Department of Health and Human Services October 6, 2005 – Federal Register Recent Federal Regulation Documents
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Substances Prohibited From Use in Animal Food or Feed
The Food and Drug Administration (FDA) is proposing to amend 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 brains and spinal cords from cattle 30 months of age and older, the brains and spinal cords from cattle of any age not inspected and passed for human consumption, the entire carcass of cattle not inspected and passed for human consumption if the brains and spinal cords have not been removed, tallow that is derived from the materials prohibited by this proposed rule that contains more than 0.15 percent insoluble impurities, and mechanically separated beef that is derived from the materials prohibited by this proposed rule. These measures will further strengthen existing safeguards designed to help prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle.
The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers; Public Workshop
The Food and Drug Administration (FDA) Philadelphia District, in cooperation with AdvaMed's Medical Technology Learning Institute, is announcing a public workshop on FDA device regulations. This 1 1/2-day public workshop for start up and small device manufacturers and their suppliers will include both industry and FDA perspectives and a question and answer period. Date and Time: The public workshop will be held on Tuesday, October 11, 2005, from 8:30 a.m. to 5:30 p.m. and Wednesday, October 12, 2005, from 8:30 a.m. to 12 noon. Location: The public workshop will be held at The Wyndham Philadelphia at Franklin Plaza, 17th and Race St., Philadelphia, PA 19103, 215-448-2000. For further hotel information and driving directions, go to https://www.wyndham.com/hotels/PHLFP. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Contact: For FDA: Judy Summers-Gates, Food and Drug Administration, rm. 900, U.S. Customhouse, 200 Chestnut St., Philadelphia, PA 19106, 215-717- 3008, FAX: 215-597-4660, e-mail: judith.summers-gates@fda.gov. For AdvaMed: Krystine McGrath, 202-434-7237, FAX: 202-783-8750, kmcgrath@advamed.org; or Dia Black, 202-434-7231, FAX: 202-783-8750, e- mail: dblack@avamed.org. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number), and the registration fee of $350 per person to the AdvaMed contacts (see Contact). The registration fee for FDA employees is waived. To register via the Internet go to https://www.advamed.org/philadelphia. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Payment forms accepted are major credit card (MasterCard, Visa, or American Express) or company check. If you wish to pay by check contact Krystine McGrath (see Contact). For more information on the meeting, or for questions on registration, contact Krystine McGrath or Dia Black (see Contact). Attendees are responsible for their own accommodations. The registration fee will be used to offset the expenses of hosting the workshop, including meals (breakfasts and a lunch), refreshments, meeting rooms, and training materials. It also includes a networking reception on Tuesday, October 11, 2005. Space is limited, therefore interested parties are encouraged to register early. There will be no onsite registration. If you need special accommodations due to a disability, please contact Judy Summers-Gates at least 7 days in advance of the workshop.
Draft Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Functional Indications for Implantable Cardioverter Defibrillators.'' Many implantable cardioverter defibrillators (ICDs) currently have a functional indication. This draft guidance is designed to describe ICD functional indications and the types of devices appropriate for the indication; to provide guidance regarding labeling, advertising, and promotion of ICDs with an approved functional indication and cardiac resynchronization therapy defibrillators (CRT/ICDs) with an approved indication that describes the function of the ICD component; and to discuss when to submit an application for an investigational device exemption (IDE) for a study involving a potential new patient population for an ICD with an approved functional indication.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled ``Medicare Care Management Performance Demonstration (MCMP),'' System No. 09-70-0562. MCMP demonstration tests a payment methodology for physician practices that combines Medicare fee-for-service payments with performance-based payments for improvements in information technology systems, patient education, care management, and quality of care. Improvements in these areas are expected to generate savings to the Medicare program to offset the costs of the performance payments. Mandated by Section 649 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), the MCMP Demonstration seeks to provide incentives for physicians to adopt and integrate information technology systems into their practices, and to improve quality as defined by key measurable outcomes. The primary purpose of the system is to establish a pay-for- performance three year pilot with physicians to promote the adoption and use of health information technology to improve the quality of patient care for chronically ill Medicare patients. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain health benefits programs. We have provided background information about the new system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Privacy Act of 1974; Deletion of System of Records
CMS proposes to delete 14 systems of records from its inventory subject to the Privacy Act of 1974 (Title 5 United States Code 552a).
Privacy Act of 1974; Report of New System of Records
In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to establish a new system of records (SOR) titled ``Medicare Drug Data Processing System (DDPS),'' System No. 09- 70-0553. On December 8, 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173). MMA amends the Social Security Act (the Act) by adding the Medicare Part D Program under Title XVIII and mandate that CMS establish a voluntary Medicare prescription drug benefit program effective January 1, 2006. Under the new Medicare Part D benefit, the Act allows Medicare payment to plans that contract with CMS to provide qualified Part D prescription drug coverage as described in 42 Code of Federal Regulations (CFR) Sec. 423.401. As a condition of payment, all Part D plans must submit data and information necessary for CMS to carry out payment provisions (Sec. 1860D-15(c)(1)(C) and (d)(2) of the Act, and 42 CFR 423.322). The primary purpose of this system is to collect, maintain, and process information on all Medicare covered and non-covered drug events, including non-Medicare drug events, for Medicare beneficiaries participating in the Part D voluntary prescription drug coverage under the Medicare program. The system will process drug event transactions and other drug events as necessary for CMS to help determine appropriate payment of covered drugs. The DDPS will consist of the transaction validation processing, storing and maintaining the drug event data in a large-scale database, and staging the data into data marts to support beneficiary and plan analysis of incurred payment. Information in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist Quality Improvement Organizations; (3) assist Part D prescription drug plans; (4) support an individual or organization for a research, evaluation or epidemiological project; (5) support constituent requests made to a congressional representative; (6) support litigation involving the agency; and (7) combat fraud and abuse in certain health benefits programs. We have provided background information about the new system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled ``Medicare Physician Group Practice Demonstration (PGPD),'' System No. 09-70-0559. The PGPD tests a payment methodology for physician practices that combines Medicare fee-for-service payments with performance-based payments for improvements in patient management and quality of care. Improvements in these areas are expected to generate savings to the Medicare program to offset the costs of the performance payments. Mandated by Section 412 of the Benefits Improvement & Protection Act of 2000, the PGPD seeks to provide incentives for physicians to adopt care management strategies and to improve quality as defined by key measurable processes and outcomes. The primary purpose of the system is to establish a pay-for- performance three year pilot with physicians to encourage the coordination of care, promote investment in administrative structure and process, and reward physicians for improving health care processes and outcomes. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain health benefits programs. We have provided background information about the new system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.
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