National Center for Advancing Translational Sciences
The mission of the National Center for Advancing Translational Sciences (NCATS) is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.
General information about this opportunity
Last Known Status
National Institutes of Health, Department of Health and Human Services
Type(s) of Assistance Offered
B - Project Grants
Small Business Reauthorization Act of 2000, Public Law 106-554
Public Health Service Act, Title IV, Section 479-481 487F, Public Law 99-158
Public Health Service Act, Title III, Section 301, Public Law 78-410, 341 U.S.C. 287-288
The 21st Century Cures Act, Title II, Part A, Section 2037, Public Law 114-114-255
For carrying out section 301 and title IV of the PHS Act with respect to translational sciences, $576,456,000: Provided, That up to $10,000,000 shall be available to implement section 402C of the PHS Act, relating to the Cures Acceleration Network: Provided further, That funds appropriated may be used to support the reorganization and activities required to eliminate the National Center for Research Resources: Provided further, That the Director of the NIH shall ensure that, of all funds made available to Institute, Center, and Office of the Director accounts within‘‘Department of Health and Human Services, National Institutes of Health,’’ at least $487,767,000 is provided to the Clinical and Translational Sciences Award program.
Who is eligible to apply/benefit from this assistance?
Biomedical investigators at any nonprofit or for-profit organization, company, or institution engaged in biomedical research.
The required credentials of the applicant are described in the relevant Funding Opportunity Announcement.
What is the process for applying and being award this assistance?
Preapplication coordination is not applicable.
2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. Cooperative agreement applications must be submitted using the electronic SF424 form per the instructions in the NIH Guide for Grants and Contracts. Forms can be found at http://grants.nih.gov/grants/ElectronicReceipt/index.htm and submitted to http://www.grants.gov/web/grants/home.html;jsessionid=9H2lTpJpw1VLC1TBJzYsdhwG2Kt6fHGG2v2vC2S8nvjDBvqsMqmn. Small business grant applicants must use the SF424 for Small Business grants at: http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_SBIR_STTR_Adobe_VerB.pdf
The initial review of applications from eligible institutions is conducted by committees comprised of authorities in various fields of biomedical research and science education, as appropriate. Each application is given a peer evaluation for merit. Recommendations for award are forwarded to the NCATS Advisory Council for the second level of review and recommendation for award.
Contact the headquarters or regional location, as appropriate for application deadlines
Approval/Disapproval Decision Time
More than 180 days.
From 15 to 30 days. Principal investigators (P.I.) may question the substantive or procedural aspects of the review of their applications by communicating with the NCATS staff. 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
More than 180 days. SBIR grants may be renewed.
How are proposals selected?
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.
How may assistance be used?
NCATS is all about getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. A novel drug, device or intervention can take 14 years and $2 billion to develop, with a failure rate exceeding 95%. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions that can be used by all translational researchers. The Clinical and Translational Science Awards Program includes several activities to support and foster innovation in clinical and translational centers, methods, and training (UL1, KL2, TL1) . The Trial Innovation Centers awards (U24) are intended to be lead centers of excellence in clinical trials and will facilitate the implementation of multi-site clinical studies by the CTSA Network. The Recruitment Innovation Centers (U24) aim to improve participant recruitment into clinical trials by using innovative means to assess the availability of potential participants and to enroll them in a timely manner. The Collaborative Innovation Awards aim to stimulate innovative collaborative research in the NCATS’ Clinical and Translational Science Award (CTSA) Program.. Pre-application is required. The Office of Rare Disease Research (ORDR) supports a network of research consortia, each targeted to several related rare diseases (U54). ORDR also supports an extensive resource of information for the public on rare diseases. The Discovering New Therapeutic Uses for Existing Molecules (UH2/UH3) program focuses on finding new uses for existing therapies. Small Business Innovation Research (SBIR) grants (R43, R44) and Small Business Technology Transfer (STTR) grants (R41, R42) support domestic small businesses engaging in research and development that has the potential for commercialization. The Tissue Chip program funds bioengineered devices to improve the process of predicting whether drugs will be safe or toxic in humans. Through Translator, NCATS will integrate existing biomedical data to help reveal new relationships within those data and also identify novel opportunities for research. The bioprinting program will generate high throughput screenable assay models of human tissues for drug discovery.
What are the requirements after being awarded this opportunity?
Annual performance review is required. Final performance and financial reports are required 120 days following the end of the project period.
Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FSR is submitted. For awards under SNAP (other than those to foreign organizations and Federal institutions), the 3-year retention period will be calculated from the date the FSR for the entire competitive segment is submitted. Those grantees must retain the records pertinent to the entire competitive segment for 3 years from the date the FSR is submitted to NIH. Foreign organizations and Federal institutions must retain records for 3 years from the date of submission of the annual FSR to NIH. See 45 CFR 75 for exceptions and qualifications to the 3-year retention requirement (e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken). Those sections also specify the retention period for other types of grant-related records, including F&A cost proposals and property records. See 45 CFR 75 for record retention and access requirements for contracts under grants. In accordance with 45 Code of Federal Regulations, Part 74.53(e), the HHS Inspector General, the U.S. Comptroller General, or any of their duly authorized representatives have the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to awards in order to make audits, examinations, excerpts, transcripts, and copies of such documents. This right also includes timely and reasonable access to a recipient's personnel for the purpose of interview and discussion related to such documents. The rights of access are not limited to the required retention period, but shall last as long as records are retained.
Other Assistance Considerations
Formula and Matching Requirements
Statutory formula is not applicable to this assistance listing.
Matching requirements are not applicable to this assistance listing.
MOE requirements are not applicable to this assistance listing.
Length and Time Phasing of Assistance
1 to 5 years. An Electronic Transfer System is used to transfer funds. Method of awarding/releasing assistance: Letter.
Who do I contact about this opportunity?
Regional or Local Office
6701 Democracy Blvd, Room 970
Bethesda, MD 20892-4874 US
Meredith Temple O'Connor
6701 Democracy Blvd.
Bethesda, MD 20892 USA
(Project Grants) FY 18$617,275,075.00; FY 19 est $676,537,503.00; FY 20 est $555,870,873.00; FY 17$579,953,132.00; -
Range and Average of Financial Assistance
Clinical and Translational Science Award program: $1 - $24,600,001 , Therapeutics for Rare and Neglected Diseases: $49,209 - $92,677
Regulations, Guidelines and Literature
45 CFR 75. OMB Circular No. A-128, "Audits of State and Local Governments"; Reference: Public Law 98-502, the Single Audit Act of 1984. Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal Regulations at 42 CFR 52 and 42 USC 241. Department Staff Manual "Grants Administration"; Indirect Cost Register, DHHS; PHS Grants Policy Statement, DHHS Publications No. (OASH) 94-50,000, (Rev.) April 1, 1994; "NIH Grants Policy Guide," Office for Protection from Research Risks, NIH; "A Guide to Grant and Award Programs of the NIH"; and miscellaneous program literature from Headquarters Office.
Examples of Funded Projects
Fiscal Year 2017
Clinical and Translational Science activities $509,572,000 Rare Disease Research $17,924,000 Tissue Chip $16,216,000 Translator $5,155,000 Bio Printing $1,500,000 SBIR/STTR $21,215,000 New Therapeutic Uses $9,089,000 Therapeutics for Rare and Neglected Diseases $297,000Fiscal Year 2018
The Clinical and Translational Science Award program addresses the development and implementation of national standards and best practices for translation, from basic discovery to clinical and community-engaged research. The Tissue Chip for Drug Screening program supports the development of bioengineered devices to improve the process of predicting whether drugs will be safe or toxic in humans. The Rare Disease Clinical Research Network program advances medical research on rare diseases through support for clinical studies and by facilitating collaboration, study enrollment and data sharing.Fiscal Year 2019
The Clinical and Translational Science Award program addresses the development and implementation of national standards and best practices for translation, from basic discovery to clinical and community-engaged research. The Tissue Chip for Drug Screening program supports the development of bioengineered devices to improve the process of predicting whether drugs will be safe or toxic in humans. The Rare Disease Clinical Research Network program advances medical research on rare diseases through support for clinical studies and by facilitating collaboration, study enrollment and data sharing.