Department of Health and Human Services September 9, 2009 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.'' FDA is issuing this draft guidance to inform industry and agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for in vitro diagnostic devices intended for the detection or detection and differentiation of human papillomaviruses.
Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA regulations entitled ``Environmental Impact Considerations.''
Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007.'' The document provides guidance to the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels
The Food and Drug Administration (FDA) is requesting nominations for voting and nonvoting consumer representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain devices panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH).
Request for Notification from Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives on Medical Device Advisory Committee Panels and Request for Nonvoting Industry Representatives on Medical Device Advisory Committee Panels
The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Pool of Nonvoting Industry Representatives for the Risk Communication Advisory Committee and Request for Nominations for Nonvoting Industry Representatives for the Risk Communication Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a pool of nonvoting industry representative candidates available to serve as temporary nonvoting members on its Risk Communication Advisory Committee (the Committee) for the Office of the Commissioner notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations for the pool will be accepted effective with this notice.
Privacy Act of 1974; Report of an Altered System of Records Medical Staff Credentials and Privileges Records
Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09-17-0003, ``Medical Staff Credentials and Privileges Records.'' The amended and altered system of records makes several administrative revisions which includes the deletion of the Social Security Numbers (SSNs) language to comply with the Office of Management and Budget (OMB) Memorandum (M)07- 16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information (May 22, 2007); and the HHS Directive Memorandum of October 6, 2008 to all Operating Division Heads to develop and execute a plan to eliminate the unnecessary collection and use of SSNs; and the inclusion of a new routine use to comply with OMB (M)07-16 and the HHS Memorandum dated September 19, 2007 to incorporate Notification of Breach Routine Use language; and the update of the Appendix 1 of the SOR.
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