Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.

Components of Participating Organizations

Center for Food Safety and Applied Nutrition (CFSAN)/Office of Food Defense, Communication and Emergency Response/Food Defense Oversight Team
Office of Regulatory Affairs (ORA)

Funding Opportunity Title

Innovative Food Defense Program (R18)

Activity Code

R18 Research Demonstration and Disseminations Projects

Announcement Type

New

Related Notices
None
Funding Opportunity Announcement (FOA) Number

PAR-12-116

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103  

FOA Purpose

The Innovative Food Defense Program (IFDP) grants are designed to generate food defense tools and resources that are easily replicated and can complement, aid in the development of, or improve State, local, Tribal and territorial (SLTT)  food defense programs. The known overlap between food safety (unintentional contamination) and food defense (intentional contamination) is extensive and the pool of resources available is often the same.  As the Food Safety Modernization Act recognizes the evolution of the relationship between food safety and food defense, 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 incident or event.

Key Dates
Posted Date

March 9, 2012

Open Date (Earliest Submission Date)

April 15, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

June 15, 2012, 2013, 2014, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2012, 2013, 2014

Advisory Council Review

Not Applicable

Earliest Start Date(s)

August 2012, 2013, 2014

Expiration Date

June 16, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the HHS Grants Policy Statement). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The Food and Drug Administration (FDA or Agency) is announcing the availability of grant funds for the support of the development of innovative food defense projects. FDA will support projects covered by this notice under Title III of the Public Health Service Act, Section 317R (42 U.S.C. 247b-20) and Section 1004 of the Food and Drug Administration Amendments Act of 2007 (21 U.S.C. 2104).  FDA's 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, tribal, and territorial 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.  FDA has adopted 3 broad strategies that encompass its food defense activities:

(1) Awareness (Prevention/Preparedness):  Increase awareness among federal, state, local, Tribal and territorial 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) Food Defense Oversight Team website at www.fda.gov/FoodDefense.

As the FDA continues to move forward our food defense goals by increasing preparedness, encouraging the development of 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 our regulatory stakeholders to consider the possibilities of incorporating food defense ideas into their food safety related programs.

FDA has relied on the States assisting with the Food Safety  activities through formal contracts, partnership agreements, and other arrangements. Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and the FDA Food Safety Modernization Act of 2011, 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 results in maximizing consumer protection. FDA continues to believe that these grants will be able to generate innovative Food Defense tools and resources that will benefit State, local, Tribal and territorial 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 defense program accomplishments that have been generated out of this work you can visit the ORA Web site at http://www.fda.gov/ForFederalStateandLocalOfficials/CooperativeAgreementsCRADAsGrants/ucm234305.htm#IFDP.

Project Goals, Definitions, and Examples

The specific goal of this program is to generate innovative food defense tools and resources that complement, develop, or may improve State, local, tribal and territorial food defense programs and which may then be applied to food defense programs nationwide. Examples of food defense oversight team tools and resources that are available publicly, online at www.FDA.gov/FoodDefense include:  ALERT and Employees FIRST programs, the Food Defense Mitigation Strategies Database, the Food Related Emergency Exercise Boxed set (FREE-B), among others.  Previously the FDOT has participated in programs addressing food defense including 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.  

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. 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.

2. Education and Awareness Information Dissemination

Another key project area is the development of innovative food defense awareness education projects and materials for SLTT 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. These should not be duplicative of the basic elements contained within the ALERT / FIRST initiatives messages. Innovative food defense training projects being submitted under this section may include:

Consider enlisting the use of the Food Related Emergency Exercise boxed set (FREE-B) for a series of workshops, seminars and/or tabletop exercises to develop food defense capacities or to improve existing food defense capacities.

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 FDA's Vulnerability Assessment Software Tool

The FDA is interested in SLTT regulatory agencies use of the Vulnerability Assessment software tool to conduct vulnerability assessments (VAs). Utilizing the software to conduct these assessments will assist in the identification of vulnerabilities within the farm-to-table continuum and assist in the development of potential mitigation strategies.  Sharing the vulnerability and mitigation strategies attained during these can assist the FDA in targeting educational and awareness campaigns, to decrease the likelihood of an intentional contamination event on the food supply.  Sensitive information can 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.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations, and the submission of a sufficient number of meritorious applications.

FDA intends to commit up to $300,000 to this grant program in FY 2012. Future year amounts will depend on annual appropriations.

It is anticipated that up to three (3) awards will be made, not to exceed $100,000 in total costs (direct plus indirect) per award, per year. The length of support will be for one (1) year from the date of the award. Because the nature and scope of the proposed activities will vary from application to application, the size of each award may also vary.

Award Budget

Not to exceed $100,000 per award.

Award Project Period

One (1) year 

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Governments

This grant program is only available to State, local, Tribal and territorial government food regulatory agencies. Only State, Local, Tribal and Territorial regulatory food safety agencies have the authority to regulate facilities covered under food defense programs. Therefore other applicants would not meet the eligibility requirements or objectives of this grant program. (See additional information on eligibility in section III.3 of this document). Academic institutions and other organizations are encouraged to partner with their State, local, Tribal and territorial government food 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.

Grantees with a currently funded grant under the Innovative Food Defense Program are not eligible to apply under this FOA.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Required Registrations

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

All Program Director(s)/Principal Investigator9s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

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

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with an eligible organization described in Section III.1 who possesses the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop and submit a grant application. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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

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

These grants are available to SLTT governments and MUST have national implications or applications that can enhance Federal, SLTT 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, SLTT food safety regulatory agencies.  

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Required and Optional Components

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

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirement:

PHS 398 Research Plan Component

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

Applications must include the following information in the Research Strategy attachment not to exceed 5 pages in length:

Applicants should also consider the application scoring criteria (Significance, Investigator(s), Innovation, Approach and Environment) in Section V. when completing the Research Strategy attachment.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix

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

3. Submission Dates and Times

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

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

No more than 50% of the total award may be used to conduct 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. Subcontract amounts of greater than 25% of the award may be permissible upon program review and approval from the technical review panel and program staff.

Non-allowable costs: Include but are not limited to: (1) Purchase of equipment (defined as an item of property that has an acquisition cost of $5,000 or more); (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 HHS Grants Policy Statement for additional information regarding costs.

Funds may not be used to offset or to conduct regulatory food inspections for food safety regulatory agencies.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the FDA Grants Management Staff. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the FDA mission, all applications submitted to the FDA in support of biomedical and behavioral research are evaluated for scientific and technical merit through the FDA peer review system.

For this particular announcement, note the following:

Only the review criteria described below will be considered in the review process. All applications submitted to the FDA in support of this announcement are evaluated for scientific and technical merit through the FDA peer review system.

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:

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is the purpose of the work plan and its relevance to FDA clear? Is the work plan timely in terms of currency of the issues to be addressed and the amount of interest that may be generated in response? Are milestones clear, defined, applicable, and timely as projected?  

Significance=20% of score   

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the experience, training, or other indication of competence support the selection of the principal investigator/director as the key person to manage this particular project? Does the proposed team bring complementary and integrated expertise to the project (Cross functional and interagency)? Is support staff included in the plan?  Is it sufficient?

Investigator(s)=15% of score 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

The applications should present sufficient information to demonstrate that such work develops or employs novel concepts, approaches, methodologies, tools, or technologies for food defense planning within the respective state.  Is the work plan original and clearly stated?  Are the innovative ideas attainable and reasonable?  How collaborative is the approach at an intra-state level?

Innovation=30% of score   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

Approach=20% of score

Environment

Will the environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Environment=15% of score   

Additional Review Criteria

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

Protections for Human Subjects

Not applicable.

Inclusion of Women, Minorities, and Children 

Not applicable.

Vertebrate Animals

Not applicable.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

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

Budget and Period of Support

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

Does the amount requested from FDA appear reasonable as partial support of the total work plan, facilities, staff, etc.?  Is the budget organized, reasonable, and clearly stated?  Does the budget account for the proposed work plan?

Provision of Family Care Facilities

Not applicable.

Applications from Foreign Organizations

Not applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Not applicable.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Group(s) in accordance with FDA's Objective Review Policy and Procedures, using the stated review criteria.

As part of the objective review process, all applications:

Applications will be assigned to the appropriate FDA Center/Office. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted in the HHS Grants Policy Statement.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

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 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 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 project activities covering a six-month period. A report template will be provided to grantees by the Grants Management staff.

A final report of the outcomes of the grant and a final Financial Status Report (FSR) are required within 90 days of the expiration date of the project period as noted on the Notice of Grant Award, and in the HHS Grants Policy Statement. 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 tool or resource.

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.  Quarterly conference calls and web meetings are also conducted, and recipients are expected to participate in these information sharing opportunities.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the HHS Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding FDA grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@FDA.gov

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

Scientific/Research Contact(s)

Jason Bashura.
FDA/CFSAN
5100 Paint Branch (HFS-007), 2A-004
College Park, MD, 20740
Telephone: 240-402-2912
E-mail: mailto: jason.bashura@fda.hhs.gov, fooddefense@fda.hhs.gov
Or access the internet at: www.fda.gov/FoodDefense

Peer Review Contact(s)

William J. Foust
FDA/ORA/Division of Federal-State Relations
12420 Parklawn Drive, Room 3017
Rockville, MD 20857
Telephone: 301-796-3470
E-mail: william.foust@fda.hhs.gov

Lisa Ko
FDA/OAGS/DASG
5630 Fishers Lane, Rm. 1096
Rockville, MD 20857
Telephone:  301-827-5095
Fax:  301-827-1044
Email:  lisa.ko@fda.hhs.gov

Financial/Grants Management Contact(s)

Lisa Ko
FDA/OAGS/DASG
5630 Fishers Lane, Rm. 1096
Rockville, MD 20857
Telephone: 301-827-5095
Fax: 301-827-1044
Email: lisa.ko@fda.hhs.gov

Section VIII. Other Information

Recently issued policy notices may affect your application submission.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


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