Department of Health and Human Services November 27, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Draft Guidance for Industry and Food and Drug Administration Staff; Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products Under the Federal Food, Drug, and Cosmetic Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act.'' This guidance is intended for manufacturers, retailers, importers, and FDA staff. The guidance describes FDA's current thinking regarding the appropriate preliminary timetable for its review of applications for Modified Risk Tobacco Products (MRTPs) under the Federal Food, Drug, and Cosmetic Act (the act), as modified by the Federal Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2010 through September 30, 2011
The Federal Medical Assistance Percentages (FMAP) and Enhanced Federal Medical Assistance Percentages (eFMAP) for Fiscal Year 2011 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2010 through September 30, 2011. This notice announces the calculated FMAP and eFMAP rates that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of Federal matching for State medical assistance (Medicaid) and Children's Health Insurance Program (CHIP) expenditures, Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments. The table gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
Screening Framework Guidance for Synthetic Double-Stranded DNA Providers
To reduce the risk that individuals with ill intent may exploit the commercial application of nucleic acid synthesis technology to access genetic material derived from or encoding Select Agents or Toxins, the U.S. Government has developed recommendations for a framework for synthetic nucleic acid screening. This document is intended to provide guidance to producers of synthetic genomic products regarding the screening of orders so that these orders are filled in compliance with current U.S. regulations and to encourage best
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Evaluation of In Vitro Estrogen Receptor Transcriptional Activation and In Vitro Cell Proliferation Assays for Endocrine Disruptor Chemical Screening: Request for Nominations for an Independent Expert Peer Review Panel and Submission of Relevant In Vitro and In Vivo Data
NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), is planning to convene an independent scientific peer review panel (hereafter, Panel) to assess the validation status of an in vitro stably-transfected estrogen receptor (ER) transcriptional activation (TA) Assay (LUMI-CELL[supreg] ER assay) and an in vitro cell proliferation assay (CertiChem MCF-7 Cell Proliferation assay) for their usefulness and limitations in determining whether and to what extent chemicals can interact with estrogen receptors in vitro.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the GuideLines Into Decision Support (GLIDES).'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Medicare and Medicaid Programs; Conditional Approval of Application by the American Association for Accreditation of Ambulatory Surgery Facilities for Continued Deeming Authority for Ambulatory Surgical Centers
This final notice announces our decision to conditionally approve, with a 180 day probationary period, the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for continued recognition as a national accreditation program for ambulatory surgical centers seeking to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs; Approval of the Accreditation Commission for Health Care for Deeming Authority for Hospices
This final notice announces our decision to approve the Accreditation Commission for Health Care (ACHC) for recognition as a national accreditation program for hospices seeking to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs; Approval of the Application by the Joint Commission for Continued Deeming Authority for Hospitals
This final notice announces the approval of a deeming application from the Joint Commission for continued recognition as a national accreditation program for hospitals that request participation in the Medicare or Medicaid programs.
Medicare Program; Town Hall Meeting on the Fiscal Year 2011 Applications for New Medical Services and Technologies Add-on Payments and Informational Workshop on the Application Process and Criteria for New Medical Services and Technologies Add-on Payments
This notice announces a Town Hall meeting to discuss fiscal year (FY) 2011 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2011 new medical services and technologies applications meet the substantial clinical improvement criterion.
Health and Human Services Acquisition Regulation
The Department of Health and Human Services (HHS) is revising its Federal Acquisition Regulation (FAR) Supplementthe HHS Acquisition Regulation (HHSAR) in its entirety to reflect statutory, FAR, and government-wide and HHS policy changes since the last revision to the HHSAR in December 2006.
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