Genome Integrity Assays Program Opportunity Fund - Administrative Supplements

The Opportunity Fund is designed to provide funds for cross-testing, allow for further validation, and establish the breadth of applicability of promising tools as well as to enhance the collaborations in the Program.

Eligibility

Applicants must be an active grantee within the program, "Expanding Genome Integrity Assays to Population Studies, RFA-ES-17-006 ".

Applications Goals and Priorities

Applications must be within the scope of the parent cooperative agreement and compelling justification must be made for a need that is not included in the original aims.

Proposals are expected to focus on:

• expediting scientific opportunities based, for example, on a novel and promising tool
• determining the ease and/or breadth of application of an assay by, for example, cross-testing the product by other investigators or on populations not studied in the parent U01
• improving the translational or comprehensive aspects of an assay by including the expertise of new academic or industry partners to, for example, develop kit forms of the product or to upscale.
• meeting unexpected needs of a project, such as adding subjects in a population study to deal with drop-outs, adding new technology that could significantly improve outcomes and product

Program Priorities

Opportunity Fund program priority will be on fostering collaborations to reach the stated goals. Compelling justification for all requests is essential and will be the primary basis for funding decisions

The following criteria will be used to score applications and determine a funding plan:

• Studies that will likely benefit or advance the overall goals of the Genome Integrity Assays Program rather than a single project
• Interactions among investigators and cross-testing of promising assays and protocols in order to perfect or broaden the application of tools in determination of genome integrity capacity
• Budget request and justification
• Programmatic balance across the projects and disciplines.

Budget

Budgets are limited to $100,000 direct costs per application for a duration not exceeding one year.

The budget will be a consideration in funding decisions and requests may be reduced based on program decisions or availability of funds.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional).

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

• Application Due Date(s) April 7, 2020, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-ES-20-009 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.

• All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed, with the following additional requirements:

• Select "Revision" in the "Type of Application" field
• Face Page (Form Page 1):
• Research Strategy (5 pages)
  • At a minimum, the Research Strategy section should be completed and must include:
    • 1. A summary or abstract for each funded parent award or project. (1 page)
    • 2. . A single research proposal (3 pages) that includes
    • 3.. Project Management Plan (1 page) defining:

      • Specific aims

      • Brief background

      • Research strategy

      • Description of the benefit to the individual project, program area, and the goals of the Genome Integrity Assays Program as a whole. Collaborations among more than one U01 need to include identical abstracts and aims and are to list the collaborating project(s). Construct budgets within each application specific to the local collaborating partner U01.

      • Roles/areas of responsibility of the participants

      • Process for decision making, if necessary

      • Data sharing and communication plans among investigators

    • Project/Performance Sites section (Form Page 2):
      • Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
      • Senior/Key Personnel section (Form Page 2): list the PD/PI as the first person (regardless of their role on the supplement activities). List any senior/Key Personnel who are being added for whom additional funds are being requested through this supplement; include a biographical sketch for each.

5. Budget for Entire Proposed Project Period (Form Page 5) A proposed budget should be submitted using the PHS 398 budget forms and should only include funds requested for the proposed supplement activities.

• Detailed budget page and budget justification (Form Page 4)

6. Other Approvals. If applicable, attach documentation in the Appendix section indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must be ensured, if additional human subjects' involvement is planned for the supplement component

?NIEHS and NCI will conduct administrative reviews of applications submitted to their Institute and will evaluate the supplement proposals to determine overall merit.

Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Applications that are not responsive to the terms of this NOSI will not be considered for this initiative.