May 2022: The National Institutes of Health (NIH) is informing the research community of its implementation of a provision in the revised common rule under which public health surveillance activities may be deemed not to be research for the purposes of the regulation (45 CFR 46.102(I)(2)): https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-activities-deemed-not-be-research-public-health-surveillance/index.html
November 2020: New FDA Guidance is available on Certificates of Confidentiality: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-activities-deemed-not-be-research-public-health-surveillance/index.html