Department of Health and Human Services April 11, 2024 – Federal Register Recent Federal Regulation Documents
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Notice of Availability of Draft Health Center Program Policy Guidance Regarding Services To Support Transitions in Care for Justice-Involved Individuals Reentering the Community
HRSA is inviting public comment on the draft Health Center Program Policy Guidance Regarding Services to Support Transitions in Care for Justice-Involved Individuals Reentering the Community. The purpose of the draft Policy Information Notice (PIN) is to propose Health Center Program policy guidance for all health centers that apply for and receive federal award funds under the Health Center Program, as authorized by section 330 of the Public Health Service (PHS) Act (including sections 330(e), (g), (h), and (i)), as well as section 330 subrecipient organizations and Health Center Program look-alikes, to clarify the conditions under which they may provide certain health services as part of the Health Center Program scope of project to certain incarcerated/detained individuals. This draft PIN establishes policy guidance that identifies a set of health services that a health center may provide, the locations at which such services may be provided, the target population for such services (specifically, incarcerated/detained individuals who are scheduled for release from a carceral setting within 90 days), and other pertinent circumstances under which the health center may, on its own behalf and subject to all section 330 requirements, provide such services to justice-involved individuals reentering the community to support their care transition from the carceral setting to the community within the scope of their Health Center Program project.
Privacy Act of 1974; System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the Administration for Children and Families (ACF), Office of Child Support Services (OCSS): System No. 09-80-0381, "OCSS National Directory of New Hires, HHS/ACF/OCSS."
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Announcement of the Fifth Meeting of the 2025 Dietary Guidelines Advisory Committee
The Departments of Health and Human Services and Agriculture announce the fifth meeting of the 2025 Dietary Guidelines Advisory Committee (Committee). This meeting will be open to the public virtually.
Determination That VISTARIL (Hydroxyzine Pamoate) Oral Suspension, 25 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 mg/5 mL, if all other legal and regulatory requirements are met.
Determination That KEMSTRO (Baclofen) Orally Disintegrating Tablets, 10 Milligrams and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that KEMSTRO (baclofen) orally disintegrating tablets, 10 milligrams (mg) and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for baclofen orally disintegrating tablets, 10 mg and 20 mg, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Requirements: Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; DUVYZAT (givinostat)
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that DUVYZAT (givinostat), approved on March 21, 2024, manufactured by Italfarmaco S.p.A., meets the criteria for a priority review voucher.
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