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

2

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?

3

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)

4

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

5

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)

7

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

8

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

9

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

10

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

11

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)

12

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

13

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

14

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

15

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

16

Questions and Thank you!

17