Department of Health and Human Services January 28, 2008 – Federal Register Recent Federal Regulation Documents
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Food Labeling: Revision of Reference Values and Mandatory Nutrients; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to April 30, 2008, the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of November 2, 2007 (72 FR 62149). In the ANPRM, FDA requested comments on what new reference values the agency should use to calculate the percent daily value (DV) in the Nutrition Facts and Supplement Facts labels and what factors the agency should consider in establishing such new reference values. In addition, FDA requested comments on whether it should require that certain nutrients be added or removed from the Nutrition Facts and Supplement Facts labels. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
National Advisory Council on the National Health Service Corps
The Health Resources and Services Administration published a meeting notice for the National Advisory Council on the National Health Service Corps in the Federal Register of January 15, 2008 (FR Doc. E8- 581), on page 2510. The beginning date of the meeting has changed.
Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the draft guidance entitled ``Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.''
Awards to Eleven Office of Refugee Resettlement Shelter Care Providers
This notice is hereby given that an award will be made to an unaccompanied alien shelter care provider, Southwest Regional Youth Village, Vincennes, Indiana, in the amount of $586,719. This funding will support services through September 30, 2008. This funding will support the expansion of secure program bed capacity to meet the number of unaccompanied alien children referrals from the Department of Homeland Security (DHS). The program is mandated by section 462 of the Homeland Security Act to ensure appropriate placement of all referrals from the DHS. ORR's ability to meet this mandate is often a challenge since the program is completely tied to DHS interior apprehension strategies and the sporadic number of border crossers. The program has very specific requirements for the provision of services. This grantee is one of the only entities with the infrastructure, licensing, experience and appropriate level of trained staff to meet the service requirements for secure capacity. The program's ability to meet the number of secure referrals from DHS can only be accommodated through the expansion of this program through the supplemental award process.
Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements
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 notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, and cosmetics that may not be marketed or sold in the United States.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food and Drug Administration Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey of Food Safety and Nutrition Information Provided to Pregnant Women by Health Care Providers and the Special Supplemental Nutrition Program for Women, Infants, and Children Educators
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Survey of Food Safety and Nutrition Information Provided to Pregnant Women by Health Care Providers and WIC Educators'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medicare Program; Meeting of the Practicing Physicians Advisory Council
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
Medicare Program; Request for Nominations for Members of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC)
This notice announces the request for nominations for consideration for membership on the Medicare Evidence Development and Coverage Advisory Committee (MedCAC). We are requesting nominations for both voting and nonvoting members to serve on the MedCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We have a special interest in ensuring that women, minority groups, and physically challenged individuals are adequately represented on the MedCAC. Therefore, we encourage nominations of qualified candidates from these groups. The MedCAC reviews and evaluates medical literature, reviews technology assessments, and examines data and information on the effectiveness and appropriateness of medical items and services that are covered or eligible for coverage under Medicare. The MedCAC advises the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare and Medicaid Services (CMS), as requested by the Secretary, whether medical items and services are reasonable and necessary under Title XVIII of the Social Security Act.
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