42 U.S.C. § 280g-7b

Current through P.L. 118-78 (published on www.congress.gov on 07/30/2024)

Section 280g-7b - HHS public-private partnership for rare neurodegenerative diseases

(a) Establishment

Not later than one year after December 23, 2021, the Secretary of Health and Human Services (referred to in this section as the "Secretary") shall establish and implement a Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the Food and Drug Administration, and one or more eligible entities (to be known and referred to in this section as the "Partnership") through cooperative agreements, contracts, or other appropriate mechanisms with such eligible entities, for the purpose of advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amytrophic lateral sclerosis and other rare neurodegenerative diseases. The Partnership shall-

(1) establish partnerships and consortia with other public and private entities and individuals with expertise in amyotrophic lateral sclerosis and other rare neurodegenerative diseases for the purposes described in this subsection;

(2) focus on advancing regulatory science and scientific research that will support and accelerate the development and review of drugs for patients with amyotrophic lateral sclerosis and other rare neurodegenerative diseases; and

(3) foster the development of effective drugs that improve the lives of people that suffer from amyotrophic lateral sclerosis and other rare neurodegenerative diseases.

(b) Eligible entity

In this section, the term "eligible entity" means an entity that-

(1) is-

(A) an institution of higher education (as such term is defined in section 1001 ¹ 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 subsection (a) of such section;

(2) has experienced personnel with clinical and other technical expertise in the field of biomedical sciences and demonstrated connection to the patient population;

(3) demonstrates to the Secretary's satisfaction that the entity is capable of identifying and establishing collaborations between public and private entities and individuals with expertise in neurodegenerative diseases, including patients, in order to facilitate-

(A) development and critical evaluation of tools, methods, and processes-

(i) to characterize neurodegenerative diseases and their natural history;

(ii) to identify molecular targets for neurodegenerative diseases; and

(iii) to increase efficiency, predictability, and productivity of clinical development of therapies, including advancement of rational therapeutic development and establishment of clinical trial networks; and

(B) securing funding for the Partnership from Federal and non-Federal governmental sources, foundations, and private individuals; and

(4) provides an assurance that the entity will not accept funding for a 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 Secretary that the results of the project will not be influenced by any source of funding.

(c) Gifts

(1) In general

The Partnership may solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in support of basic research and research associated with phase 3 clinical trials conducted with respect to investigational drugs that are the subjects of expanded access requests under section 360bbb of title 21.

(2) Use

In addition to any amounts appropriated for purposes of carrying out this section, the Partnership may use, without further appropriation, any funds derived from a gift, grant, or other donation accepted pursuant to paragraph (1).

¹ See References in Text note below.

42 U.S.C. § 280g-7b

Pub. L. 117-79, §3, Dec. 23, 2021, 135 Stat. 1535.

EDITORIAL NOTES

REFERENCES IN TEXTSection 1001 of title 20, referred to in subsec. (b)(1)(A), was in the original "section 1001 of the Higher Education Act of 1965" and was translated as if it had read "section 101 of the Higher Education Act of 1965" to reflect the probable intent of Congress. Section 101 of the Higher Education Act of 1965 is classified to section 1001 of Title 20, Education, and defines "institution of higher education".

CODIFICATIONSection was enacted as part of the Accelerating Access to Critical Therapies for ALS Act, and not as part of the Public Health Service Act which comprises this chapter.

Consortium: The term "Consortium" means the High-Performance Green Building Partnership Consortium created in response to section 17092(c)(1) of this title to represent the private sector in a public-private partnership to promote high-performance green buildings and zero-net-energy commercial buildings.
Service: The term "Service" means the Public Health Service;
project: The terms "federally assisted housing" and "project" mean-(A) a public housing project (as such term is defined in section 3(b) of the United States Housing Act of 1937 [42 U.S.C. 1437a(b)] );(B) housing for which project-based assistance is provided under section 8 of the United States Housing Act of 1937 [42 U.S.C. 1437f] ;(C) housing that is assisted under section 1701q of title 12;(D) housing that is assisted under section 1701q of title 12, as such section existed before November 28, 1990;(E) housing financed by a loan or mortgage insured under section 1715l(d)(3) of title 12 that bears interest at a rate determined under the proviso of section 1715l(d)(5) of title 12;(F) housing insured, assisted, or held by the Secretary or a State or State agency under section 1715z-1 of title 12;(G) housing constructed or substantially rehabilitated pursuant to assistance provided under section 8(b)(2) of the United States Housing Act of 1937 [42 U.S.C. 1437f(b)(2)], as in effect before October 1, 1983, that is assisted under a contract for assistance under such section; and(H) housing that is assisted under section 8013 1 of this title.
Secretary: the term "Secretary" means-(A) the Secretary of Education for purposes of subtitle A (other than section 3201),(B) the Secretary of Agriculture for purposes of the amendments made by section 3201, and(C) the Secretary of Health and Human Services for purposes of subtitle B,
drug: the term "drug" means-(A) a beverage containing alcohol,(B) a controlled substance, or(C) a controlled substance analogue,