Department of Health and Human Services March 8, 2013 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Extension, Without Changes of Agency Information Collection for Indian Self-Determination and Education Assistance Contracts
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Bureau of Indian Affairs (BIA) and the Indian Health Service (IHS) are publishing for comment, a summary of a proposed information collection, titled ``Indian Self- Determination and Education Assistance Contracts, 25 CFR part 900,'' to be submitted to the Office of Management and Budget (OMB) for review. The information is collected to process contracts, grants or cooperative agreements (contracts) for award by BIA and IHS, as authorized by the Indian Self-Determination and Education Assistance Act (ISDEAA), as amended (25 U.S.C. 450 et seq.). This previously approved information collection (OMB Control Number 1076-0136) expires May 31, 2013.
National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Working Group Nominations
The National Institutes of Health and the Interagency Pain Research Coordinating Committee (IPRCC) are seeking nominations for membership of five working groups established to support efforts to create a comprehensive, population health level strategy for pain prevention, treatment, management, and research as recommended in the 2011 Institute of Medicine report titled ``Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.''
Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft 5-year plan describing the Agency's approach to further developing and implementing a structured framework for benefit-risk assessment in the human drug and biologic review process and the opportunity for public comment on the draft plan. This plan is part of FDA's commitments that were made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). FDA has published the draft plan on its Web site at https:// www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUs erFee/ UCM329758.pdf.
Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide'' (SECG) which updates an earlier guidance of similar title. Previously, this guidance restated the legal requirements of FDA's administrative detention regulation. This document also at one time served as FDA's guidance for administrative detention. In October 2011, FDA revised an earlier version of this guidance document to be consistent with the changes made by an interim final rule (IFR) issued in the Federal Register of May 5, 2011, and to serve as guidance for industry on administrative detention. FDA has since issued a final rule adopting the IFR as final without changes which was published in the Federal Register of February 5, 2013. Accordingly, FDA is further revising the existing guidance document to provide guidance intended to help any entity comply with the requirements in FDA's administrative detention regulation, including the amendments to these requirements made by the final rule. This notice also clarifies that this document continues to serve as FDA's guidance for administrative detention.
Office of Health Assessment and Translation Webinar on the Assessment of Data Quality in Animal Studies; Notice of Public Webinar and Registration Information
The National Toxicology Program (NTP) announces a public, web- based meeting on the assessment of data quality in animal studies. The Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS) will host the web-based meeting using Adobe[supreg] Connect TM and the public can register to attend.
Report on Carcinogens Webinar on Pentachlorophenol; Notice of Public Webinar and Registration Information
The National Toxicology Program (NTP) announces a public webinar, ``Human cancer studies on exposure to pentachlorophenol (PCP): Differentiating potential cancer effects of PCP exposure from effects due to occupational co-exposures or PCP contaminants.'' The Office of the Report on Carcinogens (ORoC), Division of the NTP (DNTP), National Institute of Environmental Health Sciences (NIEHS) will hold the webinar using Adobe[supreg] ConnectTM, and the public can register to attend.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Initial Review
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