Docket Number:
FDA-2015-D-4361
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Policy, Legislation, and International Affairs, Office of Policy

The Secretary of the Department of Health and Human Services (HHS) has the authority to accept conditional or unconditional gifts on behalf of the United States.The Secretary has delegated this gift authority to the Commissioner of Food and Drugs. This guidance provides the process and principles the Food and Drug Administration (we, FDA, or Agency) will use in implementing this authority for gifts from all sources except the Reagan-Udall Foundation (RUF).

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All written comments should be identified with this document's docket number: FDA-2015-D-4361.