21 U.S.C. § 379dd–2 — Activities of the Food and Drug Administration

(a) The Commissioner of the Food and Drug Administration must receive and assess a report. The Executive Director of "the Foundation" submits this report under a different section of this title. This section does not define "the Foundation." (b) Starting with fiscal year 2009, the Commissioner must send Congress an annual report every year. This report must summarize how the FDA used the Foundation's report in its regulatory and product review work. It must also summarize information from other grant, contract, memorandum of understanding, and cooperative agreement recipients. (c) This part of the law, and a related section of this title, do not change any grant, contract, memorandum of understanding, or cooperative agreement. This rule applies to agreements between the FDA and any other entity. It applies whether the agreement was made before, on, or after September 27, 2007.

The record. The source credit indicates that this section traces its origin to the Federal Food, Drug, and Cosmetic Act of June 25, 1938 (ch. 675), though the specific text of § 379dd–2 was added later—as § 772—by Public Law 110–85, title VI, § 601(b), enacted September 27, 2007, and published at 121 Stat. 897. The source credit does not reflect any subsequent amendment to this section since its addition in 2007. Historical context. Public Law 110–85 is commonly identified as the Food and Drug Administration Amendments Act of 2007, a broad statute that reauthorized and expanded FDA user-fee programs and added new regulatory authorities, including provisions addressing pediatric drug research and the establishment of a nonprofit foundation to support FDA's scientific and regulatory mission. The general historical understanding is that Title VI of the 2007 Act, which includes this section, was intended to formalize a public-private partnership—the Reagan-Udall Foundation for the FDA—to advance regulatory science and to require accountability through reporting mechanisms. Consistent with that understanding, this section directs the Commissioner to receive and assess reports and to inform Congress annually about how outside contributions are incorporated into FDA's work. Beyond this general context, the record does not establish the specific legislative reasoning behind the particular reporting and grant-protection provisions set out here, and no more detailed intent should be inferred.