Science.gov

Sample records for food transportation act

  1. 75 FR 22713 - Implementation of Sanitary Food Transportation Act of 2005

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ...) (58 FR 29698) that would restrict a cargo tank, tank car, or portable tank to carrying either food... recommended that DOT defer to FDA and USDA on food safety issues (69 FR 76423, December 21, 2004). In light of...; Requirements for animal food to of mammalian protein to 62 FR 30936, for renderers; provide for measures...

  2. Sanitary Transportation of Human and Animal Food. Final rule.

    PubMed

    2016-04-01

    The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. This action is part of our larger effort to focus on prevention of food safety problems throughout the food chain and is part of our implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA) and the Food Safety Modernization Act of 2011 (FSMA). PMID:27051895

  3. Transportation Security Administration Authorization Act

    THOMAS, 111th Congress

    Rep. Jackson-Lee, Sheila [D-TX-18

    2009-04-30

    06/08/2009 Received in the Senate and Read twice and referred to the Committee on Commerce, Science, and Transportation. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  4. [Food Sanitation Act and Minamata Disease].

    PubMed

    Ishihara, Nobuo

    2016-01-01

    Immediately after the official recognition of Minamata disease (1956.5.l) a study group at Kumamoto University suggested that Minamata disease was caused by food poisoning. The next year, this suggestion was accepted by the Ministry of Health and Welfare (MHW). Prior to the decision to apply the Food Sanitation Act (FSA), the local government asked MHW for the application of FSA. Soon after, the chief of the Public Health Bureau replied to the local government that the application of FSA to the Minamata area was impossible. Epidemiological investigations of residents and polluted areas, therefore, were not carried out. Data essential for the screening for exposed residents were unavailable. The criteria for the screening were presented. The Environmental Agency (EA) presented the criteria in the form of notice in 1971, which were revised in 1977. Notwithstanding the clear difference between the original and revised criteria, EA insisted that these two sets of criteria were quite similar. This insistence by EA and the absence of epidemiological data on residents and polluted area resulted in the present confusion about Minamata disease. The application of FSA was stopped by bureaucrats who had no interest in the environmental problems and by several scientists patronized by stakeholders (Chisso, Japanese Association of Chemical Industries, MHW and EA). Stakeholders suppressed science. PMID:26832624

  5. 76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... reportable food that is the subject of a summary posting and that are part of a chain of establishments with... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  6. High Labor Costs? Centralize Food Preparation and Transportation.

    ERIC Educational Resources Information Center

    Pannell, Dorothy V.

    1993-01-01

    Cites the advantages and disadvantages for school districts of centralized food preparation and of the different food systems such as hot food systems, transporting cold or frozen food, and cook-chill systems. (MLF)

  7. The Indian National Food Security Act, 2013: a commentary.

    PubMed

    Varadharajan, Kiruba Sankar; Thomas, Tinku; Kurpad, Anura

    2014-06-01

    The National Food Security Act (NFSA) 2013, passed recently by the Indian Parliament, aims to ensure food security in India, chiefly by providing cereals at subsidized prices through the Targeted Public Distribution System (TPDS) for about two-thirds of households. The predominant line of criticism of the NFSA has been the costs of such an ambitious rights-based approach in the context of decelerating economic growth and growing fiscal deficits. We argue that the food subsidy has been increasing through the last few decades and is set to climb even higher with this act but that the incremental costs, at about 0.2% of gross domestic product, are not as high as claimed. Further, recent evidence of increasing utilization of the TPDS and decreasing corruption add credence to the act's premise that significant income transfers to poor households can be achieved, thereby promoting food security as well as dietary diversity. Several concerns remain to be addressed in the design and implementation of the act, including its proposed coverage, a cereal-centric approach, the identification of beneficiaries, and its adaptability at the state level. If these are resolved effectively, the act can prove to be a significant step forward in India's long-drawn-out battle against undernutrition and food insecurity. Finally, the NFSA also provides a fresh opportunity to reform and strengthen the TPDS, which has been an integral component of India's strategy to achieve food security at the national level. PMID:25076773

  8. H. R. 3430: Food Contamination Prevention Act. Introduced in the House of Representatives, One Hundredth Congress, First Session, October 6, 1989

    SciTech Connect

    Not Available

    1989-01-01

    This bill was introduced in the House of Representatives on October 6, 1989 for the purpose of amending the Solid Waste Disposal Act to regulate the transportation in commerce of solid waste food by prohibiting certain vehicles from transporting both waste and food, and by requiring health and safety standards for certain vehicles used to transport certain waste and food. Hazardous waste, medical waste, and terminal waste cannot be transported in any vehicle that is also used to transport food, food additives, drugs, or cosmetics.

  9. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) TRADE FAIRS Requirements of Other Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a)...

  10. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) TRADE FAIRS Requirements of Other Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a)...

  11. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) TRADE FAIRS Requirements of Other Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a)...

  12. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) TRADE FAIRS Requirements of Other Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a)...

  13. Transportation Reports Elimination Act of 2014

    THOMAS, 113th Congress

    Rep. Shuster, Bill [R-PA-9

    2013-12-02

    01/09/2014 Received in the Senate and Read twice and referred to the Committee on Commerce, Science, and Transportation. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  14. Surface Transportation Board Reauthorization Act of 2014

    THOMAS, 113th Congress

    Sen. Rockefeller, John D., IV [D-WV

    2014-09-08

    12/12/2014 By Senator Rockefeller from Committee on Commerce, Science, and Transportation filed written report. Report No. 113-321. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  15. Essential Transportation Worker Identification Credential Assessment Act

    THOMAS, 113th Congress

    Rep. Jackson Lee, Sheila [D-TX-18

    2013-09-27

    07/29/2014 Received in the Senate and Read twice and referred to the Committee on Commerce, Science, and Transportation. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  16. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 862.9 Section 862.9 Food and Drugs FOOD AND DRUG... Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of...

  17. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 880.9 Section 880.9 Food and Drugs FOOD AND DRUG... Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket...

  18. Protecting Taxpayers in Transportation Asset Transfers Act

    THOMAS, 112th Congress

    Sen. Durbin, Richard [D-IL

    2011-06-16

    06/16/2011 Read twice and referred to the Committee on Commerce, Science, and Transportation. (text of measure as introduced: CR S3896-3897) (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  19. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 870.9 Section 870.9 Food and Drugs FOOD AND DRUG... Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of...

  20. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 884.9 Section 884.9 Food and Drugs FOOD AND DRUG..., and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section...

  1. 21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 890.9 Section 890.9 Food and Drugs FOOD AND DRUG... Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of...

  2. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 868.9 Section 868.9 Food and Drugs FOOD AND DRUG... Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of...

  3. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 878.9 Section 878.9 Food and Drugs FOOD AND DRUG..., and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section...

  4. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 876.9 Section 876.9 Food and Drugs FOOD AND DRUG..., and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section...

  5. Rail coal transportation under the Staggers Act

    SciTech Connect

    Carpenter, A.R.

    1984-01-01

    The Stagger's Act of 1980 offered railroads the opportunity to accelerate growth along with the coal industry in efforts to increase market for both the product (coal) and the service provided. It provides for cost recovery indexing allowing railroads to stay abreast of inflation and flexibility in setting and changing rates. It also allows railroads to enter directly into contract agreements with shippers. Railroads have used extreme caution in implementing these liberties so that the coal industry would not be severely impacted by these changes. They could have raised rates by as much as 52.3% under the new guidelines, but only raised them by 31.6% in the Eastern market and by 21.3% for export coal. The president of CSX Railroads stresses the symbiotic relationship existing between railroads and the coal industry. He suggests that separate sectors of the coal industry stop pointing fingers at one another and join hands to solve coal's competitive problems in the overseas export market. He calls for the formation of a blue-ribbon panel representing all of the parties with a stake in coal to implement such a cooperative effort. (DMC)

  6. Central transthyretin acts to decrease food intake and body weight

    PubMed Central

    Zheng, Fenping; Kim, Yonwook J.; Moran, Timothy H.; Li, Hong; Bi, Sheng

    2016-01-01

    Transthyretin (TTR) is a blood and cerebrospinal fluid transporter of thyroxine and retinol. Gene expression profiling revealed an elevation of Ttr expression in the dorsomedial hypothalamus (DMH) of rats with exercise-induced anorexia, implying that central TTR may also play a functional role in modulating food intake and energy balance. To test this hypothesis, we have examined the effects of brain TTR on food intake and body weight and have further determined hypothalamic signaling that may underlie its feeding effect in rats. We found that intracerebroventricular (icv) administration of TTR in normal growing rats decreased food intake and body weight. This effect was not due to sickness as icv TTR did not cause a conditioned taste aversion. ICV TTR decreased neuropeptide Y (NPY) levels in the DMH and the paraventricular nucleus (P < 0.05). Chronic icv infusion of TTR in Otsuka Long-Evans Tokushima Fatty rats reversed hyperphagia and obesity and reduced DMH NPY levels. Overall, these results demonstrate a previously unknown anorectic action of central TTR in the control of energy balance, providing a potential novel target for treating obesity and its comorbidities. PMID:27053000

  7. Analysis of U.S. Food and Drug Administration food allergen recalls after implementation of the food allergen labeling and consumer protection act.

    PubMed

    Gendel, Steven M; Zhu, Jianmei

    2013-11-01

    To avoid potentially life-threatening reactions, food allergic consumers rely on information on food labels to help them avoid exposure to a food or ingredient that could trigger a reaction. To help consumers in the United States obtain the information that they need, the Food Allergen Labeling and Consumer Protection Act of 2004 defined a major food allergen as being one of eight foods or food groups and any ingredient that contains protein from one of these foods or food groups. A food that contains an undeclared major food allergen is misbranded under the U.S. Food, Drug, and Cosmetic Act and is subject to recall. Food allergen labeling problems are the most common cause of recalls for U.S. Food and Drug Administration (FDA)-regulated food products. To help understand why food allergen recalls continue to occur at a high rate, information on each food allergen recall that occurred in fiscal years 2007 through 2012 was obtained from the FDA recall database. This information was analyzed to identify the food, allergen, root cause, and mode of discovery for each food allergen recall. Bakery products were the most frequently recalled food type, and milk was the most frequently undeclared major food allergen. Use of the wrong package or label was the most frequent problem leading to food allergen recalls. These data are the first reported that indicate the importance of label and package controls as public health measures. PMID:24215698

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ...In September 2011, the Food and Drug Administration (FDA or the Agency) asked the Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food Safety Modernization Act (FSMA). FDA recently released a report from IFT on these pilot projects, entitled ``Pilot Projects for Improving Product Tracing along the Food Supply System.'' FDA is announcing......

  9. 21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 886.9 Section 886.9 Food and Drugs FOOD AND DRUG... Provisions § 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic...

  10. 21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 872.9 Section 872.9 Food and Drugs FOOD AND DRUG... Provisions § 872.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic...

  11. 21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 882.9 Section 882.9 Food and Drugs FOOD AND DRUG... Provisions § 882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic...

  12. 21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 888.9 Section 888.9 Food and Drugs FOOD AND DRUG... Provisions § 888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic...

  13. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  14. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  15. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  16. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  17. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 19 Customs Duties 2 2011-04-01 2011-04-01 false Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) TRADE FAIRS Requirements of Other Laws § 147.23 Compliance with...

  18. Americans with Disabilities Act: Accessibility Guidelines for Buildings and Facilities, Transportation Facilities, Transportation Vehicles.

    ERIC Educational Resources Information Center

    Architectural and Transportation Barriers Compliance Board, Washington, DC.

    Guidelines are presented regarding accessibility to buildings and facilities, transportation facilities, and transportation vehicles by individuals with disabilities, under the Americans with Disabilities Act of 1990. These guidelines are to be applied during building design, construction, and alteration. Part 1 offers detailed facility…

  19. Energy Policy Act Transportation Rate Study: Final Report on Coal Transportation

    EIA Publications

    2000-01-01

    This is the final in a series of reports prepared for the U.S. Congress by the Secretary of Energy on coal distribution and transportation rates as mandated by Title XIII, Section 1340, Establishment of Data Base and Study of Transportation Rates, of the Energy Policy Act of 1992 (P.L. 102-486).

  20. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 892.9 Section 892.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES...

  1. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 892.9 Section 892.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES...

  2. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 892.9 Section 892.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES...

  3. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 878.9 Section 878.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  4. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 884.9 Section 884.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES General Provisions §...

  5. 21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 888.9 Section 888.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.9 Limitations...

  6. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 880.9 Section 880.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Provisions §...

  7. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 862.9 Section 862.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES...

  8. 21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 890.9 Section 890.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES General Provisions § 890.9...

  9. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 868.9 Section 868.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.9 Limitations...

  10. 21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 872.9 Section 872.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.9 Limitations...

  11. 21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 886.9 Section 886.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General Provisions § 886.9 Limitations...

  12. 21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 882.9 Section 882.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General Provisions § 882.9 Limitations...

  13. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 870.9 Section 870.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES General Provisions § 870.9 Limitations...

  14. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 864.9 Section 864.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions §...

  15. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 876.9 Section 876.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES General Provisions §...

  16. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 874.9 Section 874.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions §...

  17. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 878.9 Section 878.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC...

  18. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 874.9 Section 874.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT...

  19. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 874.9 Section 874.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT...

  20. 21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 872.9 Section 872.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.9 Limitations...

  1. 21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 890.9 Section 890.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES General Provisions § 890.9...

  2. 21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 888.9 Section 888.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.9 Limitations...

  3. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 862.9 Section 862.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES...

  4. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 870.9 Section 870.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES General Provisions § 870.9 Limitations...

  5. 21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 886.9 Section 886.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General Provisions § 886.9 Limitations...

  6. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 884.9 Section 884.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES General Provisions §...

  7. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 876.9 Section 876.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES General Provisions §...

  8. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 880.9 Section 880.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Provisions §...

  9. 21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 882.9 Section 882.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General Provisions § 882.9 Limitations...

  10. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 868.9 Section 868.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.9 Limitations...

  11. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND...

  12. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND...

  13. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND...

  14. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND...

  15. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND...

  16. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 864.9 Section 864.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND...

  17. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 864.9 Section 864.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND...

  18. 76 FR 13972 - United States Warehouse Act; Export Food Aid Commodities Licensing Agreement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... Farm Service Agency United States Warehouse Act; Export Food Aid Commodities Licensing Agreement AGENCY... (FSA) proposes adding export food aid commodities (EFAC) to the agricultural products for which... operators storing EFAC. This proposal is in response to the concerns of export food aid providers...

  19. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY Food and Drug Administration Privacy Act Record Systems § 21.20 Procedures...

  20. An Affordability Comparison Tool (ACT) for Space Transportation

    NASA Technical Reports Server (NTRS)

    McCleskey, C. M.; Bollo, T. R.; Garcia, J. L.

    2012-01-01

    NASA bas recently emphasized the importance of affordability for Commercial Crew Development Program (CCDP), Space Launch Systems (SLS) and Multi-Purpose Crew Vehicle (MPCV). System architects and designers are challenged to come up with architectures and designs that do not bust the budget. This paper describes the Affordability Comparison Tool (ACT) analyzes different systems or architecture configurations for affordability that allows for a comparison of: total life cycle cost; annual recurring costs, affordability figures-of-merit, such as cost per pound, cost per seat, and cost per flight, as well as productivity measures, such as payload throughput. Although ACT is not a deterministic model, the paper develops algorithms and parametric factors that use characteristics of the architectures or systems being compared to produce important system outcomes (figures-of-merit). Example applications of outcome figures-of-merit are also documented to provide the designer with information on the relative affordability and productivity of different space transportation applications.

  1. The Food Safety Modernization Act: a barrier to trade? Only if the science says so.

    PubMed

    McNeill, Naomi

    2012-01-01

    The Food Safety Modernization Act improves oversight of America's food safety system. Title III, which regulates imported food, may create extra burdens for importers and therefore act as a barrier to trade. What will be on trial before the World Trade Organization (WTO), however, is not the law's content, but the science supporting it. Under the WTO regime, food safety laws that could restrict the free movement of food commodities must be sufficiently justified by scientific evidence. Member states must engage in risk assessments and regulate food imports in a manner that is "no more restrictive than necessary" to protect against the health risks identified by scientific evidence. This article examines the requirements of the WTO to evaluate the FSMA's legality under WTO rules. It analyzes the case law of the WTO Panel and Appellate Body and compares the FMSA to the EU's General Food Law. PMID:24620418

  2. Using membrane transporters to improve crops for sustainable food production

    Technology Transfer Automated Retrieval System (TEKTRAN)

    With the global population predicted to grow by at least 25% by 2050, the need for sustainable production of nutritious foods is critical for human and environmental well-being. Recent advances show that specialized plant membrane transporters can be utilized to enhance yields of staple crops, incre...

  3. 21 CFR 1310.10 - Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. 1310.10 Section 1310.10 Food and Drugs DRUG ENFORCEMENT... Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. (a)...

  4. 21 CFR 1310.10 - Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act. 1310.10 Section 1310.10 Food and Drugs DRUG ENFORCEMENT... Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act. (a) The...

  5. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  6. 21 CFR 1310.10 - Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act. 1310.10 Section 1310.10 Food and Drugs DRUG ENFORCEMENT... Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act. (a) The...

  7. 21 CFR 1310.10 - Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. 1310.10 Section 1310.10 Food and Drugs DRUG ENFORCEMENT... Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. (a)...

  8. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  9. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  10. 21 CFR 1310.10 - Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. 1310.10 Section 1310.10 Food and Drugs DRUG ENFORCEMENT... Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. (a)...

  11. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  12. An analysis of the FDA Food Safety Modernization Act: protection for consumers and boon for business.

    PubMed

    Strauss, Debra M

    2011-01-01

    This article analyzes components of the FDA Food Safety Modernization Act, which was prompted by incidents of food contamination, exploring the history of its passage and explaining its significance, as well as its limitations. As the first time in 70 years that food law has been changed substantially, this new law represents only an initial but significant step in the direction of improving food safety. With bipartisan support from both Congress and the President, this legislation embodies a mandate that food safety is at this moment becoming a priority. As a result, the time is ripe for a reassessment of other areas of food laws--particularly genetically modified foods and the use of milk and meat from cloned animals and their progeny--which are allowed under current U.S. law with no labeling, preapprovals, or post-market monitoring. These areas warrant special regulation consistent with the new proactive policy towards securing the safety of the food supply. PMID:24505853

  13. THE US EPA'S DERMAL EXPOSURE RESEARCH PROGRAM IN SUPPORT OF THE FOOD QUALITY PROTECTION ACT

    EPA Science Inventory

    The Food Quality Protection Act of 1996 (FQPA) requires that children's risks to pesticide exposures be considered during the tolerance-setting process. FQPA requires exposure assessments to be conducted for all pesticides sources, not just food sources. It also requires tha...

  14. 77 FR 20353 - United States Warehouse Act; Export Food Aid Commodities Licensing Agreement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-04

    ... commodities to be stored. On March 15, 2011 (76 FR 13972-13973), FSA published a notice in the Federal... developed in response to concerns of export food aid providers; specifically, the sanitation and security of...; ] DEPARTMENT OF AGRICULTURE Farm Service Agency United States Warehouse Act; Export Food Aid...

  15. 78 FR 57320 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ...The Food and Drug Administration (FDA or we) is announcing two public meetings to discuss two proposed rules aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically. The Foreign Supplier Verification Programs (FSVP) proposal establishes requirements for importers to verify that their foreign suppliers are implementing the modern,......

  16. Energy Policy Act transportation rate study: Interim report on coal transportation

    SciTech Connect

    1995-10-01

    The primary purpose of this report is to examine changes in domestic coal distribution and railroad coal transportation rates since enactment of the Clean Air Act Amendments of 1990 (CAAA90). From 1988 through 1993, the demand for low-sulfur coal increased, as a the 1995 deadline for compliance with Phase 1 of CAAA90 approached. The shift toward low-sulfur coal came sooner than had been generally expected because many electric utilities switched early from high-sulfur coal to ``compliance`` (very low-sulfur) coal. They did so to accumulate emissions allowances that could be used to meet the stricter Phase 2 requirements. Thus, the demand for compliance coal increased the most. The report describes coal distribution and sulfur content, railroad coal transportation and transportation rates, and electric utility contract coal transportation trends from 1979 to 1993 including national trends, regional comparisons, distribution patterns and regional profiles. 14 figs., 76 tabs.

  17. Provisions of the Food Security Act of 1985. Agricultural Information Bulletin Number 498.

    ERIC Educational Resources Information Center

    Glaser, Lewrene K.

    This report summarizes the 18 titles of the Food Security Act of 1985 and compares it with previous legislation where applicable. It describes the act's provisions for dairy; wool and mohair; wheat; feed grains; cotton; rice; peanuts; soybeans; sugar; other general commodity provisions; trade; conservation; credit; agricultural research,…

  18. 75 FR 70011 - Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 13.'' This document is intended to assist mammography facilities and their personnel in meeting the requirements of the Mammography Quality Standards Act (MQSA)...

  19. Finite element simulation of food transport through the esophageal body

    PubMed Central

    Yang, Wei; Fung, Tat Ching; Chian, Kerm Sim; Chong, Chuh Khiun

    2007-01-01

    The peristaltic transport of swallowed material in the esophagus is a neuro-muscular function involving the nerve control, bolus-structure interaction, and structure-mechanics relationship of the tissue. In this study, a finite element model (FEM) was developed to simulate food transport through the esophagus. The FEM consists of three components, i.e., tissue, food bolus and peristaltic wave, as well as the interactions between them. The transport process was simulated as three stages, i.e., the filling of fluid, contraction of circular muscle and traveling of peristaltic wave. It was found that the maximal passive intraluminal pressure due to bolus expansion was in the range of 0.8-10 kPa and it increased with bolus volume and fluid viscosity. It was found that the highest normal and shear stresses were at the inner surface of muscle layer. In addition, the peak pressure required for the fluid flow was predicted to be 1-15 kPa at the bolus tail. The diseases of systemic sclerosis or osteogenesis imperfecta, with the remodeled microstructures and mechanical properties, might induce the malfunction of esophageal transport. In conclusion, the current simulation was demonstrated to be able to capture the main characteristics in the intraluminal pressure and bolus geometry as measured experimentally. Therefore, the finite element model established in this study could be used to further explore the mechanism of esophageal transport in various clinical applications. PMID:17457965

  20. Using membrane transporters to improve crops for sustainable food production

    PubMed Central

    Schroeder, Julian I.; Delhaize, Emmanuel; Frommer, Wolf B.; Guerinot, Mary Lou; Harrison, Maria J.; Herrera-Estrella, Luis; Horie, Tomoaki; Kochian, Leon V.; Munns, Rana; Nishizawa, Naoko K.; Tsay, Yi-Fang; Sanders, Dale

    2013-01-01

    With the global population predicted to grow by at least 25 per cent by 2050, the need for sustainable production of nutritious foods is critical for human and environmental health. Recent advances show that specialized plant membrane transporters can be used to enhance yields of staple crops, increase nutrient content and increase resistance to key stresses, including salinity, pathogens and aluminium toxicity, which in turn could expand available arable land. PMID:23636397

  1. 78 FR 59751 - Transportation Infrastructure Financing and Innovation Act (TIFIA) Program; Agency Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-27

    ... Office of the Secretary Transportation Infrastructure Financing and Innovation Act (TIFIA) Program... Infrastructure Financing and Innovation Act (TIFIA) program to pay the subsidy cost of supporting Federal credit..., including the use of appropriate automated, electronic, mechanical, or other technological...

  2. Industry invites regulation: the passage of the Pure Food and Drug Act of 1906.

    PubMed Central

    Barkan, I D

    1985-01-01

    Ending its 27-year stranglehold on proposals for federal pure food and drug legislation, Congress passed the Pure Food and Drug Act and its companion bill, the Meat Inspection Act, on June 30, 1906. An unprecedented convergence of consumer, scientific, and industrial support in 1906 prompted such action; most industries even planned for it, hoping regulation would restore the competitiveness of their products on weak foreign and domestic markets. The ways in which these interests converged, and the reasons therefore, suggest a change in their relationships to each other and with the federal government as America headed into the twentieth century. Images p21-a p21-b PMID:3881052

  3. 78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-08

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice, request for comments. SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing...

  4. 78 FR 10107 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food... human consumption (the produce safety proposed rule) and for current good manufacturing practice and... 1960s, FDA established HACCP-based regulations for seafood (21 CFR part 123) in 1995 (60 FR...

  5. 78 FR 6762 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food... produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk... (60 FR 65096, December 18, 1995) and for juice (21 CFR part 120) in 2001 (66 FR 6138, January 19,...

  6. 78 FR 76187 - Transportation Infrastructure Financing and Innovation Act (TIFIA) Program; Agency Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-16

    ...-day Federal Register notice was published on September 27, 2013, 2013 (78 FR 59751). Since the... Office of the Secretary Transportation Infrastructure Financing and Innovation Act (TIFIA) Program... Transportation Infrastructure Financing and Innovation Act (TIFIA) program to pay the subsidy cost of...

  7. Professional Networks among Rural School Food Service Directors Implementing the Healthy, Hunger-Free Kids Act

    ERIC Educational Resources Information Center

    Lubker Cornish, Disa; Askelson, Natoshia M.; Golembiewski, Elizabeth H.

    2015-01-01

    Purpose/Objectives: This study was designed to explore the professional networks of rural school food service directors (FSD), the resources they use for implementing the Healthy, Hunger-free Kids Act of 2010 (HHFKA), and their needs for information and support to continue to implement successfully. Methods: Rural FSD participated in an in-depth…

  8. EVALUATION OF A PROTOCOL FOR DRINKING WATER TREATMENT DATA REQUIRED BY THE FOOD QUALITY PROTECTION ACT

    EPA Science Inventory

    Under the Food Quality Protection Act (FQPA), the USEPA Office of Pesticide Programs (OPP) considers drinking water as a route for pesticide exposure in its human health risk assessments, and may require data on the fate of a pesticide in drinking water be supplied to OPP by the ...

  9. Scaling behaviors of weighted food webs as energy transportation networks.

    PubMed

    Zhang, Jiang; Guo, Liangpeng

    2010-06-01

    Food webs can be regarded as energy transporting networks in which the weight of each edge denotes the energy flux between two species. By investigating 21 empirical weighted food webs as energy flow networks, we found several ubiquitous scaling behaviors. Two random variables A(i) and C(i) defined for each vertex i, representing the total flux (also called vertex intensity) and total indirect effect or energy store of i, were found to follow power law distributions with the exponents alpha approximately 1.32 and beta approximately 1.33, respectively. Another scaling behavior is the power law relationship, C(i) approximately A(i)(eta), where eta approximately 1.02. This is known as the allometric scaling power law relationship because A(i) can be treated as metabolism and C(i) as the body mass of the sub-network rooted from the vertex i, according to the algorithm presented in this paper. Finally, a simple relationship among these power law exponents, eta=(alpha-1)/(beta-1), was mathematically derived and tested by the empirical food webs. PMID:20303987

  10. The Implementation of the Food Safety Modernization Act and the Strength of the Sustainable Agriculture Movement.

    PubMed

    Wiseman, Samuel R

    2015-01-01

    In the wake of growing public concerns over salmonella outbreaks and other highly publicized food safety issues, Congress passed the FDA Food Safety Modernization Act in 2011, which placed more stringent standards on food growing and packaging operations. In negotiations preceding the Act's passage, farmers of local, sustainable food argued that these rules would unduly burden local agricultural operations or, at the extreme, drive them out of business by creating overly burdensome rules. These objections culminated in the addition of the Tester-Hagan Amendment to the Food Safety Modernization Act, which created certain exemptions for small farms. Proposed Food and Drug Administration (FDA) rules to implement the Act threatened to weaken this victory for small farm groups, however, prompting a loud response from small farmers and local food proponents. The FDA's second set of proposed rules, issued in September 2014 in response to these and other complaints, were, perhaps surprisingly, responsive to small farmers' concerns. Using comments submitted to the FDA, this article explores the responses of the agriculture industry and public health organizations, as well as small farm groups, consumers of local food, and sustainable agriculture interests (which, for simplicity, I alternately describe as comprising the "sustainable agriculture" or "small farm" movement), to three aspects of the FDA's proposed rules--involving manure application, on-farm packing activities, and exemptions for very small farms--to assess the strength of the sustainable agriculture movement. The rules involving manure application and on-farm packing, it turns out, reveal little about the independent political strength of the local food movement, as large industry groups also objected to these provisions. But for the third issue discussed here--exemptions for very small farms--the interests of sustainable agriculture groups were directly opposed to both industry and public health organizations

  11. 75 FR 35338 - Implementation of Regulations Required Under Title XI of the Food, Conservation and Energy Act of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ...-AB07 Implementation of Regulations Required Under Title XI of the Food, Conservation and Energy Act of... participants regarding compliance. In enacting Title XI of the Food, Conservation and Energy Act of 2008 (Farm..., and its coverage was to encompass the complete chain of commerce and give the Secretary of...

  12. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise...

  13. 40 CFR 2.308 - Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... information obtained under the Federal Food, Drug and Cosmetic Act. 2.308 Section 2.308 Protection of... § 2.308 Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic... Cosmetic Act, as amended, 21 U.S.C. 301 et seq. (2) Petition means a petition for the issuance of...

  14. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise...

  15. 40 CFR 2.308 - Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... information obtained under the Federal Food, Drug and Cosmetic Act. 2.308 Section 2.308 Protection of... § 2.308 Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic... Cosmetic Act, as amended, 21 U.S.C. 301 et seq. (2) Petition means a petition for the issuance of...

  16. 40 CFR 2.308 - Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... information obtained under the Federal Food, Drug and Cosmetic Act. 2.308 Section 2.308 Protection of... § 2.308 Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic... Cosmetic Act, as amended, 21 U.S.C. 301 et seq. (2) Petition means a petition for the issuance of...

  17. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise...

  18. 40 CFR 2.308 - Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... information obtained under the Federal Food, Drug and Cosmetic Act. 2.308 Section 2.308 Protection of... § 2.308 Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic... Cosmetic Act, as amended, 21 U.S.C. 301 et seq. (2) Petition means a petition for the issuance of...

  19. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise...

  20. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise...

  1. 40 CFR 2.308 - Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... information obtained under the Federal Food, Drug and Cosmetic Act. 2.308 Section 2.308 Protection of... § 2.308 Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic... Cosmetic Act, as amended, 21 U.S.C. 301 et seq. (2) Petition means a petition for the issuance of...

  2. 78 FR 26845 - Privacy Act of 1974; Department of Transportation, Office of the Secretary of Transportation; DOT...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ... Privacy Act statement in the Federal Register published on January 17, 2008 (73 FR 3316-3317). Docket: For... published in the Federal Register at 75 FR 82132, December 29, 2010, and 77 FR 42796, July 20, 2012... of Transportation; DOT/ALL-25; Department of Transportation Biographies System of Records...

  3. Coast Guard and Maritime Transportation Act of 2014

    THOMAS, 113th Congress

    Rep. Hunter, Duncan D. [R-CA-50

    2014-02-06

    04/02/2014 Received in the Senate and Read twice and referred to the Committee on Commerce, Science, and Transportation. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  4. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES § 1310.11 Reinstatement of exemption for...

  5. 76 FR 13643 - FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... accountability for domestic and foreign food and animal feed firms in the supply chain from farm to U.S. table... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-N-0134, FDA-2011-N-0143, FDA-2011-N-0144, FDA- 2011-N-0145, and FDA-2011-N-0146] FDA Food Safety Modernization Act: Title III--A...

  6. 78 FR 36711 - Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Food and Drug Administration Safety and Innovation Act Title VII--Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of...: Food and Drug Administration, HHS. ACTION: Notification of public meeting; request for...

  7. Two underestimated threats in food transportation: mould and acceleration.

    PubMed

    Janssen, S; Pankoke, I; Klus, K; Schmitt, K; Stephan, U; Wöllenstein, J

    2014-06-13

    Two important parameters are often neglected in the monitoring of perishable goods during transport: mould contamination of fresh food and the influence of acceleration or vibration on the quality of a product. We assert the claim that it is necessary to focus research on these two topics in the context of intelligent logistics in this opinion paper. Further, the technical possibilities for future measurement systems are discussed. By measuring taste deviations, we verified the effect on the quality of beer at different vibration frequencies. The practical importance is shown by examining transport routes and market shares. The general feasibility of a mobile mould detection system is established by examining the measurement resolution of semiconductor sensors for mould-related gases. Furthermore, as an alternative solution, we present a concept for a miniaturized and automated culture-medium-based system. Although there is a lack of related research to date, new efforts can make a vital contribution to the reduction of losses in the logistic chains for several products. PMID:24797139

  8. Two underestimated threats in food transportation: mould and acceleration

    PubMed Central

    Janssen, S.; Pankoke, I.; Klus, K.; Schmitt, K.; Stephan, U.; Wöllenstein, J.

    2014-01-01

    Two important parameters are often neglected in the monitoring of perishable goods during transport: mould contamination of fresh food and the influence of acceleration or vibration on the quality of a product. We assert the claim that it is necessary to focus research on these two topics in the context of intelligent logistics in this opinion paper. Further, the technical possibilities for future measurement systems are discussed. By measuring taste deviations, we verified the effect on the quality of beer at different vibration frequencies. The practical importance is shown by examining transport routes and market shares. The general feasibility of a mobile mould detection system is established by examining the measurement resolution of semiconductor sensors for mould-related gases. Furthermore, as an alternative solution, we present a concept for a miniaturized and automated culture-medium-based system. Although there is a lack of related research to date, new efforts can make a vital contribution to the reduction of losses in the logistic chains for several products. PMID:24797139

  9. Compilation of the Food Stamp Act of 1977 and Other Selected Federal Nutrition Statutes. 98th Congress, 2d Session.

    ERIC Educational Resources Information Center

    Congress of the U.S., Washington, DC. House Committee on Agriculture.

    This is a compilation of the Food Stamp Act of 1977 and other selected Federal nutrition statutes, including those relating to the Act and major authorities for domestic commodity distribution. The section on the Act itself covers policy, definitions, establishment, eligibility, issuance and use of coupons, value of allotment, approval of food…

  10. Howard Coble Coast Guard and Maritime Transportation Act of 2014

    THOMAS, 113th Congress

    Rep. Hunter, Duncan D. [R-CA-50

    2014-12-01

    12/04/2014 Received in the Senate and Read twice and referred to the Committee on Commerce, Science, and Transportation. (All Actions) Notes: For further action, see S.2444, which became Public Law 113-281 on 12/18/2014. Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  11. Coast Guard and Maritime Transportation Act of 2012

    THOMAS, 112th Congress

    Rep. LoBiondo, Frank A. [R-NJ-2

    2012-06-01

    06/07/2012 Subcommittee on Coast Guard and Maritime Transportation Discharged. (All Actions) Notes: For further action, see H.R.2838, which became Public Law 112-213 on 12/20/2012. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  12. 75 FR 28042 - Privacy Act of 1974: System of Records; Department of Homeland Security Transportation Security...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-19

    ... Transportation Security Enforcement Record System (69 FR 71828, December 10, 2004.) TSA's mission is to protect... rule published on August 4, 2006 in 71 FR 44223. II. Privacy Act The Privacy Act embodies fair... records is also based on ``need to know.'' Electronic access is limited by computer security measures...

  13. The Food Safety Modernization Act: Implications for U.S. Small Scale Farms.

    PubMed

    Boys, Kathryn A; Ollinger, Michael; Geyer, Leon L

    2015-01-01

    The Food Safety Modernization Act (FSMA) reforms law governing the safety of human and animal foods produced for consumption in the United States. Recognizing the challenges that the proposed regulations would impose on small farms, Congress included an amendment to exempt small farms from the full scope of FSMA requirements. This special treatment and other issues left unaddressed by FSMA, however, present challenges for buyers of small farm products and is inducing a private sector response to these regulatory gaps. This Article reviews the current treatment of small farms under FSMA and explores some key impacts and implications of FSMA on these organizations. Particular consideration is given to the unintended consequences of the Tester-Hagan Amendment and the unaddressed issue of liability for foodborne illness. PMID:26591825

  14. Recovery Act - Sustainable Transportation: Advanced Electric Drive Vehicle Education Program

    SciTech Connect

    Caille, Gary

    2013-12-13

    The collective goals of this effort include: 1) reach all facets of this society with education regarding electric vehicles (EV) and plug–in hybrid electric vehicles (PHEV), 2) prepare a workforce to service these advanced vehicles, 3) create web–based learning at an unparalleled level, 4) educate secondary school students to prepare for their future and 5) train the next generation of professional engineers regarding electric vehicles. The Team provided an integrated approach combining secondary schools, community colleges, four–year colleges and community outreach to provide a consistent message (Figure 1). Colorado State University Ventures (CSUV), as the prime contractor, plays a key program management and co–ordination role. CSUV is an affiliate of Colorado State University (CSU) and is a separate 501(c)(3) company. The Team consists of CSUV acting as the prime contractor subcontracted to Arapahoe Community College (ACC), CSU, Motion Reality Inc. (MRI), Georgia Institute of Technology (Georgia Tech) and Ricardo. Collaborators are Douglas County Educational Foundation/School District and Gooru (www.goorulearning.org), a nonprofit web–based learning resource and Google spin–off.

  15. 77 FR 70166 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ...The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's implementation of the provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) related to medical gases. This action is intended to ensure that information submitted to FDA on the implementation of the medical gas provisions of FDASIA is available to all......

  16. "Reforms Looked Really Good on Paper": Rural Food Service Responses to the Healthy, Hunger-Free Kids Act of 2010

    ERIC Educational Resources Information Center

    Cornish, Disa; Askelson, Natoshia; Golembiewski, Elizabeth

    2016-01-01

    Background: The Healthy, Hunger-Free Kids Act of 2010 (HHKA) required schools to make changes to meals provided to children. Rural school districts have limited resources, with increased obesity rates and local food insecurity. In this study we sought to understand the perceptions of rural food service directors and the barriers to implementing…

  17. Prior notice of imported food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule.

    PubMed

    2008-11-01

    The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. The final rule requires that the prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP or Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PNSI). The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." PMID:19112701

  18. Energy policy act transportation study: Interim report on natural gas flows and rates

    SciTech Connect

    1995-11-17

    This report, Energy Policy Act Transportation Study: Interim Report on Natural Gas Flows and Rates, is the second in a series mandated by Title XIII, Section 1340, ``Establishment of Data Base and Study of Transportation Rates,`` of the Energy Policy Act of 1992 (P.L. 102--486). The first report Energy Policy Act Transportation Study: Availability of Data and Studies, was submitted to Congress in October 1993; it summarized data and studies that could be used to address the impact of legislative and regulatory actions on natural gas transportation rates and flow patterns. The current report presents an interim analysis of natural gas transportation rates and distribution patterns for the period from 1988 through 1994. A third and final report addressing the transportation rates and flows through 1997 is due to Congress in October 2000. This analysis relies on currently available data; no new data collection effort was undertaken. The need for the collection of additional data on transportation rates will be further addressed after this report, in consultation with the Congress, industry representatives, and in other public forums.

  19. Flavonoids act as negative regulators of auxin transport in vivo in arabidopsis.

    PubMed

    Brown, D E; Rashotte, A M; Murphy, A S; Normanly, J; Tague, B W; Peer, W A; Taiz, L; Muday, G K

    2001-06-01

    Polar transport of the plant hormone auxin controls many aspects of plant growth and development. A number of synthetic compounds have been shown to block the process of auxin transport by inhibition of the auxin efflux carrier complex. These synthetic auxin transport inhibitors may act by mimicking endogenous molecules. Flavonoids, a class of secondary plant metabolic compounds, have been suggested to be auxin transport inhibitors based on their in vitro activity. The hypothesis that flavonoids regulate auxin transport in vivo was tested in Arabidopsis by comparing wild-type (WT) and transparent testa (tt4) plants with a mutation in the gene encoding the first enzyme in flavonoid biosynthesis, chalcone synthase. In a comparison between tt4 and WT plants, phenotypic differences were observed, including three times as many secondary inflorescence stems, reduced plant height, decreased stem diameter, and increased secondary root development. Growth of WT Arabidopsis plants on naringenin, a biosynthetic precursor to those flavonoids with auxin transport inhibitor activity in vitro, leads to a reduction in root growth and gravitropism, similar to the effects of synthetic auxin transport inhibitors. Analyses of auxin transport in the inflorescence and hypocotyl of independent tt4 alleles indicate that auxin transport is elevated in plants with a tt4 mutation. In hypocotyls of tt4, this elevated transport is reversed when flavonoids are synthesized by growth of plants on the flavonoid precursor, naringenin. These results are consistent with a role for flavonoids as endogenous regulators of auxin transport. PMID:11402184

  20. Flavonoids act as negative regulators of auxin transport in vivo in arabidopsis

    NASA Technical Reports Server (NTRS)

    Brown, D. E.; Rashotte, A. M.; Murphy, A. S.; Normanly, J.; Tague, B. W.; Peer, W. A.; Taiz, L.; Muday, G. K.

    2001-01-01

    Polar transport of the plant hormone auxin controls many aspects of plant growth and development. A number of synthetic compounds have been shown to block the process of auxin transport by inhibition of the auxin efflux carrier complex. These synthetic auxin transport inhibitors may act by mimicking endogenous molecules. Flavonoids, a class of secondary plant metabolic compounds, have been suggested to be auxin transport inhibitors based on their in vitro activity. The hypothesis that flavonoids regulate auxin transport in vivo was tested in Arabidopsis by comparing wild-type (WT) and transparent testa (tt4) plants with a mutation in the gene encoding the first enzyme in flavonoid biosynthesis, chalcone synthase. In a comparison between tt4 and WT plants, phenotypic differences were observed, including three times as many secondary inflorescence stems, reduced plant height, decreased stem diameter, and increased secondary root development. Growth of WT Arabidopsis plants on naringenin, a biosynthetic precursor to those flavonoids with auxin transport inhibitor activity in vitro, leads to a reduction in root growth and gravitropism, similar to the effects of synthetic auxin transport inhibitors. Analyses of auxin transport in the inflorescence and hypocotyl of independent tt4 alleles indicate that auxin transport is elevated in plants with a tt4 mutation. In hypocotyls of tt4, this elevated transport is reversed when flavonoids are synthesized by growth of plants on the flavonoid precursor, naringenin. These results are consistent with a role for flavonoids as endogenous regulators of auxin transport.

  1. Chewing and food consistency: effects on bolus transport and swallow initiation.

    PubMed

    Saitoh, Eiichi; Shibata, Seiko; Matsuo, Koichiro; Baba, Mikoto; Fujii, Wataru; Palmer, Jeffrey B

    2007-04-01

    Preswallow bolus formation usually occurs in the mouth for liquids and in the oropharynx for solid foods. We examined the effect of chewing on the relationship between bolus transport and swallow initiation. Fifteen healthy subjects were imaged with lateral projection videofluorography while eating liquids, solid foods, and a mixture of liquid and solid foods in upright and facedown postures. Videotapes were reviewed to measure the location of the leading edge of the barium at swallow initiation. Chewing and initial consistency each altered the relationship between food transport and swallow initiation. In particular, when chewing liquid (or consuming foods with both liquid and solid phases), a portion of the food commonly reached the hypopharynx well before swallow onset. This transport to the hypopharynx was highly dependent on gravity, but transport to the valleculae for chewed solid food was active, depending primarily on tongue-palate contact. Chewing appeared to reduce the effectiveness of the posterior tongue-palate seal, allowing oral contents to spill into the pharynx. Consuming two-phase foods with both solid and liquid phases may increase the risk of aspiration in dysphagic individuals with impaired airway protective reflexes. PMID:17347905

  2. 78 FR 55657 - Privacy Act of 1974: Implementation of Exemptions; Department of Homeland Security Transportation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ...The Department of Homeland Security is giving concurrent notice of a newly established system of records pursuant to the Privacy Act of 1974 for the ``Department of Homeland Security/Transportation Security Administration-021, TSA Pre[check]TM; Application Program System of Records'' and this proposed rulemaking. In this proposed rulemaking, the Department proposes to exempt......

  3. 77 FR 70796 - Privacy Act of 1974; Retirement of Department of Homeland Security Transportation Security...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

    ... following Privacy Act system of records notice, DHS/TSA-017 Secure Flight Test Records (June 22, 2005, 70 FR.../Transportation Security Administration- 019, Secure Flight Records (November 9, 2007, 72 FR 63711) to cover the...)-017 Secure Flight Test Records (June 22, 2005, 70 FR 36320), from its inventory of record systems....

  4. 75 FR 7978 - Privacy Act of 1974: Implementation of Exemptions; Department of Homeland Security Transportation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... Exemptions; Department of Homeland Security Transportation Security Administration-023 Workplace Violence... Security Administration-023 Workplace Violence Prevention Program System of Records and this proposed... a new system of records under the Privacy Act (5 U.S.C. 552a) titled, DHS/TSA-023 Workplace...

  5. Impact of Clean Air Act Regulations on Nitrogen Fate and Transport in Neuse River Basin

    EPA Science Inventory

    This study investigated impacts of Clean Air Act Amendment (CAAA) NOx emissions regulations on the fate and transport of nitrogen for two watersheds in the Neuse River Basin, North Carolina, USA from 1990 to 2020. The Soil and Water Assessment Tool (SWAT) and the Community Multi-...

  6. 76 FR 64354 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ...'' that appeared in the Federal Register of August 1, 2011 (76 FR 45818). In that document, FDA announced.... Background In the Federal Register of August 1, 2011 (76 FR 45818), FDA published a notice with a 78-day... HUMAN SERVICES Food and Drug Administration Burden of Food and Drug Administration Food...

  7. Energy Policy Act transportation rate study: Availability of data and studies

    SciTech Connect

    Not Available

    1993-10-13

    Pursuant to Section 1340(c) of the Energy Policy Act of 1992 (EPACT), this report presents the Secretary of Energy`s review of data collected by the Federal Government on rates for rail and pipeline transportation of domestic coal, oil, and gas for the years 1988 through 1997, and proposals to develop an adequate data base for each of the fuels, based on the data availability review. This report also presents the Energy Information Administration`s findings regarding the extent to which any Federal agency is studying the impacts of the Clean Air Act Amendments of 1990 (CAAA90) and other Federal policies on the transportation rates and distribution patterns of domestic coal, oil, and gas.

  8. 78 FR 43261 - Transportation Infrastructure Financing and Innovation Act (TIFIA) Program; Agency Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-19

    ...The Department of Transportation (DOT) invites public comments on a request to the Office of Management and Budget (OMB) to approve an Emergency Information Collection Request in accordance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 USC 3501 et seq). This request is being submitted to OMB via an Emergency Information Collection Request. On July 6, 2012,......

  9. Airborne Measurements in Support of the NASA Atmospheric Carbon and Transport - America (ACT-America) Mission

    NASA Astrophysics Data System (ADS)

    Meadows, B.; Davis, K.; Barrick, J. D. W.; Browell, E. V.; Chen, G.; Dobler, J. T.; Fried, A.; Lauvaux, T.; Lin, B.; McGill, M. J.; Miles, N. L.; Nehrir, A. R.; Obland, M. D.; O'Dell, C.; Sweeney, C.; Yang, M. M.

    2015-12-01

    NASA announced the research opportunity Earth Venture Suborbital - 2 (EVS-2) mission in support of the NASA's science strategic goals and objectives in 2013. Penn State University, NASA Langley Research Center (LaRC), and other academic institutions, government agencies, and industrial companies together formulated and proposed the Atmospheric Carbon and Transport - America (ACT - America) suborbital mission, which was subsequently selected for implementation. The airborne measurements that are part of ACT-America will provide a unique set of remote and in-situ measurements of CO2 over North America at spatial and temporal scales not previously available to the science community and this will greatly enhance our understanding of the carbon cycle. ACT - America will consist of five airborne campaigns, covering all four seasons, to measure regional atmospheric carbon distributions and to evaluate the accuracy of atmospheric transport models used to assess carbon sinks and sources under fair and stormy weather conditions. This coordinated mission will measure atmospheric carbon in the three most important regions of the continental US carbon balance: Northeast, Midwest, and South. Data will be collected using 2 airborne platforms (NASA Wallops' C-130 and NASA Langley's B-200) with both in-situ and lidar instruments, along with instrumented ground towers and under flights of the Orbiting Carbon Observatory (OCO-2) satellite. This presentation provides an overview of the ACT-America instruments, with particular emphasis on the airborne CO2 and backscatter lidars, and the, rationale, approach, and anticipated results from this mission.

  10. Airborne Measurements in Support of the NASA Atmospheric Carbon and Transport - America (ACT-America) Mission

    NASA Technical Reports Server (NTRS)

    Meadows, Byron; Davis, Ken; Barrick, John; Browell, Edward; Chen, Gao; Dobler, Jeremy; Fried, Alan; Lauvaux, Thomas; Lin, Bing; McGill, Matt; Miles, Natasha; Nehrir, Amin; Obland, Michael; O'Dell, Chris; Sweeney, Colm; Yang, Melissa

    2015-01-01

    NASA announced the research opportunity Earth Venture Suborbital -2 (EVS-2) mission in support of the NASA's science strategic goals and objectives in 2013. Penn State University, NASA Langley Research Center (LaRC), and other academic institutions, government agencies, and industrial companies together formulated and proposed the Atmospheric Carbon and Transport -America (ACT -America) suborbital mission, which was subsequently selected for implementation. The airborne measurements that are part of ACT-America will provide a unique set of remote and in-situ measurements of CO2 over North America at spatial and temporal scales not previously available to the science community and this will greatly enhance our understanding of the carbon cycle. ACT -America will consist of five airborne campaigns, covering all four seasons, to measure regional atmospheric carbon distributions and to evaluate the accuracy of atmospheric transport models used to assess carbon sinks and sources under fair and stormy weather conditions. This coordinated mission will measure atmospheric carbon in the three most important regions of the continental US carbon balance: Northeast, Midwest, and South. Data will be collected using 2 airborne platforms (NASA Wallops' C-130 and NASA Langley's B-200) with both in-situ and lidar instruments, along with instrumented ground towers and under flights of the Orbiting Carbon Observatory (OCO-2) satellite. This presentation provides an overview of the ACT-America instruments, with particular emphasis on the airborne CO2and backscatter lidars, and the, rationale, approach, and anticipated results from this mission.

  11. The success of the citizen suit: protecting consumers from inaccurate food labeling by amending the Federal Food, Drug, and Cosmetic Act.

    PubMed

    Springer, James

    2013-01-01

    The Federal Food, Drug, and Cosmetic Act ("FDCA"), amended in 1990 by the Nutrition Education and Labeling Act ("NLEA"), established a national framework for the administration and promulgation of uniform food labeling standards. Specifically, the NLEA created affirmative obligations for the food--requiring detailed disclosure of food content and strict adherence to regulations governing the use of health and nutritional claims on food packaging. To accomplish these goals, Congress tasked the Food and Drug Administration ("FDA") with the sole responsibility of the enforcement of these new requirements. Under the statutory framework of the FDCA, the United States Supreme Court ("Court") has held that there is no private right of action, of which extended to the enforcement of NLEA standards. This interpretation has left individuals with no federal outlet for relief in the enforcement of federal food labeling standards. Adherence to this interpretation is especially concerning when the FDA currently faces exponential growth in administrative responsibilities while simultaneously experiencing employment reduction, a $206 million "Sequester," and a recent government-wide shutdown. As a result, the American people are left to depend on an Agency that is struggling with drastic resource reduction while being accountable for ever increasing enforcement responsibilities. To ensure consumer protection, this Article argues that Congress should amend the FDCA to include a citizen suit provision in order to provide individuals with a right of private action for the enforcement of NLEA standards. Borrowing from the successes realized under similar citizen suit provisions found in environmental legislation, this Article argues that a citizen suit provision is amendable to the FDCA and would relieve fiscal pressures, strengthen the current enforcement framework of the FDCA, encourage more robust enforcement by the FDA and states, and ensure uniform interpretation of NLEA

  12. New Oil Pollution Act of 1990 will impact facilities, terminals, and transports in the oil industry

    SciTech Connect

    Not Available

    1990-01-01

    The magnitude of the Exxon Valdez spill galvanized the opinion of both the public and Congress on the need for new oil spill legislation. Consequently, the Oil Pollution Act of 1990 - a comprehensive prevention, response, liability, and compensation system for dealing with oil production - was passed by the 101st Congress. This book describes in detail the new law and the liabilities it imposes; the new financial responsibility requirements placed on oil-related facilities and vessels; oil spill prevention and response obligations; and the oil industry's activities to prevent and mitigate oil spills. Also discussed are the compliance problems faced by both fixed facilities and the transportation industry.

  13. Registration of food facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule.

    PubMed

    2005-10-01

    The Food and Drug Administration (FDA) is issuing a final regulation that confirms the interim final rule entitled "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003. The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003. This final rule does not make any changes to the regulatory requirements established by the interim final rule. PMID:16200686

  14. 76 FR 45820 - Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ... activities on behalf of FDA's product centers, including the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM), which have FSMA implementation responsibilities... inspection trips related to FDA's food and veterinary medicine programs, which averaged a total of...

  15. RISKIND: An enhanced computer code for National Environmental Policy Act transportation consequence analysis

    SciTech Connect

    Biwer, B.M.; LePoire, D.J.; Chen, S.Y.

    1996-03-01

    The RISKIND computer program was developed for the analysis of radiological consequences and health risks to individuals and the collective population from exposures associated with the transportation of spent nuclear fuel (SNF) or other radioactive materials. The code is intended to provide scenario-specific analyses when evaluating alternatives for environmental assessment activities, including those for major federal actions involving radioactive material transport as required by the National Environmental Policy Act (NEPA). As such, rigorous procedures have been implemented to enhance the code`s credibility and strenuous efforts have been made to enhance ease of use of the code. To increase the code`s reliability and credibility, a new version of RISKIND was produced under a quality assurance plan that covered code development and testing, and a peer review process was conducted. During development of the new version, the flexibility and ease of use of RISKIND were enhanced through several major changes: (1) a Windows{sup {trademark}} point-and-click interface replaced the old DOS menu system, (2) the remaining model input parameters were added to the interface, (3) databases were updated, (4) the program output was revised, and (5) on-line help has been added. RISKIND has been well received by users and has been established as a key component in radiological transportation risk assessments through its acceptance by the U.S. Department of Energy community in recent environmental impact statements (EISs) and its continued use in the current preparation of several EISs.

  16. 78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... and Tracing of Food'' that appeared in the Federal Register of March 5, 2013 (78 FR 14309). In the... Register of March 5, 2013 (78 FR 14309), FDA published a ] notice with a 30-day comment period to...

  17. Mechanisms Underlying Food-Drug Interactions: Inhibition of Intestinal Metabolism and Transport

    PubMed Central

    Won, Christina S.; Oberlies, Nicholas H.; Paine, Mary F.

    2012-01-01

    Food-drug interaction studies are critical to evaluate appropriate dosing, timing, and formulation of new drug candidates. These interactions often reflect prandial-associated changes in the extent and/or rate of systemic drug exposure. Physiologic and physicochemical mechanisms underlying food effects on drug disposition are well-characterized. However, biochemical mechanisms involving drug metabolizing enzymes and transport proteins remain underexplored. Several plant-derived beverages have been shown to modulate enzymes and transporters in the intestine, leading to altered pharmacokinetic (PK) and potentially negative pharmacodynamic (PD) outcomes. Commonly consumed fruit juices, teas, and alcoholic drinks contain phytochemicals that inhibit intestinal cytochrome P450 and phase II conjugation enzymes, as well as uptake and efflux transport proteins. Whereas myriad phytochemicals have been shown to inhibit these processes in vitro, translation to the clinic has been deemed insignificant or undetermined. An overlooked prerequisite for elucidating food effects on drug PK is thorough knowledge of causative bioactive ingredients. Substantial variability in bioactive ingredient composition and activity of a given dietary substance poses a challenge in conducting robust food-drug interaction studies. This confounding factor can be addressed by identifying and characterizing specific components, which could be used as marker compounds to improve clinical trial design and quantitatively predict food effects. Interpretation and integration of data from in vitro, in vivo, and in silico studies require collaborative expertise from multiple disciplines, from botany to clinical pharmacology (i.e., plant to patient). Development of more systematic methods and guidelines is needed to address the general lack of information on examining drug-dietary substance interactions prospectively. PMID:22884524

  18. PREDICTING DRUG DISPOSITION, ABSORPTION / ELIMINATION / TRANSPORTER INTERPLAY AND THE ROLE OF FOOD ON DRUG ABSORPTION

    PubMed Central

    Custodio, Joseph M.; Wu, Chi-Yuan; Benet, Leslie Z.

    2008-01-01

    The ability to predict drug disposition involves concurrent consideration of many chemical and physiological variables and the effect of food on the rate and extent of availability adds further complexity due to postprandial changes in the gastrointestinal (GI) tract. A system that allows for the assessment of the multivariate interplay occurring following administration of an oral dose, in the presence or absence of meal, would greatly benefit the early stages of drug development. This is particularly true in an era when the majority of new molecular entities are highly permeable, poorly soluble, extensively metabolized compounds (BDDCS Class 2), which present the most complicated relationship in defining the impact of transporters due to the marked effects of transporter-enzyme interplay. This review evaluates the GI luminal environment by taking into account the absorption / transport / elimination interplay and evaluates the physiochemical property issues by taking into account the importance of solubility, permeability and metabolism. We concentrate on the BDDCS and its utility in predicting drug disposition. Furthermore, we focus on the effect of food on the extent of drug availability (F), which appears to follow closely what might be expected if a significant effect of high fat meals is inhibition of transporters. That is, high fat meals and lipidic excipients would be expected to have little effect on F for Class 1 drugs; they would increase F of Class 2 drugs, while decreasing F for Class 3 drugs. PMID:18199522

  19. PATHWAY: a simulation model of radionuclide-transport through agricultural food chains

    SciTech Connect

    Kirchner, T.B.; Whicker, F.W.; Otis, M.D.

    1982-01-01

    PATHWAY simulates the transport of radionuclides from fallout through an agricultural ecosystem. The agro-ecosystem is subdivided into several land management units, each of which is used either for grazing animals, for growing hay, or for growing food crops. The model simulates the transport of radionuclides by both discrete events and continuous, time-dependent processes. The discrete events include tillage of soil, harvest and storage of crops,and deposition of fallout. The continuous processes include the transport of radionuclides due to resuspension, weathering, rain splash, percolation, leaching, adsorption and desorption of radionuclides in the soil, root uptake, foliar absorption, growth and senescence of vegetation, and the ingestion assimilation, and excretion of radionuclides by animals. Preliminary validation studies indicate that the model dynamics and simulated values of radionuclide concentrations in several agricultural products agree well with measured values when the model is driven with site specific data on deposition from world-wide fallout.

  20. Impact of Clean Air Act Regulations on Nitrogen Fate and Transport in the Neuse River Basin

    NASA Astrophysics Data System (ADS)

    Gabriel, M. C.; Knightes, C. D.; Dennis, R. L.; Cooter, E. J.

    2012-12-01

    This study investigated impacts of Clean Air Act Amendment (CAAA) NOx emissions regulations on the fate and transport of nitrogen for two watersheds in the Neuse River Basin, North Carolina, USA from 1990 to 2020. The Soil and Water Assessment Tool (SWAT) and the Community Multi-scale Air Quality (CMAQ) modeling system were used. CMAQ simulated atmospheric chemical transport and nitrogen deposition. This data was entered into SWAT which simulated watershed hydrology and water quality. Two cases were investigated: one that incorporates CAAA regulatory emissions controls in CMAQ simulation (with) and a second case that does not (without). SWAT model results forecasted a 70% decrease in inorganic nitrogen discharge from the Little River watershed and a 50% decrease for the Nahunta watershed by 2020 under the emission control (with) scenario. Denitrification and plant nitrogen uptake played important roles in nitrogen discharge from each watershed. The nitrogen discharge response time following a change in atmospheric nitrogen deposition was 4 years for the Nahunta watershed and 2 years for the Little River watershed. The longer response time for Nahunta is primarily due to a higher percentage of soybean land cover (22.5% [Nahunta]; 1.6% [Little River]). Agricultural land covers had varied nitrogen response times to changes in atmospheric deposition, particularly for soybean, hay and corn. The studied watersheds retained >80% of all nitrogen delivered by agriculture fertilization, biological fixation and atmospheric deposition.

  1. The Regulation of Medical Computer Software as a “Device” under the Food, Drug, and Cosmetic Act

    PubMed Central

    Brannigan, Vincent

    1986-01-01

    Recent developments in computer software have raised the possibility that federal regulators may claim to control medical computer software as a “device” under the Food, Drug and Cosmetic Act. The purpose of this paper is to analyze the FDCA to determine whether computer software is included in the statutory scheme, examine constitutional arguments relating to computer software, and discuss regulatory principles that should be taken into account when deciding appropriate regulation. This paper is limited to computer program output used by humans in deciding appropriate medical therapy for a patient.

  2. Enhancing Nutrition Security via India's National Food Security Act: Using an Axe instead of a Scalpel?§

    PubMed Central

    Desai, Sonalde; Vanneman, Reeve

    2016-01-01

    In September 2013, India passed a historic National Food Security Act. This paper examines the potential impact of the two central pillars of this act - expansion of the Public Distribution System and strengthening of the Integrated Child Development Schemes – on child nutrition. Using new data from the India Human Development Survey of 2011-12, this paper shows that access to subsidized grains via PDS is not related to improved child nutrition, and while ICDS seems to be related to lower child undernutrition, it has a limited reach in spite of the universalization of the program. The paper suggests that a tiered strategy in dealing with child undernutrition that starts with the identification of undernourished children and districts and follows through with different strategies for dealing with severe, acute malnutrition, followed by a focus on moderate malnutrition, could be more effective than the existing focus on cereal distribution rooted in the NFSA. PMID:27034596

  3. 76 FR 20588 - FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... examine and update current good manufacturing practice requirements and to develop an animal feed safety... methods in manufacturing, processing, packing, and holding food and feed. FDA is interested in making... three of the following five break-out sessions: Preventive Controls Guidance, On- Farm Manufacturing...

  4. 41 CFR 304-3.8 - Must I adhere to the provisions of the Fly America Act when I receive air transportation to a...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... provisions of the Fly America Act when I receive air transportation to a meeting furnished or paid by a non... provisions of the Fly America Act when I receive air transportation to a meeting furnished or paid by a non... reimbursed to your agency by the non-Federal source, the provisions of the Fly America Act do not apply....

  5. 41 CFR 304-3.8 - Must I adhere to the provisions of the Fly America Act when I receive air transportation to a...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... provisions of the Fly America Act when I receive air transportation to a meeting furnished or paid by a non... provisions of the Fly America Act when I receive air transportation to a meeting furnished or paid by a non... reimbursed to your agency by the non-Federal source, the provisions of the Fly America Act do not apply....

  6. 41 CFR 304-3.8 - Must I adhere to the provisions of the Fly America Act when I receive air transportation to a...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... provisions of the Fly America Act when I receive air transportation to a meeting furnished or paid by a non... provisions of the Fly America Act when I receive air transportation to a meeting furnished or paid by a non... reimbursed to your agency by the non-Federal source, the provisions of the Fly America Act do not apply....

  7. 41 CFR 304-3.8 - Must I adhere to the provisions of the Fly America Act when I receive air transportation to a...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... provisions of the Fly America Act when I receive air transportation to a meeting furnished or paid by a non... provisions of the Fly America Act when I receive air transportation to a meeting furnished or paid by a non... reimbursed to your agency by the non-Federal source, the provisions of the Fly America Act do not apply....

  8. 41 CFR 304-3.8 - Must I adhere to the provisions of the Fly America Act when I receive air transportation to a...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... provisions of the Fly America Act when I receive air transportation to a meeting furnished or paid by a non... provisions of the Fly America Act when I receive air transportation to a meeting furnished or paid by a non... reimbursed to your agency by the non-Federal source, the provisions of the Fly America Act do not apply....

  9. 77 FR 45636 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-01

    ... the fees authorized by section 743 of the FD&C Act on small businesses (76 FR 45818, Aug. 1, 2011.... These indirect ] and supporting FTEs function in budget, facility, human resource, information... Federal Register of August 1, 2011 (see 76 FR 45831). Utilizing the method set forth in section...

  10. 78 FR 46966 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... small businesses (76 FR 45818, August 1, 2011). The comment period for this request ended November 30... Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Thus, as the starting... FR 45639). Utilizing the method set forth in section 736(c)(1) of the FD&C Act, FDA has calculated...

  11. Transportation of perishable and refrigerated foods in mylar foil bags and insulated containers: a time-temperature study.

    PubMed

    Li, Yanyan; Schrade, John P; Su, Haiyan; Specchio, John J

    2014-08-01

    Data are lacking on the temperature changes of food during transport without the use of refrigerated trucks. The purpose of this study was to evaluate the ability of several insulated and noninsulated containers with or without frozen gel packs to keep perishable and refrigerated foods within the temperature safe zone in relationship to duration of transport. The study was designed to duplicate the practices exhibited by customers purchasing perishable food products from a cash-and-carry business. Approximately 40 perishable food items were evaluated. Four types of containers were tested: a mylar foil bag, a commercial insulated bag, a generic insulated bag, and a commercial insulated blanket. Mixed foods were placed into these containers with or without frozen gel packs, transported in unrefrigerated vehicles, and monitored for 4 h for temperature changes. Two environmental temperatures, room temperature of 21.1°C and a stress temperature of 37.8°C, were evaluated. The internal temperature and surface temperature of the food products in these containers increased slowly but remained well below the U.S. Food and Drug Administration Food Code requirements. The various containers were similar in their ability to retain coolness. The presence of frozen gel packs dramatically enhanced the cold-holding capacity of the containers. The temperature of foods increased more rapidly when stressed in a heated environment. The containers tested used with the frozen gel packs can keep the surface and internal temperatures of various perishable foods (starting at 4.4°C or less) within the Food Code recommendation of under 21.1°C for 4 h. Cash-and-carry businesses should strongly encourage their retail customers to utilize these containers with frozen gel packs to safely transport perishable foods. PMID:25198592

  12. Integrative application of active controls (IAAC) technology to an advanced subsonic transport project. Initial act configuration design study

    NASA Technical Reports Server (NTRS)

    1980-01-01

    The performance and economic benefits of a constrained application of Active Controls Technology (ACT) are identified, and the approach to airplane design is established for subsequent steps leading to the development of a less constrained final ACT configuration. The active controls configurations are measured against a conventional baseline configuration, a state-of-the-art transport, to determine whether the performance and economic changes resulting from ACT merit proceeding with the project. The technology established by the conventional baseline configuration was held constant except for the addition of ACT. The wing, with the same planform, was moved forward on the initial ACT configuration to move the loading range aft relative to the wing mean aerodynamic chord. Wing trailing-edge surfaces and surface controls also were reconfigured for load alleviation and structural stabilization.

  13. Acting discursively: the development of UK organic food and farming policy networks.

    PubMed

    TOMLINSON, Isobel Jane

    2010-01-01

    This paper documents the early evolution of UK organic food and farming policy networks and locates this empirical focus in a theoretical context concerned with understanding the contemporary policy-making process. While policy networks have emerged as a widely acknowledged empirical manifestation of governance, debate continues as to the concept's explanatory utility and usefulness in situations of network and policy transformation since, historically, policy networks have been applied to "static" circumstances. Recognizing this criticism, and in drawing on an interpretivist perspective, this paper sees policy networks as enacted by individual actors whose beliefs and actions construct the nature of the network. It seeks to make links between the characteristics of the policy network and the policy outcomes through the identification of discursively constructed "storylines" that form a tool for consensus building in networks. This study analyses the functioning of the organic policy networks through the discursive actions of policy-network actors. PMID:21290818

  14. Establishing a list of qualifying pathogens under the Food and Drug Administration Safety and Innovation Act. Final rule.

    PubMed

    2014-06-01

    The Food and Drug Administration (FDA or Agency) is issuing a regulation to establish a list of "qualifying pathogens'' that have the potential to pose a serious threat to public health. This final rule implements a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA). GAIN is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain exclusivity periods. Based on analyses conducted both in the proposed rule and in response to comments to the proposed rule, FDA has determined that the following pathogens comprise the list of ``qualifying pathogens:'' Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Coccidioides species, Cryptococcus species, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Helicobacter pylori, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule described the factors the Agency considered and the methodology used to develop the list of qualifying pathogens. As described in the preamble of this final rule, FDA applied those factors and that methodology to additional pathogens suggested via comments on the proposed rule. PMID:24908687

  15. Reauthorization of the Hazardous Materials Transportation Act. Hearing before the Committee on Commerce, Science, and Transportation, United States Senate, Ninety-Sixth Congress, second session, April 2, 1980

    SciTech Connect

    Not Available

    1980-01-01

    This Act authorizes the programs of the Materials Transportation Bureau (MTB) in the Department of Transportation; MTB, at the time, was requesting a doubling of its funds over the appropriated levels, which posed a problem with budget restraints. The committee was particularly concerned with examining the following materials-transportation programs: (1) training of personnel to respond to hazardous-materials accidents; (2) coordination of Federal efforts in regard to hazardous-materials emergency-response programs; (3) adequacy of emergency-communications systems that provide quick information to State and local authorities who are the first to reach the scene of a hazardous-materials accident; and (4) adequacy of the rules and enforcement programs of the Department of Transportation in the hazardous-materials transportation field. Witnesses included James B. King, Chairman, National Transportation Safety Board and two staff members; Howard Dugoff, Administrator, Research and Special Programs Administration, DOT, accompanied by Lee Santman, Director, Materials Transportation Bureau; and Clifford Harvison, Chairman, Hazardous Materials Advisory Council, accompanied by George Wilson, Executive Director.

  16. Direct visualization of internal respiratory and food transport dynamics in insects

    NASA Astrophysics Data System (ADS)

    Lee, Wah-Keat; Socha, John; Westneat, Mark; Harrison, Jon; Waters, James

    2007-11-01

    Although the internal physiological dynamics of large species, especially humans, are well understood, this is not true for small millimeter-sized animals such as insects. Because of their size and in general, optically opaque exteriors, direct visualization of internal insect physiology has not been possible. As such, biologists have relied on indirect techniques, such as gas exchange or pressure measurements, coupled with histology/dissection, and external observations to infer internal dynamics. A new technique, x-ray phase-contrast imaging, have, for the first time, allowed direct visualization of the internal dynamics related to insect physiology. Compression of air sacs and trachea, and the uptake and transport of food in insects have been seen for the first time. These measurements have raised many questions and call for further theoretical research into these complex systems.

  17. Linking Intertidal and Subtidal Food Webs: Consumer-Mediated Transport of Intertidal Benthic Microalgal Carbon

    PubMed Central

    Kang, Chang-Keun; Park, Hyun Je; Choy, Eun Jung; Choi, Kwang-Sik; Hwang, Kangseok; Kim, Jong-Bin

    2015-01-01

    We examined stable carbon and nitrogen isotope ratios for a large variety of consumers in intertidal and subtidal habitats, and their potential primary food sources [i.e., microphytobenthos (MPB), phytoplankton, and Phragmites australis] in a coastal bay system, Yeoja Bay of Korea, to test the hypothesis that the transfer of intertidal MPB-derived organic carbon to the subtidal food web can be mediated by motile consumers. Compared to a narrow δ13C range (−18 to −16‰) of offshore consumers, a broad δ13C range (−18 to −12‰) of both intertidal and subtidal consumers indicated that 13C-enriched sources of organic matter are an important trophic source to coastal consumers. In the intertidal areas, δ13C of most consumers overlapped with or was 13C-enriched relative to MPB. Despite the scarcity of MPB in the subtidal, highly motile consumers in subtidal habitat had nearly identical δ13C range with many intertidal foragers (including crustaceans and fish), overlapping with the range of MPB. In contrast, δ13C values of many sedentary benthic invertebrates in the subtidal areas were similar to those of offshore consumers and more 13C-depleted than motile foragers, indicating high dependence on phytoplankton-derived carbon. The isotopic mixing model calculation confirms that the majority of motile consumers and also some of subtidal sedentary ones depend on intertidal MPB for more than a half of their tissue carbon. Finally, although further quantitative estimates are needed, these results suggest that direct foraging by motile consumers on intertidal areas, and thereby biological transport of MPB-derived organic carbon to the subtidal areas, may provide important trophic connection between intertidal production and the nearshore shallow subtidal food webs. PMID:26448137

  18. Food chain transport of nanoparticles affects behaviour and fat metabolism in fish.

    PubMed

    Cedervall, Tommy; Hansson, Lars-Anders; Lard, Mercy; Frohm, Birgitta; Linse, Sara

    2012-01-01

    Nano-sized (10(-9)-10(-7) m) particles offer many technical and biomedical advances over the bulk material. The use of nanoparticles in cosmetics, detergents, food and other commercial products is rapidly increasing despite little knowledge of their effect on organism metabolism. We show here that commercially manufactured polystyrene nanoparticles, transported through an aquatic food chain from algae, through zooplankton to fish, affect lipid metabolism and behaviour of the top consumer. At least three independent metabolic parameters differed between control and test fish: the weight loss, the triglycerides∶cholesterol ratio in blood serum, and the distribution of cholesterol between muscle and liver. Moreover, we demonstrate that nanoparticles bind to apolipoprotein A-I in fish serum in-vitro, thereby restraining them from properly utilising their fat reserves if absorbed through ingestion. In addition to the metabolic effects, we show that consumption of nanoparticle-containing zooplankton affects the feeding behaviour of the fish. The time it took the fish to consume 95% of the food presented to them was more than doubled for nanoparticle-exposed compared to control fish. Since many nano-sized products will, through the sewage system, end up in freshwater and marine habitats, our study provides a potential bioassay for testing new nano-sized material before manufacturing. In conclusion, our study shows that from knowledge of the molecular composition of the protein corona around nanoparticles it is possible to make a testable molecular hypothesis and bioassay of the potential biological risks of a defined nanoparticle at the organism and ecosystem level. PMID:22384193

  19. Linking Intertidal and Subtidal Food Webs: Consumer-Mediated Transport of Intertidal Benthic Microalgal Carbon.

    PubMed

    Kang, Chang-Keun; Park, Hyun Je; Choy, Eun Jung; Choi, Kwang-Sik; Hwang, Kangseok; Kim, Jong-Bin

    2015-01-01

    We examined stable carbon and nitrogen isotope ratios for a large variety of consumers in intertidal and subtidal habitats, and their potential primary food sources [i.e., microphytobenthos (MPB), phytoplankton, and Phragmites australis] in a coastal bay system, Yeoja Bay of Korea, to test the hypothesis that the transfer of intertidal MPB-derived organic carbon to the subtidal food web can be mediated by motile consumers. Compared to a narrow δ13C range (-18 to -16‰) of offshore consumers, a broad δ13C range (-18 to -12‰) of both intertidal and subtidal consumers indicated that 13C-enriched sources of organic matter are an important trophic source to coastal consumers. In the intertidal areas, δ13C of most consumers overlapped with or was 13C-enriched relative to MPB. Despite the scarcity of MPB in the subtidal, highly motile consumers in subtidal habitat had nearly identical δ13C range with many intertidal foragers (including crustaceans and fish), overlapping with the range of MPB. In contrast, δ13C values of many sedentary benthic invertebrates in the subtidal areas were similar to those of offshore consumers and more 13C-depleted than motile foragers, indicating high dependence on phytoplankton-derived carbon. The isotopic mixing model calculation confirms that the majority of motile consumers and also some of subtidal sedentary ones depend on intertidal MPB for more than a half of their tissue carbon. Finally, although further quantitative estimates are needed, these results suggest that direct foraging by motile consumers on intertidal areas, and thereby biological transport of MPB-derived organic carbon to the subtidal areas, may provide important trophic connection between intertidal production and the nearshore shallow subtidal food webs. PMID:26448137

  20. Grapevine MATE-Type Proteins Act as Vacuolar H+-Dependent Acylated Anthocyanin Transporters1[W][OA

    PubMed Central

    Gomez, Camila; Terrier, Nancy; Torregrosa, Laurent; Vialet, Sandrine; Fournier-Level, Alexandre; Verriès, Clotilde; Souquet, Jean-Marc; Mazauric, Jean-Paul; Klein, Markus; Cheynier, Véronique; Ageorges, Agnès

    2009-01-01

    In grapevine (Vitis vinifera), anthocyanins are responsible for most of the red, blue, and purple pigmentation found in the skin of berries. In cells, anthocyanins are synthesized in the cytoplasm and accumulated into the vacuole. However, little is known about the transport of these compounds through the tonoplast. Recently, the sequencing of the grapevine genome allowed us to identify genes encoding proteins with high sequence similarity to the Multidrug And Toxic Extrusion (MATE) family. Among them, we selected two genes as anthocyanin transporter candidates and named them anthoMATE1 (AM1) and AM3. The expression of both genes was mainly fruit specific and concomitant with the accumulation of anthocyanin pigment. Subcellular localization assays in grapevine hairy roots stably transformed with AM1∷ or AM3∷green fluorescent protein fusion protein revealed that AM1 and AM3 are primarily localized to the tonoplast. Yeast vesicles expressing anthoMATEs transported acylated anthocyanins in the presence of MgATP. Inhibitor studies demonstrated that AM1 and AM3 proteins act in vitro as vacuolar H+-dependent acylated anthocyanin transporters. By contrast, under our experimental conditions, anthoMATEs could not transport malvidin 3-O-glucoside or cyanidin 3-O-glucoside, suggesting that the acyl conjugation was essential for the uptake. Taken together, these results provide evidence that in vitro the two grapevine AM1 and AM3 proteins mediate specifically acylated anthocyanin transport. PMID:19297587

  1. Integrated Application of Active Controls (IAAC) technology to an advanced subsonic transport project: Final ACT configuration evaluation

    NASA Technical Reports Server (NTRS)

    1982-01-01

    The Final ACT Configuration Evaluation Task of the Integrated Application of Active Controls (IAAC) technology project within the energy efficient transport program is summarized. The Final ACT Configuration, through application of Active Controls Technology (ACT) in combination with increased wing span, exhibits significant performance improvements over the conventional baseline configuration. At the design range for these configurations, 3590 km, the block fuel used is 10% less for the Final ACT Configuration, with significant reductions in fuel usage at all operational ranges. Results of this improved fuel usage and additional system and airframe costs and the complexity required to achieve it were analyzed to determine its economic effects. For a 926 km mission, the incremental return on investment is nearly 25% at 1980 fuel prices. For longer range missions or increased fuel prices, the return is greater. The technical risks encountered in the Final ACT Configuration design and the research and development effort required to reduce these risks to levels acceptable for commercial airplane design are identified.

  2. School Food Modernization Act

    THOMAS, 113th Congress

    Rep. Latham, Tom [R-IA-3

    2013-04-26

    07/08/2013 Referred to the Subcommittee on Early Childhood, Elementary, and Secondary Education. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  3. Eat Local Foods Act

    THOMAS, 112th Congress

    Rep. Pingree, Chellie [D-ME-1

    2011-05-04

    05/20/2011 Referred to the Subcommittee on Early Childhood, Elementary, and Secondary Education. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  4. School Food Recovery Act

    THOMAS, 112th Congress

    Rep. Petri, Thomas E. [R-WI-6

    2011-01-06

    02/25/2011 Referred to the Subcommittee on Early Childhood, Elementary, and Secondary Education. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  5. School Food Recovery Act

    THOMAS, 112th Congress

    Sen. Feinstein, Dianne [D-CA

    2011-10-17

    10/17/2011 Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry. (text of measure as introduced: CR S6604) (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  6. Food Aid Reform Act

    THOMAS, 113th Congress

    Rep. Royce, Edward R. [R-CA-39

    2013-05-15

    05/22/2013 Referred to the Subcommittee on Horticulture, Research, Biotechnology, and Foreign Agriculture. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  7. Local School Foods Act

    THOMAS, 112th Congress

    Rep. Welch, Peter [D-VT-At Large

    2011-10-04

    11/18/2011 Referred to the Subcommittee on Early Childhood, Elementary, and Secondary Education. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  8. 75 FR 8096 - Privacy Act of 1974; Department of Homeland Security Transportation Security Administration-023...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... Security Administration--023 Workplace Violence Prevention Program System of Records AGENCY: Privacy Office..., ``Department of Homeland Security/Transportation Security Administration--023 Workplace Violence Prevention... and maintain records on their Workplace Violence Prevention Program. Additionally, the Department...

  9. Biophysics of food perception

    NASA Astrophysics Data System (ADS)

    Burbidge, Adam S.; Le Révérend, Benjamin J. D.

    2016-03-01

    In this article, we present food perception across a range of time and length scales as well as across the disciplines of physics, chemistry and biology. We achieve the objective of the article by presenting food from a material science angle as well as presenting the physiology of food perception that enables humans to probe materials in terms of aroma, taste and texture. We highlight that by using simple physical concepts, one can also decipher the mechanisms of transport that link food structure with perception physiology and define the regime in which physiology operates. Most importantly, we emphasise the notion that food/consumer interaction operates across the biological fluid interface grouped under the terminology of mucus, acting as a transfer fluid for taste, aroma and pressure between food and dedicated receptors.

  10. 75 FR 18863 - Privacy Act of 1974; Department of Homeland Security Transportation Security Administration-006...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-13

    ... records notice titled, DHS/TSA-006 Correspondence Matters Tracking System Records (CMTR) (68 FR 49496... the Federal Register on June 25, 2004 (69 FR 35536). Consistent with the Privacy Act, information... (69 FR 35536). However, TSA will consider individual requests to determine whether or not...

  11. 75 FR 18860 - Privacy Act of 1974, Department of Homeland Security Transportation Security Administration-013...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-13

    ... Officer Record System (FDORS), previously published on August 18, 2003 (68 FR 49496). TSA's mission is to... reflected in the final rule published on June 25, 2004, 69 FR 35536. Consistent with the Privacy Act... Security Administration--013 Federal Flight Deck Officer Record System AGENCY: Privacy Office, DHS....

  12. The ACT transport: Panacea for the 80's or designer's illusion (panel discussion)

    NASA Technical Reports Server (NTRS)

    1976-01-01

    A panel discussion was held which attempted to make an objective and pragmatic assessment of the standing of active control technology. The discussion focused on the standing of active control technology relative to civil air transport applications, the value as opposed to the cost of the projected benefits, the need for research, development, and demonstration, the role of government and industry in developing the technology, the major obstacles to its implementation, and the probable timing of the full utilization of active control technology in commercial transportation. An edited transcription of the prepared statements of the panel members and the subsequent open discussion between the panel and the audience is presented.

  13. Report to congress: Settlements with municipal waste generators and transporters since 1991 under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980

    SciTech Connect

    Not Available

    1993-03-12

    The report to Congress summarizes the status of completed settlements and ongoing negotiations with municipal generators and transporters of municipal solid waste and municipal sewage sludge under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 since 1991.

  14. 77 FR 70792 - Privacy Act of 1974; Retirement of Department of Homeland Security Transportation Security...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

    ... Administration-009 General Legal Records (August 18, 2003, 68 FR 49496), which was written to assist attorneys in... Security/ ALL-017 General Legal Records (November 23, 2011, 76 FR 72428) to cover its legal activities.../Transportation Security Administration (TSA)-009 General Legal Records (August 18, 2003, 68 FR 49496), which...

  15. 77 FR 70795 - Privacy Act of 1974; Retirement of Department of Homeland Security Transportation Security...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

    ... Administration-012 Transportation Worker Identification Credentialing System (September 24, 2004, 69 FR 57348..., 2010, 75 FR 28046), which covers the Security Threat Assessment process associated with the... Credentialing (TWIC) System (September 24, 2004, 69 FR 57348), which was written to cover the Prototype Phase...

  16. 76 FR 42003 - Privacy Act of 1974: Implementation of Exemptions; Department of Homeland Security Transportation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-18

    ... notice of proposed rulemaking (NPRM) in the Federal Register, 75 FR 7978, February 23, 2010, proposing to... published concurrently in the Federal Register, 75 FR 8096, February 23, 2010, and comments were invited on... of Homeland Security Transportation Security Administration--023 Workplace Violence...

  17. 75 FR 43747 - Americans With Disabilities Act (ADA) Accessibility Guidelines for Transportation Vehicles

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-26

    ... accessible transit vehicles,'' 32 Medical Engineering & Physics 230-236 (2010). T303.8.1 simplifies the...., buses characterized by an elevated passenger deck located over a baggage compartment). 56 FR 45530, September 6, 1991; 63 FR 51694, September 28, 1998. The Access Board's transportation vehicle guidelines...

  18. 75 FR 28046 - Privacy Act of 1974; Department of Homeland Security Transportation Security Administration-002...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-19

    ... Transportation Security Threat Assessment System of Records (70 FR 33383, November 8, 2005). TSA's mission is to... systems as reflected in the final rule published on June 25, 2004 in 69 FR 35536. The information is... Investigation--009 Fingerprint Identification Records System (72 FR 3410, January 1, 2007). ] Exemptions...

  19. Rapid nongenomic actions of inhaled corticosteroids on long-acting β(2)-agonist transport in the airway.

    PubMed

    Horvath, Gabor; Mendes, Eliana S; Schmid, Nathalie; Schmid, Andreas; Conner, Gregory E; Fregien, Nevis L; Salathe, Matthias; Wanner, Adam

    2011-12-01

    Corticosteroids inhibit organic cation transporters (OCTs) that play an important role in drug absorption, tissue distribution and elimination. Corticosteroid sensitivity of bronchodilator trafficking in the airway tissue, however, is poorly understood. To assess the effects of inhaled corticosteroids on airway absorption and disposal mechanisms of long-acting β(2)-agonists, human airway epithelial and smooth muscle cell uptake of tritiated formoterol and salmeterol was measured in vitro. Corticosteroids caused a rapid, concentration-dependent inhibition of uptake of the cationic formoterol by airway smooth muscle cells, but not airway epithelial cells. Uptake of the non-charged lipophilic salmeterol was corticosteroid-insensitive in both cell types. In smooth muscle cells, inhaled corticosteroids inhibited formoterol uptake with a novel potency rank order: des-ciclesonide > budesonide > beclomethasone 17-monopropionate > beclomethasone dipropionate > ciclesonide > fluticasone. The inhibitory action was rapidly reversible, and was not enhanced by prolonged corticosteroid exposure or sensitive to a transcription inhibitor. Suppression of OCT3 expression using lentivirus-mediated production of shRNA reduced corticosteroid sensitivity of formoterol uptake by smooth muscle cells. Our data support a corticosteroid insensitive absorption and a corticosteroid-sensitive disposition mechanism for cationic long-acting β(2)-agonist bronchodilators in the airway. Potency rank order and other 'classical' features of anti-inflammatory effects do not apply to inhaled corticosteroids' rapid drug transport actions. PMID:21914487

  20. Food security of older adults requesting Older Americans Act Nutrition Program in Georgia can be validly measured using a short form of the U.S. Household Food Security Survey Module.

    PubMed

    Lee, Jung Sun; Johnson, Mary Ann; Brown, Arvine; Nord, Mark

    2011-07-01

    Food security is a newly recommended outcome measure for the Older Americans Act Nutrition Program (OAANP); however, it is unknown how best to evaluate the need for this program and assess its impact on a large scale. Therefore, we measured food security in all new OAANP participants and waitlisted applicants in Georgia between July and early November, 2008 (n = 4731) with the self-administered mail survey method used in the ongoing Georgia Performance Outcomes Measures project. We used a modified 6-item U.S. Household Food Security Survey Module (HFSSM) with a 30-d reference period and 2 reminder postcards. Approximately 33% of those identified completed the survey (n = 1594, mean age 74.6 ± 9.5 y, 68.6% female, 30.6% black). Most of the respondents (91%) completed all 6 food security questions, whereas 26 did not respond to any question. Infit and outfit statistics for each of the 6 questions were within an acceptable range. Psychometric properties observed in our food security data were generally similar to those in the nationally representative survey conducted by the Census Bureau and suggest that our food security statistics may be meaningfully compared with national food security statistics published by the USDA. Our findings suggest that food security can be reasonably measured by a short form of HFSSM in older adults requesting OAANP. Such methodology also can be used to estimate the extent of food insecurity and help guide program and policy decisions to meet the nutrition assistance needs of vulnerable older adults. PMID:21562242

  1. Cued to Act on Impulse: More Impulsive Choice and Risky Decision Making by Women Susceptible to Overeating after Exposure to Food Stimuli

    PubMed Central

    Yeomans, Martin R.; Brace, Aaron

    2015-01-01

    There is increasing evidence that individual differences in tendency to overeat relate to impulsivity, possibly by increasing reactivity to food-related cues in the environment. This study tested whether acute exposure to food cues enhanced impulsive and risky responses in women classified on tendency to overeat, indexed by scores on the three factor eating questionnaire disinhibition (TFEQ-D), restraint (TFEQ-R) and hunger scales. Ninety six healthy women completed two measures of impulsive responding (delayed discounting, DDT and a Go No-Go, GNG, task) and a measure of risky decision making (the balloon analogue risk task, BART) as well as questionnaire measures of impulsive behaviour either after looking at a series of pictures of food or visually matched controls. Impulsivity (DDT) and risk-taking (BART) were both positively associated with TFEQ-D scores, but in both cases this effect was exacerbated by prior exposure to food cues. No effects of restraint were found. TFEQ-D scores were also related to more commission errors on the GNG, while restrained women were slower on the GNG, but neither effect was modified by cue exposure. Overall these data suggest that exposure to food cues act to enhance general impulsive responding in women at risk of overeating and tentatively suggest an important interaction between tendency for impulsive decision making and food cues that may help explain a key underlying risk factor for overeating. PMID:26378459

  2. Integrated application of active controls (IAAC) technology to an advanced subsonic transport project. Initial ACT configuration design study

    NASA Technical Reports Server (NTRS)

    1980-01-01

    The initial ACT configuration design task of the integrated application of active controls (IAAC) technology project within the Energy Efficient Transport Program is summarized. A constrained application of active controls technology (ACT) resulted in significant improvements over a conventional baseline configuration previously established. The configuration uses the same levels of technology, takeoff gross weight, payload, and design requirements/objectives as the baseline, except for flying qualities, flutter, and ACT. The baseline wing is moved forward 1.68 m. The configuration incorporates pitch-augmented stability (which enabled an approximately 10% aft shift in cruise center of gravity and a 45% reduction in horizontal tail size), lateral/directional-augmented stability, an angle of attack limiter, wing load alleviation, and flutter mode control. This resulted in a 930 kg reduction in airplane operating empty weight and a 3.6% improvement in cruise efficiency, yielding a 13% range increase. Adjusted to the 3590 km baseline mission range, this amounts to 6% block fuel reduction and a 15.7% higher incremental return on investment, using 1978 dollars and fuel cost.

  3. Pharmacokinetic Model of the Transport of Fast-Acting Insulin From the Subcutaneous and Intradermal Spaces to Blood

    PubMed Central

    Lv, Dayu; Kulkarni, Sandip D.; Chan, Alice; Keith, Stephen; Pettis, Ron; Kovatchev, Boris P.; Farhi, Leon S.; Breton, Marc D.

    2015-01-01

    Pharmacokinetic (PK) models describing the transport of insulin from the injection site to blood assist clinical decision making and are part of in silico platforms for developing and testing of insulin delivery strategies for treatment of patients with diabetes. The ability of these models to accurately describe all facets of the in vivo insulin transport is therefore critical for their application. Here, we propose a new model of fast-acting insulin analogs transport from the subcutaneous and intradermal spaces to blood that can accommodate clinically observed biphasic appearance and delayed clearance of injected insulin, 2 phenomena that are not captured by existing PK models. To develop the model we compare 9 insulin transport PK models which describe hypothetical insulin delivery pathways potentially capable of approximating biphasic appearance of exogenous insulin. The models are tested with respect to their ability to describe clinical data from 10 healthy volunteers which received 1 subcutaneous and 2 intradermal insulin injections on 3 different occasions. The optimal model, selected based on information and posterior identifiability criteria, assumes that insulin is delivered at the administrative site and is then transported to the bloodstream via 2 independent routes (1) diffusion-like process to the blood and (2) combination of diffusion-like processes followed by an additional compartment before entering the blood. This optimal model accounts for biphasic appearance and delayed clearance of exogenous insulin. It agrees better with the clinical data as compared to commonly used models and is expected to improve the in silico development and testing of insulin treatment strategies, including artificial pancreas systems. PMID:25759184

  4. Pharmacokinetic Model of the Transport of Fast-Acting Insulin From the Subcutaneous and Intradermal Spaces to Blood.

    PubMed

    Lv, Dayu; Kulkarni, Sandip D; Chan, Alice; Keith, Stephen; Pettis, Ron; Kovatchev, Boris P; Farhi, Leon S; Breton, Marc D

    2015-07-01

    Pharmacokinetic (PK) models describing the transport of insulin from the injection site to blood assist clinical decision making and are part of in silico platforms for developing and testing of insulin delivery strategies for treatment of patients with diabetes. The ability of these models to accurately describe all facets of the in vivo insulin transport is therefore critical for their application. Here, we propose a new model of fast-acting insulin analogs transport from the subcutaneous and intradermal spaces to blood that can accommodate clinically observed biphasic appearance and delayed clearance of injected insulin, 2 phenomena that are not captured by existing PK models. To develop the model we compare 9 insulin transport PK models which describe hypothetical insulin delivery pathways potentially capable of approximating biphasic appearance of exogenous insulin. The models are tested with respect to their ability to describe clinical data from 10 healthy volunteers which received 1 subcutaneous and 2 intradermal insulin injections on 3 different occasions. The optimal model, selected based on information and posterior identifiability criteria, assumes that insulin is delivered at the administrative site and is then transported to the bloodstream via 2 independent routes (1) diffusion-like process to the blood and (2) combination of diffusion-like processes followed by an additional compartment before entering the blood. This optimal model accounts for biphasic appearance and delayed clearance of exogenous insulin. It agrees better with the clinical data as compared to commonly used models and is expected to improve the in silico development and testing of insulin treatment strategies, including artificial pancreas systems. PMID:25759184

  5. 78 FR 47712 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-06

    ... of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled... meter. 13-59 Systems and software engineering--Systems and ISO/IEC 15026-4 First edition software... HUMAN SERVICES Food and Drug Administration (formerly 2004N-0226) Food and Drug...

  6. A vacuolar iron-transporter homologue acts as a detoxifier in Plasmodium

    PubMed Central

    Slavic, Ksenija; Krishna, Sanjeev; Lahree, Aparajita; Bouyer, Guillaume; Hanson, Kirsten K.; Vera, Iset; Pittman, Jon K.; Staines, Henry M.; Mota, Maria M.

    2016-01-01

    Iron is an essential micronutrient but is also highly toxic. In yeast and plant cells, a key detoxifying mechanism involves iron sequestration into intracellular storage compartments, mediated by members of the vacuolar iron-transporter (VIT) family of proteins. Here we study the VIT homologue from the malaria parasites Plasmodium falciparum (PfVIT) and Plasmodium berghei (PbVIT). PfVIT-mediated iron transport in a yeast heterologous expression system is saturable (Km∼14.7 μM), and selective for Fe2+ over other divalent cations. PbVIT-deficient P. berghei lines (Pbvit−) show a reduction in parasite load in both liver and blood stages of infection in mice. Moreover, Pbvit− parasites have higher levels of labile iron in blood stages and are more sensitive to increased iron levels in liver stages, when compared with wild-type parasites. Our data are consistent with Plasmodium VITs playing a major role in iron detoxification and, thus, normal development of malaria parasites in their mammalian host. PMID:26786069

  7. A vacuolar iron-transporter homologue acts as a detoxifier in Plasmodium.

    PubMed

    Slavic, Ksenija; Krishna, Sanjeev; Lahree, Aparajita; Bouyer, Guillaume; Hanson, Kirsten K; Vera, Iset; Pittman, Jon K; Staines, Henry M; Mota, Maria M

    2016-01-01

    Iron is an essential micronutrient but is also highly toxic. In yeast and plant cells, a key detoxifying mechanism involves iron sequestration into intracellular storage compartments, mediated by members of the vacuolar iron-transporter (VIT) family of proteins. Here we study the VIT homologue from the malaria parasites Plasmodium falciparum (PfVIT) and Plasmodium berghei (PbVIT). PfVIT-mediated iron transport in a yeast heterologous expression system is saturable (Km ∼ 14.7 μM), and selective for Fe(2+) over other divalent cations. PbVIT-deficient P. berghei lines (Pbvit(-)) show a reduction in parasite load in both liver and blood stages of infection in mice. Moreover, Pbvit(-) parasites have higher levels of labile iron in blood stages and are more sensitive to increased iron levels in liver stages, when compared with wild-type parasites. Our data are consistent with Plasmodium VITs playing a major role in iron detoxification and, thus, normal development of malaria parasites in their mammalian host. PMID:26786069

  8. Coal slurry pipelines. Hearing before the Subcommittee on Transportation and Commerce of the Committee on Interstate and Foreign Commerce, House of Representatives, Ninety-Sixth Congress. [Coal Pipeline Act of 1980

    SciTech Connect

    Not Available

    1980-01-01

    Witnesses at an August 28, 1980 hearing on the proposed Coal Pipeline Act of 1980 (HR 6879) focused on the controversial issues of depleted ground water, contamination from waste water, and the competitive fairness to the regulated railroads and other transportation modes. The text of HR 6879 is followed by ten statements and additional materials submitted by representatives of the railroads, pipeline companies, the Environmental Protection Agency (EPA), and other agencies. Water rights cause special concerns for an already water-scarce area. Of equal importance is the need to keep the nation's rail industry viable in order to transport food and other commodities. Proponents of the pipeline, including government agencies, urged passage or eminent-domain rights, and encourage strong competition for the railroads. The EPA considers the use of recycled municipal waste water and saline water a valid solution to the water supply problem. (DCK)

  9. Antidepressants targeting the serotonin reuptake transporter act via a competitive mechanism.

    PubMed

    Apparsundaram, Subbu; Stockdale, Daniel J; Henningsen, Robert A; Milla, Marcos E; Martin, Renee S

    2008-12-01

    Although several antidepressants (including fluoxetine, imipramine, citalopram, venlafaxine, and duloxetine) are known to inhibit the serotonin transporter (SERT), whether or not these molecules compete with 5-hydroxytryptamine (serotonin) (5-HT) for binding to SERT has remained controversial. We have performed radioligand competition binding experiments and found that all data can be fitted via a simple competitive interaction model, using Cheng-Prusoff analysis (Biochem Pharmacol 22:3099-3108, 1973). Two different SERT-selective radioligands, [(3)H]N,N-dimethyl-2-(2-amino-4-cyanophenyl thio)-benzylamine (DASB) and [(3)H]S-citalopram, were used to probe competitive binding to recombinantly expressed human SERT or native SERT in rat cortical membranes. All the SERT inhibitors that we tested were able to inhibit [(3)H]DASB and [(3)H]S-citalopram binding in a concentration-dependent manner, with unity Hill coefficient. In accordance with the Cheng-Prusoff relationship for a competitive interaction, we observed that test compound concentrations associated with 50% maximal inhibition of radiotracer binding (IC(50)) increased linearly with increasing radioligand concentration for all ligands: 5-HT, S-citalopram, R-citalopram, paroxetine, clomipramine, fluvoxamine, imipramine venlafaxine, duloxetine, indatraline, cocaine, and 2-beta-carboxy-3-beta-(4-iodophenyl)tropane. The equilibrium dissociation constant of 5-HT and SERT inhibitors were also derived using Scatchard analysis of the data set, and they were found to be comparable with the data obtained using the Cheng-Prusoff relationship. Our studies establish a reference framework that will contribute to ongoing efforts to understand ligand binding modes at SERT by demonstrating that 5-HT and the SERT inhibitors tested bind to the serotonin transporter in a competitive manner. PMID:18801947

  10. Mutations in the Plasmodium falciparum chloroquine resistance transporter, PfCRT, enlarge the parasite's food vacuole and alter drug sensitivities.

    PubMed

    Pulcini, Serena; Staines, Henry M; Lee, Andrew H; Shafik, Sarah H; Bouyer, Guillaume; Moore, Catherine M; Daley, Daniel A; Hoke, Matthew J; Altenhofen, Lindsey M; Painter, Heather J; Mu, Jianbing; Ferguson, David J P; Llinás, Manuel; Martin, Rowena E; Fidock, David A; Cooper, Roland A; Krishna, Sanjeev

    2015-01-01

    Mutations in the Plasmodium falciparum chloroquine resistance transporter, PfCRT, are the major determinant of chloroquine resistance in this lethal human malaria parasite. Here, we describe P. falciparum lines subjected to selection by amantadine or blasticidin that carry PfCRT mutations (C101F or L272F), causing the development of enlarged food vacuoles. These parasites also have increased sensitivity to chloroquine and some other quinoline antimalarials, but exhibit no or minimal change in sensitivity to artemisinins, when compared with parental strains. A transgenic parasite line expressing the L272F variant of PfCRT confirmed this increased chloroquine sensitivity and enlarged food vacuole phenotype. Furthermore, the introduction of the C101F or L272F mutation into a chloroquine-resistant variant of PfCRT reduced the ability of this protein to transport chloroquine by approximately 93 and 82%, respectively, when expressed in Xenopus oocytes. These data provide, at least in part, a mechanistic explanation for the increased sensitivity of the mutant parasite lines to chloroquine. Taken together, these findings provide new insights into PfCRT function and PfCRT-mediated drug resistance, as well as the food vacuole, which is an important target of many antimalarial drugs. PMID:26420308

  11. The N-terminal basolateral targeting signal unlikely acts alone in the differential trafficking of membrane transporters in MDCK cells.

    PubMed

    Kuo, Shiu-Ming; Wang, Li-Yuan; Yu, Siyuan; Campbell, Christine E; Valiyaparambil, Sujith A; Rance, Mark; Blumenthal, Kenneth M

    2013-07-30

    We have shown previously, using confocal imaging and transport assays, that the N-terminus of sodium-dependent vitamin C transporter 2 (SVCT2) can redirect apical SVCT1 to the basolateral membrane. Here, the SVCT model was used to further characterize the basolateral targeting peptide signal. Both the length (31 amino acids) and sequence accuracy of the N-terminus of SVCT2 were found to be important in basolateral targeting activity, suggesting a structural requirement. However, the N-terminal basolateral targeting sequence did not appear to act alone, based on analyses of heterologous chimeras. Although diverse N-terminal basolateral targeting signals from multipass membrane proteins can all redirect apical protein from the same gene family to the basolateral membrane, none of the N-terminal basolateral targeting signals can redirect the transmembrane and C-terminal regions from a different gene family. Instead, the presence of these heterologous N-terminal basolateral targeting signals affected the trafficking of otherwise apical protein, causing their accumulation in a stable tubulin-like non-actin structure. Nontargeting N-terminal sequences had no effect. Similar protein retention was observed previously and in this study when the C-terminus of apical or basolateral protein was mutated. These results suggest that the N- and C-termini interact, directly or indirectly, within each gene family for basolateral targeting. Circular dichroism and two-dimensional nuclear magnetic resonance analyses both found a lack of regular secondary structure in the conserved N-terminus of SVCT2, consistent with the presence of partner(s) in the targeting unit. Our finding, a departure from the prevailing single-peptide motif model, is consistent with the evolution of basolateral transporters from the corresponding apical genes. The interaction among the N-terminus, its partner(s), and the cellular basolateral targeting machinery needs to be further elucidated. PMID:23837633

  12. Child and Adult Care Food Program: Meal Pattern Revisions Related to the Healthy, Hunger-Free Kids Act of 2010. Final rule.

    PubMed

    2016-04-25

    This final rule updates the meal pattern requirements for the Child and Adult Care Food Program to better align them with the Dietary Guidelines for Americans, as required by the Healthy, Hunger-Free Kids Act of 2010. This rule requires centers and day care homes participating in the Child and Adult Care Food Program to serve more whole grains and a greater variety of vegetables and fruit, and reduces the amount of added sugars and solid fats in meals. In addition, this final rule supports mothers who breastfeed and improves consistency with the Special Supplemental Nutrition Program for Women, Infants, and Children and with other Child Nutrition Programs. Several of the changes are extended to the National School Lunch Program, School Breakfast Program, and Special Milk Program. These changes are based on the Dietary Guidelines for Americans, science-based recommendations made by the National Academy of Medicine (formerly the Institute of Medicine of the National Academies), cost and practical considerations, and stakeholder's input. This is the first major revision of the Child and Adult Care Food Program meal patterns since the Program's inception in 1968. These improvements to the meals served in the Child and Adult Care Food Program are expected to safeguard the health of young children by ensuring healthy eating habits are developed early, and improve the wellness of adult participants. PMID:27116762

  13. Integrated Application of Active Controls (IAAC) technology to an advanced subsonic transport project: Current and advanced act control system definition study. Volume 2: Appendices

    NASA Technical Reports Server (NTRS)

    Hanks, G. W.; Shomber, H. A.; Dethman, H. A.; Gratzer, L. B.; Maeshiro, A.; Gangsaas, D.; Blight, J. D.; Buchan, S. M.; Crumb, C. B.; Dorwart, R. J.

    1981-01-01

    The current status of the Active Controls Technology (ACT) for the advanced subsonic transport project is investigated through analysis of the systems technical data. Control systems technologies under examination include computerized reliability analysis, pitch axis fly by wire actuator, flaperon actuation system design trade study, control law synthesis and analysis, flutter mode control and gust load alleviation analysis, and implementation of alternative ACT systems. Extensive analysis of the computer techniques involved in each system is included.

  14. Abcb4 acts as multixenobiotic transporter and active barrier against chemical uptake in zebrafish (Danio rerio) embryos

    PubMed Central

    2013-01-01

    Background In mammals, ABCB1 constitutes a cellular “first line of defense” against a wide array of chemicals and drugs conferring cellular multidrug or multixenobiotic resistance (MDR/MXR). We tested the hypothesis that an ABCB1 ortholog serves as protection for the sensitive developmental processes in zebrafish embryos against adverse compounds dissolved in the water. Results Indication for ABCB1-type efflux counteracting the accumulation of chemicals in zebrafish embryos comes from experiments with fluorescent and toxic transporter substrates and inhibitors. With inhibitors present, levels of fluorescent dyes in embryo tissue and sensitivity of embryos to toxic substrates were generally elevated. We verified two predicted sequences from zebrafish, previously annotated as abcb1, by cloning; our synteny analyses, however, identified them as abcb4 and abcb5, respectively. The abcb1 gene is absent in the zebrafish genome and we explored whether instead Abcb4 and/or Abcb5 show toxicant defense properties. Quantitative real-time polymerase chain reaction (qPCR) analyses showed the presence of transcripts of both genes throughout the first 48 hours of zebrafish development. Similar to transporter inhibitors, morpholino knock-down of Abcb4 increased accumulation of fluorescent substrates in embryo tissue and sensitivity of embryos toward toxic compounds. In contrast, morpholino knock-down of Abcb5 did not exert this effect. ATPase assays with recombinant protein obtained with the baculovirus expression system confirmed that dye and toxic compounds act as substrates of zebrafish Abcb4 and inhibitors block its function. The compounds tested comprised model substrates of human ABCB1, namely the fluorescent dyes rhodamine B and calcein-am and the toxic compounds vinblastine, vincristine and doxorubicin; cyclosporin A, PSC833, MK571 and verapamil were applied as inhibitors. Additionally, tests were performed with ecotoxicologically relevant compounds: phenanthrene (a

  15. 77 FR 15765 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-16

    ...The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 028'' (Recognition List Number: 028), will assist manufacturers who......

  16. 78 FR 32390 - Food and Drug Administration Safety and Innovation Act (FDASIA): Request for Comments on the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-30

    ...): Request for Comments on the Development of a Risk-Based Regulatory Framework and Strategy for Health Information Technology AGENCY: Office of the National Coordinator for Health Information Technology...: The Food and Drug Administration (FDA), Office of the National Coordinator for Health...

  17. 78 FR 52202 - Request for Comments on the Food and Drug Administration Safety and Innovation Act Section 907...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-22

    ... Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All..., 10903 New Hampshire Ave., Bldg. 32, Rm. 2320, Silver Spring, MD 20903, ] 301-796-9441, FDASIASECTION907... subgroups in summaries of product safety and effectiveness and in labeling; on the inclusion of such...

  18. Homelessness: Implementation of Food and Shelter Programs under the McKinney Act. Report to the Congress.

    ERIC Educational Resources Information Center

    Comptroller General of the U.S., Washington, DC.

    The Stewart B. McKinney Homeless Assistance Act, passed in July 1987, authorized over $400 million for fiscal year 1987 in homeless assistance for several federal programs, including the Department of Housing and Urban Development (HUD) and the Federal Emergency Management Agency (FEMA). This report examines how funds appropriated to HUD and FEMA…

  19. 78 FR 17611 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-22

    ... these new sections. On November 23, 2012 (77 FR 70166), FDA issued a Federal Register notice... FR 74852), FDA issued a notice of availability announcing publication of a draft guidance for... Administration Safety and Innovation Act Related to Medical Gases; Request for Comments Regarding...

  20. 75 FR 44163 - Implementation of Regulations Required Under Title XI of the Food, Conservation and Energy Act of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... Administration (GIPSA) published a proposed rule in the Federal Register on June 22, 2010 (75 FR 35338) proposing...; ] DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration 9 CFR Part 201 RIN 0580... 2008; Conduct in Violation of the Act AGENCY: Grain Inspection, Packers and Stockyards...

  1. Report to the Legislature on: School Breakfast and Summer Food Service Programs. MGL Chapter 15 Section 1G(f) and Chapter 61 of the Acts of 2007 Line Item 7053-1925

    ERIC Educational Resources Information Center

    Massachusetts Department of Education, 2008

    2008-01-01

    The paper presents the report on "School Breakfast and Summer Food Service Program." Pursuant to Chapter 61 of the Acts of 2007 line item 7053-1925 and Massachusetts General Laws (MGL) chapter 15 section 1G(f), this report is submitted to the Legislature. An Act establishing school-based Nutrition and Child Hunger Relief Programs was signed into…

  2. PF-05231023, a long-acting FGF21 analogue, decreases body weight by reduction of food intake in non-human primates.

    PubMed

    Thompson, W Clayton; Zhou, Yingjiang; Talukdar, Saswata; Musante, Cynthia J

    2016-08-01

    PF-05231023, a long-acting FGF21 analogue, is a promising potential pharmacotherapy for the treatment of obesity and associated comorbidities. Previous studies have shown the potential of FGF21 and FGF21-like compounds to decrease body weight in mice, non-human primates, and humans; the precise mechanisms of action remain unclear. In particular, there have been conflicting reports on the degree to which FGF21-induced weight loss in non-human primates is attributable to a decrease in food intake versus an increase in energy expenditure. Here, we present a semi-mechanistic mathematical model of energy balance and body composition developed from similar work in mice. This model links PF-05231023 administration and washout to changes in food intake, which in turn drives changes in body weight. The model is calibrated to and compared with recently published data from cynomolgus macaques treated with PF-05231023, demonstrating its accuracy in describing pharmacotherapy-induced weight loss in these animals. The results are consistent with the hypothesis that PF-05231023 decreases body weight in cynomolgus macaques solely by a reduction in food intake, with no direct effect on energy expenditure. PMID:27405817

  3. Selective FFA2 Agonism Appears to Act via Intestinal PYY to Reduce Transit and Food Intake but Does Not Improve Glucose Tolerance in Mouse Models.

    PubMed

    Forbes, Sarah; Stafford, Stuart; Coope, Gareth; Heffron, Helen; Real, Katia; Newman, Robert; Davenport, Richard; Barnes, Matt; Grosse, Johannes; Cox, Helen

    2015-11-01

    Free fatty acid receptor 2 (FFA2) is expressed on enteroendocrine L cells that release glucagon-like peptide 1 (GLP-1) and peptide YY (PYY) when activated by short-chain fatty acids (SCFAs). Functionally GLP-1 and PYY inhibit gut transit, increase glucose tolerance, and suppress appetite; thus, FFA2 has therapeutic potential for type 2 diabetes and obesity. However, FFA2-selective agonists have not been characterized in vivo. Compound 1 (Cpd 1), a potent FFA2 agonist, was tested for its activity on the following: GLP-1 release, modulation of intestinal mucosal ion transport and transit in wild-type (WT) and FFA2(-/-) tissue, and food intake and glucose tolerance in lean and diet-induced obese (DIO) mice. Cpd 1 stimulated GLP-1 secretion in vivo, but this effect was only detected with dipeptidyl peptidase IV inhibition, while mucosal responses were PYY, not GLP-1, mediated. Gut transit was faster in FFA2(-/-) mice, while Cpd 1 slowed WT transit and reduced food intake and body weight in DIO mice. Cpd 1 decreased glucose tolerance and suppressed plasma insulin in lean and DIO mice, despite FFA2(-/-) mice displaying impaired glucose tolerance. These results suggest that FFA2 inhibits intestinal functions and suppresses food intake via PYY pathways, with limited GLP-1 contribution. Thus, FFA2 may be an effective therapeutic target for obesity but not for type 2 diabetes. PMID:26239054

  4. A way through the dark and thorny thickets? The adjudication of "serious injury" under the narrative tests in the Transport Accident Act 1986 (Vic) and the Workplace Injury Rehabilitation and Compensation Act 2013 (Vic).

    PubMed

    Taliadoros, Jason

    2015-09-01

    The so-called "narrative" test provides the means by which injured persons who satisfy the statutory and common law definition of "serious injury" may bring proceedings for common law damages under s 93 of the Transport Accident Act 1986 (Vic) and s 134AB of the Accident Compensation Act 1985 (Vic) (or, for injuries after 1 July 2014, under ss 324-347 of the Workplace Injury Rehabilitation and Compensation Act 2013 (Vic)). These are among the most litigated provisions in Australia. This article outlines the legislative and political background to these provisions, the provisions themselves, and an account of the statutory and common law requirements needed to satisfy the provisions. PMID:26554209

  5. Integrated Application of Active Controls (IAAC) technology to an advanced subsonic transport project. ACT/Control/Guidance System study, volume 1

    NASA Technical Reports Server (NTRS)

    1982-01-01

    The active control technology (ACT) control/guidance system task of the integrated application of active controls (IAAC) technology project within the NASA energy efficient transport program was documented. The air traffic environment of navigation and air traffic control systems and procedures were extrapolated. An approach to listing flight functions which will be performed by systems and crew of an ACT configured airplane of the 1990s, and a determination of function criticalities to safety of flight, are the basis of candidate integrated ACT/Control/Guidance System architecture. The system mechanizes five active control functions: pitch augmented stability, angle of attack limiting, lateral/directional augmented stability, gust load alleviation, and maneuver load control. The scope and requirements of a program for simulating the integrated ACT avionics and flight deck system, with pilot in the loop, are defined, system and crew interface elements are simulated, and mechanization is recommended. Relationships between system design and crew roles and procedures are evaluated.

  6. Contamination of an arctic terrestrial food web with marine-derived persistent organic pollutants transported by breeding seabirds.

    PubMed

    Choy, Emily S; Kimpe, Linda E; Mallory, Mark L; Smol, John P; Blais, Jules M

    2010-11-01

    At Cape Vera, Devon Island (Nunavut, Canada), a colony of northern fulmars (Fulmarus glacialis) concentrates and releases contaminants through their guano to the environment. We determined whether persistent organic pollutants (POPs) from seabirds were transferred to coastal food webs. Snow buntings (Plectrophenax nivalis) were the most contaminated species, with ∑PCB and ∑DDT (mean: 168, 106 ng/g ww) concentrations surpassing environmental guidelines for protecting wildlife. When examined collectively, PCB congeners and DDT in jewel lichen (Xanthoria elegans) were lower in samples taken farther from the seabird colony, and increased with increasing δ(15)N values. However, only concentrations of p'p-DDE:∑DDT and PCB-95 were significantly correlated inversely with distance from the seabird cliffs. Linkages between marine-derived POPs and their concentrations in terrestrial mammals were less clear. Our study provides novel contaminant data for these species and supports biovector transport as a source of organic contaminants to certain components of the terrestrial food web. PMID:20801564

  7. Vertical transport of carbon-14 into deep-sea food webs

    NASA Astrophysics Data System (ADS)

    Pearcy, W. G.; Stuiver, Minze

    1983-04-01

    During the years 1973 to 1976 the carbon-14 content was higher in epipelagic and vertically migrating, upper mesopelagic animals (caught between 0 and 500 m) than in lower mesopelagic, bathypelagic, and abyssobenthic animals (500 to 5180 m) in the northeastern Pacific Ocean. Only one species of deep-sea fish had a Δ14C value as high as surface-caught fish. The 14C content of most animals was higher pre-bomb levels, but the relatively low 14C content of most deep-sea animals indicates that the majority of their carbon was not derived directly from a near-surface food chain labeled with bomb carbon. A mean residence time of about 35 y was estimated for the organic carbon pool for abyssobenthic animals based on the relative increase of radiocarbon in surface-dwelling animals since 1967. The results suggest that rapidly sinking particles from surface waters, such as fecal pellets, are not the major source of organic carbon for deep-sea fishes and large benthic invertebrates.

  8. 21 CFR 170.10 - Food additives in standardized foods.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Food additives in standardized foods. 170.10... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES General Provisions § 170.10 Food additives... the Act, which proposes the inclusion of a food additive in such definition and standard of...

  9. 21 CFR 170.10 - Food additives in standardized foods.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Food additives in standardized foods. 170.10... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES General Provisions § 170.10 Food additives... the Act, which proposes the inclusion of a food additive in such definition and standard of...

  10. 21 CFR 170.10 - Food additives in standardized foods.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Food additives in standardized foods. 170.10... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES General Provisions § 170.10 Food additives... the Act, which proposes the inclusion of a food additive in such definition and standard of...

  11. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.

    PubMed

    Basile, Edward M; Tolomeo, Deborah; Gluck, Elizabeth

    2009-01-01

    With no communication to industry except court filings in United States v. Undetermined Quantities of Boxes of Articles of Device (Shelhigh) and a draft guidance document, the Food and Drug Administration (FDA) has articulated new policies regarding export of pharmaceutical products and medical devices. FDA's departure from its historic interpretation of the export provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) significantly limits the ability of manufacturers to export misbranded drugs and medical devices that FDA deems "adulterated," contrary to the plain language and legislative intent of the FDCA. To further exacerbate the issue, FDA has begun to implement these policies without the notice-and-comment rulemaking required by the Administrative Procedures Act (APA), but rather through an enforcement proceeding brought in the United States District Court for the District of New Jersey. In a letter opinion, the District Court prevented the export of Current Good Manufacturing Practices (CGMP) --adulterated medical devices that complied with FDCA Section 801(e)(1), at least as historically interpreted by FDA. The purpose of this article is to review the history of FDA's export policies for pharmaceuticals and medical devices, particularly those aspects of the export policies that are affected by FDA's recent change in position. Three changes in FDA's interpretation of the export provisions of the FDCA will be addressed: 1) unapproved devices that a manufacturer reasonably believes are eligible for Section 510(k) clearance may no longer be exported under Section 801(e) and now must be exported under Section 802, in substantial compliance with Current CGMP; 2) adulterated devices and misbranded drugs can only be exported if the foreign purchaser's specifications cause the product to be adulterated; and 3) an article may not be exported if a like article has ever been sold or offered for sale in domestic commerce. FDA's new interpretations of FDCA

  12. Integrated Application of Active Controls (IAAC) technology to an advanced subsonic transport project: Test act system validation

    NASA Technical Reports Server (NTRS)

    1985-01-01

    The primary objective of the Test Active Control Technology (ACT) System laboratory tests was to verify and validate the system concept, hardware, and software. The initial lab tests were open loop hardware tests of the Test ACT System as designed and built. During the course of the testing, minor problems were uncovered and corrected. Major software tests were run. The initial software testing was also open loop. These tests examined pitch control laws, wing load alleviation, signal selection/fault detection (SSFD), and output management. The Test ACT System was modified to interface with the direct drive valve (DDV) modules. The initial testing identified problem areas with DDV nonlinearities, valve friction induced limit cycling, DDV control loop instability, and channel command mismatch. The other DDV issue investigated was the ability to detect and isolate failures. Some simple schemes for failure detection were tested but were not completely satisfactory. The Test ACT System architecture continues to appear promising for ACT/FBW applications in systems that must be immune to worst case generic digital faults, and be able to tolerate two sequential nongeneric faults with no reduction in performance. The challenge in such an implementation would be to keep the analog element sufficiently simple to achieve the necessary reliability.

  13. Surface Transportation Research and Development Act of 1997. House of Representatives, One Hundred Fifth Congress, Second Session

    SciTech Connect

    1998-12-31

    Mr. Sensenbrenner, from the Committee on Science, submitted this report together with additional views. The Committee on Science, to whom was referred the bill (H.R. 860) to authorize appropriations to the Department of Transportation for surface transportation research and development, and for other purposes, having considered the same, report favorably thereon with an amendment and recommend that the bill as amended do pass.

  14. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. Final rule.

    PubMed

    2016-05-10

    The Food and Drug Administration (FDA) is issuing this final rule to deem products meeting the statutory definition of "tobacco product,'' except accessories of the newly deemed tobacco products, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. With this final rule, FDA is extending the Agency's "tobacco product'' authorities in the FD&C Act to all other categories of products that meet the statutory definition of "tobacco product" in the FD&C Act, except accessories of such newly deemed tobacco products. This final rule also prohibits the sale of "covered tobacco products" to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to reduce the death and disease from tobacco products. In accordance with the Tobacco Control Act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable. PMID:27192730

  15. Transportation.

    ERIC Educational Resources Information Center

    Crank, Ron

    This instructional unit is one of 10 developed by students on various energy-related areas that deals specifically with transportation and energy use. Its objective is for the student to be able to discuss the implication of energy usage as it applies to the area of transportation. Some topics covered are efficiencies of various transportation…

  16. 77 FR 42797 - Privacy Act of 1974; Department of Transportation Office of the Secretary-DOT/OST-100...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-20

    ...; Date of birth; Social Security Number; Telephone and cell phone numbers; Physical and mailing addresses.../OST-100 Investigative Record System AGENCY: Office of the DOT Chief Information Office, Office of the Secretary, DOT. ACTION: Notice of revised Privacy Act system of records. SUMMARY: In accordance with...

  17. 7 CFR 63.1 - Act.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) NATIONAL SHEEP INDUSTRY IMPROVEMENT CENTER... Development Act, 7 U.S.C. 2008j, as amended by section 11009 of the Food, Conservation, and Energy Act of...

  18. 7 CFR 63.1 - Act.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) NATIONAL SHEEP INDUSTRY IMPROVEMENT CENTER... Development Act, 7 U.S.C. 2008j, as amended by section 11009 of the Food, Conservation, and Energy Act of...

  19. 7 CFR 63.1 - Act.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) NATIONAL SHEEP INDUSTRY IMPROVEMENT CENTER... Development Act, 7 U.S.C. 2008j, as amended by section 11009 of the Food, Conservation, and Energy Act of...

  20. 7 CFR 63.1 - Act.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) NATIONAL SHEEP INDUSTRY IMPROVEMENT CENTER... Development Act, 7 U.S.C. 2008j, as amended by section 11009 of the Food, Conservation, and Energy Act of...

  1. Is Slow-Onset Long-Acting Monoamine Transport Blockade to Cocaine as Methadone is to Heroin? Implication for Anti-Addiction Medications

    PubMed Central

    Peng, Xiao-Qing; Xi, Zheng-Xiong; Li, Xia; Spiller, Krista; Li, Jie; Chun, Lauren; Wu, Kuo-Ming; Froimowitz, Mark; Gardner, Eliot L

    2010-01-01

    The success of methadone in treating opiate addiction has suggested that long-acting agonist therapies may be similarly useful for treating cocaine addiction. Here, we examined this hypothesis, using the slow-onset long-acting monoamine reuptake inhibitor 31,345, a trans-aminotetralin analog, in a variety of addiction-related animal models, and compared it with methadone's effects on heroin's actions in the same animal models. Systemic administration of 31,345 produced long-lasting enhancement of electrical brain-stimulation reward (BSR) and extracellular nucleus accumbens (NAc) dopamine (DA). Pretreatment with 31,345 augmented cocaine-enhanced BSR, prolonged cocaine-enhanced NAc DA, and produced a long-term (24-48 h) reduction in cocaine self-administration rate without obvious extinction pattern, suggesting an additive effect of 31,345 with cocaine. In contrast, methadone pretreatment not only dose-dependently inhibited heroin self-administration with an extinction pattern but also dose-dependently inhibited heroin-enhanced BSR and NAc DA, suggesting functional antagonism by methadone of heroin's actions. In addition, 31,345 appears to possess significant abuse liability, as it produces dose-dependent enhancement of BSR and NAc DA, maintains a low rate of self-administration behavior, and dose-dependently reinstates drug-seeking behavior. In contrast, methadone only partially maintains self-administration with an extinction pattern, and fails to induce reinstatement of drug-seeking behavior. These findings suggest that 31,345 is a cocaine-like slow-onset long-acting monoamine transporter inhibitor that may act as an agonist therapy for cocaine addiction. However, its pattern of action appears to be significantly different from that of methadone. Ideal agonist substitutes for cocaine should fully emulate methadone's actions, that is, functionally antagonizing cocaine's action while blocking monoamine transporters to augment synaptic DA. PMID:20827272

  2. Integrated Application of Active Controls (IAAC) technology to an advanced subsonic transport project: current and advanced act control system definition study

    SciTech Connect

    Not Available

    1982-04-01

    The Current and Advanced Technology ACT control system definition tasks of the Integrated Application of Active Controls (IAAC) Technology project within the Energy Efficient Transport Program are summarized. The systems mechanize six active control functions: (1) pitch augmented stability (2) angle of attack limiting (3) lateral/directional augmented stability (4) gust load alleviation (5) maneuver load control and (6) flutter mode control. The redundant digital control systems meet all function requirements with required reliability and declining weight and cost as advanced technology is introduced.

  3. Integrated Application of Active Controls (IAAC) technology to an advanced subsonic transport project: Current and advanced act control system definition study

    NASA Technical Reports Server (NTRS)

    1982-01-01

    The Current and Advanced Technology ACT control system definition tasks of the Integrated Application of Active Controls (IAAC) Technology project within the Energy Efficient Transport Program are summarized. The systems mechanize six active control functions: (1) pitch augmented stability; (2) angle of attack limiting; (3) lateral/directional augmented stability; (4) gust load alleviation; (5) maneuver load control; and (6) flutter mode control. The redundant digital control systems meet all function requirements with required reliability and declining weight and cost as advanced technology is introduced.

  4. A bill to require the Transportation Security Administration to comply with the Uniformed Services Employment and Reemployment Rights Act.

    THOMAS, 112th Congress

    Sen. Lieberman, Joseph I. [ID-CT

    2011-12-14

    12/14/2011 Read twice and referred to the Committee on Commerce, Science, and Transportation. (text of measure as introduced: CR S8604) (All Actions) Notes: For further action, see H.R.3670, which became Public Law 112-171 on 8/16/2012. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  5. Integrated Application of Active Controls (IAAC) technology to an advanced subsonic transport project: Test act system description

    NASA Technical Reports Server (NTRS)

    1983-01-01

    The engineering and fabrication of the test ACT system, produced in the third program element of the IAAC Project is documented. The system incorporates pitch-augmented stability and wing-load alleviation, plus full authority fly-by-wire control of the elevators. The pitch-augmented stability is designed to have reliability sufficient to allow flight with neutral or negative inherent longitudinal stability.

  6. The ethics of postmarketing observational studies of drug safety under section 505(o)(3) of the Food, Drug, and Cosmetic Act.

    PubMed

    Evans, Barbara J

    2012-01-01

    In 2007, Congress granted the Food and Drug Administration (FDA) new powers to order pharmaceutical companies to conduct drug safety studies and clinical trials in the postmarketing period after drugs are approved The methodologies include observational studies that examine patients' insurance claims data and clinical records to infer whether drugs are safe in actual clinical practice. Such studies offer a valuable tool for improving drug safety, but they raise ethical and privacy concerns because they would entail widespread use of patients' health information in commercial research by drug manufacturers. This is the first article to explore the ethics of these section 505(0)(3) observational studies, so named after the section of the Food, Drug, and Cosmetic Act that authorizes them. Data access problems threaten to make the FDA's section 505(0)(3) study requirements unenforceable. Under existing federal privacy regulations, it appears highly unlikely that pharmaceutical companies will have reliable access to crucial data resources, such as insurance claims data and healthcare records, to use in these studies. State privacy laws present another potential barrier to data access. If pharmaceutical companies do manage to gain access to the needed data, this will raise serious privacy concerns because section 505(0)(3) observational studies do not appear to be covered by any of the major federal regulations that afford ethical and privacy protections to persons whose data are used in research. If the FDA's program of section 505(o)(3) observational studies fails because of the above problems, this failure will have a number of bad consequences: the public will be exposed to avoidable drug safety risks; taxpayers may be forced to bear the costs of having the FDA conduct drug safety investigations that would have been funded by drug manufacturers if data had been available; and, perhaps most troubling, the FDA may be forced to order postmarketing clinical trials to

  7. H.R. 2400, Report number 105-467, Parts 1, 2 and 3: This act may be cited as the Building Efficient Surface Transportation and Equity Act of 1998, introduced in the House of Representatives, One Hundred Fifth Congress, Second Session, March 27, 1998

    SciTech Connect

    1998-12-31

    This act is to authorize funds for Federal-aid highways, highway safety programs, and transit programs, and for other purposes. The topics of the act include Federal-aid highways, highway safety, federal transit administration programs, motor carrier safety, programmatic reforms and streamlining, transportation research, recreational boating safety program and railroads.

  8. Analysis of prey capture and food transport kinematics in two Asian box turtles, Cuora amboinensis and Cuora flavomarginata (Chelonia, Geoemydidae), with emphasis on terrestrial feeding patterns.

    PubMed

    Natchev, Nikolay; Heiss, Egon; Lemell, Patrick; Stratev, Daniel; Weisgram, Josef

    2009-01-01

    This study examines the kinematics and morphology of the feeding apparatus of two geoemydid chelonians, the Malayan (Amboina) box turtle (Cuora amboinensis) and the yellow-margined box turtle (Cuora flavomarginata). Both species are able to feed on land as well as in water. Feeding patterns were analysed by high-speed cinematography. The main focus of the present study is on the terrestrial feeding strategies in both Asian box turtles, because feeding on land has probably evolved de novo within the ancestrally aquatic genus Cuora. During terrestrial feeding (analysed for both species), the initial food prehension is always done by the jaws, whereas intraoral food transport and pharyngeal packing actions are tongue-based. The food uptake modes in Cuoras differ considerably from those described for purely terrestrial turtles. Lingual food prehension is typical of all tortoises (Testudinidae), but is absent in C. amboinensis and C. flavomarginata. A previous study on Terrapene carolina shows that this emydid turtle protrudes the tongue during ingestion on land, but that the first contact with the food item occurs by the jaws. Both Asian box turtles investigated here have highly movable, fleshy tongues; nonetheless, the hyolingual complex remains permanently retracted during initial prey capture. In aquatic feeding (analysed for C. amboinensis only), the prey is captured by a fast forward strike of the head (ram feeding). As opposed to ingestion on land, in the underwater grasp the hyoid protracts prior to jaw opening. The head morphology of the investigated species differs. In contrast to the Malayan box turtle, C. flavomarginata exhibits a more complexly structured dorsal lingual epithelium, a considerable palatal vault, weaker jaw adductor muscles and a simplified trochlear complex. The differences in the hyolingual morphology reflect the kinematic patterns of the terrestrial feeding transport. PMID:19010648

  9. Across-Shelf Transport of Bivalve Larvae: Can the Interface between a Coastal Current and Inshore Waters Act as an Ecological Barrier to Larval Dispersal?

    PubMed Central

    Tilburg, Charles E.; McCartney, Michael A.; Yund, Philip O.

    2012-01-01

    Using an integrated physical and biological approach, we examined across-shelf advection and exchange and the associated transport of bivalve larvae in the presence of a strong coastal current separated from the coast by a stratified inshore environment. We tested the hypothesis that the interface of the coastal current and inshore waters can act as an ecological barrier to across-shelf transport of larvae but can be overcome by wind- or tidally-induced transport. Our study region in the Gulf of Maine encompasses a coastal current that diverges from the coast as it moves downshelf. The region inshore of this current is home to several species that exhibit limited recruitment in spite of extensive upshelf larval sources. Analysis of surface water temperatures and wind velocities revealed episodic decreases in temperature along the coast correlated with alongshelf (but not upwelling) winds, indicating wind-forced onshore movement of the cold coastal current. Such wind-driven onshore migrations are more common along the northern portion of the study region where the coastal current is near the coast, tidal currents are strong, and wind directions are more conducive to onshore migration, but rarer further south where the interface between inshore waters and the coastal current is further offshore and suitable wind events are less common. The distribution of bivalve larvae was consistent with the physical measurements. There was little across-shelf variation in larval abundance where the current abuts the coast, indicating strong across-shelf exchange of larvae, but strong across-shelf variation in larval density where the stratified inshore waters separate the current from the coast, indicating weak across-shelf transport of larvae. Our results suggest that the interface between the coastal current and inshore waters may constitute a major ecological barrier to larval dispersal in the southern part of the region that may only be overcome by rare, strong wind

  10. National School Lunch Program and School Breakfast Program: Nutrition Standards for All Foods Sold in School as Required by the Healthy, Hunger-Free Kids Act of 2010. Final rule and interim final rule.

    PubMed

    2016-07-29

    This rule adopts as final, with some modifications, the National School Lunch Program and School Breakfast Program regulations set forth in the interim final rule published in the Federal Register on June 28, 2013. The requirements addressed in this rule conform to the provisions in the Healthy, Hunger-Free Kids Act of 2010 regarding nutrition standards for all foods sold in schools, other than food sold under the lunch and breakfast programs. Most provisions of this final rule were implemented on July 1, 2014, a full year subsequent to publication of the interim final rule. This was in compliance with section 208 of the Healthy, Hunger-Free Kids Act of 2010, which required that State and local educational agencies have at least one full school year from the date of publication of the interim final rule to implement the competitive food provisions. Based on comments received on the interim final rule and implementation experience, this final rule makes a few modifications to the nutrition standards for all foods sold in schools implemented on July 1, 2014. In addition, this final rule codifies specific policy guidance issued after publication of the interim rule. Finally, this rule retains the provision related to the standard for total fat as interim and requests further comment on this single standard. PMID:27476195