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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Labeling for Biosimilar and Interchangeable Biosimilar Products.'' This draft guidance is intended to help applicants develop draft labeling for proposed biosimilar and interchangeable biosimilar products. The recommendations for biosimilar and interchangeable biosimilar product labeling in this draft guidance pertain only to the prescribing information, except for certain recommendations pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, Instructions for Use). This draft guidance provides an overview of FDA's recommendations for labeling for biosimilar and interchangeable biosimilar products. When finalized, this draft guidance will revise and replace the guidance for industry entitled ``Labeling for Biosimilar Products.''

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.

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.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary Improvement Program.'' FDA is issuing this guidance to describe its policy regarding FDA's participation in the Voluntary Improvement Program (VIP). The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer's practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices. The VIP builds on the framework piloted through FDA's 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) and incorporates some of the successes and learnings from the pilot.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.'' Forms FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics, are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on postmarketing requirements (PMRs) and postmarketing commitments (PMCs) in a consistent format. These forms are expected to result in improved accuracy and timeliness of FDA's identification and review of those submissions containing information on PMRs and PMCs. This guidance covers the purpose of each form, when to use these forms, and how to submit these forms. The guidance also explains where applicants will be able to find the forms and instructions. This guidance finalizes the draft guidance of the same name issued on October 21, 2020.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Breakthrough Devices Program.'' This final guidance describes policies that FDA intends to use to implement a section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance updates the previous version of the guidance, of the same title, issued on December 18, 2018, and describes how the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities. Consistent with our obligations under the SUPPORT for Patients and Communities Act (SUPPORT Act), the Breakthrough Devices Program may be available for certain non-addictive medical products to treat pain or addiction.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #282 entitled ``Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals.'' As used in this guidance, informed consent is a documented process by which an owner or owner's agent voluntarily confirms the owner's willingness to allow their animal(s) to participate in a particular study, after having been informed of all aspects of the study that may be relevant to the owner's decision to participate. A sponsor or investigator should ensure the owner is provided with adequate information and time to allow for an informed decision about voluntary participation in a clinical investigation. This draft guidance provides recommendations on informed consent forms (ICF) used for studies that enroll client-owned companion animals (dogs, cats, and horses). FDA's Center for Veterinary Medicine (CVM) recommends all studies conducted with client-owned companion animals use an ICF and be conducted in accordance with Good Clinical Practice (GCP) guidelines.

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 Department of Health and Human Services (HHS or the Department) is committed to protecting the civil rights of individuals with disabilities under section 504 of the Rehabilitation Act of 1973 (section 504). To implement the prohibition of discrimination on the basis of disability, the Department proposes to update and amend its section 504 regulation. The proposed rule would add new provisions that clarify existing requirements under section 504 prohibiting recipients of financial assistance from the Department (recipients) from discriminating on the basis of disability in their programs and activities, including in health care, child welfare, and other human services. The proposed rule includes new requirements prohibiting discrimination in the areas of medical treatment; the use of value assessments; web, mobile, and kiosk accessibility; and requirements for accessible medical equipment, so that persons with disabilities have an opportunity to participate in or benefit from health care programs and activities that is equal to the opportunity afforded others. It also adds a section on child welfare to expand on and clarify the obligation to provide nondiscriminatory child welfare services. The proposed rule would also update the definition of disability and other provisions to ensure consistency with statutory amendments to the Rehabilitation Act, enactment of the Americans with Disabilities Act and the Americans with Disabilities Amendments Act of 2008, the Affordable Care Act, as well as Supreme Court and other significant court cases. It also further clarifies the obligation to provide services in the most integrated setting. Finally, the proposed rule would make other clarifying edits, including updating outdated terminology and references.

The Department of Health and Human Services (HHS) is modifying a system of records maintained by the Administration for Children & Families (ACF), 09-80-0327 ORR Repatriation Program Records, to reflect the change ownership of the repatriation program that was transferred to ACF's Office of Human Services Emergency Preparedness and Response (OHSEPR), and to broaden the scope of the system of records to include functionally similar records that OHSEPR uses to identify, assess, and address immediate unmet human services (i.e., social services) needs of survivors of federally-declared disasters in the United States. To reflect the transfer and broadened scope, HHS is changing the name of the system of records to OHSEPR Repatriation and Disaster Human Services Case Management Records.

Findings of research misconduct have been made against Andrew Dannenberg, M.D. (Respondent), who was a Professor of Medicine, Department of Medicine, Weill Cornell Medical College (WCMC). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants P01 CA077839, P01 CA106451, R01 CA108773, R01 CA154481, T32 CA009685, R25 CA105012, and N01 CN43302, National Institute on Deafness and Other Communication Disorders (NIDCD), NIH, grant T32 DC000027, and National Center for Advancing Translational Sciences (NCATS), NIH, grant UL1 TR000457. The administrative actions, including supervision for a period of seven (7) years, were implemented beginning on August 14, 2023, and are detailed below.

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 Administration for Children and Families' (ACF) Office of Refugee Resettlement is requesting a 3-year extension of the Serious Medical Procedure Request (SMR) Form (Office of Management and Budget #0970-0561, expiration February 29, 2024). Revisions are proposed to the currently approved form.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services seeks approval to collect information to explore the role of Head Start in the early care and education (ECE) financing landscape, as well as how the use of multiple funding sources within a single Head Start program may be associated with the provision of Head Start's comprehensive services and with state-level differences in ECE funding. Survey data will be collected from Head Start program directors and state government administrators.

The Food and Drug Administration (FDA or the Agency) is announcing the over-the-counter (OTC) monograph order request (OMOR) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OMORs. This notice publishes the OMOR fee rates under OMUFA for FY 2024. FDA plans to publish the FY 2024 OMUFA facility fee rates in a subsequent Federal Register notice (and anticipates its issuance will generally align with the timing of OMUFA facility fee rate publication for prior fiscal years).

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Mayya Tatsene from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Tatsene was convicted of a felony under Federal law for conduct that relates to the regulation of any drug product under the FD&C Act. Ms. Tatsene was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of July 8, 2023 (more than 30 days after receipt of the notice, as prescribed by regulation), Ms. Tatsene has not responded to the notice. Ms. Tatsene's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.

Notice is hereby given of a change in the meeting of the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC); September 20, 2023, first session from 1 p.m. to 2:30 p.m., EDT (OPEN), and second session from 2:30 p.m. to 4:30 p.m., EDT (CLOSED), in the original Federal Register notice.

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), ``Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act Through a Veterans Health Administration Plan.''

The Food and Drug Administration (FDA) is announcing the year two opportunity for a limited number of applicants to participate in a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program to facilitate the expedited CMC development of products under an investigational new drug application (IND), where warranted, based on the anticipated clinical benefit of earlier patient access to the products. FDA has implemented this pilot program to facilitate CMC readiness for selected Center for Biologics Evaluation and Research (CBER)- and Center for Drug Evaluation and Research (CDER)-regulated products with accelerated clinical development timelines. To accelerate CMC development and facilitate CMC readiness, the pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches, such as those described in FDA guidance, as applicable. This notice outlines the eligibility criteria and process for submitting a request to participate in the pilot.

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 (the 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 Food and Drug Administration (FDA or Agency) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the VRBPAC. A nominee may either be self- nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

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 Secretary of Health and Human Services announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will provide information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pulmonary-Allergy Drugs Advisory Committee (the Committee). The general function of the Committee 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.

The Food and Drug Administration (FDA or we) is announcing the following public meeting on ``Endpoints and Trial Designs To Advance Drug Development in Kidney Transplantation.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Use of International Standard ISO 10993-1, `Biological evaluation of medical devicesPart 1: Evaluation and testing within a risk management process'.'' This guidance was revised to incorporate updates to FDA's current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, ``Biological evaluation of medical devicesPart 1: Evaluation and testing within a risk management process'' to support premarket approval applications (PMAs), humanitarian device exemptions (HDEs), investigational device exemption (IDE) applications, premarket notifications (510(k)s), and De Novo requests.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the University of Massachusetts for the Alternatives to Guardianship Youth Resource Center cooperative agreement. The purpose of this project is to divert high school students with intellectual and developmental disabilities (I/DD) away from guardianship to less restrictive decisional supports. The target audience for this information includes youth with I/DD, families, and caregivers of high school students with I/DD, teachers, education administrators, advocates, vocational rehabilitation counselors, guidance counselors, and school district officials. The administrative supplement for FY 2023 will amount to $200,000, bringing the total award for FY 2023 to $500,000.

In compliance with the requirement for the 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.

The Children's Bureau, Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new descriptive study, Judicial, Court, and Attorney Measures of Performance (JCAMP): Feedback and Implementation. This expands on earlier work around technical assistance, as approved under Office of Management and Budget (OMB) #: 0970-0593.

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 SOHONOS (palovarotene), manufactured by Ipsen Biopharmaceuticals, Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. On October 31, 2023, the Committee will discuss and make recommendations on biologics license application (BLA) 125787 from Vertex Pharmaceuticals, Inc. for exagamglogene autotemcel (exa-cel). The applicant has requested an indication for the treatment of sickle cell disease in patients 12 years and older with recurrent vaso- occlusive crises. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) hereby gives notice that the National Vaccine Advisory Committee (NVAC) will hold an in-person meeting. The meeting will be open to the public and public comment will be heard during the meeting.

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.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Use of Open-Ended Responses to Explore Disparities in Patient Experience.'' This proposed information collection was previously published in the Federal Register on June 27th, 2023, and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment.'' This guidance assists sponsors in the clinical development of drugs for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC). This guidance finalizes the draft guidance of the same title issued on September 29, 2021.

Findings of research misconduct have been made against Ivana Frech, Ph.D. (formerly Ivana De Domenico) (Respondent), former Assistant Professor, Department of Internal Medicine, University of Utah (UU) School of Medicine. Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants R01 DK070947, R01 DK090257, and R01 DK030534, National Institute of General Medical Sciences (NIGMS), NIH, grant P50 GM082545, National Institute of Allergy and Infectious Diseases (NIAID), NIH, grant R01 AI051174, and National Heart, Lung, and Blood Institute (NHLBI), NIH, grant R01 HL026922. The administrative actions, including debarment for a period of three (3) years, were implemented beginning on August 21, 2023, and are detailed below.

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 Diagnosis and Treatment of Tethered Spinal Cord, 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.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting supplemental funding in the scope of the parent award to the 36 Rural Emergency Medical Services Training Grant (REMS) recipients funded under Notice of Funding Opportunity (NOFO) TI-23-011. These recipients have a project end date of September 29, 2024. The supplemental funding is to provide the opioid antagonist medication, naloxone, that can be used to treat respiratory depression in suspected opioid overdose patients, and for the procurement of emergency equipment used to rapidly reverse the effects of opioid overdoses. Recipients may receive up to $49,000 for the purchase of naloxone and up to $49,000 for purchasing equipment, for a total of $98,000 per recipient.

HRSA is providing supplemental funds not to exceed $1,500,000 to the Supporting Maternal Health Innovation Program, also referred to as the Maternal Health Learning and Innovation Center (MHLIC), in fiscal year (FY) 2023 to provide support and capacity building to HRSA's new maternal health award recipients under the State Maternal Health Innovation (MHI) Program (HRSA-23-108).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act.'' This guidance clarifies the enhanced drug distribution security requirements listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act). In addition, this guidance outlines and makes recommendations on the system attributes necessary to enable secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary. This guidance finalizes the draft guidance of the same title issued on June 4, 2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.'' FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program for drugs and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision making. This guidance discusses the applicability of FDA's investigational new drug application (IND) regulations to various clinical study designs that utilize real-world data (RWD) and clarifies the Agency's expectations regarding clinical studies using RWD submitted to FDA in support of a regulatory decision regarding the effectiveness or safety of a drug that are not subject to the IND regulations. This guidance finalizes the draft guidance of the same title issued on December 9, 2021.

This document establishes requirements for mandatory annual State reporting of the Core Set of Children's Health Care Quality Measures for Medicaid and the Children's Health Insurance Program (CHIP), the behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid, and the Core Sets of Health Home Quality Measures for Medicaid.

In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Migrant Health (NACMH) has scheduled a public meeting. Information about NACMH and the agenda for this meeting can be found on NACMH's website at https:// www.hrsa.gov/advisory-committees/migrant-health.

The Food and Drug Administration (FDA or Agency) 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.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule entitled ``Requirements for Tobacco Product Manufacturing Practice'' published in the Federal Register of March 10, 2023, by 30 days. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

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 (the 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.

This final rule will: revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); and make other policy- related changes. This final rule also revises our regulations on the counting of days associated with individuals eligible for certain benefits provided by section 1115 demonstrations in the Medicaid fraction of a hospital's disproportionate patient percentage (DPP) used in the disproportionate share hospital (DSH) calculation.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces a meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is soliciting nominations for membership on the Lead Exposure and Prevention Advisory Committee (LEPAC). The LEPAC is composed of 15 members that are Federal and non-Federal experts in fields associated with lead screening, the prevention of lead exposure, and services for individuals and communities affected by lead exposure.

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 Diagnosis and Management of Obsessive Compulsive Disorders in Children, 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.

On August 11, 2023, CMS published a notice in the Federal Register that sought comment on a collection of information concerning CMS-10305 (OMB control number 0938-1115) entitled ``Medicare Part C and Part D Data Validation.'' The point of contact for policy questions is incorrect. This document corrects the error.

The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA, the Agency) is proposing to withdraw approval of PEPAXTO (melphalan flufenamide) for injection, equivalent to (EQ) 20 milligrams (mg) BASE/VIAL, once every 28 days, new drug application (NDA) 214383, held by Oncopeptides AB (Oncopeptides). This notice is intended to provide an opportunity for public comment on CDER's proposed withdrawal of PEPAXTO, in accordance with the expedited withdrawal of approval procedures described in the Federal Food, Drug and Cosmetic Act (FD&C Act).

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 (the 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 Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. This meeting will be held to discuss the Strain Selection for the Influenza Virus Vaccines for the 2024 Southern Hemisphere Influenza Season. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.