Part I Overview Information


Department of Health and Human Services

Participating Organizations
Food and Drug Administration (FDA) http://www.fda.gov

Components of Participating Organizations
N/A

Title:  Innovative Food Defense Projects (R18)

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

Announcement Type
This Funding Opportunity Announcement (FOA) is a “Re-Issue” of RFA-FD-08-010

Program Announcement (PA) Number: PAR-09-203

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: June 3, 2009
Opening Date: June 15, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): N/A
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 15, 2009, 2010, 2011
AIDS Application Due Date(s): N/A
Peer Review Date(s):
August 2009, 2010, 2011 
Council Review Date(s): N/A
Earliest Anticipated Start Date(s): September 2009, 2010, 2011
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: July 16, 2011

Due Dates for E.O. 12372
Single Point of Contact program under E.O. 12372 is applicable to this Funding Opportunity Announcement.  See for relevant information and requirements http://www.whitehouse.gov/omb/grants/spoc.html

Additional Overview Content

Executive Summary

This re-issued announcement provides for the change in the funding level of the grant program.

This grant announcement is intended to encourage the development of an Innovative Food Defense Program within each State or County and to provide funding for such efforts.  Grant funding is available to State, local, and tribal agencies.

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 Food and Drug Administration (FDA or Agency) is announcing the availability of grant funds for the support of innovative food defense projects.

FDA will support projects covered by this notice under Title XVII of the Public Health Service Act, Section 1702 (42 U.S.C. 300u-1), Section 1004 of the Food and Drug Administration Amendments Act of 2007 (21 U.S.C. 2104) and, in addition, Section 909 of the Federal Food, Drug, and Cosmetic Act (as amended by the Bioterrorism Act of 2002) (21 U.S.C. 399).  FDA's project program is described in the Catalog of Federal Domestic Assistance, No. 93.103, and applicants are limited to food safety regulatory agencies of State, local, and tribal governments. Internet viewers should proceed to “Publications”.

The Public Health Service (PHS) strongly encourages all award recipients to provide a smoke-free workplace and to discourage the use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Background

Food defense is a term used to describe activities associated with protecting the nation’s food supply from intentional contamination.  The Food and Drug Administration has adopted 3 broad strategies that encompass its food defense activities:

(1) Awareness (Prevention/Preparedness):  Increase awareness among federal, state, local, and tribal governments, and the private sector, to better understand where the greatest vulnerabilities lie and develop effective protection/mitigation strategies to shield the food supply from intentional contamination;

(2) Response:  Develop the capacity for a rapid coordinated response to a food borne terrorist attack; and

(3) Recovery:  Develop the capacity for a rapid coordinated recovery from a food borne terrorist attack.    

Stakeholders must determine how to most effectively apply resources within this continuum of activities to best protect the food supply chain and consumers.  With regard to prevention and preparedness tools and information, the FDA has provided numerous documents, tools, links and references on the Center for Food Safety and Applied Nutrition’s (CFSAN) website at www.cfsan.fda.gov/fooddefense .

As we continue to move forward in meeting our food defense goals by increasing preparedness, developing response plans, and ensuring we have the tools to facilitate recovery, we must also integrate these approaches into our existing food safety infrastructure.  The overlap between food safety (unintentional contamination) and food defense (intentional contamination) is extensive and the pool of resources available is often the same.  Food safety and food defense are ongoing issues and it is critical that these programs be integrated to the maximum extent possible in order to ensure the most efficient use of resources as well as to optimize response to an event.  FDA is committed to this approach in order to make optimal use of both human and financial resources to protect public health.  As a result, FDA and State field forces may weave components of food defense awareness and education into food safety inspections.  The FDA encourages other stakeholders to consider the possibilities of incorporating food defense ideas into their food safety related programs.

FDA has relied on the States assisting with these activities through formal contracts, partnership agreements, and other arrangements. Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the demands on both the agency and the States have increased. Procedures need to be reviewed and innovative changes need to be made. These changes should increase effectiveness and efficiency and conserve resources. CFSAN will continue to support food defense programs by providing high quality, science-based work that result in maximizing consumer protection. FDA believes that these grants will be able to generate significant innovative projects and products that will benefit State and local governments, FDA, the industry, and the general public in the area of food defense, just as past awards have benefited all stakeholders in food safety.  It is anticipated that innovative food defense programs and concepts that are developed at the State and local levels could enhance programs that are developed at the Federal level. To view past innovative food safety / food defense awards that have been generated out of this work you can view the ORA Web site at www.fda.gov/ora/fed_state/Innovative_Grants.html.

Project Goals, Definitions, and Examples

The specific goal of this program is to generate products that complement, develop, or improve State and local food defense programs and which may then be applied to food defense programs nationwide. Examples of food defense projects are the ALERT / FIRST Food Defense Awareness Initiatives; Food Defense Surveillance Assignments (FDSA); Food Emergency Response Network (FERN: federal and state laboratories); and the Strategic Partnership Program Agroterrorism (SPPA) Initiative. Applications that address food defense projects and fulfill the following specific project objectives will be considered for funding. 

Each application must address only one project.  Applicants may apply for more than one project area, but must submit a separate application for each project. If an applicant should receive a fundable score on more than one topic area only the application with the highest score will be awarded.  These grants are not to be used to fund or conduct food inspections for food safety regulatory agencies.  No more than 10% of the total award can be used to conduct food safety/food defense exercises.  Food Safety agencies may subcontract up to 25% of the award to educational institutions for assistance with developing food defense awareness education projects and materials and training. 

There are five (5) key project areas identified for this effort:

1.  Innovative Food Defense Plan Integration

One key project area is the development of innovative template food defense plans and associated programs that could be integrated with established food safety programs; including continuous improvement plans for the protection of various food establishments in order to improve food defense effectiveness and efficiency.  Innovative food defense programs and methodology projects must propose to effect factors that contribute to awareness, preparedness, early response, and recovery in all, or a segment of, food industry programs. For example, projects could address key elements from the ALERT / FIRST Initiatives. The ALERT / FIRST initiatives are derived from the FDA Food Security Guidance documents written for specific segments of the food industry.  These proposals should focus on providing efficient and effective food defense awareness communications and/or have an effect on factors that contribute to a potential intentional food contamination.  Information relative to the ALERT / FIRST initiatives can be found at www.cfsan.fda.gov/fooddefense .

2. Education and Awareness Information Dissemination

Another key project area is the development of innovative food defense awareness education projects and materials for State and local food safety and food defense regulatory officials.  They:

3. Innovative Food Defense Training

FDA recognizes that there are a number of new technologies and methods for distance learning and training that may be applicable to the food industry and relevant stakeholders in relation to food defense.  Innovative food defense training should:

4.    Information Technology /  Database Development

Using current technology is obviously important in facilitating necessary communication, coordination, and information sharing during the response to and recovery from a food emergency.  To that end, the focus of this project should be on:

5.  Vulnerability Assessments using CARVER+Shock Software Tool

The FDA is interested in state and local food system regulating agencies use of the CARVER+Shock software tool to conduct vulnerability assessments (VAs). Utilizing the CARVER+Shock software to conduct these VAs will result in the identification of vulnerabilities within the farm-to-table continuum and potential mitigation strategies.  Sharing the vulnerability and mitigation strategies attained during these VAs will assist the FDA in targeting educational and awareness campaigns, to decrease the likelihood of an intentional contamination event on the food supply.  Sensitive data shall be shared through the Department of Homeland Security’s Protected Critical Information Infrastructure (PCII) program.  These VA’s should not be misconstrued as to replace the need for traditional food safety inspections.  Additional information on CARVER+Shock is available at www.cfsan.fda.gov/fooddefense .

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 R18 Grant award mechanism.  Under this mechanism, the Project Director/Principle Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

The total project period for an application requesting support may not exceed one (1) year.

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Applicants must complete and submit a detailed categorical budget using the Research & Related Budget Component.

2. Funds Available

Under this announcement, the FDA anticipates providing approximately $250,000 in support of this program in Fiscal Year 2009.  It is anticipated that at least four (4) awards will be made, not to exceed $62,500 in total costs (direct plus indirect) per award, per year. The length of support will be for one (1) year from date of award.   The number of grants funded will depend on the quality of the applications received and the availability of Federal funds to support the grant.  Grant money may not be used to fund food inspections.

Because the nature and scope of the proposed activities will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the number of applications, quality, duration, and cost of the applications received and the availability of funds.

FDA grant policies as described in the DHHS 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:

This grant program is only available to State, local, and tribal government food regulatory agencies. (See SPOC requirements stated in section IV.A of this document).

Grantees with active grant applications under the Innovative Food Defense Program are not eligible to apply under this FOA.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

These grants are available to State, local, and tribal governments and MUST have national implications or applications that can enhance Federal, State, and local food regulatory programs and are likely to impact food defense preparedness, response, and/or recovery. At the discretion of FDA, successful project formats will be made available to interested Federal, State, local, and tribal food safety regulatory agencies.  Only one grant will be awarded per State per year.  States are urged to collaborate between agencies, and other food and agriculture sector stakeholders, to submit single applications.

Resubmissions: Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewals: Renewal applications will be permitted for this FOA.

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

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.

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 NIH 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) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

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

Several 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 in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

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 and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (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 Subaward Budget Attachment(s) Form
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.)  

SPECIAL INSTRUCTIONS  

The face page of the application should indicate “Response to Innovative Food Defense Projects, PAR-09-203”.

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.

Information concerning the consortium/subcontract budget must be provided in the budget justification.  Separate budgets for each consortium/subcontract grantee are required.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: June 15, 2009 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): July 15, 2009, 2010, 2011
AIDS Application Due Date(s): N/A
Peer Review Date(s):  August 2009, 2010, 2011
Council Review Date(s): N/A
Earliest Anticipated Start Date(s): September 2009, 2010, 2011

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 Grants Management Team by email (gladys.melendez-bohler@fda.hhs.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application and the Grants.gov grant tracking number.

3.C. Application Processing

Do not send applications to the Center for Scientific Research at NIH.  Any application sent to NIH that is then forwarded to FDA, and not received in time for orderly processing, will be deemed unresponsive and returned to the applicant.

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 by the FDA. 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 FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The FDA will not accept any application that is essentially the same as one already reviewed.

4. Intergovernmental Review

This initiative is subject to intergovernmental review.

Intergovernmental review applicants are limited to one State government agency per State. Applications submitted under this program are subject to the requirements of Executive Order (E.O.) 12372.

The regulations issued under EO 12372 also apply to this program and are implemented through the DHHS regulations at 45 CFR part 100. Executive Order 12372 sets up a system for State and local government review of applications for Federal financial assistance.  Applicants (other than federally recognized Indian tribal governments) should contact the State’s Single Point of Contact (SPOC) as early as possible to alert them to the prospective application(s) and to receive any necessary instructions on the State’s review process. A current listing of SPOCs is included in the application kit. The SPOC should send any State review process recommendations to the FDA Grants Management Office address listed above. The due date for the State process recommendations is no later than 60 days after the deadline date for the receipt of applications. The FDA does not guarantee availability to accommodate or explain SPOC comments that are received after the 60 day cut-off. A current listing of SPOCs can be found at www.whitehouse.gov/omb/grants/spoc.html

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

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 on the application submission/receipt date(s).  If an application is not submitted by the receipt date(s) and time, the application will not be reviewed.

Upon receipt, applications will be evaluated for completeness and incomplete applications will not be processed or evaluated. 

Applicants are reminded that failure to include all required documents as part of the application may result in an application being considered incomplete or non-responsive.

Applicants are strongly encouraged to contact FDA to resolve any questions regarding criteria prior to submission of their application.  All questions of a technical or programmatic nature must be submitted to the FDA program staff.  All questions of an administrative or financial nature must be submitted to the Grants Management Staff.

A copy of the complete FOA can also be viewed on the Grants.gov website along with the funding application package.  A copy of the full FOA can be obtained from the Program or Grants Management contact list under “Contacts” in this FOA once the FOA is published.

Several additional separate actions are required before an applicant institution/organization can submit an application.

The following instructions are to be used in conjunction with application packet instructions:

Performance Site Locations: Enter the site of the lab or office as the Performance Site.

Senior/Key Person: Personnel are defined as the Project Director (PD)/Principal Investigator (PI) and those responsible for planning and implementing the project. Attach biographical sketches for the PD/PI and key personnel.

Budget Information: Enter the direct costs requested. Provide a narrative budget justification for each proposed personnel position, including role and proposed level of effort, and for each item of cost requested.

Non-allowable costs: Include but not limited to: (1) Purchase of equipment; (2) transportation costs exceeding coach class fares; (3) entertainment; (4) tips; (5) bar charges; (6) personal telephone calls; (7) laundry charges; (8) travel or expenses other than local mileage for local participants; (9) organization dues; (10) honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; (11) alterations or renovations; and (12) travel or per diem costs for federal employees.  Please also refer to the DHHS Grants Policy Statement for additional information regarding costs.

Work Plan/Project Narrative: Submit one attachment, which may not exceed 15 pages. In the “Work Plan” (uploaded as attachment #5) section of the application, describe the objectives and specific program arrangements.

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

Page limitations of the PHS 398 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, incorporating "Just-in-Time" information concepts.

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)

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

Section V. Application Review Information


1. Criteria 

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

All applications submitted in response to this FOA will first be reviewed for responsiveness by grants management and program staff.

Responsive applications will be reviewed and evaluated for programmatic merit by an Ad Hoc panel of experts in the subject field of the specific application. Applications will be considered for funding on the basis of their overall programmatic merit as determined through the review process. Other award criteria will include availability of funds and overall program balance in terms of geography.  Final funding decisions will be made by the Commissioner of Food and Drugs or his or her designee.

2. Review and Selection Process

Applications that are complete and responsive to this FOA will be evaluated for programmatic merit by an appropriate peer review group convened by the FDA Office of Regulatory Affairs and in accordance with FDA peer review procedures, using the review criteria stated below.

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

This award will include special terms and conditions that differ from the agency’s usual terms and conditions.  See also Section IV.5. “Funding Restrictions”.

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 goal of the FDA is to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA also may  advance the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their 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 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 will be given an overall score and judged based on all of the following criteria:

(1) Application budgets must remain within the $62,500 cap for combined direct and indirect costs. Applications exceeding this dollar amount will be returned as nonresponsive; (2) Applications must provide, in DETAIL, a sound rationale and appropriate grant design to address the objectives of the RFA; (3) the project MUST be generic enough in nature to be used by other State, local, and tribal food regulatory agencies; (4) applications must include a detailed explanation of the desired goals and outcomes of the project; (5) applications must include a full description of the project design, a detailed implementation plan, methods of execution, and a timeline for completion; (6) applications must include a detailed description of measures of effectiveness and a description of the source documents or data collection methods for establishing the baseline for measurement; and (7) applications must address the adequacy of facilities, equipment, databases, and support services and the expertise of project staff needed for the project.

Significance: Does this initiative address an important problem? If the aims of the application are achieved, how will food safety knowledge be advanced? What will be the effect of this initiative on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual framework, design, and activities 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 proposed project original and innovative? For example: Does the proposal address an innovative hypothesis or critical barrier to progress in the field? Does the proposal 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 staff? Do (es) the PD(s)/PI(s) and respective team bring complementary and integrated expertise to the conference (if applicable)?

Environment:  Do(es) the environment(s) in which the project will take place contribute to the probability of success? Do the proposed activities benefit from unique features of the stakeholder 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 programmatic merit and the rating:

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.

Previous Experience:  Is there previous experience with the organization/or the principal investigator in similar undertakings?  If so, what?

Review and Selection Process:  All applications submitted in response to this FOA will first be reviewed for responsiveness by grants management and program staff.

2.C. Resource Sharing Plan(s)

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

3. Anticipated Announcement and Award Dates

The successful applicants will receive notice of pending award about two weeks after review of applications through the Grants Management contact.

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 NIH eRA Commons

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as referenced in the DHHS Grants Policy Statement http://www.hhs.gov/grants/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.

2. Administrative and National Policy Requirements

FDA will support projects covered by this notice under Title XVII of the Public Health Service Act. , Section 1702 (42 U.S.C. 300u-1), Section 1004 of the Food and Drug Administration Amendments Act of 2007 (21 U.S.C. 2104) and, in addition, Section 909 of the Federal Food, Drug, and Cosmetic Act (as amended by the Bioterrorism Act of 2002) (21 U.S.C. 399).

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

All awards are subject to the terms and conditions, cost principles, and other considerations described in the DHHS Grants Policy Statement. The DHHS Grants Policy Statement can be found at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm The grants will be subject to all policies and requirements that govern the Grant Programs of the PHS, including the provisions of 42 CFR Part 52 and 45 CFR Parts 74 and 92.

Term and Condition will be incorporated into the award statement and will be provided to the PDPI(s) as well as to the appropriate institutional official, at the time of award.

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

3. Reporting

Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their work.

An agency Program Official or Center Program Director/Project Officer will be responsible for the normal technical and programmatic stewardship of the award and will be named in the NoA.

A mid-year Progress Report is also required no later than 180 days after the award and beginning of the budget period.  The mid-year Progress Report should contain a description of activities covering a six-month period, as well as all criteria listed in the previous paragraph.

A final Progress Report of the outcomes of the grant and a final Financial Status Report (FSR) (SF-269) are required within 90 days of the expiration date of the project period as noted on the Notice of Grant Award.  An original and two copies of each report shall be submitted to FDA’s Grants Management Office (address below). The report should include full written documentation of the project, copies of any results, materials, and project deliverables, as described in the grant application, and an analysis and evaluation of the results of the project.   The documentation must be in a form and contain sufficient detail such that other State and local food safety regulatory agencies could reproduce the final project.

Program monitoring of recipients will be conducted on an ongoing basis and written reports will be reviewed and evaluated by the project officer. Project monitoring may also be in the form of telephone conversations between the project officer/grants management specialist and the principal investigator and/or a site visit with appropriate officials of the recipient organization. The results of these monitoring activities will be recorded in the official file and may be available to the recipient upon request.

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

A Request for a Non-Competing Continuation Grant Progress Report (PHS 2590) with specific reporting instructions will be sent to Grantees two to three months prior to the start of the next budget period by the ORA/Project Officer.

A Financial Status Report (FSR) is required no later than 90 days after the end of each budget period.  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


We encourage 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/Technical Contact(s):

Don Kautter Jr.
FDA/CFSAN
5100 Paint Branch (HFS-007), 2A-001
College Park, MD, 20740
Telephone: (301) 436-1629
E-mail: donald.kautter@fda.hhs.gov
Or access the internet at:  http://www.cfsan.fda.gov/~dms/defterr.html

2. Programmatic and Peer Review Contact(s):

Jennifer Gabb
Division of Federal and State Relations
FDA/ORA
5600 Fishers Lane (HFS-150)
Rockville, MD, 20857
Telephone: (301) 827-2899
E-mail: Jennifer.Gabb@fda.hhs.gov
Or access the internet at:  http://web.ora.fda.gov/dfsr/detail.jsp?id=66

3. Financial/Grants Management Contact(s):

Gladys M. Bohler
Division of Acquisition Support and Grants
5630 Fishers Lane, Rm. 2105
Rockville, MD 20857
Telephone: (301) 827-7168
Fax: 301-827-7101
Email: gladys.melendez-bohler@fda.hhs.gov

Section VIII. Other Information


Required Federal Citations

URLs in FDA Grant Applications or Appendices:
All applications and proposals for FDA funding must be self-contained within specified page limitations.  Unless otherwise specified in this solicitation, internet addresses (URLs) should not be used to provide information necessary for the review because reviewers are under no obligation to view the Internet sites. 

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.

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.

Authority and Regulations:
FDA will support projects covered by this notice under Title XVII of the Public Health Service Act, , Section 1702 (42 U.S.C. 300u-1), Section 1004 of the Food and Drug Administration Amendments Act of 2007 (21 U.S.C. 2104) (providing in pertinent part that the Secretary may "provide to a State, for planning, developing, and implementing . . . a food safety program . . . (3) financial and other assistance," 21 U.S.C. 2104(b)) and, in addition, Section 909 of the Federal Food, Drug, and Cosmetic Act (as amended by the Bioterrorism Act of 2002) (21 U.S.C. 399) (providing that the Secretary "is authorized to make grants to States, territories, and Indian tribes . . . that undertake examinations, inspections, and investigations, and related activities under section 702 [of the Act].")  Further, 31 U.S.C. 6304 directs FDA to use grant agreements in transferring funds to the States for legally authorized, public purposes.  This project will governed by applicable federal regulations, including those found at 42 CFR 52 and at 45 CFR Parts 74 and 92.

All awards are subject to the terms and conditions, cost principles, and other considerations described in the DHHS Grants Policy Statement. The DHHS Grants Policy Statement can be found at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

This program is described in the Catalog of Federal Domestic Assistance (CFDA 93.103) at http://www.cfda.gov/ and is subject to the intergovernmental review requirements of Executive Order 12372.

Access to Research Data through the Freedom of Information Act:
The Freedom of Information Act, 5 U.S.C. 552, provides individuals with a right to access certain records in the possession of the Federal government. The government may withhold information pursuant to the exemptions and exclusions contained in the act. The exact language of the exemptions can be found in the act. Additional guidance on the exemptions and how they apply to certain documents can be found in the HHS regulations implementing the FOIA (45 CFR Part 5). Also see the HHS Web site http://www.hhs.gov/foia/.

Data included in the application may be considered trade secret or confidential commercial information within the meaning of the Freedom of Information Act (5 U.S.C. 552) and FDA's statute and implementing regulations (21 CFR 20.61). FDA will protect trade secret or confidential commercial information to the extent allowed under applicable law.

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 NIH 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.


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