Department of Health and Human Services February 14, 2006 – 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.
Proposed Collection; Comment Request, Fogarty International Center CareerTrac
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 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.
Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications,'' dated February 2006. The guidance is intended to provide sponsors with recommendations for the conduct of developmental toxicity studies for investigational preventive and therapeutic vaccines for infectious disease indications. The recommendations pertain to the assessment of the developmental toxicity potential of preventive and therapeutic vaccines for infectious diseases indicated for females of childbearing potential and pregnant individuals. This guidance document finalizes the draft guidance entitled ``Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications,'' dated August 2000.
Emerging Clostridial Disease; Public Workshop
The Food and Drug Administration (FDA), on behalf of the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID) are announcing a public workshop entitled ``Emerging Clostridial Disease.'' This public workshop is intended to develop a draft research agenda to better understand the virulence, pathogenesis, host factors, and nonantimicrobial risk factors contributing to reports of morbidity and mortality associated with Clostridium sordellii (C. sordellii) and Clostridium difficile (C. difficile). Additionally, our goals are to identify research needs and priorities that will enable rapid progress as well as to develop and provide recommendations for detecting cases and conducting surveillance of diseases and organisms. DATES: The public workshop will be held on May 11, 2006, from 8:30 a.m. to 4:30 p.m. See section III of this document for information on how to register to attend or present at the workshop. You must register by close of business on April 15, 2006, to attend or participate. We are opening a docket to receive your written or electronic comments (see ADDRESSES). Written or electronic comments must be submitted to the docket by June 15, 2006.
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