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

U.S. Food and Drug Administration  (FDA)
Center for Veterinary Medicine (CVM)

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.

Funding Opportunity Title

Minor Use Minor Species Development of Drugs; Research Project Grant (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

RFA-FD-15-004

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 intended for use in minor species. 

  • The FDA is authorized to provide grants only to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in or substantially contribute to FDA approval or conditional approval of a new animal drug.
  • Only companies developing drugs for veterinary use or parties working as research partners with such companies are eligible for grants.
  • Only studies in support of new animal drugs that such companies have had designated for specified intended uses by FDA/CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS), 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, are eligible for grants.
  • Qualified studies eligible for funding include those intended to support target animal safety or effectiveness, environmental safety, or human food safety.
  • The protocol for a proposed study must be accepted by FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) prior to application submission.
  • In addition to studies intended to directly establish target animal safety or effectiveness, the following manufacturing studies supportive of target animal safety or effectiveness are eligible for funding, provided a protocol has been accepted by FDA/CVM/ONADE:
    • 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.
  • In addition to studies intended to directly establish human food safety, a separate study to validate an analytical method prior to the conduct of an in-life human food safety study is eligible for funding, provided a protocol has been accepted by FDA/CVM/ONADE.
  • Applicants must include an explanation of 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. 

Key Dates
Posted Date

February 26, 2015

Open Date (Earliest Submission Date)

June 19, 2015; November 20, 2015; June 17, 2016; November 18, 2016; June 16, 2017; November 17, 2017.

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)

Not Applicable

Application Due Date(s)

August 14, 2015; January 15, 2016; August 12, 2016; January 13, 2017; August 11, 2017; January 12, 2018), 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 2015; April 2016; November 2016; April 2017; November 2017; April 2018.

Advisory Council Review

Not Applicable

Earliest Start Date

February 2016; June 2016; February 2017; June 2017; February 2018; June 2018.)

Expiration Date

January 13, 2018

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.


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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

FDA awards Research Project (R01) grants to institutions/organizations of all types.  This mechanism allows the PDs/PIs to define the scientific focus or objective of the research based on particular areas of interest and competence.  Although the PDs/PIs write the grant application and are responsible for conducting and supervising the research, the actual applicant is the research institution/organization.

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.

For the purposes of determining 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.  This FOA relates to grants to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug for a designated intended use.  The drug being studied must be designated through a formal request to FDA/CVM/OMUMS by the company developing the drug for veterinary use under their Investigational New Animal Drug File (INAD).

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.

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.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement. 

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.

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.  Future year amounts will depend on annual appropriations, availability of funding and awardee performance.

FDA/CVM intends to fund up to $1,000,000 yearly for fiscal year (FY) 2016, FY2017, and FY2018 in support of this grant program.

It is anticipated that up to 10 awards will be made in each FY, 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):

Year 01: $100,000 

Year 02: $100,000

Year 01: $150,000 

Year 02: $150,000

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

Note regarding indirect costs:  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.

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 (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)
  • Federal Government Agencies that are not part of HHS
  • 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)
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. Late applications will not be accepted for this FOA.

  • 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.
  • 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 a company, or a party working as the company'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.  Details regarding minor use are found under Part 2. Section I. Funding Opportunity Description.
  • The company 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.  Designated drugs are shown on the Minor Use/Minor Species Designations List on the FDA website.
  • 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.
  • The protocol for the proposed study must be accepted by FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) 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.

Studies eligible for funding:

  • Qualified studies include those that support target animal safety or effectiveness, environmental safety, or human food safety.
  • The following manufacturing studies supportive of target animal safety or effectiveness are eligible for funding, provided a protocol has been accepted by FDA/CVM/ONADE:  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.
  • In addition to studies intended to directly establish human food safety, a separate study to validate an analytical method prior to the conduct of an in-life human food safety study is eligible for funding, provided a protocol has been accepted by FDA/CVM/ONADE.

Applicants are strongly encouraged to contact FDA to resolve any unanswered questions about eligibility criteria or the application process itself before submitting their 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 any application that is essentially the same as one currently pending initial objective review unless the applicant withdraws the pending application.  When a previously unfunded application, 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.

Renewal applications are not permitted in response to this FOA.  

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

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

Page Limitations
  • 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 grant application should include the following:

  • An attached copy of the protocol accepted by the applicable FDA/CVM INAD review division in the Office of New Animal Drug Evaluation (ONADE).  The protocol submitted with the grant application should not be altered 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.
  • An attached copy of the protocol acceptance letter or a reference to the letter, from the applicable FDA/CVM INAD review division.
  • An explanation in the “Significance” section of the Research Strategy (PHS 398 Research Plan) as to how the proposed study will contribute to FDA approval or conditional approval of the designated new animal drug product for the designated intended use.
  • An attached 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.
  • An attached letter from the supplier of the product to be studied, 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. 

Letters of Support:  May include attachment of the required letter(s) described above.

Resource Sharing Plan: Not applicable.

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, with the following additional instructions:

  • Applicants may attach the study protocol accepted by FDA/CVM/ONADE in the Appendix.
  • Applicants may attach the study protocol acceptance letter from FDA/CVM/ONADE in the Appendix.
  • Study protocol is required.
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. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.  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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

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/CVM/OMUMS. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

1. Criteria

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

Responsive applications will be reviewed and evaluated for scientific and technical merit by a panel of experts.  A score will be assigned to each application based on the scientific/technical review criteria, which includes Significance, Investigators(s), Innovation, Approach, and Environment, as described below. Consultation with personnel from the appropriate FDA/CVM review divisions may take place during the review process to determine the extent to which a proposed study will provide acceptable data that could contribute to the goals of the program.

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), 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?

Innovation (10 Points)

Are the concepts, approaches or methodologies novel in a broad sense?  Is the project original and innovative for a particular product? For example, from the information provided in the application, does the study involve an aspect of new animal drug safety or effectiveness not previously addressed by other studies?

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? 

Additional Review Considerations

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

Resource Sharing Plans

Not Applicable

Budget and Period of Support

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

2. Review and Selection Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by (an) Objective Review Group(s), established by FDA/CVM/OMUMS, 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.5. 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.

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 annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements.

All new and continuing grants must comply with all regulatory requirements necessary to keep the status of the applicable Investigational New Animal Drug File (INAD) “active” and “in effect.”  Failure to meet regulatory requirements will be grounds for suspension or termination of the grant.

A final progress report, 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.

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 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)
7500 Standish Place (HFV-50)
Rockville, MD 20855
Telephone: 240-402-0568
Email: stuart.jeffrey@fda.hhs.gov

Objective Review Contact(s)

Oluyemisi (Yemisi) Akinneye
Division of Acquisition Support and Grants
Office of Acquisition & Grants Services (OAGS) (HFA-500)
Food and Drug Administration (FDA)
5630 Fishers Lane, Room 2037
Rockville, MD 20857
Telephone: 240-402-7560
Email: oluyemisi.akinneye@fda.hhs.gov

Financial/Grants Management Contact(s)

Oluyemisi (Yemisi) Akinneye
Division of Acquisition Support and Grants
Office of Acquisition & Grants Services (OAGS) (HFA-500)
Food and Drug Administration (FDA)
5630 Fishers Lane, Room 2037
Rockville, MD 20857
Telephone: 240-402-7560
Email: oluyemisi. akinneye@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.

Use of Animals in Research:

Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://awic.nal.usda.gov/government-and-professional-resources/federal-laws/animal-welfare-act) as applicable.

For research involving live vertebrate animals, the applicant organization must ensure that all Project/Performance Sites hold an Animal Welfare Assurance approved by the Office of Laboratory Animal Welfare (OLAW).

Authority and Regulations

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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