Source: https://www.law.cornell.edu/uscode/text/21/379j%E2%80%9322
Timestamp: 2017-09-21 14:26:44
Document Index: 184688792

Matched Legal Cases: ['§ 379', 'art 5', '§ 379', '§ 379', '§\u202f379', '§\u202f742', '§\u202f203', '§\u202f203', '§\u202f206', '§\u202f204', '§\u202f206']

21 U.S. Code § 379j–22 - Reauthorization; reporting requirements | US Law | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter VII › Part C › Subpart 5 › § 379j–22
21 U.S. Code § 379j–22 - Reauthorization; reporting requirements
§ 379j–22.
Beginning with fiscal year 2014, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) of the Animal Generic Drug User Fee Amendments of 2013 toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs during such fiscal year.
Beginning with fiscal year 2014, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to Committee [1] on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.
(1) ConsultationIn developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of abbreviated applications for generic new animal drugs for the first 5 fiscal years after fiscal year 2018, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(June 25, 1938, ch. 675, § 742, as added Pub. L. 110–316, title II, § 203, Aug. 14, 2008, 122 Stat. 3522; amended Pub. L. 113–14, title II, § 203, June 13, 2013, 127 Stat. 472.)
For termination of section by section 206(b) of Pub. L. 113–14, see Termination Date note below.
Section 201(b) of the Animal Generic Drug User Fee Amendments of 2013, referred to in subsec. (a), is section 201(b) of Pub. L. 113–14, which is set out as a note under section 379j–21 of this title.
Pub. L. 113–14, title II, § 206(b), June 13, 2013, 127 Stat. 474, provided that:
“Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) shall cease to be effective January 31, 2019.”
Pub. L. 110–316, title II, § 204(b), Aug. 14, 2008, 122 Stat. 3524, which provided that the amendment made by section 203 of Pub. L. 110–316 (enacting this section) would cease to be effective Jan. 31, 2014, was repealed by Pub. L. 113–14, title II, § 206(c)(1), June 13, 2013, 127 Stat. 474.