Department of Health and Human Services August 29, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Meeting of the President's Council on Sports, Fitness, and Nutrition
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Sports, Fitness, and Nutrition (PCSFN) will hold its annual meeting. The meeting will be open to the public.
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products.'' This guidance provides recommendations to industry about using placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products to treat hematologic malignancies and oncologic diseases regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance entitled ``Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development'' issued August 24, 2018.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Dronabinol (delta-9 tetrahydrocannabinol) and Its Stereoisomers; Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical Preparations of Cannabis; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled ``International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Dronabinol (delta-9 tetrahydrocannabinol) and its Stereoisomers; Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical Preparations of Cannabis'' that appeared in the Federal Register of March 1, 2019. The Agency is taking this action to allow interested persons additional time to submit comments.
Horizontal Approaches to Food Standards of Identity Modernization; Public Meeting; Request for Comments
The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``Horizontal Approaches to Food Standards of Identity Modernization.'' The purpose of the public meeting is to give interested persons an opportunity to discuss FDA's effort to modernize food standards of identity (SOI) and provide information about changes we could make to existing SOI, particularly changes that could be made across categories of standardized foods (i.e., horizontal changes), to provide flexibility for the development of healthier foods. We are also interested in discussing horizontal changes that would better facilitate innovation. This effort is part of the FDA's comprehensive, multiyear Nutrition Innovation Strategy (NIS) designed to improve healthy dietary behavior and help reduce preventable death and disease related to poor nutrition by, among other things, providing incentives for food manufacturers to produce products that have more healthful attributes.
Proposed Update of the CDC's 2006 Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is seeking public comment for updating the following guideline: Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings (2006). The purpose of this notice is to solicit feedback on best approaches on HIV screening in clinical settings and prompt linkage to treatment and care. CDC will update this guideline to ensure that HIV testing providers, public health agencies, and other stakeholders have access to up-to-date and consistent information about new evidence, current approaches, and resources for HIV testing in clinical settings.
Prospective Grant of an Exclusive Patent License: Genetically-Modified Lymphocytes for Cancer Therapy
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Intima Bioscience, Inc. (``Intima''), headquartered in New York, NY.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Information Collection Request Title: Forms for Use With Applications to the Maternal and Child Health Bureau Research and Training Grants, New
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
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