Department of Health and Human Services February 28, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated February 2007. The guidance document assists establishments with making eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products. The guidance announced in this document finalizes the draft guidance, ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated May 2004. This guidance also finalizes the draft guidance, ``Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt- Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps),'' dated June 2002 (Docket No. 2002D-0266).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification
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.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Submission for OMB Review; Comment Request; Request for Genetic Studies in a Cohort of U.S. Radiologic Technologists
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 29, 2006, pages 78445-78446 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Draft Guidance for Industry on Advisory Committee Meetings: Preparation and Public Availability of Information Given to Advisory Committee Members; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Advisory Committee MeetingsPreparation and Public Availability of Information Given to Advisory Committee Members.'' This guidance is intended to provide information to industry sponsors, applicants, and petitioners on the development, preparation, or submission of briefing materials that will be given to advisory committee members as background information prior to open FDA advisory committee meetings. The guidance will help sponsors develop, organize, and submit advisory committee briefing materials for public release and should help minimize the time and resources spent in preparing these materials for public availability. The guidance also describes the process FDA intends to follow when we make briefing materials available to the public.
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