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 NIH Guide for Grants and Contracts). 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.

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

A. Purpose and Priorities

The National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program will award grants that increase the understanding and adoption of established food safety standards, guidance, and protocols. Grants awarded through this program will be carried out in a manner that facilitates the integration of food safety standards and guidance with a variety of agricultural production systems, including conventional, sustainable, organic, and conservation and environmental practices carried out by the eligible entities. The assistance provided by these programs, to the extent practicable, shall be coordinated with and delivered in cooperation with similar services or assistance by other federal agencies or programs serving those eligible entities.

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s National Institute of Food and Agriculture (NIFA) have joined in a collaborative partnership to administer and manage the National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program. This program is designed to develop a comprehensive food safety training, education and technical assistance program for those affected by the FDA Food Safety Modernization Act (FSMA). Specifically, this program will address the needs of owners and operators of small and medium-sized farms, beginning farmers, socially disadvantaged farmers, small processors, and small fresh fruit and vegetable merchant wholesalers. The joint program will award competitive grant funds that enable awardees to establish a National Coordination Center (NCC) for Food Safety Training, Education, Extension, Outreach, and Technical Assistance and Regional Centers (RC) for Food Safety Training, Education, Extension, Outreach, and Technical Assistance across the country for food safety training, education, and technical assistance. Project Teams for the RCs will reach out into local communities to work with FSMA audiences, while coordinating on a national level through the NCC.

FDA is issuing this RFA to request applications for the establishment of a National Coordination Center (NCC) for Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program. The National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program will issue separate RFAs to request applications for the establishment of the Regional Centers (RC) for Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program once funding is available. Applicants will be selected through a peer-reviewed competitive process. The NCC will provide overall leadership for support and coordination of the RCs, while ensuring that food safety training, education, outreach, and technical assistance across the entire program are consistent with FSMA requirements. Each RC will lead, manage, and coordinate the regional development and implementation of food safety training, education, outreach and technical assistance programs for the intended audiences. The National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program will work with RCs and the NCC to help establish and maintain an effective and sustainable program that will meet the needs of intended audiences affected by new FSMA requirements.

B. Program Area Description

The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. The law enabled the Food and Drug Administration (FDA), and its Federal food safety partners, to better protect public health, while strengthening the food safety system, by focusing increasingly on preventive food safety measures. FSMA requires the Secretary of Health and Human Services to establish preventive standards for produce safety and for the manufacturing/processing, packing and holding of food. Successful implementation of new standards will require food safety training, education and technical assistance for small and mid-sized entities.

Owners and operators of small and medium-sized farms, beginning farmers, socially disadvantaged farmers, small processors, and small fresh fruit and vegetable merchant wholesalers may have limited access to adequate and affordable food safety training and education. Further, they may have limited access to the technical assistance that will enable them to comply with new food safety requirements that will be finalized under FSMA. FSMA requires that the Secretary of Health and Human Services enter into a Memorandum of Understanding or cooperative agreement with the Secretary of Agriculture to establish a competitive grant program within the National Institute of Food and Agriculture. The National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program will award competitive grants to provide food safety training, education, and technical assistance to owners and operators of small and medium-sized farms, beginning farmers, socially-disadvantaged farmers, small processors, or small fresh fruit and vegetable merchant wholesalers.

This collaborative program is to support awards that provide food safety training, education, and technical assistance to owners and operators of small and medium-sized farms, small food processors, and small fruit and vegetable vendors who will be affected by requirements to be finalized under FSMA. The program will focus on helping those key target audiences understand new Federal food safety regulations to be enacted under FSMA, thus enabling them to comply with these requirements. Training, education, and technical assistance programs are needed to provide these key target audiences with fundamental food safety knowledge, starting in advance of the finalization of the new produce safety and preventive controls requirements under FSMA and continuing after the final rules are promulgated. Training, education, and technical assistance activities conducted in advance of final rules are intended to assist farms, especially small farms, in establishing appropriate food safety measures consistent with Good Agricultural Practices (GAPs) and other existing guidance so they will be better positioned to comply with the new requirements to be finalized under FSMA. Similarly, training, education and technical assistance can help small food processors and fruit and vegetable vendors establish appropriate food safety measures consistent with existing guidance and industry best practices. When the rules are finalized, training and education materials should be modified, as needed, to be consistent with the requirements in the rules. The vision for the National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program is regional centers coordinated by a national center to ensure that regional training, education and technical assistance programs are consistent yet tailored to the differing needs of various areas of the country.

C. Program Area Priorities

For this request for applications, the National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program will accept proposals that describe a National Coordination Center for Food Safety Training, Education, Extension, Outreach, and Technical Assistance serving a leading role in coordinating the development of FSMA-related training and education programs and resources for small and medium-sized farms, beginning farmers, socially disadvantaged farmers, small processors, or small fresh fruit and vegetable merchant wholesalers. A plan for conducting education and training to a cadre of regional FSMA trainers must be developed, along with an implementation plan for extending both training and technical assistance to the targeted audiences of farmers, processors and vendors in the respective regions.

National Coordination Center (NCC) for Food Safety Training, Education, Extension, Outreach, and Technical Assistance

Program Area Priority Code A4183

Proposed Budget Requests Projects must not exceed $600,000 in total costs, including indirect costs, for project periods of up to 3 years. The program anticipates making 1 new award.

The grant awardee will responsible for the performance metrics below; therefore applications for the NCC must present a strategic plan (including methods and milestones) for how to address the following:

• Provide overall leadership for support and coordination of the future successfully-funded Regional Centers (RC) for Food Safety Training, Education, Extension, Outreach, and Technical Assistance. Frequent communication with regional project teams should include site visits, face-to-face meetings with regional teams, teleconferences, webinars, and/or other mechanisms for ensuring that teams are working collaboratively to achieve overall goals of the competitive program;
  
  
• Work collaboratively with successfully-funded RCs to ensure that training curricula and resources cover fundamental food safety practices relevant to the target audiences across all funded regional centers, and that those competencies are consistent with FSMA produce safety standards and preventive control requirements for manufacturing/processing/packing/holding food, once finalized;
  
  
• Work collaboratively with the RCs to facilitate the integration of FSMA-related food safety standards and guidance (where appropriate) with a variety of agricultural production systems, encompassing conventional, sustainable, organic, and conservation and environmental practices;
  
  
• Work collaboratively with successfully-funded RCs to ensure that all Centers are actively evaluating the impacts of their education, training, and technical assistance programs. Develop a mechanism for collating regional impacts into an overall annual national impact report. Prepare and submit to FDA an annual impact report on National Coordination Center for Food Safety Training, Education, Extension, Outreach, and Technical Assistance;
  
  
• Serve as an information and communication liaison between FDA and the RCs.
  
  
• While anticipating the full funding of the RCs, the NCC will develop fact sheets and informational resources for communicating new FSMA guidelines to the RCs, identify training and educational resources consistent with the new FSMA guidelines, develop measures to evaluate the RCs' impacts from education, training, and technical assistance programs, and identify and recruit key stakeholders (food safety professionals, food safety organizations, and prime contacts in the food industry) who can serve as informational resources to the NCC and to the future-funded Regional Centers.

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.

(A) A State cooperative extension service;

(B) a Federal, State, local, or tribal agency, a nonprofit community-based or non-governmental organization, or an organization representing owners and operators of farms, small food processors, or small fruit and vegetable merchant wholesalers that has a commitment to public health and expertise in administering programs that contribute to food safety;

(C) an institution of higher education (as defined in section 1001(a) of title 20) or a foundation maintained by an institution of higher education;

(D) A collaboration of 2 of more eligible entities described in this subsection,

(E) Such other appropriate entity, as determined by the Secretary, or

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.

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. Late applications will not be accepted for this FOA.

• 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. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

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.

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

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

The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

The FDA will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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 FDA/CFSAN 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) and type of entity (Higher education institution, State, non-profit, etc.)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Kimberly Pendleton
Email: kimberly.pendleton@fda.hhs.gov

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 20 pages.

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.

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

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

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

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

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

• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate or F&A agreement, a provisional amount up to a maximum of 10 percent (10%) of Modified Total Direct Costs will be allowed.
• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• Funds should be requested for travel to the metropolitan Washington, D.C. area for annual meetings with program staff (the applicant should budget for one meeting per year for principal grantee staff).

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

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

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

The Project Narrative (otherwise known and described as the Research Strategy in the SF424 (R&R) Application Guide) must include all of the following:

a. Introduction: Include a clear statement of the long-term goal(s) and supporting objectives of the proposed activities. Summarize the body of knowledge or other past activities that substantiate the need for the proposed project. Describe ongoing or recently completed significant activities that relate to the proposed project including the work of key project personnel. Include preliminary data/information pertinent to the proposed project. In addition, this section should include in-depth information on the following, when applicable:

(1) Estimates of the magnitude of the issues and their relevance to stakeholders.
(2) The role of stakeholders in problem identification, planning, implementation, and evaluation as appropriate.
(3) Reasons for performing the work at the proposing institution.

In order to ensure that the needs of the stakeholders are met, the applicants are strongly encouraged to include the stakeholders, specifically the target audience (mentioned in Section I A. Purpose and Priorities, Paragraph 2) as partners in the proposal.

b. Objectives: All applications must include a statement(s) of specific aims of the proposed effort in clear, concise, complete, and logically arranged terms.

c. Methods: Explicitly state the procedures or methodology you will apply to the proposed effort. This section should include but not necessarily be limited to, descriptions of:

(1) stakeholder involvement in problem identification, planning, implementation and evaluation;
(2) proposed project activities, listed sequentially;
(3) techniques to be employed in this project, including their feasibility and rationale;
(4) expected results;
(5) how training, education and technical assistance activities will be evaluated;
(6) how data will be analyzed or interpreted;
(7) plans to communicate results to stakeholders and the public;
(8) pitfalls that might be encountered; and
(9) limitations to proposed procedures.

d. Project Timetable: The proposal should outline all important phases as a function of time, year by year, for the entire project, including periods beyond the grant funding period.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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.

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

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

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 Commons 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. Late applications will not be accepted for this FOA.

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.

This initiative is not subject to intergovernmental review.

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.

The allowable cost principles as described in the HHS Grants Policy Statement must be followed with the following additional instructions:

• Equipment Funds may not be used to purchase equipment which does not have a particular scientific, technical, or programmatic purpose. It includes but is not limited to: passenger carrying vehicles, typewriters, furniture (tables, chairs, file cabinets, book cases, etc.), copy machines, fax machines, etc.
  
  
• Incentives Funds may not be used to offer targeted program participants incentives (e.g., fast-food coupons, gift certificates, etc.) to entice participation.
  
  
• Alternations & Renovations (A&R) - Funds may not be used for renovation or refurbishment of research, education, or extension space, planning, repair, rehabilitation, acquisition, or construction of buildings or facilities.
  
  
• Food: Funds may not be used for any/all meals or light refreshments, regardless if certain meals are an integral and necessary part of a meeting/training (i.e., a working meal where business is transacted).
  
  
• Indirect/F&A Costs - If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate or F&A agreement, a provisional amount up to a maximum of 10% of modified direct cost will be allowed.
  
  
• Additional funding restrictions may be part of the Notice of Award.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each.

Introduction (20 points)

This criterion is used to assess the likelihood that the coordination team will be able to plan, coordinate, evaluate and liaise with the regional centers. Elements considered include a strategic plan for: coordinating training and materials on fundamental food safety practices relevant to the target audiences developed at the regional centers, a system for tracking and evaluating training programs across all regional centers; and developing a liaison/networking plan to encourage communications among FDA, the national coordination center, and the regional centers to provide program evaluation information and educational information that will assist in the development of best practices and model programs for use by FDA in implementing FSMA guidelines.

Objectives (20 points)

This criterion is used to assess the appropriateness of goals and purposes of the project and how those goals will provide the national coordination activities to implement a strong communication system, successfully evaluate the program, and coordinate the training on fundamental food safety practices relevant to the target audiences of the national program.

Methods (20 points)

This criterion is used to assess the adequacy of the strategic plan covering the coordination plan, reporting mechanism, evaluation design and methodology, and liaison plan.

Key Personnel and Project Management (20 points)

This criterion is used to assess adequacy of proposed project management, including key staff their functions and time commitment, reporting, accounting procedures (for funds used by the collaborating institutions in the National Coordination Center for Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program), and coordination of collaborative efforts with local and/or community partners involved in the project.

Budget and Budget Justification (20 points)

This criterion is used to assess the extent to which the total budget adequately supports the objectives, is appropriate to the project objectives being proposed, and is cost effective. Elements considered include: the necessity and reasonableness of costs to carry out project activities and achieve project objectives; the appropriateness of budget allocations between the applicant and any collaborating institution(s); and appropriateness of the budget relative to time committed to the project by key project personnel.

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 score, but will not give separate scores for these items.

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Not Applicable

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.

Not Applicable

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.

Applications will be evaluated for scientific and technical merit by an Objective Review Committee, using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

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

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 Ad Hoc Review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Balanced geographic and demographic distribution of initiatives nationwide.
• Balanced representation of the types of organizations awarded.

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

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant.

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 terms and conditions found in the HHS Grants Policy Statement.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

Additional terms and conditions regarding FDA regulatory and CFSAN Programmatic requirements may be part of the Notice of Award.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

Responsibilities

Awardees

The Project Director (PD)/Principal Investigator (PI) will have the primary responsibility for:

• Managing the technical and programmatic aspects of the grant and for day-to-day management of the project or program;
• Maintaining general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff has sufficient clearance and/or background checks to work on this project or program;
• Working closely with designated officials within the recipient organization to prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements;
• Submitting mid-year and annual progress reports to the FDA Project Officer (PO) (see Reporting Requirements section);
• Submitting training materials, abstracts, manuscripts, and reviews supported under this Cooperative Agreement;
• Preparing materials for meetings with FDA personnel;
• Ensuring overall participation in a cooperative manner with FDA.

The awardee will retain custody of, and have primary rights to, the training materials developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies. In all cases, FDA must be given a royalty-free, nonexclusive, and irrevocable license for the Federal government to reproduce, publish, or otherwise use the material and to authorize others to do so for Federal purposes.

FDA

FDA PO and staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.

The responsibilities of the designated FDA support staff include:

• Involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities that is above and beyond normal program stewardship for grants.
• As appropriate, participation in the definition of objectives and approaches and in planning, conducting, analyzing, publishing, interpretations, and conclusions of the project activity.

In addition to, or in the absence of the PO, a separate FDA PO will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Any FDA curriculum or course content provided by FDA will remain the property of FDA and any proposed changes are not to be made without concurrence from FDA.

Curriculum and other training materials developed under this Cooperative Agreement such as objectives, learning outcomes, presentations, manuals, scripts, exercises, handouts, reports, documents, or other tangible materials produced by the awardee shall be free of copyrights and be in the public domain.

The Government, via the PO, will have access to materials generated under this Cooperative Agreement and may periodically review the materials under development. The FDA PO may use information obtained from the materials for the preparation of internal reports on the activities of the project.

Areas of Joint Responsibility

As relevant, the PD/PI will work collaboratively with the designated FDA support staff in reviewing the training materials and methods; training implementation and evaluation plans; data analysis; and the interpretation, publication, and dissemination of project activity and results.

As noted above, during performance of the award, the PO, with assistance from other scientific program staff who are designated based on their relevant expertise, may provide appropriate assistance, advice, and guidance as resources permit. The role of the PO will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus between the awardee and PO, and that selected FDA staff will be given the opportunity to offer input into this process. The PO will facilitate liaison activity for partnerships and provide assistance with access to FDA supported resources and services.

The PD/PI will be responsible for the timely submission of all training materials, abstracts, manuscripts, and reviews (co)authored by members of the grant and supported in part or in total under this Cooperative Agreement. Training materials and any other coordination center plans or activities shall be submitted to the FDA PO prior to use in training or to finalizing them for publication. Publications or oral presentations of work performed under this Cooperative Agreement, including training conducted using the materials developed, will require appropriate acknowledgement of FDA support. The following statement should be included in all publications and materials including promotional materials, agendas, and internet sites:

*Funding for this (insert appropriate venue, i.e.: conference, training, etc.) was made possible, in part, by the Food and Drug Administration through grant (insert grant number). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.*

Credentials (e.g., certificates, certifications, licenses, continuing education units), if applicable, should be developed under the appropriate standards such as those found under American National Standards Institute (ANSI).

Exams, assessments and other security related documents developed for ANSI/ISO/IEC 17024 accredited certification related purposes should be maintained by the awardee in accordance with the standard. Curriculum, technical reports (e.g. job/task analysis report) and other non-security related certification and curriculum documentation shall remain free of copyright and be free domain for use by FDA.

FDA retains the right to conduct audits and/or request meetings with the awardee management to discuss training programs and other related activities. The awardee will be expected to participate in progress update meetings as necessary. At the discretion of FDA, these meetings may be via conference call or electronic conferencing, with one meeting each year to be a face-to-face meeting in the Washington, D.C. metro area. For meetings at the awardee’s place of business, FDA shall be responsible for funding the travel and travel related costs for FDA personnel. The meetings may involve FDA, other grantees and personnel stipulated by FDA, in addition to the PO, together with awardee personnel.

Delineation of Substantive Involvement

• FDA will monitor and evaluate the overall conduct of the awardee under this cooperative agreement.
  
  
• FDA will take any action that may be necessary to ensure compliance with this cooperative agreement.

Reporting Requirements

Periodic program monitoring will be conducted on an ongoing basis which may be in the form of telephone conversations between the Principal Investigator and the Project Officer/Grants Management Officer/Grants Management Specialist as well as the review of written reports.

1. A Mid-Year Progress Report is required and should cover the first 6 months of activity within a budget period and must contain the following information:

• List of projects and/or activities you are working on and the reason why they are being worked on (rationale); can come from language in the Funding Opportunity Announcement as agreed on with your Project Officer (PO).
  
  
• Accomplishments/Milestones reached for each specific grant project and/or activity as of report submission date, as established in the strategic plan.
  
  
• Projected Timeline for uncompleted grant projects and or activities (expected accomplishments/milestones by the end of the current budget period of the grant).
  
  
• Information on any pending issues/concerns that are impeding completion of grant projects and/or activities.
  
  
• Key Personnel Report - If you have gone through a personnel change in the project, or expect to, please make sure the document includes information in that regard.

2. An Annual Progress Report is required and due at least 60 days prior to the next budget period start date. The Annual Progress Report is incorporated into the PHS 2590 form. Please see #3 below on the requirements of the Annual Progress Report and the PHS 2590 form.

The Annual Progress Report should include at a minimum the following:

• List of projects and/or activities you are working on and the reason why they are being worked on (rationale); this information can come from language in the Funding Opportunity Announcement as agreed on with your Project Officer (PO).
  
  
• Accomplishments/Milestones reached for each specific grant project and/or activity as of report submission date, as established in the strategic plan.
  
  
• Projected Timeline for uncompleted grant projects and or activities (expected accomplishments/milestones by the end of the current budget period of the grant).
  
  
• Information on any pending issues/concerns that are impeding completion of grant projects and/or activities.
  
  
• Key Personnel Report - If you have gone through a personnel change in the project, or expect to, please make sure the document includes information in that regard.

3. Grants with Multiple Years: In order to receive future funding, grantees are required to submit the PHS 2590 Continuation - Progress Report for a Public Health Service Grant each year.

The PHS 2590 Form is available at: http://grants.nih.gov/grants/forms.htm

The PHS 2590 Form must be submitted at least 60 days prior to the next budget period start date and to ensure your submission is a complete package, please include the following:

Form Page 1 (Face page)
Form Page 2 (Detailed budget)
Form Page 3 (Budget Justification)

Form Page 5 (Progress Report Summary): Page 5 of the PHS-2590 is the section in which you would actually incorporate your Annual Progress Report information/data. This page does have a character limit, so if you find that you do not have enough space to report on a full performance period's worth of work, you may attach a separate report to cover this information. If you do use a separate document for reporting purposes, please state so on page 5 of the PHS-2590 form (i.e. "Please see attached report"). This report should cover all activities/work that took place during the current budget performance period noted in your Notice of Grant Award (NGA).

Form page 6 (Checklist Page) if indirect costs are requested and/or if there is a change in performance site(s) that will affect facilities and administrative costs and/or if program income anticipated.

Form page 7 (Key personnel Report)

4. A required annual Federal Financial Report (FFR) using Form (SF-425) should be submitted within 90 days after the end date of the budget period and is available at:

http://grants.nih.gov/grants/forms.htm

5. Closeout Requirements (when applicable): A Final Program Progress Activity Report, Final Federal Financial Report SF-425, Final Invention Statement HHS-568 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 90 days after the expiration date of the project period. All forms can be found at: http://grants.nih.gov/grants/forms.htm.

6. The recipient will conduct, when appropriate, an annual Single Audit as required by OMB Circular A-133. This audit must be submitted to the Federal Audit Clearinghouse at the Bureau of the Census within 9 months of the close of their fiscal year. If you need information on your organization’s obligations under the Single Audit Act, please visit the following website: http://harvester.census.gov/sac/. Valuable information is included under the Frequently Asked Questions section of that website.

ALL THE ABOVE REQUIREMENTS MUST BE SENT VIA E-MAIL TO:

Kimberly Pendleton
Chief, Grants Management Officer
Email: kimberly.pendleton@fda.hhs.gov
Telephone: 240-402-7610

Prior Approval

All requests that require prior approval must include the award number and bear the signature of an authorized official of the grantee business office as well as that of the PI/PD. Any requests involving funding issues must include a new proposed budget and a narrative justification of the requested changes. If a grantee questions whether prior approval is required for an activity or cost, they should contact the assigned Grants Management Specialist prior to expenditure of funds for clarification. Below are activities that require prior approval from FDA:

1. CHANGE IN SCOPE OR OBJECTIVES

2. CHANGE IN KEY PERSONNEL

3. CHANGE IN GRANTEE ORGANIZATION

4. DEVIATION FROM TERMS AND CONDITIONS OF THE AWARD

5. CARRYOVER

6. NO COST EXTENSIONS

7. SIGNIFICANT REBUDGETING

Unallowable Costs

The following highlights unallowable cost(s) under this grant award. If a grantee questions whether a cost is allowable under this award, they should contact the assigned Grants Management Specialist prior to expenditure of funds for clarification and prior approval.

Equipment Funds may not be used to purchase equipment which does not have a particular scientific, technical, or programmatic purpose. It includes but is not limited to: passenger carrying vehicles, typewriters, furniture (tables, chairs, file cabinets, book cases, etc.), copy machines, fax machines, etc. To the greatest extent practicable, all equipment and products purchased with FDA funds should be American made.

Incentives Funds may not be used to offer targeted program participants incentives (e.g., fast-food coupons, gift certificates, etc.) to entice participation.

Alternations & Renovations (A&R) Funds may not be used for renovation or refurbishment of research, education, or extension space, planning, repair, rehabilitation, acquisition, or construction of buildings or facilities.

Food Funds may not be used for any/all meals or light refreshments, regardless if certain meals are an integral and necessary part of a meeting/training (i.e., a working meal where business is transacted).

Indirect/F&A Costs If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate or F&A agreement, a provisional amount up to a maximum of 10 percent (10%) of modified direct costs will be allowed.

Additional funding restrictions may be part of the Notice of Award.

Pre-Award Costs

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

Program Income

1. Grantees are required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the grantee s Federal Financial Report (FFR) SF-425 http://www.whitehouse.gov/sites/default/files/omb/assets/grants_forms/SF-425.pdf.

2. Examples of Program Income include (and are not limited to): fees for services performed during the grant or sub-grant period, proceeds from sale of tangible personal or real property, usage or rental fees, patent or copyright royalties, and proceeds from the sale of products and technology developed under the grant.

3. Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee is subject to the Addition Alternative for Program Income and, therefore, must only be used to further the goals of the project for which this grant was awarded.

Payment Management System (PMS)

The Payment Management System is administered by the Program Support Center (PSC), DHHS, and payments for FDA grant awards are made through the Division of Payment Management. Applicant organizations are assigned a 12-digit Entity Identification Number for payment and accounting purposes. That number is an expansion of the 9-digit Employer Identification Number assigned to an organization by the Internal Revenue Service.

Included are the following Links & Instructions for drawing down funds, reporting expenditures, required forms, and the help desk info:

Homepage: http://www.dpm.psc.gov/Default.aspx

Grant Recipient Information:
http://www.dpm.psc.gov/grant_recipient/grant_recipient.aspx?explorer.event=true

Grant Recipient Forms:
http://www.dpm.psc.gov/grant_recipient/grantee_forms.aspx?explorer.event=true

PMS Help Desk:
http://www.dpm.psc.gov/help/help.aspx?explorer.event=true

The ONE-DHHS Help Desk for PMS Support is now available Monday Friday from 7 a.m. to 9 p.m. EST (except Federal Holidays). Phone (877) 614-5533; Email PMSSupport@psc.gov

Failure to comply with the above stated Terms and Conditions could result in the suspension or termination of this cooperative agreement.

All formal correspondence/reports regarding the grant should be signed by an authorized institutional official and the Principal Investigator and should be sent to the attention of the grants management specialist, unless otherwise directed.

EXPANDED AUTHORITIES DO NOT APPLY TO THIS COOPERATIVE AGREEMENT.

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

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.

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

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
Email: commons@od.nih.gov

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: support@grants.gov

Mary Tijerina
Consumer Safety Officer
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 240-402-0405
Email: Mary.Tijerina@fda.hhs.gov

Scarlett Salem
Staff Fellow
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 240-402-2080
Email: scarlett.salem@fda.hhs.gov

Kimberly Pendleton
Chief, Grants Management Officer
Grants Management Branch
Food and Drug Administration (FDA)
Office of Acquisition & Grants Services (OAGS)
Telephone: 240-402-7610
Email: Kimberly.Pendleton@fda.hhs.gov

Kimberly Pendleton
Chief, Grants Management Officer
Grants Management Branch
Food and Drug Administration (FDA)
Office of Acquisition & Grants Services (OAGS)
Telephone: 240-402-7610
Email: Kimberly.Pendleton@fda.hhs.gov

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

Awards are made under the authorization of Section 301 of the Public Health Service Act (42 U.S.C. 241); Section 1011 of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 399(a)(4)), as amended by Section 209 of FSMA; and Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.