Department of Health and Human Services December 21, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 27 of 27
Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization.'' This guidance provides recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2 intended for the prevention or treatment of COVID- 19, including addressing the impact of emerging variants. The recommendations focus on the data and information that may be used to support a request for emergency use authorization (EUA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance supersedes the guidance entitled ``Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency'' issued on February 22, 2021.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for the public to attend the meeting, provide comments, and/or distribute printed material(s) to ACMH members. Information about the meeting is available from the designated contact person and will be posted on the HHS Office of Minority Health (OMH) website: www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH, Committees and Working Groups.
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review.'' This draft guidance provides FDA's current thinking regarding the 510(k) Third Party (3P510k) Review Program and review of Emergency Use Authorizations (EUA) requests by a third party review organizations (3PEUA review). The 3P510k Review Program and 3PEUA review create an alternative process for manufacturers to seek review of 510(k) submissions and EUA requests to assist FDA in reviewing in a timely manner. This draft guidance is not final nor is it for implementation at this time.
Determination of Regulatory Review Period for Purposes of Patent Extension; LYBALVI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LYBALVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Examination of Implied Claims in Direct-to-Consumer Prescription Drug Promotion
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled ``Examination of Implied Claims in Direct-to-Consumer Prescription Drug Promotion.''
Medicare and Medicaid Programs; Application From The Compliance Team (TCT) for Continued Approval of its Rural Health Clinics Program
This proposed notice acknowledges the receipt of an application from the Compliance Team (TCT) for continued recognition as a national accrediting organization (AO) for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Charter Renewal for Advisory Committee on Ground Ambulance and Patient Billing (GAPB)-November 16, 2023
The No Surprises Act, enacted as part of the Consolidated Appropriations Act, 2021, requires the Secretary of Health and Human Services (HHS), the Secretary of Labor, and the Secretary of the Treasury (the Secretaries) to establish and convene an advisory committee for the purpose of reviewing options to improve the disclosure of charges and fees for ground ambulance services, better inform consumers of insurance options for such services, and protect consumers from balance billing (the ``GAPB Advisory Committee'' or the ``Committee''). The Secretaries established the GAPB Advisory Committee on November 16, 2021 with a standard 2-year expiration period ending November 16, 2023. In accordance with the Federal Advisory Committee Act (FACA), HHS is hereby giving notice that the charter for the Advisory Committee on Ground Ambulance and Patient Billing (GAPB) was renewed effective November 16, 2023.
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
Federal Independent Dispute Resolution (IDR) Process Administrative Fee and Certified IDR Entity Fee Ranges
This document finalizes 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 final rules 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. The preamble to these final rules also sets forth the methodology used to calculate the administrative fee and the considerations used to develop the certified IDR entity fee ranges. This document also finalizes the amount of the administrative fee for disputes initiated on or after the effective date of these rules. Finally, this document finalizes the certified IDR entity fee ranges for disputes initiated on or after the effective date of these rules.
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