; and (B) recommendations for carrying out the programs under this Act during the 2-year period following the submission of such report, including recommendations relating to the inclusion of additional neurodegenerative diseases or disease areas within the grant programs under sections 2 and 5. (d) Duties and authorities The Collaborative shall identify and implement strategies for the Secretary— (1) for purposes of expediting the approval of drugs to treat amyotrophic lateral sclerosis, including through coordination among the centers of the Food and Drug Administration to achieve the goals specified in the draft guidance for drug sponsors entitled Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry published in September 2019; (2) to facilitate access to investigational drugs for amyotrophic lateral sclerosis pursuant to an expanded access request under section 561 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ) in a similar manner as investigational drugs for cancer are provided through Project Facilitate of the Center of Excellence for Oncology; (3) with respect to the rare neurodegenerative disease grant program established under section 5; (4) to define or develop the regulatory and translational pathway for emerging therapeutic categories; (5) to share, within the Collaborative, findings and insights related to pre-competitive research and research associated with phase 3 and phase 4 clinical trials conducted with respect to investigational drugs that are the subjects of expanded access applications under section 561 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb )