Opportunity Information: Apply for RFA FD 15 004
Apply for RFA FD 15 004
- The Food Drug Administration in the other (see text field entitled explanation of other category of funding activity for clarification) sector is offering a public funding opportunity titled "Minor Use Minor Species Development of Drugs Research Project Grant (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Jun 17, 2015 and posted on Mar 11, 2015.
- Applicants must submit their applications by Jan 13, 2018 This FOA has Multiple Receipt Dates First application receipt/due date is 08/14/2015 Second application receipt/due date is 01/15/2016 Third application receipt/due date is 08/12/2016 Fourth application receipt/due date is 01/13/2017 Fifth application receipt/due date is 08/11/2017 Sixth application receipt/due date is 01/12/2018.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- The number of recipients for this funding is limited to 10 candidate(s).
- Eligible applicants include: County governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Small businesses State governments Native American tribal governments (Federally recognized) Independent school districts City or township governments Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Special district governments For profit organizations other than small businesses.
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Opportunity Summary:
The Minor Use Minor Species Development of Drugs Research Project Grant (R01) is an FDA-funded research grant opportunity run through the Center for Veterinary Medicine (CVM), specifically the Office of Minor Use and Minor Species Animal Drug Development (OMUMS). Its main purpose is to help move new veterinary drugs closer to legal marketing by paying for qualified safety and effectiveness studies that support FDA approval or conditional approval. While principal investigators design and carry out the work, the official applicant must be the institution or organization that houses the research (for example, a university, nonprofit, company, or government entity). The program is rooted in the Minor Use and Minor Species Animal Health Act of 2004 (the MUMS Act), which was created to expand access to medications for animals and conditions that are too small or uncommon to attract enough private development funding on their own.
This opportunity focuses on so-called MUMS drugs, meaning drugs intended either for minor species or for minor uses in major species. The FDA defines the major animal species as horses, dogs, cats, cattle, swine, turkeys, and chickens; essentially every other non-human species is treated as a minor species under this framework. A "minor use" refers to a use in a major species that happens infrequently, affects relatively few animals each year in the US, or is limited to certain geographic areas. To make that definition concrete, FDA has set numerical thresholds for what counts as a "small number of animals" annually in each major species: 50,000 horses, 70,000 dogs, 120,000 cats, 310,000 cattle, 1,450,000 swine, 14,000,000 turkeys, and 72,000,000 chickens. Uses below those thresholds can qualify as minor uses, which is important because the grant is meant to support exactly these kinds of under-served veterinary needs.
A key requirement is that the drug being studied must already be formally designated as a MUMS drug for the specific intended use being proposed. That designation is not automatic and must be requested from FDA/CVM/OMUMS by the company developing the drug for veterinary use, typically under the sponsor's Investigational New Animal Drug (INAD) file. In other words, the grant is not meant for early exploratory work on any animal health idea; it is meant to help defray the costs of specific safety and effectiveness testing that is directly tied to a designated product and a designated intended use, with a clear line of sight to approval or conditional approval.
Funding is offered in two main tiers, both with limits that apply to total costs (not just direct research costs). The standard level provides up to $100,000 per year for up to two years and is meant to cover routine safety or effectiveness studies that would support approval or conditional approval of the designated product for the designated intended use. The higher level provides up to $150,000 per year for up to three years, but it is reserved for studies that are necessary and also unusually complex, long, or large. The third year is not broadly available for any project; it is specifically limited to long-term toxicology studies, reflecting the reality that some safety questions require extended observation periods.
Administratively, this is a discretionary grant using the NIH-style Research Project Grant (R01) mechanism, which gives the project director(s) and principal investigator(s) flexibility to define the scientific objective within the program's purpose. The FDA anticipated up to about 10 awards under the announcement, with an estimated total funding pool of roughly $3,000,000 and an award ceiling of $150,000 per year. There is no cost-sharing or matching requirement. Eligible applicants are broad and include state, local, and tribal governments; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); small businesses; and other for-profit organizations (excluding small businesses only where specified). The program falls under CFDA 93.103 (Food and Drug Administration).
Compliance expectations are significant because the supported studies must align with the Federal Food, Drug, and Cosmetic Act and associated regulations, as well as applicable HHS statutes and regulations. In practical terms, applicants should expect the funded work to be held to standards appropriate for evidence that could be used in a regulatory submission, since the whole point is to generate data that either leads directly to approval/conditional approval or makes a substantial contribution toward that outcome. The original announcement (Funding Opportunity Number RFA-FD-15-004) was posted March 11, 2015, used multiple receipt dates through January 2018, and is now archived (archive date February 12, 2018), but it remains a useful reference for how FDA structures OMUMS drug development support through grant funding. For access issues or administrative questions, the listed grants management contact was Oluyemisi (Yemisi) Akinneye at 240-402-7560 or Oluyemisi.Akinneye@fda.hhs.gov.
Frequently Asked Questions (FAQ)
What is the Minor Use Minor Species Development of Drugs Research Project Grant (R01)?
It is an FDA-funded research grant opportunity administered through the FDA Center for Veterinary Medicine (CVM), specifically the Office of Minor Use and Minor Species Animal Drug Development (OMUMS). It uses the NIH-style Research Project Grant (R01) mechanism.
What is the main purpose of this grant program?
The program is designed to help move new veterinary drugs closer to legal marketing by paying for qualified safety and effectiveness studies that support FDA approval or conditional approval for a specific product and a specific intended use.
Which FDA office runs this program?
The program is run through the FDA Center for Veterinary Medicine (CVM), Office of Minor Use and Minor Species Animal Drug Development (OMUMS).
Who is allowed to apply as the official applicant?
The official applicant must be the institution or organization that houses the research, such as a university, nonprofit, company, or government entity. While principal investigators design and carry out the work, the institution/organization is the applicant of record.
What kinds of organizations are eligible to apply?
Eligible applicants include state, local, and tribal governments; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); small businesses; and other for-profit organizations (excluding small businesses only where specified).
Is there a cost-sharing or matching requirement?
No. The opportunity states there is no cost-sharing or matching requirement.
What types of studies does the grant pay for?
The funding is intended for qualified safety and effectiveness studies that support FDA approval or conditional approval of a designated MUMS drug for a designated intended use. It is not intended for early exploratory research unrelated to a designated product and intended use.
What does "MUMS" mean in this context?
MUMS refers to "minor use" in a major species or "minor species." The opportunity focuses on drugs intended either for minor species or for minor uses in major species.
Which animals are considered "major species" by FDA for this program?
FDA defines the major animal species as horses, dogs, cats, cattle, swine, turkeys, and chickens.
What is a "minor species" under this framework?
Under this framework, essentially every other non-human species that is not one of the FDA-defined major species is treated as a minor species.
What is a "minor use" in a major species?
A minor use is a use in a major species that happens infrequently, affects relatively few animals each year in the United States, or is limited to certain geographic areas.
Are there numeric thresholds for what counts as a minor use?
Yes. FDA set annual thresholds for what counts as a "small number of animals" in each major species. Uses below these thresholds can qualify as minor uses.
What are the annual thresholds for a "small number of animals" for each major species?
- Horses: 50,000
- Dogs: 70,000
- Cats: 120,000
- Cattle: 310,000
- Swine: 1,450,000
- Turkeys: 14,000,000
- Chickens: 72,000,000
Does the drug need to have any special status before applying?
Yes. A key requirement is that the drug being studied must already be formally designated as a MUMS drug for the specific intended use being proposed.
Is MUMS designation automatic if a drug is for a minor species or minor use?
No. The designation is not automatic. It must be requested from FDA/CVM/OMUMS by the company developing the drug for veterinary use.
Who typically requests the MUMS drug designation?
The designation is typically requested by the company (the sponsor) developing the drug for veterinary use, generally under the sponsor's Investigational New Animal Drug (INAD) file.
Can this grant be used for early-stage exploratory animal health research?
No. The description indicates it is not meant for early exploratory work on any animal health idea. It is meant to help pay for specific safety and effectiveness testing tied to a designated product and designated intended use, with a clear path toward approval or conditional approval.
What are the funding levels available under this opportunity?
There are two main tiers. The standard level provides up to $100,000 per year for up to two years. The higher level provides up to $150,000 per year for up to three years, but only for studies that are necessary and unusually complex, long, or large.
Are the funding limits based on direct costs only, or total costs?
The limits apply to total costs, not just direct research costs.
When is the third year of funding allowed?
The third year is not generally available for any project. It is specifically limited to long-term toxicology studies.
How many awards did FDA anticipate making?
The FDA anticipated up to about 10 awards under the announcement.
What was the estimated total funding pool for this opportunity?
The estimated total funding pool was roughly $3,000,000.
What is the annual award ceiling mentioned in the announcement?
The award ceiling was $150,000 per year.
What does it mean that this is a discretionary grant using an R01 mechanism?
It means the program uses the NIH-style Research Project Grant (R01) mechanism, giving the project director(s) and principal investigator(s) flexibility to define the scientific objective within the overall purpose of supporting studies that can lead to FDA approval or conditional approval.
What legal and regulatory standards are relevant to funded projects?
Supported studies must align with the Federal Food, Drug, and Cosmetic Act and associated regulations, as well as applicable HHS statutes and regulations.
Should applicants expect the work to be conducted at a regulatory-quality standard?
Yes. Since the purpose is to generate evidence that could be used in a regulatory submission, applicants should expect the funded work to be held to standards appropriate for data supporting approval or conditional approval.
What law is this program rooted in?
The program is rooted in the Minor Use and Minor Species Animal Health Act of 2004 (the MUMS Act), which was created to expand access to medications for animal conditions that are too small or uncommon to attract enough private development funding.
What is the CFDA number associated with this program?
The program falls under CFDA 93.103 (Food and Drug Administration).
What is the Funding Opportunity Number (FON) for the archived announcement?
The Funding Opportunity Number provided is RFA-FD-15-004.
When was the original announcement posted, and what is its status now?
The original announcement was posted March 11, 2015. It used multiple receipt dates through January 2018. It is now archived, with an archive date of February 12, 2018, but it remains a useful reference for how FDA structures OMUMS drug development support through grant funding.
Who was the listed grants management contact for access or administrative questions?
The listed grants management contact was Oluyemisi (Yemisi) Akinneye at 240-402-7560 or Oluyemisi.Akinneye@fda.hhs.gov.
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