Opportunity Information: Apply for PAR 18 827
The Minor Use Minor Species Development of Drugs (R01) opportunity (PAR-18-827) is an FDA grant program run through the Center for Veterinary Medicine (CVM), specifically the Office of Minor Use and Minor Species Animal Drug Development (OMUMS). It stems from the Minor Use and Minor Species Animal Health Act of 2004 (the MUMS Act), which was created to close a long-standing gap in veterinary medicine: many animal species and niche indications do not attract enough commercial investment to generate the safety and effectiveness data needed for FDA approval. The goal of this funding is to help sponsors pay for the kinds of studies FDA requires so that more legally marketed drugs become available for minor species (basically any non-human species that is not a “major species”) and for “minor uses” in major species.
The program draws a clear distinction between major species and minor species. Major species are horses, dogs, cats, cattle, swine, turkeys, and chickens. Every other animal species (other than humans) is treated as a minor species. A “minor use” applies when a drug is intended for a major species, but for a disease/condition that occurs infrequently, affects only a small number of animals, or is limited geographically and affects only a small number of animals annually in the US. FDA has set numeric thresholds to define what “small number of animals” means for each major species: horses (50,000/year), dogs (70,000/year), cats (120,000/year), cattle (310,000/year), swine (1,450,000/year), turkeys (14,000,000/year), and chickens (72,000,000/year). Uses below those thresholds can qualify as minor uses.
A key eligibility requirement is that the product must already have a formal “minor use” or “minor species” designation from FDA/CVM/OMUMS for the specific intended use being studied before an application is submitted. In practice, the sponsor (the entity seeking approval) obtains this designation by submitting a formal request tied to their Investigational New Animal Drug (INAD) file. In addition, FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have accepted the proposed study protocol before the grant application is submitted. That protocol-acceptance step is central to this program because the funding is meant to support studies that FDA is prepared to rely on for a future approval or conditional approval decision.
The grant supports “qualified safety and effectiveness testing” that directly contributes to an FDA pathway for approval or conditional approval of the designated product for the designated use. Eligible work includes studies supporting target animal safety and/or effectiveness, environmental safety, and human food safety (when relevant, such as food-producing species). The announcement also highlights certain manufacturing-related studies as eligible when they are part of the qualified safety/effectiveness package and when ONADE has accepted the protocol in advance. These include stability studies for a MUMS drug, validation of analytical methods tied to manufacturing, studies assessing homogeneity/segregation of medicated feed containing the MUMS drug, and validation of analytical methods for medicated feeds. Separately, a standalone analytical method validation study can also be funded when it is needed before conducting an in-life human food safety study, again provided the protocol has been accepted prior to submission.
Applications are expected to make a direct, practical case for how the proposed work moves the product toward FDA approval or conditional approval. The announcement explicitly requires applicants to explain this in the “Significance” section of the Research Strategy (PHS 398 Research Plan), meaning reviewers will be looking for a tight link between the proposed study outcomes and the regulatory data requirements for the intended labeling claim. All funded work must comply with the Federal Food, Drug, and Cosmetic Act and applicable FDA regulations, along with relevant HHS statutes and regulations.
Funding is offered in two main tiers, with limits applying to total costs (not just direct costs). Level one awards provide up to $100,000 per year for up to two years and are intended for routine safety or effectiveness studies that support approval or conditional approval for the designated product and use. Level two awards provide up to $150,000 per year for up to three years, but are reserved for studies that are necessary and unusually complex, lengthy, or large. The third year is only available for long-term toxicological studies, reflecting the extended timelines typical of that type of work. The posted award ceiling is $150,000, and the program anticipated around 10 awards.
The opportunity is administered by the US Department of Health and Human Services (HHS), Food and Drug Administration, under CFDA 93.103, and it was listed as a discretionary grant mechanism. Eligibility is broad and includes many types of organizations and applicants: federal-recognized tribal governments and other tribal organizations, state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), individuals, and for-profit organizations (including small businesses and other for-profits). The opportunity was created June 12, 2018, and the original closing date was January 16, 2021.Apply for PAR 18 827
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Minor Use Minor Species Development of Drugs (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Jun 12, 2018.
- Applicants must submit their applications by Jan 16, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), 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, Individuals, For profit organizations other than small businesses, Small businesses.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Frequently Asked Questions (FAQs)
What is the Minor Use Minor Species Development of Drugs (R01) opportunity (PAR-18-827)?
PAR-18-827 is an FDA grant program that funds qualified studies needed to support FDA approval or conditional approval of animal drugs for minor species or minor uses in major species. The program is run through the FDA Center for Veterinary Medicine (CVM), specifically the Office of Minor Use and Minor Species Animal Drug Development (OMUMS).
What problem is this grant program designed to solve?
The program stems from the Minor Use and Minor Species Animal Health Act of 2004 (the MUMS Act). It was created to address a longstanding gap in veterinary medicine: many minor species and niche indications do not attract enough commercial investment to generate the safety and effectiveness data FDA requires for approval. This funding helps sponsors pay for those FDA-required studies so more drugs can be legally marketed for these needs.
Who runs and administers this funding opportunity?
The program is administered by the US Department of Health and Human Services (HHS), Food and Drug Administration (FDA), through the Center for Veterinary Medicine (CVM) and OMUMS. It is listed under CFDA 93.103 and was described as a discretionary grant mechanism.
What is the main goal of the funded work?
The goal is to fund qualified safety and effectiveness testing that directly contributes to an FDA pathway for approval or conditional approval of the designated product for the designated intended use.
What is the difference between a "minor species" and a "major species" under this program?
Major species are specifically defined as horses, dogs, cats, cattle, swine, turkeys, and chickens. Any other non-human animal species is treated as a minor species for the purposes of this program.
What is a "minor use" in a major species?
A minor use is when a drug is intended for a major species but targets a disease/condition that occurs infrequently, affects only a small number of animals, or is limited geographically and affects only a small number of animals annually in the US.
How does FDA determine whether a use in a major species qualifies as a "minor use"?
FDA has numeric annual thresholds for each major species. Uses that fall below the relevant threshold can qualify as minor uses.
What are the FDA numeric thresholds for minor use by major species?
The thresholds described in the opportunity are: horses (50,000/year), dogs (70,000/year), cats (120,000/year), cattle (310,000/year), swine (1,450,000/year), turkeys (14,000,000/year), and chickens (72,000,000/year). Uses below these thresholds can qualify as minor uses.
Is a formal FDA designation required before applying?
Yes. A key eligibility requirement is that the product must already have a formal "minor use" or "minor species" designation from FDA/CVM/OMUMS for the specific intended use being studied before an application is submitted.
How is the minor use or minor species designation obtained?
In practice, the sponsor obtains the designation by submitting a formal request tied to their Investigational New Animal Drug (INAD) file.
Is FDA protocol acceptance required before submitting the grant application?
Yes. FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have accepted the proposed study protocol before the grant application is submitted. This step is central because the grant is intended to support studies that FDA is prepared to rely on for a future approval or conditional approval decision.
What types of studies are eligible for funding?
Eligible work includes qualified safety and effectiveness testing that directly supports approval or conditional approval for the designated product and use. The opportunity describes support for target animal safety and/or effectiveness, environmental safety, and human food safety studies (when relevant, such as for food-producing species).
Are manufacturing-related studies eligible for funding?
Yes, certain manufacturing-related studies are described as eligible when they are part of the qualified safety/effectiveness package and when ONADE has accepted the protocol in advance. Examples listed include stability studies for a MUMS drug, validation of analytical methods tied to manufacturing, studies assessing homogeneity/segregation of medicated feed containing the MUMS drug, and validation of analytical methods for medicated feeds.
Can a standalone analytical method validation study be funded?
Yes. The opportunity notes that a standalone analytical method validation study can be funded when it is needed before conducting an in-life human food safety study, provided the protocol has been accepted prior to submission.
What does the application need to demonstrate about regulatory impact?
Applications are expected to make a direct, practical case for how the proposed work moves the product toward FDA approval or conditional approval. The announcement explicitly requires applicants to explain this linkage in the "Significance" section of the Research Strategy (PHS 398 Research Plan), so reviewers will look for a clear connection between the study outcomes and the regulatory data requirements for the intended labeling claim.
What compliance requirements apply to funded work?
All funded work must comply with the Federal Food, Drug, and Cosmetic Act and applicable FDA regulations, along with relevant HHS statutes and regulations.
How much funding is available under this opportunity?
The opportunity describes two main funding tiers with limits applying to total costs (not just direct costs). Level one provides up to $100,000 per year for up to two years. Level two provides up to $150,000 per year for up to three years, with the third year reserved for long-term toxicological studies. The posted award ceiling is $150,000, and the program anticipated around 10 awards.
What is the difference between Level one and Level two awards?
Level one awards (up to $100,000/year for up to two years) are intended for routine safety or effectiveness studies supporting approval or conditional approval for the designated product and use. Level two awards (up to $150,000/year for up to three years) are reserved for studies that are necessary and unusually complex, lengthy, or large.
When is a third year of funding allowed?
A third year is only available for long-term toxicological studies, reflecting the longer timelines typical of that type of work.
Do the funding caps apply to direct costs only, or total costs?
The limits described in the opportunity apply to total costs, not just direct costs.
Who is eligible to apply?
Eligibility is broad and includes: federal-recognized tribal governments and other tribal organizations, state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), individuals, and for-profit organizations (including small businesses and other for-profits).
Does the grant require the applicant to be a nonprofit organization?
No. The opportunity explicitly includes for-profit organizations (including small businesses and other for-profits), as well as nonprofits and many other applicant types.
Is this program limited to food-producing animals?
No. The program targets both minor species (which can include many non-food and food species) and minor uses in major species. Human food safety studies are included as eligible when relevant (for example, in food-producing species), but the opportunity is not described as limited only to food animals.
How does this program relate to FDA approval or conditional approval?
The funded studies are intended to produce data that FDA can rely on for a future approval or conditional approval decision for the designated product for the designated intended use. The program emphasizes protocol acceptance by ONADE as a way to ensure the studies align with FDA expectations.
What does "qualified safety and effectiveness testing" mean in the context provided?
In the context provided, it refers to studies that directly contribute to FDA regulatory requirements for approval or conditional approval of the designated MUMS drug for the designated use, including (as applicable) target animal safety, effectiveness, environmental safety, and human food safety.
When was this opportunity created, and what was the original closing date?
The opportunity was created on June 12, 2018, and the original closing date was January 16, 2021.
How many awards were anticipated?
The program anticipated around 10 awards.
What office must accept the study protocol before submission?
FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must accept the proposed study protocol before the grant application is submitted.
What office issues the minor use or minor species designation?
The designation must come from FDA/CVM/OMUMS for the specific intended use being studied.
What is the role of the sponsor in this program?
The sponsor is the entity seeking approval of the animal drug product. In practice, the sponsor obtains the required minor use or minor species designation by submitting a formal request tied to their INAD file, and they propose studies (with ONADE-accepted protocols) that the grant can fund.
What must the designation cover in order to be eligible?
The designation must be for the specific intended use being studied. A designation for a different intended use would not meet the stated requirement for submitting an application for this opportunity.
Browse more opportunities from the same category: Agriculture, Consumer Protection, Food and Nutrition
Next opportunity: Development of Online Launch Calendar, Phase III
Previous opportunity: Research and National Technical Assistance FY18-FY20
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 18 827
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 18 827) also looked into and applied for these:
| Funding Opportunity |
|---|
| Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints Apply for RFI NOT FD 18 014 Funding Number: RFI NOT FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005 Funding Number: RFA FD 19 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) Apply for RFA FD 19 009 Funding Number: RFA FD 19 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 010 Funding Number: RFA FD 19 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional) Apply for RFA FD 19 003 Funding Number: RFA FD 19 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional Apply for RFA FD 19 011 Funding Number: RFA FD 19 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional Apply for PAR 19 190 Funding Number: PAR 19 190 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional Apply for PAR 19 216 Funding Number: PAR 19 216 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Implementation of the Animal Feed Regulatory Program Standards (U18 Clinical Trial Not Allowed) Apply for RFA FD 19 021 Funding Number: RFA FD 19 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial Optional) Apply for RFA FD 19 020 Funding Number: RFA FD 19 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 019 Funding Number: RFA FD 19 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required Apply for RFA FD 19 015 Funding Number: RFA FD 19 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $37,500,000 |
| Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities. (U01) Clinical Trial Not Allowed Apply for RFA FD 19 013 Funding Number: RFA FD 19 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,500,000 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 19 016 Funding Number: RFA FD 19 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U01) Clinical Trials Not Allowed Apply for RFA FD 19 026 Funding Number: RFA FD 19 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed Apply for RFA FD 19 025 Funding Number: RFA FD 19 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,600,000 |
| Renewal Application: Critical Path Public Private Partnerships (U18) Clinical Trials Optional Apply for RFA FD 19 027 Funding Number: RFA FD 19 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 18 827", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.