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21st Century Cures Act: Regenerative Medicine Initiative
By accelerating the development and application of innovative technologies, researchers will be able to produce a revolutionary
Long desired by researchers seeking new ways to treat, cure, and even prevent brain disorders, this picture will fill major gaps in our current knowledge and provide unprecedented opportunities for exploring exactly how the brain enables the human body to record, process, utilize,.
The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.
45 CFR 75, NIH Grants Policy Statement, SF 424.
Program Accomplishments
Fiscal Year 2016: N/A. Fiscal Year 2017: $2,000,000. Fiscal Year 2018: $2,000,000.
Uses and Use Restrictions
Grants and cooperative agreements may be made to eligible institutions for the support of the BRAIN Initiative.
The grants and cooperative agreements may be used for personnel, consultant costs, equipment, supplies, travel, patient costs, animals, alterations and renovations, miscellaneous items, and Facilities and Administrative Costs (formerly known as indirect costs).
Eligibility Requirements
Applicant Eligibility
The awardee will be a university, college, hospital, public agency, nonprofit research institution or for-profit organization that applies and receives a grant for support of research by a named principal investigator.
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.
Beneficiary Eligibility
Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.
Credentials/Documentation
Applications must be submitted in compliance with instructions provided with each initiative. 2 CFR 200, Subpart E - Cost Principles applies to this program.
Aplication and Award Process
Preapplication Coordination
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 Procedures
2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program.
Award Procedures
Grants and cooperative agreements are funded based on scientific merit, program relevance, and program balance and are made annually. The initial grant award provides funds for the first budget period (usually 12 months) and letter Notice of Award indicates support recommended for the remainder of the project period, allocation of Federal funds by budget categories and special conditions, if any.
Deadlines
Not Applicable.
Authorization
21st Century Cures Act , Apprporiation75X5628, as amended by Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
Range of Approval/Disapproval Time
Regular Grants: Approximately 10 months.
Appeals
A principal investigator may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page www.nih.gov/grants/guide/notice-files/not97-232.html .
Renewals
Applications submitted for renewal are reviewed and selected for funding on a competitive basis.
Assistance Considerations
Formula and Matching Requirements
Statutory formulas are not applicable to this program. Matching requirements are not applicable to this program. MOE requirements are not applicable to this program.
Length and Time Phasing of Assistance
Grants and Cooperative Agreements: Average 3 to 5 years, and a maximum of 5 years. Renewals may be awarded for additional periods of up to 5 years based on competitive peer review. 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 reports and selected financial reports are required for continuing projects.
Final progress reports, invention statements, and expenditure reports are required at the end of the projects.
Special reports may be requested by DHHS.
Final progress reports, invention statements, and expenditure reports are required at the end of the projects.
Special reports may be requested by DHHS.
No performance monitoring is required.
Audits
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
Expenditures and other financial records, and also administrative records, must be retained for 3 years from the day on which the grantee submits the last expenditure report for the grant period.
Financial Information
Account Identification
75-2017-0-0-028.
Obigations
(Project Grants (Cooperative Agreements)) FY 16 $0; FY 17 est $2,000,000; and FY 18 est $2,000,000
Range and Average of Financial Assistance
No Data Available.
Regulations, Guidelines, and Literature
45 CFR 75, NIH Grants Policy Statement, SF 424
Information Contacts
Regional or Local Office
None. 45 CFR 75, NIH Grants Policy Statement, SF 424.
Headquarters Office
Dana A. Phares National Institutes of Health 6701 Rockledge Drive, Room 7176, Bethesda, Maryland 20832 Email: pharesda@nhlbi.nih.gov Phone: 301 827-7968
Criteria for Selecting Proposals
Not Applicable.
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