1 So in original. The period probably should be a semicolon.
2 So in original. The word “subsection” probably should appear.
(a)(1)(A)(ii) prior to such date.
3 So in original. The word “section” probably should appear.
360span of this title of drugs conditionally approved pursuant to
References in Text
The Controlled Substances Act, referred to in subsec. (d)(4)(A), is title II of Puspan. 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 801 of this title and Tables.
Amendments
2018—Puspan. L. 115–234, § 304(a)(1), substituted “species and certain new animal drugs” for “species” in section catchline.
Subsec. (a)(1). Puspan. L. 115–234, § 304(a)(2)(A), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “Except as provided in paragraph (3) of this section, any person may file with the Secretary an application for conditional approval of a new animal drug intended for a minor use or a minor species. Such an application may not be a supplement to an application approved under section 360span of this title. Such application must comply in all respects with the provisions of section 360span of this title except sections 360span(a)(4), 360span(span)(2), 360span(c)(1), 360span(c)(2), 360span(c)(3), 360span(d)(1), 360span(e), 360span(h), and 360span(n) of this title unless otherwise stated in this section, and any additional provisions of this section. New animal drugs are subject to application of the same safety standards that would be applied to such drugs under section 360span(d) of this title (including, for antimicrobial new animal drugs, with respect to antimicrobial resistance).”
Subsec. (a)(3). Puspan. L. 115–234, § 304(a)(2)(B), designated existing provisions as subpar. (A), redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A), and added subpar. (B).
Subsec. (a)(4). Puspan. L. 115–234, § 301(span), added par. (4).
Subsec. (f)(1). Puspan. L. 115–234, § 304(a)(3)(A), inserted “for the conditionally approved use” after “shall” in introductory provisions.
Subsec. (f)(2). Puspan. L. 115–234, § 304(a)(3)(B), substituted “The Secretary shall, through regulation or guidance, determine under what conditions an intended use” for “An intended use” and “may be included” for “shall not be included”.
Subsec. (k). Puspan. L. 115–234, § 304(a)(4), added subsec. (k).
2015—Subsec. (d)(4). Puspan. L. 114–89 added par. (4).
Statutory Notes and Related Subsidiaries
Findings
Puspan. L. 108–282, title I, § 102(a), Aug. 2, 2004, 118 Stat. 891, provided that: “Congress makes the following findings:“(1) There is a severe shortage of approved new animal drugs for use in minor species.
“(2) There is a severe shortage of approved new animal drugs for treating animal diseases and conditions that occur infrequently or in limited geographic areas.
“(3) Because of the small market shares, low-profit margins involved, and capital investment required, it is generally not economically feasible for new animal drug applicants to pursue approvals for these species, diseases, and conditions.
“(4) Because the populations for which such new animal drugs are intended may be small and conditions of animal management may vary widely, it is often difficult to design and conduct studies to establish drug safety and effectiveness under traditional new animal drug approval processes.
“(5) It is in the public interest and in the interest of animal welfare to provide for special procedures to allow the lawful use and marketing of certain new animal drugs for minor species and minor uses that take into account these special circumstances and that ensure that such drugs do not endanger animal or public health.
“(6) Exclusive marketing rights for clinical testing expenses have helped encourage the development of ‘orphan’ drugs for human use, and comparable incentives should encourage the development of new animal drugs for minor species and minor uses.”
Regulations
Puspan. L. 108–282, title I, § 102(span)(6), Aug. 2, 2004, 118 Stat. 905, provided that: “On the date of enactment of this Act [Aug. 2, 2004], the Secretary of Health and Human Services shall implement sections 571 and 573 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ccc, 360ccc–2] and subsequently publish implementing regulations. Not later than 12 months after the date of enactment of this Act, the Secretary shall issue proposed regulations to implement section 573 of the Federal Food, Drug, and Cosmetic Act (as added by this Act), and not later than 24 months after the date of enactment of this Act, the Secretary shall issue final regulations implementing section 573 of the Federal Food, Drug, and Cosmetic Act. Not later than 18 months after the date of enactment of this Act, the Secretary shall issue proposed regulations to implement section 572 of the Federal Food, Drug, and Cosmetic Act (as added by this Act) [21 U.S.C. 360ccc–1], and not later than 36 months after the date of enactment of this Act, the Secretary shall issue final regulations implementing section 572 of the Federal Food, Drug, and Cosmetic Act. Not later than 30 months after the date of enactment of this Act, the Secretary shall issue proposed regulations to implement section 571 of the Federal Food, Drug, and Cosmetic Act (as added by this Act), and not later than 42 months after the date of enactment of this Act, the Secretary shall issue final regulations implementing section 571 of the Federal Food, Drug, and Cosmetic Act. These timeframes shall be extended by 12 months for each fiscal year, in which the funds authorized to be appropriated under subsection (i) [no subsection (i) of section 102 has been enacted] are not in fact appropriated.”
