Department of Health and Human Services December 7, 2022 – Federal Register Recent Federal Regulation Documents

The National Advisory Committee on Children and Disasters (NACCD or the Committee) is required by section 2811A of the PHS Act, as amended by the Pandemic and All Hazards Preparedness and Advancing Innovation Act (PAHPAIA) and governed by the provisions of the Federal Advisory Committee Act (FACA). The NACCD shall evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS and ASPR to support and enhance all-hazards public health and medical preparedness, response, and recovery aimed at meeting the unique needs of children and their families across the entire spectrum of their wellbeing. The Secretary of HHS has formally delegated authority to operate the NACCD to ASPR.

The purpose of this Request for Information (RFI) is to solicit public input on a proposed revised framework for evaluating and scoring peer review criteria for National Institutes of Health (NIH) research project grant (RPG) applications. NIH is proposing a revised simplified framework that will reorganize five major regulatory criteria under three scored categories and reduce the number of non- score driving review considerations that reviewers evaluate in judging the scientific merit of RPG applications. The proposed changes pertain to those RPGs with standard review criteria. All the factors required by regulation will continue to be evaluated. NIH is not proposing to revise the regulatory criteria. Rather, NIH is proposing to revise its policy of how peer reviewers score the criteria, and how NIH organizes the criteria for review purposes. NIH believes that these changes will allow peer reviewers to refocus on the critical task of judging scientific merit and will improve those judgements by reducing bias.

The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that IMJUDO (tremelimumab), approved October 23, 2022, meets the criteria for redeeming a priority review voucher.

This proposed notice acknowledges the receipt of an application from the Center for Improvement in Healthcare Quality (CIHQ) for initial recognition as a national accrediting organization for critical access hospitals (CAHs) that wish to participate in the Medicare or Medicaid programs.