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

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Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Ryan White HIV/AIDS Program Client-Level Data Reporting System, OMB No. 0906-0039-Revision
Document Number: 2024-08610
Type: Notice
Date: 2024-04-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2024-08597
Type: Notice
Date: 2024-04-23
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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Healthcare Safety Network (NHSN). NHSN provides facilities, States, regions, and the nation with data necessary to identify problem areas, measure the progress of prevention efforts, and ultimately eliminate healthcare- associated infections (HAIs) nationwide.
PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications
Document Number: 2024-08657
Type: Notice
Date: 2024-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting-Guardant Shield Blood Collection Kit
Document Number: 2024-08656
Type: Notice
Date: 2024-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
Document Number: 2024-08655
Type: Notice
Date: 2024-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
Document Number: 2024-08649
Type: Notice
Date: 2024-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants are required to, or have agreed to, conduct is on the FDA's website entitled "Postmarketing Requirements and Commitments: Reports" (https:// www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Pos t- marketingPhaseIVCommitments/ucm064436.htm).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2024-08596
Type: Notice
Date: 2024-04-23
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 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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2024-08595
Type: Notice
Date: 2024-04-23
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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled REACH: Rural Re-Engagement and Care using Community Health Workers (CHWs) for Persons with HIV. This project is designed to collect standardized program evaluation data from health departments and HIV clinic partners who receive Federal funds for these activities.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2024-08594
Type: Notice
Date: 2024-04-23
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 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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2024-08593
Type: Notice
Date: 2024-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2024-08592
Type: Notice
Date: 2024-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2024-08591
Type: Notice
Date: 2024-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2024-08587
Type: Notice
Date: 2024-04-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2024-08586
Type: Notice
Date: 2024-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Community Services Block Grant (CSBG) Model Tribal Plan and Application (New Collection)
Document Number: 2024-08668
Type: Notice
Date: 2024-04-23
Agency: Department of Health and Human Services, Administration for Children and Families
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
Document Number: 2024-08658
Type: Notice
Date: 2024-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2024-08635
Type: Notice
Date: 2024-04-23
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: 2024-08634
Type: Notice
Date: 2024-04-23
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: 2024-08632
Type: Notice
Date: 2024-04-23
Agency: Department of Health and Human Services, National Institutes of Health
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)
Document Number: 2024-07105
Type: Rule
Date: 2024-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary
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
Document Number: 2024-08551
Type: Notice
Date: 2024-04-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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)
Document Number: 2024-08549
Type: Notice
Date: 2024-04-22
Agency: Department of Health and Human Services, Administration for Children and Families
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2024-08548
Type: Notice
Date: 2024-04-22
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity; Refugee Support Services (RSS) and RSS Set Aside Sub-Agency List (Office of Management and Budget # 0970-0556)
Document Number: 2024-08538
Type: Notice
Date: 2024-04-22
Agency: Department of Health and Human Services, Administration for Children and Families
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.
National Cancer Institute; Amended Notice of Meeting
Document Number: 2024-08483
Type: Notice
Date: 2024-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2024-08482
Type: Notice
Date: 2024-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Income Levels Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act
Document Number: 2024-08504
Type: Notice
Date: 2024-04-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
National Institute of Dental and Craniofacial Research; Notice of Meeting
Document Number: 2024-08502
Type: Notice
Date: 2024-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Fogarty International Center; Notice of Meeting
Document Number: 2024-08501
Type: Notice
Date: 2024-04-22
Agency: Department of Health and Human Services, National Institutes of Health
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
Meeting of the Board of Scientific Counselors, Office of Readiness and Response
Document Number: 2024-08448
Type: Notice
Date: 2024-04-22
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 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
Document Number: 2024-08447
Type: Notice
Date: 2024-04-22
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 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.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2024-08485
Type: Notice
Date: 2024-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2024-08484
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
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