Department of Health and Human Services December 18, 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Clinical Studies of Safety and Effectiveness of Orphan Products
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 Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee
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.
New Animal Drugs; Tylosin
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
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
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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