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

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.

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.

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.

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: https:// 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.

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.

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.

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.

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.

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.

The Food and Drug Administration (FDA) is withdrawing a notice that published in the Federal Register on January 26, 2005 (70 FR 3712).

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.

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.