Department of Health and Human Services January 27, 2005 – Federal Register Recent Federal Regulation Documents
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List of Drugs for Which Pediatric Studies Are Needed
The National Institutes of Health (NIH) is providing notice of a ``List of Drugs for Which Pediatric Studies Are Needed.'' The NIH developed the list in consultation with the Food and Drug Administration (FDA) and pediatric experts, as mandated by the Best Pharmaceuticals for Children Act. This list adds to the previously published lists prioritizing drugs most in need of study for use by children to ensure the safety and efficacy of their medication. The NIH will update the list at least annually until the Act expires on October 1, 2007.
From Concept to Consumer: Center for Biologics Evaluation and Research Working With Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies; Public Workshop; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until January 27, 2006, the comment period for the notice of public workshop and request for comments published in the Federal Register of August 31, 2004 (69 FR 53077). FDA is reopening the comment period to allow interested persons additional time to submit comments and to receive any new information.
Notice of Appeal
By designation of the Administration for Children and Families, a member of the Departmental Appeals Board has been appointed as the presiding officer for an appeal of the Administration for Children and Families' (ACF) disapproval of an amendment to the plan of the New York State Office of Children and Family Services for implementing title IV-E of the Social Security Act (Foster Care and Adoption Assistance). The purpose of this notice is to give interested parties an opportunity to participate. Requests To Participate: Requests to participate as a party or as amicus curiae must be submitted to the Departmental Appeals Board in the form specified at 45 CFR 213.15 by February 11, 2005. Within that time, those persons, groups, or organizations seeking participation as parties or amici may file petitions or request extensions of time for submitting petitions to participate, and may also contact the Board to obtain copies of the briefs that the parties have filed.
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