Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Center for Veterinary Medicine (CVM)

Funding Opportunity Title

Minor Use Minor Species Development of Drugs (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

PAR-18-827

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

  93.103

Funding Opportunity Purpose

 This Funding Opportunity Announcement (FOA) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop, or support the development of new animal drugs intended for minor use in major species or for use in minor species. 

  • The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing.
  • Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants.
  • The organization (or applicant) seeking approval of the new animal drug under investigation must hold a minor use or minor species "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, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516.
  • FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed and accepted the proposed study protocol before an applicant can submit a grant application.
Key Dates
Posted Date

June 11, 2018

Open Date (Earliest Submission Date)

June 27, 2018 (for August 27, 2018 application due date);

November 16, 2018 (for January 18, 2019 application due date);

June 14, 2019 (for August 16, 2019 application due date);

November 15, 2019 (for January 17, 2020 application due date);

June 19, 2020 (for August 14, 2020 application due date);

November 13, 2020 (for January 15, 2021 application due date)

Please note that this FOA has multiple open periods.  Each open date has a corresponding due date listed below  

Letter of Intent Due Date(s)

July 2, 2018 (for August 27, 2018 application due date);

December 3, 2018 (for January 18, 2019 application due date);

July 1, 2018 (for August 16, 2019 application due date);

December 2, 2019 (for January 17, 2020 application due date);

July 1, 2020 (for August 14, 2020 application due date);

December 1, 2020 (for January 15, 2021 application due date)

Application Due Date(s)

August 27, 2018;

January 18, 2019;

August 16, 2019;

January 17, 2020;

August 14, 2020;

January 15, 2021

by 11:59 PM Eastern Time

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2018

April 2019

November 2019

April 2020

November 2020

April 2021

Advisory Council Review

Not Applicable

Earliest Start Date

February 2019

June 2019

February 2020

June 2020

February 2021

June 2021

Expiration Date

 January 16, 2021

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    The Food & Drug Administration’s (FDA) Center for Veterinary Medicine’s (CVM) Office of Minor Use & Minor Species Animal Drug Development (OMUMS) was created after “The Minor Use and Minor Species Animal Health Act of 2004” (MUMS act) was signed into law. The MUMS act helps make more medications legally available to veterinarians and animal owners to treat minor animal species and minor uses in major animal species (MUMS drugs). Major species of animals are: horses, dogs, cats, cattle, swine, turkeys, and chickens. All other animal species (except humans) are minor species. A minor use is the intended use of a new animal drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually in the United States.

    To determine whether any particular use in a major species is a minor use, the FDA has established a specific “small number of animals” for each of the seven major animal species as follows: Horses-50,000 annually; Dogs-70,000 annually; Cats-120,000 annually; Cattle-310,000 annually; Swine-1,450,000 annually; Turkeys-14,000,000 annually; and Chickens-72,000,000 annually. Additional information about minor use and minor species is available on the FDA’s website for OMUMS.

    The FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing. The entity seeking approval of the new animal drug under investigation must hold a minor use or minor species "designation" granted by FDA/CVM/OMUMS for that drug for a specified intended use prior to application submission; the entity accomplishes this through a formal request to their Investigational New Animal Drug File (INAD).

    Qualified safety and effectiveness testing eligible for funding includes studies that support target animal safety or effectiveness, environmental safety, human food safety, and certain manufacturing studies, as well as the analytical method validation studies described below.

    • FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have accepted the proposed study protocol prior to application submission.
    • The following manufacturing studies, as part of the qualified safety and effectiveness studies, are eligible for funding if FDA/CVM/ONADE has accepted the study protocol prior to application submission:
    • A study to evaluate the stability of a MUMS drug
    • A study to validate analytical methods associated with the manufacture of a MUMS drug
    • A study to determine the homogeneity/segregation of an animal feed bearing or containing a MUMS drug
    • A study to validate analytical methods for an animal feed bearing or containing a MUMS drug.
    • A separate study to validate an analytical method prior to the conduct of an in-life human food safety study is also eligible for funding, if FDA/CVM/ONADE has accepted the study protocol prior to application submission.
    • Applicants must explain how the proposed study will contribute to FDA approval or conditional approval of the product in the application’s “Significance” section of the Research Strategy (PHS 398 Research Plan).

    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.   

    There are two levels of funding available. The FDA will award grants up to $100,000 per year for up to 2 years (level one), or up to $150,000 per year for up to 3 years in certain cases (level two). Please note the dollar limitation will apply to total costs, not direct costs. Applications for the smaller level one grants ($100,000) may be for any routine safety or effectiveness study supportive of new animal drug approval or conditional approval of the designated product for the designated intended use. Study proposals for larger level two grants ($150,000) must be for necessary studies that are of unusual complexity, duration, or size. A third year of funding is available only for long-term toxicological studies.

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for two (2) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

    CVM intends to fund up to $500,000 yearly, for fiscal year (FY) 2019, FY2020 and FY 2021 in support of this grant program.

    It is anticipated that up to 10 awards will be made, not to exceed $150,000 in total costs (direct plus indirect), per award.

    Award Budget

    There are two levels of funding available. Grants will be awarded up to $100,000 per year for up to 2 years, or up to $150,000 per year for up to 3 years in certain cases. Please note the dollar limitation will apply to total costs, not direct costs. Applications for the smaller grants ($100,000) may be for any routine safety or effectiveness study supportive of new animal drug approval or conditional approval of the designated product for the designated intended use.  Study proposals for the larger grants ($150,000) must be for necessary studies that are of unusual complexity, duration, or size.  A third year of funding is available only for long-term toxicological studies.

    An application for a given study can only be submitted for one level of funding.

    The nature and scope of the proposed research will vary from application to application; it is anticipated that the size and duration of each award will also vary. Although the financial plans of the FDA are to provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

    FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

    Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

    Level One:

    Year 01: $100,000 

    Year 02: $100,000

    Level Two:

    Year 01: $150,000 

    Year 02: $150,000

    Year 03: $150,000 (long-term toxicological study only)

    Award Project Period

    The length of support of award project periods will depend on the nature of the study, but is one-year from date of award for most studies. For those studies with an expected duration of more than one year, a second, or in some cases, a third year of noncompetitive continuation of support will depend on the following factors:

    (1) performance during the preceding year, (2) compliance with the regulatory requirements of an Investigational New Animal Drug File (INAD) and those associated with designation, and (3) availability of Federal funds. 

    The maximum project period is 3 years.   

    HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants

    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    • Non-domestic (non-U.S.) Entities (Foreign Institutions)

    Additional Information on Eligibility: 1) The applicant seeking approval of the new animal drug under investigation must hold a minor use or minor species "designation" granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug prior to application submission; and 2) FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must accept the protocol for the proposed study prior to application submission.

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
    Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

    Program Directors/Principal Investigators (PD(s)/PI(s))

    All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    Program-Specific Eligibility Requirements/Eligible Studies:

    To be eligible for this funding opportunity:

    • The applicant must be an organization, or a party working as the organization's research partner, in the process of developing, or supporting the development of, a new animal drug intended for minor use in a major species or intended for use in a minor species. Part 2. Section I. Funding Opportunity Description provides details regarding minor use.
    • The organization developing the new animal drug being studied for FDA approval must have already opened an Investigational New Animal Drug File (INAD) and must have the drug designated for a particular use for a particular species by the FDA Center for Veterinary Medicine’s Office of Minor Use & Minor Species Animal Drug Development (OMUMS) prior to submitting an application. Designation is accomplished by the submission of a formal request to the animal drug sponsor's INAD for review by FDA/CVM/OMUMS. The Minor Use/Minor Species Designations List on the FDA website shows the drugs that are currently designated.
    • Applicants must propose studies intended to provide new animal drug safety and/or effectiveness data for a designated intended use. See Studies eligible for funding below.
    • FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must accept the protocol for the proposed study prior to the submission of the grant application.
    • The study protocol must be under an active INAD file and must support the development of the designated drug product toward FDA approval or conditional approval.
    • The INAD submission number of the proposed study should appear in the cover letter of the application along with the title of the project.
    • 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, as applicable. The applicant must remain in compliance throughout the proposed project period if the FDA awards the applicant a grant.

    Studies eligible for funding:

    • Qualified safety and effectiveness testing includes studies that support target animal safety or effectiveness, environmental safety, human food safety, and certain manufacturing studies, as well as the analytical method validation studies described below, when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug for a designated use.
    • The following manufacturing studies, as part of the qualified safety and effectiveness studies, are eligible for funding, if FDA/CVM/ONADE has accepted the study protocol prior to application submission: 1) a study to evaluate the stability of a MUMS drug, 2) a study to validate analytical methods associated with the manufacture of a MUMS drug, 3) a study to determine the homogeneity/segregation of an animal feed bearing or containing a MUMS drug, and 4) a study to validate analytical methods for an animal feed bearing or containing a MUMS drug.
    • A separate study to validate an analytical method prior to the conduct of an in-life human food safety study is eligible for funding, if FDA/CVM/ONADE has accepted the study protocol prior to application submission.

    Applicants are strongly encouraged to contact FDA to resolve any unanswered questions about eligibility criteria or the application process itself before submitting an application. Please direct all questions of a technical or scientific nature to the OMUMS program staff and all questions of an administrative or financial nature to the grants management staff. See Section VII. Agency Contacts.  

    2. Cost Sharing

    This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

    The FDA will not accept duplicate or highly overlapping applications under review at the same time.  This means that the FDA will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

     The FDA will not accept any application that is essentially the same as one currently pending initial objective review unless the applicant withdraws the pending application. When a previously objectively reviewed, unfunded application, and originally submitted as an investigator-initiated application, is submitted again in response to this funding opportunity, it should be prepared as a NEW application.

    Resubmission applications are not permitted in response to this FOA.

    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the instructions in the Research Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA staff to estimate the potential review workload and plan the review.

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    • Descriptive title of proposed activity
    • Name(s), email address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity

    The letter of intent should be sent to:

    Bryce Jones, Grants Management Specialist
    Telephone: 240-402-2111
    Email: Bryce.Jones@fda.hhs.gov

    A technical session will be held for prospective applicants in July 2018; any future dates will be based on receipt of letters of intent. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process. Participation in the technical session is optional, but strongly encouraged. 

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

    • Specific Aims - One (1) page.
    • For this specific FOA, the Research Strategy section is limited to 12 pages. This 12-page limit does not apply to the study protocol accepted by FDA/CVM/ONADE; the protocol should be a separate attachment to the application in the Appendix.  
    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Project/Performance Site Locations

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Other Project Information

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Senior/Key Person Profile

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    R&R Budget

    All instructions in the SF424 (R&R) Application Guide must be followed.  with the following additional instructions:

    • Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
    • If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission.  This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
    • If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
    R&R Subaward Budget

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS 398 Cover Page Supplement

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    PHS 398 Research Plan

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

    • Specific Aims is limited to 1 page.
    • Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 12 pages. This 12-page limit does not apply to the study protocol accepted by FDA/CVM/ONADE; the study protocol should be a separate attachment in the Appendix (see below).
    • The “Significance” section of the Research Strategy (PHS 398 Research Plan) should explain how the proposed study will contribute to FDA approval or conditional approval of the designated new animal drug product for the designated intended use.

    The grant application should include the following information attached in the Appendix:

    • Attach as Appendix 1: A copy of the protocol accepted by the applicable FDA/CVM INAD review division in the Office of New Animal Drug Evaluation (ONADE). The applicant should not alter the protocol from the version accepted by FDA/CVM. Protocol changes could result in ineligibility of a grant application. It is not necessary to include the protocol forms (e.g., blank data capture forms, etc.) in the grant application.
    • Attach as Appendix 2: A copy of the protocol acceptance letter or a reference to the letter from the applicable FDA/CVM INAD review division.
    • Attach as Appendix 3: A letter from the animal drug company sponsoring the designated new animal drug under investigation documenting the relationship between the sponsor and the party submitting the grant application, if the applicant is a party other than the animal drug sponsor of the INAD providing for the designated new animal drug. The animal drug sponsor should also submit this letter to their INAD.
    • Attach as Appendix 4: A letter from the supplier of the product under investigation, stating that the product is available to the applicant in the form and quantity needed to conduct the proposed study. If negotiations regarding the supply of the study product are underway but have not been finalized at the time of application, a letter indicating such must be provided in the application.  Verification of adequate supply of study product will be necessary before an award is made. 

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    • Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    Appendix:

    • Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Attach required documents to the Appendix as described above under PHS 398 Research Plan.
    PHS Human Subjects and Clinical Trials Information

    The PHS Human Subjects and Clinical Trials Information form replaces the Human Subjects section of the Research Plan form. FOAs that do not allow clinical trials use this form for human subjects.

    When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS Assignment Request Form

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    Foreign Institutions

    Foreign (non-U.S.) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA's electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

    Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

    Additional funding restrictions may be part of the Notice of Award.  

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process.

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit.

    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 key personnel 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 the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

    Approach (25 Points)

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Does the application adequately describe the rationale, design, facilities, proposed conduct, proposed evaluation, and justification for financial support of the proposed study, including the ability of the applicant to complete the proposed study within the proposed budget and time limits?  Does the applicant acknowledge potential problem areas and consider alternative strategies?

    Environment (20 Points)

    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? 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 associated with meeting the aims of the project? Are Senior/Key Persons and other required personnel identified in the budget? Is the level of effort for Senior/Key Personnel adequate to conduct the aims of the project? Are consultants identified and their service costs adequately described in the attached budget justification? If the budget includes subaward/consortium costs, are those costs sufficiently detailed?

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.  

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items, but will not give separate scores for these items and should not consider them in providing an overall score.

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Children 

    When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable   

    Applications from Foreign Organizations

    Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by an Objective Review Committee using the stated review criteria.

    As part of the objective review, all applications:

    • Will receive a written critique.

    Appeals of objective review will not be accepted for applications submitted in response to this FOA.

    Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by objective review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    3. Anticipated Announcement and Award Dates

    Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

    Section VI. Award Administration Information
    1. Award Notices

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

    Awardees must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found in the HHS Grants Policy Statement.

    2. Administrative and National Policy Requirements

    All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), codified as amended at 41 U.S.C. § 2313, Federal award making officials are required to review and consider information about an applicant in the designated integrity and performance system (currently the Federal Awardee Performance and Integrity Information System (FAPIIS)) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgment about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205.  This provision will apply to all FDA grants and cooperative agreements.

    FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.

    Peer-reviewed articles resulting from research supported in whole or in part with FDA funds must be submitted to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines peer reviewed articles as an article describing original scientific research findings published in a scholarly scientific journal that has been peer reviewed prior to publication. The PMC archive is the designated repository for these articles for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.

    Additional terms and conditions regarding FDA regulatory and CVM/OMUMS programmatic requirements may be part of the Notice of Award.

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award.

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. 

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Dr. Stuart Jeffrey
    Office of Minor Use Minor Species Animal Drug Development (OMUMS)
    Center for Veterinary Medicine (CVM)
    Food and Drug Administration (FDA)
    Telephone: 240-402-0568
    Email: stuart.jeffrey@fda.hhs.gov

    Objective Review Contact(s)

    Bryce Jones
    Office of Acquisitions & Grants Services (OAGS)
    Food and Drug Administration
    Telephone: 240-402-2111
    Email: bryce.jones@fda.hhs.gov

    Financial/Grants Management Contact(s)

    Bryce Jones
    Office of Acquisitions & Grants Services (OAGS)
    Food and Drug Administration
    Telephone: 240-402-2111
    Email: bryce.jones@fda.hhs.gov

    Section VIII. Other Information

    All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement .

    Authority and Regulations

    Awards are made under the authorization of section 573(b) of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2(b))  and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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