Department of Health and Human Services September 26, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 29 of 29
Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients With Renal Impairment; Public Workshop
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing in Pediatric Patients With Renal Impairment.'' The purpose of the public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge, and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.
Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #273 entitled ``Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals.'' This draft guidance document, when finalized, will provide recommendations on how sponsors may voluntarily establish defined durations of use for certain antimicrobial new animal drugs used in or on the medicated feed of food-producing animals that are currently approved with one or more indications that lack a defined duration of use. Establishing defined durations of use within the approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) is intended to mitigate development of antimicrobial resistance for these antimicrobial drugs, which are important to human medicine. It also, when finalized, will propose timelines for stakeholders wishing to voluntarily align their affected applications with this guidance.
Federal Independent Dispute Resolution (IDR) Process Administrative Fee and Certified IDR Entity Fee Ranges
This document sets forth proposed rules related to the fees established by the No Surprises Act for the Federal independent dispute resolution (IDR) process, as established by the Consolidated Appropriations Act, 2021 (CAA). These proposed rules would amend existing regulations to provide that the administrative fee amount charged by the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (the Departments) to participate in the Federal IDR process, and the ranges for certified IDR entity fees for single and batched determinations will be set by the Departments through notice and comment rulemaking. These proposed rules would also set forth the methodology used to calculate the administrative fee and the considerations used to develop the certified IDR entity fee ranges. This document also proposes the amount of the administrative fee for disputes initiated on or after the later of the effective date of these rules or January 1, 2024. Finally, this document proposes the certified IDR entity fee ranges for disputes initiated on or after the later of the effective date of these rules or January 1, 2024. In accordance with 5 U.S.C. 553(b)(4), a summary of this rule may be found at https://www.regulations.gov/.
Proposed Reallotment of Fiscal Year 2022 Funds for the Low Income Home Energy Assistance Program
The Administration for Children and Families (ACF), Office of Community Service (OCS), Division of Energy Assistance announces a preliminary determination that funds from the Federal fiscal year (FFY) 2022 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to States, Territories, Tribes, and Tribal organizations that received FFY 2023 direct LIHEAP grants. The purpose of this award is to redistribute FFY 2022 annual LIHEAP funds that grant recipients were unable to obligate or carry over to FFY 2023. No sub-recipients of these grant recipients or other entities may apply for these funds.
Requirements for Additional Traceability Records for Certain Foods; Technical Amendment
The Food and Drug Administration (FDA, the Agency, or we) is correcting the final rule on requirements for additional traceability records for certain foods that published in the Federal Register of November 21, 2022. The final rule published with some editorial and inadvertent errors. This document corrects those errors.
Parentage Establishment in the Child Support Services Program
Office of Child Support Services (OCSS) proposes to replace the gender-specific term ``paternity'' with the gender-neutral term ``parentage'' throughout the Child Support Services Program to be inclusive of all family structures served by the child support services program. While title IV-D (Child Support and Establishment of Paternity) requires States and Tribes to have laws permitting the establishment of paternity and requiring genetic testing in contested paternity cases, OCSS also recognizes that title IV-D does not preclude States and Tribes from having parentage establishment laws and procedures for all families. The proposed changes to chapter III of the child support regulations recognize developments in State laws regarding parentage establishment and provide States and Tribes optional flexibility to establish parentage for all children in accordance with their laws, regardless of the gender of their parents or family structure.
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Formative Research and Tool Development''. This information collection request is designed to allow CDC's National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) to conduct formative research information collection activities used to inform many aspects of surveillance, communications, health promotion, and research project development for NCHHSTP's four priority diseases (HIV/AIDS), sexually transmitted diseases/infections (STD/STI), viral hepatitis, tuberculosis elimination (TB), and school and adolescent health (DASH).
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 Social and Economic Barriers to Receiving Optimal Services Along the Cancer Care Continuum. This mixed methods data collection effort will help CDC understand the social and economic barriers that colorectal, breast, and cervical cancer survivors and their caregivers face at each stage of the cancer care continuum, from screening through survivorship, and how these barriers may vary by population.
Submission for Office of Management and Budget Review; Title V State Sexual Risk Avoidance Education (Office of Management and Budget #0970-0551)
The Family and Youth Services Bureau (FYSB) within the Administration on Children, Youth and Families (ACYF) is accepting mandatory formula grant applications and State plans from States and Territories for the development of and implementation for Title V State Sexual Risk Avoidance Education (SRAE) Program. The Title V State SRAE Notice of Funding Opportunity (NOFO) sets forth the application requirements for recipients. This request is to extend Office of Management and Budget (OMB) approval of the request for information. No changes are proposed.
Agency Information Collection Request; 60-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.
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