Not Applicable.

Uses and Use Restrictions

Support from NCATS advances the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

NCATS strives to support research to reduce, remove or bypass costly and time-consuming bottlenecks in the therapeutic development pipeline.

NCATS unifies complementary programs in cross-cutting areas.

Clinical and Translational Science Activities include Clinical and Translational Science Awards (UL1) and training awards in clinical and translational research (KL2, TL1).

The Office of Rare Disease Research supports a network of research consortia, each targeted to a specific rare disease (U54).

ORDR also supports an extensive resource of information for the public on rare diseases.

Re-engineering Translational Sciences activities include developing Tissue Chips for Drug Screening (U18, UH2/UH3) and 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.

People Building Stronger Communities

A Brief Look on Workforce Funding

Kristin Fletcher Wins National Rising Star Award

Health Care Law Helps Save Seniors More Than $6 Billion on Prescription Drugs

Oxford Takes Part in Hidden Spire Project for Homeless

Grafton Project Aims To Turn The Town Around

Cognitive Training Benefits Can Last Up To A Decade in Older Adults

Simms/Mann Institute Introduces Education Initiative with Fellowship Program and February Think Tank

Taylor High School Teacher to Promote Volunteer Work

World Tourism Day 2014 Celebrates Tourism, Community Development

Eligibility Requirements

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 OMB Circular No. A-87.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is required.

Environmental impact information is not required for this program.

This program is excluded from coverage under E.O.

12372.

Application Procedures

This program is excluded from coverage under OMB Circular No. A-102. OMB Circular No. A-110 applies to this program. Cooperative agreement applications must be submitted using the PHS 398 form per the instructions in the NIH Guide for Grants and Contracts. Forms can be found at http://grants.nih.gov/grants/funding/phs398/phs398.html. Completed applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, MSC 7710, Bethesda, MD 20892-7710. Form SF424 must be used for small business and conference grant applications. http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_SBIR_STTR_Adobe_VerB.pdf

Award Procedures

The initial review of applications from eligible investigators and 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.

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.

Range of Approval/Disapproval Time

> 180 Days.

Appeals

> 180 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 www.nih.gov/grants/guide/1997/97.11.21/n2.html .

Renewals

> 180 Days. Grants may be renewed upon successful reapplication except for the CTSA grants. CTSA grantees must re-apply with a new application.

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 to transfer funds. Method of awarding/releasing assistance: by letter of credit.

Post Assistance Requirements

Reports

No program reports are required.

No cash reports are required.

Annual progress and financial status reports are required for all grants.

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.

Final performance and financial reports are required 90 days following the end of the project period.

Audits

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133.

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 74.53 and 92.42 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 74.48 and 92.36 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.

Financial Information

Account Identification

75-0875-0-1-552.

Obigations

(Project Grants) FY 12 $501,268,646; FY 13 est $470,242,200; and FY 14 est $545,827,501 - Clinical and Translational Science activities: FY 12 actual $462,395,000; FY 13 est $431,985,957; FY 14 est: $462,503,010
Rare Disease Research: FY 12 actual $14,710,497; FY 13 est $13,775,511; FY 14 est: $14,710,497
Cures Acceleration Network: FY 12 actual $9,889,149; FY 13 est: $9,404,969; FY 14 est: $50,000,000.
SBIR/STTR: FY 12 actual $14,274,000; FY 13 est $15,075,763; FY 14 est: $18,613,994.

Range and Average of Financial Assistance

No Data Available.

Regulations, Guidelines, and Literature

OMB Circular No. A-21, "Cost Principles for Educational Institutions." Reference: 44 FR 12368, March 6, 1979; Rev. No. 1, 47 FR 33658, August 3, 1982; Rev. No. 2, 51 FR 20908, June 9, 1986. OMB Circular No. A-110, "Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Nonprofit Organizations." Reference: 41 FR 32016, July 30, 1976. OMB Circular No. A-122, "Cost Principles for Nonprofit Organizations." OMB Circular No. A-128, "Audits of State and Local Governments"; Reference: Public Law 98-502, the Single Audit Act of 1984. OMB Circular No. A-87, "Cost Principles Applicable to Grants and Contracts with State and Local Governments"; Reference: 34 CFR 255. 45 CFR 92. Reference: 42 FR 45828. OMB Circular No. A-122, "Cost Principles for Nonprofit Organizations." Reference: 45 FR 46022, July 8, 1980. 45 CFR 74; 42 CFR 52h. 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.

Information Contacts

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

Criteria for Selecting Proposals

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.