Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act

Amyotrophic Lateral Sclerosis, or ALS, is a progressive and fatal neurodegenerative disorder, affecting around 30,000 people in the United States. Although some cases of ALS are inherited, the majority are sporadic, meaning that they occur with no cl

The ACT for ALS aims to expedite therapeutic development, enhance patient access to investigational treatments, and improve quality of life for people affected by ALS. The ACT fosters collaboration among federal, academic, industry, and advocacy partners, along with PWLE of ALS to advance innovative approaches that accelerate the development and availability of promising therapies.

Interstate, Intrastate, State (includes District of Columbia, public institutions of higher education and hospitals), Local (includes State-designated lndian Tribes, excludes institutions of higher education and hospitals, Sponsored organization, Public nonprofit institution/organization (includes institutions of higher education and hospitals), Other public institution/organization, U.S. Territories and possessions, U.S. Territories and possessions (includes institutions of higher education and hospitals), Individual/Family, Minority group, Specialized group (e.g. health professionals, students, veterans), Small business (less than 500 employees), Profit organization, Private nonprofit institution/organization (includes institutions of higher education and hospitals), Other private institutions/organizations, State Research Grants: Any public, private, nonprofit, or for-profit institution is eligible to apply. For-profit institutions are not eligible for Institutional National Research Service Awards but are eligible for Individual NRSAs. All proposals are reviewed for scientific merit, for evaluation of the qualifications of the investigators, for adequacy of the research environment, and for significance of the problem. Approved proposals compete for available funds. All Career Development Program awardees, with the exception of awardees of the Pathway to Independence Award (K99/R00), must be citizens or have been admitted to the United States for permanent residence. Candidates must be nominated for the program by a nonfederal public or private nonprofit institution located in the United States, its possessions or territories. To be eligible, postdoctoral NRSA trainees or fellows must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D. Eng., or equivalent domestic or foreign degree). SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the entire research must be performed in the United States. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.

The major elements in evaluating proposals include assessments of: (1) the scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) the soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) the degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and 8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.

Research Grant, Cooperative Agreement, Training, Fellowship and SBIR/STTR applications are reviewed initially by technical panels, composed of scientific authorities, and by the National Advisory Neurological Disorders and Stroke Council composed of leaders in medical science, education, and public affairs. Approved applications will compete on a merit basis for available funds. Formal award notices are transmitted to the grantee or awardee.

Determined as part of the NOFO

A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute, and subsequently, the P.I. and applicant institution may appeal to the NINDS appeals officer. A description of the NIH Peer Review Appeal procedures is available on the NIH home page http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html.