Department of Health and Human Services September 6, 2005 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B: Interpretation and Correction
This interim final rule clarifies our timeline for implementation of the competitive acquisition program under section 1847B of the Social Security Act and corrects technical errors that appeared in the addenda to the interim final rule with comment period published in the Federal Register on July 6, 2005 entitled ``Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B.''
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request the Office of Management and Budget (OMB) to reinstate the information collection project: ``AHRQ-HRSA Chemical, Biological, Radiological, Nuclear and Explosive (All Hazards) Preparedness Questionnaire for Healthcare Facilities for 2004 (CBRNE)''. In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(C)(2)(A), AHRQ invites the public to comment on this proposed information collection. AHRQ obtained a six-month emergency collection approval for the first wave of this information collection. This reinstatement of the previous clearance approval coves the second wave of the same survey. The respondents will be queried as to their progress in achieving the preparedness goals reported in the first wave.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M5 Data Elements and Standards for Drug Dictionaries.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes the data elements and standards that ICH recommends be made available to interested parties to assist in the development and maintenance of drug dictionaries. The draft guidance is intended to facilitate the exchange and practical use of medicinal product information at the international level, such as with postmarketing safety reporting.
Announcement of Availability of Funds for a Cooperative Agreement To Improve and Sustain the Leadership and Management Capacity and To Improve Operations and Delivery of Quality Health Care Within the Rabia Balkhi Women's Hospital
The Office of Global Health Affairs (OGHA) announces that an estimated $1.5 million in fiscal year (FY) 2005 funds are available for one (1) cooperative agreement to strengthen leadership, healthcare administration and facility management and to improve operations and improve health care delivery at Rabia Balkhi Women's Hospital (RBH) in Kabul, Afghanistan. This effort is a joint undertaking by the U.S. Department of Health and Human Services (HHS) and the Afghanistan Ministry of Public Health (MOPH). The goal of this project is to create equitable and high quality care at Rabia Balkhi Women's Hospital by developing effective leadership and management and improving operations. The funding will provide essential material resources within budgetary limitations for patient care, operations, facility management and for grant activities related to leadership and management development at RBH. A Memorandum of Understanding (MOU) between the grantee and the Afghan MOPH will detail the differentiated responsibilities of the awardee toward RBH and the conditions under which the MOPH will transfer operational and logistical authority and responsibility for management and operations of RBH to the awardee. Alongside this support, through a separate, ongoing cooperative agreement, HHS is currently providing support for staff development and continuing education at RBH, and the Department of Defense is providing approximately $1.4M in infrastructure upgrades. This new cooperative agreement is not anticipated to involve training of the clinical staff at RBH, but should include limited training and capacity-building of administrative or executive management staff. HHS, in partnership with other relevant United States Government (USG) agencies anticipates involvement in the development, administration and oversight of this hospital management improvement program. The program will be approved initially for a three-year period. It is estimated that approximately $1.5 million (including indirect costs) will be available in the first year. Funding for the cooperative agreement in subsequent years is contingent upon the availability of funds.
Determination That Penthrane (Methoxyflurane) Inhalation Liquid, 99.9 Percent, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that Penthrane (methoxyflurane) Inhalation Liquid, 99.9 percent, was withdrawn from sale for reasons of safety or effectiveness. The agency will not accept or approve abbreviated new drug applications (ANDAs) for methoxyflurane inhalation liquid, 99.9 percent.
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