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

submitted 88 years ago by Pub. L. 112-144 to r/title-21-FOOD-AND-DRUGS · 51 words · no verdicts yet

in plain englishAI-generated · not legal advice

Designated medical gases approved through the deemed-approval process in section 360ddd–1 don't owe standard drug fees. This holds whether the gas is used alone or combined with other designated gases. The exemption applies only when the combination is medically appropriate.

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.

facts

- Codified at 21 U.S.C. § 360ddd–2, titled "Inapplicability of drug fees to designated medical gases." - The provision is brief, consisting of 51 words in a single operative sentence. - Originally enacted as § 577 of the Federal Food, Drug, and Cosmetic Act (ch. 675, June 25, 1938), added by Pub. L. 112–144, title XI, § 1111 (July 9, 2012). - Source credit reflects two amendments, including a 2016 amendment by Pub. L. 114–255, div. A, title III, § 3101(a)(2)(T). - Cross-references fee provisions under 21 U.S.C. §§ 379h(a) and 379j–12(a).

the actual law source: uscode.house.gov ↗public domain

A designated medical gas, alone or in combination with another designated gas or gases (as medically appropriate) deemed under section 360ddd–1 of this title to have in effect an approved application shall not be assessed fees under section 379h(a) or 379j–12(a) of this title on the basis of such deemed approval.

Source credit: (June 25, 1938, ch. 675, § 577, as added Pub. L. 112–144, title XI, § 1111, July 9, 2012, 126 Stat. 1111; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(T), Dec. 13, 2016, 130 Stat. 1155.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 112-144 · 126 Stat. 1111
2016Amended · Pub. L. 114-255 · 130 Stat. 1155

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.

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