25 CFR 1001.4 - Application review and approval.

Science.gov (United States)

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false Application review and approval. 1001.4 Section 1001.4 Indians OFFICE OF THE ASSISTANT SECRETARY, INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR SELF-GOVERNANCE... package and determine whether or not it is complete. Upon determination that it is complete, the name of...

Studies of blood irradiator application

International Nuclear Information System (INIS)

Li Wenhong; Lu Yangqiao

2004-01-01

Transfusion is an important means for medical treatment, but it has many syndromes such as transfusion-associated graft-versus-host disease, it's occurrence rate of 5% and above 90% death-rate. Now many experts think the only proven method is using blood irradiator to prevent this disease. It can make lymphocyte of blood product inactive, so that it can not attack human body. Therefore, using irradiation blood is a trend, and blood irradiator may play an important role in medical field. This article summarized study of blood irradiator application, including the meaning of blood irradiation, selection of the dose for blood irradiation and so on

49 CFR 107.709 - Processing of an application for approval, including an application for renewal or modification.

Science.gov (United States)

2010-10-01

... TRANSPORTATION HAZARDOUS MATERIALS AND OIL TRANSPORTATION HAZARDOUS MATERIALS PROGRAM PROCEDURES Approvals... before the disposition of an application. (b) At any time during the processing of an application, the...

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...

12 CFR 211.24 - Approval of offices of foreign banks; procedures for applications; standards for approval...

Science.gov (United States)

2010-01-01

... combat money laundering. The Board also may take into account whether the home country supervisor is developing a legal regime to address money laundering or is participating in multilateral efforts to combat money laundering. In approving an application under this paragraph (c)(1)(iii), the Board, after...

[Smartphone application for blood gas interpretation].

Science.gov (United States)

Obiols, Julien; Bardo, Pascale; Garnier, Jean-Pierre; Brouard, Benoît

2013-01-01

Ninety four per cent of health professionals use their smartphone for business purposes and more than 50% has medical applications. The «Blood Gas» application was created to be part of this dynamic and participate to e-health development in France. The «Blood Gas» application facilitates interpretation of the results of blood gas analysis using an algorithm developed with reference to a medical bibliography. It can detect some complex or intricate acid-base disorders in evaluating the effectiveness of the secondary response. The application also studied the respiratory status of the patient by calculating the PaO2/FiO2 ratio and the alveol-arterial gradient. It also indicates the presence of a shunt effect. Finally, a specific module to calculate the SID (strong ion difference) depending on the model of Stewart can detect complex acid-base disorders.

30 CFR 285.913 - What happens if I fail to comply with my approved decommissioning application?

Science.gov (United States)

2010-07-01

... approved decommissioning application? 285.913 Section 285.913 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER CONTINENTAL SHELF Decommissioning Compliance with An Approved Decommissioning Application § 285.913 What...

21 CFR 515.21 - Refusal to approve a medicated feed mill license application.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Refusal to approve a medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.21 Refusal to approve a medicated feed mill license application. (a) The...

75 FR 70363 - Minden Bancorp, Inc., Minden, LA; Approval of Conversion Application

Science.gov (United States)

2010-11-17

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-53: OTS No. H-4756] Minden Bancorp..., the Office of Thrift Supervision approved the application of Minden Mutual Holding Company and MBL Bank, Minden, Louisiana, to convert to the stock form of organization. Copies of the application are...

78 FR 33426 - Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX

Science.gov (United States)

2013-06-04

...] Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX AGENCY: Food and Drug... new drug application (NDA) for ORAFLEX (benoxaprofen) Tablets, held by Eli Lilly and Co. (Lilly), Lilly Corporate Center, Indianapolis, IN 46285. Lilly has voluntarily requested that approval of this...

77 FR 50121 - Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70

Science.gov (United States)

2012-08-20

...] Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70 AGENCY: Food and Drug... new drug application (NDA) for DEXTRAN 70 (6% Dextran 70 and 0.9% NaCl or/5% Dextrose 500 mL Glass... that FDA withdraw approval of NDA 080-819, DEXTRAN 70 (6% Dextran 70 and 0.9% NaCl or/5% Dextrose 500 m...

Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

Science.gov (United States)

DiMasi, Joseph A

2013-06-01

Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean

49 CFR 107.705 - Registrations, reports, and applications for approval.

Science.gov (United States)

2010-10-01

... format may be filed by facsimile (fax) to: (202) 366-3753 or (202) 366-3308 or by electronic mail (e-mail... mailing addresses, e-mail address optional, and telephone number of the person on whose behalf the... proposed duration of the approval; (3) The transport mode or modes affected, as applicable; (4) Any...

7 CFR 1436.9 - Loan amount and loan application approvals.

Science.gov (United States)

2010-01-01

... approving authority to be ineligible for loan. (c) The maximum total principal amount of the farm storage... facility; (ii) By a yield determined reasonable by the county committee; (iii) Multiply by two (for 2 years... first time. (e) When a storage structure has a larger capacity than the applicant's needed capacity, as...

29 CFR 3.5 - Payroll deductions permissible without application to or approval of the Secretary of Labor.

Science.gov (United States)

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Payroll deductions permissible without application to or approval of the Secretary of Labor. 3.5 Section 3.5 Labor Office of the Secretary of Labor CONTRACTORS AND... STATES § 3.5 Payroll deductions permissible without application to or approval of the Secretary of Labor...

78 FR 52429 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine...

Science.gov (United States)

2013-08-23

... 558 [Docket No. FDA-2013-N-0839] New Animal Drugs; Withdrawal of Approval of New Animal Drug...: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) at the sponsors' request...

Blood drop patterns: Formation and applications.

Science.gov (United States)

Chen, Ruoyang; Zhang, Liyuan; Zang, Duyang; Shen, Wei

2016-05-01

The drying of a drop of blood or plasma on a solid substrate leads to the formation of interesting and complex patterns. Inter- and intra-cellular and macromolecular interactions in the drying plasma or blood drop are responsible for the final morphologies of the dried patterns. Changes in these cellular and macromolecular components in blood caused by diseases have been suspected to cause changes in the dried drop patterns of plasma and whole blood, which could be used as simple diagnostic tools to identify the health of humans and livestock. However, complex physicochemical driving forces involved in the pattern formation are not fully understood. This review focuses on the scientific development in microscopic observations and pattern interpretation of dried plasma and whole blood samples, as well as the diagnostic applications of pattern analysis. Dried drop patterns of plasma consist of intricate visible cracks in the outer region and fine structures in the central region, which are mainly influenced by the presence and concentration of inorganic salts and proteins during drying. The shrinkage of macromolecular gel and its adhesion to the substrate surface have been thought to be responsible for the formation of the cracks. Dried drop patterns of whole blood have three characteristic zones; their formation as functions of drying time has been reported in the literature. Some research works have applied engineering treatment to the evaporation process of whole blood samples. The sensitivities of the resultant patterns to the relative humidity of the environment, the wettability of the substrates, and the size of the drop have been reported. These research works shed light on the mechanisms of spreading, evaporation, gelation, and crack formation of the blood drops on solid substrates, as well as on the potential applications of dried drop patterns of plasma and whole blood in diagnosis. Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.

75 FR 28686 - FedFirst Financial Corporation, Monessen, PA; Approval of Conversion Application

Science.gov (United States)

2010-05-21

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-40: OTS No. H-4708] FedFirst Financial... Office of Thrift Supervision approved the application of FedFirst Financial MHC and First Federal Savings Bank, Monessen, Pennsylvania, to convert to the stock form of organization. Copies of the application...

Supplements and other changes to an approved application. Final rule.

Science.gov (United States)

2004-04-08

The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.

Nanoparticle encapsulation in red blood cells enables blood-pool magnetic particle imaging hours after injection

International Nuclear Information System (INIS)

Rahmer, J; Gleich, B; Borgert, J; Antonelli, A; Sfara, C; Magnani, M; Tiemann, B; Weizenecker, J

2013-01-01

Magnetic particle imaging (MPI) is a new medical imaging approach that is based on the nonlinear magnetization response of super-paramagnetic iron oxide nanoparticles (SPIOs) injected into the blood stream. To date, real-time MPI of the bolus passage of an approved MRI SPIO contrast agent injected into the tail vein of living mice has been demonstrated. However, nanoparticles are rapidly removed from the blood stream by the mononuclear phagocyte system. Therefore, imaging applications for long-term monitoring require the repeated administration of bolus injections, which complicates quantitative comparisons due to the temporal variations in concentration. Encapsulation of SPIOs into red blood cells (RBCs) has been suggested to increase the blood circulation time of nanoparticles. This work presents first evidence that SPIO-loaded RBCs can be imaged in the blood pool of mice several hours after injection using MPI. This finding is supported by magnetic particle spectroscopy performed to quantify the iron concentration in blood samples extracted from the mice 3 and 24 h after injection of SPIO-loaded RBCs. Based on these results, new MPI applications can be envisioned, such as permanent 3D real-time visualization of the vessel tree during interventional procedures, bleeding monitoring after stroke, or long-term monitoring and treatment control of cardiovascular diseases. (paper)

18 CFR 131.20 - Application for approval of transfer of license.

Science.gov (United States)

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Application for approval of transfer of license. 131.20 Section 131.20 Conservation of Power and Water Resources FEDERAL... a citizen of the United States of America. Subscribed and sworn to before me, a notary public of the...

Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com.

Directory of Open Access Journals (Sweden)

Derek So

Full Text Available Although there are a number of online platforms for patient-level clinical trial data sharing from industry sponsors, they are not very harmonized regarding the role of local ethics approval in the research proposal review process. The first and largest of these platforms is ClinicalStudyDataRequest.com (CSDR, which includes over three thousand trials from thirteen sponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants to state whether they have received ethics approval for their research proposal, but in most cases does not require that they submit evidence of approval. However, the website does require that applicants without ethical approval state the reason it was not required. In order to examine the perspectives of researchers on this topic, we coded every response to that question received by CSDR between June 2014 and February 2017. Of 111 applicants who stated they were exempt from ethics approval, 63% mentioned de-identification, 57% mentioned the use of existing data, 33% referred to local or jurisdictional regulations, and 20% referred to the approvals obtained by the original study. We conclude by examining the experience of CSDR within the broader context of the access mechanisms and policies currently being used by other data sharing platforms, and discuss how our findings might be used to help clinical trial data providers design clear and informative access documents.

Application for approval to construct the Waste Receiving And Processing facility

International Nuclear Information System (INIS)

1993-02-01

The following Application For Approval Of Construction is being submitted by the US Department of Energy, Richland Field Office pursuant to 40 CFR 61.07, ''Application for Approval of Construction or Modification,'' for the Waste Receiving and Processing (WRAP) Module 1 facility (also referred to as WRAP 1). The WRAP 1 facility will be a new source of radioactive emissions to the atmosphere. The WRAP 1 facility will be housed in the new 2336-W Building, which will be located in the 200 West Area south of 23rd Street and west of Dayton Avenue. The 200 West Area is located within the boundary of the Hanford Site. The mission of the WRAP 1 facility is to examine, assay, characterize, treat, and repackage solid radioactive and mixed waste to enable permanent disposal of the waste in accordance with all applicable regulations. The solid wastes to be handled in the WRAP 1 facility include low-level waste (LLW), Transuranic (TRU) waste, TRU mixed waste, and low-level mixed waste (LLMW). The WRAP 1 facility will only accept contact handled (CH) waste containers. CH waste is a waste category whose external surface dose rate does not exceed 200 mrem/h. These containers have a surface dose rate of less than 200 mrem/h

75 FR 30481 - Jacksonville Bancorp, Inc., Jacksonville, IL; Approval of Conversion Application

Science.gov (United States)

2010-06-01

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-42: OTS No. H-4706] Jacksonville..., 2010, the Office of Thrift Supervision approved the application of Jacksonville Bancorp, MHC, and Jacksonville Savings Bank, Jacksonville, Illinois, to convert to the stock form of organization. Copies of the...

78 FR 77470 - Health Insurance Exchanges; Approval of an Application by the Accreditation Association for...

Science.gov (United States)

2013-12-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-9953-FN] Health Insurance Exchanges; Approval of an Application by the Accreditation Association for Ambulatory...\\ Health Insurance Exchanges; Application by the Accreditation Association for Ambulatory Health Care To Be...

75 FR 65565 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

Science.gov (United States)

2010-10-26

... 558 [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran AGENCY...) is amending the animal drug regulations by removing those portions that reflect approval of eight new...

76 FR 10088 - Sunshine Financial, Inc., Tallahassee Florida; Approval of Conversion Application

Science.gov (United States)

2011-02-23

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-60: OTS Nos. H-4757, H-4519, and 17971... that on February 11, 2011, the Office of Thrift Supervision approved the application of Sunshine Savings MHC, Tallahassee, Florida, the federal mutual holding company for Sunshine Savings Bank...

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...

75 FR 31511 - Oneida Financial Corp., Oneida, NY; Approval of Conversion Application

Science.gov (United States)

2010-06-03

... Office of Thrift Supervision approved the application of Oneida Financial, MHC and Oneida Savings Bank... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-44: OTS No. H-4704] Oneida Financial... of Thrift Supervision. Sandra E. Evans, Federal Register Liaison. [FR Doc. 2010-13209 Filed 6-2-10; 8...

Nanodiamonds for Medical Applications: Interaction with Blood in Vitro and in Vivo.

Science.gov (United States)

Tsai, Lin-Wei; Lin, Yu-Chung; Perevedentseva, Elena; Lugovtsov, Andrei; Priezzhev, Alexander; Cheng, Chia-Liang

2016-07-12

Nanodiamonds (ND) have emerged to be a widely-discussed nanomaterial for their applications in biological studies and for medical diagnostics and treatment. The potentials have been successfully demonstrated in cellular and tissue models in vitro. For medical applications, further in vivo studies on various applications become important. One of the most challenging possibilities of ND biomedical application is controllable drug delivery and tracing. That usually assumes ND interaction with the blood system. In this work, we study ND interaction with rat blood and analyze how the ND surface modification and coating can optimize the ND interaction with the blood. It was found that adsorption of a low concentration of ND does not affect the oxygenation state of red blood cells (RBC). The obtained in vivo results are compared to the results of in vitro studies of nanodiamond interaction with rat and human blood and blood components, such as red blood cells and blood plasma. An in vivo animal model shows ND injected in blood attach to the RBC membrane and circulate with blood for more than 30 min; and ND do not stimulate an immune response by measurement of proinflammatory cytokine TNF-α with ND injected into mice via the caudal vein. The results further confirm nanodiamonds' safety in organisms, as well as the possibility of their application without complicating the blood's physiological conditions.

75 FR 28685 - Colonial Bankshares, MHC, Vineland, NJ; Approval of Conversion Application

Science.gov (United States)

2010-05-21

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-41: OTS Nos. 04983, H-3879, and H-4714... May 14, 2010, the Office of Thrift Supervision approved the application of Colonial Bankshares, MHC, and Colonial Bank, Vineland, New Jersey, to convert to the stock form of organization. Copies of the...

Nanodiamonds for Medical Applications: Interaction with Blood in Vitro and in Vivo

Directory of Open Access Journals (Sweden)

Lin-Wei Tsai

2016-07-01

Full Text Available Nanodiamonds (ND have emerged to be a widely-discussed nanomaterial for their applications in biological studies and for medical diagnostics and treatment. The potentials have been successfully demonstrated in cellular and tissue models in vitro. For medical applications, further in vivo studies on various applications become important. One of the most challenging possibilities of ND biomedical application is controllable drug delivery and tracing. That usually assumes ND interaction with the blood system. In this work, we study ND interaction with rat blood and analyze how the ND surface modification and coating can optimize the ND interaction with the blood. It was found that adsorption of a low concentration of ND does not affect the oxygenation state of red blood cells (RBC. The obtained in vivo results are compared to the results of in vitro studies of nanodiamond interaction with rat and human blood and blood components, such as red blood cells and blood plasma. An in vivo animal model shows ND injected in blood attach to the RBC membrane and circulate with blood for more than 30 min; and ND do not stimulate an immune response by measurement of proinflammatory cytokine TNF-α with ND injected into mice via the caudal vein. The results further confirm nanodiamonds’ safety in organisms, as well as the possibility of their application without complicating the blood’s physiological conditions.

Marketing Approval of Ethical Kampo Medicines.

Science.gov (United States)

Hakamatsuka, Takashi

2017-01-01

Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

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...

75 FR 51167 - Northfield Bancorp, Inc., Staten Island, NY; Approval of Conversion Application

Science.gov (United States)

2010-08-18

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-47: OTS No. H-4732] Northfield Bancorp..., 2010, the Office of Thrift Supervision approved the application of Northfield Bancorp, MHC and Northfield Bank, Staten Island, New York, to convert to the stock form of organization. Copies of the...

75 FR 31511 - Peoples Federal Bancshares, Inc., Brighton, MA; Approval of Conversion Application

Science.gov (United States)

2010-06-03

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-45: OTS No. H-4715] Peoples Federal..., 2010, the Office of Thrift Supervision approved the application of Peoples Federal MHC and Peoples Federal Savings Bank, Brighton, Massachusetts, to convert to the stock form of organization. Copies of the...

75 FR 70081 - Home Federal Bancorp, Inc., Shreveport, LA; Approval of Conversion Application

Science.gov (United States)

2010-11-16

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-52: OTS No. H-4749] Home Federal... 5, 2010, the Office of Thrift Supervision approved the application of Home Federal Mutual Holding Company of Louisiana and Home Federal Bank, Shreveport, Louisiana, to convert to the stock form of...

75 FR 71187 - Atlantic Coast Financial Corporation, Waycross, GA; Approval of Conversion Application

Science.gov (United States)

2010-11-22

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-56 OTS No. H-4438] Atlantic Coast... November 12, 2010, the Office of Thrift Supervision approved the application of Atlantic Coast Federal, MHC and Atlantic Coast Bank, Waycross, Georgia, to convert to the stock form of organization. Copies of...

Theater Blood Application Was Not Effectively Developed and Implemented

Science.gov (United States)

2015-07-17

blood product by unit; and • monitor non- Food and Drug Administration Blood Product Testing. The CONOPS document also identified over 400 specific...time of a transfusion. However, this requirement was not identified in the CONOPS document. Further, PEO DHCS officials provided a traceability ...the CONOPS document, requirements management database, and the traceability matrix increased the risk that the Theater Blood Application

Blood Clotting and Pregnancy

Medline Plus

Full Text Available ... pregnancy: Be aware of risk factors. Know your family history. Make sure your doctor knows about any ... blood clots or blood clotting disorders in your family. Remain active, with your doctor's approval. Be aware ...

75 FR 75548 - SI Financial Group, Inc., Willimantic, CT; Approval of Conversion Application

Science.gov (United States)

2010-12-03

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-57: OTS Nos. H-4750, H-4082, and 17978... that on November 10, 2010, the Office of Thrift Supervision approved the application of SI Bancorp, MHC, Willimantic, Connecticut, the federal mutual holding company for the Savings Institute Bank and Trust Company...

Blood compatibility of magnesium and its alloys.

Science.gov (United States)

Feyerabend, Frank; Wendel, Hans-Peter; Mihailova, Boriana; Heidrich, Stefanie; Agha, Nezha Ahmad; Bismayer, Ulrich; Willumeit-Römer, Regine

2015-10-01

Blood compatibility analysis in the field of biomaterials is a highly controversial topic. Especially for degradable materials like magnesium and its alloys no established test methods are available. The purpose of this study was to apply advanced test methodology for the analysis of degrading materials to get a mechanistic insight into the corrosion process in contact with human blood and plasma. Pure magnesium and two magnesium alloys were analysed in a modified Chandler-Loop setup. Standard clinical parameters were determined, and a thorough analysis of the resulting implant surface chemistry was performed. The contact of the materials to blood evoked an accelerated inflammatory and cell-induced osteoconductive reaction. Corrosion products formed indicate a more realistic, in vivo like situation. The active regulation of corrosion mechanisms of magnesium alloys by different cell types should be more in the focus of research to bridge the gap between in vitro and in vivo observations and to understand the mechanism of action. This in turn could lead to a better acceptance of these materials for implant applications. The presented study deals with the first mechanistic insights during whole human blood contact and its influence on a degrading magnesium-based biomaterial. The combination of clinical parameters and corrosion layer analysis has been performed for the first time. It could be of interest due to the intended use of magnesium-based stents and for orthopaedic applications for clinical applications. An interest for the readers of Acta Biomaterialia may be given, as one of the first clinically approved magnesium-based devices is a wound-closure device, which is in direct contact with blood. Moreover, for orthopaedic applications also blood contact is of high interest. Although this is not the focus of the manuscript, it could help to rise awareness for potential future applications. Copyright © 2015 Acta Materialia Inc. Published by Elsevier Ltd. All

Guidance for package approvals in the United Kingdom

International Nuclear Information System (INIS)

Morgan-Warren, E.J.

2004-01-01

Approval is required under the transport regulations for a wide range of package designs and operations, and applications for competent authority approval and validation are received from many sources, both in the UK and overseas. To assist package designers and applicants for approval, and to promote consistency in applications and their assessment, the UK Department for Transport issues guidance on the interpretation of the transport regulations and the requirements of an application for approval and its supporting safety case. The general guidance document, known as the Guide to an Application for UK Competent Authority Approval of Radioactive Material in Transport, has been issued for many years and updated to encompass the provisions of each successive edition of the IAEA transport regulations. The guide has been referred to in a number of international fora, including PATRAM, and was cited as a 'good practice' in the report of the IAEA TRANSAS appraisal of the UK in 2002. Specialist guides include the Guide to the Suitability of Elastomeric Seal Materials, which is the subject of a separate paper in this conference, and the Guide to the Approval of Freight Containers as Types IP-2 and IP-3 Packages. This paper discusses the guidance material and summarises the administrative and technical information required in support of applications for approval of package designs, special form and low-dispersible radioactive materials, shipments, special arrangements, modifications and validations. (author)

75 FR 70363 - Alliance Bancorp, Inc. of Pennsylvania, Broomall, PA; Approval of Conversion Application

Science.gov (United States)

2010-11-17

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-54: OTS No. H-4752] Alliance Bancorp... November 10, 2010, the Office of Thrift Supervision approved the application of Alliance Mutual Holding Company and Greater Delaware Valley Savings Bank, dba Alliance Bank, Broomall, Pennsylvania, to convert to...

76 FR 9636 - Franklin Financial Corporation, Inc., Glen Allen, VA; Approval of Conversion Application

Science.gov (United States)

2011-02-18

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-59: OTS No. H-4761] Franklin Financial... 11, 2011, the Office of Thrift Supervision approved the application of Franklin Financial Corporation MHC and Franklin Federal Savings Bank, Glen Allen, Virginia, to convert to the stock form of...

34 CFR 668.144 - Application for test approval.

Science.gov (United States)

2010-07-01

... quantitative skills; (9) If a test has been revised from the most recent edition approved by the Secretary, an... Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY... inquiries; (3) Each edition and form of the test for which the publisher requests approval; (4) The...

7 CFR 1710.406 - Loan approval.

Science.gov (United States)

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false Loan approval. 1710.406 Section 1710.406 Agriculture... GENERAL AND PRE-LOAN POLICIES AND PROCEDURES COMMON TO ELECTRIC LOANS AND GUARANTEES Application Requirements and Procedures for Loans § 1710.406 Loan approval. (a) A loan is approved when the Administrator...

75 FR 61246 - Kaiser Federal Financial Group, Inc., Covina, CA; Approval of Conversion Application

Science.gov (United States)

2010-10-04

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-51: OTS No. H-4729] Kaiser Federal... September 28, 2010, the Office of Thrift Supervision approved the application of K-Fed Mutual Holding Company and Kaiser Federal Bank, Covina, California, to convert to the stock form of organization. Copies...

Decision 97.02 : Application for approval of the Terra Nova Canada-Newfoundland benefits plan and the Terra Nova development plan

International Nuclear Information System (INIS)

1997-12-01

Petro-Canada applied to the Canada-Newfoundland Offshore Petroleum Board (the Board) for approval of its plan for the development of the Terra Nova oil and gas field of the Jeanne d'Arc Formation located about 35 km southeast of the Hibernia oilfield. Petro-Canada also submitted a benefits plan. The Board established the Terra Nova Project Environmental Assessment Panel to conduct a public review of the application and to ensure that the potential effects of the project upon the natural environment would be minimal. The Panel recommended approval of the application, subject to 75 recommendations. The Board considered the recommendations of the Panel and approved the Benefits Plan and the Development Plan subject to certain conditions being met. This document provides the details of the application, the bases for the Board's decision, the conditions imposed, and the 75 recommendations made by the Environmental Assessment Panel. . 6 tabs., 6 figs

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...

Applying for ethical approval for research: the main issues.

Science.gov (United States)

Gelling, Leslie

2016-01-13

The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

Radiolabelled blood elements techniques and clinical applications

International Nuclear Information System (INIS)

Thakur, M.L.

1992-01-01

Over the past few years, in nuclear medicine, the diagnostic applications of radiolabelled blood elements in general, and of radiolabelled white blood cells in particular, have become increasingly popular. This is primarily due to the introduction of lipid soluble 111 In-oxine as an agent, which not only is an excellent and a reliable tracer for blood cells but also enables the investigators to study the in vivo cell kinetics and map the localization of labelled cells by external gamma scintigraphy. The tracer has the modest half life of 67 hours and decays with the emission of two gamma photons (173 and 247 keV) in high abundance. This technique has provided a powerful tool to study the in vivo cell kinetics in health and localize abnormal lesions in diseases which invoke intense focal cellular concentration

Radiolabelled blood elements techniques and clinical applications

Energy Technology Data Exchange (ETDEWEB)

Thakur, M L

1993-12-31

Over the past few years, in nuclear medicine, the diagnostic applications of radiolabelled blood elements in general, and of radiolabelled white blood cells in particular, have become increasingly popular. This is primarily due to the introduction of lipid soluble {sup 111}In-oxine as an agent, which not only is an excellent and a reliable tracer for blood cells but also enables the investigators to study the in vivo cell kinetics and map the localization of labelled cells by external gamma scintigraphy. The tracer has the modest half life of 67 hours and decays with the emission of two gamma photons (173 and 247 keV) in high abundance. This technique has provided a powerful tool to study the in vivo cell kinetics in health and localize abnormal lesions in diseases which invoke intense focal cellular concentration 5 figs, 2 tabs

76 FR 41864 - Home Federal Savings and Loan Association, Ashland, KY; Approval of Conversion Application

Science.gov (United States)

2011-07-15

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-24 OTS Nos. 04246 and H4776] Home Federal Savings and Loan Association, Ashland, KY; Approval of Conversion Application Notice is hereby... Savings and Loan Association, Ashland, Kentucky, to convert to the stock form of organization. Copies of...

Prospect for application of umbilical cord blood to clinical treatment of radiation sickness

International Nuclear Information System (INIS)

Jia Tingzhen; Ke Xiaoyan

1998-01-01

Objective: To look forward to the prospect for application of umbilical cord blood to clinical treatment of radiation sickness by analyzing the results using umbilical cord blood in laboratory experiments and clinical research. Method: The data on umbilical cord blood published in literature are reviewed. Results: The umbilical blood is rich in hematopoietic stem/progenitor cells, low in immunological activity of lymphocytes, expanded significantly ex vivo under selected culture condition readily available and collected easily. Conclusion: With the above advantages, the prospect for application of umbilical cord blood is encouraging, particularly in the clinical treatment of radiation sickness

[Applications of platelets in studies on traditional Chinese medicines promoting blood circulation to remove blood stasis].

Science.gov (United States)

Wang, Feng-Qin; Chen, Cen; Xia, Zhi-Ning; Yang, Feng-Qing

2014-08-01

Thrombotic diseases in different forms become a great threat to human health. Such anti-platelet aggregation drugs as aspirin and clopidogrel are common drugs in clinic. However, along with the appearance of resistance and side effects of western anti-platelet aggregation drugs, anti-platelet aggregation traditional Chinese medicines promoting blood circulation to remove blood stasis have gradually become an important study orientation. Platelet is one of major participant in thrombosis, and plays an important role as a bioactive material in studies on traditional Chinese medicines promoting blood circulation to remove blood stasis, mainly involving two aspects--the evaluation for the anti-platelet aggregation activity of traditional Chinese medicines and the screening of their active components. This paper summarized the applications of platelets in studies on traditional Chinese medicines promoting blood circulation to remove blood stasis, so as to provide basis for further studies.

6 CFR 25.9 - Procedures for certification of approved products for Homeland Security.

Science.gov (United States)

2010-01-01

... Procedures for certification of approved products for Homeland Security. (a) Application Procedure. An applicant seeking a Certification of anti-terrorism Technology as an Approved Product for Homeland Security... application for renewal must be made using the “Application for Certification of an Approved Product for...

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...

21 CFR 515.25 - Revocation of order refusing to approve a medicated feed mill license application or suspending...

Science.gov (United States)

2010-04-01

... medicated feed mill license application or suspending or revoking a license. 515.25 Section 515.25 Food and..., FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.25 Revocation of order refusing to approve a medicated feed mill license application or suspending or revoking a...

75 FR 28685 - Oritani Financial Corp., MHC, Township of Washington, NJ; Approval of Conversion Application

Science.gov (United States)

2010-05-21

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-39: OTS Nos. H-2944 and H-4701... hereby given that on May 10, 2010, the Office of Thrift Supervision approved the application of Oritani Financial Corp., MHC, and Oritani Bank, Township of Washington, New Jersey, to convert to the stock form of...

Waste Feed Delivery Environmental Permits and Approvals Plan

International Nuclear Information System (INIS)

TOLLEFSON, K.S.

2000-01-01

This plan describes the environmental permits approvals, and other requirements that may affect establishment of a waste feed delivery system for the Hanford Site's River Protection Project. This plan identifies and screens environmental standards for potential applicability, outlines alternatives for satisfying applicable standards, and describes preferred permitting and approval approaches

Waste Feed Delivery Environmental Permits and Approvals Plan

Energy Technology Data Exchange (ETDEWEB)

TOLLEFSON, K.S.

2000-01-18

This plan describes the environmental permits approvals, and other requirements that may affect establishment of a waste feed delivery system for the Hanford Site's River Protection Project. This plan identifies and screens environmental standards for potential applicability, outlines alternatives for satisfying applicable standards, and describes preferred permitting and approval approaches.

48 CFR 2922.103-4 - Approvals.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Approvals. 2922.103-4 Section 2922.103-4 Federal Acquisition Regulations System DEPARTMENT OF LABOR SOCIOECONOMIC PROGRAMS APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Basic Labor Policies 2922.103-4 Approvals. The “agency...

Influence of blood contamination during multimode adhesive application on the microtensile bond strength to dentin.

Science.gov (United States)

Kucukyilmaz, E; Celik, E U; Akcay, M; Yasa, B

2017-12-01

The present study evaluated the effects of blood contamination performed at different steps of bonding on the microtensile bond strength (μTBS) of multimode adhesives to dentin when using the self-etch approach. Seventy-five molars were randomly assigned to three adhesive groups comprising 25 specimens each: two multimode adhesives [Single Bond Universal (SBU) and All-Bond Universal (ABU)] and a conventional one-step self-etch adhesive [Clearfil S3 Bond Plus (CSBP)]. Each group was subdivided as follows: (1) uncontaminated (control): bonding application/light curing as a positive control; (2) contamination-1 (cont-1): bonding application/light curing/blood contamination/dry as a negative control; (3) contamination-2 (cont-2): bonding application/light curing/blood contamination/rinse/dry; (4) contamination-3 (cont-3): bonding application/blood contamination/dry/bonding re-application/light curing; and (5) contamination-4 (cont-4): bonding application/blood contamination/rinse/dry/bonding re-application/light curing. Dentin specimens were prepared for μTBS testing after the composite resin application. Data were analyzed with two-way ANOVA and post-hoc tests (α = 0.05). μTBS values were similar in cont-3 groups, and ABU/cont-4 and corresponding control groups, but were significantly lower in the other groups than in their control groups (P groups showed the lowest μTBS values (P blood contaminants and reapplying the adhesive may regain the dentin adhesion when contamination occurs before light curing. Alternatively, rinsing and drying contaminants followed by adhesive re-application may be effective depending on adhesive type.

78 FR 34151 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Science.gov (United States)

2013-06-06

... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket Number FRA-2013-0050] Notice... of a signal system. FRA assigned the petition Docket Number FRA-2013-0050. Applicant: Wisconsin... Railway (CN), seeks approval of the proposed discontinuance and removal of a traffic control system (TCS...

78 FR 57857 - Medicare and Medicaid Programs; Application from the Compliance Team for Initial CMS-Approval of...

Science.gov (United States)

2013-09-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3287-PN] Medicare and Medicaid Programs; Application from the Compliance Team for Initial CMS-Approval of its Rural Health Clinic Accreditation Program AGENCY: Centers for Medicare and Medicaid Services, HHS. ACTION...

75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

Science.gov (United States)

2010-06-21

...] Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension AGENCY... Laboratories, Ltd. The supplemental NADA provides for a revised formulation of penicillin G procaine injectable... of NOROCILLIN (penicillin G procaine) Injectable Suspension by intramuscular injection in cattle...

Wetting and spreading of human blood: Recent advances and applications

OpenAIRE

Smith , F.R. ,; Brutin , David

2018-01-01

International audience; Investigation of the physical phenomena involved in blood interactions with real surfaces present new exciting challenges. The fluid mechanical properties of such a fluid is singular due its non-Newtonian and complex behaviour, depending on the surrounding ambient conditions and the donor/victim's blood biological properties. The fundamental research on the topic remains fairly recent; although it finds applications in fields such as forensic science, with bloodstain p...

Electronic Approval of Invoices (AEF)

CERN Document Server

2004-01-01

With a view to the simplification of administrative procedures, AS and FI Departments have completed the second phase of the new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. Phase II includes handling the electronic approval process of invoices whose amounts do not correspond exactly to those of the associated orders. In such cases, budgetary approval is required for the entire invoiced amount. Further information can be obtained at : http://ais.cern.ch/projs/AEF/help/F_help.htm Phase II of the procedure will be introduced gradually with effect from April 2004. Finance Department, Accounts Payable Section Tel: 72295 Organisation and Procedures Tel: 75885 Information Technologies Department,...

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.

78 FR 48177 - Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for Oxycontin

Science.gov (United States)

2013-08-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0883] Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for Oxycontin AGENCY: Food and Drug... Purdue Pharma L.P. (Purdue), One Stamford Forum, Stamford, CT 06901-3431. Purdue has voluntarily...

HSE statement on the approval of dosimetry services

International Nuclear Information System (INIS)

1992-09-01

This statement is intended to assist dosimetry services who may wish to be approved by the U.K. Health and Safety Executive under Regulation 15 of the Ionising Radiations Regulations 1985. It also serves to inform approved dosimetry services of changes in the arrangements which HSE makes for approval and reassessment of dosimetry services. A general description of the administrative arrangements for making application is given and the subsequent processing of such applications by the HSE is outlined. Background notes on the requirements of the Regulations are given in Appendix I. The fees which are chargeable from 20/8/92 are given in Appendix II. (Author)

Application for approval of the Cold Lake Expansion Project

International Nuclear Information System (INIS)

1997-02-01

Imperial Oil Resources Limited applied to the Alberta Energy and Utilities Board for approval to expand its operations at Cold Lake, Alberta and to construct and operate an electrical power plant and electrical generator substation. Imperial Oil also applied to the Alberta Environmental Protection Branch to prepare the site for a new central plant for the expansion. The company also requested a short-term groundwater withdrawal permit to provide temporary water supply for start-up. Imperial Oil claims that the project is in the public interests given the project's social, environmental and economic effects. Imperial Oil submitted this 4 volume document in support of their application. The documentation includes a project description, an environmental impact assessment, a biophysical and resource use assessment, a socio-economic assessment, and environmental baseline studies. The project is scheduled for start-up in late 1999 at a total cost of at least $440 million. refs., tabs., figs

APPLICATION OF MALARIA DETECTION OF DRAWING BLOOD CELLS USING MICROSCOPIC OpenCV

Directory of Open Access Journals (Sweden)

Antonius Herusutopo

2011-10-01

Full Text Available The goal of the research is to produce an application, which can detect malaria on patient through microscopic digital image of blood sample. The research methods are data collection, design analysis, testing and evaluation. The used application methods are image pre-processing, morphology and image segmentation using OpenCV. The expected result is a creation of application, which can be able to detect malaria on a microscopic digital image of patient blood sample. The conclusion is that the application can detect malaria from young trophozoites stadium and gametesocytes from the picture.Keywords: Detection; Malaria; Computer Vision; OpenCVINTRODUCTIONSystem technology of computer-based with artificial intelligence already can be used in medicine field, for example, to resolve the problems: detecting specific disease and its symptoms, analyzing the content of a sample, monitoring the condition of an organ, and others. Nevertheless, the medical field is very wide, so for detecting diseases problems, not yet much disease that detection can be done with a computer-based system. One example of the issues is well-known disease detection, which is malaria. Malaria is classified as a serious disease because it can cause death if it is not treated properly. Malaria has various types and can affect anyone anywhere. The symptoms of malaria is really common as it may appear in daily life, but cannot always indicate that a person infected with malaria. Indications, which can show that a person infected with malaria, are the clinical examination and blood tests.With the blood test, the treatment of malaria can be implemented correctly and precisely. It needs technology that can detect malaria correctly and precisely. The solution is the method of support vector machine that can detect malaria in humans by viewing image of appearance blood cells.METHODThe methods used in this research are data collection, analysis and design. The data collection includes

Electronic Approval of Invoices (AEF)

CERN Multimedia

2003-01-01

With a view to the simplification of administrative procedures, AS and FI Divisions have drawn up a new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. This new procedure, in its current phase, will be gradually implemented from 1 November 2003 onwards. For clarification and further information, please see: http://ais.cern.ch/projs/AEF/help/help.htm . Finance Division, Accounts Payable Tel.: 7.22.95

26 CFR 1.422-3 - Stockholder approval of incentive stock option plans.

Science.gov (United States)

2010-04-01

... comply with all applicable provisions of the corporate charter, bylaws, and applicable State law prescribing the method and degree of stockholder approval required for the issuance of corporate stock or options. If the applicable State law does not prescribe a method and degree of stockholder approval in...

77 FR 16039 - Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug Applications and 64 Abbreviated...

Science.gov (United States)

2012-03-19

...] Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug Applications and 64 Abbreviated New... Tablets... Abbott Laboratories, PA77/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157. NDA... (diphenhydramine Healthcare. HCl)) Injection Preservative Free. NDA 010021 Placidyl Abbott Laboratories...

30 CFR 18.81 - Field modification of approved (permissible) equipment; application for approval of modification...

Science.gov (United States)

2010-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES... having jurisdiction at the mine where such equipment is to be operated stating the modifications which...

44 CFR 78.9 - Planning grant approval process.

Science.gov (United States)

2010-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve applications for Planning Grants. Funds will be provided only for the flood portion of any mitigation plan, and...

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.

REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

International Nuclear Information System (INIS)

Markman, D.W.

1999-01-01

Preliminary design concepts for the proposed Subsurface Repository at Yucca Mountain indicate extensive reliance on modern, computer-based, digital control technologies. The purpose of this analysis is to investigate the degree to which the U. S. Nuclear Regulatory Commission (NRC) has accepted and approved the use of digital control technology for safety-related applications within the nuclear power industry. This analysis reviews cases of existing digitally-based control systems that have been approved by the NRC. These cases can serve as precedence for using similar types of digitally-based control technologies within the Subsurface Repository. While it is anticipated that the Yucca Mountain Project (YMP) will not contain control systems as complex as those required for a nuclear power plant, the review of these existing NRC approved applications will provide the YMP with valuable insight into the NRCs review process and design expectations for safety-related digital control systems. According to the YMP Compliance Program Guidance, portions of various NUREGS, Regulatory Guidelines, and nuclear IEEE standards the nuclear power plant safety related concept would be applied to some of the designs on a case-by-case basis. This analysis will consider key design methods, capabilities, successes, and important limitations or problems of selected control systems that have been approved for use in the Nuclear Power industry. An additional purpose of this analysis is to provide background information in support of further development of design criteria for the YMP. The scope and primary objectives of this analysis are to: (1) Identify and research the extent and precedence of digital control and remotely operated systems approved by the NRC for the nuclear power industry. Help provide a basis for using and relying on digital technologies for nuclear related safety critical applications. (2) Identify the basic control architecture and methods of key digital control

Research ethics board approval for an international thromboprophylaxis trial.

Science.gov (United States)

Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

2012-06-01

Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

50 CFR 37.22 - Approval of exploration plan.

Science.gov (United States)

2010-10-01

... § 37.21(b), the Regional Director shall promptly publish notice of the application and text of the plan... exploration plan shall be approved by the Regional Director if he determines that it satisfies the....11(b), or minimize adverse impacts on subsistence uses, the Regional Director may approve or...

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.

77 FR 74225 - Proposed Extension of the Approval of Information Collection Requirements

Science.gov (United States)

2012-12-13

... proposal to extend Office of Management and Budget (OMB) approval of the Information Collection: Work-Study... reporting requirements that include a Work Study Program application and written participation agreement. In... private school system to file with the Wage and Hour Division Administrator an application for approval of...

[Experimental study on two-way application of traditional Chinese medicines capable of promoting blood circulation and removing blood stasis with neutral property in cold and hot blood stasis syndrome I].

Science.gov (United States)

Hao, Er-Wei; Deng, Jia-Gang; Du, Zheng-Cai; Yan, Ke; Zheng, Zuo-Wen; Wang, Qin; Huang, Li-Zhen; Bao, Chuan-Hong; Deng, Xiu-Qiong; Lu, Xiao-Yan; Tang, Zhi-Ling

2012-11-01

To study the action characteristics of "two-way application and conditioned dominance" of traditional Chinese medicines with neutral property by observing the action characteristic of 10 traditional Chinese medicines capable of promoting blood circulation and removing blood stasis with neutral property in the microcirculation in rats with heat stagnation and blood stasis syndrome. The rat model with heat stagnation and blood stasis syndrome was established by injecting carrageenan and dry yeast, and the rat model with cold stagnation and blood stasis syndrome was built by the body freezing method. Ten traditional Chinese medicines with neutral property, including 5 with hot property and 5 with cold property, were selected for intervention to observe blood flow rate and flow state indicators in rat auricles and make a comparative analysis on action characteristics of traditional Chinese medicines with neutral property. ANOVA showed that among the 10 traditional Chinese medicines with neutral property, 6 such as Typhae Pollen, Sappan Lignum and Vaccariae Semen can obviously increase the blood flow rate (P traditional Chinese medicines with cold property can increase the blood flow rate (P medicines showed no notable effect; among the 5 traditional Chinese medicines with hot property, Carthamus tinctorius and Ligusticum chuanxiong can increase the blood flow rate (P traditional Chinese medicines with natural and cold properties showed similar effect on heat stagnation and blood stasis syndrome and better effect in increasing blood flow rate than those with hot property; those with natural and hot properties showed similar effect and better effect in increasing blood flow rate than those with cold property. Under the condition of heat stagnation and blood stasis syndrome, traditional Chinese medicines with neutral property have the similar action characteristics with those with cold property; wile under the condition of cold stagnation and blood stasis syndrome

75 FR 31510 - Fox Chase Bancorp, Inc., Hatboro, PA; Approval of Conversion

Science.gov (United States)

2010-06-03

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-43: OTS No. H-4707] Fox Chase Bancorp, Inc., Hatboro, PA; Approval of Conversion Application Notice is hereby given that on May 14, 2010, the Office of Thrift Supervision approved the application of Fox Chase MHC and Fox Chase Bank, Hatboro...

Blood transcriptomics: applications in toxicology

Science.gov (United States)

Joseph, Pius; Umbright, Christina; Sellamuthu, Rajendran

2015-01-01

The number of new chemicals that are being synthesized each year has been steadily increasing. While chemicals are of immense benefit to mankind, many of them have a significant negative impact, primarily owing to their inherent chemistry and toxicity, on the environment as well as human health. In addition to chemical exposures, human exposures to numerous non-chemical toxic agents take place in the environment and workplace. Given that human exposure to toxic agents is often unavoidable and many of these agents are found to have detrimental human health effects, it is important to develop strategies to prevent the adverse health effects associated with toxic exposures. Early detection of adverse health effects as well as a clear understanding of the mechanisms, especially at the molecular level, underlying these effects are key elements in preventing the adverse health effects associated with human exposure to toxic agents. Recent developments in genomics, especially transcriptomics, have prompted investigations into this important area of toxicology. Previous studies conducted in our laboratory and elsewhere have demonstrated the potential application of blood gene expression profiling as a sensitive, mechanistically relevant and practical surrogate approach for the early detection of adverse health effects associated with exposure to toxic agents. The advantages of blood gene expression profiling as a surrogate approach to detect early target organ toxicity and the molecular mechanisms underlying the toxicity are illustrated and discussed using recent studies on hepatotoxicity and pulmonary toxicity. Furthermore, the important challenges this emerging field in toxicology faces are presented in this review article. PMID:23456664

Competent authority approval of package designs in the United Kingdom

International Nuclear Information System (INIS)

Morgan-Warren, E.J.

1999-01-01

Type B packages and all packages containing fissile material, as well as special form radioactive materials, special arrangements and certain shipments, are required to be approved by the competent authority. In the United Kingdom competent authority approval is carried out on behalf of the Secretary of State by the Radioactive Materials Transport Division (RMTD) of the Department of the Environment, Transport and the Regions (DETR). Competent authority approval of a package design is given only after a detailed assessment of the design by the specialist staff of RMTD. There are three facets to the assessment procedure, namely engineering, criticality and radiation protection, and quality assurance. The engineering assessor ensures that the designer has demonstrated the integrity of the containment and shielding systems under the regulatory conditions. The criticality assessor examines criticality safety and radiation protection measures, and together with the engineering assessor, decides whether this is maintained under regulatory conditions. The quality assurance assessor verifies that the applicant has established the necessary controls to ensure that the design requirements are met. The applicant is responsible for making the case for approval, but the assessment is facilitated if the competent authority is involved with the designer at an early stage in development and during the construction of any test prototype. When a regulatory test programme is required, it is designed and carried out by the applicant, but agreed and witnessed by representatives of RMTD. Following the test programme, the applicant submits a formal application, supported by a design safety report (DSR). The DSR provides a full analysis of the design and the test results, including the behaviour of the package under normal and accident conditions of transport, the manufacturing and maintenance procedures, quality assurance and the emergency provisions for the operation of the package

Non-invasive monitoring of muscle blood perfusion by photoplethysmography: evaluation of a new application.

Science.gov (United States)

Sandberg, M; Zhang, Q; Styf, J; Gerdle, B; Lindberg, L-G

2005-04-01

To evaluate a specially developed photoplethysmographic (PPG) technique, using green and near-infrared light sources, for simultaneous non-invasive monitoring of skin and muscle perfusion. Evaluation was based on assessments of changes in blood perfusion to various provocations, such as post-exercise hyperaemia and hyperaemia following the application of liniment. The deep penetrating feature of PPG was investigated by measurement of optical radiation inside the muscle. Simultaneous measurements using ultrasound Doppler and the new PPG application were performed to elucidate differences between the two methods. Specific problems related to the influence of skin temperature on blood flow were highlightened, as well. Following static and dynamic contractions an immediate increase in muscle perfusion was shown, without increase in skin perfusion. Liniment application to the skin induced a rapid increase in skin perfusion, but not in muscle. Both similarities and differences in blood flow measured by Ultrasound Doppler and PPG were demonstrated. The radiant power measured inside the muscle, by use of an optical fibre, showed that the near-infrared light penetrates down to the vascular depth inside the muscle. The results of this study indicate the potentiality of the method for non-invasive measurement of local muscle perfusion, although some considerations still have to be accounted for, such as influence of temperature on blood perfusion.

Applications of a solid phase radioimmunoassay (SPRIA) to the micro-determination of ABO blood group

International Nuclear Information System (INIS)

Wu Fenqiang; Guo Jingyuan

1995-01-01

The authors report a simple, rapid, sensitive and accurate solid phase radioimmunoassay (SPRIA) method which has been improved. The research included the tests of its methodological parameters, sensitivity, accuracy, and the studies on its applications to the detection of blood group substances in varied forensic biological materials. The coefficient variation of intra-assay was 5.6%, and that of inter-assay was 10.15%. As to its applications to the forensic serology, the ABO blood groups of human bloodstain, hair follicular tissues and salivary stains had been tested and the results were satisfying. Later, 50 unknown type bloodly samples had been blind tested. The judging level used to identify the positive and negative wells was 800 cpm, that meant, if the radioactive count of a well were over 800 cpm, it was determined as a positive well, if that of a well were below 800 cpm, it was negative well. As SPRIA is a method of micro-determination which can micro-test the blood group antigens contained in varied forensic biological materials, it should has a good future of its applications to the forensic medicine fields

[Intra-Articular Application of Tranexamic Acid Significantly Reduces Blood Loss and Transfusion Requirement in Primary Total Knee Arthroplasty].

Science.gov (United States)

Lošťák, J; Gallo, J; Špička, J; Langová, K

2016-01-01

PURPOSE OF THE STUDY The aim of this prospective study was to investigate the effect of topical application of tranexamic acid (TXA, Exacyl) on the amount of post-operative blood loss, and blood transfusion requirement in patients undergoing primary total knee arthroplasty (TKA). Attention was paid to early complications potentially associated with TXA administration, such as haematoma, wound exudate, or knee swelling. In addition, the economic benefit of TXA treatment was also taken into account. MATERIAL AND METHODS The study included 238 patients (85 men and 153 women) who underwent primary total knee arthroplasty (TKA) at our department between January 2013 and November 2015. A group of 119 patients (41 men and 78 women) received intraarticular TXA injections according to the treatment protocol (TXA group). A control group matched in basic characteristics to the TXA group also consisted of 119 patients. The average age in the TXA group was 69.8 years, and the most frequent indication for TKA surgery was primary knee osteoarthritis (81.5%). In each patient, post-operative volume of blood lost from drains and total blood loss including hidden blood loss were recorded, as well as post-operative haemoglobin and haematocrit levels. On discharge of each patient from hospital, the size and site of a haematoma; wound exudate, if present after post-operative day 4; joint swelling; range of motion and early revision surgery, if performed, were evaluated. Requirements of analgesic drugs after surgery were also recorded. RESULTS In the TXA group, blood losses from drains were significantly lower than in the control group (456.7 ± 270.8 vs 640.5 ±448.2; p = 0.004). The median value for blood losses from drains was lower by 22% and the average value for total blood loss, including hidden losses, was also lower than in the control group (762.4 ± 345.2 ml vs 995.5 ± 457.3 ml). The difference in the total amount of blood loss between the two groups was significant (p = 0

Drugs@FDA: FDA Approved Drug Products

Science.gov (United States)

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

Application of morphological bit planes in retinal blood vessel extraction.

Science.gov (United States)

Fraz, M M; Basit, A; Barman, S A

2013-04-01

The appearance of the retinal blood vessels is an important diagnostic indicator of various clinical disorders of the eye and the body. Retinal blood vessels have been shown to provide evidence in terms of change in diameter, branching angles, or tortuosity, as a result of ophthalmic disease. This paper reports the development for an automated method for segmentation of blood vessels in retinal images. A unique combination of methods for retinal blood vessel skeleton detection and multidirectional morphological bit plane slicing is presented to extract the blood vessels from the color retinal images. The skeleton of main vessels is extracted by the application of directional differential operators and then evaluation of combination of derivative signs and average derivative values. Mathematical morphology has been materialized as a proficient technique for quantifying the retinal vasculature in ocular fundus images. A multidirectional top-hat operator with rotating structuring elements is used to emphasize the vessels in a particular direction, and information is extracted using bit plane slicing. An iterative region growing method is applied to integrate the main skeleton and the images resulting from bit plane slicing of vessel direction-dependent morphological filters. The approach is tested on two publicly available databases DRIVE and STARE. Average accuracy achieved by the proposed method is 0.9423 for both the databases with significant values of sensitivity and specificity also; the algorithm outperforms the second human observer in terms of precision of segmented vessel tree.

[Applications and approved projects on traditional Chinese medicine in National Natural Science Foundation of China in 2010].

Science.gov (United States)

Shang, Hong-cai; Huang, Jin-ling; Han, Li-wei; Pei, Ling-peng; Guo, Lin; Lin, Na; Wang, Chang-en

2011-10-01

In this article, the authors firstly summarized the number of applications submitted to and projects supported by the National Natural Science Foundation of China (NSFC) in the field of traditional Chinese medicine research in 2010. Then they described the district distribution, research direction layout and allotment of the approved projects in the three primary disciplines (traditional Chinese medicine, Chinese materia medica and integrated traditional Chinese and Western medicine) and their 43 subdisciplines. The targeting suggestions for improvement were given respectively by concluding the reason of disapproved projects from the point of view of applicants and supporting institution, and by stating the common problems existing in the review process from the perspectives of fund managers and evaluation experts. Lastly, the major funding fields in the near future were predicted in the hope of providing guidance for applicants.

13 CFR 108.380 - Final approval as a NMVC Company.

Science.gov (United States)

2010-01-01

... VENTURE CAPITAL (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.380 Final approval as a... amount of Regulatory Capital set forth in its application, pursuant to § 108.310(a)(1); and (B) The... at least 30 percent of its Regulatory Capital if the Conditionally Approved NMVC Company— (i) Already...

77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2012-10-04

... regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA...-0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This...

44 CFR 78.10 - Project grant approval process.

Science.gov (United States)

2010-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.10 Project grant approval process. The State POC will solicit applications from...

Project W-314 phase I environmental permits and approvals plan

International Nuclear Information System (INIS)

TOLLEFSON, K.S.

1999-01-01

This document describes the range of environmental actions, including required permits and other agency approvals, for Project W-314 activities in the Hanford Site's Tank Waste Remediation System. This document outlines alternative approaches to satisfying applicable environmental standards, and describes selected strategies for acquiring permits and other approvals needed for waste feed delivery to proceed. This document also includes estimated costs and schedule to obtain the required permits and approvals based on the selected strategy. It also provides estimated costs for environmental support during design and construction based on the preliminary project schedule provided

10 CFR 725.15 - Requirements for approval of applications.

Science.gov (United States)

2010-01-01

... Secret Restricted Data in C-91, Nuclear Reactors for Rocket Propulsion, will be approved only if the... propulsion and is directly engaged in or proposes to engage in a substantial research and development program in such field of work; or (ii) Is engaged in or proposes to engage in a substantial study program in...

77 FR 429 - Clarification and Further Guidance on the Fireworks Approvals Policy

Science.gov (United States)

2012-01-05

... 173 [Docket No. PHMSA-2011-0315; Notice No. 11-13] Clarification and Further Guidance on the Fireworks... fireworks approvals applications from fireworks manufacturers or their designated agents and grant approvals only to manufacturers of fireworks devices. This clarification and additional guidance follows the...

Pulsed cold plasma-induced blood coagulation and its pilot application in stanching bleeding during rat hepatectomy

Science.gov (United States)

Keping, YAN; Qikang, JIN; Chao, ZHENG; Guanlei, DENG; Shengyong, YIN; Zhen, LIU

2018-04-01

This paper presents plasma-induced blood coagulation and its pilot application in rat hepatectomy by using a home-made pulsed cold plasma jet. Experiments were conducted on blood coagulation in vitro, the influence of plasma on tissue in vivo, and the pilot application of rat hepatectomy. Experimental results show that the cold plasma can lead to rapid blood coagulation. Compared with the control sample, the plasma-induced agglomerated layer of blood is thicker and denser, and is mostly composed of broken platelets. When the surface of the liver was treated by plasma, the influence of the plasma can penetrate into the liver to a depth of about 500 μm. During the rat hepatectomy, cold plasma was proved to be effective for stanching bleeding on incision. No obvious bleeding was found in the abdominal cavities of all six rats 48 h after the hepatectomy. This implies that cold plasma can be an effective modality to control bleeding during surgical operation.

50 CFR 223.207 - Approved TEDs.

Science.gov (United States)

2010-10-01

... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Approved TEDs. 223.207 Section 223.207 Wildlife and Fisheries NATIONAL MARINE FISHERIES SERVICE, NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE MARINE MAMMALS THREATENED MARINE AND ANADROMOUS SPECIES Restrictions Applicable to Threatened Marine and Anadromous Specie...

13 CFR 115.62 - Prohibition on participation in Prior Approval program.

Science.gov (United States)

2010-01-01

... Prior Approval program. 115.62 Section 115.62 Business Credit and Assistance SMALL BUSINESS... in Prior Approval program. A PSB Surety is not eligible to submit applications under subpart B of this part. This prohibition does not extend to an Affiliate, as defined in 13 CFR § 121.103, of a PSB...

Analysis of research ethics board approval times in an academic department of medicine.

Science.gov (United States)

Tsang, Teresa S M; Jones, Meaghan; Meneilly, Graydon S

2015-04-01

As part of an ongoing effort to better understand barriers to academic research, we reviewed and analyzed the process of research ethics applications, focusing on ethics approval time, within the Department of Medicine from 2006 to 2011. A total of 1,268 applications for approval to use human subjects in research were included in our analysis. Three variables, risk category (minimal vs. non-minimal risk), type of funding, and year of submission, were statistically significant for prediction of ethics approval time, with risk status being the most important of these. The covariate-adjusted mean time for approval for minimal risk studies (35.7 days) was less than half that of non-minimal risk protocols (76.5 days). Studies funded through a for-profit sponsor had significantly longer approval times than those funded through other means but were also predominantly (87%) non-minimal risk protocols. Further investigations of the reasons underlying the observed differences are needed to determine whether improved training for research ethics board (REB) members and/or greater dialogue with investigators may reduce the lengthy approval times associated with non-minimal risk protocols. © The Author(s) 2015.

A Document Imaging Technique for Implementing Electronic Loan Approval Process

Directory of Open Access Journals (Sweden)

J. Manikandan

2015-04-01

Full Text Available The image processing is one of the leading technologies of computer applications. Image processing is a type of signal processing, the input for image processor is an image or video frame and the output will be an image or subset of image [1]. Computer graphics and computer vision process uses an image processing techniques. Image processing systems are used in various environments like medical fields, computer-aided design (CAD, research fields, crime investigation fields and military fields. In this paper, we proposed a document image processing technique, for establishing electronic loan approval process (E-LAP [2]. Loan approval process has been tedious process, the E-LAP system attempts to reduce the complexity of loan approval process. Customers have to login to fill the loan application form online with all details and submit the form. The loan department then processes the submitted form and then sends an acknowledgement mail via the E-LAP to the requested customer with the details about list of documents required for the loan approval process [3]. The approaching customer can upload the scanned copies of all required documents. All this interaction between customer and bank take place using an E-LAP system.

Development of Cell Phone Application for Blood Glucose Self-Monitoring Based on ISO/IEEE 11073 and HL7 CCD.

Science.gov (United States)

Park, Hyun Sang; Cho, Hune; Kim, Hwa Sun

2015-04-01

The objectives of this research were to develop and evaluate a cell phone application based on the standard protocol for personal health devices and the standard information model for personal health records to support effective blood glucose management and standardized service for patients with diabetes. An application was developed for Android 4.0.3. In addition, an IEEE 11073 Manager, Medical Device Encoding Rule, and Bluetooth Health Device Profile Connector were developed for standardized health communication with a glucometer, and a Continuity of Care Document (CCD) Composer and CCD Parser were developed for CCD document exchange. The developed application was evaluated by five healthcare professionals and 87 users through a questionnaire comprising the following variables: usage intention, effort expectancy, social influence, facilitating condition, perceived risk, and voluntariness. As a result of the evaluation of usability, it was confirmed that the developed application is useful for blood glucose self-monitoring by diabetic patients. In particular, the healthcare professionals stated their own views that the application is useful to observe the trends in blood glucose change through the automatic function which records a blood glucose level measured using Bluetooth function, and the function which checks accumulated records of blood glucose levels. Also, a result of the evaluation of usage intention was 3.52 ± 0.42 out of 5 points. The application developed by our research team was confirmed by the verification of healthcare professionals that accurate feedback can be provided to healthcare professionals during the management of diabetic patients or education for glucose management.

Quality assurance of approved out of programme psychiatry training and research over the past 5 years

Science.gov (United States)

Osman-Hicks, Victoria; Graham, Hannah; Leadbetter, Peter; Brittlebank, Andrew

2015-01-01

Aims and method This paper intends to analyse the number of applications, trainee demographic and approval rate of those applying for out of programme training (OOPT) or out of programme research (OOPR) between January 2008 and April 2013 using the committee’s anonymised database. We also describe the process of application and approval by the Quality Assurance Committee. Results There were 90 applications, including 10 resubmissions during the 64-month period. Most applicants (77%) were higher trainees; 53% of applicants were from the London deanery; 60% of applications were for research posts and higher degrees (OOPR). Overall, 64% were approved by the committee: 70% for OOPRs and 53% for OOPTs. Clinical implications This paper shows with transparency the breakdown of applications to the Quality Assurance Committee. Around two-thirds of applications to the committee are supported (64%). Relatively few psychiatry trainees (2.5%) have applied for an OOPT or an OOPR over the past 5 years. PMID:26191450

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...

Growth of human T lymphocyte colonies from whole blood: culture requirements and applications

International Nuclear Information System (INIS)

Knox, S.J.; Wilson, F.D.; Greenberg, B.R.; Shifrine, M.

1982-01-01

Growth of human lymphocyte colonies from whole blood following stimulation with PHA, Con A, or PPD is described. Individual colony cells were identified as T lymphocytes on the basis of surface marker and enzyme cytochemical characterizations. Colony formation increased as a power function over a wide range of cell concentrations above a critical minimal concentration. The whole blood culture system eliminates possible selective effects of lymphocyte colony techniques utilizing gradient-enriched lymphocyte fractions and more closely approximates the in vivo milieu. The whole blood colony method is more sensitive for the detection of low-level radiation effects on lymphocytes than widely used tests that measure 3 H-thymidine incorporation. In preliminary studies, researchers used the whole blood method to determine the relative radiosensitivity of lymphocytes from humans with various hematopoietic disorders, and observed abnormalities in mitogen responsiveness and colony formation in some of the patient groups. This method has wide application for studies in cellular and clinical immunology

The application of silicon sol-gel technology to forensic blood substitute development: Mimicking aspects of whole human blood rheology.

Science.gov (United States)

Stotesbury, Theresa; Illes, Mike; Wilson, Paul; Vreugdenhil, Andrew J

2017-01-01

Solution-gelation chemistry has promising applications in forensic synthetic blood substitute development. This research offers a silicon-based sol-gel approach to creating stable materials that share similar rheological properties to that of whole human blood samples. Room temperature, high water content, silicon sol-gels were created using the organosilane precursors 3-glycidoxypropyltrimethoxysilane and tetraethylorthosilicate along with various concentrations of filler and pigment. Shear-thinning non-Newtonian properties were observed within most formulations of the presented materials. The effects of colloidal concentration, temperature, age and filler addition on the viscosity of the sol-gels were investigated. SEM-EDS analysis was used to identify the behavior of the fillers within the film and support their inclusion for basic bloodstain pattern simulation. A final proposed candidate sol-gel was assessed using a previously reported passive drip simulation test on a hard, dry surface and passed. This works represents encouraging development in providing safe material alternatives to using whole human blood for forensic training and research. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Project W-521, waste feed delivery systems environmental permits and approvals plan

International Nuclear Information System (INIS)

TOLLEFSON, K.S.

1999-01-01

This document has been prepared to define the specific environmental requirements applicable to Project W-521. The document describes the permits and approvals necessary for the project to design, construct, and install planned upgrades, and provides a schedule of activities and provides cost estimates to complete the required permitting and approval activities

NONINVASIVE METHODS ASSESSMENT BLOOD FLOW IN ANTERIOR SEGMENT AND CLINICAL APPLICATION PERSPECTIVE

Directory of Open Access Journals (Sweden)

T. N. Kiseleva

2017-01-01

Full Text Available The literature review contains information on the anatomical and physiological features of the vessels of the conjunctiva, iris, ciliary body. There are data on the development and application of new non-invasive methods for the study of hemodynamics in the microvessels of anterior eye segment. To study the blood flow of the anterior segment of the eye, biomycroscopy, photography and videobiomicroscopy, television biomicroscopy of vessels, darkfield visualization, application fluorescence angiography, photoacoustic angiography, orthogonal polarization spectroscopy, laser Doppler flowmetry and OCT-angiography were used in recent years. These methods allow to determine the qualitative and quantitative characteristics of conjunctiva, iris, ciliary body microcirculation. They are highly informative for assess of various drugs effect on the vascular eye system. Investigation of hemodynamics in the eye microvessels is necessary for a fundamental approach to the study of the pathophysiology of systemic circulatory pathologies (with arterial hypertension, diabetes, etc. and changes in regional blood flow in organ of vision disease. Monitoring of anterior segment microcirculation in clinical practice makes possible to monitor the effectiveness of drug and surgical treatment.

A programmable and portable NMES device for drop foot correction and blood flow assist applications.

Science.gov (United States)

Breen, Paul P; Corley, Gavin J; O'Keeffe, Derek T; Conway, Richard; Olaighin, Gearóid

2009-04-01

The Duo-STIM, a new, programmable and portable neuromuscular stimulation system for drop foot correction and blood flow assist applications is presented. The system consists of a programmer unit and a portable, programmable stimulator unit. The portable stimulator features fully programmable, sensor-controlled, constant-voltage, dual-channel stimulation and accommodates a range of customized stimulation profiles. Trapezoidal and free-form adaptive stimulation intensity envelope algorithms are provided for drop foot correction applications, while time dependent and activity dependent algorithms are provided for blood flow assist applications. A variety of sensor types can be used with the portable unit, including force sensitive resistor-based foot switches and MEMS-based accelerometer and gyroscope devices. The paper provides a detailed description of the hardware and block-level system design for both units. The programming and operating procedures for the system are also presented. Finally, functional bench test results for the system are presented.

Credit Risk Management - Loan Approval Process

Directory of Open Access Journals (Sweden)

Lulzim Rashiti

2016-03-01

Full Text Available The aim of this study is on understanding the international regulations issued by Basel I, Basel II and Basel III to best supervise and manage credit risk management policies. Part of paper will focus on the description and impacts of the regulations and the pivotal importance they play in providing a sound banking system. Credit risk represents another important element that will be analysed considering that it lays the foundation during the loan consideration and approval process. The paper will also explain in detail procedures and responsibilities shared along the process of loan acceptance by a banker. To sum up, the overall process from application to loan approval or denial will be explained pointing out the implications that are faced along the way

Detection of EPO gene doping in blood.

Science.gov (United States)

Neuberger, Elmo W I; Jurkiewicz, Magdalena; Moser, Dirk A; Simon, Perikles

2012-11-01

Gene doping--or the abuse of gene therapy--will continue to threaten the sports world. History has shown that progress in medical research is likely to be abused in order to enhance human performance. In this review, we critically discuss the progress and the risks associated with the field of erythropoietin (EPO) gene therapy and its applicability to EPO gene doping. We present typical vector systems that are employed in ex vivo and in vivo gene therapy trials. Due to associated risks, gene doping is not a feasible alternative to conventional EPO or blood doping at this time. Nevertheless, it is well described that about half of the elite athlete population is in principle willing to risk its health to gain a competitive advantage. This includes the use of technologies that lack safety approval. Sophisticated detection approaches are a prerequisite for prevention of unapproved and uncontrolled use of gene therapy technology. In this review, we present current detection approaches for EPO gene doping, with a focus on blood-based direct and indirect approaches. Gene doping is detectable in principle, and recent DNA-based detection strategies enable long-term detection of transgenic DNA (tDNA) following in vivo gene transfer. Copyright © 2012 John Wiley & Sons, Ltd.

Decision 99-8 : Shell Canada Limited application to construct and operate an oil sands bitumen upgrader in the Fort Saskatchewan area : Shell Canada Products Limited application to amend refinery approval in the Fort Saskatchewan area

International Nuclear Information System (INIS)

1999-01-01

The Alberta Energy and Utilities Board considered an application by Shell Canada Limited to construct and operate an oil sands bitumen upgrader on Shell's property adjoining the existing Scotford refinery in the County of Strathcona. The upgrader would process bitumen from Shell's proposed Muskeg River Mine, located 70 km north of Fort McMurray, and other feedstocks available in the area. The Board also considered an application for an amendment to the existing Scotford refinery approval, Industrial Development Permit 89-10, for the processing of 3.75 million cubic metres per year of sour conversion feedstock. Under a coordinated application process, Shell filed a joint Shell Scotford Upgrader application/Environmental Impact Assessment. Issues considered with respect to these applications were: technology selection, air/health, sulphur recovery, noise/traffic, and land use conflict. Shell stated that its Scotford refinery is the most energy efficient refinery in the Americas and that is has the highest liquid yield per unit volume of crude oil feedstock of any refinery in the world. The refinery's hydrocracking capacity would make it possible to use hydro-conversion technology for its upgrader which is environmentally advantageous. After examining all of the evidence pertaining to the applications, the Board found the projects to be in the public interest and is prepared to approve the Scotford Upgrader and Scotford Refinery modifications assuming that certain prescribed conditions are met

Follow up Evaluation of Air Force Blood Donors Screening Positive for Chagas Disease

Science.gov (United States)

2017-10-05

59 MDW/SGVU SUBJECT: Professional Presentation Approval 31 JULY2017 Your paper, entitled Follow-up Evaluation of Air Force Blood Donors Screening...PUBLISHED OR PRESENTED: Follow-up Evaluation of Air Force Blood Donors Screening Positive for Chagas Disease 7. FUNDING RECEIVED FOR THIS STUDY? 0...PREVIOUS EDITIONS ARE OBSOLETE 50. DATE Page 3 of 3 Pages Follow-up Evaluation of Air Force Blood Donors Screening Positive for Chagas Disease

Applicant's guide related to requests of shipping approval and of acceptance of parcel models or radioactive products aimed at civilian use transported on public road - Guide nr 7 - Index 0, release of the 07/04/2009

International Nuclear Information System (INIS)

2009-01-01

This guide presents the recommendations made by the ASN to applicants in order to facilitate approval requests and shipping approvals related to the transportation of radioactive products. After a recall of the legal context, these recommendations address the documents to be provided in support of an approval request or of a shipping approval, the content of the safety file, the instruction delay, the approval certificate, and changes brought to the parcel model. Appendices contain issues raised by expertise based on experiences, the European PDSR (Package Design Safety Report), and a model for the elaboration of a certificate project

75 FR 82074 - Fee Adjustment for Testing, Evaluation, and Approval of Mining Products

Science.gov (United States)

2010-12-29

..., and Approval of Mining Products AGENCY: Mine Safety and Health Administration (MSHA), Labor. ACTION..., evaluating, and approving mining products as provided by 30 CFR part 5. MSHA charges applicants a fee to... materials manufactured for use in the mining industry. The new fee schedule, effective January 1, 2011, is...

Radioactive air emissions notice of construction and application for approval to construct the Hanford Waste Vitrification Plant

International Nuclear Information System (INIS)

1992-10-01

The Hanford Site is owned by the US Government and operated by the US Department of Energy, Richland Field Office. The Hanford Site manages and produces dangerous waste and mixed waste. (containing both radioactive and dangerous components). The US Department of Energy, Richland Field Office, currently stores mixed waste, resulting from various processing operations, in underground storage tanks. The Hanford Waste Vitrification Plant will be constructed and operated to process the high-activity fraction of mixed waste stored in these underground tanks. The Hanford Waste Vitrification Plant will solidify pretreated tank waste into a glass product that will be packaged for disposal in a national repository. Emissions from the Hanford Waste Vitrification Plant will be regulated by both the federal and state Clean Air Acts. The proposed Hanford Waste Vitrification Plant represents a new source of radioactive air emissions. Construction of the plant will require approval from both federal and state agencies. The Notice of Construction and Application for Approval to Construct the Hanford Waste Vitrification Plant contains information required under Title 40 of the Code of Federal Regulations, Chapter 61; and Chapter 246-247 of the Washington Administrative Code for a proposed new source of radioactive air emissions. The document contents are based on information contained in the Hanford Waste Vitrification Plant Reference Conceptual Design Report, the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report, Revision 0, and subsequent design changes made before August 1, 1992. The contents of this document may be modified to include more specific information generated during subsequent detailed design phases. Modifications will be submitted for regulatory review and approval, as appropriate

From initial application to routine operation: Reviewing the Applications for Power Uprates

International Nuclear Information System (INIS)

Garis, Ninos; Skaanberg, Lars

2007-01-01

Current plans for power uprates in Swedish nuclear power plants will lead to significant increases in seven units and a lesser increase in one unit. To date SKI has received six applications, and two more are due in 2007. A power uprate process is initiated by the application to the Government by a licensee for approval to increase the thermal output of a reactor unit. This request is addressed to the Government and is forwarded to SKI for a preliminary safety review. The result of the review is then provided by SKI as a basis for a governmental decision. Six applications have been taken through the first stage of the process; of these, three have received governmental approval and three are currently awaiting a decision. If the licensee's application is approved by the Government, deeper analyses and studies are required in order to modify the plant and update the safety analysis report and the associated technical specifications. SKI reviews this material on a continuous basis prior to test and routine operation at the increased power level. There are four stages that require attention and review by SKI; 1. Review of the application to the Government for approval to operate at increased power levels, and preparation of a suitable answer. 2. Review and approval of the preliminary safety analysis report (PSAR) 3. Review and approval of the application for testing at the higher power level 4. Review and approval of routine operation at the higher power level. A thorough description of the handling of a power uprate process can be found in the SKI PM (SKI-PM 04:11) that is available on the SKI website (in Swedish)

Effect of extraluminal ATP application on vascular tone and blood flow in skeletal muscle

DEFF Research Database (Denmark)

Nyberg, Michael Permin; Al-Khazraji, Baraa K; Mortensen, Stefan P

2013-01-01

During skeletal muscle contractions, the concentration of ATP increases in muscle interstitial fluid as measured by microdialysis probes. This increase is associated with the magnitude of blood flow, suggesting that interstitial ATP may be important for contraction-induced vasodilation. However...... studied. The rat gluteus maximus skeletal muscle model was used to study changes in local skeletal muscle hemodynamics. Superfused ATP at concentrations found during muscle contractions (1-10 µM) increased blood flow by up to 400%. In this model, the underlying mechanism was also examined by inhibition...... in interstitial ATP concentrations increases muscle blood flow, indicating that the contraction-induced increase in skeletal muscle interstitial [ATP] is important for exercise hyperemia. The vasodilator effect of ATP application is mediated by NO and prostanoid formation....

[Subjective Level of Information and Information Needs of Patients with an Approved Rehabilitation Application and Patients at the End of Rehabilitation Results of a Written Survey].

Science.gov (United States)

Walther, Anna Lena; Schreiber, Dora; Falk, Johannes; Deck, Ruth

2017-08-01

Aim The aim of the study was to identify the subjective level of information and information needs of patients with an approved rehabilitation application and patients at the end of rehabilitation with regard to preferred subjects and kind of information transfer. Method Written survey with N=283 patients with approved rehabilitation application and N=388 patients at the end of rehabilitation. Results Both groups reported high information needs particularly regarding treatments during rehabilitation, rehabilitation aftercare and rehabilitation aims. A conversation with their physician, a brochure and a website are the preferred information pathways. Conclusion Taking into account the topics for which both groups require information and the preference regarding the kind of information transfer can make a valuable contribution for the development of needs-oriented information material. © Georg Thieme Verlag KG Stuttgart · New York.

Bridging the gap between sample collection and laboratory analysis: using dried blood spots to identify human exposure to chemical agents

Science.gov (United States)

Hamelin, Elizabeth I.; Blake, Thomas A.; Perez, Jonas W.; Crow, Brian S.; Shaner, Rebecca L.; Coleman, Rebecca M.; Johnson, Rudolph C.

2016-05-01

Public health response to large scale chemical emergencies presents logistical challenges for sample collection, transport, and analysis. Diagnostic methods used to identify and determine exposure to chemical warfare agents, toxins, and poisons traditionally involve blood collection by phlebotomists, cold transport of biomedical samples, and costly sample preparation techniques. Use of dried blood spots, which consist of dried blood on an FDA-approved substrate, can increase analyte stability, decrease infection hazard for those handling samples, greatly reduce the cost of shipping/storing samples by removing the need for refrigeration and cold chain transportation, and be self-prepared by potentially exposed individuals using a simple finger prick and blood spot compatible paper. Our laboratory has developed clinical assays to detect human exposures to nerve agents through the analysis of specific protein adducts and metabolites, for which a simple extraction from a dried blood spot is sufficient for removing matrix interferents and attaining sensitivities on par with traditional sampling methods. The use of dried blood spots can bridge the gap between the laboratory and the field allowing for large scale sample collection with minimal impact on hospital resources while maintaining sensitivity, specificity, traceability, and quality requirements for both clinical and forensic applications.

76 FR 41154 - Review and Approval of Projects

Science.gov (United States)

2011-07-13

..., production fluids, tophole water, and unconventional natural gas development. In order to encourage the reuse... techniques. The ``gallon one'' regulatory threshold currently applicable under the regulations to gas well... rulemaking; provide for administrative approval of interbasin transfers of flowback and production fluids...

Modelling blood safety

NARCIS (Netherlands)

Janssen, M.P.

2010-01-01

This thesis describes the development and application of methods and models to support decision making on safety measures aimed at preventing the transmission of infections by blood donors. Safety measures refer to screening tests for blood donors, quarantine periods for blood plasma, or methods for

Application of artificial intelligence (AI) concepts to the development of space flight parts approval model

Science.gov (United States)

Krishnan, Govindarajapuram Subramaniam

1997-12-01

The National Aeronautics & Space Administration (NASA), the European Space Agency (ESA), and the Canadian Space Agency (CSA) missions involve the performance of scientific experiments in Space. Instruments used in such experiments are fabricated using electronic parts such as microcircuits, inductors, capacitors, diodes, transistors, etc. For instruments to perform reliably the selection of commercial parts must be monitored and strictly controlled. The process used to achieve this goal is by a manual review and approval of every part used to build the instrument. The present system to select and approve parts for space applications is manual, inefficient, inconsistent, slow and tedious, and very costly. In this dissertation a computer based decision support model is developed for implementing this process using artificial intelligence concepts based on the current information (expert sources). Such a model would result in a greater consistency, accuracy, and timeliness of evaluation. This study presents the methodology of development and features of the model, and the analysis of the data pertaining to the performance of the model in the field. The model was evaluated for three different part types by experts from three different space agencies. The results show that the model was more consistent than the manual evaluation for all part types considered. The study concludes with the cost and benefits analysis of implementing the models and shows that implementation of the model will result in significant cost savings. Other implementation details are highlighted.

Self-monitored blood pressure: a role in clinical practice?

Science.gov (United States)

Padfield, Paul L

2002-02-01

Electronic self-monitoring of blood pressure is increasing in popularity and most international guidelines on the management of hypertension approve cautious use of the technique in the assessment of potentially hypertensive individuals. A recent editorial in the Archives of Internal Medicine suggested that it was "appropriate to encourage the widespread use of self recorded BP as an important adjunct to the clinical care of the patient with hypertension". Such a statement is based on increasing evidence that self-monitoring of blood pressure gives similar information to daytime ambulatory blood pressure -- a now well-established technology in the management of hypertension. Suggested strategies for the use of self-monitoring of blood pressure include monitoring in individuals whose clinical risk status is low enough that they need not necessarily be given medical therapy simply on the basis of a clinic pressure (i.e. at a 10 year risk of cardiovascular disease below 20%). The threshold for defining 'normotension/hypertension' is now regarded as being broadly similar for ABPM and SBPM and is set at 135/85 mmHg. In a recent meta-analysis of all available studies the average difference between these techniques, using the same patients, is -1.7/1.2 mmHg. There is some evidence that careful use of self-monitoring may improve blood pressure control in patients who are otherwise resistant to care. Self-monitoring of blood pressure has now been shown in at least one major prospective study to predict outcome better than clinic pressures and in that setting it now has equivalence to the use of ABPM. There remain issues regarding the availability of validated devices, the quality of training of patients in their use and the possibility that inaccurate recording might occur, either deliberately or by accident. Self-monitoring of blood pressure may well not give the same readings as carefully measured blood pressure by research nurses but its use is clearly superior to

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.

Free blood donation mobile applications.

Science.gov (United States)

Ouhbi, Sofia; Fernández-Alemán, José Luis; Toval, Ambrosio; Idri, Ali; Pozo, José Rivera

2015-05-01

Blood donation (BD) is a noble act and mobile applications (apps) can help increase awareness about it. This paper analyzes and assesses the characteristics of free apps for BD as regards features and functionality. A search in Google Play, Apple Apps store, Blackberry App World and Windows Mobile App store was carried out to select 169 free BD apps from the 188 apps identified. The results presented in this paper show that the majority of the apps selected have been developed for the Android operating system. Moreover, most of the apps selected are available to help users search for donors. Few of the apps could not be installed and/or accessed. Of those that could be installed: half of them do not require any kind of authentication; a few of them are available in more than one language; half of them have a geographical restriction; around 60 % of them do not notify the user of BD events and requests; one, which is available for Android and iOS, can connect with a laboratory; around 45 % of them allow users to share information via social networks, and the majority of them do not provide BD recommendations. These results are used as a basis to provide app developers with certain recommendations. There is a need for better BD apps with more features in order to increase the number of volunteer donors.

Basic and clinical application progression of invigorating blood and dissolving stasis Chinese medicine in ophthalmology

Directory of Open Access Journals (Sweden)

Ying Wang

2017-06-01

Full Text Available Invigorating blood and dissolving stasis method is a kind of unique therapy of Traditional Chinese Medicine(TCMtreatment, which efficacy has become increasingly prominent in the treatment of ophthalmology. With the further studies of blood stasis and invigorating blood and dissolving stasis therapy, it is widely used in clinical ophthalmology, and get good effects beyond thought, especially when western medicine has no curative effects. It improved the cure rate of fundus oculi disease from the eyelids, conjunctiva, lacrimal sac, vitreous body to the choroid and retina, optic nerve and macula lutea, from surface to fundus, or pathological changes related to inflammation, degeneration, necrosis, atrophy, hyperplasia of fibrous tissue hyperplasia. This paper is aim to explain the definition of invigorating blood and dissolving stasis and make a review of basic research and clinical application about it in several diseases.

Dried blood spot measurement: application in tacrolimus monitoring using limited sampling strategy and abbreviated AUC estimation.

Science.gov (United States)

Cheung, Chi Yuen; van der Heijden, Jaques; Hoogtanders, Karin; Christiaans, Maarten; Liu, Yan Lun; Chan, Yiu Han; Choi, Koon Shing; van de Plas, Afke; Shek, Chi Chung; Chau, Ka Foon; Li, Chun Sang; van Hooff, Johannes; Stolk, Leo

2008-02-01

Dried blood spot (DBS) sampling and high-performance liquid chromatography tandem-mass spectrometry have been developed in monitoring tacrolimus levels. Our center favors the use of limited sampling strategy and abbreviated formula to estimate the area under concentration-time curve (AUC(0-12)). However, it is inconvenient for patients because they have to wait in the center for blood sampling. We investigated the application of DBS method in tacrolimus level monitoring using limited sampling strategy and abbreviated AUC estimation approach. Duplicate venous samples were obtained at each time point (C(0), C(2), and C(4)). To determine the stability of blood samples, one venous sample was sent to our laboratory immediately. The other duplicate venous samples, together with simultaneous fingerprick blood samples, were sent to the University of Maastricht in the Netherlands. Thirty six patients were recruited and 108 sets of blood samples were collected. There was a highly significant relationship between AUC(0-12), estimated from venous blood samples, and fingerprick blood samples (r(2) = 0.96, P AUC(0-12) strategy as drug monitoring.

[Responsibility: Towards a fifth principle in blood transfusion's ethics. Applicability and limits of Hans Jonas's responsibility principle].

Science.gov (United States)

Nélaton, C

2016-09-01

Nowadays, in France, anonymity, gratuity, volunteering, non-profit are recognized as ethical principles in blood transfusion. Can we add responsibility to this list? Can a logo named "Responsiblood" efficiently encourage blood donation? This article explores Hans Jonas's reform of the responsibility concept in order to measure its applicabilities and limits in the field of blood transfusion. Indeed, this concept - rethought by Jonas - seems to be a good encouragement which avoids the pitfalls of the concept of duty and of the idea of payment for blood donation. But can't we also see in this reform a threat to blood transfusion because of technophobia and the heuristics of fear that it involves? Copyright © 2016 Elsevier Masson SAS. All rights reserved.

75 FR 27863 - Savings Bank of Maine, MHC and Savings Bank of Maine, Gardiner, Maine; Approval of Conversion...

Science.gov (United States)

2010-05-18

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-38: OTS Nos. 06947 and H 4709] Savings Bank of Maine, MHC and Savings Bank of Maine, Gardiner, Maine; Approval of Conversion Application Notice is hereby given that on May 7, 2010, the Office of Thrift Supervision approved the application of...

Joint protocol relating to the application of the Vienna Convention and the Paris Convention. Signature, ratification, acceptance, approval or accession. Status as of 31 December 1996

International Nuclear Information System (INIS)

1997-01-01

The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 31 December 1996. The Joint Protocol entered into force on 27 April 1992

Joint protocol relating to the application of the Vienna Convention and the Paris Convention. Signature, ratification, acceptance, approval or accession. Status as of 31 December 1996

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-02-28

The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 31 December 1996. The Joint Protocol entered into force on 27 April 1992.

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...

[Survey of blood donors on the topic of "reimbursement for blood donors"].

Science.gov (United States)

Zeiler, T; Kretschmer, V

1995-02-01

Remuneration for blood donors, in the way as presently handled by governmental and communal blood transfusion services in Germany, is not generally accepted. It is feared that donors are recruited with increased risk to transmit infectious diseases, especially AIDS. Alternative incentives are discussed. After the so-called AIDS scandal in Germany, a change in the donor motivation was to be expected, associated with an increased willingness to renounce remuneration. Therefore, we performed the present survey, in which we evaluated the donor's willingness to renounce remuneration, possibilities of cashless remuneration and other alternative incentives. During March and April 1994, a total of 1,157 blood donors of the University Blood Bank Marburg were questioned anonymously by a questionnaire in the framework of whole-blood donations. Beside the above-mentioned aspects demoscopic data were included (age, sex, profession, journey). Cutting of remuneration without any other compensation was refused by 86.1% of the donors, 77% would not want to further donate blood in this case. Transfer of money to a bank account instead of cash payment was accepted by 78.6%, the use of non-negotiable cheques by 68.7%. Alternative compensation by tickets for theater, concert, cinema or coupons for restaurants met with the approval of only 27.3%; under these circumstances, 36.9% would be willing to continue blood donation. With increasing age and number of donations, but largely independent of social status, donors attached greater importance to retention of remuneration. Cutting of remuneration would result in a considerable reduction of the willingness to donate blood within the population of donors of the governmental and communal blood transfusion services. However, an increase of virus safety of the blood products would not be reached in this way, since especially the long-term donors would be driven away. Considerable bottlenecks, particularly in the specific blood supply of

30 CFR 7.83 - Application requirements.

Science.gov (United States)

2010-07-01

...) Injector nozzle; (9) Injection fuel pump; (10) Governor; (11) Turbocharger, if applicable; (12) Aftercooler... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in Underground Coal Mines § 7.83 Application requirements. (a) An application for approval of a diesel engine...

Application for Approval : White Rose Canada-Newfoundland Benefits Plan and White Rose Development Plan : Decision 2001.01

International Nuclear Information System (INIS)

Stanley, H.H.

2001-01-01

The White Rose offshore oil development project is located in the Jeanne d'Arc Basin 350 km east of Newfoundland. It is a co-venture between Husky Oil Operations Ltd. and Petro-Canada. The project is expected to recover 230 million barrels of oil over a 12 year period. This report explains the decision of the Canada-Newfoundland Offshore Petroleum Board regarding the application by Husky Oil and its partner for approval of its plans for the development of the White Rose oil field. The White Rose Development Plan describes the proponent's interpretation of the geology and reservoir characteristics of the oil field and provides estimates of hydrocarbon reserves. The drilling approach that the proponents plan to use at their facilities were also described along with the environmental parameters of the facilities. The Board's responsibility is to ensure that hydrocarbons are produced in accordance with good oil field practice including efficient recovery, prevention of waste and safe operational practices. The White Rose Canada-Newfoundland Benefits Plan addresses issues in the areas that will benefit the province, including: an East Coast Regional Office in St. John's, Newfoundland; employment; research and development; goods and services; disadvantaged individuals and groups; and monitoring and reporting. In terms of protection of the environment, the Board makes its assessment under the guidance of the Canadian Environmental Assessment Act which deals with issues such as the effects of routine releases of greenhouse gas emissions, drilling discharges, production discharges and accidental discharges. It also sets rules for decommissioning and abandonment of floating production, storage and off loading vessels and underwater facilities. The Board considered the application and has decided to approve the Benefits Plan, subject to certain conditions described in this report. tabs., figs., appendices

Frequency distribution of ABO and Rh (D) blood group alleles in ...

African Journals Online (AJOL)

Kassahun Tesfaye

2014-09-22

Sep 22, 2014 ... Rh (D). Abstract Background: Frequency distribution of blood groups is important as it is used in mod- ern medicine ... sion practice. The need for ... The study design was approved by the Research Ethics Com- mittee, College ...

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...

Standardization and application of indirect ELISA for diagnosis of Mycoplasma bovis in bovine blood serum samples

Directory of Open Access Journals (Sweden)

Samira Moraes Cunha de Mesquita

2015-06-01

Full Text Available ABSTRACT. Mesquita S.M.C., Mansur F.J., Nascimento E.R., Barreto M.L. & Kimura L.M.S. [Standardization and application of indirect ELISA for diagnosis of Mycoplasma bovis in bovine blood serum samples.] Padroniza- ção e aplicação de ELISA indireto para diagnóstico de Mycoplasma bovis em amostras de soro sanguíneo bovino. Revista Brasileira de Medicina Veterinária, 37(2:101-107, 2015. Universidade Federal Fluminense, Faculdade de Veteriná- ria, Rua Vital Brazil Filho, 64, Vital Brazil, Niterói, RJ 24230-340, Brasil. E-mail: samira.veterinaria@gmail.com International researchers presented results indicating frequent involvement of Mycoplasma spp. as a causative agent of mastitis in cattle, associating its presence with significant economic losses to farmers. Mycoplasma bovis is the species most reported and relevant, because it causes more severe disease. The level of antibodies against M. bovis remains high for several months and can be detected by ELISA. The aim of this work was to develop an indirect ELISA with whole cell antigen of M. bovis (strain Donetta PG 45 with subsequent application in bovine blood serum samples for detection of antibodies against M. bovis. The immunization of cows A and B by inoculating an immunogen against M. bovis to obtain hyperimmune blood serum was the first stage of this work, then the stage of standardization of ELISA was proceeded. The concentration of 2 mg of antigen/mL for coating the microtiter plates was decided by statistical analyses. The optical density value 0,2 was determined as the limit of reactivity discrimination of samples (the cut-off point. The hyperimmune blood serum sample of the cow A (collected 30 days after immunization was chosen as the positive control and, the fetal calf serum was chosen as negative control of the assay. In addition, the ideal optimal dilutions found for blood serum samples was 1:400 and for conjugate was 1:10.000 and the substrate used was the ortho

Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC Approved Packages

International Nuclear Information System (INIS)

1993-10-01

This directory contains a Report of NRC Approved Packages (Volume 1). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

15 CFR 400.32 - Procedure for review of request for approval of manufacturing or processing.

Science.gov (United States)

2010-01-01

... approval of manufacturing or processing. 400.32 Section 400.32 Commerce and Foreign Trade Regulations... REGULATIONS OF THE FOREIGN-TRADE ZONES BOARD Manufacturing and Processing Activity-Reviews § 400.32 Procedure for review of request for approval of manufacturing or processing. (a) Request as part of application...

Joint protocol relating to the application of the Vienna Convention and the Paris Convention. Status list as of 12 September 2000. Signature, ratification, acceptance, approval or accession

International Nuclear Information System (INIS)

2000-01-01

The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 12 September 2000. The Joint Protocol entered into force on 27 April 1992

Joint Protocol relating to the application of the Vienna Convention and the Paris Convention. Status list as of 30 September 2002. Signature, ratification, acceptance, approval or accession

International Nuclear Information System (INIS)

2002-01-01

The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 30 September 2002. The Joint Protocol entered into force on 27 April 1992

14 CFR 121.909 - Approval of Advanced Qualification Program.

Science.gov (United States)

2010-01-01

... criteria. Each AQP must have separate curriculums for indoctrination, qualification, and continuing... the training and evaluation of CRM and technical skills and knowledge. An application for approval of... must meet all the requirements of this subpart. (2) Each indoctrination, qualification, and continuing...

Radioprotective activity of curcumin-encapsulated liposomes against genotoxicity caused by Gamma Cobalt-60 irradiation in human blood cells.

Science.gov (United States)

Nguyen, Minh-Hiep; Pham, Ngoc-Duy; Dong, Bingxue; Nguyen, Thi-Huynh-Nga; Bui, Chi-Bao; Hadinoto, Kunn

2017-11-01

While the radioprotective activity of curcumin against genotoxicity has been well established, its poor oral bioavailability has limited its successful clinical applications. Nanoscale formulations, including liposomes, have been demonstrated to improve curcumin bioavailability. The objective of the present work was (1) to prepare and characterize curcumin-encapsulated liposomes (i.e. size, colloidal stability, encapsulation efficiency, and payload), and (2) subsequently to evaluate their radioprotective activity against genotoxicity in human blood cells caused by Gamma Cobalt-60 irradiation. The curcumin-encapsulated liposomes were prepared by lipid-film hydration method using commercial phosphatidylcholine (i.e. Phospholipon ® 90G). The blood cells were obtained from healthy male donors (n = 3) under an approved ethics protocol. The cell uptake and the radioprotective activity of the curcumin-encapsulated liposomes were characterized by fluorescence microscopy and micronucleus assay, respectively. Nanoscale curcumin-encapsulated liposomes exhibiting good physical characteristics and successful uptake by the human blood cells were successfully prepared. The radioprotective activity of the curcumin-encapsulated liposomes was found to be dependent on the curcumin concentration, where an optimal concentration existed (i.e. 30 μg/mL) independent of the irradiation dose, above which the radioprotective activity had become stagnant (i.e. no more reduction in the micronuclei frequency). The present results established for the first time the radioprotective activity of curcumin-encapsulated liposomes in human blood cells, which coupled by its well-established bioavailability, boded well for its potential application as a nanoscale delivery system of other radioprotective phytochemicals.

78 FR 40270 - Sunnyside Federal Savings and Loan Association of Irvington, Irvington, New York; Approval of...

Science.gov (United States)

2013-07-03

... DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency [OCC Charter Number 702397] Sunnyside Federal Savings and Loan Association of Irvington, Irvington, New York; Approval of Conversion...) approved the application of Sunnyside Federal Savings and Loan Association of Irvington, Irvington, New...

Update on the use of blood and blood products in ruminants.

Science.gov (United States)

Balcomb, Christie; Foster, Derek

2014-07-01

The use of whole blood and/or blood products is indicated in ruminant medicine. The goal of this article is to summarize previous literature on blood groups in ruminants and camelids, list indications for transfusion, and describe collection and transfusion techniques applicable to small ruminants and cattle that can be used in practice. Copyright © 2014 Elsevier Inc. All rights reserved.

Absorbed dose calculations to blood and blood vessels for internally deposited radionuclides

International Nuclear Information System (INIS)

Akabani, G.; Poston, J.W. Sr.

1992-01-01

At present, absorbed dose calculations for radionuclides in the human circulatory system use relatively simple models and are restricted in their applications. To determine absorbed doses to the blood and to the surface of the blood vessel wall, Monte Carlo calculations were performed using the code Electron Gamma Shower (EGS4). Absorbed doses were calculated for the blood and the blood vessel wall (lumen) for different blood vessel sizes. The radionuclides chosen for this study were those commonly used in nuclear medicine. No diffusion of the radionuclide into the blood vessel was or cross fire between blood vessels was assumed. Results are useful in assessing the doses to blood and blood vessel walls for different nuclear medicine procedures

75 FR 12251 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

Science.gov (United States)

2010-03-15

... Lenders. OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

78 FR 17937 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

Science.gov (United States)

2013-03-25

... Lenders. OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

77 FR 63323 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

Science.gov (United States)

2012-10-16

... Lenders OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

Radiolabelled blood cells

Energy Technology Data Exchange (ETDEWEB)

Lavender, J.P.

1986-12-01

After the introduction of gamma-emitting labels for blood-cells the use of radio-labelled blood cells is not only limited to kinetics of blood cells but it is also possible to localise inflammations, abscesses and thrombus. The most commonly applied label for red cells is Tc-99m. The most widely used technique for labelling granulocytes or platelets is In-111-oxine. In future the labelling of blood cells will be more simple and more specific due to monoclonal antibodies onto the platelet or the granulocyte cell surface. Labelled red cells have their main application in blood-pool imaging and in localisation of gastrointestinal bleeding. Besides the determination of the platelet life-span in haematologic disorders labelled platelets allow to localise thrombus and to show abnormal vasculature in the rejecting kidney. The commonest application for In-111-oxin labelled granulocytes is to show abdominal inflammations to localise inflamed bowel segments and to assess the inflammatory activity in chronic inflammatory bowel diseases. Moreover brain abscesses, bone sepsis and lung sepsis can be identified.

Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products. Final rule.

Science.gov (United States)

2015-07-08

The Food and Drug Administration (FDA or the Agency) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.

Absorbed dose calculations to blood and blood vessels for internally deposited radionuclides

International Nuclear Information System (INIS)

Akabani, G.; Poston, J.W.

1991-05-01

At present, absorbed dose calculations for radionuclides in the human circulatory system used relatively simple models and are restricted in their applications. To determine absorbed doses to the blood and to the surface of the blood vessel wall, EGS4 Monte Carlo calculations were performed. Absorbed doses were calculated for the blood and the blood vessel wall (lumen) for different blood vessels sizes. The radionuclides chosen for this study were those commonly used in nuclear medicine. No diffusion of the radionuclide into the blood vessel was assumed nor cross fire between vessel was assumed. Results are useful in assessing the dose in blood and blood vessel walls for different nuclear medicine procedures. 6 refs., 6 figs., 5 tabs

12 CFR 225.12 - Transactions not requiring Board approval.

Science.gov (United States)

2010-01-01

... Merger Act. The merger or consolidation of a subsidiary bank of a bank holding company with another bank... application under this subpart if it determines that the merger or consolidation would have a significant adverse impact on the financial condition of the bank holding company, or otherwise requires approval...

Considerations, clues and challenges: Gaining Ethical and Trust research approval when using the NHS as a research setting

International Nuclear Information System (INIS)

Jonker, Leon; Cox, Diane; Marshall, Gill

2011-01-01

Substantial changes have been made in recent years to the process of obtaining ethical and research governance approval for research projects in the NHS. The advent of the Integrated Research Application System (IRAS) has streamlined the process, providing a single point of entry. Ethical approval gained in one part of the country is now valid throughout the UK. The previous process of gaining research governance approval in NHS Trusts was maligned and it has been overhauled with the introduction of the National Institute of Health Research (NIHR) Coordinated System for gaining NHS Permission. In addition to updating the reader about the new processes around gaining ethical and Trust approval for research within an NHS setting, essential research project documentation needed for submission are discussed. The aspects of a proposal that Ethics Committees and Trust R and D Departments consider when reviewing applications are highlighted. The implemented changes to the research approval processes will mostly benefit large multi-centre studies; small scale unfunded studies and student projects are potentially at risk of being marginalised in the quest for a streamlined ethics and NHS Trust research governance approval process. However, researchers' familiarity with the approval system should minimise rejection rates and delays.

Considerations, clues and challenges: Gaining Ethical and Trust research approval when using the NHS as a research setting

Energy Technology Data Exchange (ETDEWEB)

Jonker, Leon, E-mail: leon.jonker@cumbria.ac.uk [Faculty of Health and Wellbeing, University of Cumbria, Lancaster LA1 3JD (United Kingdom); Research and Development Department, North Cumbria University Hospitals NHS Trust, Carlisle CA2 7HY (United Kingdom); Cox, Diane; Marshall, Gill [Faculty of Health and Wellbeing, University of Cumbria, Lancaster LA1 3JD (United Kingdom)

2011-08-15

Substantial changes have been made in recent years to the process of obtaining ethical and research governance approval for research projects in the NHS. The advent of the Integrated Research Application System (IRAS) has streamlined the process, providing a single point of entry. Ethical approval gained in one part of the country is now valid throughout the UK. The previous process of gaining research governance approval in NHS Trusts was maligned and it has been overhauled with the introduction of the National Institute of Health Research (NIHR) Coordinated System for gaining NHS Permission. In addition to updating the reader about the new processes around gaining ethical and Trust approval for research within an NHS setting, essential research project documentation needed for submission are discussed. The aspects of a proposal that Ethics Committees and Trust R and D Departments consider when reviewing applications are highlighted. The implemented changes to the research approval processes will mostly benefit large multi-centre studies; small scale unfunded studies and student projects are potentially at risk of being marginalised in the quest for a streamlined ethics and NHS Trust research governance approval process. However, researchers' familiarity with the approval system should minimise rejection rates and delays.

NMR blood vessel imaging method and apparatus

International Nuclear Information System (INIS)

Riederer, S.J.

1988-01-01

A high speed method of forming computed images of blood vessels based on measurements of characteristics of a body is described comprising the steps of: subjecting a predetermined body area containing blood vessels of interest to, successively, applications of a short repetition time (TR) NMR pulse sequence during the period of high blood velocity and then to corresponding applications during the period of low blood velocity for successive heart beat cycles; weighting the collected imaging data from each application of the NMR pulse sequence according to whether the data was acquired during the period of high blood velocity or a period of low blood velocity of the corresponding heart beat cycle; accumulating weighted imaging data from a plurality of NMR pulse sequences corresponding to high blood velocity periods and from a plurality of NMR pulse sequences corresponding to low blood velocity periods; subtracting the weighted imaging data corresponding to each specific phase encoding acquired during the high blood velocity periods from the weighted imaging data for the same phase encoding corresponding to low blood velocity periods in order to compute blood vessel imaging data; and forming an image of the blood vessels of interest from the blood vessel imaging data

Requirements, guidance and logic in planning environmental investigations: Approval versus implementation

International Nuclear Information System (INIS)

Brice, D.A.; Meredith, D.V.; Harris, M.Q.

1993-01-01

In today's litigious society, it is important for both private parties and government to plan and conduct environmental investigations in a scientifically sound manner, documenting the purpose, methods, and results in a consistent fashion throughout the exercise. Planning documents are prepared during the initial phases of environmental investigations. Project objectives, including data quality requirements, specific work to be conducted to fulfill data needs, and operating procedures are specified. Regulatory agency approval of these documents is often required prior to plan implementation. These approvals are necessary and appropriate to fulfilling the agency's mandated role. Many guidance documents prepared by regulatory agencies suggest the content and format of various scoping documents. These guidances help standardize thought processes and considerations in planning, and provide a template to ensure that both the plan and the proposed work will fulfill regulatory requirements. This work describes the preparation and use of guidance documents for planning environmental studies. The goals and some of the pitfalls of such documents are discussed. Guidance should include the following elements: the purpose of the guidance and a description of where it applies; the type of items to be addressed in planning; identification of requirements are applicable to all projects for which the guidance is intended; identification of requirements only applicable in certain situations; a description of items to facilitate planning; a suggested format for fulfilling requirements; example applications of the guidance. Disagreements arise between planners and reviewers/approvers when elements of guidance are used as leverage to require work not directly related to project objectives. Guidance may be inappropriately used as a milestone by which site-specific plans are judged. Regulatory agency review and approval may be regarded as a primary objective of the plan

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

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.

Approval of devices and facilities using ionizing radiations for medical purposes

International Nuclear Information System (INIS)

1977-01-01

This Order made by the Ministers of Health and Social Security, Agriculture and Labour amends a previous Decree of 23 April 1969 in particular concerning the classification of medical or dental radiodiagnostic devices subject to approval. The technical conditions to be complied with for such devices and facilities have also been amended. Finally, it is provided that, as regards facilities with heavy equipment subject to licensing (Act of 31 December 1970), approval is subject to compliance with the licensing conditions and is requested together with the application for a licence. (NEA) [fr

22 CFR 3a.4 - Procedure for requesting approval.

Science.gov (United States)

2010-04-01

... is also required by law for the applicant's acceptance of civil employment from a foreign government... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Procedure for requesting approval. 3a.4 Section 3a.4 Foreign Relations DEPARTMENT OF STATE GENERAL ACCEPTANCE OF EMPLOYMENT FROM FOREIGN GOVERNMENTS...

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.

[Applications and approved projectsof general program, young scientist fund and fund for less developedregion of national natural science funds in discipline of Chinese materia medica, NSFC in 2012].

Science.gov (United States)

Huang, Ming-Qing; Han, Li-Wei; Wu, Xiu-Hong; Bi, Ming-Gang; Shang, Hong-Cai; Liu, Yun-Fang; He, Wei-Ming; Li, Dan-Dan; Dong, Yan; Wang, Chang-En

2013-01-01

The applications accepted and approved by general program, young scientist fund and fund for less developed region of national natural science funds in the discipline of Chinese materia medica, NSFC in 2012 have been introduced. The research contents of the funded projects in the popular research areas have been summarized and the problems in the applications have been analyzed to give a reference to the scientists in the field of Chinese materia medica.

78 FR 60763 - Clarification on Fireworks Policy Regarding Approvals or Certifications for Firework Series

Science.gov (United States)

2013-10-02

... 173 [Docket No. PHMSA-2013-0205; Notice No. 13-14] Clarification on Fireworks Policy Regarding Approvals or Certifications for Firework Series AGENCY: Pipeline and Hazardous Materials Safety... applications for firework device series. PHMSA has required separate applications for each individual firework...

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...

High intensity focused ultrasound technology, its scope and applications in therapy and drug delivery.

Science.gov (United States)

Phenix, Christopher Peter; Togtema, Melissa; Pichardo, Samuel; Zehbe, Ingeborg; Curiel, Laura

2014-01-01

Ultrasonography is a safe, inexpensive and wide-spread diagnostic tool capable of producing real-time non-invasive images without significant biological effects. However, the propagation of higher energy, intensity and frequency ultrasound waves through living tissues can induce thermal, mechanical and chemical effects useful for a variety of therapeutic applications. With the recent development of clinically approved High Intensity Focused Ultrasound (HIFU) systems, therapeutic ultrasound is now a medical reality. Indeed, HIFU has been used for the thermal ablation of pathological lesions; localized, minimally invasive ultrasound-mediated drug delivery through the transient formation of pores on cell membranes; the temporary disruption of skin and the blood brain barrier; the ultrasound induced break-down of blood clots; and the targeted release of drugs using ultrasound and temperature sensitive drug carriers. This review seeks to engage the pharmaceutical research community by providing an overview on the biological effects of ultrasound as well as highlighting important therapeutic applications, current deficiencies and future directions.

42 CFR 409.87 - Blood deductible.

Science.gov (United States)

2010-10-01

..., from an individual or a blood bank, a replacement offer that meets the criteria specified in paragraph... replacement of blood. A blood replacement offer made by a beneficiary, or an individual or a blood bank on... red cells if the replacement blood meets the applicable criteria specified in Food and Drug...

Quantification of surgical blood loss.

Science.gov (United States)

Lee, Marcel H; Ingvertsen, Britt T; Kirpensteijn, Jolle; Jensen, Asger L; Kristensen, Annemarie T

2006-06-01

To compare gravimetric and colorimetric methods of quantifying surgical blood loss, and to determine if there is a correlation between preoperative hemostatic tests (buccal mucosa bleeding time [BMBT] and intraoperative blood loss). Prospective clinical study. Dogs (n=15) admitted for cutaneous tumor excision, orthopedic procedure, or exploratory laparotomy. Intraoperative blood loss was quantified by measuring irrigation fluid and weighing surgical sponges used for blood and fluid collection during surgery. Results of gravimetric measurements were then correlated to blood loss quantified using spectrophotometric analysis of hemoglobin (Hb) content. Hemostatic variables including BMBT were measured before surgery and compared with the calculated amount of blood loss. Blood loss quantified by gravimetric measurement showed a significant correlation with colorimetric determination of Hb content in surgical sponges and collected irrigation fluid (r=0.93, P<.0001). BMBT correlated weakly but significantly with intraoperative blood loss (r=0.56, P<.05). Quantifying intraoperative blood loss using spectrophotometric Hb analysis accurately assessed the amount of blood loss; however, it is a time-consuming procedure, primarily applicable as a research tool. Gravimetric evaluation of intraoperative blood loss was found to be an accurate method, which can be recommended for use in a clinical setting. Estimation of blood loss using a gravimetric method is accurate and applicable in the clinical setting and provides surgeons with a simple and objective tool to evaluate intraoperative blood loss.

7 CFR 762.130 - Loan approval and issuing the guarantee.

Science.gov (United States)

2010-01-01

... complete until all information required to make an approval decision, including the information for an... lender's loan or line of credit conditions and requirements since submission of the application (except... compensation, and personal life insurance (when required) are in effect; (iii) Truth in lending requirements...

40 CFR 57.405 - Formulation, approval, and implementation of requirements.

Science.gov (United States)

2010-07-01

... (CONTINUED) AIR PROGRAMS (CONTINUED) PRIMARY NONFERROUS SMELTER ORDERS Supplementary Control System...) Each NSO application shall include a complete description of any supplementary control system in... operational manual). (b) SCS content of the order. (1) Each NSO shall include an approved version of the plan...

30 CFR 57.22304 - Approved equipment (II-A mines).

Science.gov (United States)

2010-07-01

...) Cutting and drilling equipment used at a face or bench shall be approved by MSHA under the applicable requirements of 30 CFR parts 18 through 36. (b) While cutting or drilling is in progress, equipment not... nonapproved equipment is taken to a face or bench after blasting. (d) Mine power transformers and stationary...

An overview of leech and its therapeutic applications

Directory of Open Access Journals (Sweden)

Parimannan Sivachandran

2015-05-01

Full Text Available Hirudotherapy has a broad spectrum of therapeutic application in the medical field ranging from cardiology, gynaecology, ophthalmology, plastic and reconstructive surgeries. In medieval and early modern medicine, leeches were used to remove blood from patients in an attempt to balance the biological humours. Leeches are widely used to treat venous congestion in microvascular replantation, free and conventional flap surgery and traumatology. Recently, Food and Drug Administration has approved the usage of live leeches as medical device for therapeutic applications. Presently, some of the leech species have declined dramatically in its population due to the over utilization of leech for medicinal purposes and also due to pollution in several parts of the world particularly in European and Asian countries. This review presents an overview of leech including the history, biology, classification, and its application as medical device. Further, it also covers the controversies and misconception related to leech species identification and complications of post hirudotherapy.

Application of dried blood spot cards to determine olive oil phenols (hydroxytyrosol metabolites) in human blood.

Science.gov (United States)

de Las Hazas, María Carmen López; Motilva, Maria José; Piñol, Carme; Macià, Alba

2016-10-01

In this study, a fast and simple blood sampling and sample pre-treatment method based on the use of the dried blood spot (DBS) cards and ultra-performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS) for the quantification of olive oil phenolic metabolites in human blood was developed and validated. After validation, the method was applied to determine hydroxytyrosol metabolites in human blood samples after the acute intake of an olive oil phenolic extract. Using the FTA DMPK-A DBS card under optimum conditions, with 20µL as the blood solution volume, 100µL of methanol/Milli-Q water (50/50, v/v) as the extraction solvent and 7 disks punched out from the card, the main hydroxytyrosol metabolites (hydroxytyrosol-3-O-sulphate and hydroxytyrosol acetate sulphate) were identified and quantified. The developed methodology allowed detecting and quantifying the generated metabolites at low μM levels. The proposed method is a significant improvement over existing methods to determine phenolic metabolites circulating in blood and plasma samples, thus making blood sampling possible with the volunteer pricking their own finger, and the subsequent storage of the blood in the DBS cards prior to chromatographic analysis. Copyright © 2016 Elsevier B.V. All rights reserved.

Application of forensic luminol for blood detection in endodontic files

Directory of Open Access Journals (Sweden)

Rodrigo ARRUDA-VASCONCELOS

Full Text Available Abstract Introduction Blood is a biological material with high potential of infectious transmission in dental environments, including herpes simplex, hepatitis and AIDS. Aim To investigate the efficacy of luminol in detecting blood in endodontic files before and after the sterilization process. Material and method Luminol was used to investigate the presence or absence of traces of blood tissue in 50 endodontic files, visible to naked eye or not, after performing endodontic treatment and after the cleaning/sterilization process. The results obtained were tabulated and statistically analyzed by using the Friedman’s test at a significance level of 5% (p<0.05. Result By naked eye, it was found that 31/50 files showed no trace of blood, 8/50 showed a slight presence of blood and 11/50 showed a considerable presence of blood after endodontic treatment. After the use of luminol, however, 16/50 endodontic files showed no trace of blood, 19/50 showed a slight presence of blood and 15/50 showed a considerable presence of blood. After the cleaning and sterilization process, no blood was detected in the files. Conclusion It was concluded that the luminol solution is effective in detecting blood tissue in endodontic files as well as in validating the cleaning/sterilization process.

Waste feed delivery environmental permits and approvals plan

International Nuclear Information System (INIS)

Papp, I.G.

1998-01-01

This document describes the range of environmental actions, including required permits and other agency approvals, that may affect waste feed delivery (WFD) activities in the Hanford Site's Tank Waste Remediation System (TWRS). This plan expands on the summary level information in the Tank Waste Remediation System Environmental Program Plan (HNF 1773) to address requirements that are most pertinent to WFD. This plan outlines alternative approaches to satisfying applicable environmental standards, and describes selected strategies for acquiring permits and other approvals needed for WFD to proceed. Appendices at the end of this plan provide preliminary cost and schedule estimates for implementing the selected strategies. The rest of this section summarizes the scope of WFD activities, including important TWRS operating information, and describes in more detail the objectives, structure, and content of this plan

Fabrication of Semiordered Nanopatterned Diamond-like Carbon and Titania Films for Blood Contacting Applications.

Science.gov (United States)

Nandakumar, Deepika; Bendavid, Avi; Martin, Philip J; Harris, Kenneth D; Ruys, Andrew J; Lord, Megan S

2016-03-23

Biomaterials with the ability to interface with, but not activate, blood components are essential for a multitude of medical devices. Diamond-like carbon (DLC) and titania (TiO2) have shown promise for these applications; however, both support platelet adhesion and activation. This study explored the fabrication of nanostructured DLC and TiO2 thin film coatings using a block copolymer deposition technique that produced semiordered nanopatterns with low surface roughness (5-8 nm Rrms). These surfaces supported fibrinogen and plasma protein adsorption that predominantly adsorbed between the nanofeatures and reduced the overall surface roughness. The conformation of the adsorbed fibrinogen was altered on the nanopatterned surfaces as compared with the planar surfaces to reveal higher levels of the platelet binding region. Planar DLC and TiO2 coatings supported less platelet adhesion than nanopatterned DLC and TiO2. However, platelets on the nanopatterned DLC coatings were less spread indicating a lower level of platelet activation on the nanostructured DLC coatings compared with the planar DLC coatings. These data indicated that nanostructured DLC coatings may find application in blood contacting medical devices in the future.

ELECTRONIC COMPLIANCE AND APPROVAL PROJECT (ECAP)

Energy Technology Data Exchange (ETDEWEB)

Hope Morgan; Richard A. Varela; Deborah LaHood; Susan Cisco; Mary Ann Benavides; Donna Burks

2002-11-01

The Texas Railroad Commission (RRC), working in partnership with the United States Department of Energy and the oil and gas industry it regulates, is implementing a strategy for improving efficiency in regulations and significantly reducing administrative operating costs through the Electronic Compliance and Approval Process (ECAP). The project will streamline regulatory compliance and reporting by providing the ability to electronically submit, process, and query oil and gas applications and reports through the Internet-based ECAP system. Implementation of an ECAP drilling permit pilot project began September 1999 after funding resources were secured--a $700,000 grant from the U.S. Department of Energy and an appropriation of $1.4 million from the Texas Legislature. The pilot project involves creating the ability to file, review, and approve a well's drilling permit application through a completely electronic process. The pilot project solution will ultimately provide the infrastructure, technology, and electronic modules to enable the filing of all compliance permits and performance reports through the internet from a desktop computer. The pilot project was conducted in three phases. The first phase, implemented May 2000, provided the infrastructure that allows the electronic filing and approval of simple drilling permit applications, associated fees, and attachments. The official ''roll-out'' of ECAP and the first electronically filed drilling permit application occurred on May 11, 2000 in Dallas in conjunction with an Internet Workshop sponsored by the Petroleum Technology Transfer Council. After the completion of Phase I, the ECAP team conducted an extensive review of progress to date and analyzed requirements and opportunities for future steps. The technical team identified core infrastructure modifications that would facilitate and better support future development and expansion of the ECAP system and work began on database structure

78 FR 77203 - Agency Requests for Renewal of a Previously Approved Information Collection(s): War Risk...

Science.gov (United States)

2013-12-20

... Previously Approved Information Collection(s): War Risk Insurance, Applications and Related Information... determine the eligibility of the applicant and the vessel(s) for participation in the war risk insurance... Control Number: 2133-0011. Title: War Risk Insurance, Applications and Related Information. Form Numbers...

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 ...

IAEA Board of Governors approves IAEA action plan to combat nuclear terrorism

International Nuclear Information System (INIS)

2002-01-01

The IAEA Board of Governors today approved in principal an action plan designed to upgrade worldwide protection against acts of terrorism involving nuclear and other radioactive materials. In approving the plan, the Board has recognized that the first line of defense against nuclear terrorism is the strong physical protection of nuclear facilities and materials. 'National measures for protecting nuclear material and facilities are uneven in their substance and application,' the IAEA says. 'There is wide recognition that the international physical protection regime needs to be strengthened.'

Blood loss predictive factors and transfusion practice during percutaneous nephrolithotomy of kidney stones: a prospective study [version 1; referees: 1 approved, 2 approved with reservations

Directory of Open Access Journals (Sweden)

Firtantyo Adi Syahputra

2016-06-01

Full Text Available Objectives Bleeding is the most common complication of percutaneous nephrolithotomy (PCNL. Injudicious transfusion is frequently performed in current practice, even though it is not always needed. This study aimed to identify the predictive factors of blood loss in the PCNL procedure and evaluate the perioperative transfusion practice.   Methods A prospective study of PCNL was randomly performed by two consultants of endo-urology at our institution. The inclusion criteria were adults with kidney pelvic stones >20 mm or stone in inferior calyx >10 mm or staghorn stone. Those with coagulopathy, under anti-coagulant treatment or open conversion were excluded. A full blood count was taken at baseline and during 12, 24, 36, 72-hours post-operatively. Factors such as stone burden, sex, body surface area, shifting of hematocrit level and amount of blood transfused were analyzed statistically using line regression to identify the predictive factors of total blood loss (TBL.   Results Eighty-five patients were enrolled in this study. Mean TBL was 560.92 ± 428.43 mL for both endo-urology surgeons. Stone burden was the most influential factor for TBL (p=0.037. Our results revealed that TBL (mL = -153.379 + 0.229 × stone burden (mm2 + 0.203 x baseline serum hematocrit (%; thus considerably predicted the need for blood transfusion. A total of 87.1% patients did not receive perioperative transfusion, 3.5% received intra-operative transfusion, 7.1% received post-operative transfusion, 23% had both intra and post-operative transfusion, resulting in a cross-matched transfusion ratio of 7.72. Mean perioperative blood transfused was 356.00 ± 145.88 mL.

Safety regulation for the design approval of special form radioactive sources

International Nuclear Information System (INIS)

Cho, Woon-Kap

2009-01-01

Several kinds of special form radioactive sources for industrial, medical applications are being produced in Korea. Special form radioactive sources should meet strict safety requirements specified in the domestic safety regulations and the design of the sources should be certified by the regulatory authority, the Ministry of Education, Science and Technology (MEST). Several safety tests such as impact, percussion, heating, and leak tests are performed on the sources according to the domestic regulations and the international safety standards such as ANSI N542-1977 and ISO 2919-1999(E). As a regulatory expert body, Korea Institute of Nuclear Safety (KINS) assesses various types of application documents, such as safety analysis report, quality assurance program, and other documents evidencing fulfillment of requirements for design approval of the special form radioactive sources, submitted by a legal person who intends to produce special form radioactive sources and then reports the assessment result to MEST. A design approval certificate is issued to the applicant by MEST on the basis of a technical evaluation report presented by KINS.

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 ...

Microfluidic Devices for Blood Fractionation

Directory of Open Access Journals (Sweden)

Chwee Teck Lim

2011-07-01

Full Text Available Blood, a complex biological fluid, comprises 45% cellular components suspended in protein rich plasma. These different hematologic components perform distinct functions in vivo and thus the ability to efficiently fractionate blood into its individual components has innumerable applications in both clinical diagnosis and biological research. Yet, processing blood is not trivial. In the past decade, a flurry of new microfluidic based technologies has emerged to address this compelling problem. Microfluidics is an attractive solution for this application leveraging its numerous advantages to process clinical blood samples. This paper reviews the various microfluidic approaches realized to successfully fractionate one or more blood components. Techniques to separate plasma from hematologic cellular components as well as isolating blood cells of interest including certain rare cells are discussed. Comparisons based on common separation metrics including efficiency (sensitivity, purity (selectivity, and throughput will be presented. Finally, we will provide insights into the challenges associated with blood-based separation systems towards realizing true point-of-care (POC devices and provide future perspectives.

Unique identification code for medical fundus images using blood vessel pattern for tele-ophthalmology applications.

Science.gov (United States)

Singh, Anushikha; Dutta, Malay Kishore; Sharma, Dilip Kumar

2016-10-01

Identification of fundus images during transmission and storage in database for tele-ophthalmology applications is an important issue in modern era. The proposed work presents a novel accurate method for generation of unique identification code for identification of fundus images for tele-ophthalmology applications and storage in databases. Unlike existing methods of steganography and watermarking, this method does not tamper the medical image as nothing is embedded in this approach and there is no loss of medical information. Strategic combination of unique blood vessel pattern and patient ID is considered for generation of unique identification code for the digital fundus images. Segmented blood vessel pattern near the optic disc is strategically combined with patient ID for generation of a unique identification code for the image. The proposed method of medical image identification is tested on the publically available DRIVE and MESSIDOR database of fundus image and results are encouraging. Experimental results indicate the uniqueness of identification code and lossless recovery of patient identity from unique identification code for integrity verification of fundus images. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Novel stable dendrimersome formulation for safe bioimaging applications

Science.gov (United States)

Filippi, M.; Patrucco, D.; Martinelli, J.; Botta, M.; Castro-Hartmann, P.; Tei, L.; Terreno, E.

2015-07-01

Dendrimersomes are nanosized vesicles constituted by amphiphilic Janus dendrimers (JDs), which have been recently proposed as innovative nanocarriers for biomedical applications. Recently, we have demonstrated that dendrimersomes self-assembled from (3,5)12G1-PE-BMPA-G2-(OH)8 dendrimers can be successfully loaded with hydrophilic and amphiphilic imaging contrast agents. Here, we present two newly synthesized low generation isomeric JDs: JDG0G1(3,5) and JDG0G1(3,4). Though less branched than the above-cited dendrimers, they retain the ability to form self-assembled, almost monodisperse vesicular nanoparticles. This contribution reports on the characterization of such nanovesicles loaded with the clinically approved MRI probe Gadoteridol and the comparison with the related nanoparticles assembled from more branched dendrimers. Special emphasis was given to the in vitro stability test of the systems in biologically relevant media, complemented by preliminary in vivo data about blood circulation lifetime collected from healthy mice. The results point to very promising safety and stability profiles of the nanovesicles, in particular for those made of JDG0G1(3,5), whose spontaneous self-organization in water gives rise to a homogeneous suspension. Importantly, the blood lifetimes of these systems are comparable to those of standard liposomes. By virtue of the reported results, the herein presented nanovesicles augur well for future use in a variety of biomedical applications.Dendrimersomes are nanosized vesicles constituted by amphiphilic Janus dendrimers (JDs), which have been recently proposed as innovative nanocarriers for biomedical applications. Recently, we have demonstrated that dendrimersomes self-assembled from (3,5)12G1-PE-BMPA-G2-(OH)8 dendrimers can be successfully loaded with hydrophilic and amphiphilic imaging contrast agents. Here, we present two newly synthesized low generation isomeric JDs: JDG0G1(3,5) and JDG0G1(3,4). Though less branched than the above

Clinical applications of immunoglobulin: update

Directory of Open Access Journals (Sweden)

Marcia Cristina Zago Novaretti

2011-06-01

Full Text Available Human immunoglobulin is the most used blood product in the clinical practice. Immunoglobulin applications have increased quickly since the elucidation of its immunomodulatory and antiinflammatory properties which turned this blood product into a precious tool in the treatment of numerous diseases that present with humoral immune deficiency or that cause immune system dysfunction. Currently, the approved indications for Ig are: primary immunodeficiencies, secondary immunodeficiencies (multiple myeloma or chronic lymphoid leukemia, Kawasaki syndrome, immune thrombocytopenic purpura, Guillain Barré syndrome, graft-versus-host disease following bone marrow transplantation and repeat infections in HIV children. On the other hand, there are numerous "off-label" indications of immunoglobulin, which represent 20-60% of all clinical applications of this drug. It is important to study all these indications and, above all, the scientific evidence for its use, in order to provide patients with a new therapeutic option without burdening the health system. This review results from a wide selection of papers identified in the Pubmed and Lilacs scientific electronic databases. A group of descriptors were used from human immunoglobulin to the names of each disease that immunoglobulin is clinically applied. Our main objective is to list the numerous indications of immunoglobulin, both authorized and "off-label" and to analyze these indications in the light of the most recent scientific evidence.

Effects of ionizing radiation on blood and blood components: A survey

International Nuclear Information System (INIS)

1997-04-01

The present publication reviews, in a comprehensive manner, the relevant literature on the effects of ionizing radiation on whole blood, blood cells, and other blood components. It presents the interested reader with sufficient information and data to facilitate rational decisions in relation to the feasibility of irradiation of blood and blood products for the purposes stated above. The IAEA expects that this can promote a wider use of the technology for improving health care practice in Member States, particularly in view of the recent spread of conventional as well as ''modern'' diseases which exert immunosuppressive effects in afflicted patients, with pathological consequences. Innumerable patients could thus benefit from this application of ionizing energy. 209 refs, 1 tab

Guidelines for approved medical officers on health surveillance of radiation workers

International Nuclear Information System (INIS)

O'Donovan, N.; Hone, C.

1988-11-01

As a result of the adoption of the Council of the European Communities Directive No. 80/836 Euratom which lays down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation, there is a need for nominating Approved Medical Officers whose functions in respect of hospital workers are outlined in the Department of Health Circular, Oct. 1983 (Appendix 1), and which are considered applicable to all other workers. This document outlines the role of the Approved Medical Officer and proides information to aid him/her in this work (author)

13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

Science.gov (United States)

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT... § 302.18 of this chapter: (a) Strategy Grants shall comply with the applicable provisions of part 303 of...

The beneficial effect of Batroxobin on blood loss reduction in spinal fusion surgery

DEFF Research Database (Denmark)

Hu, Hui-Min; Chen, Li; Frary, Charles Edward

2015-01-01

Objective Our objective was to evaluate the efficacy and safety of Batroxobin on blood loss during spinal operations. Methods After obtaining approval from the ethics committee at the hospital along with informed written consent, we performed a double-blind, randomized, placebo-controlled study w...

New Applications of the Human Whole Blood Pyrogen Assay (PyroCheck).

Science.gov (United States)

Fennrich; Wendel; Hartung

1999-01-01

The absence of pyrogens in injectable drugs is an indispensable safety control because contaminants causing fever pose a life-threatening risk to the patient resulting in the worst case in death by shock. When fever- inducing agents, i.e.pyrogens, come into contact with the immunocompetent cells in blood, these cells release mediators which transmit the fever signal to the thermoregulatory centre of the brain. The Phamocopoeia lists currently two test systems for pyrogenicity: 1. The in vivo rabbit pyrogen test which measures the fever reaction following injection of the sample to the animals. 2. The in vitro Limulus Amebocyte Lysate assay (LAL) which measures the coagulation in a lysate prepared from the blood of the horseshoe crab specifically initiated by endotoxins, i.e. cell wall components from Gram-negative bacteria. The new test presented here (PyroCheck) exploits the reaction of monocytes/macrophages for the detection of pyrogens: human whole blood taken from healthy volunteers is incubated in the presence of the test sample in any form, be it a solution, a powder or even solid material. Pyrogenic contaminations initiate the release of the "endogenous pyrogen" Interleukin-1beta determined by ELISA after a fixed incubation time. The technology presently listed in the Pharmacopoeia is limited to parenteralia (rabbit test: biologicals and pharmaceuticals, LAL: predominantly pharmaceuticals). In the EU Medical Devices Directive from 1995 the rabbit pyrogen test for medical products is in some cases requested. (in some cases LAL of an eluate from the device). However, pyrogen-testing needs to cover also innovative high-tech products such as medical devices (implants, medical plastic materials, dialysis machines), cellular therapies and species-specific agents (e.g. recombinant proteins). Here we report that the human blood test PyroCheck is suitable for testing filters in air quality control as well as for assessing medical devices and biocompatibility

Exogenous applications of plant growth regulators influence the reproductive growth of citrus sinensis osbeck cv. blood red

International Nuclear Information System (INIS)

Khan, A.S.; Malik, A.U.; Ahmad, S.; Ahmad, I.

2014-01-01

To study the influence of exogenous applications of plant growth regulators on the reproductive behaviour of low bearing sweet orange (Citrus sinensis Osbeck) trees, three separate experiments were conducted on twelve years old 'Blood Red' Sweet orange trees budded on Rough Lemon (Citrus jambheri L.) root stock. In the first experiment, trees were sprayed with 20 mg L-1 2, 4-D and GA3 alone or in combination at mid bloom (MB) stage, whilst in the second and third experiments 20 mg L-1 2, 4-D and GA3 alone or in combination were sprayed at MB + 6 weeks after MB, and at MB + 22 and 28 weeks after MB stages, respectively. A single tree was selected as an experimental unit and each treatment was replicated four times. Data regarding the flowering intensity, flower drop, fruit set, fruit drop and fruit harvest percentages (%) were collected and analyzed statistically. In all experiments exogenous application of 20 mg L-1 2, 4-D and GA3 alone or in combination to Blood Red sweet orange trees reduced the flower drop % and increased the fruit set % as compared to untreated trees. Application 2, 4-D and GA3 alone or in combination at MB did not affect the fruit drop % and fruit harvest % in contrast to untreated trees. The trees sprayed with 20 mg L-1 GA3 alone or in combination with 2, 4-D at MB + 22 and 28 weeks after MB exhibited highest reduction in the fruit drop % compared to control trees. In conclusions application GA3 (20 mg L-1) alone or in combination of 2, 4-D (20 mg L-1) at MB + 22 and 28 weeks after MB can be used effectively to increase the fruit set and reduce the fruit drop in Blood Red sweet oranges. (author)

Evolution of blood pressure management in acute intracerebral hemorrhage [version 1; referees: 4 approved

Directory of Open Access Journals (Sweden)

Stacy Chu

2017-11-01

Full Text Available Intracerebral hemorrhage (ICH remains a prevalent and severe cause of death and disability worldwide. Control of the hypertensive response in acute ICH has been a mainstay of ICH management, yet the optimal approaches and the yield of recommended strategies have been difficult to establish despite a large body of literature. Over the years, theoretical and observed risks and benefits of intensive blood pressure reduction in ICH have been studied in the form of animal models, radiographic studies, and two recent large, randomized patient trials. In this article, we review the historical and developing data and discuss remaining questions surrounding blood pressure management in acute ICH.

Revised guideline for the approval procedure of package designs in Germany

International Nuclear Information System (INIS)

Nitsche, F.; Roedel, R.

2004-01-01

The IAEA Regulations for the Safe Transport of Radioactive Material, TS-R-1 are applied in Germany through the implementation of the Dangerous Goods Transport Regulations for class 7 of the International Modal Organisations (ADR, RID, IMDG-Code, ICAO-TI). Based on this the approval procedures for packages designs applied in Germany are in compliance with the provisions of TS-R-1. The Guideline R 003 issued by the Ministry of Transport, Building and Housing (BMVBW) in 1991 is the basis for the package design approval procedures in Germany. This Guideline has been reviewed and revised to reflect latest developments in the regulations as well as in the regulatory practice. In particular it has been extended to the approval procedures of Type C packages, packages subject to transitional arrangements, special form and low dispersible radioactive material and provides more detailed information to the applicant about the requested documentation. Publication of this revised guideline has been delayed but it is expected to take place in October 2004. The paper gives an overview about the main parts and provisions of this revised Guideline R 003 with the focus on package design approval procedures

Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective

Directory of Open Access Journals (Sweden)

von Dadelszen Peter

2010-07-01

Full Text Available Abstract Background For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs. In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN, to gain insight into the Canadian system. Methods The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Results Each REB had a different application form. Most (n = 9 had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days. Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. Conclusions For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review.

Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial

Directory of Open Access Journals (Sweden)

Latter David

2009-06-01

Full Text Available Abstract Background Diffuse microvascular bleeding remains a common problem after cardiac procedures. Systemic use of antifibrinolytic reduces the postoperative blood loss. The purpose of this study was to examine the effectiveness of local application of tranexamic acid to reduce blood loss after coronary artery bypass grafting (CABG. Methods Thirty eight patients scheduled for primary isolated coronary artery bypass grafting were included in this double blind, prospective, randomized, placebo controlled study. Tranexamic acid (TA group (19 patients received 1 gram of TA diluted in 100 ml normal saline. Placebo group (19 patients received 100 ml of normal saline only. The solution was purred in the pericardial and mediastinal cavities. Results Both groups were comparable in their baseline demographic and surgical characteristics. During the first 24 hours post-operatively, cumulative blood loss was significantly less in TA group (median of 626 ml compared to Placebo group (median of 1040 ml (P = 0.04. There was no significant difference in the post-op Packed RBCs transfusion between both groups (median of one unit in each (P = 0.82. Significant less platelets transfusion required in TA group (median zero unit than in placebo group (median 2 units (P = 0.03. Apart from re-exploration for excessive surgical bleeding in one patient in TA group, no difference was found in morbidity or mortality between both groups. Conclusion Topical application of tranexamic acid in patients undergoing primary coronary artery bypass grafting led to a significant reduction in postoperative blood loss without adding extra risk to the patient.

Autologous Blood Transfusion for Postpartum Hemorrhage.

Science.gov (United States)

Greenawalt, Julia A; Zernell, Denise

Postpartum hemorrhage (PPH) is a leading contributor to maternal morbidity and mortality in the United States and globally. Although the rate of PPH is generally decreasing nationally, severity of PPH appears to be increasing, potentially related to the various comorbidities associated with women of childbearing age. There is increasing evidence of risks associated with allogeneic blood transfusion, which has historically been the classic therapeutic approach for treatment to PPH. Pregnant women are particularly susceptible to the implications of sensitization to red cell antigens, a common sequela to allogenic blood transfusion. Autologous blood transfusion eliminates the potential of communicable disease transmission as well as the conceivable threat of a blood transfusion reaction. Recent technological advances allow cell salvage coupled with the use of a leukocyte filter to be used as an alternative approach for improving the outcome for women experiencing a PPH. Modest changes in standard operating procedure and continued training in use and application of cell salvaged blood may assist in minimizing negative outcomes from PPH. Salvaged blood has been demonstrated to be at least equal and often superior to banked blood. We discuss nursing implications for application of this technology for women with PPH. Continued research is warranted to evaluate the impact that application of cell salvage with filtration has on the patient experiencing a PPH.

Implementation of a patient blood management program in pediatric scoliosis surgery.

Science.gov (United States)

Pérez-Ferrer, A; Gredilla-Díaz, E; de Vicente-Sánchez, J; Sánchez Pérez-Grueso, F; Gilsanz-Rodríguez, F

2016-02-01

To determine whether the implementation of a blood conservation program, and the adoption and progressive association of different methods, reduces transfusion requirements in pediatric patients undergoing scoliosis surgery of different origins. Quasi-experimental, nonrandomized, descriptive study, approved by the Ethics Committee for Research of our institution. 50 pediatric patients (ASA I-III) aged 5 to 18 years, undergoing scoliosis surgery of any etiology by a single posterior or double approach (anterior and posterior) were included. A historical group with no alternatives to transfusion: Group No ahorro=15 patients (retrospective data collection) was compared with another 3 prospective study groups: Group HNA (acute normovolemic hemodilution)=9 patients; Group HNA+Rec (intraoperative blood salvage)=14 patients, and Group EPO (HNA+Rec+erythropoietin±preoperative donation)=12 patients; according with the implementation schedule of the transfusion alternatives in our institution. The rate of transfusion in different groups (No ahorro, HNA, HNA+Rec, EPO) was 100, 66, 57, and 0% of the patients, respectively, with a mean±SD of 3.40±1.59; 1.33±1.41; 1.43±1.50; 0±0 RBC units transfused per patient, respectively. Statistically significant differences (P<.001) were found in both the transfusion rate and number of RBC units. The application of a multimodal blood transfusion alternatives program, individualized for each pediatric patient undergoing scoliosis surgery can avoid transfusion in all cases. Copyright © 2015 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

True HIV seroprevalence in Indian blood donors.

Science.gov (United States)

Choudhury, N; Ayagiri, A; Ray, V L

2000-03-01

The National AIDS Control Organization (NACO), the apex body for controlling AIDS in India, projected that HIV seroprevalence would increase from 7/1000 in 1995 to 21.2/1000 in 1997. A high incidence (8.2%) of HIV was observed in blood donors. This study was carried out to find out the true HIV positivity in Indian blood donors. Blood donors from our centre were followed for more than 5 years to determine the true HIV seroprevalence and our result was compared with similar studies from India. Voluntary and relative blood donors who visited the SGPGIMS, Lucknow, since 1993 to June 1998 were included. They were screened for HIV 1/2 by ELISA kits (WHO approved). First-time HIV-positive samples were preserved frozen for further study (stage-I). They were repeated in duplicate and retested with other kits. If found positive, the sample was labelled as ELISA positive (stage-II). ELISA-positive samples were confirmed by Western Blot (WB) at stage-III. A total of 65 288 donors were included and 834 (12.8/1000) were reactive at stage-I. But 1.1/1000 donors were found to be ELISA positive at stage-II, and 0.28/1000 donors were positive by WB at stage-III. The 'seropositivity' rate from the NACO was significantly (P commercial blood banks. The HIV prevalence of blood donors (and national prevalence) is to be reassessed.

Directory of certificates of compliance for radioactive materials packages. Volume 1, Revision 17: Report of NRC approved packages

International Nuclear Information System (INIS)

1994-10-01

This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

Tissue bank. A new biomedical applications of ionizing radiation

International Nuclear Information System (INIS)

Rubio, Tatiana; Ribbeck, Jessica

1999-01-01

The entire staff of the Irradiation Section has helped to develop the semi-commercial application of two technological areas of irradiation: sterilization of medical supplies and food preservation. Some biomedical applications, such as the irradiation of whole blood and its components, as well as of different pharmaceutical and cosmetics products have also been routinely carried out. A Center for processing biological tissues has been added recently. At the end of 1996, a Tissue Bank for producing bone and skin grafts was evaluated and approved by the Chilean Nuclear Energy Commission (CCHEN). The first activities began the following year, and cooperation agreements with potential users were signed. At the same time the International Atomic Energy Agency (IAEA) sent an expert to give assistance, who also carried out a surgical operation with irradiated bone grafts in the Hospital del Trabajador. The year finished with the presentation to IAEA of a technical cooperation project, which was subsequently approved. A clean room where the Bank in formation will operate was set up in 1998 and the implementation of the laboratory was started with the support of the IAEA. At present the Bank has produced its first results with irradiated bone grafts, that have been used to close bronchopleural fistulas. By year's end more samples of bone grafts will be produced and sterilized by ionizing radiation, in compliance with the international standards. (author)

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

Science.gov (United States)

Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

2017-12-05

To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track

78 FR 28275 - Office of Commercial Space Transportation; Safety Approval Performance Criteria

Science.gov (United States)

2013-05-14

... provide as a service, scenario based physiology training, which includes hypobaric chamber training. BST may offer its scenario based physiology altitude training as a service to a prospective launch and...: Notification of criteria used to evaluate the Black Sky Training, Inc. (BST) safety approval application...

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...

Blood gas testing and related measurements: National recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

Science.gov (United States)

Dukić, Lora; Kopčinović, Lara Milevoj; Dorotić, Adrijana; Baršić, Ivana

2016-10-15

Blood gas analysis (BGA) is exposed to risks of errors caused by improper sampling, transport and storage conditions. The Clinical and Laboratory Standards Institute (CLSI) generated documents with recommendations for avoidance of potential errors caused by sample mishandling. Two main documents related to BGA issued by the CLSI are GP43-A4 (former H11-A4) Procedures for the collection of arterial blood specimens; approved standard - fourth edition, and C46-A2 Blood gas and pH analysis and related measurements; approved guideline - second edition. Practices related to processing of blood gas samples are not standardized in the Republic of Croatia. Each institution has its own protocol for ordering, collection and analysis of blood gases. Although many laboratories use state of the art analyzers, still many preanalytical procedures remain unchanged. The objective of the Croatian Society of Medical Biochemistry and Laboratory Medicine (CSMBLM) is to standardize the procedures for BGA based on CLSI recommendations. The Working Group for Blood Gas Testing as part of the Committee for the Scientific Professional Development of the CSMBLM prepared a set of recommended protocols for sampling, transport, storage and processing of blood gas samples based on relevant CLSI documents, relevant literature search and on the results of Croatian survey study on practices and policies in acid-base testing. Recommendations are intended for laboratory professionals and all healthcare workers involved in blood gas processing.

Dermal application of nitric oxide releasing acidified nitrite-containing liniments significantly reduces blood pressure in humans.

Science.gov (United States)

Opländer, Christian; Volkmar, Christine M; Paunel-Görgülü, Adnana; Fritsch, Thomas; van Faassen, Ernst E; Mürtz, Manfred; Grieb, Gerrit; Bozkurt, Ahmet; Hemmrich, Karsten; Windolf, Joachim; Suschek, Christoph V

2012-02-15

Vascular ischemic diseases, hypertension, and other systemic hemodynamic and vascular disorders may be the result of impaired bioavailability of nitric oxide (NO). NO but also its active derivates like nitrite or nitroso compounds are important effector and signal molecules with vasodilating properties. Our previous findings point to a therapeutical potential of cutaneous administration of NO in the treatment of systemic hemodynamic disorders. Unfortunately, no reliable data are available on the mechanisms, kinetics and biological responses of dermal application of nitric oxide in humans in vivo. The aim of the study was to close this gap and to explore the therapeutical potential of dermal nitric oxide application. We characterized with human skin in vitro and in vivo the capacity of NO, applied in a NO-releasing acidified form of nitrite-containing liniments, to penetrate the epidermis and to influence local as well as systemic hemodynamic parameters. We found that dermal application of NO led to a very rapid and significant transepidermal translocation of NO into the underlying tissue. Depending on the size of treated skin area, this translocation manifests itself through a significant systemic increase of the NO derivates nitrite and nitroso compounds, respectively. In parallel, this translocation was accompanied by an increased systemic vasodilatation and blood flow as well as reduced blood pressure. We here give evidence that in humans dermal application of NO has a therapeutic potential for systemic hemodynamic disorders that might arise from local or systemic insufficient availability of NO or its bio-active NO derivates, respectively. Copyright © 2012 Elsevier Inc. All rights reserved.

Hepatobiliary system functional analysis by blood flow and clearance delay model

International Nuclear Information System (INIS)

Aboltins, A.; Reinholds, E.

2002-01-01

A mathematical model for describing liver uptake-excretion is developed and approved. Model is based on different timing delays in hepatobiliary and blood flow system elements. Series of scintigraphic images with 99m Tc-mebrofenins or 99m Tc-HIDA taken with standard nuclear medicine gamma camera are used as the real data for calculations. The time-activity curves are obtained from many regions of human body - heart, liver, gallbladder, spleen, aorta, vein, etc. Both first pass and dynamic acquisition data are used. Results are calculated using real system parameters and compared to real scintigraphy data. Mathematical simulations are made to show difference of hepatobiliary system function at three main points: normal function, good blood flow with bad hepatic function and bad blood flow with good hepatic function. (authors)

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

Transient spontaneous engraftment of CD34 hematopoietic cord blood stem cells as seen in peripheral blood: treatment of leprosy patients with anemia by placental umbilical cord whole blood transfusion.

Science.gov (United States)

Bhattacharya, N

2006-01-01

Cord blood, because of its rich mix of fetal and adult hemoglobin, high platelet and white blood cell (WBC) counts, and a plasma filled with cytokine and growth factors, as well as its hypoantigenic nature and altered metabolic profile, has all the potential of a real and safe alternative to adult blood transfusion. Our experience of 74 units (50 ml-146 ml mean, 86 ml +/- 7.6 ml SD, median 80 ml, mean packed cell volume 48 +/- 4.1 SD, mean percent hemoglobin concentration 16.2 g/dl +/- 1.8 g/dl of placental umbilical cord whole blood collection (from 1 April 1999) after lower uterine cesarean section (LUCS) from consenting mothers and transfusion of the same to 16 informed, consenting patients with percent plasma hemoglobin 8 g/dl or less, is presented here. After collection the blood was immediately preserved in the refrigerator and transfused within 72 hours of collection. Fifteen males and one female, aged 12-72 yrs (mean 48.4 yrs) participated: five cases were pausibacillary type (PB) and 11 cases were multibacillary type (MB). The clinical spectrum of the cases varied widely from the tuberculoid to the lepromatous type and one patient presented with gangrene of the leg preceding an auto amputation which was infested with maggots. Each case was approved by the institutional ethical committee and received two to eight units of freshly collected placental umbilical cord blood in one transfusion without encountering any clinical, immunological or non-immunological reaction. Seven days after completion of the placental umbilical cord blood transfusion, the peripheral blood hematopoietic stem cell (CD34) estimation revealed a rise from the pretransfusion base level (.09%), varying from 3.6% to 16.2%, in 75% of the cases, without provoking any clinical graft vs host reaction in any of the leprosy victims. This value returned to normal within three months in most cases.

40 CFR 145.31 - Approval process.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Approval process. 145.31 Section 145.31 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE UIC PROGRAM REQUIREMENTS Program Approval, Revision and Withdrawal § 145.31 Approval process. (a...

40 CFR 52.2122 - Approval status.

Science.gov (United States)

2010-07-01

... sources covered by CTGs issued by the previous January. (b) EPA disapproved South Carolina's generic...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Carolina § 52.2122 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves South Carolina's plans for...

Commercial Clinical Application of Boron Neutron Capture Therapy

International Nuclear Information System (INIS)

1999-01-01

CRADA No. 95-CR-09 among the LITCO--now Bechtel BWXT Idaho, LLC; a private company, Neutron Therapies Limited Liability Company, NTL formerly Ionix Corporation; and Washington State University was established in 1996 to further the development of BNCT. NTL has established a laboratory for the synthesis, under US FDA approved current Good Manufacturing Practices (cGMP) guidelines, of key boron intermediates and final boron agents for BNCT. The company has focused initially on the development of the compound GB-10 (Na 2 B 10 H 10 ) as the first boron agent of interest. An Investigational New Drug (IND) application for GB-10 has been filed and approved by the FDA for a Phase I human biodistribution trial in patients with non-small cell lung cancer and glioblastoma multiforme at UW under the direction of Professor Keith Stelzer, Principal Investigator (PI). These trials are funded by NTL under a contract with the UW, Department of Radiation Oncology, and the initial phases are nearing completion. Initial results show that boron-10 concentrations on the order of 100 micrograms per gram (100 ppm) can be achieved and maintained in blood with no indication of toxicity

Quantitative determination of sirolimus in dog blood using liquid chromatography-tandem mass spectrometry, and its applications to pharmacokinetic studies.

Science.gov (United States)

Lee, Jong-Hwa; Cha, Kwang-Ho; Cho, Wonkyung; Park, Junsung; Park, Hee Jun; Cho, Youngseok; Hwang, Sung-Joo

2010-12-01

A rapid, sensitive method of detecting sirolimus in blood was developed and applied in pharmacokinetic studies employing deionized water for hemolysis and a weakly basic mobile phase to enhance chromatographic peak intensity. Dog blood samples were processed via liquid-liquid extraction and the amounts of sirolimus and tacrolimus, an internal standard, were quantified by LC-MS/MS. Specificity, the lower limit of quantification, linearity, accuracy, precision, dilution, recovery, matrix effects, robustness and stability were within the acceptable range for assay validation. The concentration of sirolimus was quantifiable in blood samples for up to 36 h after the dog had received a 3 mg/kg dose of sirolimus. These observations suggest that sirolimus can be detected at low levels in dog blood using a basic mobile phase and metal-free hemolysis. This method is therefore applicable to pharmacokinetic studies in dogs. Copyright (c) 2010 Elsevier B.V. All rights reserved.

77 FR 9865 - Clarification on the Division 1.1 Fireworks Approvals Policy

Science.gov (United States)

2012-02-21

... 173 [Docket No. PHMSA-2011-0157; Notice No. 11-6] Clarification on the Division 1.1 Fireworks.... 11-6 clarifying PHMSA's policy regarding the fireworks approvals program. Furthermore, in this... applications for Division 1.1 fireworks that have been examined and assigned a recommended shipping description...

75 FR 48302 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

Science.gov (United States)

2010-08-10

....gov ). FOR FURTHER INFORMATION CONTACT: For information on credit account approval for reimbursable..., at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable... Inspection Service [Docket No. APHIS-2010-0071] Notice of Request for Extension of Approval of an Information...

78 FR 54617 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

Science.gov (United States)

2013-09-05

...] Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval for... (202) 799-7039 before coming. FOR FURTHER INFORMATION CONTACT: For information on credit account... Coordinator, at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable...

77 FR 74129 - Approval and Promulgation of Implementation Plans; Texas; Public Participation for Air Quality...

Science.gov (United States)

2012-12-13

...'s policy is that all comments received will be included in the public docket without change and may... Plant-Wide Applicability Limit (PAL) Permit Applications 1. Analysis of Submitted Rules 2. How do the... 116. Chairman Bryan W. Shaw, Ph.D., submitted these amendments to EPA for approval as revisions to the...

40 CFR 52.1772 - Approval status.

Science.gov (United States)

2010-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Carolina § 52.1772 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves North Carolina's plans for... CTGs issued by the previous January. (b) New Source review permits issued pursuant to section 173 of...

Efficacy of a brief multifactorial adherence-based intervention on reducing the blood pressure of patients with poor adherence: protocol for a randomized clinical trial

Directory of Open Access Journals (Sweden)

Llobera Joan

2010-09-01

Full Text Available Abstract Background Lowering of blood pressure by antihypertensive drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to antihypertensive medications reduces their effectiveness and increases the risk of adverse events. In terms of relative risk reduction, an improvement in medication adherence could be as effective as the development of a new drug. Methods/Design The proposed randomized controlled trial will include patients with a low adherence to medication and uncontrolled blood pressure. The intervention group will receive a multifactorial intervention during the first, third, and ninth months, to improve adherence. This intervention will include motivational interviews, pill reminders, family support, blood pressure self-recording, and simplification of the dosing regimen. Measurement The primary outcome is systolic blood pressure. The secondary outcomes are diastolic blood pressure, proportion of patients with adequately controlled blood pressure, and total cost. Discussion The trial will evaluate the impact of a multifactorial adherence intervention in routine clinical practice. Ethical approval was given by the Ethical Committee on Human Research of Balearic islands, Spain (approval number IB 969/08 PI. Trial registration Current controlled trials ISRCTN21229328

Microfluidic Devices for Blood Fractionation

OpenAIRE

Hou, Han Wei; Bhagat, Ali Asgar S.; Lee, Wong Cheng J.; Huang, Sha; Han, Jongyoon; Lim, Chwee Teck

2011-01-01

Blood, a complex biological fluid, comprises 45% cellular components suspended in protein rich plasma. These different hematologic components perform distinct functions in vivo and thus the ability to efficiently fractionate blood into its individual components has innumerable applications in both clinical diagnosis and biological research. Yet, processing blood is not trivial. In the past decade, a flurry of new microfluidic based technologies has emerged to address this compelling problem. ...

9 CFR 147.52 - Approved tests.

Science.gov (United States)

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry...

30 CFR 14.10 - Post-approval product audit.

Science.gov (United States)

2010-07-01

..., AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... based. MSHA will select an approved conveyor belt to be audited; the selected belt will be...

42 CFR 8.21 - Applicability.

Science.gov (United States)

2010-10-01

... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS CERTIFICATION OF OPIOID... Adverse Action Regarding Withdrawal of Approval of an Accreditation Body § 8.21 Applicability. The... body of an adverse action taken regarding withdrawal of approval of the accreditation body under the...

40 CFR 123.61 - Approval process.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a...; and (6) Briefly outline the fundamental aspects of the State's proposed program, and the process for...

A system for oxygen-15 labeled blood for medical applications

International Nuclear Information System (INIS)

Subramanyam, R.; Bucelewicz, W.M.; Hoop, B. Jr.; Jones, S.C.

1977-01-01

Oxygen-15 labeled compounds in blood have been used successfully for cerebral circulation and cerebral oxygen metabolism measurements. The present paper describes a system for the rapid sequential production of 15 O-HgB, C 15 O-Hgb and H 2 15 O in blood under sterile and pyrogen-free conditions. A tonometer has been adopted for labeling blood without hemolysis and foam production. (author)

28 CFR 58.26 - Procedures for inclusion on the approved provider list.

Science.gov (United States)

2010-07-01

... provider list. (a) As used in this section the term “provider” means a provider of a personal financial... of a Personal Financial Management Course” (application), including all appendices, and submit it at... directors; and a merger or consolidation with another entity; (2) The provider shall request approval by...

75 FR 30861 - Proposed Extension of the Approval of Information Collection Requirements

Science.gov (United States)

2010-06-02

... industrial homework as necessary to prevent circumvention or evasion of the minimum wage requirements of the... at not less than 85 percent of the applicable minimum wage or less than $1.60, whichever is higher... DEPARTMENT OF LABOR Wage and Hour Division Proposed Extension of the Approval of Information...

A viewpoint on the approval context of strategic environmental assessments

International Nuclear Information System (INIS)

Kontić, Branko; Kontić, Davor

2012-01-01

A reflection on the last report from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application and effectiveness of the Directive on Strategic Environmental Assessment (SEA) is provided. It covers the inadequacies of the approval/permitting context of SEA, which appears to be increasingly applied by a significant number of Member States in recent years. A viewpoint is provided on the main deficiencies of such praxis. As a practical defence of the planning context of SEA, the authors propose that the EC should consider a clear recommendation to Member States to cease performing SEA in the approval/permitting context until proper amendments to the SEA Directive are made and implemented. - Highlights: ► Administrative and permitting context of SEA, has ousted the primary environmental impact assessment goal. ► The approval context moves from the environmental protection to the area of political power and economy. ► SEA and EIA are misused. ► Environmental evaluations should be used for improving the projects/plans/programmes and not for permitting them.

Development of materials with blood compatibility by radiation processing

International Nuclear Information System (INIS)

Roesinger, S.; Fischer, J.P.; Fuhge, P.

1982-01-01

Biomedical applications, for example for rendering plastic materials blood compatible, have become a very important problem in recent years. Surface-grafted materials for blood compatibility have attracted attention for intra- and extracorporal applications. Numerous aspects of grafting monomers on to polymer surfaces by different grafting methods have been given. A large amount of work has been done during the last ten years, but nobody has prepared materials with properties that are desirable for long-term medical application in the human body, for example as replacements for small arteries or veins. The evaluation of blood compatibility of different plastic materials, and the search for correlations between blood compatibility and physical properties of the plastic materials surfaces, are well-known problems in the biomedical applications of polymers. This paper briefly reviews an approach to help solving these problems. (author)

Indico CONFERENCE: Candidate participant's registration/application

CERN Multimedia

CERN. Geneva; Ferreira, Pedro

2017-01-01

In this tutorial you are going to learn how to apply as a candidate participant (if the event requires approval from the event manager) or to register (if participation to the event doesn't require approval from an event manager) to the conference using the registration form for the event. You are also going to learn how to approve a candidate participant's application as an event manager.

40 CFR 52.1323 - Approval status.

Science.gov (United States)

2010-07-01

... on January 16, 1979 (44 FR 3274) are met. (b) The Administrator approves Rule 10 CSR 10-2.290 as.... (c) The Administrator approves Rule 10 CSR 10-2.230 as identified under § 52.1320, paragraph (c)(70... SIP would be the emission limits stated in the rule. (d) The Administrator approves Rule 10 CSR 10-5...

78 FR 4124 - Approval of Subzone Status, Coamo Property & Investments, LLC, Coamo, PR

Science.gov (United States)

2013-01-18

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-107-2012] Approval of Subzone Status, Coamo Property & Investments, LLC, Coamo, PR On October 9, 2012, the Executive Secretary of the Foreign-Trade... the proposed operator, Coamo Property & Investments, LLC, in Coamo, Puerto Rico. The application was...

Self-separation of blood plasma from whole blood during the capillary flow in microchannel

Science.gov (United States)

Nunna, Bharath Babu; Zhuang, Shiqiang; Lee, Eon Soo

2017-11-01

Self-separation of blood plasma from whole blood in microchannels is of great importance due to the enormous range of applications in healthcare and diagnostics. Blood is a multiphase complex fluid, composed of cells suspended in blood plasma. RBCs are the suspended particles whose shape changes during the flow of blood. The primary constituents of blood are erythrocytes or red blood cells (RBCs), leukocytes or white blood cells (WBCs), thrombocytes or platelets and blood plasma. The existence of RBCs in blood makes the blood a non-Newtonian fluid. The current study of separation of blood plasma from whole blood during self-driven flows in a single microchannel without bifurcation, by enhancing the capillary effects. The change in the capillary effect results in a change in contact angle which directly influences the capillary flow. The flow velocity directly influences the net force acting on the RBCs and influence the separation process. The experiments are performed on the PDMS microchannels with different contact angles by altering the surface characteristics using plasma treatment. The change in the separation length is studied during the capillary flow of blood in microchannel. Bharath Babu Nunna is a researcher in mechanical engineering and implementing the novel and innovative technologies in the biomedical devices to enhance the sensitivity of the disease diagnosis.

14 CFR 414.11 - Application.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Application. 414.11 Section 414.11 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Application Procedures § 414.11 Application. (a) The application must...

Protocol for a national blood transfusion data warehouse from donor to recipient

Science.gov (United States)

van Hoeven, Loan R; Hooftman, Babette H; Janssen, Mart P; de Bruijne, Martine C; de Vooght, Karen M K; Kemper, Peter; Koopman, Maria M W

2016-01-01

Introduction Blood transfusion has health-related, economical and safety implications. In order to optimise the transfusion chain, comprehensive research data are needed. The Dutch Transfusion Data warehouse (DTD) project aims to establish a data warehouse where data from donors and transfusion recipients are linked. This paper describes the design of the data warehouse, challenges and illustrative applications. Study design and methods Quantitative data on blood donors (eg, age, blood group, antibodies) and products (type of product, processing, storage time) are obtained from the national blood bank. These are linked to data on the transfusion recipients (eg, transfusions administered, patient diagnosis, surgical procedures, laboratory parameters), which are extracted from hospital electronic health records. Applications Expected scientific contributions are illustrated for 4 applications: determine risk factors, predict blood use, benchmark blood use and optimise process efficiency. For each application, examples of research questions are given and analyses planned. Conclusions The DTD project aims to build a national, continuously updated transfusion data warehouse. These data have a wide range of applications, on the donor/production side, recipient studies on blood usage and benchmarking and donor–recipient studies, which ultimately can contribute to the efficiency and safety of blood transfusion. PMID:27491665

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...

Application of Thinned-Skull Cranial Window to Mouse Cerebral Blood Flow Imaging Using Optical Microangiography

Science.gov (United States)

Wang, Ruikang K.

2014-01-01

In vivo imaging of mouse brain vasculature typically requires applying skull window opening techniques: open-skull cranial window or thinned-skull cranial window. We report non-invasive 3D in vivo cerebral blood flow imaging of C57/BL mouse by the use of ultra-high sensitive optical microangiography (UHS-OMAG) and Doppler optical microangiography (DOMAG) techniques to evaluate two cranial window types based on their procedures and ability to visualize surface pial vessel dynamics. Application of the thinned-skull technique is found to be effective in achieving high quality images for pial vessels for short-term imaging, and has advantages over the open-skull technique in available imaging area, surgical efficiency, and cerebral environment preservation. In summary, thinned-skull cranial window serves as a promising tool in studying hemodynamics in pial microvasculature using OMAG or other OCT blood flow imaging modalities. PMID:25426632

Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).

Science.gov (United States)

Gnanasakthy, Ari; DeMuro, Carla; Clark, Marci; Haydysch, Emily; Ma, Esprit; Bonthapally, Vijayveer

2016-06-01

To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic license applications by the FDA Office of Hematology and Oncology Products (OHOP) between January 2010 and December 2014, to elucidate challenges faced by OHOP for approving PRO labeling, and to understand challenges faced by drug manufacturers to include PRO end points in oncology clinical trials. FDA Drug Approval Reports by Month were reviewed to obtain the number of new molecular entities and biologic license applications approved from 2010 to 2014. Drugs approved by the FDA OHOP during this period were selected for further review, focusing on brand and generic name; approval date; applicant; indication; PRO labeling describing treatment benefit, measures, end point status, and significant results; FDA reviewer feedback on PRO end points; and study design of registration trials. First in class, priority review, fast track, orphan drug, or accelerated approval status was retrieved for selected oncology drugs from 2011 to 2014. Descriptive analyses were performed by using Microsoft Excel 2010. Of 160 drugs approved by the FDA (2010-2014), 40 were approved by OHOP. Three (7.5%) of the 40 received PRO-related labeling (abiraterone acetate, ruxolitinib phosphate, and crizotinib). Compared with nononcology drugs (2011-2014), oncology drugs were more likely to be orphan and first in class. The majority of oncology drug reviews by FDA were fast track, priority, or accelerated. Although symptoms and functional decrements are common among patients with cancer, PRO labeling is rare in the United States, likely because of logistical hurdles and oncology study design. Recent developments within the FDA OHOP to capture PROs in oncology studies for the purpose of product labeling are encouraging. © 2016 by American Society of Clinical Oncology.

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)

1993-10-01

This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

Blood group genotyping: from patient to high-throughput donor screening.

Science.gov (United States)

Veldhuisen, B; van der Schoot, C E; de Haas, M

2009-10-01

Blood group antigens, present on the cell membrane of red blood cells and platelets, can be defined either serologically or predicted based on the genotypes of genes encoding for blood group antigens. At present, the molecular basis of many antigens of the 30 blood group systems and 17 human platelet antigens is known. In many laboratories, blood group genotyping assays are routinely used for diagnostics in cases where patient red cells cannot be used for serological typing due to the presence of auto-antibodies or after recent transfusions. In addition, DNA genotyping is used to support (un)-expected serological findings. Fetal genotyping is routinely performed when there is a risk of alloimmune-mediated red cell or platelet destruction. In case of patient blood group antigen typing, it is important that a genotyping result is quickly available to support the selection of donor blood, and high-throughput of the genotyping method is not a prerequisite. In addition, genotyping of blood donors will be extremely useful to obtain donor blood with rare phenotypes, for example lacking a high-frequency antigen, and to obtain a fully typed donor database to be used for a better matching between recipient and donor to prevent adverse transfusion reactions. Serological typing of large cohorts of donors is a labour-intensive and expensive exercise and hampered by the lack of sufficient amounts of approved typing reagents for all blood group systems of interest. Currently, high-throughput genotyping based on DNA micro-arrays is a very feasible method to obtain a large pool of well-typed blood donors. Several systems for high-throughput blood group genotyping are developed and will be discussed in this review.

Thermal Blood Clot Formation and use in Microfluidic Device Valving Applications

Science.gov (United States)

Tai, Yu-Chong (Inventor); Shi, Wendian (Inventor); Guo, Luke (Inventor)

2014-01-01

The present invention provides a method of forming a blood-clot microvalve by heating blood in a capillary tube of a microfluidic device. Also described are methods of modulating liquid flow in a capillary tube by forming and removing a blood-clot microvalve.

Drugs Approved for Kidney (Renal Cell) Cancer

Science.gov (United States)

... Your Treatment Research Drugs Approved for Kidney (Renal Cell) Cancer This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Kidney (Renal Cell) Cancer Afinitor (Everolimus) Aldesleukin Avastin (Bevacizumab) Axitinib Bevacizumab Cabometyx ( ...

77 FR 59090 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adhesives and...

Science.gov (United States)

2012-09-26

... Promulgation of Air Quality Implementation Plans; Pennsylvania; Adhesives and Sealants Rule AGENCY... manufacture, sale, use, or application of adhesives, sealants, primers, and solvents. The SIP revision also... proposed rulemaking (NPR) which proposed approval of Pennsylvania's adhesives and sealants regulations in...

78 FR 60766 - Clarification on Fireworks Policy Regarding Approvals or Certifications for Specialty Fireworks...

Science.gov (United States)

2013-10-02

... 173 [Docket No. PHMSA-2013-0206; Notice No. 13-15] Clarification on Fireworks Policy Regarding Approvals or Certifications for Specialty Fireworks Devices AGENCY: Pipeline and Hazardous Materials Safety... applications for specialty fireworks devices. Specialty fireworks devices are fireworks devices in various...

Comparative analysis of autologous blood transfusion and allogeneic blood transfusion in surgical patients

OpenAIRE

Long, Miao-Yun; Liu, Zhong-Han; Zhu, Jian-Guang

2014-01-01

Objective: To investigate application effects of autologous blood transfusion and allogeneic blood transfusion in surgically treated patients receiving spine surgery, abdomen surgery and ectopic pregnancy surgery. Methods: 130 patients who would undergo selective operations were divided into autologous transfusion group and allogeneic transfusion group. Both groups received the same anesthesia, and there was no significant difference in transfusion volume or fluid infusion volume. Results: Th...

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.

77 FR 8865 - Recent Postings of Broadly Applicable Alternative Test Methods

Science.gov (United States)

2012-02-15

... Applicable Alternative Test Methods AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. SUMMARY: This notice announces the broadly applicable alternative test method approval decisions... INFORMATION CONTACT: An electronic copy of each alternative test method approval document is available on the...

VALUE CHANGE DIAMETERRED BLOOD CELLS ATHLETES IN THE PHYSICAL LOAD

Directory of Open Access Journals (Sweden)

Lidiya Yurevna Rubtsova

2017-05-01

Full Text Available Background: to study the nature of distribution of erythrocytes on diameter in the circulating blood of skiers-racers during achievement of a threshold of anaerobic threshold (AТ. Materials and methods: Professional Skiers racers (young men and men, girls and women at the age of 17–37 years (n = 33 are еxamined in the conditions of physical activity on the stationary bicycle. The research is conducted according to the protocol approved by local committee on bioethics in case of Institute of Physiology of Komi Scientific Centre of the Ural Branch of the Russian Academy of Sciences. Samples of blood were taken from an elbow vein on an empty stomach, then from finger capillaries to, - on a threshold of anaerobic exchange, after execution of loading “to the full” and in 5 min restoration. On the stained blood smears measured diameter of 50 erythrocytes. Results processed statistically with use of an application program package of Windows (Basic, 2011. Results: At stage AT at 36% of athletes defined increase in average diameter of erythrocytes from 7,46 ± 0,06 to 7,68 ± 0,08 µm (р<0,05, without changes at 12% (7,45 ± 0,04 – 7,43 ± 0,05 µm and reduction of the size of cells at 52% from 7,51± 0,04 to 7,35 ± 0,05 µm (р<0,05. In the conditions of a maximum load (men have 337,1 ± 12,4 W and women have 246,7 ± 10,8 W and during the 5-minute recovery diameter of erythrocytes returned to the original value. Conclusion: Thus, the individual nature of change of average diameter of erythrocytes at athletes is shown during achievement of ANSPs and probably corresponds to selective elimination preferentially macro- or microcytes.

Measurement of cerebral blood flow the blood sampling method using 99mTc-ECD. Simultaneous scintigram scanning of arterial blood samples and the brain with a gamma camera

International Nuclear Information System (INIS)

Hachiya, Takenori; Inugami, Atsushi; Iida, Hidehiro; Mizuta, Yoshihiko; Kawakami, Takeshi; Inoue, Minoru

1999-01-01

To measure regional cerebral blood flow (rCBF) by blood sampling using 99m Tc-ECD we devised a method of measuring the radioactive concentration in arterial blood sample with a gamma camera. In this method the head and a blood sample are placed within the same visual field to record the SPECT data of both specimens simultaneously. The results of an evaluation of the counting rate performance, applying the 30 hours decaying method using 99m Tc solution showed that this method is not comparable to the well-type scintillation counter and in clinical cases the active concentration in arterial blood sample remained well within the dynamic range. In addition, examination of the influence of scattered radiation from the brain by the dilution method showed that it was negligible at a distance of more than 7.5 cm between the brain and the arterial blood sample. In the present study we placed a head-shaped phantom next to the sample. The results of the examinations suggested that this method is suitable for clinical application, and because it does not require a well-type scintillation counter, it is expected to find wide application. (author)

7 CFR 1942.5 - Application review and approval.

Science.gov (United States)

2010-01-01

... Collection Policies for Consumer or Commercial Debts,” organization, business operations, insurance and..., management agreements, or other agreements when facility management will be provided by other than the... applicant bears a close and genuine relationship to the original applicant (such as two organizations that...

Predicting Factors for Allogeneic Blood Transfusion and Excessive Postoperative Blood Loss after Single Low-Dosage Intra-Articular Tranexamic Acid Application in Total Knee Replacement

Directory of Open Access Journals (Sweden)

Paphon Sa-ngasoongsong

2017-01-01

Full Text Available Background. Recently, intra-articular tranexamic acid (IA-TXA application has become a popular method for perioperative blood loss (PBL reduction in total knee replacement (TKR. Nevertheless, through our knowledge, no previous studies had shown the correlation perioperative factors and the risk of excessive PBL or need of blood transfusion (BT after IA-TXA. Materials and Methods. A retrospective study was conducted in patients underwent 299 primary TKRs, using IA-TXA, during 2-year period (2013-2014. Patient’s characteristic and perioperative data were reviewed and collected. PBL was measured as total hemoglobin loss (THL, estimated total blood loss (ETBL, and drainage volume per kg (DV/kg. Excessive PBL was defined as PBL that exceeded 90th percentile. Results. From multivariate analysis, low preoperative hemoglobin (Hb level and body mass index (BMI were the significant predictors of postoperative BT (p<0.0001 and 0.003, resp.. Excessive THL significant associated with preoperative Hb (p<0.0001. Excessive ETBL significantly associated with preoperative Hb, height, preoperative range-of-motion, and creatinine clearance (p<0.05 all. Low BMI and large prosthesis size were the significant predictors of excessive DV/kg (p=0.0001 and 0.002, resp.. Conclusions. Low preoperative Hb and BMI were the significant risks of postoperative transfusion after TKR with IA-TXA. Moreover, multiple perioperative factors could result in higher PBL.

A Safety Management Model for FAR 141 Approved Flight Schools

OpenAIRE

Mendonca, Flavio A. C.; Carney, Thomas Q

2017-01-01

The Safety Management Annex (Annex 19), which became applicable in November 2013, consolidates safety management provisions previously contained in six other International Civil Aviation Organization (ICAO) Annexes, and will serve as a resource for overarching state safety management responsibilities. Through Annex 19, ICAO has required that its member states develop and implement safety management systems (SMS) to improve safety. This mandate includes an approved training organization that i...

Trends in global approvals of biotech crops (1992-2014).

Science.gov (United States)

Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

2015-01-01

With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits.

40 CFR 52.2352 - Change to approved plan.

Science.gov (United States)

2010-07-01

... Utah's approved State Implementation Plan (SIP). This rule language pertains to State Sales Tax... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Change to approved plan. 52.2352... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Utah § 52.2352 Change to approved...

Collision Based Blood Cell Distribution of the Blood Flow

Science.gov (United States)

Cinar, Yildirim

2003-11-01

Introduction: The goal of the study is the determination of the energy transferring process between colliding masses and the application of the results to the distribution of the cell, velocity and kinetic energy in arterial blood flow. Methods: Mathematical methods and models were used to explain the collision between two moving systems, and the distribution of linear momentum, rectilinear velocity, and kinetic energy in a collision. Results: According to decrease of mass of the second system, the velocity and momentum of constant mass of the first system are decreased, and linearly decreasing mass of the second system captures a larger amount of the kinetic energy and the rectilinear velocity of the collision system on a logarithmic scale. Discussion: The cause of concentration of blood cells at the center of blood flow an artery is not explained by Bernoulli principle alone but the kinetic energy and velocity distribution due to collision between the big mass of the arterial wall and the small mass of blood cells must be considered as well.

75 FR 43588 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

Science.gov (United States)

2010-07-26

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule... FINRA Rule 4320 in the Consolidated FINRA Rulebook July 20, 2010. On May 21, 2010, the Financial... application by their terms. For more information about the rulebook consolidation process, see Information...

76 FR 78706 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

Science.gov (United States)

2011-12-19

... incorporated NYSE Rule 2A (Jurisdiction) as part of the process of developing a consolidated rulebook..., among other things, rulemaking, examinations, disciplinary actions, and listing applications. NYSE Rule... executives, employees and approved persons in connection with their conduct of the business of member...

78 FR 17633 - Notice of Request for Extension of a Currently Approved Information Collection

Science.gov (United States)

2013-03-22

... on the quality of the human environment during agency planning and decision-making processes. For... processing the application for financial assistance or request for approval. Having environmental information... consideration during planning and decision-making as required by NEPA. The analysis of potential environmental...

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…

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

40 CFR 725.370 - EPA review of the TME application.

Science.gov (United States)

2010-07-01

... unreasonable risk of injury to health and the environment as a result of test marketing. ... Marketing § 725.370 EPA review of the TME application. General procedures for review of all submissions... with test marketing activities after receipt of EPA approval. (c) In approving a TME application, EPA...

Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-

Science.gov (United States)

2017-11-22

This final rule adopts without changes an interim final rule with request for comments published in the Federal Register on March 23, 2017. On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. The Drug Enforcement Administration (DEA) maintains FDA-approved products of oral solutions containing dronabinol in schedule II of the Controlled Substances Act.

Optimization and application of octadecyl-modified monolithic silica for solid-phase extraction of drugs in whole blood samples.

Science.gov (United States)

Namera, Akira; Saito, Takeshi; Ota, Shigenori; Miyazaki, Shota; Oikawa, Hiroshi; Murata, Kazuhiro; Nagao, Masataka

2017-09-29

Monolithic silica in MonoSpin for solid-phase extraction of drugs from whole blood samples was developed to facilitate high-throughput analysis. Monolithic silica of various pore sizes and octadecyl contents were synthesized, and their effects on recovery rates were evaluated. The silica monolith M18-200 (20μm through-pore size, 10.4nm mesopore size, and 17.3% carbon content) achieved the best recovery of the target analytes in whole blood samples. The extraction proceeded with centrifugal force at 1000rpm for 2min, and the eluate was directly injected into the liquid chromatography-mass spectrometry system without any tedious steps such as evaporation of extraction solvents. Under the optimized condition, low detection limits of 0.5-2.0ngmL -1 and calibration ranges up to 1000ngmL -1 were obtained. The recoveries of the target drugs in the whole blood were 76-108% with relative standard deviation of less than 14.3%. These results indicate that the developed method based on monolithic silica is convenient, highly efficient, and applicable for detecting drugs in whole blood samples. Copyright © 2017 Elsevier B.V. All rights reserved.

48 CFR 750.7105 - Approving authorities.

Science.gov (United States)

2010-10-01

... CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS Extraordinary Contractual Actions To Protect Foreign Policy Interests of the United States 750.7105 Approving authorities. All authority to approve actions...

10 CFR 455.140 - Approval of applications from institutions and coordinating agencies for technical assistance and...

Science.gov (United States)

2010-01-01

... DEPARTMENT OF ENERGY ENERGY CONSERVATION GRANT PROGRAMS FOR SCHOOLS AND HOSPITALS AND BUILDINGS OWNED BY.... (h) Funds which become available to a grantee after the installation of all approved measures, due to...

Safety of Therapeutic Fever Induction in Cancer Patients Using Approved PAMP Drugs

Directory of Open Access Journals (Sweden)

Uwe Rudolf Max Reuter

2018-04-01

Full Text Available William Coley, between 1895 and 1936, treated hundreds of cancer patients using infusions of fever inducing bacerial extracts. Similar experiments were done by Klyuyeva and co-workers in the 1940ies in Russia using trypanosoma extracts. Many remissions and cures were reported. We have conjectured that pathogen associated molecular pattern substances (PAMP are the molecular explanation for the beneficial treatments in both groups. We could show that a combination of PAMP can eradicate solid tumours in cancer mice if applied several times. Accordingly, we suggested to combine PAMP containing approved drugs to treat cancer patients using a protocol similar to the old fever induction regimen. In this retrospective phase-1 study we report on the fever induction capacity and safety of applications of bacterial extracts, combinations of bacterial extracts with approved drugs, and combinations of approved drugs in 131 mainly cancer patients. Adverse reactions were those which can be expected during a feverish infection and mild. Over 523 fever inductions, no severe adverse reaction was observed.

75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2010-07-02

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2010-M-0068...

78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-06-12

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2011-06-02

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

Vedolizumab: first global approval.

Science.gov (United States)

Poole, Raewyn M

2014-07-01

Vedolizumab [Entyvio(®) (US, Europe)], a humanized monoclonal antibody α4β7 integrin receptor antagonist, has been developed by Millennium Pharmaceuticals (d/b/a Takeda Pharmaceuticals International) for the treatment of ulcerative colitis and Crohn's disease. Vedolizumab has received its first global approval for the treatment of ulcerative colitis and Crohn's disease in the US, for use in adult patients with moderate-to-severe disease who have had an inadequate response, loss of response or intolerance to one or more standard therapies (corticosteroids, immunomodulators or tumour necrosis factor-α inhibitor) or demonstrated dependence on corticosteroids. Vedolizumab has since been approved for ulcerative colitis and Crohn's disease in the EU, Norway, Iceland and Liechtenstein. This article summarizes the milestones in the development of vedolizumab leading to its first approval for the treatment of ulcerative colitis and Crohn's disease.

77 FR 59679 - Central Vermont Public Service Corporation (Millstone Power Station, Unit 3); Order Approving...

Science.gov (United States)

2012-09-28

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0044; Docket No. 50-423] Central Vermont Public Service Corporation (Millstone Power Station, Unit 3); Order Approving Application Regarding Corporate Restructuring and Conforming Amendment I Dominion Nuclear Connecticut, Inc. (DNC), Central Vermont Public Service...

19 CFR 115.55 - Termination of approval.

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2010-04-01

... vehicle by a major repair or alteration of any of the essential features required in § 115.51. Repairs by... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Individual Road Vehicles § 115.55 Termination of approval. Approval of a road...

20 CFR 617.22 - Approval of training.

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2010-04-01

.... Perkins Vocational and Applied Technology Education Act, and employers). (i) This means that training is...) Conditions for approval. Training shall be approved for an adversely affected worker if the State agency...) available for an adversely affected worker. (i) This means that for the worker for whom approval of training...

Blood transfusion and resuscitation using penile corpora: an experimental study.

Science.gov (United States)

Abolyosr, Ahmad; Sayed, M A; Elanany, Fathy; Smeika, M A; Shaker, S E

2005-10-01

To test the feasibility of using the penile corpora cavernosa for blood transfusion and resuscitation purposes. Three male donkeys were used for autologous blood transfusion into the corpus cavernosum during three sessions with a 1-week interval between each. Two blood units (450 mL each) were transfused per session to each donkey. Moreover, three dogs were bled up until a state of shock was produced. The mean arterial blood pressure decreased to 60 mm Hg. The withdrawn blood (mean volume 396.3 mL) was transfused back into their corpora cavernosa under 150 mm Hg pressure. Different transfusion parameters were assessed. The Assiut faculty of medicine ethical committee approved the study before its initiation. For the donkey model, the mean time of blood collection was 12 minutes. The mean time needed to establish corporal access was 22 seconds. The mean time of blood transfusion was 14.2 minutes. The mean rate of blood transfusion was 31.7 mL/min. Mild penile elongation with or without mild penile tumescence was observed on four occasions. All penile shafts returned spontaneously to their pretransfusion state at a maximum of 5 minutes after cessation of blood transfusion. No extravasation, hematoma formation, or color changes occurred. Regarding the dog model, the mean rate of transfusion was 35.2 mL/min. All dogs were resuscitated at the end of the transfusion. The corpus cavernosum is a feasible, simple, rapid, and effective alternative route for blood transfusion and venous access. It can be resorted to whenever necessary. It is a reliable means for volume replacement and resuscitation in males.

77 FR 22789 - Withdrawal of Approval of Part of a New Animal Drug Application; Tiamulin

Science.gov (United States)

2012-04-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0262... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of... to the production indications for use of increased rate of weight gain and improved feed efficiency...

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

30 CFR 75.1108 - Approved conveyor belts.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved conveyor belts. 75.1108 Section 75... Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1108 Approved conveyor belts. (a) Until December 31, 2009 conveyor belts placed in service in underground coal mines shall be: (1) Approved under...

Revisiting blood transfusion and predictors of outcome in cardiac surgery patients: a concise perspective [version 1; referees: 2 approved

Directory of Open Access Journals (Sweden)

Carlos E Arias-Morales

2017-02-01

Full Text Available In the United States, cardiac surgery-related blood transfusion rates reached new highs in 2010, with 34% of patients receiving blood products. Patients undergoing both complex (coronary artery bypass grafting [CABG] plus valve repair or replacement and non-complex (isolated CABG cardiac surgeries are likely to have comorbidities such as anemia. Furthermore, the majority of patients undergoing isolated CABG have a history of myocardial infarction. These characteristics may increase the risk of complications and blood transfusion requirement. It becomes difficult to demonstrate the association between transfusions and mortality because of the fact that most patients undergoing cardiac surgery are also critically ill. Transfusion rates remain high despite the advances in perioperative blood conservation, such as the intraoperative use of cell saver in cardiac surgery. Some recent prospective studies have suggested that the use of blood products, even in low-risk patients, may adversely affect clinical outcomes. In light of this information, we reviewed the literature to assess the clinical outcomes in terms of 30-day and 1-year morbidity and mortality in transfused patients who underwent uncomplicated CABG surgery.

Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

Science.gov (United States)

Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

2015-01-01

Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.

Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

Directory of Open Access Journals (Sweden)

Jing Hao

Full Text Available Fixed-dose combinations (FDC contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed.Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients.New molecular entities (NMEs, new therapeutic biologics license applications (BLAs and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC and only already marketed drugs (Non-NMEs-FDC. Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed.During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31 after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39 before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24 years to the patent and exclusivity life of the single active ingredients in the combination.FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.

24 CFR 266.105 - Application requirements.

Science.gov (United States)

2010-04-01

... HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Housing Finance Agency Requirements § 266.105 Application requirements. (a) Applications for approval as a HUD...

78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-03-21

... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...

78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-08-19

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0462...

75 FR 36099 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2010-06-24

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug...; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-M-0317...

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...

14 CFR 21.621 - Issuance of letters of TSO design approval: import articles.

Science.gov (United States)

2010-01-01

... performance standards of the State of Design and any other performance standards the FAA may prescribe to... to the FAA one copy of the technical data required in the applicable performance standard through its State of Design. (b) The FAA issues the letter of TSO design approval that lists any deviation granted...

27 CFR 5.55 - Certificates of label approval.

Science.gov (United States)

2010-04-01

..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Requirements for Approval of... certificates of label approval and certificates of exemption from label approval, as well as appeal procedures...

Blood oxygenation level dependent (BOLD). Renal imaging. Concepts and applications

International Nuclear Information System (INIS)

Nissen, Johanna C.; Haneder, Stefan; Schoenberg, Stefan O.; Michaely, Henrik J.

2010-01-01

Many renal diseases as well as several pharmacons cause a change in renal blood flow and/or renal oxygenation. The blood oxygenation level dependent (BOLD) imaging takes advantage of local field inhomogeneities and is based on a T2 * -weighted sequence. BOLD is a non-invasive method allowing an estimation of the renal, particularly the medullary oxygenation, and an indirect measurement of blood flow without administration of contrast agents. Thus, effects of different drugs on the kidney and various renal diseases can be controlled and observed. This work will provide an overview of the studies carried out so far and identify ways how BOLD can be used in clinical studies. (orig.)

46 CFR 188.10-3 - Approved container.

Science.gov (United States)

2010-10-01

... 46 Shipping 7 2010-10-01 2010-10-01 false Approved container. 188.10-3 Section 188.10-3 Shipping... PROVISIONS Definition of Terms Used in This Subchapter § 188.10-3 Approved container. This term means a container which is properly labeled, marked and approved by DOT for the commodity which it contains. [CGFR...

78 FR 16159 - Application Procedures and Criteria for Approval of Providers of a Personal Financial Management...

Science.gov (United States)

2013-03-14

... and Criteria for Approval of Providers of a Personal Financial Management Instructional Course by... personal financial management instructional course (``providers'') satisfy all prerequisites of the United... in an instructional course concerning personal financial management (``instructional course'' or...

Clinical effects of blood donor characteristics in transfusion recipients: protocol of a framework to study the blood donor-recipient continuum.

Science.gov (United States)

Chassé, Michaël; McIntyre, Lauralyn; Tinmouth, Alan; Acker, Jason; English, Shane W; Knoll, Greg; Forster, Alan; Shehata, Nadine; Wilson, Kumanan; van Walraven, Carl; Ducharme, Robin; Fergusson, Dean A

2015-01-19

When used appropriately, transfusion of red blood cells (RBCs) is a necessary life-saving therapy. However, RBC transfusions have been associated with negative outcomes such as infection and organ damage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource. This study will create a framework to analyse the influence of blood donor characteristics on recipient outcomes. We will conduct a multisite, longitudinal cohort study using blood donor data routinely collected by Canadian Blood Services, and recipient data from health administrative databases. Our project will include a thorough validation of primary data, the linkage of various databases into one large longitudinal database, an in-depth epidemiological analysis and a careful interpretation and dissemination of the results to assist the decision-making process of clinicians, researchers and policymakers in transfusion medicine. Our primary donor characteristic will be age of blood donors and our secondary donor characteristics will be donor-recipient blood group compatibility and blood donor sex. Our primary recipient outcome will be a statistically appropriate survival analysis post-RBC transfusion up to a maximum of 8 years. Our secondary recipient outcomes will include 1-year, 2-year and 5-year mortality; hospital and intensive care unit length of stay; rehospitalisation; new cancer and cancer recurrence rate; infection rate; new occurrence of myocardial infarctions and need for haemodialysis. Our results will help determine whether we need to tailor transfusion based on donor characteristics, and perhaps this will improve patient outcome. Our results will be customised to target the different stakeholders involved with blood transfusions and will include presentations, peer-reviewed publications and the use of the dissemination network of blood supply organisations. We obtained approval from the

75 FR 39932 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2010-07-13

...; Comment Request; Recognition Application for Sustainable Water Leadership Program (Renewal) AGENCY... Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval... to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention...

Quantitative assessment of limb blood flow using Tc-99m labeled red blood cells

International Nuclear Information System (INIS)

Itoh, Kazuo; Shougase, Takashi; Kawamura, Naoyuki; Tsukamoto, Eriko; Nakada, Kunihiro; Sakuma, Makoto; Furudate, Masayori

1987-01-01

A quantitative assessment of limb blood flow using a non-diffusible radioindicator, Tc-99m labeled red blood cells, was reported. This was an application of venous occlusion plethysmography using radionuclide which was originally proposed by M. Fukuoka et al. The peripheral blood flow (mean ± s.e.) of 30 legs in a normal control group was 1.87 ± 0.08 ml/100 ml/min. In heart diseases (46 legs), it was 1.49 ± 0.13 ml/100 ml/min. The limb blood flow between a control group and heart diseases was statistically significant (p < 0.01) in the t-test. The peripheral blood flow at rest between diseased legs and normal legs in occlusive arterial disorders was also statistically significant (p < 0.01) in a paired t-test. RAVOP was done after the completion of objective studies such as radionuclide angiography or ventriculography. Technique and calculation of a blood flow were very easy and simple. RAVOP study which was originally proposed by Fukuoka et al. was reappraised to be hopeful for quantitative measurement of limb blood flow as a non-invasive technique using Tc-99m labeled red blood cells. (author)

Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project

Science.gov (United States)

Dixon-Woods, Mary; Foy, Chris; Hayden, Charlotte; Al-Shahi Salman, Rustam; Tebbutt, Stephen; Schroter, Sara

2016-01-01

Objective Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. Design Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. Participants 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. Results Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. Limitations This study was a non-randomised comparison cohort study. Some data were missing. Conclusions An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision. PMID:27580832

Promising cardiovascular and blood pressure effects of the SGLT2 inhibitors: a new class of antidiabetic drugs.

Science.gov (United States)

Chrysant, S G

2017-03-01

Patients with type 2 diabetes mellitus (T2DM) exhibit an increased risk of cardiovascular (CV) events. Treatment of these patients with traditional as well as newer glucose-lowering drugs has not demonstrated superiority in CV outcomes compared to placebo, despite effective control of diabetes. However, the recently FDA-approved sodium-glucose cotransporter 2 (SGLT2) inhibitors for the treatment of T2DM have demonstrated promising CV-protecting and blood pressure-lowering effects in addition to their effectiveness in glucose lowering, making them a novel class of drugs for the treatment of T2DM. So far, there are three SGLT2 inhibitors approved by the FDA and EMA for the treatment of T2DM: canagliflozin, dapagliflozin and empagliflozin. They exert their antihyperglycemic effect through inhibition of SGLT2 in the kidney and significantly reduce glucose reabsorption from the proximal renal tubule. By blocking glucose reabsorption, they lead to loss of calories, weight, abdominal and total body fat, blood pressure and CV complications. One CV outcomes randomized trial and several short-term studies have shown reductions in CV events and blood pressure in patients with T2DM. It is the hope that large ongoing long-term outcome studies will provide further much-needed information, when they are completed. Copyright 2017 Clarivate Analytics.

The family name Solimonadaceae Losey et al. 2013 is illegitimate, proposals to create the names 'Sinobacter soli' comb. nov. and 'Sinobacter variicoloris' contravene the Code, the family name Xanthomonadaceae Saddler and Bradbury 2005 and the order name Xanthomonadales Saddler and Bradbury 2005 are illegitimate and notes on the application of the family names Solibacteraceae Zhou et al. 2008, Nevskiaceae Henrici and Johnson 1935 (Approved Lists 1980) and Lysobacteraceae Christensen and Cook 1978 (Approved Lists 1980) and order name Lysobacteriales Christensen and Cook 1978 (Approved Lists 1980) with respect to the classification of the corresponding type genera Solibacter Zhou et al. 2008, Nevskia Famintzin 1892 (Approved Lists 1980) and Lysobacter Christensen and Cook 1978 (Approved Lists 1980) and importance of accurately expressing the link between a taxonomic name, its authors and the corresponding description/circumscription/emendation.

Science.gov (United States)

Tindall, B J

2014-01-01

In a recent publication the name Solimonadaceae Losey et al. 2013 has been proposed as a replacement name for the family name Sinobacteraceae Zhou et al. 2008. This course of action contravenes the current Code governing the nomenclature of prokaryotes, making Solimonadaceae Losey et al. 2013 an illegitimate name that neither has claim to priority nor can be used as a correct name. Closer examination of publications dealing with the taxonomy of members of the genera Solimonas and Sinobacter and the placement of these taxa at the rank of family and order reveal problems associated with the application of the family names Sinobacteraceae Zhou et al. 2008, Nevskiaceae Henrici and Johnson 1935 (Approved Lists 1980) and Lysobacteraceae Christensen and Cook 1978 (Approved Lists 1980) and the order names Lysobacterales Christensen and Cook 1978 (Approved Lists 1980) and Xanthomonadales Saddler and Bradbury 2005.

Stroke and Drug Delivery--In Vitro Models of the Ischemic Blood-Brain Barrier

DEFF Research Database (Denmark)

Tornabene, Erica; Brodin, Birger

2016-01-01

of permeation pathways across the barrier in ischemic and postischemic brain endothelium is important for development of new medical treatments. The blood-brain barrier, that is, the endothelial monolayer lining the brain capillaries, changes properties during an ischemic event. In vitro models of the blood-brain......Stroke is a major cause of death and disability worldwide. Both cerebral hypoperfusion and focal cerebral infarcts are caused by a reduction of blood flow to the brain, leading to stroke and subsequent brain damage. At present, only few medical treatments of stroke are available, with the Food...... and Drug Administration-approved tissue plasminogen activator for treatment of acute ischemic stroke being the most prominent example. A large number of potential drug candidates for treatment of ischemic brain tissue have been developed and subsequently failed in clinical trials. A deeper understanding...

Streamlining the Capstone Process: A Time-Saving Approval System for Graduate Theses/Projects

Science.gov (United States)

Grooms, James; Kline, Douglas; Cummings, Jeffrey

2016-01-01

Capstones have become an integral part of many information systems programs, both at the undergraduate and graduate level. One of the challenges can be tracking the process from the start of the capstone to completion. This paper describes the analysis, design and implementation of a web application for the approval workflow of a master's program…

Applications of copolymer for rapid identification of bacteria in blood culture broths using matrix-assisted laser desorption ionization time-of-flight mass spectrometry.

Science.gov (United States)

Ashizawa, Kazuho; Murata, Syota; Terada, Takashi; Ito, Daisuke; Bunya, Masaru; Watanabe, Koji; Teruuchi, Yoko; Tsuchida, Sachio; Satoh, Mamoru; Nishimura, Motoi; Matsushita, Kazuyuki; Sugama, Yuji; Nomura, Fumio

2017-08-01

Matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) can be used to identify pathogens in blood culture samples. However, sample pretreatment is needed for direct identification of microbes in blood culture bottles. Conventional protocols are complex and time-consuming. Therefore, in this study, we developed a method for collecting bacteria using polyallylamine-polystyrene copolymer for application in wastewater treatment technology. Using representative bacterial species Escherichia coli and Staphylococcus capitis, we found that polyallylamine-polystyrene can form visible aggregates with bacteria, which can be identified using MALDI-TOF MS. The processing time of our protocol was as short as 15min. Hemoglobin interference in MALDI spectra analysis was significantly decreased in our method compared with the conventional method. In a preliminary experiment, we evaluated the use of our protocol to identify clinical isolates from blood culture bottles. MALDI-TOF MS-based identification of 17 strains from five bacterial species (E. coli, Klebsiella pneumoniae, Enterococcus faecalis, S. aureus, and S. capitis) collected by our protocol was satisfactory. Prospective large-scale studies are needed to further evaluate the clinical application of this novel and simple method of collecting bacteria in blood culture bottles. Copyright © 2017 Elsevier B.V. All rights reserved.

Application of a magnetic fluid seal to rotary blood pumps

International Nuclear Information System (INIS)

Mitamura, Y; Arioka, S; Azegami, M; Sakota, D; Sekine, K

2008-01-01

A magnetic fluid seal enables mechanical contact-free rotation of a shaft without frictional heat and material wear and hence has excellent durability. However, the durability of a magnetic fluid seal decreases in liquid. The life of a seal applied to a rotary blood pump is not known. We have developed a magnetic fluid seal that has a shield mechanism minimizing the influence of the rotary pump on the magnetic fluid. The developed magnetic fluid seal worked for over 286 days in a continuous flow condition, for 24 days (on-going) in a pulsatile flow condition and for 24 h (electively terminated) in blood flow. The magnetic fluid seal is promising as a shaft seal for rotary blood pumps

Application of a Heat- and Steam-Generating Sheet Increases Peripheral Blood Flow and Induces Parasympathetic Predominance

Directory of Open Access Journals (Sweden)

Yoshinao Nagashima

2011-01-01

Full Text Available To promote the practical application of a Japanese traditional medical treatment, such as hot compresses, we developed a plaster-type warming device consisting of a heat- and steam-generating sheet (HSG sheet. First, we tested its effects when applied to the anterior abdominal wall or lumbar region of women complaining of a tendency towards constipation. Application of the sheet to either region produced a feeling of comfort in the abdomen, as assessed by a survey of the subjects. The significant increases in the total hemoglobin observed in these regions suggested an increase in peripheral blood flow, and significant increases in the HF component on ECG and in the amplitude of gastric motility suggested parasympathetic predominance. We concluded that application of the HSG sheet improves the peripheral hemodynamics and autonomic regulation, induces a feeling of comfort in the abdomen, and provides a beneficial environment for the improvement of gastrointestinal movements.

Blood pressure effects of sodium-glucose co-transport 2 (SGLT2) inhibitors.

Science.gov (United States)

Oliva, Raymond V; Bakris, George L

2014-05-01

Management of hypertension in diabetes is critical for reduction of cardiovascular mortality and morbidity. While blood pressure (BP) control has improved over the past two decades, the control rate is still well below 50% in the general population of patients with type 2 diabetes mellitus (T2DM). A new class of oral glucose-lowering agents has recently been approved; the sodium-glucose co-transporter 2 (SGLT2) inhibitors, which act by eliminating large amounts of glucose in the urine. Two agents, dapagliflozin and canagliflozin, are currently approved in the United States and Europe, and empagliflozin and ipragliflozin have reported Phase 3 trials. In addition to glucose lowering, SGLT2 inhibitors are associated with weight loss and act as osmotic diuretics, resulting in a lowering of BP. While not approved for BP-lowering, they may potentially aid BP goal achievement in people within 7-10 mm Hg of goal. It should be noted that the currently approved agents have side effects that include an increased incidence of genital infections, predominantly in women. The approved SGLT2 inhibitors have limited use based on kidney function and should be used only in those with an estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2 for dapagliflozin and ≥45 mL/min/1.73 m2 for canagliflozin. Cardiovascular outcome trials are ongoing with these agents and will be completed within the next 4-5 years. Copyright © 2014 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

Trends in global approvals of biotech crops (1992–2014)

Science.gov (United States)

Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

2015-01-01

ABSTRACT With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992–2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits. PMID:26039675

23 CFR 1200.10 - Application.

Science.gov (United States)

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Application. 1200.10 Section 1200.10 Highways NATIONAL... PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS Application, Approval, and Funding of the Highway Safety Program § 1200.10 Application. Each fiscal year, a State's...

Blood flow analysis with considering nanofluid effects in vertical channel

Science.gov (United States)

Noreen, S.; Rashidi, M. M.; Qasim, M.

2017-06-01

Manipulation of heat convection of copper particles in blood has been considered peristaltically. Two-phase flow model is used in a channel with insulating walls. Flow analysis has been approved by assuming small Reynold number and infinite length of wave. Coupled equations are solved. Numerical solution are computed for the pressure gradient, axial velocity function and temperature. Influence of attention-grabbing parameters on flow entities has been analyzed. This study can be considered as mathematical representation to the vibrance of physiological systems/tissues/organs provided with medicine.

Benefits of standard format and content for approval of packaging for radioactive material

International Nuclear Information System (INIS)

Pstrak, D.; Osgood, N.

2004-01-01

The U.S. Nuclear Regulatory Commission (NRC) uses Regulatory Guide 7.9, ''Standard Format and Content of Part 71 Applications for Approval of Packaging for Radioactive Material'' to provide recommendations on the preparation of applications for approval of Type B and fissile material packages. The purpose of this Regulatory Guide is to assist the applicant in preparing an application that demonstrates the adequacy of a package in meeting the 10 CFR Part 71 packaging requirements. NRC recently revised Regulatory Guide 7.9 to reflect current changes to the regulations in Part 71 as a result of a recent rulemaking that included changes to the structural, containment, and criticality requirements for packages. Overall, the NRC issues Regulatory Guides to describe methods that are acceptable to the NRC staff for implementing specific parts of the NRC's regulations, to explain techniques used by the NRC staff in evaluating specific problems, and to provide guidance to applicants. It is important to note the specific purpose of this Regulatory Guide. As the name indicates, this Guide sets forth a standard format for application submission that is acceptable to the NRC staff that, when used by the applicant, will accomplish several objectives. First, use of the guide provides a consistent and repeatable approach that indicates the information to be provided by the applicant. Second, the organization of the information in the application will assist the reviewer(s) in locating information. Ultimately, accomplishing these objectives will help to ensure the completeness of the information in the application as well as decrease the review time. From an international perspective, use of a standard format approach could enhance the efficiency with which Competent Authorities certify and validate packages for use in the packaging and transportation of radioactive material worldwide. This streamlined approach of preparing package applications could ultimately lead to uniform

75 FR 64248 - Approval for Manufacturing Authority Foreign-Trade Zone 196 ATC Logistics & Electronics (Cell...

Science.gov (United States)

2010-10-19

... Authority Foreign-Trade Zone 196 ATC Logistics & Electronics (Cell Phone Kitting) Fort Worth, TX Pursuant to... Foreign-Trade Zones Board (the Board) adopts the following Order: Whereas, ATC Logistics & Electronics... Logistics & Electronics, as described in the application and Federal Register notice, is approved, subject...

76 FR 38992 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update to Materials...

Science.gov (United States)

2011-07-05

... for Pennsylvania. Since the publication of the last IBR update, EPA has approved the following... revision'' and ``Applicable geographic area'' columns for the entry ``Continuous Source Testing Manual.'' 2... section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding ``good cause...

78 FR 45152 - Approval and Promulgation of Implementation Plans and Designation of Areas; North Carolina...

Science.gov (United States)

2013-07-26

... North Carolina SIP meets the requirements of section 182(b)(5) applicable for purposes of redesignation...] Approval and Promulgation of Implementation Plans and Designation of Areas; North Carolina; Redesignation... supplemented on March 28, 2013, the State of North Carolina, through the North Carolina Department of...

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...

HyApproval - Handbook for the approval of hydrogen refuelling stations - First preliminary achievements

Energy Technology Data Exchange (ETDEWEB)

Wurster, R.; Vandendungen, G.; Guichard, J.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.; Landinger, H.

2007-05-15

The EU-funded project HyApproval [www.hyapproval.org] aims at developing a universal Handbook to facilitate the approval process of Hydrogen Refuelling Stations (HRS) in Europe. The main goal of the HyApproval partnership with 22 partners from Europe and one each from China, Japan and the USA is to provide a Handbook of technical and regulatory requirements to assist authorisation officials, companies and organisations in the safe implementation and operation of HRS. Achievements during the first 15 months: analyses of HRS technology concepts and of equipment and safety distances/ Intermediate Design Paper/ Regulations, Codes and Standards (RCS) review and comparison/ first Handbook draft and first review sessions with HySafe experts/ safety matrix/ identification of accident scenarios/ agreement on safety documentation/ critical review of reliability data from collections and risk studies/ risk assessment (RA) criteria definition and RA/ matrix of acceptability and awareness levels/ database of Fire Associations and First Responders/ calendar of hydrogen events/ general description of CGH{sub 2} interfaces. (au)

78 FR 59754 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Science.gov (United States)

2013-09-27

..., LLC, Ms. Rhonda Nicoloff, Managing Member, 1505 South Redwood Road, Salt Lake City, UT 84104. GRYR seeks approval of the proposed discontinuance and removal of the automatic block signal (ABS) system...

76 FR 79537 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Adhesives and Sealants Rule

Science.gov (United States)

2011-12-22

... Promulgation of Air Quality Implementation Plans; Delaware; Adhesives and Sealants Rule AGENCY: Environmental..., sale, use, or application of adhesives, sealants, primers, and solvents. EPA is approving this SIP... miscellaneous industrial adhesives control techniques guideline (CTG) category in accordance with the...

Pharmaceutical protein production by yeast: towards production of human blood proteins by microbial fermentation

DEFF Research Database (Denmark)

Martinez Ruiz, José Luis; Liu, Lifang; Petranovic, Dina

2012-01-01

Since the approval of recombinant insulin from Escherichia coli for its clinical use in the early 1980s, the amount of recombinant pharmaceutical proteins obtained by microbial fermentations has significantly increased. The recent advances in genomics together with high throughput analysis...... of recombinant therapeutics using yeast Saccharomyces cerevisiae as a model platform, and discusses the future potential of this platform for production of blood proteins and substitutes....

30 CFR 36.6 - Application procedures and requirements.

Science.gov (United States)

2010-07-01

... diesel engine, including joints and gaskets; the turbulence or precombustion chamber, if applicable; injector assembly and nozzle details; and any surfaces that form the combustion chamber or part thereof..., EVALUATION, AND APPROVAL OF MINING PRODUCTS APPROVAL REQUIREMENTS FOR PERMISSIBLE MOBILE DIESEL-POWERED...

Analysis of the Education Program Approval Process: A Program Evaluation.

Science.gov (United States)

Fountaine, Charles A.; And Others

A study of the education program approval process involving the Veterans Administration (VA) and the State Approving Agencies (SAAs) had the following objectives: to describe the present education program approval process; to determine time and costs associated with the education program approval process; to describe the approval process at…

PERIPHERAL BLOOD FILM - A REVIEW FEATURE ARTICLES

African Journals Online (AJOL)

be abreast with its clinical utility and proper application of the reports in the management of patients. Keywords: Peripheral blood smear, Preparation, Examination, Interpretation, Reporting, Blood cells morphology. FEATURE ARTICLES. Ann Ibd. Pg. Med 2014. Vol.12, No.2 71-79. Annals of Ibadan Postgraduate Medicine.

Application of blood-pool agents in visualization of peripheral vessels

International Nuclear Information System (INIS)

Giovagnoni, A.; Catalano, C.

2007-01-01

Effective arterial imaging is essential in patients with peripheral arterial disease (PAD) in whom a revascularization procedure is planned. Digital subtraction angiography (DSA) has traditionally been regarded as the gold standard for imaging in peripheral arterial disease, but this technique is subject to certain limitations, such as the risks of adverse reactions associated with arterial catheterization and iodinated contrast agents. Contrast-enhanced magnetic resonance angiography is now recommended as an effective and useful imaging technique in peripheral arterial disease, since it offers high enhanced contrast between blood and stationary tissue and fast acquisition times. However, extracellular gadolinium contrast agents rapidly diffuse into the interstitial spaces, and thus are suitable only for first-pass imaging. This limitation can be overcome by the use of blood-pool (intravascular) contrast agents, such as gadofosveset trisodium (Vasovist, Bayer Schering Pharma AG, Berlin, Germany), which are retained within the blood vessels and hence facilitate both first-pass and steady-state imaging with high spatial resolution. Blood-pool agents, therefore, offer improved imaging, particularly of distal vessels, compared with extracellular contrast agents. Examples of first-pass and steady-state imaging with gadofosveset are presented. (orig.)

Efficient recovery of whole blood RNA - a comparison of commercial RNA extraction protocols for high-throughput applications in wildlife species

Directory of Open Access Journals (Sweden)

Schwochow Doreen

2012-06-01

Full Text Available Abstract Background Since the emergence of next generation sequencing platforms, unprecedented opportunities have arisen in the study of natural vertebrate populations. In particular, insights into the genetic and epigenetic mechanisms of adaptation can be revealed through study of the expression profiles of genes. However, as a pre-requisite to expression profiling, care must be taken in RNA preparation as factors like DNA contamination, RNA integrity or transcript abundance can affect downstream applications. Here, we evaluated five commonly used RNA extraction methods using whole blood sampled under varying conditions from 20 wild carnivores. Results Despite the use of minute starting volumes, all methods produced quantifiable RNA extracts (1.4 – 18.4 μg with varying integrity (RIN 4.6 - 7.7, the latter being significantly affected by the storage and extraction method used. We observed a significant overall effect of the extraction method on DNA contamination. One particular extraction method, the LeukoLOCK™ filter system, yielded high RNA integrity along with low DNA contamination and efficient depletion of hemoglobin transcripts highly abundant in whole blood. In a proof of concept sequencing experiment, we found globin RNA transcripts to occupy up to ¼ of all sequencing reads if libraries were not depleted of hemoglobin prior to sequencing. Conclusion By carefully choosing the appropriate RNA extraction method, whole blood can become a valuable source for high-throughput applications like expression arrays or transcriptome sequencing from natural populations. Additionally, candidate genes showing signs of selection could subsequently be genotyped in large population samples using whole blood as a source for RNA without harming individuals from rare or endangered species.

7 CFR 1610.4 - Loan applications.

Science.gov (United States)

2010-01-01

... Regulations of the Department of Agriculture (Continued) RURAL TELEPHONE BANK, DEPARTMENT OF AGRICULTURE LOAN POLICIES § 1610.4 Loan applications. No application for a loan will be considered for approval by the Bank... of the applicant for a Bank loan and the amount thereof. Loan application forms are available from...

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...

"Les Grangettes" no longer approved hospital as of 1.1.2012

CERN Multimedia

HR Department

2012-01-01

The negotiations for a new tariff agreement with "Les Grangettes", conducted jointly by CERN and partner international organizations, did not reach a positive conclusion. As a result, "Les Grangettes" ceased being an approved hospital on 31 December 2011.   This means that for hospitalizations in "Les Grangettes" as of 1 January 2012 the conditions applicable to unapproved hospitals will apply. In particular: no third-party payment (i.e. you will be charged directly); reimbursement at a fixed 80% rate, whatever the expenses incurred; and expenses incurred will not contribute towards increasing FCA. CHIS members looking for an alternative are invited to consider “Clinique Générale Beaulieu” (located in the same area of Geneva and with which the existing agreement has been extended for 2012 and 2013) or another approved hospital (see the list on the CHIS web site). Note that, as a transitory measur...

13 CFR 120.1824 - How will an SISMBD receive notice of an approval or denial of a loan or request for an advance...

Science.gov (United States)

2010-01-01

... advance under an SISMBD Loan? (a) Applicants will receive notice of approval or denial of an SISMBD Loan... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false How will an SISMBD receive notice of an approval or denial of a loan or request for an advance under an SISMBD Loan? 120.1824 Section...

Protocol for a national blood transfusion data warehouse from donor to recipient.

Science.gov (United States)

van Hoeven, Loan R; Hooftman, Babette H; Janssen, Mart P; de Bruijne, Martine C; de Vooght, Karen M K; Kemper, Peter; Koopman, Maria M W

2016-08-04

Blood transfusion has health-related, economical and safety implications. In order to optimise the transfusion chain, comprehensive research data are needed. The Dutch Transfusion Data warehouse (DTD) project aims to establish a data warehouse where data from donors and transfusion recipients are linked. This paper describes the design of the data warehouse, challenges and illustrative applications. Quantitative data on blood donors (eg, age, blood group, antibodies) and products (type of product, processing, storage time) are obtained from the national blood bank. These are linked to data on the transfusion recipients (eg, transfusions administered, patient diagnosis, surgical procedures, laboratory parameters), which are extracted from hospital electronic health records. Expected scientific contributions are illustrated for 4 applications: determine risk factors, predict blood use, benchmark blood use and optimise process efficiency. For each application, examples of research questions are given and analyses planned. The DTD project aims to build a national, continuously updated transfusion data warehouse. These data have a wide range of applications, on the donor/production side, recipient studies on blood usage and benchmarking and donor-recipient studies, which ultimately can contribute to the efficiency and safety of blood transfusion. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

76 FR 64237 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adhesives and Sealants Rule

Science.gov (United States)

2011-10-18

...-9480-5] Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adhesives and Sealants... chemical production and polytetrafluoroethylene operations; from paint, resin, and adhesive manufacturing; and from adhesive and sealant application. This SIP revision also pertains to an addition of a new...

28 CFR 58.25 - Qualifications for approval as providers of a personal financial management instructional course.

Science.gov (United States)

2010-07-01

... of a personal financial management instructional course. 58.25 Section 58.25 Judicial Administration... Qualifications for approval as providers of a personal financial management instructional course. (a) Definition... personal financial management instructional course must be in compliance with all applicable laws and...

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

49 CFR 1522.109 - TSA review and approval.

Science.gov (United States)

2010-10-01

... 49 Transportation 9 2010-10-01 2010-10-01 false TSA review and approval. 1522.109 Section 1522.109..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening Program...

49 CFR 1522.115 - Renewal of TSA approval.

Science.gov (United States)

2010-10-01

... 49 Transportation 9 2010-10-01 2010-10-01 false Renewal of TSA approval. 1522.115 Section 1522.115..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening Program...

29 CFR 1952.157 - Changes to approved plan.

Science.gov (United States)

2010-07-01

... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS North Carolina § 1952.157 Changes to approved plan. (a) Legislation. (1) On March 29, 1994, the Assistant Secretary approved North Carolina's... section 17 of the Act as amended on November 5, 1990. (2) [Reserved] (b) The Voluntary Protection Program...

38 CFR 21.7220 - Course approval.

Science.gov (United States)

2010-07-01

...) VOCATIONAL REHABILITATION AND EDUCATION All Volunteer Force Educational Assistance Program (Montgomery GI...; Pub. L. 98-525) (b) Course approval criteria. In administering benefits payable under 38 U.S.C...) Section 21.4265—Practical training approved as institutional training or on-job training; (10) Section 21...

78 FR 47822 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Science.gov (United States)

2013-08-06

..., Glendale, NY 11386. LIRR and NYA jointly seek approval of the proposed discontinuance of the automatic..., S72, and S73 will be removed, as well as the pipe-connected center-lock crossover equipment on...

Incorporating consideration of health impacts into land use development approval processes: Development of a Health Background Study Framework.

Science.gov (United States)

Moloughney, Brent W; Bursey, Gayle E; Neumann, Jana; Leeming, Daniel H; Gutmann, Christine E; Sivanand, Bhavna; Mowat, David L

2014-09-12

This project involved development of a Health Background Study (HBS) Framework to support consideration of health impacts within municipalities' approval process for land use development. Peel Public Health and Toronto Public Health led the project with the participation of planners, urban designers, engineers, public health staff and development industry representatives. Historical growth in the Region of Peel and suburban Toronto has resulted in extensive low-density development, creating car-dependent communities with disconnected streets and segregated land uses. The inclusion of an HBS in developers' applications to municipalities is one approach by which health-related expectations for the built environment can be established within the approval process. Development of the HBS Framework used the six core elements of the built environment with the strongest evidence for impact on health and was informed by analysis of the provincial and local policy contexts, practices of other municipalities and stakeholder interviews. The Framework's contents were refined according to feedback from multidisciplinary stakeholder workshops. The HBS Framework identifies minimum standards for built environment core elements that developers need to address in their applications. The Framework was created to be simple and instructive with applicability to a range of development locations and scales, and to various stages of the development approval process. Peel Public Health is leading several initiatives to support the use of the HBS as a part of the development application process. The HBS Framework is a tool that public health and planning can use to support the consideration of health impacts within municipalities' land use development processes.

76 FR 44583 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2011-07-26

... designated method are manufactured in an ISO 9001-registered facility. Also, an applicant must submit a minor... of Management and Budget (OMB) for review and approval. This is a request to renew an existing... and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725...

75 FR 69658 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2010-11-15

... Activities; Submission to OMB for Review and Approval; Comment Request; Experimental Use Permits (EUPs) for... activity. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of... instrument or form, if applicable. Abstract: The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA...

Estimating the cost of blood: past, present, and future directions.

Science.gov (United States)

Shander, Aryeh; Hofmann, Axel; Gombotz, Hans; Theusinger, Oliver M; Spahn, Donat R

2007-06-01

Understanding the costs associated with blood products requires sophisticated knowledge about transfusion medicine and is attracting the attention of clinical and administrative healthcare sectors worldwide. To improve outcomes, blood usage must be optimized and expenditures controlled so that resources may be channeled toward other diagnostic, therapeutic, and technological initiatives. Estimating blood costs, however, is a complex undertaking, surpassing simple supply versus demand economics. Shrinking donor availability and application of a precautionary principle to minimize transfusion risks are factors that continue to drive the cost of blood products upward. Recognizing that historical accounting attempts to determine blood costs have varied in scope, perspective, and methodology, new approaches have been initiated to identify all potential cost elements related to blood and blood product administration. Activities are also under way to tie these elements together in a comprehensive and practical model that will be applicable to all single-donor blood products without regard to practice type (e.g., academic, private, multi- or single-center clinic). These initiatives, their rationale, importance, and future directions are described.

33 CFR 115.70 - Advance approval of bridges.

Science.gov (United States)

2010-07-01

... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Advance approval of bridges. 115... BRIDGES BRIDGE LOCATIONS AND CLEARANCES; ADMINISTRATIVE PROCEDURES § 115.70 Advance approval of bridges. (a) The General Bridge Act of 1946 requires the approval of the location and plans of bridges prior...

Red Blood Cell Membrane-Cloaked Nanoparticles For Drug Delivery

Science.gov (United States)

Carpenter, Cody Westcott

Herein we describe the development of the Red Blood Cell coated nanoparticle, RBC-NP. Purified natural erythrocyte membrane is used to coat drug-loaded poly(lacticco-glycolic acid) (PLGA). Synthetic PLGA co-polymer is biocompatible and biodegradable and has already received US FDA approval for drug-delivery and diagnostics. This work looks specifically at the retention of immunosuppressive proteins on RBC-NPs, right-sidedness of natural RBC membranes interfacing with synthetic polymer nanoparticles, sustained and retarded drug release of RBC-NPs as well as further surface modification of RBC-NPs for increased targeting of model cancer cell lines.

A microfluidic chip for direct and rapid trapping of white blood cells from whole blood

Science.gov (United States)

Chen, Jingdong; Chen, Di; Yuan, Tao; Xie, Yao; Chen, Xiang

2013-01-01

Blood analysis plays a major role in medical and science applications and white blood cells (WBCs) are an important target of analysis. We proposed an integrated microfluidic chip for direct and rapid trapping WBCs from whole blood. The microfluidic chip consists of two basic functional units: a winding channel to mix and arrays of two-layer trapping structures to trap WBCs. Red blood cells (RBCs) were eliminated through moving the winding channel and then WBCs were trapped by the arrays of trapping structures. We fabricated the PDMS (polydimethylsiloxane) chip using soft lithography and determined the critical flow velocities of tartrazine and brilliant blue water mixing and whole blood and red blood cell lysis buffer mixing in the winding channel. They are 0.25 μl/min and 0.05 μl/min, respectively. The critical flow velocity of the whole blood and red blood cell lysis buffer is lower due to larger volume of the RBCs and higher kinematic viscosity of the whole blood. The time taken for complete lysis of whole blood was about 85 s under the flow velocity 0.05 μl/min. The RBCs were lysed completely by mixing and the WBCs were trapped by the trapping structures. The chip trapped about 2.0 × 103 from 3.3 × 103 WBCs. PMID:24404026

Directory of certificates of compliance for radioactive materials packages. Volume 3, Revision 14: Report of NRC approved quality assurance programs for radioactive materials packages

International Nuclear Information System (INIS)

1994-10-01

This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

Trends in approval times for genetically engineered crops in the United States and the European Unio

NARCIS (Netherlands)

Smart, Richard D.; Blum, Matthias; Wesseler, J.H.H.

2017-01-01

Genetically engineered (GE) crops are subject to regulatory oversight to Ensure their safety for humans and the environment. Their approval in the European Union (EU) starts with an application in a given Member State followed by a scientific risk assessment, and ends with a political

77 FR 50936 - Approval and Promulgation of Air Quality Implementation Plans; Nevada; Regional Haze State and...

Science.gov (United States)

2012-08-23

... Letter at page 6. EPA's BART guidelines did not establish bright-line thresholds for cost- effectiveness... applicable thresholds for incremental cost-effectiveness or visibility improvement for the reasons discussed... thresholds for cost-effectiveness or visibility improvement, or challenge EPA's authority to approve a BART...

E-Approval Plans in Research Libraries

Science.gov (United States)

Pickett, Carmelita; Tabacaru, Simona; Harrell, Jeanne

2014-01-01

Research libraries have long invested in approval plan services, which offer an economical way to acquire scholarly and scientific publications. Traditional approval plans have evolved and now enable libraries to expand their e-book offerings to better serve researchers. Publishers offer a myriad of e-book purchasing options. These range from…

Premarket Approvals (PMA)

Data.gov (United States)

U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

Science.gov (United States)

2010-05-24

... proposal. This information is required for: (1) FHA lender approval, (2) Annual renewal of each FHA lender... following information: Title of Proposal: FHA Lender Approval, Annual Renewal, Periodic Updates and Required... and HUD-92001-C. Description of the Need for the Information and Its Proposed Use: This information is...

25 CFR 224.82 - What activities will the Department continue to perform after approval of a TERA?

Science.gov (United States)

2010-04-01

... assist the tribe in evaluating the physical, economic, financial, cultural, social, environmental, and... AND SELF DETERMINATION ACT Implementation of Tribal Energy Resource Agreements Applicable Authorities and Responsibilities § 224.82 What activities will the Department continue to perform after approval...

Pathogen reduction of blood components.

Science.gov (United States)

Solheim, Bjarte G

2008-08-01

, but not licensed by the FDA), while the method of Riboflavin light treatment of plasma still is under development. In addition to pathogen reduction the methods, however, result in some reduction of coagulation factor activity. For platelets only Psoralen and Riboflavin light treatment have been implemented. Both are CE marked products in Europe but only approved for clinical trials in the USA. The methods affect platelet activity, but result in clinically acceptable platelets with only slightly reduced CCI and increased demand for platelet transfusions. Pathogen reduction of red blood cells with FRALE (S-303) or INACTINE (PEN110) has so far resulted in the formation of antibodies against neo-epitopes on red blood cells. A promising method for Riboflavin treatment of red blood cells is under development. This manuscript reviews the current experience and discusses future trends.

25 CFR 103.16 - How does BIA approve or reject a loan guaranty or insurance application?

Science.gov (United States)

2010-04-01

..., or if necessary, from liquidating loan collateral. Lenders are expected to obtain a first lien security interest in enough collateral to reasonably secure repayment of each loan guaranteed or insured... 25 Indians 1 2010-04-01 2010-04-01 false How does BIA approve or reject a loan guaranty or...

7 CFR 1710.105 - State regulatory approvals.

Science.gov (United States)

2010-01-01

... and Basic Policies § 1710.105 State regulatory approvals. (a) In States where a borrower is required... loans are approved by RUS: (1) Loans requiring an Environmental Impact Statement; (2) Loans to finance...

14 CFR 414.9 - Pre-application consultation.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Pre-application consultation. 414.9 Section 414.9 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Application Procedures § 414.9 Pre-application...

24 CFR 232.505 - Application and application fee.

Science.gov (United States)

2010-04-01

... approval. An application for insurance of a fire safety loan under this part shall be considered only in... HOUSING AND URBAN DEVELOPMENT MORTGAGE AND LOAN INSURANCE PROGRAMS UNDER NATIONAL HOUSING ACT AND OTHER AUTHORITIES MORTGAGE INSURANCE FOR NURSING HOMES, INTERMEDIATE CARE FACILITIES, BOARD AND CARE HOMES, AND...

Perspectives used for gaining approval of budgets.

Science.gov (United States)

Franks-Joiner, G L

1990-01-01

Nurse executives think about problems using a certain perspective which may influence decisions on budgetary matters. The nurse executives' perspective used in decision-making may influence which budget proposals are developed and approved. A study was performed to determine the perspective used by nurse executives in decision-making on supplementary budget item proposals and whether perspective use influenced approval. Findings showed that use of the system view or dual-domain perspective in a proposal may enhance nurse executives' changes of gaining approval.

78 FR 2315 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-01-10

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 15402 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 11947 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-02-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 17281 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 16317 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-03-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 66909 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-11-07

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... below, receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

77 FR 21143 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-04-09

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 25010 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-04-26

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... below, receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

77 FR 34455 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-06-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 55891 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 55892 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 59239 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-26

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

Predicting future blood supply and demand in Japan with a Markov model: application to the sex- and age-specific probability of blood donation.

Science.gov (United States)

Akita, Tomoyuki; Tanaka, Junko; Ohisa, Masayuki; Sugiyama, Aya; Nishida, Kazuo; Inoue, Shingo; Shirasaka, Takuma

2016-11-01

Simulation studies were performed to predict the future supply and demand for blood donations, and future shortfalls. Using data from all donations in 2006 to 2009, the Markov model was applied to estimate future blood donations until 2050. Based on data concerning the actual use of blood products, the number of blood products needed was estimated based on future population projections. We estimated that the number of blood donations increased from 5,020,000 in 2008 to 5,260,000 in 2012, but will decrease to 4,770,000 units by 2025. In particular, the number of donors in their 20s and 30s decreased every year. Moreover, the number of donations required to supply blood products would have been increased from 5,390,000 in 2012 to 5,660,000 units in 2025. Thus, the estimated shortfall of blood donations is expected to increase each year from 140,000 in 2012 to 890,000 in 2025 and then more than double to 1,670,000 in 2050. If the current blood donation behaviors continue, a shortfall of blood availability is likely to occur in Japan. Insufficient blood donations are mainly related to a projected reduction in population of 20 to 30 year olds, a significant group of donors. Thus, it is crucial to recruit and retain new donors and to develop recommendations for proper use of blood products to minimize unnecessary use. This study provides useful information that can be used by governments to help ensure the adequacy of the blood supply through promoting donations and conserving blood resources. © 2016 AABB.

Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project.

Science.gov (United States)

Dixon-Woods, Mary; Foy, Chris; Hayden, Charlotte; Al-Shahi Salman, Rustam; Tebbutt, Stephen; Schroter, Sara

2016-08-31

Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. This study was a non-randomised comparison cohort study. Some data were missing. An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision. Published by the BMJ Publishing Group Limited. For permission to use (where not

A clinical governance framework for blood services.

Science.gov (United States)

Williamson, L M; Benjamin, R J; Devine, D V; Katz, L M; Pink, J

2015-05-01

The elements of clinical governance, which ensure excellence in clinical care, can be applied to blood services. In this survey, their application in a range of blood providers was gauged, with the aim of identifying best practice and producing a generalizable framework. The Medical Directors of members of the Alliance of Blood Operators surveyed how different elements of clinical governance operated within their organizations and developed recommendations applicable in the blood service environment. The recommendations that emerged highlighted the importance of an organization's culture, with the delivery of optimal clinical governance being a corporate responsibility. Senior management must agree and promote a set of values to ensure that the system operates with the patient and donor at its heart. All staff should understand how their role fits into the 'journey to the patient', and a culture of openness promoted. Thus, reporting of errors and risks should be actively sought and praised, with penalties applied for concealment. Systems should exist to collect, analyse and escalate clinical outcomes, safety data, clinical risk assessments, incident reports and complaints to inform organizational learning. Clinical governance principles from general health care can be applied within blood services to complement good manufacturing practice. This requires leadership, accountability, an open culture and a drive for continuous improvement and excellence in clinical care. © 2015 International Society of Blood Transfusion.

Application of solid-phase radioimmunoassay in determining antibodies to Aujeszky's disease virus in blood serum of vaccinated pigs

International Nuclear Information System (INIS)

Rodak, L.; Smid, B.; Valicek, L.

1983-01-01

In the blood sera of pigs vaccinated with inactivated vaccines manufactured by three different manufacturers the RIA method was used to determine the specific antibodies to the virus of Aujeszky's disease. In certain groups of vaccinated pigs the results of the RIA examination are unfavourably affected by the bond of antibodies to the cellular antigenous determinants. This proves that following vaccination antibodies are formed not only against the viral antigen but also against the antigens of cells on which the vaccination virus is propagated. These shortcomings are eliminated by the use of suitable cellular cultures for the preparation of viral and control antigens. Antigens are applicable for RIA and for ELISA examinations of blood sera of infected and vaccinated pigs. The advantages are described of the RIA and ELISA methods as compared with the virus neutralization test. (author)

Application of solid-phase radioimmunoassay in determining antibodies to Aujeszky's disease virus in blood serum of vaccinated pigs

Energy Technology Data Exchange (ETDEWEB)

Rodak, L; Smid, B; Valicek, L [Vyzkumny Ustav Veterinarniho Lekarstvi, Brno-Medlanky (Czechoslovakia)

1983-11-01

In the blood sera of pigs vaccinated with inactivated vaccines manufactured by three different manufacturers the RIA method was used to determine the specific antibodies to the virus of Aujeszky's disease. In certain groups of vaccinated pigs the results of the RIA examination are unfavourably affected by the bond of antibodies to the cellular antigenous determinants. This proves that following vaccination antibodies are formed not only against the viral antigen but also against the antigens of cells on which the vaccination virus is propagated. These shortcomings are eliminated by the use of suitable cellular cultures for the preparation of viral and control antigens. Antigens are applicable for RIA and for ELISA examinations of blood sera of infected and vaccinated pigs. The advantages are described of the RIA and ELISA methods as compared with the virus neutralization test.

75 FR 69660 - Cross-Media Electronic Reporting Rule State Authorized Program Revision Approval: State of Hawaii

Science.gov (United States)

2010-11-15

... Authorized Program Revision Approval: State of Hawaii AGENCY: Environmental Protection Agency (EPA). ACTION... Reporting, of the State of Hawaii's request to revise certain of its EPA-authorized programs to allow... meet the applicable subpart D requirements. On February 16, 2010, the State of Hawaii Department of...

Observations and suggestions for improved transport/packaging approvals

International Nuclear Information System (INIS)

Vaughan, C.

2004-01-01

This paper has been developed from my personal experience as Manager, Facility Licensing with Global Nuclear Fuels in Wilmington, NC over the past four years. All of my examples involve the movement of Type A, fissile material, however, the observations and recommendations clearly have universal application to the movement of other nuclear materials. The observations are global in nature embracing the US, Canada, Japan, the European Union as well others. All of these countries openly report and ascribe to the fact that they have adopted the IAEA Regulations for the Safe Transport of Radioactive Material. The materials involved typically include UF 6 , UO 2 powder, BWR fuel assemblies and process intermediates. Many of the papers here discuss the technical details of testing and the interpretation of the test results associated with the approval of transport packages. The technical details of demonstrating safety are of course very important in the overall assurance of safety. My discussion involves, for the most part, Section VIII - Approval and Administrative Requirements of TS-R-1. I have focused on this area because significant non-productive time is spent on these administrative matters and to a degree this non-productive time spent potentially detracts from meeting the objective of safe transport of nuclear materials

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.

New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting, October 28, 2011.

Science.gov (United States)

Walsh, John; Roberts, Ruth; Vigersky, Robert A; Schwartz, Frank

2012-03-01

Glucose meters (GMs) are routinely used for self-monitoring of blood glucose by patients and for point-of-care glucose monitoring by health care providers in outpatient and inpatient settings. Although widely assumed to be accurate, numerous reports of inaccuracies with resulting morbidity and mortality have been noted. Insulin dosing errors based on inaccurate GMs are most critical. On October 28, 2011, the Diabetes Technology Society invited 45 diabetes technology clinicians who were attending the 2011 Diabetes Technology Meeting to participate in a closed-door meeting entitled New Criteria for Assessing the Accuracy of Blood Glucose Monitors. This report reflects the opinions of most of the attendees of that meeting. The Food and Drug Administration (FDA), the public, and several medical societies are currently in dialogue to establish a new standard for GM accuracy. This update to the FDA standard is driven by improved meter accuracy, technological advances (pumps, bolus calculators, continuous glucose monitors, and insulin pens), reports of hospital and outpatient deaths, consumer complaints about inaccuracy, and research studies showing that several approved GMs failed to meet FDA or International Organization for Standardization standards in postapproval testing. These circumstances mandate a set of new GM standards that appropriately match the GMs' analytical accuracy to the clinical accuracy required for their intended use, as well as ensuring their ongoing accuracy following approval. The attendees of the New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting proposed a graduated standard and other methods to improve GM performance, which are discussed in this meeting report. © 2012 Diabetes Technology Society.

Poet Marion Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

Poet Portland Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves the petition, with modifications, from Poet Biorefining-Portland, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

Poet Alexandria Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Alexandria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

Poet Laddonia Approval

Science.gov (United States)

This update Auugust 9, 2016 letter from EPA approves with modifications, the petition from Poet Biorefining Laddonia, Poet Laddonia Facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act f

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.

Hemomath the mathematics of blood

CERN Document Server

Fasano, Antonio

2017-01-01

This book illustrates applications of mathematics to various processes (physiological or artificial) involving flowing blood, including hemorheology, microcirculation, coagulation, kidney filtration and dialysis, offering a historical overview of each topic. Mathematical models are used to simulate processes normally occurring in flowing blood and to predict the effects of dysfunctions (e.g. bleeding disorders, renal failure), as well as the effects of therapies with an eye to improving treatments. Most of the models have a completely new approach that makes patient-specific simulations possible. The book is mainly intended for mathematicians interested in medical applications, but it is also useful for clinicians such as hematologists, nephrologists, cardio-surgeons, and bioengineers. Some parts require no specific knowledge of mathematics. The book is a valuable addition to mathematics, medical, biology, and bioengineering libraries.

Application of artificial intelligence (AI) concepts to the development of space flight parts approval model

Science.gov (United States)

Krishnan, G. S.

1997-01-01

A cost effective model which uses the artificial intelligence techniques in the selection and approval of parts is presented. The knowledge which is acquired from the specialists for different part types are represented in a knowledge base in the form of rules and objects. The parts information is stored separately in a data base and is isolated from the knowledge base. Validation, verification and performance issues are highlighted.

Brachial blood flow under relative levels of blood flow restriction is decreased in a nonlinear fashion.

Science.gov (United States)

Mouser, J Grant; Ade, Carl J; Black, Christopher D; Bemben, Debra A; Bemben, Michael G

2018-05-01

Blood flow restriction (BFR), the application of external pressure to occlude venous return and restrict arterial inflow, has been shown to increase muscular size and strength when combined with low-load resistance exercise. BFR in the research setting uses a wide range of pressures, applying a pressure based upon an individual's systolic pressure or a percentage of occlusion pressure; not a directly determined reduction in blood flow. The relationship between relative pressure and blood flow has not been established. To measure blood flow in the arm under relative levels of BFR. Forty-five people (18-40 years old) participated. Arterial occlusion pressure in the right arm was measured using a 5-cm pneumatic cuff. Blood flow in the brachial artery was measured at rest and at pressures between 10% and 90% of occlusion using ultrasound. Blood flow decreased in a nonlinear, stepped fashion. Blood flow decreased at 10% of occlusion and remained constant until decreasing again at 40%, where it remained until 90% of occlusion. The decrease in brachial blood flow is not proportional to the applied relative pressure. The prescription of blood flow restriction should take into account the stimulus provided at each relative level of blood flow. © 2017 Scandinavian Society of Clinical Physiology and Nuclear Medicine. Published by John Wiley & Sons Ltd.

Poet Fostoria Approval

Science.gov (United States)

This August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Fostoria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6)

Arterial blood oxygen saturation during blood pressure cuff-induced hypoperfusion

International Nuclear Information System (INIS)

Kyriacou, P A; Shafqat, K; Pal, S K

2007-01-01

Pulse oximetry has been one of the most significant technological advances in clinical monitoring in the last two decades. Pulse oximetry is a non-invasive photometric technique that provides information about the arterial blood oxygen saturation (SpO 2 ) and heart rate, and has widespread clinical applications. When peripheral perfusion is poor, as in states of hypovolaemia, hypothermia and vasoconstriction, oxygenation readings become unreliable or cease. The problem arises because conventional pulse oximetry sensors must be attached to the most peripheral parts of the body, such as finger, ear or toe, where pulsatile flow is most easily compromised. Pulse oximeters estimate arterial oxygen saturation by shining light at two different wavelengths, red and infrared, through vascular tissue. In this method the ac pulsatile photoplethysmographic (PPG) signal associated with cardiac contraction is assumed to be attributable solely to the arterial blood component. The amplitudes of the red and infrared ac PPG signals are sensitive to changes in arterial oxygen saturation because of differences in the light absorption of oxygenated and deoxygenated haemoglobin at these two wavelengths. From the ratios of these amplitudes, and the corresponding dc photoplethysmographic components, arterial blood oxygen saturation (SpO 2 ) is estimated. Hence, the technique of pulse oximetry relies on the presence of adequate peripheral arterial pulsations, which are detected as photoplethysmographic (PPG) signals. The aim of this study was to investigate the effect of pressure cuff-induced hypoperfusion on photoplethysmographic signals and arterial blood oxygen saturation using a custom made finger blood oxygen saturation PPG/SpO 2 sensor and a commercial finger pulse oximeter. Blood oxygen saturation values from the custom oxygen saturation sensor and a commercial finger oxygen saturation sensor were recorded from 14 healthy volunteers at various induced brachial pressures. Both pulse

Arterial blood oxygen saturation during blood pressure cuff-induced hypoperfusion

Science.gov (United States)

Kyriacou, P. A.; Shafqat, K.; Pal, S. K.

2007-10-01

Pulse oximetry has been one of the most significant technological advances in clinical monitoring in the last two decades. Pulse oximetry is a non-invasive photometric technique that provides information about the arterial blood oxygen saturation (SpO2) and heart rate, and has widespread clinical applications. When peripheral perfusion is poor, as in states of hypovolaemia, hypothermia and vasoconstriction, oxygenation readings become unreliable or cease. The problem arises because conventional pulse oximetry sensors must be attached to the most peripheral parts of the body, such as finger, ear or toe, where pulsatile flow is most easily compromised. Pulse oximeters estimate arterial oxygen saturation by shining light at two different wavelengths, red and infrared, through vascular tissue. In this method the ac pulsatile photoplethysmographic (PPG) signal associated with cardiac contraction is assumed to be attributable solely to the arterial blood component. The amplitudes of the red and infrared ac PPG signals are sensitive to changes in arterial oxygen saturation because of differences in the light absorption of oxygenated and deoxygenated haemoglobin at these two wavelengths. From the ratios of these amplitudes, and the corresponding dc photoplethysmographic components, arterial blood oxygen saturation (SpO2) is estimated. Hence, the technique of pulse oximetry relies on the presence of adequate peripheral arterial pulsations, which are detected as photoplethysmographic (PPG) signals. The aim of this study was to investigate the effect of pressure cuff-induced hypoperfusion on photoplethysmographic signals and arterial blood oxygen saturation using a custom made finger blood oxygen saturation PPG/SpO2 sensor and a commercial finger pulse oximeter. Blood oxygen saturation values from the custom oxygen saturation sensor and a commercial finger oxygen saturation sensor were recorded from 14 healthy volunteers at various induced brachial pressures. Both pulse

Revisiting blood transfusion and predictors of outcome in cardiac surgery patients: a concise perspective [version 1; referees: 2 approved

OpenAIRE

Carlos E Arias-Morales; Nicoleta Stoicea; Alicia A Gonzalez-Zacarias; Diana Slawski; Sujatha P. Bhandary; Theodosios Saranteas; Eva Kaminiotis; Thomas J Papadimos

2017-01-01

In the United States, cardiac surgery-related blood transfusion rates reached new highs in 2010, with 34% of patients receiving blood products. Patients undergoing both complex (coronary artery bypass grafting [CABG] plus valve repair or replacement) and non-complex (isolated CABG) cardiac surgeries are likely to have comorbidities such as anemia. Furthermore, the majority of patients undergoing isolated CABG have a history of myocardial infarction. These characteristics may increase the risk...

The Impact of a Topical Sexual Enhancement Cream on the Female Sexual Response and Its Relationship to Clitoral Blood Flow.

Science.gov (United States)

Pelekanos, Michael; Stofman, Guy M; Niren, Neil

2016-12-13

The aim of this investigation was to determine, through two Investigational Review Board (IRB)-approved studies, if a new topical vasodilating cream (NTVC; Life Science Enhancement Corporation, Pittsburgh PA) could improve female sexual response. Study I subjectively evaluated sexual female response as accessed by a modification of the Female Intervention Efficacy Index (FIEI). FIEI was developed at the University of California as an immediate outcome measure of medical intervention to treat female sexual dysfunction.1 In Study II, 10 randomly selected positive responders from Study I were subsequently analyzed objectively with clitoral plethysmography in order to determine the effect of the NTVC and placebo on blood flow.2 RESULTS: In the subjective Study I (81 patients ranging in age from 18 to 63), a positive response trend for the NTVC was demonstrated compared to the placebo. In the objective Study II, 10 randomly selected patients who responded positive in Study I were objectively evaluated for response of increased blood flow in the clitoris after application of both the NTVC and placebo. The clitoral blood flow was shown to have increased with statistical significance for the NTVC in all 10 patients compared to the placebo, with the NTVC exhibiting an average 69% increase in clitoral blood flow. The female sexual response is complex. In the subjective Study I, the NTVC demonstrated positive trends for enhanced lubrication, genital sensation, intercourse, and overall sexual experience. In the objective Study II, 10 of the positive subjective responders from Study I were randomly selected to evaluate their response to the NTVC compared to the placebo. This was done via Doppler plethysmography (DP). All 10 patients demonstrated a statistically significant response rate for increase in clitoral blood flow using the NTVC compared to the placebo, with an average blood flow increase of 69%. This portion of the investigation demonstrates a significant positive end

Immunotherapy Combination Approved for Advanced Kidney Cancer

Science.gov (United States)

FDA has approved the combination of the immunotherapy drugs nivolumab (Opdivo) and ipilimumab (Yervoy) as an initial treatment for some patients with advanced kidney cancer. The approval is expected to immediately affect patient care, as this Cancer Currents post explains.

Poet Leipsic Approval

Science.gov (United States)

This August 9, 2016 letter from EPA approves,wtih modifications, the petition from Poet Biorefining-Leipsic, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs

Optoelectronic investigation of nanodiamond interactions with human blood

Science.gov (United States)

Ficek, M.; Wróbel, M. S.; Wasowicz, M.; Jedrzejewska-Szczerska, M.

2016-03-01

We present optoelectronic investigation of in vitro interactions of whole human blood with different nanodiamond biomarkers. Plasmo-chemical modifications of detonation nanodiamond particles gives the possibility for controlling their surface for biological applications. Optical investigations reveal the biological activity of nanodiamonds in blood dependent on its surface termination. We compare different types of nanodiamonds: commercial non-modified detonation nanodiamonds, and nanodiamonds modified by MW PACVD method with H2-termination, and chemically modified nanodiamond with O2-termination. The absorption spectra, and optical microscope investigations were conducted. The results indicate haemocompatibility of non-modified detonation nanodiamond as well as modified nanodiamonds, which enables their application for drug delivery, as well as sensing applications.

State-of-the-art technocology in blood purification at present

Directory of Open Access Journals (Sweden)

Zhi-hong LIU

2011-02-01

Full Text Available Objective To review the recent advancement in clinical practices and studies on blood purification techniques,and to provide a guide for further studies on its application in military medicine.Methods Literature published in recent five years limited to blood purification field either in English or Chinese were retrieved by searching PubMed and CHKD.Analysis and summary were performed based on the literature.Results The advancements in blood purification in recent five years could be categorized into four fields,i.e.hemodialysis(HD,peritoneal dialysis(PD,continuous renal replacement therapy(CRRT,and adsorption therapy.The development in HD was aimed at promoting the ability of removal of toxic elements producing uremia and online monitor techniques,and PD was aimed at improvement of patients’ general condition and intervention to reduce the risk factors affecting long-term outcomes,and preparation of new PD solutions to improve the efficacy of PD.In regard to CRRT,the current progress had been focused on initiation time,dose and proposal of new hypothesis for high-volume hemofiltration(HVHF application.Adsorption therapy was another choice of blood purification.Domestic military medicine progress in blood purification in our armed forces was focused on techniques that could be used in treatment of casualties in war,including the basic and clinical study of extracorporeal circuit intervention(ECI for treatment of critically ill patients,problems arising from anticoagulation in ECI for patients with trauma,chemical agents poisoning,and adsorption technique.Conclusions Recently,the main advancement of blood purification technique is combined application of series techniques such as dialysis,hemofiltration,adsorption,and plasma exchange in treatment of critically ill patients.Studies on blood purification in domestic military medicine should be updated continuously to follow closely to the latest achievement in world,and translate these latest

Application of optical coherence tomography for noninvasive blood glucose monitoring during hyperglycemia

Science.gov (United States)

Larin, Kirill V.; Ashitkov, Taras V.; Motamedi, Massoud; Esenaliev, Rinat O.

2003-10-01

Approximately 14 million people in the USA and more than 140 million people worldwide suffer from Diabetes Mellitus. The current glucose sensing technique involves a finger puncture several times a day to obtain a droplet of blood for chemical analysis. Recently we proposed to use optical coherence tomography (OCT) for continuous noninvasive blood glucose sensing through skin. In this paper we tested the OCT technique for noninvasive monitoring of blood glucose concentration in lip tissue of New Zealand rabbits and Yucatan micropigs during glucose clamping experiments. Obtained results show good agreement with results obtained in skin studies, good correlation of changes in the OCT signal slope measured at the depth of 250 to 500 μm with changes in blood glucose concentration, and higher stability of the OCT data points than that obtained from skin.

45 CFR 95.611 - Prior approval conditions.

Science.gov (United States)

2010-10-01

... Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GENERAL ADMINISTRATION... for Department approval, signed by the appropriate State official, to the Director, Administration for... of procurement activities beyond that approved in the APD; (D) A change in system concept, or a...

Multi-criteria approval for evaluating landscape management strategies (Case study: Fruška Gora National Park

Directory of Open Access Journals (Sweden)

Lakićević Milena D.

2015-01-01

Full Text Available This paper deals with the problem of multi-criteria evaluation of four management strategies for Fruška Gora National Park. The criteria set was defined in ac­cordance with the IUCN guidelines for management of national parks. Four strategies were evaluated by testing preference intensities for each alternative with the respect to each cri­terion. Alternatives with preference above the approval threshold were approved, and a multi-criteria approval matrix was generated. According to the matrix, the most suitable management strategy was identified. It implies an intense protection of natural resources and landscape diversity in the national park by applying bio-engineering measures. This illustrative example proved that multi-criteria approval can be considered as a good deci­sion support tool when there is no need for a deeper insight into cardinal values of criteria weights and alternatives, or if the decision maker has to select few from many of alterna­tives to reduce the decision problem. For a more precise analysis, it is recommended to combine multi-criteria approval with other decision support tools, and future studies might deal with this problem in order to define an alternative framework for decision making in landscape management. [Projekat Ministarstva nauke Republike Srbije, br. 174003: Theory and application of analytic hierarchy process (AHP in multi-criteria decision making under conditions of risk and uncer­tainty (individual and group context

8 CFR 207.6 - Control over approved refugee numbers.

Science.gov (United States)

2010-01-01

... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Control over approved refugee numbers. 207... ADMISSION OF REFUGEES § 207.6 Control over approved refugee numbers. Current numerical accounting of approved refugees is maintained for each special group designated by the President. As refugee status is...

47 CFR 400.5 - Approval and award.

Science.gov (United States)

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Approval and award. 400.5 Section 400.5 Telecommunication NATIONAL TELECOMMUNICATIONS AND INFORMATION ADMINISTRATION, DEPARTMENT OF COMMERCE, AND NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION E-911 GRANT PROGRAM § 400.5 Approval...

13 CFR 302.18 - Post-approval requirements.

Science.gov (United States)

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Post-approval requirements. 302.18 Section 302.18 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE... Federal cost principles (collectively, “Post-Approval Requirements”). A Recipient's failure to comply with...

Surface coating for blood-contacting devices

Science.gov (United States)

Nair, Ajit Kumar Balakrishnan

The major problems always encountered with the blood-contacting surfaces are their compatibility, contact blood damage, and thrombogenicity. Titanium nitride (TiN) is a hard, inert, ceramic material that is widely used in the engineering industry. TiN has been proven to be a good biomaterial in its crystalline form, in orthopedic, and in tissue implant applications. This dissertation describes a method to coat amorphous TiN on the blood-contacting surfaces of certain medical devices using the room-temperature sputtering process and to characterize, to test, and to evaluate the coating for a reliable, durable, and compatible blood-contacting surface The blood-compatibility aspects were evaluated with standard, established protocols and procedures to prove the feasibility. An amorphous TiN coating is developed, characterized, tested, and blood compatibility evaluated by applying to the blood-contacting surfaces of stainless steel, catheters, and blood filters. The flexibility characteristics were proven by applying it to the diaphragms of the pulsatile pneumatic ventricular assist device. The results show that amorphous titanium nitride is flexible and adherent to polymeric substrates like polyurethane and polyester. Blood compatibility evaluation showed comparable results with catheters and superior behavior with stainless steel and polyester filters. It is concluded that amorphous titanium nitride can be considered to be applied to the surfaces of some of the medical devices in order to improve blood compatibility.

75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

Science.gov (United States)

2010-05-05

... [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations by...

12 CFR 614.4470 - Loans subject to bank approval.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Loans subject to bank approval. 614.4470 Section 614.4470 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LOAN POLICIES AND OPERATIONS Loan Approval Requirements § 614.4470 Loans subject to bank approval. (a) The following loans...

Application of Long-Range Surface Plasmon Resonance for ABO Blood Typing

Directory of Open Access Journals (Sweden)

Wanida Tangkawsakul

2016-01-01

Full Text Available In this study, we demonstrate a long-range surface plasmon resonance (LR-SPR biosensor for the detection of whole cell by captured antigens A and B on the surface of red blood cells (RBCs as a model. The LR-SPR sensor chip consists of high-refractive index glass, a Cytop film layer, and a thin gold (Au film, which makes the evanescent field intensity and the penetration depth longer than conventional SPR. Therefore, the LR-SPR biosensor has improved capability for detecting large analytes, such as RBCs. The antibodies specific to blood group A and group B (Anti-A and Anti-B are covalently immobilized on a grafting self-assembled monolayer (SAM/Au surface on the biosensor. For blood typing, RBC samples can be detected by the LR-SPR biosensor through a change in the refractive index. We determined that the results of blood typing using the LR-SPR biosensor are consistent with the results obtained from the agglutination test. We obtained the lowest detection limits of 1.58 × 105 cells/ml for RBC-A and 3.83 × 105 cells/ml for RBC-B, indicating that the LR-SPR chip has a higher sensitivity than conventional SPR biosensors (3.3 × 108 cells/ml. The surface of the biosensor can be efficiently regenerated using 20 mM NaOH. In summary, as the LR-SPR technique is sensitive and has a simple experimental setup, it can easily be applied for ABO blood group typing.

49 CFR 1150.3 - Information about applicant(s).

Science.gov (United States)

2010-10-01

...) Facts showing that applicant is either a common carrier by railroad or has been organized to implement the proposal for which approval is being sought. (c) A statement indicating whether the rail line will..., the extent of control, and whether any of them control other common carriers. (2) As exhibit A, any...

78 FR 71709 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Science.gov (United States)

2013-11-29

... President Operations, 202 Mason Avenue, Cape Charles, VA 23310. NS and BCR seek approval of the proposed..., Norfolk, VA. The Coleman Place Interlocking will be redesigned and renewed with electronic control... will move west approximately 1,000 feet. The existing No. 2 power-crossover switch will be converted to...

77 FR 24723 - AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA

Science.gov (United States)

2012-04-25

.... IRESSA is indicated as monotherapy after failure of both platinum-based and docetaxel chemotherapies for the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer who... a condition of approval under subpart H failed to verify and confirm clinical benefit. In a letter...

Blood histamine release: A new allergy blood test

International Nuclear Information System (INIS)

Faraj, B.A.; Gottlieb, G.R.; Camp, V.M.; Lollies, P.

1985-01-01

Allergen-mediated histamine release from human leukocytes represents an important model for in vitro studies of allergic reactions. The purpose of this study was to determine whether the measurement of histamine released in allergic patients (pts) by radioenzymatic assay following mixing of their blood with common allergens represents a reliable index for diagnosis of atopic allergy. Three categories of allergies were used: (1) housedust and mite; (2) cat and dog dander; (3) trees and grasses and ragweed mixture. The presence of allergy was established by intradermal skin testing in the study group of 82 pts. Significant atopy was defined as ≥ 3+ (overall range 0-4 +, negative to maximum) on skin testing. The test was carried out in tubes with 0.5 ml heparinized blood, 0.5 ml tris albumin buffer, and one of the allergens (60-100 PNU/ml). In 20 controls without allergy, there always was ≤ 4% histamine release (normal response). A significant allergen-mediated histamine release, ranging from 12 to 30% of the total blood histamine content, was observed in 96% of the pts with skin test sensitivity of ≥ 3+. There was good agreement between skin testing and histamine release in terms of the allergen causing the response. Thus, measurement of histamine release in blood in response to allergen challenge represents a clinically useful in vitro test for the diagnosis of atopic allergy. Because data can be obtained from a single sample and are highly quantitative, this new method should have application to the longitudinal study of allergic pts and to the assessment of interventions

42 CFR 460.18 - CMS evaluation of applications.

Science.gov (United States)

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false CMS evaluation of applications. 460.18 Section 460... ELDERLY (PACE) PACE Organization Application and Waiver Process § 460.18 CMS evaluation of applications. CMS evaluates an application for approval as a PACE organization on the basis of the following...

48 CFR 52.222-16 - Approval of Wage Rates.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false Approval of Wage Rates. 52....222-16 Approval of Wage Rates. As prescribed in 22.407(b), insert the following clause: Approval of Wage Rates (FEB 1988) All straight time wage rates, and overtime rates based thereon, for laborers and...

7 CFR 1717.609 - RUS approval of general manager.

Science.gov (United States)

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of general manager. 1717.609 Section... Operational Controls § 1717.609 RUS approval of general manager. (a) If a borrower's mortgage or loan contract... general manager of the borrower's system, such approval is hereby granted provided that the borrower is in...

28 CFR 551.11 - Authority to approve a marriage.

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Authority to approve a marriage. 551.11... MISCELLANEOUS Marriages of Inmates § 551.11 Authority to approve a marriage. (a) The Warden may approve the marriage of a federal inmate confined in a federal institution. This authority may not be delegated below...

Occlusion cuff for routine measurement of digital blood pressure and blood flow

DEFF Research Database (Denmark)

Lassen, N A; Krähenbühl, B; Hirai, M

1977-01-01

A miniaturized blood pressure cuff made of plastic material and applicable to fingers and toes is described. The cuff was compared to rubber cuffs and to bladder-free cuffs. It was found to be more reliable than the former type and much easier to use than the latter type. It is recommended for us...

76 FR 67238 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change by BATS...

Science.gov (United States)

2011-10-31

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65619, File No. SR-BATS-2011-032] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change by BATS Exchange, Inc. To Adopt Rules Applicable to Auctions Conducted by the Exchange for Exchange-Listed Securities October 25, 2011. I. Introduction On August 22, 2011,...

2016 in review: FDA approvals of new molecular entities.

Science.gov (United States)

Griesenauer, Rebekah H; Kinch, Michael S

2017-11-01

An overview of drugs approved by FDA in 2016 reveals dramatic disruptions in long-term trends. The number of new molecular entities (NMEs) dropped, reflecting the lowest rate of small-molecule approvals observed in almost five decades. In addition, the pace of industry consolidation slowed substantially. The impact of mergers and acquisitions decreased the total number of organizations with past approval experience and continued research and development (R&D) activities to 102, divided evenly between more established pharmaceutical and newer biotechnology companies. Despite these substantial differences, the industry continued to pursue regulatory incentives, as evidenced by a continued increase in the fraction of NMEs approved using an orphan or priority designation, and almost all oncology drugs approved in 2016 utilized these mechanisms. Copyright © 2017 Elsevier Ltd. All rights reserved.

Quality assurance in production and use of special form radioactive material - focal points in BAM approvals

International Nuclear Information System (INIS)

Rolle, A.; Buhlemann, L.

2004-01-01

BAM as the competent authority for approval of special form radioactive material attaches great importance to a detailed audit of the required quality assurance programs for design, manufacture, testing, documentation, use, maintenance and inspection. Applicants have to submit, together with application documentation information on general arrangements for quality assurance, as well as on quality assurance in production and in operation. Fields where BAM has often found deficiencies are leak test methods, weld seam quality and the safety level after use

Optofluidic Sensor for Inline Hemolysis Detection on Whole Blood

DEFF Research Database (Denmark)

Zhou, Chen; Keshavarz Hedayati, Mehdi; Zhu, Xiaolong

2018-01-01

Hemolysis is the rupture of red blood cells and constitutes the most common reason for unsuitable blood samples in the clinic. To detect hemolysis, one has to separate the hemoglobin in blood plasma from that in red blood cells. However, current methods entail centrifugation for cell......-time inline detection on whole blood without extra sample preparation like centrifugation. Long-term testing with inline integration in a modified, commercial blood gas analyzer shows high reliability and repeatability of the measurements even with the presence of interference from bilirubin. We envision...... that the present work has large potential in improving diagnosis quality by enabling PoC hemolysis detection in blood gas analyzers and can also lend unique sensing capabilities to other applications dealing with complex turbid media....

Blood Compatibility of Sulfonated Cladophora Nanocellulose Beads

Directory of Open Access Journals (Sweden)

Igor Rocha

2018-03-01

Full Text Available Sulfonated cellulose beads were prepared by oxidation of Cladophora nanocellulose to 2,3-dialdehyde cellulose followed by sulfonation using bisulfite. The physicochemical properties of the sulfonated beads, i.e., high surface area, high degree of oxidation, spherical shape, and the possibility of tailoring the porosity, make them interesting candidates for the development of immunosorbent platforms, including their application in extracorporeal blood treatments. A desired property for materials used in such applications is blood compatibility; therefore in the present work, we investigate the hemocompatibility of the sulfonated cellulose beads using an in vitro whole blood model. Complement system activation (C3a and sC5b-9 levels, coagulation activation (thrombin-antithrombin (TAT levels and hemolysis were evaluated after whole blood contact with the sulfonated beads and the results were compared with the values obtained with the unmodified Cladophora nanocellulose. Results showed that neither of the cellulosic materials presented hemolytic activity. A marked decrease in TAT levels was observed after blood contact with the sulfonated beads, compared with Cladophora nanocellulose. However, the chemical modification did not promote an improvement in Cladophora nanocellulose hemocompatibility in terms of complement system activation. Even though the sulfonated beads presented a significant reduction in pro-coagulant activity compared with the unmodified material, further modification strategies need to be investigated to control the complement activation by the cellulosic materials.

Blood Compatibility of Sulfonated Cladophora Nanocellulose Beads.

Science.gov (United States)

Rocha, Igor; Lindh, Jonas; Hong, Jaan; Strømme, Maria; Mihranyan, Albert; Ferraz, Natalia

2018-03-07

Sulfonated cellulose beads were prepared by oxidation of Cladophora nanocellulose to 2,3-dialdehyde cellulose followed by sulfonation using bisulfite. The physicochemical properties of the sulfonated beads, i.e., high surface area, high degree of oxidation, spherical shape, and the possibility of tailoring the porosity, make them interesting candidates for the development of immunosorbent platforms, including their application in extracorporeal blood treatments. A desired property for materials used in such applications is blood compatibility; therefore in the present work, we investigate the hemocompatibility of the sulfonated cellulose beads using an in vitro whole blood model. Complement system activation (C3a and sC5b-9 levels), coagulation activation (thrombin-antithrombin (TAT) levels) and hemolysis were evaluated after whole blood contact with the sulfonated beads and the results were compared with the values obtained with the unmodified Cladophora nanocellulose. Results showed that neither of the cellulosic materials presented hemolytic activity. A marked decrease in TAT levels was observed after blood contact with the sulfonated beads, compared with Cladophora nanocellulose. However, the chemical modification did not promote an improvement in Cladophora nanocellulose hemocompatibility in terms of complement system activation. Even though the sulfonated beads presented a significant reduction in pro-coagulant activity compared with the unmodified material, further modification strategies need to be investigated to control the complement activation by the cellulosic materials.

7 CFR 1942.111 - Applicant eligibility.

Science.gov (United States)

2010-01-01

... applicant apply to commercial sources for financing. To provide a basis for referral of only those applicants who may be able to finance projects through commercial sources, approval officials should maintain... must determine whether financing from commercial sources at reasonable rates and terms is available. If...

21 CFR 814.104 - Original applications.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Original applications. 814.104 Section 814.104...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.104 Original... applicant. (d) Address for submissions and correspondence. Copies of all original HDEs amendments and...

77 FR 62200 - Approval and Promulgation of Implementation Plans; New Mexico; Revisions to the New Source Review...

Science.gov (United States)

2012-10-12

... applicant must demonstrate that emissions from the proposed construction and operation of a facility ``will... source undergoing a physical change or change in the method of operation that does not trigger major NSR... of identified PM 2.5 precursors based on an approved interprecursor trading hierarchy and ratio in...

National Heart, Lung, and Blood Institute and the translation of cardiovascular discoveries into therapeutic approaches.

Science.gov (United States)

Galis, Zorina S; Black, Jodi B; Skarlatos, Sonia I

2013-04-26

The molecular causes of ≈4000 medical conditions have been described, yet only 5% have associated therapies. For decades, the average time for drug development through approval has taken 10 to 20 years. In recent years, the serious challenges that confront the private sector have made it difficult to capitalize on new opportunities presented by advances in genomics and cellular therapies. Current trends are disturbing. Pharmaceutical companies are reducing their investments in research, and biotechnology companies are struggling to obtain venture funds. To support early-stage translation of the discoveries in basic science, the National Institutes of Health and the National Heart, Lung, and Blood Institute have developed new approaches to facilitating the translation of basic discoveries into clinical applications and will continue to develop a variety of programs that create teams of academic investigators and industry partners. The goal of these programs is to maximize the public benefit of investment of taxpayer dollars in biomedical research and to lessen the risk required for industry partners to make substantial investments. This article highlights several examples of National Heart, Lung, and Blood Institute-initiated translational programs and National Institutes of Health translational resources designed to catalyze and enable the earliest stages of the biomedical product development process. The translation of latest discoveries into therapeutic approaches depends on continued federal funding to enhance the early stages of the product development process and to stimulate and catalyze partnerships between academia, industry, and other sources of capital.

New Breast Cancer Treatment Approved | NIH MedlinePlus the Magazine

Science.gov (United States)

... Breast Cancer Treatment Approved Follow us New Breast Cancer Treatment Approved Photo: Wikimedia Commons IN THE NEWS - Breast ... Food and Drug Administration approved a new breast cancer treatment that aims to reduce the risk of the ...

21 CFR 314.510 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival...

Science.gov (United States)

2010-04-01

... Serious or Life-Threatening Illnesses § 314.510 Approval based on a surrogate endpoint or on an effect on... well-controlled. The applicant shall carry out any such studies with due diligence. ...

FDA approves efavirenz. Food and Drug Administration.

Science.gov (United States)

Highleyman, L

1998-10-01

The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.

Camphor induces cold and warm sensations with increases in skin and muscle blood flow in human.

Science.gov (United States)

Kotaka, Tomohiko; Kimura, Shoji; Kashiwayanagi, Makoto; Iwamoto, Jun

2014-01-01

Application of camphor to the skin has been empirically thought to improve blood circulation. However, camphor's effects on blood circulation to the skin and on thermal sensation have not been well elucidated. In this study, we examined its effects on the quality of sensation as well as on skin and muscle blood flow in human. Nine adults (average age 37±9.4 years) participated in the study. Petroleum jelly containing 5%, 10%, 20% camphor, or 2% menthol was separately applied to the skin on the medial side of one forearm of each subject. Just after the application, camphor at each concentration induced a cold sensation in a dose-dependent manner. Within 10 min, each subject reported that the cold sensation had faded, after which it was replaced by a warm sensation. As reported previously, a cold sensation was induced by application of 2% menthol, but the subjects did not adapt to that sensation. In addition, menthol did not induce a warm sensation at all. Application of menthol has been shown to increase blood flow in the skin. Finally, we measured blood flow in skin and muscle after the application of camphor or menthol. Application of camphor or menthol separately induced increases in local blood flow in the skin and muscle. The present results indicate that camphor induces both cold and warm sensations and improves blood circulation.

Real Time Intraoperative Monitoring of Blood Loss with a Novel Tablet Application

Science.gov (United States)

Sharareh, Behnam; Woolwine, Spencer; Satish, Siddarth; Abraham, Peter; Schwarzkopf, Ran

2015-01-01

Introduction : Real-time monitoring of blood loss is critical in fluid management. Visual estimation remains the standard of care in estimating blood loss, yet is demonstrably inaccurate. Photometric analysis, which is the referenced “gold-standard” for measuring blood loss, is both time-consuming and costly. The purpose of this study was to evaluate the efficacy of a novel tablet-monitoring device for measurement of Hb loss during orthopaedic procedures. Methods : This is a prospective study of 50 patients in a consecutive series of joint arthroplasty cases. The novel System with Feature Extraction Technology was used to measure the amount of Hb contained within surgical sponges intra-operatively. The system’s measures were then compared with those obtained via gravimetric method and photometric analysis. Accuracy was evaluated using linear regression and Bland-Altman analysis. Results : Our results showed a significant positive correlation between Triton tablet system and photometric analysis with respect to intra-operative hemoglobin and blood loss at 0.92 and 0.91, respectively. Discussion : This novel system can accurately determine Hb loss contained within surgical sponges. We believe that this user-friendly software can be used for measurement of total intraoperative blood loss and thus aid in a more accurate fluid management protocols during orthopaedic surgical procedures. PMID:26401167

14 CFR 21.8 - Approval of articles.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval of articles. 21.8 Section 21.8 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS General § 21.8 Approval of articles. If an article is required to be...

48 CFR 1819.7203 - Mentor approval process.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Mentor approval process... ADMINISTRATION SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS NASA Mentor-Protégé Program 1819.7203 Mentor approval process. (a) An entity seeking to participate as a mentor must apply to the NASA Headquarters...

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.

Study of measurement of the alcohol biomarker phosphatidylethanol (PEth) in dried blood spot (DBS) samples and application of a volumetric DBS device.

Science.gov (United States)

Beck, Olof; Kenan Modén, Naama; Seferaj, Sabina; Lenk, Gabriel; Helander, Anders

2018-04-01

Phosphatidylethanol (PEth) is a group of phospholipids formed in cell membranes following alcohol consumption. PEth measurement in whole blood samples is established as a specific alcohol biomarker with clinical and medico-legal applications. This study further evaluated the usefulness of dried blood spot (DBS) samples collected on filter paper for PEth measurement. Specimens used were surplus volumes of venous whole blood sent for routine LC-MS/MS quantification of PEth 16:0/18:1, the major PEth homolog. DBS samples were prepared by pipetting blood on Whatman 903 Protein Saver Cards and onto a volumetric DBS device (Capitainer). The imprecision (CV) of the DBS sample amount based on area and weight measurements of spot punches were 23-28%. Investigation of the relationship between blood hematocrit and PEth concentration yielded a linear, positive correlation, and at around 1.0-1.5μmol/L PEth 16:0/18:1, the PEth concentration increased by ~0.1μmol/L for every 5% increase in hematocrit. There was a close agreement between the PEth concentrations obtained with whole blood samples and the corresponding results using Whatman 903 (PEth DBS =1.026 PEth WB +0.013) and volumetric device (PEth DBS =1.045 PEth WB +0.016) DBS samples. The CV of PEth quantification in DBS samples at concentrations≥0.05μmol/L were ≤15%. The present results further confirmed the usefulness of DBS samples for PEth measurement. Copyright © 2018 Elsevier B.V. All rights reserved.

[Reporting ethics board approval in German medical theses and journals].

Science.gov (United States)

Zenz, Michael; Zenz, Julia; Grieger, Maximilian

2018-06-05

Since 1975, the Declaration of Helsinki of the World Medical Association (WMA) has clearly required ethics committee approval for research into humans. Nevertheless, this Declaration is violated quite often. As many English-language publications have addressed the theme of ethics board approval in theses and other published works, it is now to be investigated in Germany for the first time.From 2013 to 2014, a total of 1,482 medical theses at four selected universities in addition to three German-language scientific journals were reviewed. In 543 theses, reference to ethics approval would have been required according to the criteria of the Declaration of Helsinki.However, ethics approval was stated in only 58.7% of cases, and even less frequently if the prevailing doctoral regulations or instructions did not refer to the necessity of obtaining ethics approval. Theses on pediatrics mentioned ethics approval most frequently (78.6%), whereas the proportion of surgical papers was the lowest (34.9%). Among the journals, Der Nervenarzt mentioned ethics approval most frequently (59.4%) and Der Chirurg least frequently (30%).Our results point to significant deficits in mentioning ethics approval in medical theses and publications. These deficits could easily be compensated for by a thorough approach of the referees of doctoral regulations and by journal reviewers and editors.

27 CFR 4.50 - Certificates of label approval.

Science.gov (United States)

2010-04-01

..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Requirements for Approval of Labels of... of exemption from label approval, as well as appeal procedures, see part 13 of this chapter. [T.D...

Arterial blood oxygen saturation during blood pressure cuff-induced hypoperfusion

Energy Technology Data Exchange (ETDEWEB)

Kyriacou, P A [School of Engineering and Mathematical Sciences, City University, London EC1V 0HB (United Kingdom); Shafqat, K [School of Engineering and Mathematical Sciences, City University, London EC1V 0HB (United Kingdom); Pal, S K [St Andrew' s Centre for Plastic Surgery and Burns, Broomfield Hospital, Chelmsford, CM1 7ET (United Kingdom)

2007-10-15

Pulse oximetry has been one of the most significant technological advances in clinical monitoring in the last two decades. Pulse oximetry is a non-invasive photometric technique that provides information about the arterial blood oxygen saturation (SpO{sub 2}) and heart rate, and has widespread clinical applications. When peripheral perfusion is poor, as in states of hypovolaemia, hypothermia and vasoconstriction, oxygenation readings become unreliable or cease. The problem arises because conventional pulse oximetry sensors must be attached to the most peripheral parts of the body, such as finger, ear or toe, where pulsatile flow is most easily compromised. Pulse oximeters estimate arterial oxygen saturation by shining light at two different wavelengths, red and infrared, through vascular tissue. In this method the ac pulsatile photoplethysmographic (PPG) signal associated with cardiac contraction is assumed to be attributable solely to the arterial blood component. The amplitudes of the red and infrared ac PPG signals are sensitive to changes in arterial oxygen saturation because of differences in the light absorption of oxygenated and deoxygenated haemoglobin at these two wavelengths. From the ratios of these amplitudes, and the corresponding dc photoplethysmographic components, arterial blood oxygen saturation (SpO{sub 2}) is estimated. Hence, the technique of pulse oximetry relies on the presence of adequate peripheral arterial pulsations, which are detected as photoplethysmographic (PPG) signals. The aim of this study was to investigate the effect of pressure cuff-induced hypoperfusion on photoplethysmographic signals and arterial blood oxygen saturation using a custom made finger blood oxygen saturation PPG/SpO{sub 2} sensor and a commercial finger pulse oximeter. Blood oxygen saturation values from the custom oxygen saturation sensor and a commercial finger oxygen saturation sensor were recorded from 14 healthy volunteers at various induced brachial pressures

Establishment of reference values for complete blood count and blood gases in cynomolgus monkeys (Macaca fascicularis)

Science.gov (United States)

NAKAYAMA, Shunya; KOIE, Hiroshi; KANAYAMA, Kiichi; KATAKAI, Yuko; ITO-FUJISHIRO, Yasuyo; SANKAI, Tadashi; YASUTOMI, Yasuhiro; AGEYAMA, Naohide

2017-01-01

Cynomolgus monkeys are closely related to humans phylogenetically, and this has resulted in their widespread use as a preclinical model. Hematological data with regard to these monkeys are thus important. Although reference values for blood components and sex hormones have been established for cynomolgus monkeys, those for arterial blood gases have not. The arterial blood gases quickly reflect respiratory and circulatory dynamics, and are thus useful for animal management and safe general anesthesia and surgical operations. Furthermore, since O2 is transported by RBC, CBC and blood gases are closely related. The present study aimed to establish reference values for arterial blood gases and CBC in cynomolgus monkeys over a wide age range. Blood gases and CBC of arterial blood, collected from 41 female and 21 male anesthetized monkeys, were measured. Age correlated with RBC, HGB and HCT in the CBC. Values differed significantly between males and females in pCO2, CO2 concentration, MCV and MCH. The pH of blood was equivalent to that of humans and pCO2 was more stable, whereas MCV and MCH were lower than those in humans. Erythrocytes were smaller and less pigmented than in other Macaca species. Several relationships between gender and age, and blood gases and CBC were identified in cynomolgus monkeys. In conclusion, these reference values will be useful as markers for veterinary applications and in the care and maintenance of these animals. PMID:28381665

14 CFR 21.609 - Approval for deviation.

Science.gov (United States)

2010-01-01

... deviation. (a) Each manufacturer who requests approval to deviate from any performance standard of a TSO shall show that the standards from which a deviation is requested are compensated for by factors or... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval for deviation. 21.609 Section 21...

Ordinal Position, Approval Motivation, and Interpersonal Attraction

Science.gov (United States)

Nowicki, Stephen, Jr.

1971-01-01

Results of the study suggest that birth-order effects might be included within the wider framework of approval-dependency theory. Females tend to account for a significant share of birth-order effects. More particularly, firstborn females accounted for much of the differences in expressed attraction as well as need for social approval. (Author)

48 CFR 1316.603-2 - Application.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Application. 1316.603-2 Section 1316.603-2 Federal Acquisition Regulations System DEPARTMENT OF COMMERCE CONTRACTING METHODS AND... Application. (a) With the written approval from the authorized designee in CAM 1301.70, in extreme cases, the...

78 FR 44881 - Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Disapproval of PM2.5

Science.gov (United States)

2013-07-25

... promulgated by the 2008 implementation rule does not conflict with the decision. Wisconsin's submission did... accounting for the condensable fraction of PM 2.5 and PM 10 emissions in applicability determinations and... role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in...

19 CFR Appendix B to Part 191 - Sample Formats for Applications for Specific Manufacturing Drawback Rulings

Science.gov (United States)

2010-04-01

... rulings must be submitted to and reviewed and approved by CBP Headquarters. A specific manufacturing... Ruling Under 19 U.S.C. 1313(a) and 1313(b) (Combination) COMPANY LETTERHEAD (Optional) U.S. Customs and.... Customs will not approve an application which shows an unincorporated division or company as the applicant...

Drugs Approved for Neuroblastoma

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

42 CFR 102.73 - Approval of benefits.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Approval of benefits. 102.73 Section 102.73 Public... PROGRAM Secretarial Determinations § 102.73 Approval of benefits. When the Secretary has determined that benefits will be paid to a requester and has calculated the type and amount of such benefits, he will...

76 FR 66117 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2011-10-25

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... notice lists the projects, described below, receiving approval for the consumptive use of water pursuant...

76 FR 53526 - Projects Approved for Consumptive Uses of Water