Department of Health and Human Services November 2009 – Federal Register Recent Federal Regulation Documents
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Medicaid Program: State Flexibility for Medicaid Benefit Packages and Premiums and Cost Sharing
This final rule temporarily delays the effective date of the November 25, 2008 final rule entitled, ``Medicaid Program; Premiums and Cost Sharing'' and the December 3, 2008 final rule entitled, ``Medicaid Program; State Flexibility for Medicaid Benefit Packages'' until July 1, 2010.
Medicare Program; Solicitation of Independent Accrediting Organizations To Participate in the Advanced Diagnostic Imaging Supplier Accreditation Program; Correction
This document corrects a technical error in the notice entitled ``Medicare Program; Solicitation of Independent Accrediting Organizations to Participate in the Advanced Diagnostic Imaging Supplier Accreditation Program'' which was posted for public inspection by the Office of the Federal Register on October 30, 2009, and published in the Federal Register on November 25, 2009.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Oral Dosage Form New Animal Drugs; Chlortetracycline Powder
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Alpharma Inc. The ANADA provides for use of generic chlortetracycline soluble powder to make medicated drinking water for cattle, swine, chickens, and turkeys for the treatment of several bacterial diseases.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, January 27, 2010. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the sufficiency of currently available evidence to determine whether the results of pharmacogenomic testing affect health outcomes of patients with cancer when used as a guide for certain drug treatments. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
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.
Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020
The U.S. Department of Health and Human Services (HHS) announces the next federal advisory committee meeting regarding the national health promotion and disease prevention objectives for 2020. This meeting will be open to the public and will be held online via WebEx software. The Secretary's Advisory Committee on National Health
Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment
The Food and Drug Administration (FDA) is amending a final rule that appeared in the Federal Register of April 29, 2009 (74 FR 19385) (as amended in the Federal Register of June 30, 2009 (74 FR 31177). The final rule requires important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDs). This document is intended to clarify some provisions in the final rule which may be unclear. Specifically,
Guidance for Industry on Residual Solvents in Drug Products Marketed in the United States; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Residual Solvents in Drug Products Marketed in the United States.'' On July 1, 2008, the United States Pharmacopeia (USP) published a new test requirement for the control of residual solvents, General Chapter ``Residual Solvents,'' which replaced USP General Chapter ``Organic Volatile Impurities.'' The change affects all compendial drug products marketed in the United States. This guidance reflects FDA's recommendations on how to comply with those USP changes.
New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 29 new animal drug applications (NADAs) and 2 abbreviated new animal drug applications (ANADAs) from Intervet, Inc., to Schering-Plough Animal Health Corp.
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: ``Spreading Techniques to Radically Reduce Antibiotic Resistant Bacteria (Methicillin Resistant Staphylococcus aureus, or MRSA).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 350 1-3520, AHRQ invites the public to comment on this proposed information collection.
Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010
This final rule with comment period implements changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also implements or discusses certain provisions of the Medicare Improvements for Patients and Providers Act of 2008. (See the Table of Contents for a
Medicare Program; Solicitation of Independent Accrediting Organizations To Participate in the Advanced Diagnostic Imaging Supplier Accreditation Program
This notice announces to independent accreditation organizations an opportunity to submit applications to participate in the advanced diagnostic imaging supplier accreditation program as a designated accreditation organization. Advanced diagnostic imaging accreditation is required for suppliers furnishing the technical component (TC) of advanced diagnostic imaging services. This notice contains information on accreditation application guidelines for CMS approval of suppliers who furnish the TC of advanced diagnostic imaging services.
Organizational Integrity of Entities Implementing Leadership Act Programs and Activities
The Department of Health and Human Services (HHS) is issuing this Notice of Proposed Rulemaking (NPRM) to obtain input from stakeholders and other interested parties. This is a proposal to amend the rule governing the separation that must exist between a recipient of HHS funds to implement HIV/AIDS programs and activities under the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 and an affiliate organization that engages in activities that are not consistent with a policy opposing prostitution and sex trafficking. The proposed rule relaxes the criteria for recipient affiliate separation, and simplifies the process for compliance with the statutory requirement that recipients of HHS Leadership Act HIV/ AIDS funds have a policy explicitly opposing prostitution and sex trafficking. This proposal eliminates the requirement that recipients prepare and file additional documentation specifically to demonstrate adherence to this policy. The documentation will instead consist of a statement in the awarding document to which the prime recipient must agree in order to receive Leadership Act HIV/AIDS funds.
Diseases Transmitted through the Food Supply
Section 103 (d) of the Americans with Disabilities Act of 1990, Public Law 101-336, requires the Secretary to publish a list of infectious and communicable diseases that are transmitted through handling the food supply and to review and update the list annually. The Centers for Disease Control and Prevention (CDC) published a final list on August 16, 1991 (56 FR 40897) and updates on September 8, 1992 (57 FR 40917); January 13, 1994 (59 FR 1949); August 15, 1996 (61 FR 42426); September 22, 1997 (62 FR 49518-9); September 15, 1998 (63 FR 49359), September 21, 1999 (64 FR 51127); September 27, 2000 (65 FR 58088), September 10, 2001 (66 FR 47030), and September 27, 2002 (67 FR 61109), September 26, 2006 (71 FR 56152), and November 17, 2008 (73 FR 67871). The final list has been reviewed in light of new information and has been revised as set forth below.
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