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

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National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2024-08500
Type: Notice
Date: 2024-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2024-08499
Type: Notice
Date: 2024-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Development of a Universal Symbol for Language Assistance Services in Health Settings
Document Number: 2024-08409
Type: Notice
Date: 2024-04-19
Agency: Department of Health and Human Services
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.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2024-08398
Type: Notice
Date: 2024-04-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2024-08431
Type: Notice
Date: 2024-04-19
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.
National Center for Complementary and Integrative Health; Notice of Closed Meeting
Document Number: 2024-08286
Type: Notice
Date: 2024-04-19
Agency: Department of Health and Human Services, National Institutes of Health
340B Drug Pricing Program; Administrative Dispute Resolution Regulation
Document Number: 2024-08262
Type: Rule
Date: 2024-04-19
Agency: Department of Health and Human Services
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.
Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Polyvalent Vaccines and Methods for Making Them
Document Number: 2024-08361
Type: Notice
Date: 2024-04-19
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, on behalf of the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to University Health Network, located in Toronto, Canada, its rights to the technologies and the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.
Meeting of the National Advisory Council on Migrant Health
Document Number: 2024-08345
Type: Notice
Date: 2024-04-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2024-08122
Type: Notice
Date: 2024-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2024-08112
Type: Notice
Date: 2024-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2024-08164
Type: Notice
Date: 2024-04-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2024-08184
Type: Notice
Date: 2024-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2024-08178
Type: Notice
Date: 2024-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2024-08111
Type: Notice
Date: 2024-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2024-08110
Type: Notice
Date: 2024-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2024-08013
Type: Notice
Date: 2024-04-16
Agency: Department of Health and Human Services, National Institutes of Health
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2024-08011
Type: Notice
Date: 2024-04-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Center for Drug Evaluation and Research Center for Clinical Trial Innovation
Document Number: 2024-07829
Type: Notice
Date: 2024-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing this notice to announce the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI aims to be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the quality and efficiency of drug development and regulatory decision making. C3TI's mission is to promote existing and future CDER clinical trial innovation activities through enhanced communication and collaboration. Existing CDER clinical development innovation programs will continue to operate according to their established processes with C3TI serving to synthesize lessons learned across those programs. C3TI will also be providing additional opportunities for sponsors of innovative clinical trials in the project areas described below to interact with CDER staff with the goal of fostering knowledge sharing both internally and externally.
Agency Information Collection Activities: Submission for OMB Review; Public Comment Request; Prevention and Public Health Fund Evidence-Based Falls Prevention Program Information Collection; OMB Control Number 0985-0039
Document Number: 2024-08009
Type: Notice
Date: 2024-04-16
Agency: Department of Health and Human Services
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.
Medicare Program; Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, July 25-26, 2024
Document Number: 2024-08008
Type: Notice
Date: 2024-04-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the public meeting dates for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Thursday, July 25, 2024 and Friday, July 26, 2024. 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 on issues related to clinical diagnostic laboratory tests.
Public Meeting on June 25, 2024 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2025
Document Number: 2024-08005
Type: Notice
Date: 2024-04-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Notice of Closed Meeting
Document Number: 2024-07961
Type: Notice
Date: 2024-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2024-07934
Type: Notice
Date: 2024-04-16
Agency: Department of Health and Human Services
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.
Solicitation of Nominations for Appointment to the Healthcare Infection Control Practices Advisory Committee
Document Number: 2024-07851
Type: Notice
Date: 2024-04-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Healthcare Infection Control Practices Advisory Committee (HICPAC). HICPAC consists of 14 experts in fields including, but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical and environmental microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related fields.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2024-07885
Type: Notice
Date: 2024-04-15
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Application by the Accreditation Commission for Health Care (ACHC) for Continued CMS Approval of Its Home Infusion Therapy (HIT) Accreditation Program
Document Number: 2024-07884
Type: Notice
Date: 2024-04-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the Accreditation Commission for Health Care (ACHC) for continued recognition as a national accrediting organization that accredits suppliers of home infusion therapy (HIT) services that wish to participate in the Medicare or Medicaid programs.
Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program
Document Number: 2024-07274
Type: Rule
Date: 2024-04-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary, Department of the Treasury
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).
Notice of Closed Meeting
Document Number: 2024-07850
Type: Notice
Date: 2024-04-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Solicitation of Nominations for Appointment to the Advisory Council for the Elimination of Tuberculosis
Document Number: 2024-07849
Type: Notice
Date: 2024-04-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.
Meeting of the Advisory Board on Radiation and Worker Health, Subcommittee for Dose Reconstruction Review, National Institute for Occupational Safety and Health
Document Number: 2024-07848
Type: Notice
Date: 2024-04-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Subcommittee for Dose Reconstruction Review 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.
Meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health
Document Number: 2024-07847
Type: Notice
Date: 2024-04-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2024-07746
Type: Notice
Date: 2024-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meeting
Document Number: 2024-07745
Type: Notice
Date: 2024-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974; System of Records
Document Number: 2024-07823
Type: Notice
Date: 2024-04-12
Agency: Department of Health and Human Services, Administration for Children and Families
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying a system of records maintained by the Office of Family Assistance (OFA) within the Administration for Children and Families (ACF), 09-80-0375 OFA Temporary Assistance for Needy Families (TANF) Data System. The modification will add Tribal TANF records from a separate system of records, 09-80-0373 OFA Tribal Temporary Assistance for Needy Families (Tribal TANF), which is now being rescinded; and will change the name of the system of records 09-80-0375 to Temporary Assistance for Needy Families (TANF) Data.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2024-07757
Type: Notice
Date: 2024-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2024-07796
Type: Notice
Date: 2024-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meetings
Document Number: 2024-07792
Type: Notice
Date: 2024-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meetings
Document Number: 2024-07791
Type: Notice
Date: 2024-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2024-07790
Type: Notice
Date: 2024-04-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2024-07806
Type: Notice
Date: 2024-04-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 B. multivorans Ice Machine Multistate Investigation. This is an outbreak investigation which aims to evaluate the associations between Burkholderia multivorans infections among hospitalized patients and potential exposures to nonsterile ice and water from ice machines to help inform measures to prevent ongoing transmission.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2024-07805
Type: Notice
Date: 2024-04-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2024-07803
Type: Notice
Date: 2024-04-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2024-07801
Type: Notice
Date: 2024-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2024-07799
Type: Notice
Date: 2024-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2024-07798
Type: Notice
Date: 2024-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2024-07797
Type: Notice
Date: 2024-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Availability of Draft Health Center Program Policy Guidance Regarding Services To Support Transitions in Care for Justice-Involved Individuals Reentering the Community
Document Number: 2024-07630
Type: Notice
Date: 2024-04-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Privacy Act of 1974; System of Records
Document Number: 2024-07668
Type: Notice
Date: 2024-04-11
Agency: Department of Health and Human Services, Administration for Children and Families
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the Administration for Children and Families (ACF), Office of Child Support Services (OCSS): System No. 09-80-0381, "OCSS National Directory of New Hires, HHS/ACF/OCSS."
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