Department of Health and Human Services November 16, 2020 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a virtual meeting. The meeting will be open to the public and public comment will be heard during the meeting.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.'' This guidance is intended to explain FDA implementation of the revised statutory provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) amended the statutory provisions relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom sensitive and identifiable information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled in a legal proceeding to disclose identifiable sensitive information about the research participant, created or compiled for the research. As amended, a CoC prohibits a researcher from disclosing such information unless a specified exception applies. This guidance finalizes the draft guidance of the same title issued on November 25, 2019.