Department of Health and Human Services March 4, 2005 – Federal Register Recent Federal Regulation Documents

Medicare Program; Meeting of the Advisory Panel on Medicare Education-March 22, 2005: Location Change
Document Number: 05-4272
Type: Notice
Date: 2005-03-04
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 notice replaces the meeting notice published on February 25, 2005 (70 FR 9362) due to a change in the meeting location.
Enhancing Healthcare Provider's Ability To Prevent Sexual Violence
Document Number: 05-4247
Type: Notice
Date: 2005-03-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-4242
Type: Notice
Date: 2005-03-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity; Comment Request Proposed Projects
Document Number: 05-4236
Type: Notice
Date: 2005-03-04
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Advisory Committee on Organ Transplantation; Request for Nominations for Voting Members
Document Number: 05-4223
Type: Notice
Date: 2005-03-04
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill up to 13 vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR Part 121) and, in accordance with Pub. L. 92- 463, was chartered on September 1, 2000.
Revised Compliance Policy Guide Regarding Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability
Document Number: 05-4218
Type: Notice
Date: 2005-03-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of draft revisions to Compliance Policy Guide (CPG) Sec. 110.310 entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides written guidance to FDA and Customs and Border Protection (CBP) staff on enforcement of section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulations, which require prior notice for food imported or offered for import into the United States. The CPG has been revised to provide additional guidance to FDA and CBP staff regarding specific situations covering routine shipments of food that are transported through the United States, arriving from and exiting to the same country, and regarding the Harmonized Tariff Schedule (HTS) code that is part of the planned shipment information.
Risk Assessment of the Public Health Impact from Foodborne Listeria Monocytogenes in Smoked Finfish; and Evaluation of Food Code Provisions That Address Preventive Controls for Listeria Monocytogenes in Retail and Foodservice Establishments; Request for Comments and for Scientific Data and Information
Document Number: 05-4217
Type: Notice
Date: 2005-03-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting comments and scientific data and information that would assist the agency in its plans to conduct a risk assessment for Listeria monocytogenes in smoked finfish (smoked finfish risk assessment), and evaluate the provisions of the 2001 Food Code that address preventive controls for L. monocytogenes in retail and foodservice establishments. The purpose of the smoked finfish risk assessment is to ascertain the impact on public health from the reduction and/or prevention of L. monocytogenes growth and recontamination during the manufacturing and/or processing of hot- and cold-smoked finfish. The smoked finfish risk assessment and the evaluation of the Food Code provisions for preventive controls for L. monocytogenes in retail and foodservice establishments support the agency's commitment to the Listeria Action Plan (revised 2003) that FDA and the Centers for Disease Control and Prevention (CDC) developed to reduce L. monocytogenes illnesses associated with the consumption of ready-to-eat (RTE) foods.
Contract Review Meeting
Document Number: 05-4180
Type: Notice
Date: 2005-03-04
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Notice of Meeting; Interagency Autism Coordinating Committee
Document Number: 05-4171
Type: Notice
Date: 2005-03-04
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-4167
Type: Notice
Date: 2005-03-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Medical Devices; Device Tracking
Document Number: 05-4161
Type: Notice
Date: 2005-03-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys
Document Number: 05-4160
Type: Notice
Date: 2005-03-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reports of Corrections and Removals
Document Number: 05-4159
Type: Notice
Date: 2005-03-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications
Document Number: 05-4158
Type: Notice
Date: 2005-03-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of 76 new drug applications (NDAs) and 60 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B
Document Number: 05-3992
Type: Proposed Rule
Date: 2005-03-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement provisions of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 that require the implementation of a competitive acquisition program for certain Medicare Part B drugs not paid on a cost or prospective payment system basis. Beginning January 1, 2006, physicians will generally be given a choice between obtaining these drugs from vendors selected through a competitive bidding process or directly purchasing these drugs and being paid under the average sales price system. We are seeking comments on which of the proposed approaches we should use to implement the competitive acquisition program as well as the criteria and standards that should be applied in the selection and enrollment of vendors.