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

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.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on May 30, 2024. The topic for this meeting will be "Artificial Intelligence in Diabetes Precision Medicine: Real world data, real world opportunities and challenges". The meeting is open to the public.

Notice is hereby given of the formation of a subcommittee of the Center for Substance Abuse Prevention National Advisory Council (CSAP NAC) to be known as the Substance Use Prevention Workforce. The subcommittee reports to the CSAP NAC, and of its findings, which are further deliberated by the CSAP NAC. The expected lifespan of the subcommittee is approximately one year. It is estimated that subcommittee meetings will occur approximately on a monthly basis via web conference.

The National Advisory Committee on Seniors and Disasters (NACSD) will conduct a public meeting on Monday, May 20, 2024 (2:30 p.m.-4:30 p.m. ET). Notice of the meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act (FACA). The NACSD is required by section 2811B of the Public Health Service Act (PHS) Act (42 U.S.C. 300hh-10c), as amended by the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA), Public Law 116-22, and governed by the provisions of the Federal Advisory Committee Act (FACA). The NACSD provides expert advice and guidance to the U.S. Department of Health and Human Services (HHS) regarding all-hazards public health and medical preparedness, response, and recovery activities related to meeting the unique needs of older adults. ASPR manages and convenes the NACSD on behalf of the Secretary of HHS. The NACSD will discuss and deliberate questions posed by ASPR on climate and health equity. Procedures for Public Participation: The public and expert stakeholders are invited to observe the meeting either in-person or virtually and pre-registration is required. The pre-registration link and a more detailed agenda will be available on the NACSD website. Anyone may submit questions and comments to the NACSD by email (NACSD@hhs.gov) before the meeting. American Sign Language translation and Communication Access Real-Time Translation will be provided. We would like to specifically seek input from the public on climate and health equity considerations in disaster training as well as opportunities and strategic priorities for national public health and medical preparedness, response, and recovery specific to the needs of older adults. Representatives from industry, academia, health professions, health care consumer organizations, non-federal government agencies, or community-based organizations may request up to five minutes to speak directly to the Committee. Requests to speak to the Committee will be approved in consultation with the Committee Chair and based on time available during the meeting. Requests to speak to the NACSD during the public meeting must be sent to NACSD@hhs.gov by close of business on May 15, 2024. Please provide the full name, credentials, official position(s), and relevant affiliations for the speaker and a brief description of the intended topic. Presentations that contain material with a commercial bias, advertising, marketing, or solicitations will not be allowed. A meeting summary will be available on the NACSD website post meeting.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Puerto Rico Ombudsman Office for the Elderly (PROOE) for the project Puerto Rico Disaster Assistance Grant which is through the Older Americans Act, Disaster Assistance for State Units on Aging (SUAs) and Tribal Organizations in Major Disasters Declared by the President and the Consolidated Appropriations Act, 2023.

The Food and Drug Administration (FDA) is requesting nominations for a nonvoting representative of the interests of the tobacco growers to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups. A nominee may either be self-nominated or nominated by an organization. In addition, FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting representative of the interests of the tobacco growers industry to serve on the TPSAC, notify FDA in writing. Nominations will be accepted for either the representative to serve on TPSAC or for the selection group effective with this notice.

In accordance with the requirements of the Privacy Act of 1974, as amended, the U.S. Department of Health and Human Services (HHS) is establishing two new systems of records that will be maintained by the Administration for Children and Families (ACF), Office on Trafficking in Persons (OTIP): System No. 09-80-0391, Anti- Trafficking Information Management System (ATIMS) Records; and System No. 09-80-0392, National Human Trafficking Training and Technical Assistance Center (NHTTAC) Participant Records.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #187A entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach." This guidance is intended to clarify FDA's requirements and recommendations with respect to heritable intentional genomic alterations (IGAs) in animals. The guidance is being issued as one of two companion documents. This guidance, entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach," describes FDA's risk-based regulatory approach to the oversight of heritable IGAs in animals. This means that for people or companies developing certain types of IGAs in animals, FDA may not expect them to submit an application or get approval before marketing their product. For other types of IGAs in animals that do go through the approval process, the companion draft guidance document, GFI #187B entitled "Heritable Intentional Genomic Alterations in Animals: The Approval Process" describes how the approval process applies to heritable IGAs in animals.

This final notice announces our decision to approve The Joint Commission (TJC) for initial recognition as a national accrediting organization (AO) for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.

This symposium is sponsored by the National Institutes of Health (NIH), Office of Research on Women's Health (ORWH), and the title of this year's symposium is "Synergy in Science: Innovations in Autoimmune Disease Research and Care." The symposium will discuss the convergence of cutting-edge insights and collaborative efforts in the realm of autoimmune diseases.

This rule finalizes requirements under titles IV-E and IV-B for children in foster care who are LGBTQI+ (an umbrella term used in this regulation). The proposed rule was published on September 28, 2023. Federal law requires that state and tribal title IV-E and IV-B agencies ("agencies") ensure that each child in foster care receives "safe and proper" care and has a case plan that addresses the specific needs of the child while in foster care to support their health and wellbeing. To meet these and other related statutory requirements, this final rule requires agencies to ensure that placements for all children are free from harassment, mistreatment, and abuse. The final rule requires that title IV-E and IV-B agencies ensure a Designated Placement is available for all children who identify as LGBTQI+ and specifies the Designated Placement requirements.

This notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued approval by the Centers for Medicare & Medicaid Services (CMS) of CHAP's national accrediting organization program for suppliers providing home infusion therapy (HIT) services and 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, CMS will 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.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled "Listening Session: Optimizing FDA's Use of and Processes for Advisory Committees." The purpose of the listening session is to solicit feedback on the Agency's use of and processes for its advisory committee system.

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 or Agency) is announcing the availability of a draft document entitled "Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry." Allogeneic cells of human origin may be expanded in culture to manufacture medical products consisting of live cells, inactivated cells, cell lysates, or other cell-based materials such as cell-derived particles. The draft guidance document provides sponsors of allogeneic cell-based medical products recommendations for determining the appropriate cell safety testing to support an investigational new drug application (IND) or a biologics license application (BLA). Cell safety testing should be based on a risk analysis that considers the expansion potential of the cells, the reagents that are used to expand the cells in culture, and the number of individuals the cell-based medical product is capable of treating.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with our regulations after we revoked specific requirements pertaining to the use of partially hydrogenated oils in certain foods or as a direct or indirect food substance.

The Food and Drug Administration (FDA, Agency, or we) has determined that FLUDARABINE PHOSPHATE Injection, 50 milligrams (mg)/2 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is amending the food additive regulations to update the production organism Corynebacterium lilium that has been scientifically reclassified to Corynebacterium glutamicum. This action is being taken to improve the accuracy and clarity of the regulations.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public, limited only by the number of audio and web conference lines (500 audio and web conference lines are available). Time will be available for public comment. Registration is required.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic 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.

This notice acknowledges the receipt of an application from The Compliance Team (TCT) for continued approval by the Centers for Medicare & Medicaid Services (CMS) of TCT's national accrediting organization program for suppliers providing home infusion therapy (HIT) services and 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, CMS will 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #287 entitled "Raw Data for Safety and Effectiveness Studies." This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine's (CVM's) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes our recommendations for submitting raw data.

The Department of Health and Human Services (HHS or "Department") is issuing this final rule to modify the Standards for Privacy of Individually Identifiable Health Information ("Privacy Rule") under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The Department is issuing this final rule after careful consideration of all public comments received in response to the notice of proposed rulemaking (NPRM) for the HIPAA Privacy Rule to Support Reproductive Health Care Privacy ("2023 Privacy Rule NPRM") and public comments received on proposals to revise provisions of the HIPAA Privacy Rule in the NPRM for the Confidentiality of Substance Use Disorder (SUD) Patient Records ("2022 Part 2 NPRM").

The Food and Drug Administration is reopening the comment period for the draft guidance for industry entitled "Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination and Removal of a Foreign Manufacturer's Goods From Detention Without Physical Examination; Draft Guidance for Industry; Availability" that published in the Federal Register of February 12, 2024. We are taking this action in response to a request to extend the comment period to allow additional time for interested parties to submit comments.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled "Pregnancy Exposure Registry Enrollment Project: A Survey of Healthcare Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications."

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.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications." This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions.

The Food and Drug Administration (FDA or Agency) is establishing a public docket entitled "Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration's Office of Clinical Pharmacology." The purpose of this docket is to solicit input from interested parties on specific and actionable policy topics that could be prioritized, developed, and implemented by the staff of the Center for Drug Evaluation and Research's (CDER's) Office of Clinical Pharmacology (OCP) to support effective drug development programs.

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 electronic user fee payment request forms.

This notice announces the application of the Association for the Advancement of Blood and Biotherapies (AABB) for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program. We have determined that AABB meets or exceeds the applicable CLIA requirements. We are announcing the re-approval and grant AABB deeming authority for a period of 6 years.

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 Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the 2024 Racial and Ethnic Approaches to Community Health (REACH) Lark Galloway-Gilliam for Advancing Health Equity Award Challenge (REACH Lark Award Challenge). This biennial challenge was established in 2019 to recognize extraordinary individuals, organizations, or community coalitions associated with the REACH program whose work has contributed to the implementation of culturally tailored interventions that advance health equity, reduce health disparities, and increase community engagement to address preventable risk behaviors (e.g., tobacco use, poor nutrition, and physical inactivity).

The Office of Community Services (OCS), Administration for Children and Families (ACF) requests a 3-year extension of the Community Services Block Grant (CSBG) State Plan, CSBG Eligible Entity Master List, and the American Customer Survey Index (ACSI) forms (OMB #0970-0382, expiration 8/31/2024). There are no changes requested to these information collections.

The Office of Refugee Resettlement (ORR), Administration for children and Families (ACF), U.S. Department of Health and Human Services (HHS), seeks an update to the existing data collection for the form ORR-5: Refugee Data Submission System for Formula Funds Allocations and Service Analysis (OMB#: 0970-0043, expiration 4/30/ 2024) and requests an extension of approval for three years. Minor changes to the form ORR-5 are as proposed in the description section. Since the previous comment period, there are additional minor proposed edits: an additional data element to clarify whether the initial client assessment was completed and a change to spacing in headers to improve data processing. ACF estimates the proposed changes will not increase response 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.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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 a generic clearance to collect information to support social and behavioral research used by FDA about drug products.

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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Direct Reading Methodologies, Sensors, and Robotics Technology Assessment in Lab/Simulator-based Settings. The proposed data collection will allow NIOSH to assess the safety and health considerations of these rapidly changing direct reading methods, sensor, and robotics technologies.

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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Evaluation of HIV Self-Testing and Clinical Testing Guidelines Implementation. This project is designed to collect data from HIV healthcare providers, working in various settings, on the awareness and uptake of HIV-related guidelines.

The Office of Community Services (OCS), Administration for Children and Families (ACF), requests an approval of the Community Services Block Grant (CSBG) Model Tribal Plan.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC). CHAC consists of 18 experts in fields associated with public health; epidemiology; laboratory practice; immunology; infectious diseases; substance use disorder; behavioral science; health education; healthcare delivery; state health programs; clinical care; preventive health; medical education; health services and clinical research; health equity; and healthcare financing, who are selected by the Secretary, HHS.

The Office of Community Services (OCS), Administration for Children and Families (ACF) requests approval of revisions of the Community Services Block Grant (CSBG) Annual Progress Report, (OMB #0970-0492, expiration 6/30/2024). This includes an extension with minor changes to the currently approved Annual Report, a proposed revised version of the Annual Report for use in future fiscal years, the submission of the Tribal Annual Report and Tribal Short Form, and the removal of supplemental funding reports that are no longer in use.

The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) is requesting a 3-year extension of the Refugee Support Services (RSS) and RSS Set Aside Sub-Agency List (Office of Management and Budget # 0970-0556). ORR is not proposing any changes to the form.

The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) seeks input from language access stakeholders, including organizations representing and/or serving communities with Limited English Proficiency (LEP), to inform the development of a universal symbol informing people about the availability of language assistance services in health settings. This is NOT a solicitation for proposals or proposal abstracts.

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 a revision of the currently approved information collection project: "Medical Expenditures Panel SurveyHousehold and Medical Provider Components." In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection.

The Health Resources and Services Administration administers section 340B of the Public Health Service (PHS) Act, which is referred to as the "340B Drug Pricing Program" or the "340B Program." This final rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The final rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution (ADR) process. This final rule revises the 340B administrative dispute resolution process set forth in the Code of Federal Regulations.

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

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.

The Administration for Community Living (ACL) 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 extension of this ACL Prevention and Public Health Fund Evidence-Based Falls Prevention Program Information Collection.

This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule for calendar year 2025. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.

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

This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment program, as well as 2025 user fee rates for issuers offering qualified health plans (QHPs) through federally facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also includes requirements related to the auto re-enrollment hierarchy; essential health benefits; failure to file Federal income taxes to reconcile advance payments of the premium tax credit (APTC); non- standardized plan option limits in the FFEs and SBE-FPs and a related exceptions process; standardized plan options in the FFEs and SBE-FPs; special enrollment periods (SEPs); direct enrollment (DE) entities supporting Exchange applications and enrollments; the Insurance Affordability Program enrollment eligibility verification process; requirements for agents, brokers, web-brokers, and DE entities assisting Exchange consumers; network adequacy; public notice procedures for section 1332 waivers; prescription drug benefits; updates to the Consumer Operated and Oriented Plan (CO-OP) Program; and State flexibility on the effective date of coverage in the Basic Health Program (BHP).

In accordance with the Federal Advisory Committee Act, 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 Council for the Elimination of Tuberculosis (ACET). ACET consists of 10 experts including the Chair in fields associated with public health, epidemiology, immunology, infectious diseases, pulmonary disease, pediatrics, tuberculosis, microbiology, and preventive health care delivery.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following 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 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.

HRSA is inviting public comment on the draft Health Center Program Policy Guidance Regarding Services to Support Transitions in Care for Justice-Involved Individuals Reentering the Community. The purpose of the draft Policy Information Notice (PIN) is to propose Health Center Program policy guidance for all health centers that apply for and receive federal award funds under the Health Center Program, as authorized by section 330 of the Public Health Service (PHS) Act (including sections 330(e), (g), (h), and (i)), as well as section 330 subrecipient organizations and Health Center Program look-alikes, to clarify the conditions under which they may provide certain health services as part of the Health Center Program scope of project to certain incarcerated/detained individuals. This draft PIN establishes policy guidance that identifies a set of health services that a health center may provide, the locations at which such services may be provided, the target population for such services (specifically, incarcerated/detained individuals who are scheduled for release from a carceral setting within 90 days), and other pertinent circumstances under which the health center may, on its own behalf and subject to all section 330 requirements, provide such services to justice-involved individuals reentering the community to support their care transition from the carceral setting to the community within the scope of their Health Center Program project.