Department of Health and Human Services April 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing a request for information and comments on the development of an FDA Data and Technology Strategic Plan. As part of our User Fee Program commitments and Omnibus Bill requirements, FDA will develop and publish an FDA Data and Technology Strategic Plan by September 30, 2023. This plan will define and shape the future course of FDA's data and technology capabilities, building on the existing FDA Modernization Framework. The plan will also integrate Agency and center strategies.

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group (IRG) Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.

This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, passive enrollment, network adequacy, and other programmatic areas. This final rule will also codify regulations implementing section 118 of Division CC of the Consolidated Appropriations Act, 2021, section 11404 of the Inflation Reduction Act, and includes provisions that will codify existing sub-regulatory guidance in the Part C, Part D, and PACE programs.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``A Risk- Based Approach to Monitoring of Clinical InvestigationsQuestions and Answers.'' This guidance provides information on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combination products. The guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry entitled ``Oversight of Clinical InvestigationsA Risk-Based Approach to Monitoring'' (August 2013) by providing additional information to facilitate sponsors' implementation of risk-based monitoring. This guidance finalizes the draft guidance entitled ``A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers,'' issued on March 15, 2019.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection activity associated with statutory and regulatory food labeling requirements.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or view the meeting remotely by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is requested for attending in person and required for viewing the webcast and presenting oral statements. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/ iccvamforum-2023.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will discuss the Biologics License Application (BLA) 125781 from Sarepta Therapeutics, Inc. for delandistrogene moxeparvovec with the requested indication for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Office of Child Care (OCC), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the CCDF Consumer Education website and Reports of Serious Incidents and Death (Office of Management and Budget (OMB) #: 0970-0473, expiration date: April 30, 2023). There are no changes requested to the reporting requirements.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on controlled correspondence related to generic drug development.

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 Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will discuss the biologics license application (BLA) 125768 from Pfizer, Inc. for ABRYSVO (Respiratory Syncytial Virus Vaccine) with the requested indication for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age by active immunization of pregnant individuals. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

In compliance with of 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.

The Food and Drug Administration (FDA or we) is proposing to amend our standard of identity (SOI) regulations that specify salt (sodium chloride) as a required or optional ingredient to permit the use of salt substitutes in standardized foods, to reduce the sodium content. Reducing sodium may help reduce the risk of hypertension, a leading cause of heart disease and stroke. The proposed rule, if finalized, would help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized foods lower in sodium while maintaining the basic nature and essential characteristics of the foods.

The Substance Abuse and Mental Health Services Administration published a document in the Federal Register of April 5, 2023, announcing the meeting of the SAMHSA Center for Substance Abuse Prevention National Advisory Council (CSAP NAC) of April 25, 2023. The document contained incorrect date in the Dates section.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with our imports program.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.

This proposed rule would update payment rates, including implementing the second phase of the Patient Driven Payment Model (PDPM) parity adjustment recalibration. This proposed rule also proposes updates to the diagnosis code mappings used under PDPM, the SNF Quality Reporting Program (QRP), and the SNF Value-Based Purchasing (VBP) Program. We are also proposing to eliminate the requirement for facilities to actively waive their right to a hearing in writing, instead treating the failure to submit a timely request for a hearing as a constructive waiver.