Department of Health and Human Services October 5, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Stimulant Use Disorders: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of stimulant use disorders. Specifically, this guidance addresses FDA's current recommendations regarding the overall development program and clinical trial designs for the development of drugs to support indications of treatment of moderate to severe cocaine use disorder, treatment of moderate to severe methamphetamine use disorder, or treatment of moderate to severe prescription stimulant use disorder.
Revocation of Eleven Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Luminostics, Inc., for the Clip COVID Rapid Antigen Test; NeuMoDx Molecular, Inc., a QIAGEN Company, for the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay; LGC, Biosearch Technologies for the SARS-CoV-2 Real-Time and End-Point RT-PCR Test; LGC, Biosearch Technologies, for the Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test; Becton, Dickinson and Co. for the BD Veritor At-Home COVID-19 Test; Verily Life Sciences for the Verily COVID-19 RT-PCR Test; Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3); Xtrava Health for the SPERA COVID-19 Ag Test; Exact Sciences Laboratories for the COVID-Flu Multiplex Assay; Exact Sciences Laboratories for the SARS-CoV-2 (N gene detection) Test; and dba SpectronRx for the Hymon SARS-CoV-2 Test Kit. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holders. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
Reorganization of the National Center for Chronic Disease Prevention and Health Promotion
CDC has modified its structure. This notice announces the reorganization of the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP). NCCDPHP has realigned the Division of Adolescent and School Health from the National Center National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP).
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.
Notice of Meeting for the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC)
The Secretary of Health and Human Services (Secretary) announces a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The ISUDCC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person. 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 meeting will include reports from the ISUDCC Working Groups, and discussion of the ISUDCC's recommendations to HHS on how the Federal Government can further integrate and coordinate harm reduction approaches and strategies across the continuum of prevention, treatment, and recovery policies, programs, and practices.
Submission for Office of Management and Budget (OMB) Review; ORR-3 and ORR-4 Report Forms for the Unaccompanied Refugee Minors Program (OMB #0970-0034)
The Office of Refugee Resettlement (ORR) is requesting a 3- year extension of the ORR-3 and ORR-4 Report Forms (OMB #: 0970-0034, expiration 02/29/2024). There are very minimal changes requested to the report forms; ORR proposes minor revisions to the form instructions to improve clarity in certain sections and provide additional guidance for providers on how to assess youth functioning.
Expedited Office of Management and Budget Review and Public Comment: Office of Human Services Emergency Preparedness and Response Disaster Human Services Case Management Intake Assessment, Resource Referral, and Case Management Plan
The Office of Human Services Emergency Preparedness and Response (OHSEPR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) and inviting public comments on the proposed collection. OHSEPR's Disaster Human Services Intake Assessment, Resource Referral, and Case Management Plan collection is part of a system of tools that OHSEPR utilizes to support disaster survivors during response missions. ACF is requesting immediate approval for this information collection but also requesting comments to inform any updates prior to requesting an extension of approval within six months.
Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Radiological Devices Panel of the Medical Devices Advisory 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.
Supplemental Evidence and Data Request on Evidence Map on Home and Community Based Services
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 Evidence Map on Home and Community Based Services, 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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
