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
Active
Program Number
93.350
Federal Agency/Office
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
Cooperative Agreements
Program Accomplishments
Not Applicable.
Authorization
Public Health Service Act, Title IV, Section 479-481 487F, Public Law 99-158; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564; Public Health Service Act, Title III, Section 301, Public Law 78-410, 341 U.S.C 287-288.
Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
None.
Beneficiary Eligibility
Biomedical investigators at any nonprofit or for-profit organization, company, or institution engaged in biomedical research.
Credentials/Documentation
The required credentials of the applicant are described in the relevant Funding Opportunity Announcement. This program is excluded from coverage under 2 CFR 200, Subpart E - Cost Principles.
What is the process for applying and being award this assistance?
Pre-Application Procedure
Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.
Application Procedure
This program is excluded from coverage under 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. 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
Award Procedure
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.
Deadlines
Contact the headquarters or regional office, as appropriate, for application deadlines.
Approval/Disapproval Decision Time
> 180 Days.
Appeals
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.
Renewals
> 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) consortium. 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. Re-engineering Translational Sciences activities include Discovering New Therapeutic Uses for Existing Molecules (UH2/UH3). 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.
What are the requirements after being awarded this opportunity?
Reporting
No program reports are required. No cash reports are required. Annual progress and financial status reports are required for all grants and cooperative agreements. Final performance and financial reports are required 90 days following the end of the project period. Annual progress and financial status reports are required for all grants and cooperative agreements.. Final performance and financial reports are required 90 days following the end of the project period.
Auditing
In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503.
Records
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
This program has no statutory formula.
This program has no matching requirements.
This program does not have MOE requirements.
Length and Time Phasing of Assistance
1 to 5 years. An Electronic Transfer System is used to transfer funds. Method of awarding/releasing assistance: by letter of credit.
Who do I contact about this opportunity?
Regional or Local Office
None.
Headquarters Office
Sylvia Parsons 6701 Democracy Blvd, Room 988, Bethesda, Maryland 20892-4874 Email: parsonss@mail.nih.gov Phone: 3014350860
Website Address
http://www.ncats.nih.gov
Financial Information
Account Identification
75-0875-0-1-552 - National Center for Advancing Translational Sciences.
Obligations
(Project Grants) FY 14 $530,596; FY 15 est $528,361; and FY 16 est $546,685
Range and Average of Financial Assistance
No Data Available.
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 2014: Clinical and Translational Science activities $473,554,000
Rare Disease Research $16,704,000
Cures Acceleration Network $9,810,000
SBIR/STTR $17,109,000
New Therapeutic Uses $13,419,000. Fiscal Year 2015: Clinical and Translational Science activities $472,226,000
Rare Disease Research $15,179,000
Cures Acceleration Network $9,835,000
SBIR/STTR $17,968
New Therapeutic Uses $13,153,000. Fiscal Year 2016: Clinical and Translational Science activities $472,766,000
Rare Disease Research $15,179,000
Cures Acceleration Network $25,835,000
SBIR/STTR $19,953
New Therapeutic Uses $12,952,000.

 



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