Department of Health and Human Services November 29, 2024 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application
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 the information collection provisions of medicated feed mill license reporting.
Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on financial disclosure by clinical investigators.
Use of Circulating Tumor Deoxyribonucleic Acid for Curative-Intent Solid Tumor Drug Development; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development." This guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor DNA (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage (curative-intent) setting. This guidance finalizes the draft guidance entitled "Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development" issued on May 2, 2022.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Centers for Independent Living Program Performance Report (0985-0061)
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This proposed revision of a currently approved information collection request (ICR Rev) solicits comments on the information collection requirements related to the Centers for Independent Living (CILs) under the Rehabilitation Act of 1973, 29 U.S.C. 701, et seq. (the Act).
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.
Meetings of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that an in-person meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB); the main focus of the meeting is to solicit feedback from invited presenters and members of the public on the 2025-2020 National Action Plan on Combating Antibiotic Resistant Bacteria. The meeting will be open to the public as well as streamed live on hhs.gov/live. A pre- registered public comment and innovation spotlight session will be held during the meeting. Pre-registration is required for members of the public who wish to present their comments or innovations live during the meeting.
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with administrative detention and banned medical devices.
General Compliance Program Guidance; Industry Segment-Specific Compliance Program Guidance for Skilled Nursing Facilities and Nursing Facilities; Resources for Industry; Availability
OIG is announcing the availability of the following resources for industry: General Compliance Program Guidance (GCPG) and Industry Segment-Specific Compliance Program Guidance for Skilled Nursing Facilities and Nursing Facilities (Nursing Facility ICPG).
Adjustments for Disaster-Recovery States to the Fiscal Year 2024 and Fiscal Year 2025 Federal Medical Assistance Percentage (FMAP) Rates for Federal Matching Shares for Medicaid and Title IV-E Foster Care, Adoption Assistance, and Guardianship Assistance Programs
This notice announces the adjusted Federal Medical Assistance Percentage (FMAP) rates for the Fiscal Year 2024 and Fiscal Year 2025 for disaster-recovery FMAP adjustment States made available under the Social Security Act (the "Act"), as enacted in section 2006 of the Patient Protection and Affordable Care Act of 2010 ("Affordable Care Act"). The Social Security Act adjusts the regular FMAP rate for qualifying states that have experienced a major, statewide disaster. The percentages listed are for Fiscal Year 2024, retroactively effective from October 1, 2023 through September 30, 2024, and for Fiscal Year 2025, effective October 1, 2024 through September 30, 2025. Table 1 gives the Fiscal Year 2024 Disaster-Recovery Adjusted FMAP Rates and Table 2 gives the Fiscal Year 2025 Disaster-Recovery Adjusted FMAP Rates.
Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2025, Through September 30, 2026
The Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for fiscal year 2026 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2025, through September 30, 2026. This notice announces the calculated FMAP rates, in accordance with the Act, that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of Federal matching for state medical assistance (Medicaid), Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Title IV-E Foster Care Maintenance payments, Adoption Assistance payments and Kinship Guardianship Assistance payments, and the eFMAP rates for the Children's Health Insurance Program (CHIP) expenditures. Table 1 gives figures for each of the 50 states, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. This notice reminds states of adjustments available for states meeting requirements for disproportionate employer pension or insurance fund contributions and adjustments for disaster recovery. Based on the criteria for a qualifying state, one state meets the requirements for an adjustment for disaster recovery.
Notice of Availability of Final Health Center Program Policy Guidance Regarding Services To Support Transitions in Care for Justice-Involved Individuals Reentering the Community
The final Health Center Program Policy Guidance Regarding Services to Support Transitions in Care for Justice-Involved Individuals Reentering the Community Policy Information Notice (JI-R PIN) has been developed to assist health centers who choose to provide certain primary health care services to support the transition of JI-R individuals from the carceral setting back into the community setting.
Proposed Collection; 60-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (National Institute Allergy and Infectious Diseases)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of Allergy and Infectious Diseases (NIAID) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
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