21 U.S.C. § 360ccc–1 — Index of legally marketed unapproved new animal drugs for minor species

(a) Establishment and content. (1) The Secretary must establish an index limited to (A) new animal drugs for minor species where there is reasonable certainty the animal or its edible products will not be consumed by humans or food-producing animals, and (B) new animal drugs for minor food-producing species, used only in a hatchery, tank, pond, or similar contained man-made structure during an early, non-food life stage, where human safety is shown under the section 360b(d) standard, including antimicrobial-resistance rules for antimicrobial drugs. (2) A drug contained in, or a product of, a transgenic animal cannot be indexed. (b) Conferences. Anyone planning to file an index request is entitled to one or more conferences with the Secretary to discuss the requirements for indexing. (c) Request for determination of eligibility for inclusion in index. (1) Anyone may ask the Secretary whether a drug may be eligible for the index. The request must include (A) the need for the drug, the species, the proposed use and conditions of use, and anticipated annual distribution; (B) information supporting that the use meets subsection (a)(1)(A) or (B); (C) the drug's components and composition; (D) a description of the manufacturing, processing, and packing methods, facilities, and controls; (E) an environmental assessment under the National Environmental Policy Act of 1969, or information supporting a categorical exclusion from that requirement; (F) information supporting that the drug is safe under section 360b(d) for people exposed through its manufacture or use; and (G) any other information the Secretary deems necessary. (2) Within 90 days (for a subsection (a)(1)(A) request) or 180 days (for a subsection (a)(1)(B) request), the Secretary must grant or deny the request and notify the requester. The Secretary must grant it if (A) the same drug, dosage form, and intended use is not already approved or conditionally approved; (B) the proposed use meets subsection (a)(1)(A) or (B); (C) the requester has established appropriate manufacturing and control specifications and understands good manufacturing practice requirements; (D) the drug will not significantly affect the human environment; and (E) the drug is safe for people exposed through its manufacture or use. If denied, the requester gets notice and an opportunity for an informal conference, and a denial following that conference is a final agency action subject to judicial review. (d) Request for addition to index. (1) Once found eligible under subsection (c), the requester may ask that the drug be added to the index. That request must include (A) a copy of the eligibility determination; (B) a written report meeting the requirements of paragraph (2); (C) a proposed index entry; (D) facsimile labeling; (E) anticipated annual distribution; (F) a written commitment to manufacture the drug and any animal feed containing it under current good manufacturing practices; (G) a written commitment to label, distribute, and promote it only as described in the index entry; (H) information submitted to the expert panel, if the Secretary specifically requests it; and (I) any additional requirements the Secretary prescribes by regulation or order. (2) The report must (A) be authored by a qualified expert panel; (B) evaluate all available target-animal safety and effectiveness information, including anecdotal information; (C) state the panel's opinion on whether the drug's benefits for the minor species outweigh its risks to the target animal, considering the harm caused by not having an approved or conditionally approved drug for that species; (D) include information from which labeling can be written; and (E) recommend whether the drug should be limited to use under a licensed veterinarian's supervision. (3) A "qualified expert panel" (A) is composed of experts qualified by scientific training and experience to evaluate target-animal safety and effectiveness, (B) operates external to FDA, and (C) is not subject to chapter 10 of title 5. The Secretary defines the panel's selection criteria and operating procedures by regulation. (4) Within 180 days of receiving the listing request, the Secretary must grant or deny it. The Secretary must grant it if the drug still meets the subsection (a) eligibility criteria and, based on the expert panel's report and other available information, the drug's benefits for the minor species outweigh its risks to the target animal, considering the harm caused by the absence of an approved or conditionally approved drug for that species. If denied, the requester gets notice and an informal conference, and the Secretary's decision following that conference is a final agency action subject to judicial review. (e) Index contents; publication. (1) For each listed drug, the index must include (A) the name and address of the index holder; (B) the drug's name and its intended use and conditions of use; (C) product labeling; and (D) any conditions and limitations the Secretary deems necessary. (2) The Secretary must publish the index and revise it periodically. (3) The Secretary may establish, by regulation, a process for reporting changes to how an indexed drug is manufactured or labeled. (f) Removal from index; suspended listing. (1) After notice and an opportunity for an informal conference, the Secretary must remove a drug from the index if (A) the expert panel failed to meet the Secretary's regulatory requirements; (B) new information, evaluated with the evidence available at listing, shows the drug's benefits no longer outweigh its risks to the target animal; (C) the subsection (c)(2) conditions are no longer satisfied; (D) manufacturing does not follow current good manufacturing practices; (E) labeling, distribution, or promotion does not match the index entry; (F) the listed conditions and limitations were not followed; or (G) the listing request contained an untrue statement of material fact. The Secretary's decision following the informal conference is a final agency action subject to judicial review. (2) If the Secretary finds a reasonable probability that using the drug would risk human or animal health, the Secretary may (A) immediately suspend the listing, (B) promptly notify the listed person, and (C) offer that person an informal conference; that decision, too, is a final agency action subject to judicial review. (g) Regulations concerning exemptions for investigational use. To support indexing, and as far as consistent with public health, the Secretary must issue regulations exempting minor-species investigational new animal drugs and animal feeds containing them from section 360b of this title, for use by experts qualified to investigate their safety and effectiveness. Those regulations may require recordkeeping and reporting of investigational data — including analytical reports by investigators — to let the Secretary evaluate safety and effectiveness if the drug is later submitted for indexing. (h) Labeling contents. The labeling of an indexed drug must state, prominently and conspicuously — (1) "LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED—MIF #" followed by the index file number, and "Extra-label use is prohibited"; (2) — unless indexed for an early life stage of a food-producing animal — "This product is not to be used in animals intended for use as food for humans or food-producing animals"; and (3) any other information the Secretary prescribes in the index listing. (i) Records and reports. (1) The index-listing holder must keep records, and report to the Secretary, data on experience and other information about the drug or any feed containing it, as the Secretary requires by regulation or order, when needed to determine whether grounds for removal under subsection (f) exist. Where the Secretary deems it appropriate, that regulation or order must also allow the affected person to examine similar information the Secretary has received. (2) Anyone required to keep these records, and anyone in charge or custody of them, must let a Secretary-designated officer or employee access, copy, and verify them at reasonable times upon request. (j) Public disclosure of safety and effectiveness data. (1) Safety and effectiveness data submitted for an index request, if not already publicly disclosed, must be made available on request — unless extraordinary circumstances are shown — if (A) no work is being or will be done to index the drug, (B) the Secretary has determined the drug cannot be indexed and all legal appeals are exhausted, (C) indexing has been terminated and all legal appeals are exhausted, or (D) the Secretary has determined the drug is not a new animal drug. (2) Anyone requesting that data must include a verified statement promising not to disclose it to anyone else (A) to help obtain, or as part of a plan to obtain, the right to make, use, or market the drug outside the United States, and (B) without first getting an identical verified statement from anyone the data is shared with, a copy of which must go to the Secretary. (k) Date of determination in the case of recommended controls under the CSA. If the Secretary notifies a requester under subsection (d) that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act, a decision to add the drug to the index does not take effect until the interim final rule controlling the drug is issued.