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

The Substance Abuse and Mental Health Services Administration published a document in the Federal Register of January 9, 2024, announcing the solicitation for public comments on questions from the Task Force on Maternal Health. The document contained incorrect date in the DATES section.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Medical Imaging 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 Family and Youth Service Bureau (FYSB) is proposing to collect comprehensive Prevention Plans from grant recipients that have been awarded funding for a new prevention demonstration project to design and implement prevention and intervention services tailored to prevent at-risk youth from experiencing homelessness.

The Family and Youth Services Bureau's Runaway and Homeless Youth (RHY) Program is requesting a 3-year extension of the Runaway and Homeless YouthHomeless Management Information System (RHY-HMIS) data collection efforts (OMB #0970-0573, expiration 07/31/2024). There are no changes requested to the data elements.

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.

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.

Pursuant to Public Law 92-463, notice is hereby given of the meeting on February 27, 2024, of the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services National Advisory Council (CMHS NAC). The meeting is open to the public and will include consideration of the meeting minutes from the August 29, 2023, SAMHSA, CMHS NAC meeting; updates from the CMHS Director; remarks from SAMHSA's Assistant Secretary; updates on Statewide Consumer Network Grants; updates on Subcommittee Tasks; Legislative updates; and Tribal updates. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/ meetings. The meeting will be held at SAMHSA, 5600 Fishers Lane, 5W11, Rockville, MD 20857. Attendance by the public will be limited to space available and will be limited to the open sessions of the meeting. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Council. Presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making public comment must notify the contact person, Pamela Foote, CMHS NAC Designated Federal Officer (DFO) on or before February 13, 2024. Up three minutes will be allotted for each public comment as time permits. Written comments received in advance of the meeting will be considered for inclusion in the official record. The open meeting session may also be accessed virtually. Please register on-line at https://snacregister.samhsa.gov, to attend on either on site or virtually, submit written or brief oral comments, or request special accommodations for persons with disabilities. To communicate with the CMHS NAC DFO please see the contact information below. Meeting information and a roster of Council members may be obtained by accessing the SAMHSA Committee website at https://www.samhsa.gov/ about-us/advisory-councils/cmhs-national-advisory-council or by contacting the DFO. Council Name: SAMHSA's Center for Mental Health Services National Advisory Council. Date/Time/Type: February 27, 2024, 9:00 a.m. to 4:30 p.m. (EST), Open. Place: SAMHSA, 5600 Fishers Lane, Rockville, Maryland 20857. Contact: Pamela Foote, Designated Federal Officer, CMHS National Advisory Council, 5600 Fishers Lane, Rockville, Maryland 20857 (mail), Telephone: (240) 276-1279, Email: pamela.foote@samhsa.hhs.gov.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces the public webinar ``Implementing Computational Approaches for Regulatory Safety Assessments.'' The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). Interested persons may participate via the web meeting platform. Time will be allotted for questions from the audience. Information about the webinar and registration are available at https://ntp.niehs.nih.gov/go/commprac- 2024.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public. Time will be available for public comment.

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 Updating the Measurement Criteria for AHRQ's National Healthcare Quality and Disparities Report (NHQDR), 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.

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Oral Health Basic Screening Survey for Children. The project provides State-specific data on dental caries (tooth decay) and dental sealants from a State-representative sample of elementary school children or children enrolled in Head Start programs and has been used by States to monitor oral health status of children and evaluate public health programs and policies.

The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) and inviting public comments on the proposed collection. The Affordable Housing and Supportive Services Demonstration was appropriated by the Departments of Labor, Health and Human Services, and Related Agencies Appropriations Bill, 2023 through the Social Services Research Demonstration program (SSRD). The House report language directs ACF to provide a report on the findings of this demonstration within 1 year after grants are awarded. ACF is soliciting public comment within the next 30 days and requesting expedited approval from OMB to collect information to study the implementation of this demonstration program to inform this report. Following initial approval, ACF will request an extension of approval within 6 months. This extension process will include additional commenting opportunities.

The purpose of this Request for Information (RFI) is to invite input on the development of a National Institutes of Health (NIH)-wide strategic plan to advance autoimmune disease research. NIH is seeking input from members of the scientific community, Federal partners, academic institutions, the private sector, health professionals, professional societies, advocacy groups, patient communities, and other interested members of the public.

The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat medical countermeasure (MCM) priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the issuance of material threat MCM priority review vouchers as well as the approval of products redeeming a voucher. FDA has determined that FABHALTA (iptacopan) capsules, approved December 5, 2023, meets the redemption criteria.

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 The Effect of Dietary Digestible Carbohydrate Intake on Risk of Cardiovascular Disease, 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.

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove four specified solvents.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application. The guidance also finalizes the updates based on advances in scientific knowledge and regulatory expectations to the first version of the ICH guidance for industry ``Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin,'' issued in September 1998. Lastly, the guidance replaces the draft guidance ``Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin'' issued on November 14, 2022.

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 ADZYNMA (ADAMTS13, recombinant-krhn), manufactured by Takeda Pharmaceuticals U.S.A., Inc., meets the criteria for a priority review voucher.

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) within the U.S. Department of Health and Human Services (HHS) is proposing to collect nationally representative survey data to learn more about where parents look for and find information about Child Care and Early Education (CCEE); how parents assess the people, places, or things that may offer CCEE information; what types of CCEE information parents look for; and how parents use information to make CCEE selections. The study aims to gather information that may be used by Child Care Lead Agencies to inform their consumer education efforts.

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 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.

In accordance with section 1111(g) of 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) has scheduled a public meeting. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory- committees/heritable-disorders/.

This final rule implements the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program). This final rule also makes several updates to certification criteria and standards recognized by the Program. The Program updates include revised certification criteria for ``decision support interventions,'' ``patient demographics and observations,'' and ``electronic case reporting,'' as well as a new baseline version of the United States Core Data for Interoperability (USCDI) standard to Version 3. Additionally, this final rule provides enhancements to support information sharing under the information blocking regulations. The implementation of these provisions advances interoperability, improves algorithm transparency, and supports the access, exchange, and use of electronic health information (EHI). This final rule also updates numerous technical standards in the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs for health IT developers and users of health IT.

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 (PRA).

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 pertaining to ``Expedited Programs for Serious ConditionsDrugs and Biologics.''

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.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is inviting public comments on revisions to an approved information collection. The request consists of several forms that allow the Unaccompanied Children (UC) Program to process release of unaccompanied children from ORR custody and provide services after release.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Indian Health Service (IHS) of the Department of Health and Human Services (HHS or ``the Department'') is issuing this Notice of Proposed Rulemaking (NPRM) proposing the removal of regulations appearing in the Code of Federal Regulations (CFR). These outdated regulations do not align with the current statutory text.

The Division of Program Innovation (DPI), Office of Child Support Services (OCSS), Administration for Children and Families (ACF) is requesting a 3-year extension of the Access and Visitation Survey: Annual Report (Office of Management and Budget #: 0970-0204, expiration 6/30/2024). There are no requested changes to the form.

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.

A Federal Register notice published on October 24, 2023, detailed and sought public comment on recommendations under development by the Infant, Child, and Adolescent Preventive Services (ICAPS) Program, regarding updates to the HRSA-supported preventive services guidelines for infants, children, and adolescents in the Bright Futures Periodicity Schedule footnotes. The proposed updates are related to six existing footnotes. The ICAPS Program convenes health professionals to develop draft recommendations for HRSA's consideration. Twenty-five respondents provided comments which were received and considered as detailed below. On December 29, 2023, HRSA accepted as final the ICAPS Program's recommended update to the six footnotes. None of the footnote updates change the HRSA-supported clinical recommendations and therefore none of these updates make any changes to coverage without cost-sharing, as each of the footnotes merely update references to the supporting evidence base for existing recommendations or adds additional descriptive text. Please see https://mchb.hrsa.gov/programs-impact/bright-futures for additional information.

A Federal Register notice published on September 29, 2023, detailed and sought public comment on recommendations under development by the Women's Preventive Services Initiative (WPSI), regarding updates to the HRSA-supported Women's Preventive Services Guidelines (Guidelines). The proposed updates specifically related to Screening for Urinary Incontinence. WPSI convenes health professionals to develop draft recommendations for HRSA's consideration. Two public comments were received and considered as detailed below. On December 28, 2023, HRSA accepted as final WPSI's recommended updates to the Screening for Urinary Incontinence guideline. Under applicable law, non-grandfathered group health plans and health insurance issuers offering non- grandfathered group and individual health insurance coverage must include coverage, without cost sharing, for certain preventive services, including those provided for in the HRSA-supported Guidelines. The Departments of Labor, Health and Human Services, and the Treasury have previously issued regulations describing how group health plans and health insurance issuers apply the coverage requirements. Please see https://www.hrsa.gov/womens-guidelines for additional information.

The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).

This is the second of two planned notices informing the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSA). This notice includes the lists of HPSAs in a designated status as of December 2, 2023. The lists are available on the shortage area topic page on HRSA's data.hrsa.gov website. The first Federal Register notice was published on July 3, 2023, and included HPSAs in a designated status and those proposed for withdrawal, while extending the transition time communicated in the prior notice published on July 7, 2022. State primary care offices had additional time to submit HPSA data that was re-evaluated in preparation for the publication of this notice. This second Federal Register notice includes the lists of HPSAs in a designated status and withdraws designations proposed for withdrawal not meeting the requirements for designation as of the data pull on December 2, 2023.

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.

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, Agency, or we) is announcing the availability of a draft guidance entitled ``Potency Assurance for Cellular and Gene Therapy Products.'' FDA is issuing this draft guidance to provide recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the product lifecycle. FDA is recommending a comprehensive approach to potency assurance of CGT products that is grounded in quality risk management. For investigational products, we describe how to progressively implement a strategy for potency assurance during product development and provide additional considerations to help assure the potency of products that are undergoing rapid clinical development. For licensed products, we describe requirements for potency assurance, including testing required for lot release.

The Food and Drug Administration (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing the availability of version 2.3 of the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRS) for Vaccines (Specifications). The version update is not applicable to CBER- regulated drug products marketed for human use with approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs); CBER-regulated therapeutic biological products marketed for human use with approved Biologic License Applications (BLAs); Whole Blood or blood components; and human cells, tissues, and cellular and tissue- based products (HCT/Ps) regulated solely under the Public Health Service Act.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed revision for the Alzheimer's and Dementia Program Data Reporting Tool (ADP-DRT) OMB Control Number 0985-0022.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 information collection (IC) extension solicits comments on the information collection requirements relating to the Performance Data for State Grants for Assistive Technology Program Annual Progress Report (OMB Control Number 0985-0042).

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed revision for the information collection requirements related to the State Health Insurance Assistance Program (SHIP) Client Contact Forms OMB Control Number 0985-0040.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data from Eligible Afghan Arrivals (EAAs) in need of direct legal services through Immigration Legal Services for Afghan Arrivals (ILSAA) to determine eligibility.