Department of Health and Human Services December 18, 2008 – Federal Register Recent Federal Regulation Documents

National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: E8-30097
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-30096
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Studies of Safety and Effectiveness of Orphan Products
Document Number: E8-30061
Type: Notice
Date: 2008-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Office of Orphan Product Development (OPD) is providing notice of a funding opportunity announcement for Federal assistance. The goal of the OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E8-30029
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E8-30028
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E8-30026
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee
Document Number: E8-30024
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC) Technical Reports Review Subcommittee (TRR Subcommittee). The primary agenda topic is the peer review of the findings and conclusions presented in six draft NTP Technical Reports of rodent toxicology and carcinogenicity studies in conventional rats and mice. The TRR Subcommittee meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft reports (see ``Request for Comments'' below). The TRR Subcommittee deliberations on the draft reports will be reported to the NTP BSC at a future meeting.
National Library of Medicine; Notice of Closed Meeting
Document Number: E8-30010
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meeting
Document Number: E8-30008
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Meeting
Document Number: E8-29884
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-29883
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: E8-29882
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs; Tylosin
Document Number: E8-29861
Type: Rule
Date: 2008-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Elanco Animal Health. The supplemental NADAs provide for use of tylosin tartrate soluble powder in drinking water of swine followed by tylosin phosphate in medicated swine feed for the treatment and control of swine dysentery and the control of porcine proliferative enteropathies.
State Long-Term Care Partnership Program: Reporting Requirements for Insurers
Document Number: E8-28388
Type: Rule
Date: 2008-12-18
Agency: Office of the Secretary, Department of Health and Human Services
This final rule sets forth reporting requirements for private insurers that issue qualified long-term care insurance policies in States participating in the State Long-Term Care Partnership Program established under the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109- 171). Section 6021 of the DRA requires that the Secretary of Health and Human Services (the Secretary) specify a set of reporting requirements and collect data from insurers on qualified long-term care insurance policies issued under the program and the subsequent use of the benefits under these policies. Under a State Long-Term Care Partnership Program, an amount equal to the benefits received under the long-term care insurance policy is disregarded in determining the assets of an individual for purposes of Medicaid eligibility and estate recovery.
Office of the Assistant Secretary for Planning and Evaluation; Privacy Act of 1974; Report of New System of Records
Document Number: E8-28345
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, the Office of Assistant Secretary for Planning and Evaluation (ASPE) is proposing to establish a new system of records, called the Partnership for Long Term Care Data Set. The Partnership allows states to offer special Medicaid asset disregards to persons purchasing specially certified long term care insurance policies. This program and the data collection were established by the Deficit Reduction Act of 2005Section 6021. Although the Privacy Act requires only that the ``routine uses'' portion of the system be published for comment, ASPE invites comments on all portions of this notice. Elsewhere in today's Federal Register, a related final rulemaking establishing the State Long Term Care Partnership: Reporting Requirements for Insurers.
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