§ 360bbb–5.
(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
(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.
(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.
([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, § 1102], July 9, 2012, [126 Stat. 1108]; [Pub. L. 115–52, title VI, § 602], Aug. 18, 2017, [131 Stat. 1048]; [Pub. L. 117–180, div. F, title V, § 5005], Sept. 30, 2022, [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].)