Department of Health and Human Services September 23, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
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 Comment Request for Review of ACF Disaster Case Management Implementation Guide; Office of Human Services Emergency Preparedness and Response
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces that the Administration for Children and Families (ACF), Office of Human Services Emergency Preparedness and Response (OHSEPR) intends to submit to notice in the Federal Register for comments on the ACF Disaster Case Management Implementation Guide, dated December 10, 2008.
Current Good Manufacturing Practice Requirements for Combination Products
The Food and Drug Administration (FDA or agency) proposes to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for ``single-entity'' and ``co-packaged'' combination products.
Availability of Grant Funds for the Support of Cooperative Agreement Award to Georgetown University Entitled: Genome Wide Methylation Arrays for Detecting Markers of Increased Susceptibility to Mammary Cancer Caused by In-Utero Exposures to Endocrine Disruptors (U01)
The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and Office of New Animal Drugs (ONADE) is announcing the availability of grant funds for the support of a sole source, cooperative agreement award to Georgetown University, Lombardi Cancer Research Center and Department of Oncology entitled: ``Genome Wide Methylation Arrays for Detection Markers of Increased Susceptibility to Mammary Cancer Caused by In-Utero Exposures to Endocrine Disruptors (U01).'' The main purpose of this study is to help gain an understanding of the extent to which exposures to endocrine disruptors early in life increase later susceptibility to developing breast cancer by inducing heritable epigenetic changes in transcription factors, which are linked to increased breast cancer risk. The study is subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331, et seq.) regulations issued under it and applicable Department of Health and Human Services statutes and regulations.
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