21 U.S.C. § 360bbb-5

Current through P.L. 118-106 (published on www.congress.gov on 10/04/2024)

Section 360bbb-5 - Critical Path Public-Private Partnerships

(a) Establishment

The Secretary, acting through the Commissioner of Food and Drugs, may enter into collaborative agreements, to be known as Critical Path Public-Private Partnerships, with one or more eligible entities to implement the Critical Path Initiative of the Food and Drug Administration by developing innovative, collaborative projects in research, education, and outreach for the purpose of fostering medical product innovation, enabling the acceleration of medical product development, manufacturing, and translational therapeutics, and enhancing medical product safety.

(b) Eligible entity

In this section, the term "eligible entity" means an entity that meets each of the following:

(1) The entity is-

(A) an institution of higher education (as such term is defined in section 1001 of title 20) or a consortium of such institutions; or

(B) an organization described in section 501(c)(3) of title 26 and exempt from tax under section 501(a) of such title.

(2) The entity has experienced personnel and clinical and other technical expertise in the biomedical sciences, which may include graduate training programs in areas relevant to priorities of the Critical Path Initiative.

(3) The entity demonstrates to the Secretary's satisfaction that the entity is capable of-

(A) developing and critically evaluating tools, methods, and processes-

(i) to increase efficiency, predictability, and productivity of medical product development; and

(ii) to more accurately identify the benefits and risks of new and existing medical products;

(B) establishing partnerships, consortia, and collaborations with health care practitioners and other providers of health care goods or services; pharmacists; pharmacy benefit managers and purchasers; health maintenance organizations and other managed health care organizations; health care insurers; government agencies; patients and consumers; manufacturers of prescription drugs, biological products, diagnostic technologies, and devices; and academic scientists; and

(C) securing funding for the projects of a Critical Path Public-Private Partnership from Federal and nonfederal governmental sources, foundations, and private individuals.

(c) Funding

The Secretary may not enter into a collaborative agreement under subsection (a) unless the eligible entity involved provides an assurance that the entity will not accept funding for a Critical Path Public-Private Partnership project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless the entity provides assurances in its agreement with the Food and Drug Administration that the results of the Critical Path Public-Private Partnership project will not be influenced by any source of funding.

(d) Annual report

Not later than 18 months after September 27, 2007, and annually thereafter, the Secretary, in collaboration with the parties to each Critical Path Public-Private Partnership, shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives-

(1) reviewing the operations and activities of the Partnerships in the previous year; and

(2) addressing such other issues relating to this section as the Secretary determines to be appropriate.

(e) Definition

In this section, the term "medical product" includes a drug, a biological product as defined in section 262 of title 42, a device, and any combination of such products.

(f) Authorization of appropriations

To carry out this section, there is authorized to be appropriated $1,380,822 for the period beginning on October 1, 2022 and ending on December 23, 2022.¹

¹See 2022 Amendment notes below.

21 U.S.C. § 360bbb-5

June 25, 1938, ch. 675, §566, as added Pub. L. 110-85, title VI, §603, Sept. 27, 2007, 121 Stat. 898; amended Pub. L. 112-144, title XI, §11021102,, 126 Stat. 1108; Pub. L. 115-52, title VI, §602, Aug. 18, 2017, 131 Stat. 1048; Pub. L. 117-180, div. F, title V, §50055005,, 136 Stat. 2167; Pub. L. 117-229, div. C, title III, §301, Dec. 16, 2022, 136 Stat. 2311; Pub. L. 117-328 div. FF, title III, §3101, Dec. 29, 2022, 136 Stat. 5807.

EDITORIAL NOTES

AMENDMENTS2022-Subsec. (f). Pub. L. 117-328 which directed the substitution of "$6,000,000 for each of fiscal years 2023 through 2027" for "$1,265,753 for the period beginning on October 1, 2022 and ending on December 23, 2022", could not be executed because "$1,265,753" did not appear after the intervening amendment by section 301 of Pub. L. 117-229. See below. Pub. L. 117-229 substituted "$1,380,822 for the period beginning on October 1, 2022 and ending on December 23, 2022" for "$1,265,753 for the period beginning on October 1, 2022 and ending on December 16, 2022". Pub. L. 117-180 substituted "$1,265,753 for the period beginning on October 1, 2022 and ending on December 16, 2022" for "$6,000,000 for each of fiscal years 2018 through 2022".2017-Subsec. (f). Pub. L. 115-52 substituted "2018 through 2022" for "2013 through 2017". 2012-Subsec. (f). Pub. L. 112-144 amended subsec. (f) generally. Prior to amendment, text read as follows: "To carry out this section, there are authorized to be appropriated $5,000,000 for fiscal year 2008 and such sums as may be necessary for each of fiscal years 2009 through 2012."