Department of Health and Human Services May 10, 2010 – Federal Register Recent Federal Regulation Documents
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The National Institutes of Health and the Food and Drug Administration Joint Leadership Council: Stakeholders Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting, in conjunction with the National Institutes of Health (NIH), to solicit comments from interested persons on how the agencies can more effectively collaborate to advance the translation of biomedical research discoveries into approved diagnostics and therapies as well as promote science to enhance the evaluation tools used for regulatory review. A newly formed NIH-FDA Joint Leadership Council will help ensure that regulatory considerations form an increasing component of biomedical research planning, and that the latest science is integrated into the regulatory review process.
National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM): International Workshop on Alternative Methods To Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM announce an upcoming ``International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions.'' The workshop will bring together an international group of scientific experts from government, industry, and academia to review the current state of the science, availability, and future need for alternative methods that can reduce, refine, and replace the use of animals for human and veterinary vaccine post-licensing potency and safety testing. Plenary and breakout
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Federal Agency Responses to Interagency Coordinating Committee on the Validation of Alternative Methods Recommendations on the Murine Local Lymph Node Assay, An Alternative Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products: Notice of Availability
U.S. Federal agency responses to Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) test method recommendations on the murine local lymph node assay (LLNA), an alternative safety testing method used to assess the potential of chemicals and products to cause allergic contact dermatitis (ACD), are now available. ICCVAM recommended an updated LLNA test method protocol, a reduced LLNA procedure (rLLNA), and LLNA test method performance standards. In accordance with the ICCVAM Authorization Act, ICCVAM previously forwarded recommendations to Federal agencies and made these recommendations available to the public (74 FR 50212). Agencies have now notified ICCVAM in writing of their findings and ICCVAM is making these responses available to the public. Federal agency responses are available on the NICEATM-ICCVAM Web site at https:// iccvam.niehs.nih.gov/methods/immunotox/rLLNA.htm and https:// iccvam.niehs.nih.gov/methods/immunotox/llnaPerfStds.htm. The ICCVAM recommendations are provided in ICCVAM Test Method Evaluation Reports, which are available on the NICEATM-ICCVAM Web site at https:// iccvam.niehs.nih.gov/methods/immunotox/LLNA-LD/TMER.htm and https:// iccvam.niehs.nih.gov/methods/immunotox/PerfStds/llna-ps.htm.
Proposed Collection; Comment Request; The Framingham Heart Study (FHS)
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Submission for OMB Review; Comment Request; Lost People Finder System
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Library of Medicine (NLM), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 8, 2010 (Vol. 75, No. 25, p. 6207) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
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