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

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, 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 product jurisdiction and combination product regulations.

This notice announces the second public meeting of the Ground Ambulance and Patient Billing (GAPB) Advisory Committee on August 16, 2023. The GAPB Advisory Committee will make recommendations with respect to the disclosure of charges and fees for ground ambulance services and insurance coverage, consumer protection and enforcement authorities of the Departments of Labor, Health and Human Services, and the Treasury (the Departments) and relevant States, and the prevention of balance billing to consumers. The recommendations will address options, best practices, and identified standards to prevent instances of balance billing; steps that can be taken by State legislatures, State insurance regulators, State attorneys general, and other State officials as appropriate, consistent with current legal authorities regarding consumer protection; and, legislative options for Congress to prevent balance billing.

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for calendar year 2024 based on our continuing experience with these systems. In this proposed rule, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. This proposed rule also would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Rural Emergency Hospital Quality Reporting (REHQR) Program. This proposed rule would also establish payment for certain intensive outpatient services under Medicare, beginning January 1, 2024. In addition, this proposed rule would update and refine requirements for hospitals to make public their standard charge information and enforcement of hospital price transparency. We also propose to codify provisions of the Consolidated Appropriations Act, 2023, in Community Mental Health Centers Conditions of Participation (CoPs). We propose to revise the personnel qualifications of Mental Health Counselors and add personnel qualifications for Marriage and Family Therapists in the CMHC CoPs. We also seek comment on separate payment under the Inpatient Prospective Payment System (IPPS) for establishing and maintaining access to a buffer stock of essential medicines to foster a more reliable, resilient supply of these medicines. Finally, we propose to address any future revisions to the IPPS Medicare Code Editor (MCE), including any additions or deletions of claims edits, as well as the addition or deletion of ICD-10 diagnosis and procedure codes to the applicable MCE edit code lists, outside of the annual IPPS rulemakings. Additionally, we propose a technical correction to the Rural Emergency Hospital Conditions of Participation.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC or Board). This meeting is partially open to the public.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Advisory Committee to the Director Data and Surveillance Workgroup (DSW). The DSW consists of approximately 15 members who are experts in fields associated with public health science and practice; policy development, analysis, and implementation; and surveillance and informatics.

Notice is hereby given of the combined (joint) meeting on August 30, 2023, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) four National Advisory Councils: the SAMHSA National Advisory Council (NAC), the Center for Mental Health Services NAC, the Center for Substance Abuse Prevention NAC, the Center for Substance Abuse Treatment NAC; and the two SAMHSA Advisory Committees: Advisory Committee for Women's Services (ACWS) and the Tribal Technical Advisory Committee (TTAC).

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2024 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2024 rates for the small business establishment fee ($6,196), the non-small business establishment fee ($20,036), and the reinspection fee ($18,588) for outsourcing facilities; provides information on how the fees for FY 2024 were determined; and describes the payment procedures outsourcing facilities should follow.

The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2024 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies that are applying to be directly accredited by FDA.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2024, which apply from October 1, 2023, through September 30, 2024, and provides information on how the fees for FY 2024 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

HHS exempts certain records in an existing system of records maintained by OCSE within ACF from the accounting, access, and amendment requirements of the Privacy Act. The affected system of records is OCSE Federal Case Registry of Child Support Orders, HHS/ACF/ OCSE, System No. 09-80-0385. Only case files marked with the Family Violence Indicator (FVI) will be exempted, to align with a restriction in section 453(b)(2) of the Social Security Act which prohibits disclosure of case files marked with the FVI to anyone other than a court or agent of a court, to avoid harm to the custodial parent or the child of such parent.

The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2024 rates for GDUFA III fees. These fees are effective on October 1, 2023, and will remain in effect through September 30, 2024.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Indian Health Service Medical Staff Credentials Application,'' OMB Control Number 0917-0009, which expires August 31, 2023.

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 Office of Child Care invites public comment on the rules and regulations of the Tribally administered Child Care and Development Fund (CCDF) program as part of the Administration for Children and Families' (ACF) commitment to creating partnerships with Tribal Nations to identify and implement solutions that transcend traditional program boundaries. As part of that commitment, OCC seeks input on the requirements, regulations, and processes for Tribal Nations that administer CCDF. This Request for Information (RFI) specifically seeks public comment on the following topics of the Tribal child care programCCDF Funding Policies for Tribes, CCDF Administration, Improving Families' Access to Child Care, and Increasing Child Care Supply in Tribal Communitiesbut input on any aspect of the Tribally administered CCDF program is welcome. OCC will host a Tribal consultation during the RFI public comment period.

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. On September 27, 2023, the committee will discuss and make recommendations on biologics license application (BLA) 125782 from BrainStorm Therapeutics, Inc. for debamestrocel (autologous bone marrow-derived mesenchymal stromal cells induced to secrete neurotrophic factors). The applicant has requested an indication for the treatment of amyotrophic lateral sclerosis (ALS). The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

ACF, ORR, Division of Refugee Health (DRH) announces the intent to award supplements in the aggregate amount of up to $466,563 to nine grant recipients under Notice of Funding Opportunity: Direct Services for Survivors of Torture, HHS-2022-ACF-ORR-ZT-0051. The purpose of the awards is to ensure that the 222 Nicaraguan Humanitarian Parolees (NHP) who were brought to the United States will have access to holistic care and services. This supplement will enable the identified grant recipients in California, Florida, Georgia, Maryland, Minnesota, Texas, and Virginia to provide access to medical, mental health, social, and legal services to NHP within their geographic service areas, and coordinate with The Center for Victims of Torture in Minnesota and other providers to serve NHP outside their service areas. The goal of these services is to help the NHP improve their health, find employment and stable housing, and regularize their immigration status.

The Administration for Children and Families' (ACF) Office of Planning, Research, and Evaluation (OPRE) requests Office of Management and Budget (OMB) approval for an overarching generic clearance to collect data on programs serving youth transitioning out of foster care as part of the Chafee Strengthening Outcomes for Transition to Adulthood Project. The generic mechanism will allow ACF to conduct rapid-cycle evaluations that would not otherwise be feasible under the timelines associated with the Paperwork Reduction Act of 1995. The purpose of these data collections submitted under the generic will be to inform ACF programming by building the evidence about what works to improve outcomes for the target population and to identify innovative learning methods that address common evaluation challenges.

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 announcing the availability of a final guidance for industry entitled ``M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk'' (M7(R2) Guidance) and two supplemental documents entitled ``M7(R2) Addendum: Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes'' (M7(R2) Addendum) and ``M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Questions and Answers'' (M7(R2) Questions and Answers). The M7(R2) Guidance, M7(R2) Addendum, and M7(R2) Questions and Answers were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance and supplemental documents are intended to harmonize the considerations for assessment and control of DNA reactive (mutagenic) impurities. The M7(R2) Guidance and M7(R2) Addendum replace the guidance for industry entitled ``M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk,'' issued on March 14, 2018. The M7(R2) Guidance, M7(R2) Addendum, and M7(R2) Questions and Answers, also finalize the draft guidances for industry entitled ``M7(R2) Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes'' and ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk Questions and Answers'' issued on April 7, 2022, and September 29, 2020, respectively.

The Food and Drug Administration (FDA or we) is reopening the comment period for the notice entitled ``Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quantitative Research on Front of Package Labeling on Packaged Foods,'' published in the Federal Register of June 15, 2023, to allow interested parties additional time to submit comments. We are taking this action due to technical difficulties experienced on the final two days of the comment period that may have prevented some interested parties from submitting comments.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual listening session entitled ``Public Meeting and Listening Session for Developing FDA's Center for Tobacco Products' Strategic Plan.'' The purpose of the listening session is to obtain feedback on the proposed strategic goals that are being used to develop FDA's Center for Tobacco Products' (CTP) comprehensive Strategic Plan. FDA will provide information on the proposed goals and provide the public an opportunity to provide open public comment.

The Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation (OPRE) at the U.S. Department of Health and Human Services is proposing to collect information to examine a promising strategy to support the child care and early education (CCEE) workforce in Colorado as part of the Building and Sustaining the CCEE Workforce BASE project. This project aims to build evidence about workforce development strategies designed to promote, retain, and advance the CCEE workforce by improving the economic well- being of CCEE workers.

The Food and Drug Administration (FDA) 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.

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) 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 (PRA).

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 National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to Elgia Therapeutics Inc. (``Elgia''), headquartered in La Jolla, CA.

The Department of Health and Human Services (HHS) is seeking public comment on its draft Scientific Integrity Policy through the Department of Health and Human Services website at https://www.hhs.gov/ programs/research/scientificintegrity.

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 dates and times of a virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) in August of 2023. In addition, it announces 8 new membership appointments to the Panel. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center payment system; and supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as we prepare the annual update for the OPPS.

The Departments of Health and Human Services and Agriculture announce the third meeting of the 2025 Dietary Guidelines Advisory Committee (Committee). This meeting will be open to the public virtually. Additionally, this notice informs the public of the opportunity to provide oral comments virtually to the Committee regarding its work.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is proposing to collect data from grantee agencies participating in the Voluntary Agencies Matching Grant Program. Client data collected will include enrollment information, demographics, and program outcomes.

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections (``Draft Guideline: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections''). The Draft Guideline: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections updates the Guideline for infection control in health care personnel, 1998 (``1998 Guideline''), Part E: Epidemiology and Control of Selected Infections Transmitted Among Health Care Personnel and Patients, and its corresponding recommendations in Part II of the 1998 Guideline: ``8. Measles;'' ``10. Mumps;'' ``15. Rubella;'' and ``21. Varicella.'' The updated recommendations in the Draft Guideline: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections are intended for use by the leaders and staff of healthcare facilities and systems' Occupational Health Services (OHS), as further provided herein. These updated recommendations will help facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) who have been exposed or infected and may be contagious to others in the workplace.

This notice acknowledges the receipt of an application from The Joint Commission (TJC) for continued recognition as a national accrediting organization providing home infusion therapy (HIT) services that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) 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.

This notice extends the comment period for a 60-day notice request for proposed information collection request associated with the notice [Document Identifier: CMS-576 and CMS-576A] entitled ``Organ Procurement Organization (OPO) Request for Designation as an OPO, Health Insurance Benefits Agreement, and Supporting Regulations'' that was published in the June 13, 2023 Federal Register. The comment period for the information collection request, which would have ended on August 14, 2023, is extended to August 28, 2023.

The Indian Health Service (IHS or Service) administers the Catastrophic Health Emergency Fund (CHEF) pursuant to section 202 of the Indian Health Care Improvement Act (IHCIA). The purpose of the CHEF is to meet the extraordinary medical costs associated with the treatment of victims of disasters or catastrophic illnesses who are within the responsibility of the Service. This notice proposes regulations governing the administration of the CHEF.

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.

In accordance with subsection (e)(12) of 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 Social Security Administration (SSA), ``Determining Enrollment or Eligibility for Insurance Affordability Programs Under the Patient Protection and Affordable Care Act.''

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 ELEVIDYS (delandistrogene moxeparvovec-rokl), manufactured by Sarepta Therapeutics, Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry.'' The management of manufacturing changes presents many challenges for human cellular therapy or gene therapy (CGT) products due to the complexity of these products. The draft guidance provides sponsors of Investigational New Drug Applications (INDs) and applicants of Biologics License Applications (BLAs) for CGT products, with recommendations regarding product comparability and the management of manufacturing changes for investigational and licensed CGT products. The purpose of this draft guidance is to provide FDA's current thinking on management and reporting of manufacturing changes for CGT products based on a life-cycle approach, and comparability studies to assess the effect of manufacturing changes on product quality.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act.'' The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to require certain postmarketing studies and clinical trials for prescription drugs at the time of approval or after approval if FDA becomes aware of new safety information. This draft guidance describes the factors FDA considers when determining whether an applicant has demonstrated good cause for failure to comply with the timetable for completion of studies or clinical trials required under the provisions. This draft guidance also provides information on relevant procedures, including how an applicant should communicate with FDA regarding compliance with these required studies and trials and describes actions FDA may take for noncompliance with the requirements.

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 its public advisory committees for the Center for Drug Evaluation and Research (CDER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CDER's public advisory committees. 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 Food and Drug Administration (FDA) is announcing the renewal of the National Mammography Quality Assurance Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the National Mammography Quality Assurance Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the July 7, 2025, expiration date.

In accordance with the Public Health Service Act and the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) scheduled a public meeting to be held Thursday, August 10, 2023, and Friday, August 11, 2023. Information about ACHDNC and the agenda for this meeting can be found on ACHDNC's website at https:// www.hrsa.gov/advisory-committees/heritable-disorders/index.ht ml.

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 proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Shigella Hypothesis Generating Questionnaire (SHGQ). The SHGQ supports shigellosis cluster and outbreak investigations. CDC will collect state and local health department furnished shigellosis case data.

OCSS proposes to provide temporary relief to states from certain child support program performance requirements and penalties during natural disasters and other calamities which have a negative impact on state child support program operations. The proposed rule would provide ACF with ongoing authority to modify performance measure requirements when states are affected by natural disasters and other calamities that have resulted, or are expected to result, in the failure of state child support programs to achieve performance standards for paternity establishment, support order establishment, and current collections. The proposed rule will enable states to avoid the imposition of penalties due to adverse data reliability audit findings during, and subsequent to, natural disasters and other calamities, including pandemics and declared public health emergencies.

The Department of Health and Human Services, Administration for Children and Families proposes to amend the Child Care and Development Fund (CCDF) regulations. This notice of proposed rulemaking (NPRM) proposes changes to lower families' child care costs, which can be a significant financial strain for families and disincentivize work, training, and education. It proposes changes to improve child care provider payment rates and practices to increase parent choice for child care arrangements and help stabilize operations for participating providers. It also proposes ways for CCDF Lead Agencies to streamline eligibility and enrollment processes so families can receive child care assistance faster and so program bureaucracy is less likely to disrupt parent employment, training, and education and impede access to child care. The NPRM also includes technical and other changes to improve clarity and program implementation.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Oasis Institute for the project National Volunteer Care Corps.

HRSA will provide supplemental funding to the Enhancing Systems of Care for Children with Medical Complexity Coordinating Center during fiscal year 2023 to provide training, resources, and education to support states in their efforts to sustainably finance patient/family centered health care homes for children with medical complexity (CMC).

The National Biodefense Science Board (NBSB) will publicly meet using an online format. Notice of the meeting is required under section 10 (a)(2) of the Federal Advisory Committee Act (FACA). The NBSB provides expert advice and guidance to HHS regarding current and future chemical, biological, radiological, and nuclear threats, as well as other matters related to disaster preparedness and response. ASPR manages and convenes the NBSB on behalf of the Secretary of HHS.

CDC has modified its structure. This notice announces the reorganization of the Office of Laboratory Science and Safety and the establishment of the Center for Laboratory Systems and Response.

CDC has modified its structure. This notice announces the reorganization of the National Center for Health Statistics (NCHS).

CDC has modified its structure. This notice announces the reorganization of the Strategic Business Initiatives Unit (SBI). SBI converted from an activity within the Office of the Director of the Office of the Chief Operating Officer to a stand-alone business service office known as the Office of Strategic Business Initiatives.

CDC has modified its structure. This notice announces the reorganization of the Office of the Chief Information Officer (OCIO). OCIO restructured to optimize support for the CDC Moving Forward reorganization and Data Modernization Initiatives.

CDC has modified its structure. This notice announces the reorganization of the former Human Resources Office. In addition to functional realignments and new functional entities, the Human Resources Office was retitled to the Office of Human Resources.

CDC has modified its structure. This notice announces the reorganization of the State, Tribal, Local, and Territorial Public Health Infrastructure and Workforce, henceforth referred to as the Public Health Infrastructure Center (PHIC). PHIC reorganized to enhance and enable coordination for partners collectively working to bolster the Nation's public health infrastructure.

CDC has modified its structure. This notice announces the reorganization of the National Center on Birth Defects and Developmental Disabilities (NCBDDD). NCBDDD realigned the Office of Genomics and Precision Public Health from the Office of Science to the NCBDDD, retitled and made mission and functional statements updates to some organizational entities.

The Food and Drug Administration (FDA, Agency, or we) 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.

This notice provides an updated Statement of Organization, Functions, and Delegations of Authority for HHS' Office of the Assistant Secretary for Public Affairs, replacing the statement as last amended in 2015. The statement is republished in full.

The invention described below will be a first-in-class, reversible, hormonal contraceptive method for males and is co-owned by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, and The Population Council, Inc., a New York not-for-profit corporation based in New York City (``Population Council''). The co-owners will complete the Phase 2b clinical stage of development in 2024 and are seeking a licensee and investor/collaborator for the Phase 3 clinical stage, anticipated to begin as early as 2024.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.'' This draft guidance describes FDA's current recommendations for optimizing and standardizing dietary management in clinical trials for the development of drug products intended to treat inborn errors of metabolism (IEM) when dietary management is a key component of patients' metabolic control. Optimizing and standardizing dietary management in these patients before they enter clinical trials and during clinical trials is essential to providing an accurate evaluation of the efficacy of new drug products. This guidance revises the draft guidance of the same name issued on July 24, 2018.

The Office of Child Support Services (OCSS) (formerly the Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) to extend approval of the Income Withholding for Support Order (IWO), with minor changes, for an additional three years. The current OMB approval expires September 30, 2023.

This proposed rule describes the agency's proposed actions to comply with the remand from the district court to craft a remedy in light of the United States Supreme Court's decision in American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), relating to the adjustment of Medicare payment rates for drugs acquired under the 340B Program from calendar year (CY) 2018 through September 27th of CY 2022.

This proposed rule would set forth routine updates to the Medicare home health payment rates for calendar year (CY) 2024 in accordance with existing statutory and regulatory requirements. This rule wouldprovide information on home health utilization trends and solicits comments regarding access to home health aide services; implement home health payment-related changes; rebase and revise the home health market basket and revise the labor-related share; codify statutory requirements for disposable negative pressure wound therapy (dNPWT); and implement the new items and services payment for the home intravenous immune globulin (IVIG) benefit. In addition, it proposes changes to the Home Health Quality Reporting Program (HH QRP) requirements and the expanded Home Health Value-Based Purchasing (HHVBP) Model; to implement the new Part B benefit for lymphedema compression treatment items, codify the Medicare definition of brace, and make other codification changes based on recent legislation; to add an informal dispute resolution (IDR) and special focus program (SFP) for hospice programs; to codify DMEPOS refill policy; and to revise Medicare provider and supplier enrollment requirements.