Department of Health and Human Services November 9, 2009 – Federal Register Recent Federal Regulation Documents
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Office of Assistant Secretary for Administration and Management and Office of the Assistant Secretary for Resources and Technology; Statement of Organization, Functions, and Delegations of Authority
The Department of Health and Human Services (HHS) is reorganizing a portion of two offices, the Office of the Assistant Secretary for Resources and Technology (ASRT) and the Office of the Assistant Secretary for Administration and Management (ASAM), both of which are located within the Office of the Secretary (OS). The reorganization is designed to increase the efficiency and effectiveness of these two offices by consolidating the resource-related functions, including budget, grants, acquisition, finance, and the American Recovery and Reinvestment Act (Recovery Act) coordination, under ASRT and the administrative functions under ASAM. The titles of the Assistant Secretary for Resources and Technology (ASRT) and the Assistant Secretary for Administration and Management (ASAM) will also be changed to the Assistant Secretary for Financial Resources (ASFR) and Assistant Secretary for Administration (ASA), respectively. This reorganization also will transfer support for the Office of Small & Disadvantaged Business Utilization (OSDBU) from ASAM to ASRT, while maintaining the Office's same direct-line reporting structure to the Deputy Secretary. Finally, this reorganization will transfer direct- line reporting of the Office of the Chief Information Office from ASRT to the Deputy Secretary while moving day-to-day support for OCIO from ASRT to ASA.
Prospective Granting of an Exclusive License
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS), is contemplating the granting of an exclusive worldwide license to practice the invention embodied in the patent application referred to below to International Rollforms, Inc., having a place of business in Deptford, New Jersey. CDC intends to grant rights to practice this invention to no other licensees. The patent rights in this invention have been assigned to the government of the United States of America. The patent to be licensed is:
Proposed Collection; Comment Request; Clinical Trials Reporting Program (CTRP) Database (NCI)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion,'' dated November 2009. This guidance is intended for establishments that collect Whole Blood and blood components intended for transfusion. The document provides recommendations for testing of donations of Whole Blood and blood components for West Nile Virus (WNV) using an FDA-licensed donor screening assay. FDA believes that the use of a licensed nucleic acid test (NAT) will reduce the risk of transmission of WNV, and therefore recommends use of a licensed NAT to screen donors of Whole Blood and blood components intended for transfusion. The guidance announced in this notice finalizes the recommendations as to Whole Blood and blood components contained in the draft guidance ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated April 2008. The recommendations as to HCT/P donor specimens contained in the draft guidance are not being finalized at this time because FDA believes additional public discussion is warranted.
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