Department of Health and Human Services October 18, 2006 – Federal Register Recent Federal Regulation Documents
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Notice of Hearing: Reconsideration of Disapproval of Minnesota State Plan Amendment 05-015B
This notice announces an administrative hearing to be held on December 4, 2006, at 233 N. Michigan Avenue, Suite 600, the Illinois Room, Chicago, IL 60601, to reconsider CMS' decision to disapprove Minnesota State plan amendment 05-015B. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by November 2, 2006.
Notice of Hearing: Reconsideration of Disapproval of New York State Plan Amendment 05-49
This notice announces an administrative hearing to be held on November 22, 2006, at 26 Federal Plaza, Room 38-110a, New York, NY, 10278, to reconsider CMS' decision to disapprove New York State plan amendment 05-49.
Availability of Draft Toxicological Profiles
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)] directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 20th set of toxicological profiles, which consists of one new draft and six updated drafts, prepared by ATSDR for review and comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of a Currently Approved Information Collection; Program Announcement and Grant Application Instructions Template for the Older Americans Act Title IV Discretionary Grant Program
The Administration on Aging (AoA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of Information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the standard Program Announcement and Grant Application Instructions template for Older Americans Act Title IV Discretionary Grant Program.
Guidance for Industry on Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV.'' The guidance is intended to encourage sponsors to submit to FDA applications for fixed dose combination (FDC), co-packaged, and single- entity versions of antiretroviral drugs for the treatment of human immunodeficiency virus (HIV). The availability of a wide range of safe and effective antiretroviral products may help facilitate a wider distribution of anti-HIV drugs to better meet the demands of the global HIV/AIDS pandemic.
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ALTACE (ramipril), GEMZAR (gemcitabine), LESCOL (fluvastatin), SANDOSTATIN LAR (octreotide), and SEREVENT (salmeterol). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.
Medicare Program; Medicare Part D Data
This proposed rule would allow the Secretary to use the claims information that is now being collected for Part D payment purposes for other research, analysis, reporting, and public health functions. The Secretary needs to use this data because other publicly available data are not, in and of themselves, sufficient for the studies and operations that the Secretary needs to undertake as part of the Department of Health and Human Service's obligation to oversee the Medicare program, protect the public health, and respond to Congressional mandates.
Office of the National Coordinato for Health Information Technology, American Health Information Community Chronic Care Workgroup Meeting
This notice announces the eleventh meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup
This notice announces the third meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy and Security Workgroup Meeting
This notice announces the fourth meeting of the American Health Information Community Confidentiality, Privacy and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the eleventh meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Record Workgroup Meeting
This notice announces the eleventh meeting the American Health Information Community Electronic Health Record Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
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