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.
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.
The Secretary shall define the criteria for selection of a qualified expert panel and the procedures for the operation of the panel by regulation.
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.
The decision of the Secretary following an informal conference shall constitute final agency action subject to judicial review.
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 sectionof 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.
The labeling of a new animal drug that is the subject of an index listing shall state, prominently and conspicuously-
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 [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. § 360ccc-1
REFERENCES IN TEXTThe National Environmental Policy Act of 1969, referred to in subsec. (c)(1)(E), is Pub. L. 91-190, Jan. 1, 1970, 83 Stat. 852, as amended, which is classified generally to chapter 55 (§4321 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under sectionof Title 42 and Tables.The Federal Advisory Committee Act, referred to in subsec. (d)(3)(C), is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is set out in the Appendix to Title 5, Government Organization and Employees.The Controlled Substances Act, referred to in subsec. (k), is title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section of this title and Tables.
AMENDMENTS2018-Subsec. (h)(1). Pub. L. 115-234, §302(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: " 'NOT APPROVED BY FDA.-Legally marketed as an FDA indexed product. Extra-label use is prohibited.';". Subsec. (h)(2). Pub. L. 115-234, §302(2), substituted "or food-producing animals" for "or other animals". 2015-Subsec. (k). Pub. L. 114-89 added subsec. (k).
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2018 AMENDMENT Pub. L. 115-234, title III, §302, Aug. 14, 2018, 132 Stat. 2436, provided that the amendment made by section 302 is effective Oct. 1, 2018.