42 USC 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
Terms Used In 42 USC 280g-7b
- Appropriation: The provision of funds, through an annual appropriations act or a permanent law, for federal agencies to make payments out of the Treasury for specified purposes. The formal federal spending process consists of two sequential steps: authorization
- Gift: A voluntary transfer or conveyance of property without consideration, or for less than full and adequate consideration based on fair market value.
- Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
- Secretary: means the Secretary of Health and Human Services. See 42 USC 201
- Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
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).