21st Century Cures Act - Precision Medicine Initiative

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

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.

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.

Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

Other Transactions, Contracts, IAAs, 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).

Other Transactions, Contracts, IAAs, 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).

Other Transactions, Grants and Cooperative Agreements: Average 3 to 5 years. Renewals may be awarded for additional periods. Method of rewarding/releasing assistance: funding is provided through Monthly Demand Payment System or an Electronic Transfer System

Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.

2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. For Grants and Cooperative Agreements, 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. For Other Transactions, Section 402 (n) of the Public Health Service Act, 42 U.S.C. 282 (n) apply to this program.

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. For Other Transactions the Research Opportunity Announcement (ROA) will detail the review process for each initiative.

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. Other Transactions are awarded based on the criteria stated within the research opportunity announcement for each initiative.

Grants/Cooperative Agreements: Approximately 10 months. Other Transactions: varies

Applications submitted for renewal are reviewed and selected for funding on a competitive basis.

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 . For Other Transactions the Research Opportunity Announcement (ROA) will detail the appeals process for each initiative.