Department of Health and Human Services August 28, 2024 – Federal Register Recent Federal Regulation Documents
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Medicare and Medicaid Programs and the Children's Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes
This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; makes changes relating to Medicare graduate medical education (GME) for teaching hospitals; updates the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); and makes other policy- related changes.
Proposed Information Collection Activity; Title IV-E Programs Quarterly Financial Report (0970-0510)
The Administration for Children and Families (ACF) Children's Bureau plans to submit revisions to an approved generic information collection (GenIC) under the umbrella generic: Generic Clearance for Financial Reports used for ACF Non-Discretionary Grant Programs (0970- 0510). This request revises form CB-496, the Title IV-E Programs Quarterly Financial Report, used by title IV-E agencies to submit financial claims for the title IV-E entitlement grant programs.
Supplemental Evidence and Data Request on Medical Therapies for Locally Advanced Gastric Adenocarcinoma
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Medical Therapies for Locally Advanced Gastric Adenocarcinoma, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LIVMARLI (maralixibat)
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that LIVMARLI (maralixibat), approved on September 29, 2021, manufactured by Mirum Pharmaceuticals, Inc., meets the criteria for a priority review voucher.
Determination That FENTANYL CITRATE Injections, Equivalent to 2.5 Milligram Base/50 Milliliter and Equivalent to 5 Milligram Base/100 Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that FENTANYL CITRATE Injections, equivalent to 2.5 milligram (mg) base/50 milliliter (mL) (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for FENTANYL CITRATE Injections, EQ 2.5 mg base/50 mL (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), if all other legal and regulatory requirements are met.
Patient Engagement Advisory Committee; Notice of Meeting-Patient-Centered Informed Consent in Clinical Study
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the 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.
Meetings of the Substance Abuse and Mental Health Services Administration's Tribal Technical Advisory Committee (TTAC), and Joint Meeting of the TTAC and Indian Health Service (IHS) National Tribal Advisory Committee on Behavioral Health (NTAC)
Notice is hereby given for the meetings on September 17, 2024, of the Substance Abuse and Mental Health Services Administration's Tribal Technical Advisory Committee (TTAC); and on September 18, 2024, a joint meeting with the TTAC and Indian Health Service (IHS) National Tribal Advisory Committee on Behavioral Health (NTAC). Both meetings are open to the public and will be held in person and virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/ meetings. The TTAC meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; updates on SAMHSA priorities; follow up on topics related to the previous TTAC meetings; and council discussions. The joint meeting of the SAMHSA TTAC and IHS NTAC will include discussion on improving behavioral health for American Indian and Alaska Natives.
Notice of Award of a Single Source Cooperative Agreement To Fund California Department of Public Health; Chicago Department of Public Health; Delaware Department of Health and Social Services; Florida Department of Health; Georgia Department of Public Health; Houston Department of Health and Human Services; Illinois Department of Public Health; Indiana State Department of Health; Los Angeles County Department of Public Health; Michigan Department of Health and Human Services; Mississippi State Department of Health; New Jersey Department of Health and Senior Services; New York City Department of Health and Mental Hygiene; New York State Department of Health; North Carolina Department of Health and Human Services; Oregon Health Authority; Pennsylvania Department of Health; Philadelphia Department of Public Health; Puerto Rico Department of Health; San Francisco Department of Public Health; Texas Department of State Health Services; Virginia Department of Health; and Washington State Department of Health
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces 23 separate awards to fund the California Department of Public Health; Chicago Department of Public Health; Delaware Department of Health and Social Services; Florida Department of Health; Georgia Department of Public Health; Houston Department of Health and Human Services; Illinois Department of Public Health; Indiana State Department of Health; Los Angeles County Department of Public Health; Michigan Department of Health and Human Services; Mississippi State Department of Health; New Jersey Department of Health and Senior Services; New York City Department of Health and Mental Hygiene; New York State Department of Health; North Carolina Department of Health and Human Services; Oregon Health Authority; Pennsylvania Department of Health; Philadelphia Department of Public Health; Puerto Rico Department of Health; San Francisco Department of Public Health; Texas Department of State Health Services; Virginia Department of Health; and Washington State Department of Health. The total amount of awards is approximately $16,305,555 in Federal Fiscal Year (FFY) 2025, with an expected total funding of approximately $81,527,775 for the five-year period of performance, subject to availability of funds. The awards will support implementation of the Medical Monitoring Project (MMP), an ongoing public health surveillance program funded since 2005 and designed to learn more about the experiences and needs of adults aged 18 or older living with HIV (PWH) in the United States.
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