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.
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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 |
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