Australia). School of Electrical Engineering & Telecommunications

2006-01-01

There is growing worldwide interest in the use of market-based policy instruments for climate change regulation in the electricity sector. These mechanisms would seem to offer some efficiency and flexibility advantages over more traditional regulatory approaches, while being highly compatible with competitive market-based electricity industries. Australia has been an early and enthusiastic adopter of both electricity industry restructuring and market-based environmental instruments. This paper first outlines some of these recent policy developments. It then describes the objectives, design and outcomes to date of electricity industry restructuring, the Mandatory Renewable Energy Target, the NSW Greenhouse Benchmarks, the Queensland 13% Gas scheme and Government accredited Green Power. From this, some key design lessons are drawn for such market-based instruments. These include the perils of abstraction in scheme design, the vital importance of setting appropriate baselines in 'baseline and credit' schemes, the possibility that such measures may interact in ways that reduce their environmental effectiveness, 'market for lemon' risks with tradable instruments that have measurement, verification or 'additionality' difficulties, and the challenges of creating transparent liquid markets for these mechanisms. The mixed performance of these Australian schemes to date illustrates the need for great care in designing such market-based approaches. 36 refs., 2 figs.

Competitive Market Analysis of Transplant Centers and Discrepancy of Wait-Listing of Recipients for Kidney Transplantation

OpenAIRE

Cho, P. S.; Saidi, R. F.; Cutie, C. J.; Ko, D. S. C.

2015-01-01

Background: There are over 250 kidney transplant programs in the USA. Objective: To determine if highly competitive regions, defined as regions with a higher number of transplant centers, will approve and wait-list more end-stage renal disease (ESRD) candidates for transplant despite consistent incidence and prevalence of ESRD nationwide. Methods: ESRD Network and OPTN data completed in 2011 were obtained from all transplant centers including listing data, market saturation, market share, org...

Synthesis of the report on the french gas market opening 24 october 2002

International Nuclear Information System (INIS)

Syrota, J.

2002-10-01

This document takes stock on the french gas market opening since august 2000, date of putting into force of the Directive 98/30/CE and proposes recommendations, after taking concerned parties opinion, on the the main questions relative to the future gas regulation: the market, the european harmonization, the tariffs, the distribution access, the transparency. (A.L.B.)

Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

Science.gov (United States)

Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

2017-01-01

The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Customer choice and green power marketing in the United States: how far can it take us?

International Nuclear Information System (INIS)

Wiser, Ryan; Bolinger, Mark; Holt, Edward

2000-01-01

This article explores whether and to what extent individuals are willing to voluntarily pay a premium for products that provide public environmental benefits. In particular, we critically review and analyze the status and impacts of U.S. green power marketing to date. Green power marketing - the business of selling electricity products distinguished by their environmental attributes - seeks to develop a private market for renewable energy driven by consumer demand for green products. Debate has centered on the ability of such a market to provide a significant level of support for renewable energy sources. This paper examines experience to date with green power markets in the United States, proving an historical overview, reviewing product offerings, assessing customer response, and calculating overall support for renewable energy. While market research shows that a majority of the populace states a willingness to pay a premium for renewable energy, early experience with green power marketing shows that those attitudes have not yet translated into large-scale behavior change, tracking experience in other environment product markets. While a niche market for green power does exist, the data presented in this paper indicate that the collective impact of customer-driven demand on renewable generation has been modest thus far. Much will need to be done if this market is to play a strong role in supporting renewable energy in the early part of the millennium. Several lessons on how to potentially improve the prospects of green power marketing are therefore discussed. (author)

New drugs: evidence relating to their therapeutic value after introduction to the market.

Science.gov (United States)

Ujeyl, Mariam; Schlegel, Claudia; Walter, Siegbert; Gundert-Remy, Ursula

2012-02-01

Drug approval is based on three criteria: quality, efficacy, and safety. We investigated the types of study design and statistical methods employed to demonstrate safety and efficacy of proprietary medicinal products (PMPs) that were approved for use in the European Union through the centralized procedure. We retrospectively analyzed the European Public Assessment Reports of PMPs that the European Medicinal Agency approved, either initially or for extended indications, in 2009 and 2010. Data were analyzed for 39 PMPs: 64% of these were new active substances, and 36% were approved for extended indications. 46% of the PMPs had been studied in an active-control trial. In only 28%, superiority of the new PMPs compared to active control had been tested. 46% of the approvals included testing of a patient-relevant primary endpoint. The median size of population used to demonstrate safety was 1700 persons. The centralized procedure does not require comparative information from active-control trials. Accordingly, as our descriptive analysis revealed, this information is often not available at the time of market introduction. Pivotal studies only rarely clearly demonstrate an added therapeutic value of a new PMP compared to existing alternatives.

76 FR 56362 - Removal of Approved Non-U.S.-Licensed Space Stations From the Section 214 Exclusion List

Science.gov (United States)

2011-09-13

...'s web page, the Bureau plans to insert a link entitled Space Stations Approved for U.S. Market Access. Once users click on that link, they will be taken to a page with that same title that provides... pursuant to the DISCO II procedures. The web page will include links to other lists already maintained for...

76 FR 66211 - Enhancement of Electricity Market Surveillance and Analysis Through Ongoing Electronic Delivery...

Science.gov (United States)

2011-10-26

... later, in Order No. 2000,\\12\\ the Commission encouraged the voluntary formation of RTOs to administer the transmission grid on a regional basis. To date, the Commission has approved six RTOs and ISOs: PJM... Operator Corporation (CAISO); and Southwest Power Pool, Inc. (SPP). Together, these six RTOs and ISOs serve...

30 CFR 18.95 - Approval of machines constructed of components approved, accepted or certified under Bureau of...

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of machines constructed of components... APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.95 Approval of machines constructed of components approved...

A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus.

Science.gov (United States)

Ekins, Sean; Freundlich, Joel S; Coffee, Megan

2014-01-01

We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.

78 FR 18393 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Order Granting Approval of a Proposed...

Science.gov (United States)

2013-03-26

... Financial and Quantitative Analysis, Vol. 44, 1427-1457 (2009) (``Weaver Study''); H. Bessembinder, J. Hao.... Venkataraman & A. Waisburd, ``The Value of the Designated Market Maker'' Journal of Financial and Quantitative... Value of the Specialist: Empirical Evidence from the CBOE'' Journal of Financial Markets, Vol. 9, no. 2...

No longer "if," but "when": the coming abbreviated approval pathway for follow-on biologics.

Science.gov (United States)

Kelly, Jeremiah J; David, Michael

2009-01-01

Abbreviated approval of follow-on biologics involves answering complex scientific, legal, and policy questions. The Food and Drug Administration (FDA or the Agency) asserts that it lacks the statutory authority to approve follow-on versions of biologics licensed under Section 351 of the Public Health Service Act (PHSA). Despite persuasive arguments to the contrary the one hundred and tenth Congress entertained four legislative proposals to give FDA this authority, each markedly different. It is no longer a question of "if," but "when" FDA will receive authority to review and license abbreviated applications for follow-on biologics. Any legislation in the one hundred and eleventh Congress must determine: (1) if FDA should be granted authority to develop an abbreviated pathway through rulemaking or guidance; (2) if human clinical trials should be mandatory or discretionary; (3) the feasibility of interchangeability determinations in light of patient safety concerns; (4) the duration of marketing exclusivity for associated products; (5) which products are eligible for follow-on approval; and (6) the degree to which uniformity is achievable between the FD&C Act and the PHSA. This paper recommends the one hundred and eleventh Congress strike a balance between patient safety, incentives for product innovation, price competition, and the need for a flexible, transparent process that capitalizes on FDA's growing expertise with follow-on biologics approvals under Section 505(b)(2) of the FD&C Act.

Fundamentals unknown : momentum, mean-reversion and price-to-earnings trading in an artificial stock market

NARCIS (Netherlands)

Schasfoort, Joeri; Stockermans, Christopher

2017-01-01

The use of fundamentalist traders in the stock market models is problematic since fundamental values in the real world are unknown. Yet, in the literature to date, fundamentalists are often required to replicate key stylized facts. The authors present an agent-based model of the stock market in

Teen Dating Violence

Science.gov (United States)

... Room Social Media Publications Injury Center Teen Dating Violence Recommend on Facebook Tweet Share Compartir On This ... serious forms of violence. What is teen dating violence? Teen Dating Violence [550 KB, 2 Pages, 508] ...

26 CFR 1.664-4 - Calculation of the fair market value of the remainder interest in a charitable remainder unitrust.

Science.gov (United States)

2010-04-01

... by multiplying the net fair market value (as of the appropriate valuation date) of the property... valuation date is, in the case of an inter vivos transfer, the date on which the property is transferred to... rate in the case of transfers for which the valuation date is after April 30, 1989, or 10 percent in...

Lessons for public health campaigns from analysing commercial food marketing success factors

DEFF Research Database (Denmark)

Aschemann-Witzel, Jessica; JA Perez-Cueto, Federico; Niedzwiedzka, Barbara

2012-01-01

Background: Commercial food marketing has considerably shaped consumer food choice behaviour. Meanwhile, public health campaigns for healthier eating have had limited impact to date. Social marketing suggests that successful commercial food marketing campaigns can provide useful lessons for public...... sector activities. The aim of the present study was to empirically identify food marketing success factors that, using the social marketing approach, could help improve public health campaigns to promote healthy eating. Methods: In this case-study analysis, 27 recent and successful commercial food...... in the communication related to the food. Visual as well as written material was gathered, complemented by semi-structured interviews with 12 food market trend experts and 19 representatives of food companies and advertising agencies. Success factors were identified by a group of experts who reached consensus through...

Church Schools, Educational Markets and the Rural Idyll

Science.gov (United States)

Hemming, Peter J.; Roberts, Christopher

2018-01-01

Researchers have begun to explore the role that faith schools play in contemporary educational markets but the emphasis to date has been on urban rather than rural contexts. This article approaches the issue of marketisation through a qualitative case-study comparison of two Anglican primary schools in contrasting rural localities in England and…

Promotion as a Tool in Sustaining the Destination Marketing Activities

Directory of Open Access Journals (Sweden)

Ivo Mulec

2010-01-01

Full Text Available Promoting the tourism destination in the right and best possible way is today one of vital marketing activities of all Destination Management Organizations. Only successful promotion can entice and attract potential travelers to visit the destination. The number of new destinations is increasing every year and some of them are quite similar. Market segmentation is one of the starting points for devising marketing strategy. Only by presenting the destination to the right segment of potential clients in the right way will a destination maximize the effectiveness of its marketing and promotion. Tourism destination marketers will continue to face considerable challenges in the future: they will have to take account of the needs, wants and expectations of more mature and knowledgeable customers, and the corresponding need for more up-to-date and reliable information upon which to base decision-making. In the future only marketing which includes collaborative dimensions will meet its objectives fully.

Modelling short and long-term risks in power markets: Empirical evidence from Nord Pool

International Nuclear Information System (INIS)

Nomikos, Nikos K.; Soldatos, Orestes A.

2010-01-01

In this paper we propose a three-factor spike model that accounts for different speeds of mean reversion between normal and spiky shocks in the Scandinavian power market. In this model both short and long-run factors are unobservable and are hence estimated as latent variables using the Kalman filter. The proposed model has several advantages. First, it seems to capture in a parsimonious way the most important risks that practitioners face in the market, such as spike risk, short-term risk and long-term risk. Second, it explains the seasonal risk premium observed in the market and improves the fit between theoretical and observed forward prices, particularly for long-dated forward contracts. Finally, closed-form solutions for forward contracts, derived from the model, are consistent with the fact that the correlation between contracts of different maturities is imperfect. The resulting model is very promising, providing a very useful policy analysis and financial engineering tool to market participants for risk management and derivative pricing particularly for long-dated contracts.

Biosimilars approval process.

Science.gov (United States)

Zuñiga, Leyre; Calvo, Begoña

2010-04-01

For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier. Copyright 2009 Elsevier Inc. All rights reserved.

Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances ('legal highs') in New Zealand.

Science.gov (United States)

Rychert, Marta; Wilkins, Chris; Witten, Karen

2017-09-01

New Zealand's Psychoactive Substances Act (2013) established the world's first regulated market for 'low risk' psychoactive products ('legal highs'). Under an interim PSA regime, 47 existing products were permitted to be continued to be sold. To explore issues with the implementation of regulatory systems to monitor the safety of products on the legal market under the interim Psychoactive Substances Act regime. Semi-structured interviews with 30 key stakeholders, including industry, government agency, health and drug service professionals were conducted, transcribed and analysed thematically. In retrospect stakeholders questioned the decision to approve strong synthetic cannabinoid smoking products, noting their health risks because of product formulation, inconsistent manufacturing practices and smoking as the means of administration. Industry actors claimed the decision to approve synthetic cannabinoid smokeable products prevented potentially safer products from gaining market share. The system for withdrawing approved products which were subsequently found to be harmful was criticised for the poor quality of data available, limited engagement with health professionals and the slowness of product withdrawal. Many of the problems with the regime were attributed to the urgency under which the legal market under the interim Psychoactive Substances Act was established and implemented. The selection of 'safer' products, implementation of the product monitoring system, and engagement with health professionals may have benefited from more time and resources. An incremental approach to establishing the new market may have made the regulatory management of the new regime more workable. [Rychert M, Wilkins C, Witten K. Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances ('legal highs') in New Zealand. Drug Alcohol Rev 2017;00:000-000]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

76 FR 24082 - Notice With Respect to List of Countries Denying Fair Market Opportunities for Government-Funded...

Science.gov (United States)

2011-04-29

..., suppliers, or bidders in foreign government-funded airport construction projects. DATES: Effective Date... to U.S. products, suppliers, or bidders in connection with airport construction projects of $500,000... Fair Market Opportunities for Government-Funded Airport Construction Projects AGENCY: Office of the...

77 FR 23791 - Notice With Respect to List of Countries Denying Fair Market Opportunities for Government-Funded...

Science.gov (United States)

2012-04-20

..., suppliers, or bidders in foreign government-funded airport construction projects. DATES: Effective Date... to U.S. products, suppliers, or bidders in connection with airport construction projects of $500,000... Fair Market Opportunities for Government-Funded Airport Construction Projects AGENCY: Office of the...

Drugs Approved for Breast Cancer

Science.gov (United States)

... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Raloxifene Hydrochloride Tamoxifen Citrate Drugs ...

Retail gas markets - a case of regulated deregulation?

International Nuclear Information System (INIS)

Wood, T.

2001-01-01

While much has been said recently on the introduction of full retail contestability in Australia's gas markets, the process is far from over. The General Manager (Retail) with Origin Energy-and a new addition to the Australian Gas Association Board-provides an overview of the process to date, and how it might progress in the future. He concluded that in Australia, the retail gas market is relatively small and the processes initiated to achieve full retail competition are still largely fragmented across jurisdictions. These factors have potential to generate costs which could severely dent, if not exceed the anticipated benefit of competition

2016 Offshore Wind Technologies Market Report

Energy Technology Data Exchange (ETDEWEB)

Musial, Walter; Beiter, Philipp; Schwabe, Paul; Tian, Tian; Stehly, Tyler; Spitsen, Paul; Robertson, Amy; Gevorgian, Vahan

2017-08-08

The 2016 Offshore Wind Technologies Market Report was developed by the National Renewable Energy Laboratory (NREL) for the U.S. Department of Energy (DOE) and is intended to provide offshore wind policymakers, regulators, developers, researchers, engineers, financiers, and supply chain participants, with quantitative information about the offshore wind market, technology, and cost trends in the United States and worldwide. In particular, this report is intended to provide detailed information on the domestic offshore wind industry to provide context to help navigate technical and market barriers and opportunities. The scope of the report covers the status of the 111 operating offshore wind projects in the global fleet through December 31, 2016, and provides the status and analysis on a broader pipeline of 593 projects at some stage of development. In addition, this report provides a wider assessment of domestic developments and events through the second quarter of 2017 to provide a more up-to-date discussion of this dynamically evolving industry.

THE ROLE OF MARKETING AND BRAND IN BANKING

Directory of Open Access Journals (Sweden)

Svetlana Vukotić

2015-10-01

Full Text Available One of the key tasks for modern banks is finding ways and methods for creating sustainable competition advantage in increasingly competitive financial markets. The role of marketing within this task is beyond doubt, especially in bank services quality area. The quality is reached through putting clients in the epicentre and by giving them special treatment. Marketing has been a little slow in taking part in this financial, that is, banking area. This lag is being made up for by more personal attitudes to clients. Information technology application made this way of functioning easier, it created a data base which included some important personal dates in clients’ lives. The ambition to be different is closely connected to brand creation. Once it has been determined what makes a brand, it is necessary to express it through marketing activities. This very relation is the foundation for marketing and brand relationship. These are the main topics of this paper about banking sector specific points. Brands offer rational as well as emotional benefit. It will be even more stressed in the future.

Post-market monitoring: legal framework in Brazil and first results

OpenAIRE

Marcia A. Melo; Ederson A. Kido; Paulo P. Andrade

2010-01-01

Brazil is presently (2010) the second largest producer of Genetically Modified (GM) crops. The legal framework to support both research activities and the commercial release of Genetically Modified Organisms (GMOs) is, however, very recent, as the Biosafety Law dates back from 2005. After the indispensable risk analysis, done by National Technical Committee for Biosafety (CTNBio), a GM plant can be approved for commercial release. Nevertheless, as stated in the Normative Resolution nr. 5 (NR-...

Chronic Disease Prevalence and Medicare Advantage Market Penetration

Directory of Open Access Journals (Sweden)

Steven W. Howard

2015-10-01

Full Text Available By March 2015, 30% of all Medicare beneficiaries were enrolled in Medicare Advantage (MA plans. Research to date has not explored the impacts of MA market penetration on individual or population health outcomes. The primary objective of this study is to examine the relationships between MA market penetration and the beneficiary’s portfolio of cardiometabolic diagnoses. This study uses 2004 to 2008 Medical Expenditure Panel Survey (MEPS Household Component data to construct an aggregate index that captures multiple diagnoses in one outcome measure (Chronic Disease Severity Index [CDSI]. The MEPS data for 8089 Medicare beneficiaries are merged with MA market penetration data from Centers for Medicare and Medicaid Services (CMS. Ordinary least squares regressions are run with SAS 9.3 to model the effects of MA market penetration on CDSI. The results suggest that each percentage increase in MA market penetration is associated with a greater than 2-point decline in CDSI (lower burden of cardiometabolic chronic disease. Spill-over effects may be driving improvements in the cardiometabolic health of beneficiary populations in counties with elevated levels of MA market penetration.

Drugs Approved for Thyroid Cancer

Science.gov (United States)

... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

The market of the activities bound to the wastes situation 2002-2003 and perspectives 2004; Le marche des activites liees aux dechets situation 2002-2003 et perspectives 2004

Energy Technology Data Exchange (ETDEWEB)

NONE

2003-12-01

This study presents the different activities bound to the wastes, evaluates the economical stakes, the short-dated development perspectives, identifies the new markets and analyzes the regulations impact on the short-dated markets. It concerns the non hazardous and hazardous wastes. (A.L.B.)

Electricity market design for facilitating the integration of wind energy. Experience and prospects with the Australian National Electricity Market

International Nuclear Information System (INIS)

MacGill, Iain

2010-01-01

Australia has been an early and enthusiastic adopter of both electricity industry restructuring and market-based environmental regulation. The Australian National Electricity Market (NEM) was established in 1999 and Australia also implemented one of the world's first renewable energy target schemes in 2001. With significant recent growth in wind generation, Australia provides an interesting case for assessing different approaches to facilitating wind integration into the electricity industry. Wind project developers in Australia must assess both potential energy market and Tradeable Green Certificate income streams when making investments. Wind-farm energy income depends on the match of its uncertain time varying output with the regional half hourly market price; a price that exhibits daily, weekly and seasonal patterns and considerable uncertainty. Such price signals assist in driving investments that maximize project value to the electricity industry as a whole, including integration costs and benefits for other participants. Recent NEM rule changes will formally integrate wind generation in the market's scheduling processes while a centralized wind forecasting system has also been introduced. This paper outlines experience to date with wind integration in the NEM, describes the evolution of market rules in response and assesses their possible implications for facilitating high future wind penetrations. (author)

Bullying Predicts Reported Dating Violence and Observed Qualities in Adolescent Dating Relationships.

Science.gov (United States)

Ellis, Wendy E; Wolfe, David A

2015-10-01

The relationship between reported bullying, reported dating violence, and dating relationship quality measured through couple observations was examined. Given past research demonstrating similarity between peer and dating contexts, we expected that bullying would predict negative dating experiences. Participants with dating experience (n = 585; 238 males, M(age) = 15.06) completed self-report assessments of bullying and dating violence perpetration and victimization. One month later, 44 opposite-sex dyads (M(age) = 15.19) participated in behavioral observations. In 10-min sessions, couples were asked to rank and discuss areas of relationship conflict while being video-recorded. Qualities of the relationship were later coded by trained observers. Regression analysis revealed that bullying positively predicted dating violence perpetration and victimization. Self-reported bullying also predicted observations of lower relationship support and higher withdrawal. Age and gender interactions further qualified these findings. The bullying of boys, but not girls, was significantly related to dating violence perpetration. Age interactions showed that bullying was positively predictive of dating violence perpetration and victimization for older, but not younger adolescents. Positive affect was also negatively predicted by bullying, but only for girls. These findings add to the growing body of evidence that adolescents carry forward strategies learned in the peer context to their dating relationships. © The Author(s) 2014.