Part I Overview Information


Department of Health and Human Services

Participating Organizations
Center for Veterinary Medicine (CVM) (http://www.fda.gov/AnimalVeterinary/default.htm)

Components of Participating Organizations
Office of Minor Use and Minor Species (MUMS) Animal Drug Development (http://www.fda.gov/cvm/minortoc.htm)

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

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Request for Applications (RFA) Number: RFA-FD-10-001  

Note: The policies, guidelines, terms, and conditions stated in this announcement differ from those used by the NIH. At this time the FDA does not follow the New NIH Review Guidelines and Scoring Criteria, therefore the FDA has Opted out of transitioning to the new Adobe Forms B instructions and page limitation requirements associated with the Enhanced Peer Review Guidelines. Applicants are encouraged to use the Adobe Forms A instructions for this FOA submission.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.103 

Key Dates
Release/Posted Date: April 8, 2010
Opening Date:  April 8, 2010, July 02, 2010, January 03, 2011, June 10, 2011 (Earliest dates an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable.
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): May 14, 2010, September 3, 2010, February 4, 2011, August 5, 2011
AIDS Application Due Date(s): Not Applicable
Peer Review Date(s): June 11, 2010, November 16, 2010, March 25, 2011, September 23, 2011
Council Review Date(s): September 7, 2010, February 8, 2011, June 7, 2011, December 6, 2011
Earliest Anticipated Start Date(s): September 2010, March 2011,  July 2011,  February 2012 Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: August 6, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


Section II. Award Information

1. Mechanism of Support

2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information

2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the FDA
    C. Application Processing   
           1. Submitting On-Time
           2. Two Day Window to Correct eRA Identified Errors/Warnings
           3. Viewing an Application in the eRA Commons
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Section V. Application Review Information
1. Criteria
2. Review Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information  

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. 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 owner 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 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 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.  Applicants must include an explanation of how the proposed study will help gain approval or conditional approval of the designated product in the application’s “Background and Significance” section.  All funded studies are subject to the requirements of the 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.

Section II. Award Information


1. Mechanism of Support

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 Project 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.

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.

2. Funds Available

Of the estimated $750,000 available in each fiscal year 2010, 2011, and 2012, FDA anticipates funding approximately 8-10 awards in each FY, subject to availability of funds.  Grants will be awarded up to $50,000 or up to $100,000 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 ($50,000) may be for any safety or effectiveness study supportive of new animal drug approval or conditional approval.  Study proposals for the larger grants ($100,000) 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.

Because 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 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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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.

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.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

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

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

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an applicationSeveral of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the eRA Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see Section VI.3.C.1. for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:  

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) PD/PI Registration in the eRA Commons: Refer to the eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 480-0434

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to FDA. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by FDA (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Research & Related Budget, as appropriate

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:

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, for assembling the application materials outlined below, and for 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, a 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. 

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: Apirl 8, 2010, July 02, 2010, January 03, 2011, June 10, 2011 (Earliest dates an application may be submitted to Grants.gov) .
Application Due Date(s): May 14, 2010, September 03, 2010, February 04, 2011, August 05, 2011
Peer Review Date(s): June 11, 2010, November 16, 2010, March 25, 2011, September 23, 2011
Council Review Date(s): September 07, 2010, February 8, 2011, June 07, 2011, December 06, 2011
Earliest Anticipated Start Date(s): September 2010, April 2011, July 2011, February 2012

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the FDA

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp  and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

In order to expedite the review, applicants are requested to notify the FDA Referral Office by email Michelle.Fuller@fda.hhs.gov  when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA Commons system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, FDA provides applicants a two day error correction window to correct any eRA Commons identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to FDA for further processing.

Upon receipt, applications will be evaluated for completeness by the FDA and responsiveness by the FDA. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

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.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review under the terms of Executive Order 12372.

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 http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

6. Other Submission Requirements 

PD/PI Credential (e.g., Agency Login)

The FDA requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

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:

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the Adobe Forms Version A Application Guide. The Adobe Forms A application instruction guide can be found in the attachment section of Grants.gov.

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Foreign Applications (Non-Domestic [non-U.S.] Entities)

Indicate how the proposed project has specific relevance to the mission and objectives of the FDA and has the potential for significantly advancing the health sciences in the United States. 

Section V. Application Review Information


1. Criteria 

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 found to be non-responsive will be returned to the applicant without further consideration.

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).

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 second review by the National Cancer Institute, National Cancer Advisory Board (NCAB) 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 his 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 drug product.

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 requested budget must be within the dollar limits outlined, up to $50,000 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 $100,000 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 $50,000 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.

The protocol should be submitted in the application.  Page limits, font size, and margins should comply with the Application Guide, Electronic Submission of Grant Applications.

2. Review and Selection Process

Review Process

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

As part of the scientific peer review, all applications will:

The goals of FDA’s supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by Michelle Fuller, Peer Review contact, and in accordance with FDA peer review procedures, using the review criteria stated below.

Scientific/Technical Review Criteria

The panel of experts will review the application based on the following scientific and technical merit criteria:

The specific review criteria described below will be considered in the review process and will provide the basis for the score(s) from each reviewer for each project reviewed.

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 significantly contribute to the approval or conditional approval of the designated drug product?

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?

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?

Investigators: 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 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?

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? 

In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating and must be addressed by applicants.

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not provide 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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Additional Review Considerations

As applicable for the project proposed, reviewers will address 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.  As applicable for the FOA or submitted application, 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.

Selection Process

Applications submitted in response to this FOA 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:

3. Anticipated Announcement and Award Dates

Earliest anticipated Start/Award Date: September 2010, March 2011, July 2011,  February 2012  

Section VI. Award Administration Information


1. Award Notices

After the peer 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. For details, applicants may refer to 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. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Section IV.5., “Funding Restrictions.”       

2. Administrative and National Policy Requirements

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 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.

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.

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

3. Reporting

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.

Section VII. Agency Contacts


FDA encourages your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Dr. Joan Gotthardt
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) 276-9331
Email: joan.gotthardt@fda.hhs.gov

2. Peer Review Contact(s):

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

3. Financial/Grants Management Contact(s):

Vieda Hubbard
Division of Acquisition Support and Grants
Office of Acquisition and Grants Services (HFA-500)
Food and Drug Administration
5630 Fishers Lane, Room 2141
Rockville, Maryland  20857
Telephone: (301) 827-7177
Email: vieda.hubbard@fda.hhs.gov

Section VIII. Other Information


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. FDA 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.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
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.


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