Fast Track 5
Cookie Grosky
The site is secure.
The ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
This new pilot effort shares the same goals as the NSF SBIR/STTR Phase I and Phase II funding opportunities, but the NSF SBIR/STTR Fast-Track pilot programs have different eligibility requirements. Small businesses applying to the NSF SBIR/STTR Fast-Track pilot programs must have a lineage of NSF research funding, at least one Senior/Key Personnel to have undergone formal customer discovery training, and the entire team must already be in place (not yet to be determined) at the time of proposal submission. For further information see Eligibility Criteria.
NSF proposals are confidential and will only be shared with a select number of reviewers and NSF staff (as appropriate). All reviewers have agreed to maintain the confidentiality of the proposal content. Proposals to NSF do not constitute a public disclosure. If selected for an award, the company will be prompted to write a publicly available abstract that summarizes the intellectual merit and broader impact of the project.
The NSF SBIR/STTR Fast-Track pilot programs do not support clinical trials or proposals from companies whose commercialization pathway involves the production, distribution, or sale by the company of chemical components, natural or synthetic variations thereof, or other derivatives related to Schedule I controlled substances.
NSF SBIR/STTR Fast-Track pilot proposals will not be accepted in Grants.gov. NSF Fast-Track SBIR and STTR pilot proposals are nearly identical but differ in the amount of work performed by the small business and a not-for-profit institution or a Federally funded research and development center (FFRDC) (as noted in the budget). For more details about the unique requirements of NSF STTR Fast-Track pilot awards, please refer to the Eligibility Information and Proposal Preparation and Submission Instructions sections of this solicitation.
An Intellectual Property (IP) Rights agreement is required for STTR proposals and strongly recommended for SBIR proposals when there is a subaward to another institution. A fully signed agreement is not required for STTR proposals at the initial proposal submission but will be required before a recommendation for an award can be made.
A small business must receive an official invitation via the Project Pitch, a process to submit a full Fast-Track proposal. Details regarding this process as well as how to submit a Fast-Track Project Pitch can be found in Section III.A. of this document. Small businesses that meet the Fast-Track eligibility criteria can submit a Fast-Track Project Pitch at any time. Small businesses that have been invited to submit a full Fast-Track proposal can submit a proposal based on that Project Pitch at any time up to 4 months after the date of the invitation.
In addition to the standard NSF Merit Review Criteria, this solicitation provides additional clarification on how Intellectual Merit and Broader Impact might be applied to startups and small businesses. Additional solicitation-specific merit review criteria focused on Commercialization Potential is also applied.
Four documents: Biographical Sketch(es), Current and Pending (Other) Support forms, Collaborators and Other Affiliations (COA), and Synergistic Activities must be submitted for the PI, Co-PI (if STTR), and each Senior/Key Personnel specified in the proposal. Biographical Sketches and Current and Pending Support forms must be prepared using SciENcv: Science Experts Network Curriculum Vitae. Collaborators & Other Affiliations (COA) Information is prepared using the instructions and spreadsheet template.
In accordance with Section 10632 of the CHIPS and Science Act of 2022 (42 U.S.C. 19232), the Authorized Organizational Representative (AOR) must certify that all individuals identified as Senior/Key Personnel have been made aware of and have complied with their responsibility under that section to certify that the individual is not a party to a Malign Foreign Talent Recruitment Program.
In accordance with Section 223(a)(1) of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (42 U.S.C. 6605(a)(1)), each individual identified as Senior/Key Personnel is required to certify in SciENcv that the information provided in the Biographical Sketch and Current and Pending (Other) Support documents are accurate, current, and complete. Senior/Key Personnel are required to update their Current and Pending (Other) Support disclosures prior to award, and at any subsequent time the agency determines appropriate during the term of the award. See additional information on NSF Disclosure Requirements in the PAPPG, Chapter II.B. Each Senior/Key Person must also certify prior to proposal submission that they are not a party to a Malign Foreign Talent Recruitment Program and annually thereafter for the duration of the award.
Additional information on the due diligence process, used as part of the review and selection process, is included in Section VI. The due diligence process may include requests for clarification of the company structure, key personnel, conflicts of interest, foreign influence, cybersecurity practices, or other issues as determined by NSF. Participation in the due diligence process is not a guarantee that an award will be made.
SBIR/STTR Fast-Track proposals that have been declined by NSF are NOT eligible for reconsideration. A decision by NSF not to provide additional funding following either the Stage Gate 1 or Stage Gate 2 review will NOT be eligible for reconsideration or termination review as defined in Chapter XII.A.4 of the PAPPG.
Any proposal submitted in response to this solicitation should be submitted in accordance with the NSF Proposal & Award Policies & Procedures Guide (PAPPG) that is in effect for the relevant due date to which the proposal is being submitted. The NSF PAPPG is regularly revised and it is the responsibility of the proposer to ensure that the proposal meets the requirements specified in this solicitation and the applicable version of the PAPPG. Submitting a proposal prior to a specified deadline does not negate this requirement.
Synopsis of Program: The NSF SBIR/STTR and SBIR/STTR Fast-Track pilot programs support moving scientific excellence and technological innovation from the lab to the market. By funding startups and small businesses, NSF helps build a strong national economy and stimulates the creation of novel products, services, and solutions in private, public, or government sectors with potential for broad impact; strengthens the role of small business in meeting federal research and development needs; increases the commercial application of federally supported research results; and develops and increases the US workforce, especially by fostering and encouraging participation by socially and economically disadvantaged and women-owned small businesses.
These NSF SBIR/STTR Fast-Track pilot programs provide fixed amount cooperative agreements for the development of a broad range of technologies based on discoveries in science and engineering with potential for societal and economic impacts. Unlike fundamental or basic research activities that focus on scientific and engineering discovery itself, the NSF SBIR/STTR Fast-Track pilot programs support the creation of opportunities to move use-inspired and translational discoveries out of the lab and into the market or other use at scale, through startups and small businesses. The NSF SBIR/STTR Fast-Track pilot programs do not solicit specific technologies or procure goods and services from startups and small businesses. Any invention conceived or reduced to practice with the assistance of SBIR/STTR funding is subject to the Bayh-Dole Act. For more information refer to SBIR/STTR Frequently Asked Questions #75.
There are significant benefits for SBIR/STTR Fast-Track recipients: the submission of only one proposal for Phase I and Phase II and a faster transition from Phase I to Phase II. While startups and small businesses face many challenges, NSF SBIR/STTR Fast-Track funding is intended to specifically focus on challenges associated with technological innovation; that is, on the creation of new products, services, and other scalable solutions based on fundamental science or engineering. A successful Fast-Track proposal must demonstrate how NSF funding will help the small business create a proof-of-concept or prototype by retiring technical risk.
c80f0f1006