Call for Collaborating Partners for the OWH National Lupus Awareness Campaign
The U.S. Department of Health and Human Services (HHS), Office of Public Health and Science (OPHS), Office on Women's Health (OWH) announces the development of a National Lupus Awareness campaign with the Advertising Council and invites public and private sector lupus and women's health related organizations to participate as collaborating partners to provide advice on the development and dissemination of the campaign materials.
Grants to States for Operation of Qualified High Risk Pools
This rule finalizes the interim final rule with comment period that was published on July 27, 2007, regarding extended funding for seed and operational grants for State High Risk Pools under the Public Health Service Act.
Guidance for Industry on the Food and Drug Administration Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues; Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance document entitled ``FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues.'' FDA is withdrawing its guidance in response to the release by the Environmental Protection Agency (EPA) of its final ``White Paper Concerning Dietary Exposure to Cry9C Protein Produced by STARLINK Corn and the Potential Risks Associated With Such Exposure,'' the availability of which is announced elsewhere in this issue of the Federal Register.
Medicare and Medicaid Programs; The Det Norske Veritas Healthcare, Inc (DNV) for Deeming Authority for Hospitals
This proposed notice with comment period acknowledges the receipt of a deeming application from Det Norske Veritas Healthcare (DNV) for recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare Program; Meeting of the Practicing Physicians Advisory Council, May 19, 2008
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
Substances Prohibited From Use in Animal Food or Feed
The Food and Drug Administration (FDA) is amending the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals. These materials include the following: The entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle; the brains and spinal cords from cattle 30 months of age and older; the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not removed; tallow that is derived from BSE-positive cattle; tallow that is derived from other materials prohibited by this rule that contains more than 0.15 percent insoluble impurities; and mechanically separated beef that is derived from the materials prohibited by this rule. These measures will further strengthen existing safeguards against BSE.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2009
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2009 (for discharges occurring on or after October 1, 2008 and on or before September 30, 2009) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. We are proposing to revise existing policies regarding the PPS within the authority granted under section 1886(j) of the Act.
Amendment to the Fiscal Year 2009 Service Area Competition-New and Competing Continuation Funding
HRSA is announcing the reissuance of Fiscal Year 2009 Service Area CompetitionNew and Competing Continuation Funding (HRSA Announcement Numbers HRSA-09-095, HRSA-09-096, HRSA-09-097, and HRSA- 09-098). The HRSA Electronic Handbook (EHB) application deadline for project periods beginning in November and December 2008 has been changed and the list of available service areas has been updated. The new EHB application deadline for HRSA-09-095 is May 9, 2008. (The grants.gov application deadline of April 7, 2008 remains the same.) All other requirements of HRSA-09-095 remain the same. Please see the chart on pages 6 and 7 of the guidance for a complete listing of all application deadlines. In addition, corrections to two service areas listed in the Service Area Competition guidance have been made. In Appendix F of the guidance, Bismarck, ND, is incorrectly listed as an available service area in fiscal year (FY) 2009. The correct service area that is currently available in FY 2009 is Beulah, ND. Also, Clay, WV, is incorrectly listed as an available service area in FY 2009. The correct service area that is currently available in FY 2009 is Blacksville, WV. Bismarck, ND and Clay, WV, are not available service areas for the FY 2009 Service Area Competition. For a complete listing of all available service areas for the FY 2009 Service Area Competition funding opportunity, please see Appendix F of the guidance.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability
The Food and Drug Administration (FDA) is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by applicants of approved drug and biological products. This is the agency's report on the status of the studies applicants have agreed to or are required to conduct.
Draft Guidance for Industry on Developing Coronary Drug Eluting Stents; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Coronary Drug-Eluting Stent (DES) Guidance Document Workshop.'' FDA is cosponsoring the workshop with the Advanced Medical Technology Association (AdvaMed). The purpose of the workshop is to discuss the draft guidance entitled ``Coronary Drug-Eluting Stents: Nonclinical and Clinical Studies'' announced in the Federal Register of March 27, 2008, and its companion document entitled ``Coronary Drug- Eluting Stents-Nonclinical and Clinical Studies (Companion Document)'' (the Companion Document). The workshop intends to solicit additional comments on the issues and questions presented in the draft guidance during the open comment period.
Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets; Public Workshop; Request for Comments
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public workshop entitled ``Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets.'' The purpose of the public workshop is to solicit information and views from interested persons on best practices and principles for the design and evaluation of pharmacoepidemiologic safety studies using large electronic healthcare data sets. The input from this workshop will be used to develop a draft Guidance to Industry, and to provide consistent review criteria for FDA to use in evaluating protocols and study reports submitted to the agency.
New Animal Drugs; Enrofloxacin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA provides for use of enrofloxacin injectable solution in swine for the treatment and control of respiratory disease.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
The Food and Drug Administration (FDA) 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 medical device labeling regulations.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail firstname.lastname@example.org.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
Section 931 of the Public Health Service Act (PHS Act), 42 U.S.C. 299c, established a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2008. To fill these positions in accordance with the legislative mandate establishing the Council, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. Individuals are particularly sought with experience and success in activities specified in the summary above.