Department of Health and Human Services January 11, 2023 – Federal Register Recent Federal Regulation Documents

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public. Time will be available for public comment.

The seventh iteration of the Prescription Drug User Fee Act (PDUFA VII), incorporated as part of the FDA User Fee Reauthorization Act of 2022, highlights the goal of advancing model-informed drug development (MIDD). The Food and Drug Administration (FDA or Agency) is announcing the continuation of the MIDD Paired Meeting Program that affords sponsors who are selected for participation the opportunity to meet with Agency staff to discuss MIDD approaches in medical product development. Meetings under the program will be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) during fiscal years 2023-2027. This program is being conducted to fulfill FDA's performance commitment under PDUFA VII. For this program, MIDD is defined as the application of exposure-based, biological, and/or statistical models derived from non-clinical and clinical data sources to address drug development and/ or regulatory issues (see Supplementary Information, I. Background, and II. Eligibility and Selection for Participation of this notice). For each approved proposal, the program consists of two meetings between sponsors or applicants and the relevant center that provide an opportunity for drug developers and FDA to discuss the application of MIDD approaches to the development and regulatory evaluation of medical products in development.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $4,000,000, with an expected total funding of approximately $20,000,000 over a 5-year period, to the Pan American Health Organization (PAHO). The award will continue support to PAHO in developing and implementing coordinated national and regional public health programs in the Americas that are consistent with the World Health Organization's International Health Regulations (IHR) strategies and the CDC global health priorities for improving infectious disease surveillance and response, building public health infrastructure and systems, sharing knowledge, tools and other resources in support of applied epidemiology, and developing improved prevention and control strategies for infectious disease, such as arboviruses, coronaviruses, chikungunya, dengue, yellow fever, Zika, HIV, poxviruses, foodborne, antimicrobial resistant and healthcare facility-acquired infectious diseases.

The Food and Drug Administration (FDA or Agency) 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 mpox. FDA has issued an Authorization for an in vitro diagnostic device as requested by Life Technologies Corporation (a part of Thermo Fisher Scientific 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 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 Maternal Mortality Review Information Application (MMRIA). MMRIA is a standardized data collection system that allows Maternal Mortality Review Committees (MMRCs) to abstract relevant data from a variety of sources, document committee decisions, and analyze data to better understand the contributing factors and preventability of pregnancy- related deaths in order to develop recommendations for prevention.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.