Department of Health and Human Services September 20, 2021 – Federal Register Recent Federal Regulation Documents

Findings of research misconduct have been made against Ya Wang, M.D., Ph.D. (Respondent), retired Professor and Director, Division of Experimental Radiation Oncology, Department of Radiation Oncology, Winship Cancer Institute, Emory University (EU). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants P30 CA138292 and R01 CA186129 and National Institute of General Medical Sciences (NIGMS), NIH, grant R01 GM080771. The administrative actions, including debarment for a period of four (4) years, were implemented beginning on August 4, 2021, and are detailed below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled ``Questions and Answers on Biosimilar Development and the BPCI Act.'' The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, and also describes FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled ``Questions and Answers on Biosimilar Development and the BPCI Act'' issued December 12, 2018.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's National Advisory Council on Migrant Health (NACMH or Council) has scheduled a public meeting. Information about NACMH and the agenda for this meeting can be found on the NACMH website at: https://bphc.hrsa.gov/qualityimprovement/ strategicpartnerships/nacmh.