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

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for WINLEVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for QULIPTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration's (FDA or the Agency) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TACK ENDOVASCULAR SYSTEM (4F, 1.5-4.5 MILLIMETERS (MM)) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Administration for Children and Families' (ACF) Office of Community Services (OCS) is requesting from OMB a three-year extension of the Social Services Block Grant (SSBG) Post-Expenditure Report, Pre- Expenditure Report, and Intended Use Plan (OMB #0970-0234). OCS is proposing to make minor editorial modifications to some column titles in the Pre- and Post-Expenditure Reports, for clarification.

OCSS eliminates the non-Federal share of program expenditures requirement for Tribal child support programs, including the 90/10 and 80/20 cost sharing rates. Based upon the experiences of and consultations with Tribes and Tribal organizations, we have determined that the non-Federal share requirement limits growth, causes disruptions, and creates instability.

This document corrects technical and typographical errors in the final rule that appeared in the November 16, 2023 issue of the Federal Register, entitled ``Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program'' (referred to hereafter as the ``CY 2024 PFS final rule''). The effective date was January 1, 2024.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to address the use of master files by applications licensed under the Public Health Service Act (PHS Act). This final rule codifies FDA's existing approach that former approved applications for certain biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that have been deemed to be licenses for the biological products under the PHS Act may continue to incorporate by reference drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information contained in a drug master file (DMF) if such information was being referenced at the time the application was deemed to be a license. This final rule also codifies FDA's general practices regarding the referencing of information in master files by applications licensed under the PHS Act, including applications for combination products licensed under the PHS Act, and by investigational new drug applications (INDs) for products that would be subject to licensure under the PHS Act.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer's Goods from DWPE.'' The draft guidance, when finalized, will provide recommendations for collecting a representative sample for products subject to DWPE under an import alert due to the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition. When finalized, the draft guidance will also help foreign manufacturers and other processors of fish and fishery products subject to DWPE introduce evidence to FDA to support a request to have products removed from DWPE.

The Department of Health and Human Services (HHS) is issuing a final rule establishing standards and procedures by which it may require acceptance and priority performance of certain contracts or orders to promote the national defense over other contracts or orders with respect to health resources. This final rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense. This rule finalizes the regulations as proposed in the Notice of Proposed Rule Making (NPRM) of August 16, 2023, with minor technical edits based on comments received.

This document corrects technical and typographical errors in the final rule with comment period that appeared in the Federal Register on November 22, 2023, titled ``Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction'' (referred to hereafter as the ``CY 2024 OPPS/ASC final rule with comment period'').