Department of Health and Human Services March 28, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
General Considerations for Animal Studies Intended To Evaluate Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``General Considerations for Animal Studies Intended to Evaluate Medical Devices.'' FDA developed this guidance document to assist medical device sponsors, testing facilities, and other persons involved in designing, conducting, and reporting the results of animal studies intended to assess the safety of medical devices to support premarket submissions. These animal studies typically provide initial evidence of device safety, which may include device performance and handling, and the biological effects when used in a living system.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Members
The National Advisory Council for Healthcare Research and Quality (the Council) advises the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) with respect to activities proposed or undertaken to carry out AHRQ's statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and works within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven new members will be appointed to replace seven current members whose terms will expire in November 2023.
OWH Observance Champions; Correction
The Office of the Assistant Secretary for Health published a document in the Federal Register of September 14, 2022, inviting public and private sector organizations to apply to become a Women's Health Champion. The document includes contact information for a staff member who is no longer working in the Office on Women's Health.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Metarrestin and Its Analogs for the Treatment of Metastatic Cancers
The National Center for Advancing Translational Sciences, 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 Oncala Bio Inc. (``Oncala Bio''), headquartered in Bend, OR.
Advisory Committee on Breast Cancer in Young Women; Meeting
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Advisory Committee on Breast Cancer in Young Women (ACBCYW). This meeting is open to the public, limited only by audio and web conference lines (150 web conference participant spaces available). Online registration is required.
Yogurt Products Deviating From Standard of Identity; Temporary Permit for Market Testing
The Food and Drug Administration (FDA or we) is announcing that we have issued a temporary permit to Chobani, LLC (the applicant) to market test lower fat yogurt products deviating from the general definition and standard of identity for yogurt with modified milkfat and fat-containing flavoring ingredients, and yogurt deviating from the yogurt standard of identity by using ultrafiltered nonfat milk as a basic dairy ingredient. The temporary permit will allow the applicant to evaluate commercial viability of the products and to collect data on consumer acceptance of the products.
Soft (Hydrophilic) Daily Wear Contact Lenses-Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Soft (Hydrophilic) Daily Wear Contact LensesPerformance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidance identified in this notice was developed in accordance with the final guidance entitled ``Safety and Performance Based Pathway.''
Statement of Organization, Functions, and Delegations of Authority
The Centers for Medicare and Medicaid Services, Center for Medicare, Office of Minority Health has modified its organizational structure.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on April 24, 2023. The topic for this meeting will be ``Type 1 Diabetes (T1D): Evolving Concepts in the Pathophysiology, Screening and Prevention''. The meeting is open to the public.
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