Department of Health and Human Services October 9, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Determination of Regulatory Review Period for Purposes of Patent Extension; ENTEREG; U.S. Patent Nos. 5,250,542 and 5,434,171
The Food and Drug Administration (FDA) has determined the regulatory review period for ENTEREG and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
Draft Guidance for Industry and Food and Drug Administration Staff; the Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 13.'' This document is intended to provide guidance to mammography facilities and their personnel. It represents FDA's current thinking on the final regulations implementing the Mammography Quality Standards Act of 1992 (MQSA). This guidance document updates previous guidance. This draft guidance is not final nor is it in effect at this time.
Medical Devices; Immunology and Microbiology Devices; Classification of Respiratory Viral Panel Multiplex Nucleic Acid Assay
The Food and Drug Administration (FDA) is announcing the classification of the respiratory viral panel multiplex nucleic acid assay into class II (special controls). The special controls that will apply to the device are three guidance documents entitled: ``Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay,'' as applicable, ``Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays,'' and as applicable,``Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.'' The agency classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance documents that will serve as the special controls for this device.
Guidances for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Documents: Respiratory Viral Panel Multiplex Nucleic Acid Assay; and Testing for Human Metapneumovirus Using Nucleic Acid Assays; and Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays; Availability
The Food and Drug Administration (FDA) is announcing the availability of the special controls guidance document entitled ``Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay,'' and two companion special controls guidance documents entitled ``Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays'' and ``Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.'' These guidance documents describe a means by which respiratory viral panel multiplex nucleic acid assays may comply with the requirement of special controls for class II devices. The guidance documents include recommendations for performance
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
Section 931 of the Public Health Service Act (PHS Act), 42 U.S.C. 299c, established a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.
Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (0MB) approve the proposed information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component through 2012.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
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