; (2) for the entity’s direct costs incurred in providing such drug consistent with the research mission of the grant; or (3) for the direct and indirect costs of the entity in conducting research with respect to the drug involved. (e) Definitions In this section: (1) The term eligible entity means a participating clinical trial site or sites sponsored by a small business concern (as defined in section 3(a) of the Small Business Act ( 15 U.S.C. 632(a) ) that is the sponsor of a drug that is the subject of an investigational new drug application under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ). (2) The term participating clinical trial means a phase 3 clinical trial conducted pursuant to an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) or section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) to investigate a drug intended to prevent, diagnose, mitigate, treat, or cure amyotrophic lateral sclerosis. (3) The term participating clinical trial site means a nonprofit or public health care facility, or network of facilities, at which patients participating in a participating clinical trial receive an investigational drug through such trial. 3. HHS Collaborative for Neurodegenerative Diseases (a) Establishment Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services shall establish and implement a Collaborative for Neurodegenerative Diseases between the National Institutes of Health and the Food and Drug Administration (to be known and referred to in this section as the Collaborative ), which shall— (1) enter into a cooperative agreement, contract, or other instrument with a private entity or entities under which such private entity or entities will operate the Collaborative; (2) focus on advancing regulatory improvements and scientific research that will support and accelerate the development and approval of drugs for patients with amyotrophic lateral sclerosis