Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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's (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP), is announcing the availability of a Cooperative Agreement to be awarded under a Limited Competition. The estimated amount of funds available for support of this cooperative agreement is $600,000 (direct and indirect costs) for fiscal year 2014. It is anticipated than an additional four years of support will be available, depending on annual appropriations and successful performance.

The entities eligible to apply for funding under this Cooperative Agreement must represent State departments of agriculture and/or State departments of health as a primary purpose.

 

As FDA stated in the proposed produce safety rule ("Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption," 78 Fed. Reg. 3504 (Jan 14, 2013)), FDA anticipates that some States may choose to adopt requirements modeled after the provisions of a final federal product safety rule and may choose to perform inspections under their own authorities to enforce those provisions of their State laws. Such actions would be beneficial to public health because they would further drive compliance with a final federal produce safety rule, would help ensure consistency of implementation throughout the United States, and would leverage existing expertise, knowledge, and enforcement authorities of state regulatory staff.

 

This Cooperative Agreement ’s purpose is to obtain information to assist States in improving their efforts to address produce safety by aligning their requirements and enforcement mechanisms with those of FDA. Better knowledge of State capabilities and intentions also will assist FDA in planning for implementation of its produce rule. The information will assist FDA and States in making long term improvements to the national food safety system by strengthening federal and State collaboration and enhancing State program capacity and capability relating to produce safety.

The primary objective of this cooperative agreement is to obtain information relating to:

(1) Current State requirements applicable to produce on farms and State legal authority to conduct inspections, take samples, perform training, provide education and technical assistance, and take enforcement action relating to compliance with on-farm produce safety requirements.

(2) The resources needed by States to conduct these activities as part of their implementation of State requirements that are aligned with FDA’s produce safety rule.

The application must include the following activities:

1) Compare the requirements of selected States (determined by FDA in collaboration with awardee) concerning the production of fruits and vegetables by farms to the requirements in FDA’s produce safety rule.

• Compare State authorities regarding on-farm inspections, sampling, and enforcement to FDA's authorities for such activities.
• Identify the responsibilities and jurisdiction of State departments that have roles related to on-farm produce safety, including inspections, sampling, enforcement, training, and technical assistance.
• Identify areas where major revisions of State laws and/or regulations would be needed to align State requirements with FDA’s produce safety rule.

2) Identify, for selected States (determined by FDA in collaboration with awardee), the resources needed to conduct activities under a State produce safety rule that has been aligned with FDA’s produce safety rule. Identify metrics and develop models using those metrics to identify resources needed for:

• Training, technical support, and technical assistance
• Information technology and laboratory capabilities
• Inspection and compliance activities

3) Draft a strategic plan that includes goals and milestones for developing information to assist States in aligning their requirements with FDA's produce rule and identifying the resources needed for implementation of the aligned requirements.

By way of example, project activities also could include:

• Draft a strategy for increasing State capacity to assume primary responsibility for a comprehensive produce safety program.
• Develop pilot programs to assess the usefulness to States of specific information developed under this Cooperative Agreement.
• Draft a plan for work sharing between FDA and States that addresses joint work planning and prioritization of inspections, the sharing of inspection and laboratory data, and coordinated compliance and enforcement actions.

 

Section II. Award Information

FDA 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

The entities eligible to apply for funding under this Cooperative Agreement must represent State departments of agriculture and/or State departments of health as a primary purpose. The competition is limited because these entities have a unique role in working with States and fostering federal-State collaboration in the areas covered by this Cooperative Agreement.

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 

eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with 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 an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (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

Only one application per institution (normally identified by having a unique TIN number) is allowed.

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

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed activity

Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)

Names of other key personnel

Participating institution(s)

Number and title of this funding opportunity

The letter of intent should be sent by email to: [email protected] and [email protected].

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 requirements:

For this specific FOA, the Research Strategy section is limited to 30 pages.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

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

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,

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report 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 applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. eRA and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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.

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

This award may only be used for activities associated with achieving the goals and objectives of the cooperative agreement and work proposed by the grantee. Work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under this cooperative agreement must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures.

Allowable costs:

1. Salaries

2. Accounting services

3. Supplies for meetings related to the award

4. Travel and per diem to attend travel for training and attending meetings related to the grant.

5. Printing, shipping, and mailing

6. Web site server, software, hosting, development and integration, computers and other hardware

7. Pass through of funds to national associations/organizations representing food and animal feed regulatory programs and laboratories. FDA must be provided with a copy of the third party agreement showing involvement and transfer of funds to other associations.

8. Development and publishing of policy and/or procedures, manuals, journal articles, and other publications.

Non-allowable costs:

1. Facilities and work covered under current contracts, cooperative agreements/grants, partnership funds, and other sources cannot be counted towards the fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures other sources of FDA funding and these cooperative agreements.

2. Vehicle purchases are not permitted.

3. Cooperative agreement funds may not be utilized for new building construction. Remodeling of existing facilities may be allowed, with prior approval, provided that remodeling costs do not exceed 10% of the grant award amount.

Funding Plan: Years 2 through 5 of funding for noncompetitive continuation of support will depend on performance, program progress, and the availability of federal funds.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (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 SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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 Office of Acquisition and Grants (OAGS) and responsiveness by the FDA Office of Regulatory Affairs (ORA).  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-13-030.

Section V. Application Review Information

1. Criteria

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.

Overall Impact

Reviewers will provide an overall impact 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.

The rational and design of the applicant's strategy to meet the goals of cooperative agreement (total weight = 40%)

Demonstration of effectiveness in working with State regulatory entities to accomplish the goals of this cooperative agreement (total weight = 20%)

Demonstration of effectiveness in working with other associations (total weight = 20%)

Demonstration of resources necessary to assess State program legal and regulatory authority related to food safety (total weight = 20%)

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?

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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 score.

Applications from Foreign Organizations

Not Applicable

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Panel, in accordance with FDA objective review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate FDA Institute or Center. 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:

Scientific and technical merit of the proposed project as determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the review of the application is completed, the PD/PI will receive his or her Summary Statement (written critique) via email.

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, SAM 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

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.

Support will be in the form of a cooperative agreement.  Substantive involvement by the awarding agency is inherent in the cooperative agreement award.  Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement. 

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.

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

An annual Financial Status Report (FSR) (SF-269) must be sent to FDA's grants management officer within 90 days of the budget period end date of each twelve month cooperative agreement.  Failure to file the annual FSR in a timely fashion will be grounds for suspension or termination of the cooperative agreement. 

For continuing cooperative agreements, mid-year reports and an annual program progress report are also required.  For such cooperative agreements, the Non-Competing Continuation Progress Report (PHS-2590) will be considered the program progress report for the fourth quarter of the budget period. 

The recipient must file a final program progress report, and FSR, within 90 days after the end date of the project period as noted on the notice of the cooperative agreement award.

The final program progress report must provide full written documentation of the project and summaries of accomplishments and goals, as described in the grant application. The documentation must be in a form and contain sufficient detail such that other entities could reproduce the final project.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

Scientific/Research Contact(s)

Matt Avis
FDA, Office of Partnerships
Telephone: 301-796-5830
Email: [email protected]

Financial/Grants Management Contact(s)

Oluyemisi (Yemisi) Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 240-402-7560
Email: [email protected]

Section VIII. Other Information

Recently issued trans-FDA 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 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.