21 U.S.C. § 360ddd–2 — Inapplicability of drug fees to designated medical gases

This section is about designated medical gases — gases that receive an approved drug application through a special process. That process is described in section 360ddd–1 of this title. It lets such gases be "deemed" to have an approved application. Normally, a drug's approved application comes with fees. Those fees are set out in section 379h(a) and section 379j–12(a) of this title. This section creates an exception. A designated medical gas may have an approved application only because it was deemed approved under section 360ddd–1. In that case, no fee under section 379h(a) or 379j–12(a) may be charged based on that deemed approval. The exception also covers combinations. A designated medical gas may be combined with another designated gas, or with several designated gases. This is allowed as long as the combination is medically appropriate. Even when combined this way, the fee exemption still applies. That is because the approval traces back to the same deemed-approval process. In short, this section blocks fees for medical gases whose only approval basis is the deemed-approval pathway. That pathway is section 360ddd–1. The block applies whether the gas is used alone or in a medically appropriate combination.

The record shows that this section originated as part of the Federal Food, Drug, and Cosmetic Act of June 25, 1938 (ch. 675), though the specific provision codified here, § 577, was not part of the original 1938 enactment. According to the source credit, § 577 was added by Public Law 112–144, title XI, § 1111, on July 9, 2012 (126 Stat. 1111). The credit further indicates that the section was subsequently amended once, by Public Law 114–255, division A, title III, § 3101(a)(2)(T), on December 13, 2016 (130 Stat. 1155). Public Law 112–144 is generally known as the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. FDASIA is commonly understood to have reauthorized and expanded various FDA user-fee programs and to have included additional provisions addressing drug shortages, generic drug regulation, and related regulatory matters. Title XI of that Act, which added this section, is associated with provisions concerning medical gases, reflecting a broader legislative effort during that period to establish a regulatory pathway for these products. Beyond this general context, the record does not establish the specific legislative reasoning behind exempting deemed-approved designated medical gases from the particular user fees referenced in the text. Any more detailed account of congressional intent for this precise provision would be speculative and is not supported by the materials provided.