Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
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Proposed Data Collection Submitted for Public Comment and Recommendations
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.
Proposed Information Collection Activity; Community Services Block Grant (CSBG) Model Tribal Plan and Application (New Collection)
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the "generic" clearance process. Generally, this is an expedited clearance process by which agencies may obtain OMB's approval of collection of information requests that are "usually voluntary, low- burden, and uncontroversial," do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that may be submitted under that umbrella. This notice is intended to advise the public of our intent to extend OMB's approval of our MACPro (Medicaid and CHIP Program) umbrella and all of the individual generic collection of information requests that fall under that umbrella. This notice also provides the public with general instructions for obtaining documents that are associated with such collections and for submitting comments.
Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE)
This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas. This final rule also codifies existing sub-regulatory guidance in the Part C and Part D programs.
Medicare Program Public Meeting for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding-May 28-30, 2024
This notice announces the dates and times of the virtual Healthcare Common Procedure Coding System (HCPCS) public meeting to be held from May 28, 2024, through May 30, 2024, to discuss CMS' preliminary coding, Medicare benefit category, and payment determinations, if applicable, for new revisions to the HCPCS Level II code set for non-drug and non-biological items and services, as well as how to register for those meetings.
Proposed Information Collection Activity; Community Services Block Grant (CSBG) Annual Progress Report (Office of Management and Budget No. 0970-0492)
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.
Proposed Information Collection Activity; Refugee Support Services (RSS) and RSS Set Aside Sub-Agency List (Office of Management and Budget # 0970-0556)
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.
Income Levels Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act
HRSA is updating income levels used to identify a "low-income family" for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in titles III, VII, and VIII of the Public Health Service Act. HHS periodically publishes in the Federal Register low-income levels to be used by institutions receiving grants or cooperative agreement awards to determine eligibility for programs providing training for disadvantaged individuals, individuals from disadvantaged backgrounds, or individuals from low-income families.
Meeting of the Board of Scientific Counselors, Office of Readiness and Response
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, Office of Readiness and Response, (BSC, ORR). This virtual meeting is open to the public. Time will be available for public comment.
Solicitation of Nominations for Appointment to the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment
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.
Development of a Universal Symbol for Language Assistance Services in Health Settings
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
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
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.
340B Drug Pricing Program; Administrative Dispute Resolution Regulation
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
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
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Government-Owned Inventions; Availability for Licensing
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
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
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
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
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
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.
Agency Information Collection Request; 30-Day Public Comment Request
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.
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