Department of Health and Human Services October 27, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of monkeypox. FDA has issued an Authorization for an in vitro diagnostic device as requested by Abbott Molecular, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the August 9, 2022, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves monkeypox virus. On the basis of such determination, the Secretary of HHS declared, on September 7, 2022, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to the FD&C Act, subject to terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

The seventh iteration of the Prescription Drug User Fee Amendments (PDUFA VII) included as part of the FDA User Fee Reauthorization Act of 2022 highlights the goal of advancing and facilitating the development and timely approval of drugs and biological products for rare diseases, including rare diseases in children. The Food and Drug Administration (FDA or Agency) is announcing the Rare Disease Endpoint Advancement Pilot Meeting Program (RDEA Pilot Program) established under the seventh iteration of PDUFA that affords sponsors who are admitted into the RDEA Pilot Program additional engagement opportunities with the Agency to discuss efficacy endpoint development in rare disease drug and biological product development programs. Meetings under the program will be conducted by FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) during fiscal years (FYs) 2023 to 2027. For each sponsor whose RDEA program proposal (RDEA proposal or proposal) is admitted into the program, up to four meetings that will provide an opportunity for medical product developers to discuss rare disease endpoint development will be held between the sponsor and CDER or CBER. To promote innovation and evolving science, novel endpoints developed through the RDEA Pilot Program may be presented by FDA (e.g., in a guidance or public workshop or on a public-facing website) as case studies, including novel endpoints for drugs that have not yet been approved or biological products that have not yet been licensed by FDA for a given indication.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of data or other information and to allow 60 days for public comment in response to the notice. This information collection (IC) solicits comments on the IC requirements, outlined in the Lifespan Respite Care Reauthorization Act of 2020, Section 2904, which requires Lifespan Respite Care Program grantees to report data, information, and metrics for the purpose of program evaluation. Such data, information, and metrics are to be used to identify ``. . . effective programs and activities funded . . .'' through ACL's Lifespan Respite Care Program grants.

The Food and Drug Administration (FDA) is postponing the joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee scheduled for November 18, 2022. Future meeting dates will be announced in the Federal Register.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.