Skip to main content

21 U.S.C. § 360bbb-5 - U.S. Code - Unannotated Title 21. Food and Drugs § 360bbb-5. Critical Path Public-Private Partnerships

Welcome to FindLaw's Cases & Codes, a free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw's Learn About the Law.


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.


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.


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 $6,000,000 for each of fiscal years 2013 through 2017.

Cite this article: - 21 U.S.C. § 360bbb-5 - U.S. Code - Unannotated Title 21. Food and Drugs § 360bbb-5. Critical Path Public-Private Partnerships - last updated January 01, 2018 |

FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature or via Westlaw before relying on it for your legal needs.

Was this helpful?

Thank you. Your response has been sent.

Copied to clipboard