Department of Health and Human Services August 2024 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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.
Catastrophic Health Emergency Fund
The Indian Health Service (IHS or Service) administers the Catastrophic Health Emergency Fund (CHEF) pursuant to section 202 of the Indian Health Care Improvement Act (IHCIA). The purpose of the CHEF is to meet the extraordinary medical costs associated with the treatment of victims of disasters or catastrophic illnesses who are within the responsibility of the Service. This document finalizes the regulations governing the administration of the CHEF, with clarifying edits, and responds to comments received on the proposed rule.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group (IRG) Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.
Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age
The Food and Drug Administration is issuing a final rule to make conforming changes as required by the Further Consolidated Appropriations Act, 2020 (Appropriations Act), which established a new Federal minimum age of sale for tobacco products. These conforming changes include increasing the minimum age of sale for cigarettes, smokeless tobacco, and covered tobacco products from 18 to 21 years of age; increasing the minimum age for age verification by means of photographic identification for cigarettes, smokeless tobacco, and covered tobacco products from under the age of 27 to under the age of 30; increasing the minimum age of individuals who may be present or permitted to enter facilities that maintain vending machines to sell cigarettes, smokeless tobacco, or covered tobacco products from 18 to 21 years of age; and increasing the minimum age of individuals who may be present or permitted to enter facilities that maintain self-service displays that sell cigarettes or smokeless tobacco from 18 to 21 years of age.
Announcing the Intent To Award a Single-Source Supplement for the Strengthening the Direct Care Workforce: A Technical Assistance and Capacity Building Initiative
The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the National Council on Aging for the "Strengthening the Direct Care Workforce: A Technical Assistance and Capacity Building Initiative". The administrative supplement for FY 2024 will be in the amount of $1,787,524 bringing the total award for FY 2024 to $3,087,207. The supplement will provide sufficient resources to enable the grantee and their partners to increase funding for technical assistance (TA) to state aging and disability partnerships to collaborate with workforce entities to strengthen the Direct Care Workforce. The funding will enable the grantee to support additional states, including at more robust levels than originally planned.
Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Proposed Modifications to Data Collection Fields and Data Validation Procedures; Final Notice
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces revised plans for data collection fields for reporting of pregnancy success rates from assisted reproductive technology (ART) programs and for data validation procedures. This reporting is required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA). This notice also responds to public comments received in response to CDC's 2023 request for comment in a Federal Register notice.
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.
Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers
The Food and Drug Administration (FDA, Agency, or we) is announcing a minor, technical modification to an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the "Voluntary Malfunction Summary Reporting Program."
Voluntary Malfunction Summary Reporting Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers." This final guidance document is intended to help manufacturers better understand and use the VMSR Program. This guidance describes and clarifies several aspects of the VMSR Program, including the FDA's approach to determining the eligibility of product codes for the program and the conditions for submitting medical device reports (MDRs) for device malfunctions in summary format under the program.
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.
Authorization of Emergency Use of a Freeze-Dried Plasma Product for Treatment of Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use of a freeze-dried plasma product, octaplasLG Powder, for emergent treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical.
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.
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 reinstate OMB's approval of our generic umbrella (CMS-10398, OMB control number 0938-1148) 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.
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.
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, is publishing the following summary of a proposed collection for public comment.
Determination That DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (Diltiazem Hydrochloride), 125 Milligrams/125 Milliliters (1 Milligram/Milliliter) and 250 Milligrams/250 Milliliters (1 Milligram/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or the Agency) has determined that DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem hydrochloride (HCl)), 125 milligrams (mg)/125 milliliters (mL) (1 mg/ mL) and 250 mg/250 mL (1 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for diltiazem HCl, 125 mg/125 mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL), if all other legal and regulatory requirements are met.
Fiscal Year (FY) 2024 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements in scope of the parent award for the five eligible grant recipients funded in FY22 and FY23 under the Grants to Prevent Prescription Drug/Opioid Overdose Program (PDO), Notice of Funding Opportunity (NOFO) SP-21-002. Recipients may receive up to $279,266 each for a total of $1,396,330 across the program. These recipients have a project end date for use of these supplemental funds of September 29, 2025. The supplemental funding will be used to fund a comprehensive Training of Trainer (ToT) model to enhance workforce development and capacity in the arena of preventing prescription drug/ overdose related deaths and adverse events within existing projects funded under the PDO program.
Fiscal Year (FY) 2024 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting an administrative supplement in scope of the parent award for one eligible grant recipient funded under the FY 2023 Provider's Clinical Support SystemMedications for Opioid Use Disorder (PCSS-MOUD), Notice of Funding Opportunity (NOFO) TI-23-014. The recipient may receive up to $1,000,000. This supplement provides support to the recipient with a project end date of September 30, 2025. The supplemental funding will be used to support increased fees from the training platform service as a result of an increase in the number of practitioners accessing training from the program.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) hereby gives notice that the National Vaccine Advisory Committee (NVAC) will hold an in-person meeting. The meeting will be open to the public and public comment will be heard during the meeting.
Submission for Office of Management and Budget Review; Head Start Program Performance Standards (Office of Management and Budget #: 0970-0148)
The Administration for Children and Families (ACF) is requesting a 3-year extension of the information collection requirements under the Head Start Program Performance Standards (Office of Management and Budget (OMB) #0970-0148, expiration August 31, 2024). On August 21, 2024, the Office of Head Start (OHS) published a final rule: Supporting the Head Start Workforce and Consistent Quality Programming. This information collection contains changes to recordkeeping requirements as described in this final rule.
Fiscal Year (FY) 2024 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements in scope of the parent award for the 26 eligible grant recipients funded in FY 2022 under the First Responders- Comprehensive Addiction and Recovery Act (FR-CARA), Notice of Funding Opportunity (NOFO) TI-22-008. Recipients may receive up to $58,190 each, for a total of $1,512,940 across the program. These recipients have a project end date for use of these supplemental funds of September 29, 2025. The supplements will be used to fund a Training of Trainer (ToT) model to rapidly expand workforce development and capacity in the arena of preventing overdose related deaths and adverse events within existing projects funded under the FR-CARA program.
Reorganization of the National Center for Injury Prevention and Control
CDC has modified its structure. This notice announces the National Center for Injury Prevention and Control (NCIPC) reorganization. NCIPC established the Behavioral Integration Branch.
Announcing the Intent To Award a Single-Source Supplement for the Eldercare Locator
The Administration for Community Living (ACL) announces its intent to award a single-source supplement to the current cooperative agreement held by USAging for the Eldercare Locator. The purpose of this funding is to continue operation of the Disability Information and Access Line (DIAL). Originally funded in FY 2021 to connect people with disabilities to information about COVID-19 and assistance with accessing the COVID-19 vaccine, DIAL has become a critical resource for people with disabilities to get information and connect to state and local organization able to provide assistance serving over 100,000 since launching in June, 2021.
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled "Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide." The Mammography Quality Standards Act of 1992 (MQSA) final rule amended FDA's regulations to address, among other things, standards for accreditation bodies, certifying agencies, mammography equipment, quality assurance testing, and clinical image quality, as well as to require certain breast density information be provided by mammography facilities to patients and their healthcare providers. The small entity compliance guide (SECG) is intended to help small entities comply with the MQSA final rule.
Withdrawal of Approval and Amending of Mammography Quality Standards Act Alternative Standards
The Food and Drug Administration (FDA or the Agency) is announcing the withdrawal of two Mammography Quality Standards Act (MQSA) Alternative Standards and the amending of one Alternative Standard due to the updated MQSA regulations.
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