Department of Health and Human Services July 21, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
National Health and Nutrition Examination Survey (NHANES) Stored Biologic Specimens: Guidelines for Proposals to Use Samples and Proposed Cost Schedule
The National Health and Nutrition Examination Survey (NHANES) is a program of periodic surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Examination surveys conducted since 1960 by NCHS, have provided national estimates of health and nutritional status of the United States civilian non-institutionalized population. To add to the large amount of information collected for the purpose of describing the health of the population in the most recent survey, serum, urine and limited plasma samples were collected and stored for future research projects. Specimens are currently available from NHANES III (conducted from 1988-1994) and from NHANES 1999-2008. In 1999, NHANES became a continuous survey with data release every two years. Specimens are available from two year survey cycles after the demographic file has been released to the public. Participants in the survey that began in 1999 signed a separate consent document agreeing to specimen storage allowing their biologic specimens to be used for approved research projects.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products (VICH GL45); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (198) entitled ``Draft Guidance for Industry on Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products,'' VICH GL45. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance is an annex to a VICH guidance entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision),'' VICH GL3(R), that published in the Federal Register of November 23, 2007 (72 FR 65751). This draft VICH guidance document is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in VICH GL3(R).
Ajinomoto Co., Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Ajinomoto Co., Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of N-[N-[3- (3-hydroxy-4-methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1- methyl ester, monohydrate (CAS Reg. No. 714229-20-6) for use as a non- nutritive sweetener in tabletop applications and powdered beverage mixes. Ajinomoto Co., Inc., also proposes that this additive be identified as advantame.
Advisory Committee; Risk Communication Advisory Committee; Termination and Recharter
The Food and Drug Administration (FDA) is announcing the termination and the recharter of the Risk Communication Advisory Committee (the committee). These actions are needed to implement the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Amendments Act of 2007, to change the committee from a discretionary to a statutory committee. This document also amends the agency's regulations which list advisory committees to reflect that the Risk Communication Advisory Committee has been rechartered and to revise the function statement.
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