§ 360ff.
(e)
Marketing of rare pediatric disease products
(2)
Postapproval production report
The sponsor of an approved rare pediatric disease product shall submit a report to the Secretary not later than 5 years after the approval of the applicable rare pediatric disease product application. Such report shall provide the following information, with respect to each of the first 4 years after approval of such product:
(A)
The estimated population in the United States suffering from the rare pediatric disease.
(B)
The estimated demand in the United States for such rare pediatric disease product.
(C)
The actual amount of such rare pediatric disease product distributed in the United States.
([June 25, 1938, ch. 675, § 529], as added [Pub. L. 112–144, title IX, § 908], July 9, 2012, [126 Stat. 1094]; amended [Pub. L. 114–113, div. A, title VII, § 765], Dec. 18, 2015, [129 Stat. 2286]; [Pub. L. 114–229, § 2(a)], Sept. 30, 2016, [130 Stat. 943]; [Pub. L. 114–255, div. A, title III, § 3013(a)], Dec. 13, 2016, [130 Stat. 1093]; [Pub. L. 116–159, div. C, title I, § 2105], Oct. 1, 2020, [134 Stat. 729]; [Pub. L. 116–215, div. B, title II, § 1211], Dec. 11, 2020, [134 Stat. 1045]; [Pub. L. 116–260, div. BB, title III, § 321], Dec. 27, 2020, [134 Stat. 2932]; [Pub. L. 117–9, § 1(a)(4)], Apr. 23, 2021, [135 Stat. 257].)