- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Policy, Planning, Legislation, and Analysis, Office of PolicyOffice of Medical Products and Tobacco, Center for Biologics Evaluation and ResearchOffice of Medical Products and Tobacco, Center for Drug Evaluation and ResearchOffice of Medical Products and Tobacco, Center for Devices and Radiological HealthOffice of Medical Products and Tobacco, Center for Tobacco ProductsOffice of Foods and Veterinary Medicine, Center for Food Safety and Applied NutritionOffice of Foods and Veterinary Medicine, Center for Veterinary MedicineOffice of the Commissioner, Office of the Chief Scientist
This draft guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) (Public Law 114-255) amended the Public Health Service Act (PHS Act), section 301(d) (42 U.S.C. 241(d)) relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled to disclose identifiable and sensitive information about the research participant, created or compiled for purposes of the human subject research. As amended, the statute broadened the protections by affirmatively prohibiting holders of CoCs from disclosing such information unless a specific exception applies.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-3592 .