Department of Health and Human Services February 2005 – Federal Register Recent Federal Regulation Documents

National Institute of Mental Health; Amended Notice of Meeting
Document Number: 05-3881
Type: Notice
Date: 2005-02-28
Agency: Department of Health and Human Services, National Institutes of Health
Intramammary Dosage Forms; Ceftiofur
Document Number: 05-3834
Type: Rule
Date: 2005-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The NADA provides for the veterinary prescription use of ceftiofur hydrochloride suspension, by intramammary infusion, for the treatment of clinical mastitis in lactating dairy cattle.
Medical Devices; Medical Device Reporting; Companion to Direct Final Rule
Document Number: 05-3833
Type: Proposed Rule
Date: 2005-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is proposing to amend its regulation governing reporting of deaths, serious injuries, and certain malfunctions related to medical devices. We are revising the regulation into plain language to make the regulation easier to understand, and we are making technical corrections. Elsewhere in this issue of the Federal Register, we are publishing a direct final rule that is identical to this proposed rule. This proposed rule will provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule.
Government-Owned Inventions; Availability for Licensing
Document Number: 05-3832
Type: Notice
Date: 2005-02-28
Agency: Department of Health and Human Services, National Institutes of Health
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.
Government-Owned Inventions; Availability for Licensing
Document Number: 05-3830
Type: Notice
Date: 2005-02-28
Agency: Department of Health and Human Services, National Institutes of Health
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.
Medical Devices; Medical Device Reporting
Document Number: 05-3829
Type: Rule
Date: 2005-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending its regulation governing reporting of deaths, serious injuries, and certain malfunctions related to medical devices. We are revising the regulation into plain language to make the regulation easier to understand, and we are making technical corrections. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule.
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 05-3748
Type: Notice
Date: 2005-02-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 05-3742
Type: Notice
Date: 2005-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 05-3741
Type: Notice
Date: 2005-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-3712
Type: Notice
Date: 2005-02-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-3711
Type: Notice
Date: 2005-02-28
Agency: Office of the Secretary, Department of Health and Human Services
State Health Fraud Task Force Grants; Availability of Funds; Request for Applications; Correction
Document Number: 05-3710
Type: Notice
Date: 2005-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups
Document Number: 05-3752
Type: Notice
Date: 2005-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice invites nominations of members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). Seven vacancies will exist on the Panel as of March 31, 2005. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. The advice provided by the Panel will be considered as CMS prepares its annual updates of the hospital Outpatient Prospective Payment System (OPPS) through rulemaking. The panel was recently rechartered for a 2-year period through November 21, 2006. Nominations: Nominations will be considered if received no later than March 15, 2005 at 5 p.m. e.s.t. Mail or deliver nominations to the following address: CMS; Attn: Shirl Ackerman-Ross, Designated Federal Officer (DFO), Advisory Panel on APC Groups; Center for Medicare Management (CMM), Hospital & Ambulatory Policy Group (HAPG), Division of Outpatient Care (DOC); 7500 Security Boulevard, Mail Stop C4-05-17; Baltimore, MD 21244-1850. Web Site: For additional information on the APC Panel and updates to the Panel's activities, search our Web site at: http:// www.cms.hhs.gov/faca/apc/default.asp. Advisory Committees' Information Lines: You may also refer to the CMS Advisory Committee Information Hotlines at 1-877-449-5659 (toll- free) or 410-786-9379 (local) for additional information.
Medicare Program; Changes in Geographical Boundaries of Durable Medical Equipment Regional Service Areas
Document Number: 05-3729
Type: Notice
Date: 2005-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces changes to the geographical boundaries of the four Durable Medical Equipment (DME) service areas applicable to future awards of the Medicare Administrative Contracts (MACs). We identify which States and territories are assigned to each of the four DME service areas, and include the factors and criteria that we used to change the geographical boundaries.
Medicare Program; Durable Medical Equipment Regional Carrier Service Areas and Related Matters
Document Number: 05-3728
Type: Rule
Date: 2005-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule provides a mechanism for us to expeditiously make changes to the durable medical equipment regional carrier (DMERC) service area boundaries without notice and comment rulemaking. Through this mechanism, we can change the geographical boundaries served by the regional contractors that process durable medical equipment claims through issuance of a Federal Register notice and make other minor changes in the contract administration of the DMERCs. The mechanism provides a method for increasing or decreasing the number of DMERCs, changing the boundaries of DMERCs based on criteria other than the boundaries of the Common Working File sectors, and awarding new contractors to perform statistical analysis or maintain the national supplier clearinghouse. We will publish these changes and their justifications in a Federal Register notice, rather than through notice and comment rulemaking. Although we may change the number and configuration of regional carriers, we are not altering the criteria and factors that we use in awarding contracts. Through this final rule, we are improving the contracting process so that we can swiftly meet the challenges of the changing healthcare industry and address the changing needs of beneficiaries, suppliers, and the Medicare program.
Medicare Program; Procedures for Maintaining Code Lists in the Negotiated National Coverage Determinations for Clinical Diagnostic Laboratory Services
Document Number: 05-3727
Type: Notice
Date: 2005-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice finalizes the procedures proposed in the Federal Register on December 24, 2003 (68 FR 74607). It establishes the procedures for maintaining the lists of codes that were included in the national coverage determinations (NCDs) that were announced in an addendum to the final rule published in the Federal Register on November 23, 2001 (66 FR 58788). The final notice also sets forth the circumstances in which a laboratory is permitted to use the date a specimen was retrieved from storage for testing as the date of service instead of the date of collection.
Fiscal Year (FY) 2005 Funding Opportunity
Document Number: 05-3645
Type: Notice
Date: 2005-02-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $11,000,000 (total costs) for a one-year project period to the Florida Department of Children and Families. This is not a formal request for applications. Assistance will be provided only to the Florida Department of Children and Families based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: OA-05-002. Catalog of Federal Domestic Assistance (CFDA) Number: 93.003.
National Center for Health Statistics (NCHS), Board of Scientific Counselors
Document Number: 05-3643
Type: Notice
Date: 2005-02-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Domestic Violence Prevention Enhancement and Leadership Through Alliances (DELTA) Program
Document Number: 05-3633
Type: Notice
Date: 2005-02-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Part D Reinsurance Payment Demonstration
Document Number: 05-3621
Type: Notice
Date: 2005-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice informs interested Prescription Drug Plan (PDP) sponsors and Medicare Advantage (MA) organizations of an opportunity to participate in the Part D Reinsurance Payment Demonstration beginning in contract year 2006.
National Human Genome Research Institute Notice of Closed Meeting
Document Number: 05-3575
Type: Notice
Date: 2005-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs; Solicitation of Proposals for the Private, For-Profit Demonstration Project for the Program of All-Inclusive Care for the Elderly (PACE); Cancellation of Withdrawal
Document Number: 05-3553
Type: Notice
Date: 2005-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document cancels the withdrawal of the ``Notice for the Solicitation of Proposals for the Private, For-Profit Demonstration Project for the Program of All-Inclusive Care for the Elderly (PACE)'' published in the Federal Register on November 26, 2004. The November 26, 2004 notice was published in error, and we do not wish to withdraw the original notice of solicitation published on August 10, 2001. The solicitation notice solicited proposals from private, for- profit organizations for a fully-capitated joint Medicare and Medicaid demonstration. The goal of the solicitation notice was to determine whether the risk-based long-term care model employed by the nonprofit PACE could be replicated successfully by for-profit organizations.
Medicare Program; Meeting of the Advisory Panel on Medicare Education-March 22, 2005
Document Number: 05-3552
Type: Notice
Date: 2005-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) on March 22, 2005. The Panel advises and makes recommendations to the Secretary of the Department 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 meeting is open to the public. This meeting replaces the February 24, 2005 meeting that was canceled.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2004
Document Number: 05-3551
Type: Notice
Date: 2005-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2004 through December 2004, 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. Finally, this notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 05-3550
Type: Notice
Date: 2005-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Emergency Processing Under the Office of Management and Budget Review; Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice; Withdrawal
Document Number: 05-3596
Type: Notice
Date: 2005-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing a notice that published in the Federal Register on January 26, 2005 (70 FR 3712).
Implantation or Injectable Dosage Form New Animal Drugs; Euthanasia Solution
Document Number: 05-3595
Type: Rule
Date: 2005-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for use of an injectable solution of pentobarbital sodium and phenytoin sodium for humane, painless, and rapid euthanasia of dogs.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Radioactive Drug Research Committees
Document Number: 05-3594
Type: Notice
Date: 2005-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Radioactive Drug Research Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms; Availability
Document Number: 05-3593
Type: Notice
Date: 2005-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms'' dated February 2005. The draft document is intended to provide guidance to manufacturers using spore- forming microorganisms in the production of certain biological products. The draft guidance document provides recommendations to industry in response to changes made to the requirements for spore- forming microorganisms to allow greater flexibility in manufacturing.
Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability
Document Number: 05-3592
Type: Notice
Date: 2005-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps),'' dated November 2004. The guidance document provides medical device manufacturers with information about performing studies to support modifying the indication for use of communicable disease tests to include testing of cadaveric blood specimens to screen donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance document recommends a suggested protocol to modify the indication for use to include testing of cadaveric blood specimens.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 05-3577
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 05-3576
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 05-3574
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-3573
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 05-3572
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 05-3570
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 05-3569
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 05-3568
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-3567
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-3566
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institutes of Mental Health; Notice of Closed Meetings
Document Number: 05-3565
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism, Notice of Closed Meeting
Document Number: 05-3564
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 05-3563
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communications Disorders; Notice of Closed Meeting
Document Number: 05-3562
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 05-3561
Type: Notice
Date: 2005-02-24
Agency: National Institutes of Health, Department of Health and Human Services, Department of Health of Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 05-3557
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 05-3556
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-3546
Type: Notice
Date: 2005-02-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration