Participating Organization(s)	U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) (http://www.fda.gov/AnimalVeterinary/default.htm The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring 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	Office of Minor Use and Minor Species (MUMS) Animal Drug Development (http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/default.htm
Funding Opportunity Title	Minor Use Minor Species Development of Drugs; Research Project Grant (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of FOA RFA-FD-10-001
Related Notices	June 7, 2013 - See Notice NOT-FD-13-014. Notice of Correction, FDA is modifying some of the dates and text.
Funding Opportunity Announcement (FOA) Number	RFA-FD-12-003
Companion FOA	None
Number of Applications	Applicants may submit more than one application, provided each application is scientifically distinct. See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
FOA 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/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. Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. 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. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the application’s Background and Significance section. 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.

Posted Date	January 6, 2012
Open Date(s) (Earliest Submission Date)	January 13, 2012; June 01, 2012; October 12, 2012; June 07, 2013; October 11, 2013; June 06, 2014 (Changed to June 20, 2014 per NOT-FD-13-014); October 10, 2014 (Changed to November 21, 2014 per NOT-FD-13-014). (Earliest dates an application may be submitted to Grants.gov. Please note that this FOA has multiple open periods. Each "open" period has a corresponding due date listed below. For example, applications for the open period starting January 13, 2012, must be submitted by February 17, 2012.
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	February 17, 2012; July 20, 2012; December 07, 2012; (New Dates August 16, 2013; January 03, 2014; August 15, 2014; January 16, 2015 per NOT-FD-13-014), [ Dates removed:July 26,2013; December 06, 2013; July 18, 2014; December 05, 2014] by 5:00 PM eastern standard time. Notice: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. A registration process is necessary before submission and applicants are highly encouraged to start the process at least 4-6 weeks prior to the grant submission date. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	April 4, 2012; September 12, 2012; January 30, 2013; September 18, 2013; January 29, 2014; September 17, 2014; January 28, 2015
Secondary Review	(New Dates April 4, 2012; September 12, 2012; January 30, 2013; October 11, 2013; February 28, 2014; October 10, 2014; March 13, 2015 per NOT-FD-13-014), Old Dates: June 2012; November 2012; June 2013; December 2013; June 2014; December 2014; June 2015
Earliest Start Date(s)	(Dates Removed per NOT-FD-13-014)July 2012; December 2012; July 2013; January 2014; July 2014; January 2015; July 2015
Expiration Date	(Extended to January 17, 2015 per NOT-FD-13-014), Originally December 6, 2014
Due Dates for E.O. 12372	Not Applicable

Mechanism of Support. This FOA will utilize the Research Project (R01) grant. All awards will be subject to all policies and requirements that govern the research grant programs of the Public Health Service Act (PHS Act) (42 U.S.C. 262) as incorporated in the HHS Grants Policy Statement, dated January 1, 2007 (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm), including the provisions of 42 CFR part 52 and 45 CFR Parts 74 and 92. The regulations issued under Executive Order 12372 do not apply to this program. The National Institutes of Health (NIH) modular grant program does not apply to this FDA grant program.

Funds Available and Anticipated Number of Awards. Subject to the availability of funds, it is anticipated that $750,000 will be made available in FY2012, FY2013, FY2014, and FY2015. FDA/CVM anticipates funding approximately 8-10 awards in each FY.

Budget and Project Period. Grants will be awarded up to $75,000 or up to $125,000 in total (direct plus indirect) costs per year for up to 3 years. Please note the dollar limitation will apply to total costs. Applications for the smaller grants ($75,000) may be for any safety or effectiveness study supportive of new animal drug approval or conditional approval of the designated product for a designated intended use. Study proposals for the larger grants ($125,000) must be for studies that are of necessity of unusual complexity, duration, or size. The length of support will depend on the nature of the study. For those studies with an expected duration of more than one (1) 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 INAD; and (3) availability of Federal funds. A third year of funding is available only for long-term toxicological studies.

Application Research Strategy Length: The R01 application Research Strategy section of the PHS398 may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1. are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.

Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Special Date(s). This FOA uses non-standard due dates. See Section IV.3. for Submission, Review and Anticipated Start Dates.

Application Materials. See Section IV.1 for application materials.
All applications must utilize the current forms and instructions.

General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:

SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm

General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/

Hearing Impaired. Telecommunications for the hearing impaired are available at:
TTY: (301) 480-0434.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA). 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.

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

RESEARCH OBJECTIVES

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. For the purposes of determining whether any particular use in a major species is a minor use, 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 OMUMS is available on FDA’s Website at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/default.htm.

The primary goal of FDA’s OMUMS grant program is to support the development of new animal drugs intended for minor use for major species or intended for use for minor species. Only new animal drugs that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. 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. Applicants must include an explanation of how the proposed study will help gain approval or conditional approval of the designated product for a designated intended use in the application’s Background and Significance section. 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.

For specific information about the mission of each FDA Center, see About FDA at www.fda.gov.

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

Funding Instrument	Grant This FOA will use the Research Project (R01) grant. The Research Project (R01) grant is an award made to support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing the investigator’s specific interest and competencies, based on the mission of the FDA. The Program Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project. This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). All foreign applicants must complete and submit budget requests using the Research & Related Budget component.
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	Of the estimated $750,000 available in each fiscal year, FDA anticipates funding approximately 8-10 awards in each FY, subject to availability of funds.
Award Budget	Grants will be awarded up to $75,000 or up to $125,000 in total (direct plus indirect) costs per year for up to three (3) years. Please note the dollar limitation will apply to total costs, not direct costs. Applications for the smaller grants ($75,000) may be for any safety or effectiveness study supportive of new animal drug approval or conditional approval of the designated product for a designated intended use. Study proposals for the larger grants ($125,000) must be for studies that are of necessity of unusual complexity, duration, or size. 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 http://www.hhs.gov/grantsnet/adminis/gpd/index.htm will apply to the applications submitted and awards made in response to this FOA. Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.
Award Project Period	The length of support of award project periods will depend on the nature of the study. For those studies with an expected duration of more than one (1) 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 INAD; and (3) availability of Federal funds. A third year of funding is available only for long-term toxicological studies.

All awards will be subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the HHS Grants Policy Statement dated January 1, 2007 (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm), including the provisions of 42 CFR Part 52 and 45 CFR Parts 74 and 92. The regulations issued under Executive Order 12372 do not apply to this program. The National Institute of Health (NIH) modular grant program does not apply to this FDA grant program.

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

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) 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 to apply.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi

This FOA does not require cost sharing as defined in the current HHS Grants Policy Statement (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm).

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

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial objective review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.

Resubmission applications are not permitted in response to this FOA.

Renewal applications are not permitted in response to this FOA.

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

• Specific Aims - One (1) page
• Research Strategy - Twelve (12) pages.

Optional Components:

PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-Domestic [non-U.S.] Entities)
FDA policies concerning grants to foreign (non-U.S.) organizations can be found in the HHS Grants Policy Statement (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm)

Applications from foreign organizations must:

• Request budgets in U.S. dollars;
• Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component) (see NOT-OD-06-096);
• Not include any charge-back of customs and import fees;
• Comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF;
• If appropriate, request funds for up to 8% administrative costs (excluding equipment) (see NOT-OD-01-028, March 29, 2001);
• Comply with Federal/FDA policies on human subjects, animals, and biohazards;
• Comply with Federal/FDA biosafety and biosecurity regulations (see Section VI.2., Administrative and National Policy Requirements ); and
• Indicate in the 398 Research Plan how the proposed project has specific relevance to the mission and objectives of FDA and has the potential for significantly advancing science in the United States.

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.

Special Instructions

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, FDA requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the FDA, assembling the application materials outlined below, and coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

The total budget for all years of the proposed project must be requested in Budget Period 1. Do not complete Budget Periods 2 or 3. They are not required and will not be accepted with the application.

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

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to 12 pages.

Resource Sharing Plan

• Data Sharing Plan: Not Applicable
• Sharing Model Organisms: Not Applicable
• Genome Wide Association Studies (GWAS): Not Applicable:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign (non-US) institutions must follow policies described in the HHS Grants Policy Statement, (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm) and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications in advance of the deadline to ensure they have time to make any corrections that might be necessary for successful submission.

Organizations must submit applications via 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, an electronic system for grants administration.

Applicants are responsible for viewing their application 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 SF 424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

Applications must be submitted electronically following the instructions described in the SF 424 (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 SF 424(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.

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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

FDA grants management and program staff will review all applications submitted in response to this notice. To be responsive, an application must be submitted in accordance with the requirements of this notice. Applications that are incomplete and/or nonresponsive will not be reviewed.

The FDA will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Applicants are strongly encouraged to contact FDA to resolve any unanswered questions about criteria 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 Agency Contacts, Section VII of this document).

For this particular announcement, note the following:

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. Consultation with the proper FDA review division may also occur during this phase of the review to determine whether a proposed study will provide acceptable data that could contribute to the goals of the program. Responsive applications will be subject to a secondary review for concurrence with the recommendations made by the first-level reviewers, and funding decisions will be made by the Commissioner of Food and Drugs or her designee.

Applicants must propose studies intended to provide new animal drug safety and/or effectiveness data.

There must be an explanation in the Background and Significance section of the application regarding how the proposed study will contribute to approval or conditional approval of the designated new animal drug product for a designated intended use.

The Study protocol proposed in the grant application must be under an active Investigational New Animal Drug (INAD) file and must support the development of the designated drug product towards approval or conditional approval to qualify the application for scientific and technical review. Additional INAD information is described as follows:

• The protocol for the proposed study must be determined to be acceptable by the applicable FDA INAD review division prior to submission of the grant application, and a copy of the protocol must be included in the grant application. (Page limits, font size, and margins should comply with the Application Guide, Electronic Submission of Grant Applications.)
• The number assigned to the INAD that includes the proposed study should appear in the cover letter of the application with the title of the project.
• A copy of the letter or a reference to the letter, from the applicable FDA INAD review division, accepting the protocol must be included in the grant application.
• Protocols that would otherwise be eligible for an exemption from the INAD regulations must be conducted under an active INAD to be eligible for funding under this FDA grant program.
• If the sponsor of the INAD is other than the principal investigator listed on the application, a letter from the sponsor permitting access to the INAD must be submitted in both the INAD and in the grant application.
• The name(s) of the principal investigator(s) named in the application and in the study protocol must be submitted to the INAD.
• Studies involving already approved products, intended to evaluate new MUMS indications, are also subject to these INAD requirements.

The requested budget must be within the dollar limits outlined, up to $75,000 in total costs per year for up to 3 years for any safety or effectiveness study supportive of new animal drug approval or conditional approval, or up to $125,000 in total costs per year for up to 3 years for studies that are of necessity of unusual complexity, duration, or size. The length of support will depend on the nature of the study. For those studies with an expected duration of more than one (1) 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 INAD; and (3) availability of Federal funds. Note: A third (3rd) year of funding is available only for long-term toxicological studies.

Any application received that requests support over the maximum amount allowable for that particular study will be considered non-responsive. Applications requesting more than $75,000 must document the necessity for a study of unusual complexity, duration, or size.

In an appendix to the application, there must be evidence that the product to be studied is available to the applicant in the form and quantity needed for the study proposed. A current letter from the supplier as an appendix will be acceptable. 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.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does this study address an important problem? Does the study proposed in the application address an aspect of new animal drug safety or effectiveness that will substantially contribute to the approval or conditional approval of the designated drug product?

Investigator(s)

Are the PD(s)/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Do(es) the PD(s)/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Does the application establish that the investigators involved are appropriate to the nature of the study proposed?

Innovation

Is the project original and innovative for this product? For example: does the application involve an aspect of new animal drug safety or effectiveness not previously satisfactorily addressed by other studies?

Approach

Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? 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?

Environment

Does the environment/facility in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Does the application establish that the environment/facility in which the proposed study will be conducted will facilitate the study being completed within budget and on time?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

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

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 impact/priority score.

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.

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate expert objective review panel established by CVM/OMUMS in accordance with FDA objective review procedures, using the review criteria stated above.

As part of the objective review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial objective review, recommended applications will receive a second level of review. 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.

After the objective review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

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 the DUNS, CCR Registration, and Transparency Act requirements.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement link http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

Applications must propose studies intended to provide new animal drug safety and/or effectiveness data.

Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. There must be an explanation in the Background and Significance section of the application regarding how the proposed study will contribute to approval or conditional approval of the designated drug product for a designated intended use.

The study protocol proposed in the grant application must have been determined by the applicable FDA INAD review division to be acceptable under an active INAD in order to qualify the application for scientific and technical review. A copy of the FDA protocol concurrence letter or a reference to the letter must be included in the grant application. The source of the drug intended for use in the proposed study must be identified in the INAD and in the application.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

The grantee must file a final program progress report, financial status report, and invention statement within 90 days after the end date of the project period as noted on the notice of grant award. When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement dated October 1, 2006 (http://www.hhs.gov/grantsnet.adminis/gpd/). All new and continuing grants must comply with all regulatory requirements necessary to keep the status of their INAD active and in effect. Failure to meet regulatory requirements will be grounds for suspension or termination of the grant.

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.

A listing and justification of study changes that occurred in the past year must be included in the Non-Competing Continuation Grant Progress Report (PHS 2590).

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

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. See the http://www.hhs.gov/grantsnet/adminis/gpd/index.htm for additional information on this reporting requirement.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Dr. Stuart Jeffrey
Office of Minor Use and Minor Species Animal Drug Development (OMUMS)
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place (HFV-50)
Rockville, Maryland 20855
Telephone: (240) 276-8604
Email: stuart.jeffrey@fda.hhs.gov

Michelle Fuller
Office of Management, Financial Resources
Center for Veterinary Medicine
Food and Drug Administration
7529 Standish Place
Rockville, Maryland 20855
Telephone: (240) 276-9736
Email: michelle.fuller@fda.hhs.gov).

Vieda Hubbard
Division of Acquisition Support and Grants
Office of Acquisition and Grants Services (HFA-500)
Food and Drug Administration
5630 Fishers Lane, Room 1079
Rockville, Maryland 20857
Telephone: (301) 827-7177
Email: vieda.hubbard@fda.hhs.gov

Required Federal Citations

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 (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) 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://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Sharing of Model Organisms:
HHS is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the FDA recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the HHS Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an FDA application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using FDA funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. HHS has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

URLs in FDA Grant Applications or Appendices:
All applications and proposals for FDA funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the FDA grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

This program is not subject to the intergovernmental review requirements of Executive Order 12372. FDA’s research program is described in the Catalog of Federal Domestic Assistance (CFDA), No. 93.103 (http://www.cfda.gov/). FDA will support the studies covered by this notice under the authority of Section 301 of the Public Health Service Act as amended (42 U.S.C. 241) and under applicable federal regulations at 42 CFR Part 52 and 45 CFR Parts 74 and 92. All grant awards are subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the HHS Grants Policy Statement.

Smoke-Free Workplace:
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.