Department of Health and Human Services December 9, 2024 – Federal Register Recent Federal Regulation Documents
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Notice of Availability of Draft Health Center Program Scope Policy Manual Guidance
HRSA requests public comments on the Draft Health Center Program Scope of Project Manual (draft Scope Policy Manual). The draft Scope Policy Manual provides updated policy guidance on what constitutes the Health Center Program scope of project under the Public Health Service Act (PHS Act).
Proposed Information Collection Activity; Electronic Document Exchange (Office of Management and Budget #: 0970-0435)
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the Office of Management and Budget (OMB) to approve the Electronic Document Exchange (EDE), with minor revisions, for an additional three years. State child support agencies (CSAs) use the EDE to improve case processing. The current OMB approval expires on June 30, 2025.
Submission for Office of Management and Budget Review; Child Support Portal Registration (Office of Management and Budget #: 0970-0370)
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) approve the "Child Support Portal Registration," with minor revisions, for an additional three years. The OCSS Child Support Portal ("Portal") contains applications to help state child support agencies administer their programs. Authorized Portal users must register with OCSS to access Portal applications and provide OCSS with certain Portal application preferences. The current OMB approval expires on February 28, 2025.
Submission for Office of Management and Budget for Review and Approval; “State SNAP Agency NDNH Matching Program Performance Report” (Office of Management Budget #: 0970-0464)
OCSS is requesting the Office of Management and Budget (OMB) to approve the "State SNAP Agency NDNH Matching Program Performance Report," with minor revisions, for an additional three years. State agencies administering their Supplemental Nutrition Assistance Program (SNAP) provide the annual performance report to OCSS in accordance with the computer matching agreement between state SNAP agencies and OCSS. The current OMB approval expires on February 28, 2025.
Clinical Trials Registration and Results Information Submission
The Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), is amending its regulation governing clinical trials registration and results information submission to update throughout the regulation the internet web address or uniform resource locator (URL) of the site that provides information about formatting of information for submission, procedures, and tools as specified in the regulation.
Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments
This final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for, the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; updates to the Medicare Diabetes Prevention Program expanded model; payment for dental services inextricably linked to specific covered medical services; updates to drugs and biological products paid under Part B including immunosuppressive drugs and clotting factors; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or a Medicare Advantage Prescription Drug (MA-PD) plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to Clinical Laboratory Fee Schedule regulations; updates to the diabetes payment structure and PHE flexibilities; expansion of colorectal cancer screening and Hepatitis B vaccine coverage and payment; establishing payment for drugs covered as additional preventive services; Medicare Parts A and B Overpayment Provisions of the Affordable Care Act and Medicare Parts C and D Overpayment Provisions of the Affordable Care Act.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Extended-Release/Long-Acting Opioid Analgesic Postmarketing Requirement
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee (the Committees). The general function of the Committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Standardized Format for Electronic Submission of Marketing Application Content for the Planning of Bioresearch Monitoring Inspections for Center for Drug Evaluation and Research Submissions; Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of the guidance for industry entitled "Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions." This guidance describes the electronic submission of certain data and information in standardized formats. This information is used by the Center for Drug Evaluation and Research (CDER) in the planning of, and by FDA's Office of Inspections and Investigations (OII) in the conduct of, BIMO inspections.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; HRSA Ryan White HIV/AIDS Program Part F Regional AIDS Education and Training Center Program Activities
In compliance with the Paperwork Reduction Act of 1995, HRSA 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. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Supplemental Evidence and Data Request on Medical Care for Adults With Down Syndrome
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Medical Care for Adults with Down Syndrome, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a webcast on January 7, 2025. This virtual meeting will be open to the public.
Proposed Information Collection Activity; Request for Certification of Adult Victims of Human Trafficking
The Administration for Children and Families (ACF), Office on Trafficking in Persons (OTIP) is requesting a 3-year extension of the form: Request for Certification of Adult Victims of Human Trafficking (RFC) form (Office of Management and Budget (OMB) #: 0970-0454, expiration April 30, 2025).
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