The Department of Health and Human Services (HHS) was created as the Department of Health, Education, and Welfare on April 11, 1953 (5 U.S.C. app.).
HHS is the Cabinet-level department of the Federal executive branch most involved with the Nation's human concerns. In one way or another, it touches the lives of more Americans than any other Federal agency. It is a department of people serving people, from newborn infants to persons requiring health services to our most elderly citizens.
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This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial...
Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers
This final rule establishes national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to plan adequately for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It will also assist providers and suppliers to...
This action removes the outmoded regulations for the Smallpox Vaccine Injury Compensation Program. The program and its implementing regulation have been rendered obsolete by the expiration of the Declaration Regarding Administration of Smallpox Countermeasures under the Smallpox Emergency Personnel Protection Act of 2003 and incorporation of the...
This final rule modernizes the Head Start Program Performance Standards, last revised in 1998. In the Improving Head Start for School Readiness Act of 2007, Congress instructed the Office of Head Start to update its performance standards and to ensure any such revisions to the standards do not eliminate or reduce quality, scope, or types of...
Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective...
Prospective Grant of Start-Up Exclusive Evaluation Patent License: Development of Autologous Tumor-reactive T Cells Isolated From Peripheral Blood for the Treatment of Metastatic Follicular Thyroid Cancer and Metastatic Soft Tissue Sarcomas
The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-up Exclusive Evaluation Patent License to MedGene Therapeutics, Inc. (``MedGene'') located in Bethesda, MD to practice the inventions embodied in the patent applications listed Supplementary Information...
Prospective Grant of Exclusive Patent License: Development of Adeno-Associated Virus-Based Vectors for the Treatment of Menkes Disease and Related Copper Transport Disorders
The Eunice Kennedy Shriver National Institute of Child Health and Human Development, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the...
The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork...