21 U.S.C. § 360bbb–5: Critical Path Public-Priv…

Summary

The Secretary of Health and Human Services, through the FDA Commissioner, may make collaborative agreements called Critical Path Public-Private Partnerships with eligible groups. These partnerships fund research, education, and outreach projects to help create new medical products, speed up their development and manufacturing, move treatments from research to patients faster, and make products safer. An eligible entity is a college or university (or group of them) or a tax-exempt 501(c)(3) nonprofit. It must have experienced staff and biomedical expertise. It must be able to develop and test tools and methods to make development more efficient and to better find benefits and risks, form partnerships with many health and industry stakeholders, and raise money from government and private sources. The entity must agree not to take money from makers or distributors of FDA-regulated products unless it promises the funding will not affect project results. The Secretary and partners must report to the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee within 18 months after September 27, 2007 and every year after, reviewing the partnerships’ activities. "Medical product" includes drugs, biological products (as defined in 42 U.S.C. 262), devices, and combinations. Congress authorized $1,380,822 for the period October 1, 2022 through December 23, 2022 to carry out this work.

Title 21, §360bbb–5

Food and Drugs, Source: USLM XML via OLRC

(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.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2022—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.”

§360bbb–5 Critical Path Public-private Partnerships

Summary

Title 21, §360bbb–5

Notes & Related Subsidiaries

Editorial Notes

Amendments

Citations & Metadata