Minor Use Minor Species (MUMS) Grants Meg Oeller & Stuart Jeffrey FDA/CVM/OMUMS

1. Minor Use Minor Species (MUMS) Grants Meg Oeller & Stuart Jeffrey FDA/CVM/OMUMS Aquaculture Drug Coordination Workshop Bozeman, MT July 30, 2014

2. Who you gonna call? • Dr. Stuart Jeffrey • stuart.jeffrey@fda.hhs.gov • (240) 402-0568

3. 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?

4. 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)

5. 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

6. 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

7. 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)

8. Grant money, continued • Two open application periodsper Fiscal Year (FY) • 2nd open period in FY has only the money left over after the first round

9. 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

10. 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

11. 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

12. 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)

13. 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

14. 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

15. 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

16. 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

17. Questions and Thank you!