Department of Health and Human Services September 2023 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 346
Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #273 entitled ``Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals.'' This draft guidance document, when finalized, will provide recommendations on how sponsors may voluntarily establish defined durations of use for certain antimicrobial new animal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.
Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice entitled ``Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications'' that appeared in the Federal Register of June 2, 2023. The document announced the withdrawal of approval (as of July 3, 2023) of eight abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of ANDA 077029, Calcipotriene Solution, 0.005% after receiving a withdrawal request from Tolmar, Inc., 701 Centre Ave., Fort Collins, CO 80526. Before FDA withdrew the approval of this ANDA, Tolmar, Inc. informed FDA that it did not want the approval of the ANDA withdrawn. Because Tolmar, Inc. timely requested that approval of ANDA 077029 not be withdrawn, the approval is still in effect. This document corrects that error.
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.
Yogurt Products Deviating From Standard of Identity; Amendment of Temporary Marketing Permit
The Food and Drug Administration (FDA or we) are amending Chobani, LLC's temporary permit to market test lower-fat yogurt products. The temporary permit is amended to allow the use of the test product as an ingredient in other nonstandardized food applications including drinkable beverages, dips, and sauces. This amendment will allow the applicant to continue to test market the test product, as ingredients, in whole or in part, in other nonstandardized foods and collect data on consumer acceptance of the test product.
Request for Information on the DRAFT Scientific Integrity Policy of the National Institutes of Health
The National Institutes of Health (NIH) is soliciting comments and suggestions from the public on the DRAFT ``Scientific Integrity Policy of the National Institutes of Health'' (DRAFT NIH Scientific Integrity Policy). The DRAFT NIH Scientific Integrity Policy codifies NIH's long-standing expectations to preserve scientific integrity throughout all NIH activities, establishes key roles and responsibilities for those who will lead the agency's scientific integrity program, and, as appropriate, establishes relevant reporting and evaluation mechanisms.
World Trade Center Health Program; Notices of Funding Opportunities Public Information Sessions
The Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH), in the Department of Health and Human Services, announces two public information sessions to provide information on current research funding opportunities published by the World Trade Center (WTC) Health Program. These sessions will provide information to members of the public who may be interested in submitting applications for funding consideration on the scope of the announcements, the application process, the peer review process. CDC staff, including individuals from the NIOSH Office of Extramural Programs (OEP), the WTC Health Program, and CDC's Office of Grants Services (OGS) will answer questions about the four notices of funding opportunities (NOFOs) for FY2024 listed in this notice.
National One Health Framework To Address Zoonotic Diseases and Advance Public Health Preparedness in the United States: A Framework for One Health Coordination and Collaboration Across Federal Agencies; Availability of Informational Webinars
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the availability of informational webinars related to the draft framework titled ``National One Health Framework to Address Zoonotic Diseases and Advance Public Health Preparedness in the United States: A Framework for One Health Coordination and Collaboration across Federal Agencies (NOHF-Zoonoses).''
In-Home Disposal Systems for Opioid Analgesics; Request for Information; Reopening of the Comment Period
The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the notice entitled ``In-Home Disposal Systems for Opioid Analgesics; Request for Information'' published in the Federal Register of April 4, 2023. FDA is reopening the comment period to allow interested persons additional time to develop and submit comments.
Submission for OMB Review; Office of Refugee Resettlement Annual Survey of Refugees (Office of Management and Budget #0970-0033)
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services seeks an update to the existing data collection for the Annual Survey of Refugees. The Annual Survey of Refugees is a yearly sample survey of refugee households entering the U.S. in the previous 5 fiscal years. The requested update is based upon results of a multi-year effort in instrument redesign and field testing. ACF estimates the proposed changes will increase response burden from 48 to 50 minutes per respondent.
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