§ 379j–22.
(d)
Reauthorization
(1)
Consultation
In 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 2028, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A)
the Committee on Energy and Commerce of the House of Representatives;
(B)
the Committee on Health, Education, Labor, and Pensions of the Senate;
(C)
scientific and academic experts;
(D)
veterinary professionals;
(E)
representatives of patient and consumer advocacy groups; and
(F)
the regulated industry.
(2)
Prior public input
Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—
(A)
publish a notice in the Federal Register requesting public input on the reauthorization;
(B)
hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);
(C)
provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and
(D)
publish the comments on the Food and Drug Administration’s Internet Web site.
(3)
Periodic consultation
(4)
Public review of recommendations
After negotiations with the regulated industry, the Secretary shall—
(A)
present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;
(B)
publish such recommendations in the Federal Register;
(C)
provide for a period of 30 days for the public to provide written comments on such recommendations;
(D)
hold a meeting at which the public may present its views on such recommendations; and
(E)
after consideration of such public views and comments, revise such recommendations as necessary.
(5)
Transmittal of recommendations
(6)
Minutes of negotiation meetings
([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]; [Pub. L. 115–234, title II, § 203], Aug. 14, 2018, [132 Stat. 2435]; [Pub. L. 118–15, div. B, title III, § 2313], Sept. 30, 2023, [137 Stat. 93].)