Department of Health and Human Services May 27, 2010 – Federal Register Recent Federal Regulation Documents
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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.
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.
Proposed Collection; Comment Request; Assessing the Long-Term Impacts of the John E. Fogarty International Center's Research and Training Programs
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 John E. Fogarty International Center, 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.
Office of Child Support Enforcement; Privacy Act of 1974; Computer Matching Agreement
In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Temporary Assistance for Needy Families (TANF) program.
Total Inward Leakage Requirements for Respirators
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), will hold a second public meeting concerning the proposed rule for Total Inward Leakage Requirements for Respirators that was published in the Federal Register on Friday, October 30, 2009 (74 FR 56141). The purpose of the meeting is to allow participants to make presentations to NIOSH, share results of any new research that may be available or in process in the area of filtering facepiece or other half-mask respirator inward leakage measurement, and offer any additional comments on the anticipated economic impact of the proposed rule.
Food Labeling Workshop; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with the University of Arkansas (UA), is announcing a public workshop entitled ``Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups.
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated May 2010. The guidance announced in this notice provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive FDA recommendations intended to minimize the possible risk of transmission of CJD and vCJD from blood and blood products. This guidance document amends the January 2002 guidance document of the same title by: Incorporating donor deferral recommendations for donors who have received a transfusion of blood or blood components in France since 1980, providing updated scientific information on CJD and vCJD, revising labeling recommendations for Whole Blood and blood components intended for transfusion, and recognizing AABB's full Donor History Questionnaire Version 1.3 as an acceptable mechanism for collection of donor history information. The guidance announced in this notice supersedes the guidance document entitled ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated January 2002 (2002 guidance), and the draft guidance document entitled ``Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products''' dated August 2006 (2006 draft guidance).
Tobacco Product Advertising and Promotion to Youth and Racial and Ethnic Minority Populations; Request for Comments
The Food and Drug Administration (FDA) is soliciting information, research, and ideas to assist FDA in fulfilling its responsibilities regarding tobacco product advertising and promotion that is designed to appeal to specific racial and ethnic minority populations in the United States. For the same reasons, we are also interested in receiving information about the advertising and promotion of menthol and other cigarettes to youth in general, and to youth in minority communities. After reviewing the submitted information, research, and ideas, FDA will be better able to fulfill its responsibilities under The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
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