Department of Health and Human Services March 2009 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 317
Medicare Program; Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Correcting Amendment
This correcting amendment corrects a technical error in the amendatory instructions of the regulations text in the final rule entitled ``Medicare Program; Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)'' published in the January 2, 2009 Federal Register (74 FR 166). In that final rule, we implemented section 1834(a)(16)(B) of the Social Security Act (the Act) requiring certain Medicare suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) to furnish CMS with a surety bond. In addition, in the January 2, 2009 final rule, we responded to public comments on the August 1, 2007 proposed rule (72 FR 42001). The effective date for the January 2, 2009 final rule was March 3, 2009.
Medicare and Medicaid Programs; Approval of the Joint Commission for Continued Deeming Authority for Hospices
This final notice announces the approval of a deeming application from the Joint Commission for continued recognition as a national accreditation program for hospices that request participation in the Medicare or Medicaid programs.
Medicare Program; Announcement of Rechartering and Meeting of the Advisory Panel on Medicare Education, April 22, 2009
This notice announces the renewal of the charter of the Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This notice also announces a meeting of the Panel in accordance with the Federal Advisory Committee Act. This meeting is open to the public.
Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee
This notice announces a request for nominations for consideration for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other things, the MEDCAC advises the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services on whether medical items and services are ``reasonable and necessary'' and therefore eligible for coverage under Title XVIII of the Social Security Act.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2008
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2008 through December 2008, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities.
Medicare, Medicaid, and CLIA Programs; Approval of the American Osteopathic Association as a CLIA Accreditation Organization
This notice announces CMS' grant of deeming authority to the American Osteopathic Association (AOA) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that the requirements of the AOA accreditation process are equal to or more stringent than the CLIA condition level requirements, and that the AOA has met the requirements of CMS. Consequently, laboratories that are voluntarily accredited by the AOA and continue to meet the AOA requirements will be deemed to meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to Federal validation and complaint investigation surveys conducted by CMS or its designee.
Change of Addresses and Names; Technical Amendment
The Food and Drug Administration (FDA) is amending its
Agency Emergency Processing Under Office of Management and Budget Review; Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the burden hours required to implement the new statutory requirements for the user fees and fee waivers reductions provisions of the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Federal Food, Drug, and Cosmetic Act (the act)).
Developing a Consolidated Pediatric Rheumatology Observational Registry; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Developing a Consolidated Pediatric Rheumatology Observational Registry.'' This 2-day public workshop is intended to seek constructive input from key stakeholders in the pediatric rheumatology community, the pharmaceutical industry and the public to explore the value and feasibility of developing a consolidated pediatric rheumatology observational registry.
Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Source Plasma Establishments
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation to participate in a pilot evaluation program for CBER's eSubmitter Program (eSubmitter). CBER's eSubmitter has been customized as an automated biologics license application (BLA) and BLA supplement (BLS) submission system for blood and blood components. Participation in the pilot program is open to blood establishments that collect Source Plasma. The pilot program is intended to provide industry and CBER regulatory review staff the opportunity to evaluate the eSubmitter system and determine if it facilitates the BLA/BLS submission process. The purpose of this notice is to invite blood establishments that collect Source Plasma to submit a request to CBER if they are interested in participating in this pilot program.
Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated March 2009. The draft guidance document notifies establishments that manufacture Whole Blood and blood components intended for use in transfusion, and establishments that make eligibility determinations for donors of HCT/Ps about FDA approval of a biologics license application for an enzyme-linked immunosorbent assay (ELISA) test system for the detection of antibodies to Trypanosoma cruzi (T. cruzi). The draft guidance also notifies establishments that make donor eligibility determinations for HCT/P donors that FDA has determined T. cruzi to be a relevant communicable disease under current regulations. In addition, the guidance provides recommendations for using a licensed test for antibodies to T. cruzi to test individual human donors, including donors of Whole Blood and blood components for transfusion and HCT/P donors (living and cadaveric (non-heart beating)), for antibodies to T. cruzi in plasma and serum samples. The guidance document does not apply to Source Plasma.
Public Comment Session for Cancer Patients' CAM Information Needs Comment Period
In compliance with the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Public Comment on Tribal Consultation Sessions
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of one-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal governments operating Head Start (including Early Head Start) programs. The purpose of the Consultation Sessions is to discuss ways to better meet the needs of Indian, including Alaska Native, children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987
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 the reporting and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA) (Public Law 100- 293).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees for the Electro-Metallurgical Corporation Facility, Niagara Falls, NY, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Electro-Metallurgical Corporation facility, Niagara Falls, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees for the Baker Perkins Atomic Weapons Employer Facility in Saginaw, MI, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Baker Perkins Atomic Weapons Employer facility in Saginaw, Michigan, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
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