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Clinical Trial Award

Grants to USA, Canada, and International IHEs, For-Profits, and
Agencies for Health Research to Benefit the Military Community

Agency Type:

Federal

Funding Source:

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U.S. Department of Defense (DoD) - Congressionally Directed Medical Research Programs (CDMRP)

LOI Date:

07/29/20

Deadline Date:

08/13/20 11:59 PM ET

Description:

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Grants to USA, Canada, and International IHEs, biotechnology companies, foundations, government agencies, research institutes, and military-related institutions to support health research and human clinical trials. A letter of intent is required before submitting a full application. Specific approvals may be required by the FDA prior to application submission deadline unless applying to the Planning Phase with Clinical Trial application category. Funding is intended to address priority health topics for military Service members, Veterans, and other military health system beneficiaries.

The PRMRP challenges the scientific and clinical communities to address at least one of the FY20 PRMRP Topic Areas with original ideas that foster new directions along the entire spectrum of research and clinical care. Topic areas can be found at: https://cdmrp.army.mil/funding/pa/FY20-PRMRP-CTA.pdf#page=4

The PRMRP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on a disease or condition. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, Phase 0), to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.

A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. This outcome represents a direct effect on the subject of that intervention or interaction. 

The program seeks applications in laboratory, clinical, behavioral, epidemiologic, and other areas of research to advance knowledge in disease etiology, improve prevention, detection, diagnosis, treatment, and quality of life for those affected by a relevant disease or condition, and to develop and validate clinical care or public health guidelines

For information about allowable expenses: https://cdmrp.army.mil/funding/pa/FY20-PRMRP-GAI.pdf#page=19.

GrantWatch ID#:

GrantWatch ID#: 189628

Estimated Total Program Funding:

$45,000,000

Number of Grants:

The CDMRP expects to fund approximately 11 Clinical Trial Award applications (5 Planning Phase with Clinical Trial and 6 Clinical Trial Only).

Estimated Size of Grant:

Planning Phase (optional): Maximum of $500,000 for direct costs (plus indirect costs).
Clinical Trial: No maximum funding limit; requested funding must be appropriate for the scope of work proposed.

Term of Contract:

The proposed clinical trial is expected to begin no later than 9 months after the award date.

Planning Phase (optional): Maximum period of performance is 18 months.
Clinical Trial: Maximum period of performance is 4 years.

Additional Eligibility Criteria:

All organizations, including international organizations, are eligible to apply.

Government Agencies Within the United States: Local, state, and Federal Government agencies are eligible to the extent that applications do not overlap with the fully funded internal programs. Such agencies are required to explain how the applications do not overlap with internal programs.

As applications may be submitted by extramural organizations and intramural Department of Defense (DoD) organizations, these terms are defined below:

- Extramural Organization: An eligible non-DoD organization. Examples of extramural organizations include academic institutions, biotechnology companies, foundations, Federal Government organizations other than the DoD, and research institutes.

- Intramural DoD Organization: A DoD laboratory, DoD military treatment facility, and/or DoD activity embedded within a civilian medical center. Intramural Submission: Application submitted by a DoD organization for an intramural investigator working within a DoD laboratory or military treatment facility or in a DoD activity embedded within a civilian medical center.

Applications from an intramural DoD organization or from an extramural non-DoD Federal organization may be submitted through a research foundation.

Organizations must be able to access .gov and .mil websites in order to fulfill the financial and technical deliverable requirements of the award and submit invoices for payment.

USAMRAA makes awards to eligible organizations, not to individuals.

Funding from this award mechanism must support a clinical trial and cannot be used for animal studies.

Pre-Application Information:

Submission and Review Dates and Times:
- Release date: April 8, 2020
- Pre-Application (Letter of Intent): July 29, 2020, 5:00 p.m. Eastern time (ET)
- Application: August 13, 2020, 11:59 p.m. ET
- End of Application Verification Period: 5:00 p.m. ET, August 18, 2020
- Peer Review: October 2020
- Programmatic Review: January 2021

Cost sharing/matching is not an eligibility requirement.

For-profit organizations must obtain the Grants Officer’s approval prior to incurring any obligations and expenditures before the beginning date of the initial budget period of a new award.

eBRAP:
- PIs must be registered in eBRAP to submit a pre-application. PIs are encouraged to start the registration processes for eBRAP early to ensure that there is sufficient time for completion prior to the submission deadline. There is no grace period.
- During eBRAP registration, the PI must request to be affiliated with the organization from the list of organizations already registered with eBRAP. If the PI’s organization is not already registered with eBRAP, then the PI must invite an Authorized Organizational Representative (AOR) to register the organization. The AOR does not need to complete the organization registration in eBRAP prior to the pre-application submission deadline in order for the preapplication to be submitted.

The following steps are required as part of the Grants.gov registration process. Allow up to 8 weeks for the completion of the Grants.gov registration process. Registering early is advised.

- DUNS Number - Applicant organizations and all sub-recipient organizations must have a DUNS number to submit applications to Grants.gov. Register online for DUNS number at https://fedgov.dnb.com/webform.
- SAM Registry - The applicant organization must also be registered in the Entity Management functional area of the SAM with an “Active” status to submit applications through the Grants.gov portal. Allow several weeks to complete the entire SAM registration process at https://www.sam.gov/.
- Commercial and Government Entity (CAGE) Code. The applicant organization must have a CAGE code, which can be requested at: https://cage.dla.mil/Request
- Authorized Organizational Representative
- Applicants must create a Grants.gov Workspace

View this opportunity on Grants.gov at: https://www.grants.gov/web/grants/view-opportunity.html?oppId=326165

Human Subject Resource Document: https://ebrap.org/eBRAP/public/Program.htm

Contact Information:

Before starting your grant application, please review the funding source's website listed below for updates/changes/addendums/conferences/LOIs.

All pre-applications for both extramural and intramural organizations must be submitted to: https://ebrap.org/eBRAP/public/index.htm

Full applications from extramural organizations must be submitted through Grants.gov.
Intramural DoD organizations may submit full applications to either eBRAP or Grants.gov.
Grants.gov application: https://apply07.grants.gov/apply/login.faces?userType=applicant&cleanSession=1

Help@ebrap.org - for program announcement related questions. Or call 301-682-5507.

Questions related to application submission through the Grants.gov portal should be directed to: support@grants.gov or call 800-518-4736.

CFDA Number:

12.420

Funding or Pin Number:

W81XWH-20-PRMRP-CTA

URL for Full Text (RFP):

Geographic Focus:

USA: 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 City;   New York;   North Carolina;   North Dakota;   Ohio;   Oklahoma;   Oregon;   Pennsylvania;   Rhode Island;   South Carolina;   South Dakota;   Tennessee;   Texas;   Utah;   Vermont;   Virginia;   Washington, DC;   Washington;   West Virginia;   Wisconsin;   Wyoming

USA Territories: American Samoa (USA)   Guam (USA)   Puerto Rico (USA)   Virgin Islands (USA)   Northern Mariana Islands (USA)

USA Compact Free Associations: The Federated States of Micronesia (USA)   Marshall Islands (USA)   Republic of Palau (USA)

Canada: Alberta;   British Columbia;   Manitoba;   New Brunswick;   Newfoundland and Labrador;   Northwest Territories;   Nova Scotia;   Nunavut;   Ontario;   Prince Edward Island;   Quebec;   Saskatchewan;   Yukon;

Israel

International country outside of the USA, Israel and Canada.

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