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Grant Analysis

Purpose & Target

This grant from the U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), aims to support research and development of new animal drugs for 'minor uses in major species' or for 'minor animal species' (MUMS drugs). It provides funding for qualified safety and effectiveness testing required for FDA approval or conditional approval of these designated veterinary drugs. - Target recipients: Institutions or organizations, or their research partners, developing MUMS animal drugs. - Target size: Not specified by size, but by role in drug development. - SECTOR-SPECIFIC: Animal Health, Veterinary Medicine, Pharmaceutical Research (Veterinary). - Geographic scope: Domestic (U.S.) and non-domestic (non-U.S.) entities are eligible. - Key filtering criteria: Must have an Investigational New Animal Drug (INAD) file with FDA/CVM, hold a MUMS 'designation' for the drug, and have FDA/CVM/ONADE concurrence on the proposed study protocol. - Grant frequency and program context: This is a recurring R01 Research Project Grant opportunity with multiple application due dates annually until January 2027. It stems from the 'Minor Use and Minor Species Animal Health Act of 2004' (MUMS Act) to increase availability of medications for less common animal health needs.

Financial Structure

Award Budget: Varies based on nature and scope of proposed research.
Maximum funding per year: $250,000 in total costs (direct and indirect) for Year 01, $250,000 for Year 02, and $250,000 for Year 03 (only for long-term toxicological studies).
Maximum project period funding: Up to $750,000 over a maximum of 3 years for long-term toxicological studies. For most studies, funding is for 1 year.
Currency: USD
Eligible costs: Qualified safety and effectiveness testing, including studies supporting target animal safety/effectiveness, environmental safety, human food safety, and certain manufacturing studies (stability, analytical methods, homogeneity/segregation of feed). Analytical method validation studies are also eligible.
Ineligible costs: Not explicitly detailed, but costs must be directly related to the eligible testing and development of MUMS drugs.
Matching fund requirements: No cost sharing is required.
Indirect cost policies:
If an applicant has a negotiated Federal indirect cost rate, a copy of the agreement must be provided.
If no negotiated rate, a 'de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC)' will be allowed.
For foreign and international organizations, indirect/F&A costs are funded at a fixed rate of 8 percent of MTDC (with specific exceptions for American University of Beirut and World Health Organization).
Payment schedule and mechanisms: Not explicitly detailed, but subject to HHS Grants Policy Statement. Annual financial and performance reporting is required to ensure continuation of funds.
Financial reporting requirements: Annual Federal Financial Reports (FFR) submitted electronically via Payment Management System (PMS) within 90 days after budget period end. A Final FFR is due within 120 days after project period expiration.
Audit requirements: Recipients are subject to annual audit requirements per 45 CFR 75.501, based on annual Federal fund expenditure threshold levels. Foreign recipients have the same audit requirements as for-profit organizations.
Program Income: Any program income generated during the project period must be reported.

Eligibility Requirements

Organizational Eligibility

Eligible organization types include:
Higher Education Institutions (Public/State Controlled, Private, Hispanic-serving, HBCUs, TCCUs, Alaska Native and Native Hawaiian Serving, AANAPISIs)
Nonprofits (with or without 501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses and Other For-Profit Organizations)
Local Governments (State, County, City/Township, Special District Governments, Indian/Native American Tribal Governments (Federally Recognized or Other))
Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations)
Non-domestic (non-U.S.) Entities (Foreign Organizations)
The applicant must be an organization, or a party working as its research partner, developing or supporting the development of a 'designated new animal drug intended for minor use in a major species or intended for use in a minor species' (MUMS).
The organization seeking FDA approval of the new animal drug must have:
Already opened an 'Investigational New Animal Drug (INAD)' file with FDA/CVM.
Already hold a 'minor use or minor species (MUMS) designation' granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use.
FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have 'reviewed and concurred with the protocol for the proposed study' before application submission.
Studies involving products already approved by FDA for veterinary use that are intended to evaluate new MUMS indications are also subject to the above INAD requirements.
The applicant must be in compliance with INAD and designation regulations at the time of application submission and remain compliant throughout the project period if awarded.

Technical Expertise Requirements

The proposed studies must be 'qualified safety and effectiveness testing' that will result in or substantially contribute to FDA approval or conditional approval of a MUMS-designated drug.
Eligible studies include:
Target animal safety or effectiveness studies.
Environmental safety studies.
Human food safety studies.
Certain manufacturing studies (stability, analytical methods for manufacture/feed homogeneity/segregation).
Analytical method validation studies (including those prior to in-life human food safety studies).

Registration Requirements

Applicant organizations must complete and maintain active registrations in:
System for Award Management (SAM), including renewal at least annually. Foreign organizations need an 'NCAGE' code for SAM.
eRA Commons (organization must identify at least one 'Signing Official' and one 'Program Director/Principal Investigator' (PD/PI) account).
Grants.gov.
All PD(s)/PI(s) must have an eRA Commons account and affiliate it with the applicant organization.

Exclusion Criteria

Applications that are duplicate or highly overlapping with other applications under review by FDA at the same time will not be accepted.
Resubmission applications are not permitted in response to this NOFO.

Application Process

Application Process Timeline and Deadlines

Open Date (Earliest Submission Date):
May 24, 2024 (for July 26, 2024 application due date)
November 29, 2024 (for January 31, 2025 application due date)
May 23, 2025 (for July 25, 2025 application due date)
November 28, 2025 (for January 30, 2026 application due date)
May 22, 2026 (for July 24, 2026 application due date)
November 27, 2026 (for January 29, 2027 application due date)
Letter of Intent Due Date(s) (Optional but encouraged):
June 21, 2024 (for July 26, 2024 application due date)
December 27, 2024 (for January 31, 2025 application due date)
June 20, 2025 (for July 25, 2025 application due date)
December 26, 2025 (for January 30, 2026 application due date)
June 19, 2026 (for July 24, 2026 application due date)
December 25, 2026 (for January 29, 2027 application due date)
Application Due Date(s) (Latest date for submission):
July 26, 2024
January 31, 2025
July 25, 2025
January 30, 2026
July 24, 2026
January 29, 2027 (Latest deadline)
All applications are due by 11:59 PM Eastern Time.
Late applications will not be accepted.
Scientific Merit Review: October 2024, April 2025, October 2025, April 2026, October 2026, April 2027.
Earliest Start Date: December 2024, June 2025, December 2025, June 2026, December 2026, June 2027.
Expiration Date: January 30, 2027.

Required Documentation and Submission Materials

Applications must be submitted electronically via ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Required forms and sections (following Research (R) Instructions in How to Apply - Application Guide, with specific NOFO modifications):
SF424(R&R) Cover
SF424(R&R) Project/Performance Site Locations
SF424(R&R) Other Project Information
SF424(R&R) Senior/Key Person Profile (PD(s)/PI(s) must include eRA Commons ID)
R&R Budget (detailed breakdown and narrative justification for each year of support; attach most recent Federal indirect cost rate agreement if applicable)
R&R Subaward Budget (if applicable)
PHS 398 Cover Page Supplement
PHS 398 Research Plan:
- Specific Aims (limited to 1 page)
- Research Strategy (limited to 12 pages, excluding study protocol)
- Significance section must explain contribution to FDA approval/conditional approval and reference the specific designated intended use.
PHS Human Subjects and Clinical Trials Information (if applicable)
PHS Assignment Request Form
Mandatory Appendix Attachments:
Appendix 1: Copy of the study protocol 'concurred with' by FDA/CVM Office of New Animal Drug Evaluation (ONADE). No alterations from the concurred version allowed.
Appendix 2: Copy of the protocol concurrence letter or reference to the letter with submission identifier from FDA/CVM/ONADE review division.
Appendix 3: Letter from the entity sponsoring the designated new animal drug documenting the relationship with the applicant (if applicant is not the sponsor).
Appendix 4: Letter from the product supplier stating availability of product in required form and quantity. If negotiations are ongoing, a letter indicating this must be provided, with verification of supply needed before award.

Project Implementation Timeline and Reporting Obligations

Grant duration: Typically 1 year for most studies; maximum of 3 years for long-term toxicological studies.
Continuation of support for multi-year projects depends on:
Performance during the preceding year.
Compliance with INAD and designation regulatory requirements.
Availability of Federal funds.
Reporting requirements:
Financial Reporting: Annual Federal Financial Reports (FFR) submitted electronically via PMS within 90 days after the end of the calendar quarter in which the budget period ended.
Performance Reporting: Research Performance Progress Report (RPPR) submitted annually using eRA Commons (for multi-year awards) within 60 days prior to the start of the next budget period.
A Final RPPR, Final Invention Statement (if applicable), and Federal Financial Report are required for closeout (within 120 days after project period expiration).
Monitoring: FDA conducts desk reviews (requesting policies, expenditures, accounting records, invoices, etc.) and site visits as needed. Foreign entities are subject to the same monitoring.

Application Assistance

Applicants are strongly encouraged to contact FDA with questions about eligibility or the application process before applying.
Technical/scientific questions: Dr. Janah Maresca, OMUMS, CVM, FDA (Email: [email protected]; Phone: 301-796-5079).
Administrative/financial questions: Terrin Brown, OAGS, FDA (Email: [email protected]).
For system issues (ASSIST, eRA Commons, Grants.gov): eRA Service Desk or Grants.gov Customer Support.

Evaluation Criteria

Scored Review Criteria (Total 100 Points)

Significance (25 Points):
Does the proposed study address an aspect of new animal drug safety or effectiveness that will substantially contribute to the FDA approval or conditional approval of the designated drug product?
Investigator(s) (20 Points):
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Do they have appropriate experience and training?
If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?
If collaborative/multi-PD/PI, do investigators have complementary/integrated expertise, and are their leadership/governance/organizational structure appropriate?
Approach (25 Points):
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims?
Does the application adequately describe the rationale, design, facilities, proposed conduct, proposed evaluation, and justification for financial support?
Is the ability of the applicant to complete the study within the proposed budget and time limits demonstrated?
Are potential problems, alternative strategies, and benchmarks for success presented?
Environment (20 Points):
Will the scientific environment contribute to the probability of success?
Are institutional support, equipment, and other physical resources adequate?
Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Budget (10 Points):
Is the requested budget and duration reasonable relative to the proposed research?
Does the budget adequately describe the costs?
Are Senior/Key Persons and other required personnel identified, and is their level of effort adequate?
Are consultants identified and their service costs described?
If subaward/consortium costs, are they sufficiently detailed?

Additional Review Criteria (Not Separately Scored, but Impact Overall Score)

Vertebrate Animals:
Evaluation of proposed procedures (species, strains, ages, sex, numbers).
Justification for species use and why non-animal models cannot be used.
Interventions (analgesia, anesthesia, sedation, palliative care, humane endpoints) to limit discomfort/distress/pain/injury.
Methods of euthanasia and justification if not consistent with AVMA Guidelines.
Biohazards:
Assessment of potential hazards to research personnel/environment.
Determination of adequate protection if needed.

Additional Review Considerations (Not Scored, but Considered)

Applications from Foreign Organizations:
Assessment of whether the project presents special opportunities (unusual talent, resources, populations, environmental conditions) not readily available in the U.S. or augmenting existing U.S. resources.
Select Agent Research:
Review of information on select agent(s) used, registration status of entities, monitoring procedures, and biosafety/biocontainment/security plans.
Resource Sharing Plans:
Reviewers will comment on the reasonableness of the plan or rationale for not sharing resources.
Authentication of Key Biological and/or Chemical Resources:
Review of plans for identifying and ensuring the validity of resources.

Compliance & Special Requirements

Regulatory Compliance Requirements

All funded studies are subject to the requirements of the 'Federal Food, Drug and Cosmetic Act (21 U.S.C. 331 et seq.)', regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations.
Project administration must comply with federal civil rights laws prohibiting discrimination (race, color, national origin, disability, age, and in some circumstances, religion, conscience, and sex).
Must take reasonable steps to provide meaningful access to persons with limited English proficiency and ensure programs are accessible to persons with disabilities.

Data Protection and Privacy

This award is subject to the 'Financial Conflict of Interest (FCOI)' regulation at 42 CFR Part 50 Subpart F.
'Certificates of Confidentiality' (42 U.S.C. 241(d)) are deemed issued for research involving identifiable, sensitive information collected or used in biomedical, behavioral, clinical, or other research funded by FDA.
Data Management and Sharing Plan is not applicable for this NOFO.

Intellectual Property Policies

Program income from patents and inventions is handled per regulations.

Risk Management and Security

Prohibition on obligating or spending grant funds for telecommunications and video surveillance services or equipment from specific prohibited entities (e.g., Huawei, ZTE, Hytera, Hikvision, Dahua) or entities owned/controlled by covered foreign countries, as described in 2 CFR 200.216 and Pub. L. 115-232, section 889.
Recipients with cumulative Federal awards over $10,000,000 must report and maintain information in SAM about civil, criminal, and administrative proceedings related to Federal awards.

Unique Aspects and Challenges

The grant is highly specific to 'Minor Use Minor Species (MUMS)' animal drug development, requiring pre-existing 'INAD' files and MUMS 'designation' for the drug under investigation, and FDA concurrence on the study protocol prior to application.
Requires detailed understanding and adherence to FDA's veterinary drug development and approval processes.
The application process emphasizes scientific merit and direct contribution to FDA approval pathways.

Cross-Cutting Considerations

Use of Animals in Research: No Federal funds can be expended for research involving animals without an 'Animal Welfare Assurance' (OLAW-approved). The grantee must ensure compliance of all performance sites and provide relevant documentation to FDA/OLAW.
Projects involving human subjects research or FDA-defined clinical trials require specific documentation and compliance with PHS Human Subjects and Clinical Trials Information forms.

Grant Details