21st Century Cures Act - Precision Medicine Initiative

To provide support for initiatives funded under the 21st Century Cures Ac, the All of Us Research Program will gather data from one million or more people living in the United States to accelerate research and improve health.

By taking into account individual differences in lifestyle, environment,
and biology, researchers will uncover paths toward delivering precision medicine.

Agency - Department of Health and Human Services

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.

Office - See Regional Agency Offices.



Program Accomplishments

Fiscal Year 2016: n/a. Fiscal Year 2017: $40,000,000. Fiscal Year 2018: $40,000,000.

Uses and Use Restrictions

Grants and cooperative agreements may be made to eligible institutions for the support of the All of Us Research Program projects.

The awards 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 an award 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

The 21st Century Cures Act; Apprporiation75X5628; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

Range of Approval/Disapproval Time

Grants/Cooperative Agreements: Approximately 10 months.

Appeals

For grants/cooperative agreements: 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. See the following for information on how assistance is awarded/released: Funding is provided through Monthly Demand Payment System or an Electronic Transfer System. 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 $40,000,000; and FY 18 est $40,000,000

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

See Regional Agency Offices.

Headquarters Office

JUSTIN HENTGES National Institutes of Health 6011 Executive Blvd, Suite 214, ROCKVILLE, Maryland 20852 Email: Justin.hentges@nih.gov Phone: 3015940651

Criteria for Selecting Proposals

For grants and cooperative agreements, funding decisions are based on scientific merit (42 CFR 52h) and program relevance. Scientific merit review encompasses: the peer review criteria detailed in the specific funding announcement, as well as the significance, approach, and innovation of the proposed research; the competency of the principal investigator; the adequacy of the resources and environment; the proposed budget and requested period of support; and, where applicable, the adequacy of the measures for protecting against adverse effects upon humans, animals, or the environment.



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