Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) has determined that QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5 mg and 15 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Brendon Gagne for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Gagne was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. Gagne's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Gagne was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of January 5, 2024 (30 days after receipt of the notice), Mr. Gagne had not responded. Mr. Gagne's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled 2025 and 2027 National Youth Risk Behavior Survey (YRBS). CDC is requesting a three-year approval to reinstate, with changes, the data collection for the national YRBS, a biennially school-based survey of high school students in the United States. This project includes a validation study that will inform the development of questions for the 2027 YRBS questionnaire.

This document corrects technical and typographical errors in the final rule entitled, ``Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing'' that was published in the Federal Register on January 9, 2024, and has a stated effective of February 8, 2024.

The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2024. This notice is issued under the Controlled Substances Act (CSA).

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award(s) of approximately $8,000,000 for Year 1 funding to MOHSS, $4,000,000 for Year 1 funding to Rwanda Biomedical Center, $3,000,000 for Year 1 funding to South African Medical Research Council, $3,000,000 for Year 1 funding to SANAC, $500,000 for Year 1 funding to TACAIDS, $500,000 for Year 1 funding to PO-RALG, and $6,000,000 for Year 1 funding to VAAC. The(se) award(s) will strengthen comprehensive and integrated service delivery for prevention, implement strategies and activities that strengthen local entities, support the coordination, management, and monitoring of multi-sectoral implementation, foster the government's capacity to provide comprehensive management of the HIV program, and implement a sustainable and quality-assured HIV diagnostic, testing, and health information management program in Namibia, Rwanda, South Africa, Tanzania, and Vietnam. Funding amounts for years 2-5 will be set at continuation.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $100,000, with an expected total funding of approximately $500,000 over a 5-year period, to International Panel Physicians Association Inc. The award will secure the services of IPPA to facilitate communication and training on the technical instructions that govern the pre-departure health assessment and treatment of U.S.- bound immigrants and refugees.

This proposed notice acknowledges the receipt of a deeming application from DNV Healthcare USA Inc. (DNV) for continued Centers for Medicare & Medicaid Services (CMS) approval of its psychiatric hospital accreditation program. The statute requires that within 60 days of receipt of an organization's complete application, CMS must publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.