(a) Establishment and content
(1) The Secretary shall establish an index limited to—
(A) new animal drugs intended for use in a minor species for which there is a reasonable certainty that the animal or edible products from the animal will not be consumed by humans or food-producing animals; and
(B) new animal drugs intended for use only in a hatchery, tank, pond, or other similar contained man-made structure in an early, non-food life stage of a food-producing minor species, where safety for humans is demonstrated in accordance with the standard of section
360b(d) of this title (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance).
(2) The index shall not include a new animal drug that is contained in or a product of a transgenic animal.
(b) Conferences
Any person intending to file a request under this section shall be entitled to one or more conferences to discuss the requirements for indexing a new animal drug.
(c) Request for determination of eligibility for inclusion in index
(1) Any person may submit a request to the Secretary for a determination whether a new animal drug may be eligible for inclusion in the index. Such a request shall include—
(A) information regarding the need for the new animal drug, the species for which the new animal drug is intended, the proposed intended use and conditions of use, and anticipated annual distribution;
(B) information to support the conclusion that the proposed use meets the conditions of subparagraph (A) or (B) of subsection (a)(1) of this section;
(C) information regarding the components and composition of the new animal drug;
(D) a description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such new animal drug;
(E) an environmental assessment that meets the requirements of the National Environmental Policy Act of 1969 [42 U.S.C.
4321 et seq.], as amended, and as defined in 21 CFR Part
25, as it appears on August 2, 2004, and amended thereafter or information to support a categorical exclusion from the requirement to prepare an environmental assessment;
(F) information sufficient to support the conclusion that the proposed use of the new animal drug is safe under section
360b(d) of this title with respect to individuals exposed to the new animal drug through its manufacture or use; and
(G) such other information as the Secretary may deem necessary to make this eligibility determination.
(2) Within 90 days after the submission of a request for a determination of eligibility for indexing based on subsection (a)(1)(A) of this section, or 180 days for a request submitted based on subsection (a)(1)(B) of this section, the Secretary shall grant or deny the request, and notify the person who requested such determination of the Secretary's decision. The Secretary shall grant the request if the Secretary finds that—
(A) the same drug in the same dosage form for the same intended use is not approved or conditionally approved;
(B) the proposed use of the drug meets the conditions of subparagraph (A) or (B) of subsection (a)(1), as appropriate;
(C) the person requesting the determination has established appropriate specifications for the manufacture and control of the new animal drug and has demonstrated an understanding of the requirements of current good manufacturing practices;
(D) the new animal drug will not significantly affect the human environment; and
(E) the new animal drug is safe with respect to individuals exposed to the new animal drug through its manufacture or use.
If the Secretary denies the request, the Secretary shall thereafter provide due notice and an opportunity for an informal conference. A decision of the Secretary to deny an eligibility request following an informal conference shall constitute final agency action subject to judicial review.
(d) Request for addition to index
(1) With respect to a new animal drug for which the Secretary has made a determination of eligibility under subsection (c), the person who made such a request may ask that the Secretary add the new animal drug to the index established under subsection (a). The request for addition to the index shall include—
(A) a copy of the Secretary's determination of eligibility issued under subsection (c);
(B) a written report that meets the requirements in subsection (d)(2) of this section;
(C) a proposed index entry;
(D) facsimile labeling;
(E) anticipated annual distribution of the new animal drug;
(F) a written commitment to manufacture the new animal drug and animal feeds bearing or containing such new animal drug according to current good manufacturing practices;
(G) a written commitment to label, distribute, and promote the new animal drug only in accordance with the index entry;
(H) upon specific request of the Secretary, information submitted to the expert panel described in paragraph (3); and
(I) any additional requirements that the Secretary may prescribe by general regulation or specific order.
(2) The report required in paragraph (1) shall—
(A) be authored by a qualified expert panel;
(B) include an evaluation of all available target animal safety and effectiveness information, including anecdotal information;
(C) state the expert panel's opinion regarding whether the benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm being caused by the absence of an approved or conditionally approved new animal drug for the minor species in question;
(D) include information from which labeling can be written; and
(E) include a recommendation regarding whether the new animal drug should be limited to use under the professional supervision of a licensed veterinarian.
(3) A qualified expert panel, as used in this section, is a panel that—
(A) is composed of experts qualified by scientific training and experience to evaluate the target animal safety and effectiveness of the new animal drug under consideration;
(B) operates external to FDA; and
(C) is not subject to chapter 10 of title 5.
The Secretary shall define the criteria for selection of a qualified expert panel and the procedures for the operation of the panel by regulation.
(4) Within 180 days after the receipt of a request for listing a new animal drug in the index, the Secretary shall grant or deny the request. The Secretary shall grant the request if the request for indexing continues to meet the eligibility criteria in subsection (a) and the Secretary finds, on the basis of the report of the qualified expert panel and other information available to the Secretary, that the benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm caused by the absence of an approved or conditionally-approved new animal drug for the minor species in question. If the Secretary denies the request, the Secretary shall thereafter provide due notice and the opportunity for an informal conference. The decision of the Secretary following an informal conference shall constitute final agency action subject to judicial review.
(e) Index contents; publication
(1) The index established under subsection (a) shall include the following information for each listed drug—
(A) the name and address of the person who holds the index listing;
(B) the name of the drug and the intended use and conditions of use for which it is being indexed;
(C) product labeling; and
(D) conditions and any limitations that the Secretary deems necessary regarding use of the drug.
(2) The Secretary shall publish the index, and revise it periodically.
(3) The Secretary may establish by regulation a process for reporting changes in the conditions of manufacturing or labeling of indexed products.
(f) Removal from index; suspended listing
(1) If the Secretary finds, after due notice to the person who requested the index listing and an opportunity for an informal conference, that—
(A) the expert panel failed to meet the requirements as set forth by the Secretary by regulation;
(B) on the basis of new information before the Secretary, evaluated together with the evidence available to the Secretary when the new animal drug was listed in the index, the benefits of using the new animal drug for the indexed use do not outweigh its risks to the target animal;
(C) the conditions of subsection (c)(2) of this section are no longer satisfied;
(D) the manufacture of the new animal drug is not in accordance with current good manufacturing practices;
(E) the labeling, distribution, or promotion of the new animal drug is not in accordance with the index entry;
(F) the conditions and limitations of use associated with the index listing have not been followed; or
(G) the request for indexing contains any untrue statement of material fact,
the Secretary shall remove the new animal drug from the index. The decision of the Secretary following an informal conference shall constitute final agency action subject to judicial review.
(2) If the Secretary finds that there is a reasonable probability that the use of the drug would present a risk to the health of humans or other animals, the Secretary may—
(A) suspend the listing of such drug immediately;
(B) give the person listed in the index prompt notice of the Secretary's action; and
(C) afford that person the opportunity for an informal conference.
The decision of the Secretary following an informal conference shall constitute final agency action subject to judicial review.
(g) Regulations concerning exemptions for investigational use
For purposes of indexing new animal drugs under this section, to the extent consistent with the public health, the Secretary shall promulgate regulations for exempting from the operation of section
360b of this title minor species new animal drugs and animal feeds bearing or containing new animal drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of minor species animal drugs. Such regulations may, at the discretion of the Secretary, among other conditions relating to the protection of the public health, provide for conditioning such exemption upon the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such article, of data (including but not limited to analytical reports by investigators) obtained as a result of such investigational use of such article, as the Secretary finds will enable the Secretary to evaluate the safety and effectiveness of such article in the event of the filing of a request for an index listing pursuant to this section.
(h) Labeling contents
The labeling of a new animal drug that is the subject of an index listing shall 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 applicable minor species index file number and a period) "Extra-label use is prohibited.";
(2) except in the case of new animal drugs indexed for use in 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) such other information as may be prescribed by the Secretary in the index listing.
(i) Records and reports
(1) In the case of any new animal drug for which an index listing pursuant to subsection (a) is in effect, the person who has an index listing shall establish and maintain such records, and make such reports to the Secretary, of data relating to experience, and other data or information, received or otherwise obtained by such person with respect to such drug, or with respect to animal feeds bearing or containing such drug, as the Secretary may by general regulation, or by order with respect to such listing, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (f). Such regulation or order shall provide, where the Secretary deems it to be appropriate, for the examination, upon request, by the persons to whom such regulation or order is applicable, of similar information received or otherwise obtained by the Secretary.
(2) Every person required under this subsection to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.
(j) Public disclosure of safety and effectiveness data
(1) Safety and effectiveness data and information which has been submitted in support of a request for a new animal drug to be indexed under this section and which has not been previously disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown—
(A) if no work is being or will be undertaken to have the drug indexed in accordance with the request,
(B) if the Secretary has determined that such drug cannot be indexed and all legal appeals have been exhausted,
(C) if the indexing of such drug is terminated and all legal appeals have been exhausted, or
(D) if the Secretary has determined that such drug is not a new animal drug.
(2) Any request for data and information pursuant to paragraph (1) shall include a verified statement by the person making the request that any data or information received under such paragraph shall not be disclosed by such person to any other person—
(A) for the purpose of, or as part of a plan, scheme, or device for, obtaining the right to make, use, or market, or making, using, or marketing, outside the United States, the drug identified in the request for indexing; and
(B) without obtaining from any person to whom the data and information are disclosed an identical verified statement, a copy of which is to be provided by such person to the Secretary, which meets the requirements of this paragraph.
(k) Date of determination in the case of recommended controls under the CSA
In the case of a request under subsection (d) to add a drug to the index under subsection (a) with respect to a drug for which the Secretary provides notice to the person filing the request that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C.
801 et seq.], a determination to grant the request to add such drug to the index shall not take effect until the interim final rule controlling the drug is issued in accordance with section
201(j) of the Controlled Substances Act [21 U.S.C.
811(j)].