minor use minor species (mums) grants meg oeller & stuart jeffrey fda/cvm/omums
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Minor Use Minor Species (MUMS) Grants
Meg Oeller & Stuart Jeffrey FDA/CVM/OMUMS
Aquaculture Drug Coordination Workshop
Bozeman, MT July 30, 2014
Who you gonna call?
Dr. Stuart Jeffrey
stuart.jeffrey@fda.hhs.gov
(240) 402-0568
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MUMS GRANTS What are they? Who is eligible to apply? What kind of studies can be
funded? How much money is available? When are the application
periods? What is the process? What registrations are
required? What is the spending
timeframe?
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What are MUMS Grants?
Money to defray the costs of safety and effectiveness studies to support a New Animal Drug Application (NADA)
for products for minor uses and for
minor species (like fish)
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Who is eligible to apply?
Sponsors of “Designated” Products
Their research partners – need a letter from the sponsor identifying the partnership in the Investigational New Animal Drug File (INAD) and in the grant application
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What kind of studies can be funded?
Clinical trials PK/PD (effectiveness) Target animal safety Human food safety Environmental studies We plan to include some
manufacturing studies – watch for new Request for Applications (RFA) starting FY 2016 6
How much grant money is available?
The Statute authorizes $2 million (or more)
Authorization ≠ Appropriations Current appropriation is
$750,000/year Two funding levels:
Up to $75,000 (e.g., effectiveness study) Up to $125,000 (e.g., HFS tissue residue)
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Grant money, continued
Two open application periods per Fiscal Year (FY)
2nd open period in FY has only the money left over after the first round
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When are the open periods?
See the CVM website - http://www.fda.gov/
AnimalVeterinary/NewsEvents/CVMUpdates/ucm401845.htm
Includes link to the actual RFA, which lists open periods for multiple years to help with long-range planning
FY 2015, Part 1 open period ends 8/16/2014
FY 2015, Part 2 is 11/21/2014 -1/16/2015
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What is the process? FIRST: The product must be
“designated” through CVM/OMUMS AND
The study protocol must have been reviewed and accepted by CVM/ONADE
THEN: Allow 6 weeks to obtain the registrations that are needed to apply
Links are found in the RFA
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Registrations needed
Acquire a DUNS number
Grants.gov: one-time registration
System for Awards Management (SAM): must renew registration annually
eRA Commons: applicant and all Program Directors/Principal Investigators - one-time registration
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Application Download the application from
grants.gov and apply electronically
Don’t wait until the last minute! Allow time to fix unexpected errors
Resource: SF424 (R&R) Application Guide (Link in RFA)
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Then… Applications are retrieved by
FDA’s Office of Acquisitions and Grant Services (OAGS) and screened for eligibility by OMUMS
Qualified applications are reviewed and scored
Funding is awarded based upon scores
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Grant Funding Outcomes
Following completion of the review process, you will be informed of the approval status of your application, and whether it will be funded in full or partially funded, based on availability of funds
If your application was not funded, you may reapply in the next round
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What is the time period for spending the grant monies?
Monies are meant to be used in the 12-month period following the date of the award
Multi-year funding can be approved for long-term, more complex studies
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More information:Designation: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm064838.htm
RFA announcements:Go to http://www.grants.gov and search for the keyword “MUMS” in the “Grant Opportunities” search box at the top
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Questions and Thank you!
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