42 U.S.C. § 280g: HHS public-private partnership for rare neurodegenerative diseases

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; 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 foster the development of effective drugs that improve the lives of people that suffer from amyotrophic lateral sclerosis and other rare neurodegenerative diseases. an institution of higher education (as such term is defined in section 1001 1 of title 20) or a consortium of such institutions; or 1 See References in Text note below. an organization described in section 501(c)(3) of title 26 and exempt from tax under subsection (a) of such section; has experienced personnel with clinical and other technical expertise in the field of biomedical sciences and demonstrated connection to the patient population; to characterize neurodegenerative diseases and their natural history; to identify molecular targets for neurodegenerative diseases; and to increase efficiency, predictability, and productivity of clinical development of therapies, including advancement of rational therapeutic development and establishment of clinical trial networks; and securing funding for the Partnership from Federal and non-Federal governmental sources, foundations, and private individuals; and 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. 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 . 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).