and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
Center for Veterinary Medicine (CVM), http://www.fda.gov/cvm/minortoc.htm
Components of Participating
Organizations
Office
of Minor Use and Minor Species (MUMS) Animal Drug Development
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
Request for Applications (RFA) Number: RFA-FD-09-008
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.
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: May
20, 2009
Opening Date: June 1, 2009 (Earliest date 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): July 1, 2009
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): July 2009
Council Review
Date(s): August 2009
Earliest Anticipated Start Date(s): September 2009
Additional Information to be Available Date (Activation Date): Not Applicable
Expiration
Date: July 2, 2009
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.
Receipt, Review, and Anticipated Start Dates
1. Letter of Intent
B.
Submitting an Application Electronically to the NIH
C. Application
Processing
4. Intergovernmental
Review
5. Funding Restrictions
6. Other Submission
Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection
Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C. Resource Sharing Plan(s)
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
- Required Federal Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The Research Project
Grant (R01) is an award to support a discrete, specified, circumscribed project
to be performed by named Project Directors/Principal
Investigators (PDs/PIs) in the areas representing the investigators specific
interest and competencies based on the mission of FDA.
FDA Awards 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 Office of Minor Use & Minor Species Animal Drug Development (OMUMS) was created to promote the development of drugs intended for minor use in major species of animals or for use in minor species of animals (MUMS drugs). Major species of animals are: horses, dogs, cats, cattle, pigs, turkeys, and chickens. All other animal species (except humans) are minor species. A minor use in a major species is one that involves use of a drug in no more than the following number of animals of a major species in the United States on an annual basis: Horses-50,000; Dogs-70,000; Cats-120,000; Cattle-310,000; Pigs-1,450,000; Turkeys-14,000,000; Chickens-72,000,000. Additional information about OMUMS is available on FDA s Website at www.fda.gov/cvm/minortoc.htm.
The primary goal of FDA’s OMUMS grant program is to support the development of drugs intended for minor use or intended for use in minor species. Only animal drugs that have qualified for designation in accordance with the provisions of 21 CFR Part 516 are eligible for grants. FDA is authorized to provide grants for designated new animal drugs to defray the costs of qualified safety and effectiveness testing, or expenses incurred in the development of processes and procedures associated with manufacture of a designated MUMS drug. However, this FOA only relates to grants to defray 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 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 (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 theResearch Project Grant (R01) award mechanism. 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.
All awards will be subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the DHHS 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 CFD 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 for FY 2009, FDA anticipates funding
approximately 8-10 awards, 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 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. A third year of funding is available only for long-term
toxicological studies. 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 DHHS 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.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
The
following organizations/institutions are eligible to apply:
The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including Sate and local units of government). Federal agencies that are not part of the Department of Health and Human Services (HHS) may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c)(4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards.
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 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 NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
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.
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant 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. The FDA review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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 DHHS Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
Resubmissions. Applicants are not permitted to submit a resubmission application in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
To comply with the President’s Management Agenda, HHS is participating as a partner in the new government-wide grants.gov application site. Applicants should apply electronically by visiting the web site www.grants.gov and following instructions under Apply for Grants. Users of grants.gov will be able to download a copy of the application package, complete it offline, and then upload and submit the application via the grants.gov web site. Applicants are strongly encouraged to use the tips posted on www.grants.gov under the announcement number when preparing your submission. This process is similar to the R01 Grant Application process currently used at the FDA. You can visit the following website for helpful background on preparing to apply, preparing an application, and submitting an application to Grants.gov: http://era.nih.gov/ElectronicReceipt/. In order to apply electronically, the applicant must have a Data Universal Number System (DUNS) number, and register in the Central Contractor Registration (CCR) database, in eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm, and in grants.gov (further information below).
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.
A one-time registration is required for institutions/organizations at both:
A registration process with Grants.gov and eRA Commons is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional 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) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Several of the steps in 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 in both Grants.gov and the Commons. The FDA will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
All
applications must be submitted electronically through Grants.gov. 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 Grants Info -- Telephone 301-710-0267; Email: [email protected].
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 and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply. Note the link below provides additional information to the adobe transition submission process http://era.nih.gov/ElectronicReceipt/files/adobe)transition.pdf.
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 (See Section IV.6.,
Special Instructions, regarding appropriate required
budget component.)
Research and
Related Subaward Budget Attachment(s) Form
Optional Components:
PHS398
Cover Letter File
Foreign Organizations (Non-Domestic [non-U.S.] Entities)
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 new section of the research plan, entitled Multiple PD/PI Leadership Plan [Section 14 of the Research Plan Component in the SF424 (R&R)], 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: June 1, 2009 (Earliest date an application may be
submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
Application
Due Date(s): July 1, 2009
Peer
Review Date(s): July 2009
Council
Review Date(s): September 2009
Earliest
Anticipated Start Date(s): September 2009
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.
In order to expedite the review, applicants are requested to notify the FDA Referral Office by email [email protected] 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
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.
Once an application package has been successfully submitted through Grants.gov, any 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 application image to determine if any further action is necessary.
Upon receipt, applications will be evaluated for completeness. Incomplete and 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 merit 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 DHHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
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
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to FDA in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed. Note the link below provides additional information regarding the adobe transition submission process http://era.nih.gov/ElectronicReceipt/files/adobe_transition.pdf.
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)Not Applicable
Foreign Applications (Non-Domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of 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. The review panel may advise the program staff about the appropriateness of the proposals to the goals of the MUMS grant program. 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.
Program Review Criteria
Applicants must propose studies intended to provide 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 product approval or conditional approval.
The Study protocol proposed in the grant application must be under an active Investigational New Animal Drug file (INAD) 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 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 n 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.
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.
Scientific/Technical Review Criteria
The panel of experts will review the application based on the following scientific and technical merit criteria:
2. Review and
Selection 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 the Center for Veterinary Medicine/OMUMS in
accordance with FDA peer review procedures, using the review criteria stated
below.
As part of the scientific peer review, all applications will:
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:
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.
Significance: Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?
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?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
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 principal investigator and other researchers? Do(es) the PD(s)/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Do(es) the scientific environment(s) 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?
2.A.
Additional Review Criteria
In
addition to the above criteria, the following items will continue to be
considered in the determination of scientific merit and the rating:
Care and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the adequacy of the plans for
their care and use will be assessed. See the Other Research Plan Sections of
the PHS398 Research Plan component of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
2.B. Additional Review Considerations
Budget
and Period of Support: The reasonableness of the proposed
budget and the appropriateness of the requested period of support in relation
to the proposed research may be assessed by the reviewers. The priority score
should not be affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents 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 or that augment existing U.S. resources will be assessed.
2.C. Resource Sharing Plan(s)3.
Anticipated Announcement and Award Dates
Earliest anticipated Start/Award Date: September 2009.
Section
VI. Award Administration Information
1. Award Notices
After the review of the
application is completed, the PD/PI will be able to access his or her Summary
Statement (written critique) via the NIH eRA Commons.
If the
application is under consideration for funding, FDA may request information
from the applicant prior to making the award. For details, applicants may
refer to the DHHS 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 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 product approval or conditional approval.
Only animal drugs that have qualified for designation in accordance with the provisions of 21 CFR Part 516 are eligible for grants.
The study protocol proposed in the grant application must be under an active INAD in order to qualify the application for scientific and technical review.
All FDA grant and cooperative agreement awards include the DHHS Grants Policy Statement as part of the NoA. For these terms of award, see the DHHS Grants Policy Statement. DHHS 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 DHHS Grants Policy
Statement dated October 1, 2006 (http://www.hhs.gov/grantsnet.adminis/gpd/).
Also, 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 DHHS 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.
FDA encourages your inquiries concerning this funding opportunity and welcomes the opportunity to answer questions from potential applicants.
1. Scientific/Research Contact(s):
Dr. Meg Oeller, Director
Office of Minor Use and Minor Species Animal Drug
Development (OMUMS)
HFV-50, Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, Maryland 20855
Telephone: (240) 276-9005
Email: [email protected]
2. Financial/Grants Management Contact(s):
Vieda
Hubbard, Grants Management Specialist
Division of Acquisition Support and Grants
Office of Acquisitions and Grants Services (HFA-500)
Food and Drug Administration
5630 Fishers Lane, Room 2141
Rockville, MD 20857
Telephone: (301) 827-7177
Email: [email protected]
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 Research Data:
Investigators submitting an FDA application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
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.
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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an FDA application or contract proposal, beginning
with the October 1, 2004 receipt date, 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.
Standards for
Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a set
of decision tools on "Am I a covered entity?" Information on the
impact of the HIPAA Privacy Rule on FDA processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
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 described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service
Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and
45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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