DoD Gulf War Illness, Therapeutic/Biomarker Trial Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

DoD Gulf War Illness, Therapeutic/Biomarker Trial Award

The FY20 GWIRP Therapeutic/Biomarker Trial Award supports large-scale, pivotal ( Phase IIb-III) clinical trials that will revolutionize the clinical management of GWI. The Therapeutic/Biomarker Trial Award targets the “C...

79
match
Deadline 2109 days ago Location Alabama Type grant Level Federal Closed posted Mar 24, 2020
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$8,000,000.
  • Next deadline: September 10, 2020.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
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The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

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Deadline
2109 days ago
Sep 10, 2020
Total pool
$8M

About this opportunity

The FY20 GWIRP Therapeutic/Biomarker Trial Award supports large-scale, pivotal ( Phase IIb-III) clinical trials that will revolutionize the clinical management of GWI. The Therapeutic/Biomarker Trial Award targets the “Confirmation” phase of the research pipeline as outlined in Section II.A.2. The proposed research should lead to an approach that is fundamentally better than interventions already approved or in clinical development. Objective biomarkers to measure the biological effect of an investigational therapeutic or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual Gulf War Veteran or Gulf War Veteran subgroup must be included in the trial design.Development of markers for the purposes of measurement of disease progression without consideration of the therapeutic development process will not be supported.Principal Investigators (PIs) are expected to have experience in successfully leading large-scale projects and demonstrated ability (through personal experience or via a commitment from a collaborating clinical investigator) to implement a clinical project successfully.Funding from this award mechanism must support a clinical trial. Investigators seeking funding for a preclinical research project should consider one of the other FY20 GWIRP Program Announcements being offered.For proposed research that will require Food and Drug Administration (FDA) involvement, project readiness requirements at the time of application submission include: proof of availability of and access to clinical reagents ( therapeutics) that meet regulatory compliance guidelines, proof of availability of and access to appropriate subject population(s), validated projections for patient recruitment, and submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312). It is the responsibility of the applicant to provide evidence from the Institutional Review Board (IRB) of record or the FDA if an IND or IDE is not required.If an IND is required, the IND application must be submitted to the FDA by the FY20 GWIRP Therapeutic/Biomarker Trial Award application submission deadline. The IND should be specific for the product ( the product should not represent a derivative or alternate version of the investigational agent described in the IND application) and indication to be tested in the proposed clinical trial. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/ howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm.If an IDE is required, the IDE application must be submitted to the FDA by the FY20 GWIRP Therapeutic/Biomarker Trial Award application submission deadline. The IDE should be specific for the device ( should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical trial.Refer to Attachment 8, Regulatory Strategy, for additional details on documentation of FDA applications. The Government reserves the right to withdraw funding if an IND or IDE application and/or international regulatory application is necessary but has not been submitted prior to the application submission deadline.Biorepository Contribution Option: In FY17, the GWIRP awarded infrastructure support for a Gulf War Illness Biorepository. The Boston Integrative Network (BBRAIN) for GWI has now been established for the retention and distribution of Gulf War Veteran biospecimens and/or data related to GWI research. Applicants to the FY20 GWIRP are encouraged to contribute Gulf War Veteran biospecimens and data to this repository network.

Funding agency

Defense Health Agency Contracting Activity - DHACA
Federal agency

Tags

Healthcare & Biotech Manufacturing Arts & Culture Education & Research Construction & Housing Veterans Transportation & Logistics Science, Tech & Engineering (STEM)
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Who can apply

Eligibility details aren't on file yet — check the agency source link in the Documents tab for the latest rules.

Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming
  • District of Columbia

How to apply

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Source documents

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Canonical NOFO, application packet, and forms
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Citation details

Source systemgrants.gov
Source ID325756
PostedMar 24, 2020

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