21 U.S.C. § 379d — Automation of Food and Drug Administration

(a) In General. This section directs the Secretary of Health and Human Services to automate appropriate Food and Drug Administration activities. The Secretary acts through the Commissioner of Food and Drugs to do this. The goal stated in the text is to ensure timely review of activities regulated under this chapter. The section does not list which specific activities must be automated. It leaves that choice to the Secretary's judgment, so long as automation serves the goal of timely review. It also does not set a deadline for completing this automation. The text does not describe what "automate" means beyond the general instruction to use automation to speed up regulatory review. (b) Authorization of Appropriations. Congress authorizes funding for each fiscal year to carry out this automation effort. The amount authorized is whatever sum is "necessary" to carry out the section. The text does not set a specific dollar figure or cap. It leaves the exact appropriated amount to be decided through the normal appropriations process each year. This subsection does not itself provide the money; it only authorizes Congress to appropriate it later.

The record. According to the source credit, this section originates from the Federal Food, Drug, and Cosmetic Act of June 25, 1938 (ch. 675), though the specific provision was not part of the original 1938 enactment. It was added as § 712 by Public Law 101-635, title IV, § 401, on November 28, 1990 (104 Stat. 4585). It was subsequently renumbered as § 711 by Public Law 102-571, title I, § 106(3), on October 29, 1992 (106 Stat. 4498). The source credit reflects one substantive addition and one renumbering, indicating limited amendment activity since enactment. Historical context. The 1990 enacting legislation, Public Law 101-635, is generally known as the Safe Medical Devices Act of 1990, an act commonly associated with strengthening FDA oversight of medical devices and related administrative processes. Provisions authorizing automation of agency activities, such as this section, are consistent with broader efforts during this era to modernize federal regulatory agencies and improve the efficiency of review processes. However, the record does not establish the specific legislative intent behind this particular provision, including why Congress chose to mandate automation in this form or what specific administrative concerns prompted its inclusion. Readers should treat any characterization of purpose beyond the general legislative context of the broader 1990 Act as informed inference rather than documented fact.