Department of Health and Human Services October 29, 2008 – Federal Register Recent Federal Regulation Documents

National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E8-25835
Type: Notice
Date: 2008-10-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-25817
Type: Notice
Date: 2008-10-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
Document Number: E8-25791
Type: Notice
Date: 2008-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-25779
Type: Notice
Date: 2008-10-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Council on Graduate Medical Education; Notice of Meeting
Document Number: E8-25775
Type: Notice
Date: 2008-10-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Proposed Information Collection Activity; Comment Request
Document Number: E8-25752
Type: Notice
Date: 2008-10-29
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
Document Number: E8-25741
Type: Notice
Date: 2008-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the waiver requirement procedures that are recommended by the agency for in vivo demonstration of bioequivalence for generic soluble powder oral dosage form products and Type A medicated articles.
Memorandum of Understanding With the U.S. Army Medical Research Institute of Infectious Diseases
Document Number: E8-25740
Type: Notice
Date: 2008-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with the U.S. Army Research Institute of Infectious Diseases (USAMRIID). This MOU identifies the terms of collaboration between FDA and USAMRIID in the area of emergency preparedness. Specifically this MOU provides for the sharing of information and collaborative activities related to biological threat agents and diagnostics to detect such biological threat agents in order to assist both parties in more efficiently preparing for and responding to emergencies in which such diagnostic tests may be used.
Memorandum of Understanding With the National Heart, Lung, and Blood Institute, a Part of the National Institutes of Health
Document Number: E8-25738
Type: Notice
Date: 2008-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA's Center for Biologics Evaluation and Research (CBER) and the National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH). This MOU outlines the terms of collaboration between CBER and NHLBI in areas of mutual concern for protecting and improving the public health. Specifically this MOU provides for the implementation of a plan for promoting better communication and understanding of regulations, policies, and statutory responsibilities, and to serve as a forum for discussion of scientific and clinical topics, questions, and problems that may arise. This MOU also provides the framework for sharing of information.
Food Additives Permitted in Feed and Drinking Water of Animals; Methyl Esters of Conjugated Linoleic Acid (Cis-9, Trans-11 and Trans-10, Cis-12-Octadecadienoic Acids)
Document Number: E8-25719
Type: Rule
Date: 2008-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic acids) as a source of fatty acids in swine diets. This action is in response to a food additive petition filed by BASF Corp. (BASF), 100 Campus Dr., Florham Park, NJ.
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