21 U.S.C. § 360ccc — Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs

(a) Application requirements (1)(A) Except as paragraph (3) limits, any person may file an application for conditional approval of (i) a new animal drug intended for a minor use or minor species, or (ii) a new animal drug not intended for a minor use or minor species if (I) it is intended to treat a serious or life-threatening disease or condition, or addresses an unmet animal or human health need, and (II) the Secretary determines that proving effectiveness would require a complex or particularly difficult study. (B) By September 30, 2019, the Secretary had to issue guidance or regulations further clarifying the (A)(ii) criteria. (C) Such an application must comply with section 360b of this title, except that several listed subsections of that section — (a)(4), (b)(2), (c)(1) through (3), (d)(1), (e), (h), and (n) — do not apply unless this section says otherwise. (D) These drugs are subject to the same safety standard applied to new animal drugs generally under section 360b(d) of this title, including antimicrobial-resistance rules for antimicrobial drugs. (2) The applicant must submit — (A) all information required under section 360b(b)(1) of this title except section 360b(b)(1)(A); (B) full reports of investigations showing whether the drug is safe under section 360b(d), including antimicrobial-resistance data where relevant, and showing a reasonable expectation of effectiveness; (C) data establishing a conditional dose; (D) projections of expected need and the basis for that expectation; (E) information on the quantity of drug expected to be distributed yearly to meet that need; and (F) a commitment to conduct additional investigations to fully demonstrate effectiveness under section 360b(d)(1)(E) within 5 years. (3)(A) A person may not file this kind of application if (i) the drug is contained in, or is a product of, a transgenic animal; (ii) the person already filed a conditional-approval application for the same drug, same dosage form, and same intended use, whether or not it was approved; or (iii) the person obtained the application or its data from someone else who filed such an application for the same drug, dosage form, and intended use. (B) No one may file under (1)(A)(ii) for a drug containing an antimicrobial active ingredient. (4) Beginning October 1, 2018, all applications under this subsection must be submitted electronically in the format the Secretary requires. (b) Order of approval or hearing. Within 180 days of filing (or a longer period the Secretary and applicant agree to), the Secretary must either (1) issue a one-year conditional approval order if none of the subsection (c) grounds for denial apply, and publish a Federal Register notice, or (2) give the applicant an opportunity for an informal hearing on whether the application can be conditionally approved. (c) Order of approval or refusal after hearing. After notice and an informal hearing, the Secretary must refuse conditional approval if (1) certain safety grounds under section 360b(d)(1)(A) through (D) or (F) through (I) of this title apply; (2) the submitted information does not sufficiently show a reasonable expectation that the drug will work as claimed; or (3) another person already has full approval for the same drug, dosage form, and intended use, and can supply enough of it. If none of these apply, the Secretary must grant a one-year conditional approval and publish it. Any refusal order must state the findings it is based on. (d) Effective period; renewal; refusal of renewal. A conditional approval lasts one year and is renewable annually for up to 4 additional 1-year terms — 5 years total — unless extended under subsection (h). In addition: (1) the applicant may request renewal no later than 90 days before the 1-year period ends; (2) the approval is deemed renewed at the end of the year (or a 90-day extension the Secretary may grant to finish review) unless the Secretary determines before then that (A) the applicant failed to submit a timely renewal request, (B) the request fails to show (i) the applicant is making sufficient progress toward full approval and is likely to obtain it before the 5-year cap, (ii) the quantity distributed matches the approved use, absent adequate explanation, or (iii) the same drug has not since received full approval by a holder who can supply enough of it, or (C) safety grounds under section 360b(e)(1)(A), (B), or (D) through (F) apply; (3) if the Secretary decides before the deadline not to renew, the Secretary must issue an order refusing renewal, ending the conditional approval, but must then offer the applicant an informal hearing on whether to reinstate it; and (4) for a drug the Secretary is evaluating for scheduling under the Controlled Substances Act, conditional approval does not take effect until the interim final scheduling rule is issued, and in that case "date of approval" means whichever is later — the conditional approval date or the scheduling-rule date. (e) Withdrawal of conditional approval. (1) The Secretary must withdraw conditional approval if another person has received full approval for the same drug, dosage form, and intended use, and can supply enough of it. (2) After notice and an informal hearing, the Secretary must withdraw conditional approval if (A) safety grounds under section 360b(e)(1)(A), (B), or (D) through (F) apply, or (B) new information, combined with what was known at approval, shows there is no longer a reasonable expectation the drug will work as claimed. (3) The Secretary may also withdraw approval, after notice and hearing, if grounds under section 360b(e)(2) apply. (f) Labeling. (1) The label for a conditionally approved use must (A) bear the statement "conditionally approved by FDA pending a full demonstration of effectiveness under application number," and (B) contain other information the Secretary prescribes. (2) The Secretary will determine, by regulation or guidance, when a conditionally approved use may be included on the same label as a fully approved use. (g) Amendment of application. A conditionally approved application may not be amended or supplemented to add new uses. (h) Order of approval after conditional approval period termination. 180 days before the termination date under subsection (d), the applicant must have submitted all information needed for a complete application under section 360b(b)(1), or the conditional approval ends. After review, the Secretary must either (1) approve the full application if none of the section 360b(d)(1) refusal grounds apply, or (2) offer a hearing on whether it can be approved. Once approved, labeling and administrative records are updated accordingly. If the Secretary has not approved the full application by the termination date, the conditional approval ends, unless the Secretary grants a single 180-day extension to finish reviewing the application. That extension decision is entirely within the Secretary's discretion and is not subject to judicial review. (i) Judicial review. A Secretary decision under subsection (c), (d), or (e) refusing or withdrawing conditional approval is a final agency action subject to judicial review. (j) Definition. "Transgenic animal" means an animal whose genome contains a nucleotide sequence intentionally modified in vitro, and its progeny — but not an animal whose genome was modified only through selective breeding. (k) Sunset. (1) The Secretary's authority to grant conditional approval under subsection (a)(1)(A)(ii), for drugs not intended for a minor use or minor species, ends October 1, 2028. (2) After that date, the Secretary (A) may not accept new applications of that type, but (B) may continue all activities for drugs already conditionally approved that way. (3) Until October 1, 2032, the Secretary may still accept full-approval applications under section 360b of this title for drugs conditionally approved under (a)(1)(A)(ii).