Opportunity ID: 283827

General Information

Document Type: Grants Notice
Funding Opportunity Number: W81XWH-16-GWIRP-IIRFA
Funding Opportunity Title: DoD Gulf War Illness Investigator-Initiated Focused Research Award
Opportunity Category: Discretionary
Opportunity Category Explanation: –
Funding Instrument Type: Cooperative Agreement
Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation: –
Expected Number of Awards: 11
Assistance Listings: 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: May 13, 2016
Last Updated Date: –
Original Closing Date for Applications: Oct 20, 2016
Current Closing Date for Applications: Oct 20, 2016
Archive Date: Nov 19, 2016
Estimated Total Program Funding: $7,360,000
Award Ceiling: $0
Award Floor: $0

Eligibility

Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility: –

Additional Information

Agency Name: Dept. of the Army — USAMRAA
Description: The Investigator-Initiated Focused Research Award is being offered for the first time in FY16; however, this mechanism is derived from the previously offered FY06-FY15 GWIRP Investigator-Initiated Research Award (IIRA).
The Investigator-Initiated Focused Research Award supports research to promote new ideas or continued development of applied research in GWI that is aimed at diagnosis or therapeutic advancement. Applications must articulate the pathway to making a clinical impact for Veterans with GWI even if a clinical impact is not an immediate outcome. All applications must focus on Veterans of the 1990-1991 Persian Gulf War affected by GWI. It is the responsibility of the Principal Investigator (PI) to clearly and explicitly articulate the project’s potential impact on GWI.
This award supports projects at different stages of development. PIs should apply to the Investigator-Initiated Focused Research Award under one of three different Tiers. It is the responsibility of the applicant to select the Tier that is most appropriate for the research proposed. This choice should be based on the scope of the research proposed and not the funding level.
The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under each Tier:
 Tier 1 – Discovery: Tier 1 is intended to support innovative, high-risk/ high-reward research that is in the earliest stages of development. Research should have the potential to yield new approaches for diagnosis or treatment specific to GWI. Innovation is an important component of the Tier 1 award. An application may demonstrate innovation not only by investigating a novel approach to therapy or diagnostics specific for GWI, but also by studying a concept that has been shown to be effective for other illnesses, but has not yet been studied in Veterans with GWI. Preliminary data are not required; however, the project should include well-formulated objectives and a study design based on a strong scientific rationale. Examples of activities supported by Tier 1 include: investigations characterizing basic GWI pathobiology or symptom clustering aimed at molecular characterization.
 Tier 2 – Applied Research: Tier 2 is intended to promote the investigation of more mature ideas aimed at therapeutic or diagnostic advancement that are supported by evidence in the GWI field. This research must accelerate progress toward treatment or diagnosis of GWI. All proposed research projects should include a well-formulated, testable hypothesis based on preliminary data and hold translational potential to improve GWI treatment and/or diagnosis. The types of activities supported by Tier 2 include, but are not limited to: clinical development of diagnostic approaches, active compound screening, or development of methods to measure target binding and/or the potential for undesirable effects at related but unintended targets. Presentation of preliminary data in the field of GWI is required.
 Tier 3 – Preclinical Validation: Tier 3 is intended to support activities aimed at validating and optimizing promising candidates for GWI treatment. Studies to collect data required for repurposing an existing U.S. Food and Drug Administration (FDA)-approved drug or therapy for a new indication related to GWI are also of interest. Applications must include preliminary data and other supporting information relevant to the proposed phase of research for GWI. These data are not required to have come from the GWI research field. The proposed studies are expected to be empirical in nature and product-driven. Applications must include an identified bioactive lead (or limited class of leads) and background data supporting a putative mechanism of action, proof of identity and purity of compounds, availability of bioactivity assays and preclinical GWI models to assess in vivo efficacy or desirable mechanism-specific activity at the intended therapeutic target. Examples of activities that will be supported by Tier 3 include, but are not limited to: secondary validation of lead compounds, optimization of pharmacological properties, studies on formulation and stability, development of Good Manufacturing Practices (GMP) production methods, and collection of various data required for Investigational New Drug submission.
Applications Proposing Biomarker(s) Research: Applicants must present a rationale for why the proposed biomarkers would be specific for Gulf War-related exposures and not induced by unrelated factors or events subsequent to Gulf War deployment. Investigations involving derivation of GWI diagnostic biomarkers from animal models will not be supported.
Research involving human subjects is permitted under this Program Announcement/Funding Opportunity but is restricted to studies without clinical trials. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. For more information on clinical research, see Human Subject Resource Document at https://cdmrp.org/Program_Announcements_and_Forms/. PIs interested in applying for funding for a clinical trial should use the FY16 GWIRP Treatment Evaluation Award mechanism. For information about that mechanism, see http://cdmrp.army.mil/funding/gwirp.shtml. Retrospective studies or other non-interventional clinical studies involving human subjects are acceptable under the Investigator-Initiated Focused Research Award.
Link to Additional Information: –
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

CDMRP Help Desk

301-682-5507
Email:help@eBRAP.org

Version History

Version Modification Description Updated Date

Folder 283827 Full Announcement-FY16 GWIRP IIRFA -> gwirp_fy16_iifra pa_gg.pdf

Packages

Agency Contact Information: CDMRP Help Desk
301-682-5507
Email: help@eBRAP.org
Who Can Apply: Organization Applicants

Assistance Listing Number Competition ID Competition Title Opportunity Package ID Opening Date Closing Date Actions
12.420 PKG00223507 May 13, 2016 Oct 20, 2016 View

Package 1

Mandatory forms

283827 RR_SF424_2_0-2.0.pdf

283827 RR_Budget_1_3-1.3.pdf

283827 RR_KeyPersonExpanded_2_0-2.0.pdf

283827 PerformanceSite_2_0-2.0.pdf

Optional forms

283827 RR_SubawardBudget30_1_3-1.3.pdf

2025-07-09T13:47:57-05:00

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