Department of Health and Human Services 2023 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Spokane Tribe to include the counties of Spokane and Whitman in the State of Washington. The final PRCDA for the Spokane Tribe now includes the Washington counties of Ferry, Lincoln, Spokane, Stevens, and Whitman. The sole purpose of this expansion is to authorize additional Spokane Tribal members and beneficiaries to receive Purchased/Referred Care (PRC) services.

This Request for Comment seeks information from stakeholders, broadly defined, on concepts currently under consideration by parties negotiating a World Health Organization (WHO) Pandemic Preparedness Agreement. It seeks information on how stakeholders' efforts to facilitate response efforts, including the rapid creation and equitable deployment of safe and effective vaccines, diagnostic tests, and treatments, can be advanced or hindered by concepts and commitments under consideration by the negotiating parties as reflected in current negotiating text.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Data Standards for Drug and Biological Product Submissions Containing Real- World Data.'' This guidance provides recommendations to sponsors to help support compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) when submitting study data derived from real-world data (RWD) sources in applicable regulatory submissions using standards specified in the Data Standards Catalog. FDA is publishing this guidance as part of a series of guidance documents under its program to evaluate the use of real-world evidence (RWE) in regulatory decision making. This guidance finalizes the draft guidance of the same title issued on October 22, 2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.'' This guidance provides considerations for sponsors proposing to design a registry or to use an existing registry to support regulatory decision-making about a drug's effectiveness or safety. FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance on the use of RWE in regulatory decision-making. This guidance finalizes the draft guidance of the same title issued on November 30, 2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, investigators, and other stakeholders entitled ``Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.'' This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient. This guidance finalizes the draft guidance of the same title issued on December 23, 2021.

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.

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, Improving Customer Experience (OMB Circular A-11, Section 280 Implementation).

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.

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.

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.''

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.

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.