It is critical that applicants follow the Research (R) 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

FDA believes that the intent of this cooperative agreement is to fund an entity that has active working relationships with local food producers, processors, or enterprises and/or organizations that have demonstrated experience developing and providing science-based, culturally specific food safety training, education and outreach, for local food producers and processors, with an emphasis on those that are involved in diversified, sustainable, organic and identity-preserved agricultural operations; beginning and socially disadvantaged farmers; value-added farm businesses and small-size processors; and direct and intermediate supply chain participants.  The local food producers and processors targeted by this cooperative agreement may or may not be covered under FSMA (e.g., due to sales or distribution channels), however, should handle commodities relevant to these regulations.  Subcontracts to other organizations that meet the intent noted above are encouraged.  It is expected that applicants will specifically include collaboration between and among national and regional food safety leaders; relevant diversified, sustainable, organic and identity-preserved agricultural businesses or organizations; colleges, universities and related land grant cooperative extension programs; and regional and local food sector organizations, among others, to reach the intended audience.  In addition, applicants are expected to collaborate with the established FDA Food Safety Modernization Act (FSMA) Alliances and other organizations deliver FSMA education and outreach. Extensive cooperation and coordination with FDA CFSAN and other FDA program offices, Regional Centers (administered under the USDA-NIFA Food Safety Outreach Program), state agencies implementing FSMA, and the United States Department of Agriculture (USDA) and other Federal organizations that have a vested interest in food safety among local food producer stakeholders is also expected.

The primary objective of this cooperative agreement is to provide training, education, and outreach, address training gaps (e.g., by developing training materials) and to facilitate identification of appropriate technical assistance resources for local food producers and processors related to applicable federal preventive controls regulations under FSMA, especially the Produce Safety and Preventive Controls for Human Food rules.  Research to evaluate the program should also be completed, which includes data collection and analysis, to assess the impact of education, outreach and technical assistance on addressing training/knowledge gaps of the target audience previously identified.

This cooperative agreement should also support development and delivery of alternate curricula for the FSMA Produce Safety Rule. Subcontracts to other organizations interested or engaged in developing and/or delivering alternate curricula training to this target audience are encouraged to meet this objective. 

In addition, consideration should be given to local food producers not currently subject to the regulatory requirements but that have conveyed an interest in or have identified economic incentives to comply (i.e., marketplace requirements to comply or business growth outlooks) with such regulations.

Program Area Description

FSMA was signed into law in 2011 and provided FDA with a legislative mandate to require comprehensive, prevention-based controls across the food supply along with other prevention-focused tools in order to create substantial improvements in the Agency’s approach to food safety. Standards that FDA is directed to issue under FSMA include hazard analysis and risk-based preventive controls for both human food and animal food and standards for produce safety, among other rulemaking and guidance development activities. The regulations include requirements for training and employee qualifications.

Additionally, FSMA calls for enhanced partnerships and integration with FDA’s food safety Federal, State, local, tribal and territorial partners in order to achieve public health goals. To this end, the Agency has been working with such partners to develop and implement an integrated food safety system. To be successful, a national integrated food safety system must build upon the work currently being done by FDA and our regulatory and public health partners. Additional work is needed in terms of active communication, coordination, and support.  One important step towards implementing a national integrated food safety system will entail the education, outreach, training and understanding technical assistance needs for local food producers that grow, harvest, pack or hold produce or process foods.  Additionally, it is FDA’s role and responsibility to collaborate with other food regulatory agencies, and to support state, local and tribal regulatory and public health programs working to meet these standards.

To build and maintain a national integrated food safety system, outreach and training related to FSMA will continue to be necessary to support local food producers and food manufacturer/processors.  FDA anticipates that local food producers and processors will need food safety education and training that addresses the regulatory requirements of the applicable FSMA rules and also encompasses specific practices associated with produce farming and food manufacturing/processing relevant to their scale of production and management practices.  Additionally, these local food stakeholders frequently have limited access to adequate and affordable food safety training, education, outreach, and technical assistance. FDA will engage in a cooperative agreement with one or more collaborators that develop and implement food safety training, education, and outreach to key local food stakeholders, including farmers, packers and manufacturers/processors that grow, harvest, pack and hold produce and process food affected by FSMA. It is expected that existing training materials, such as the standardized curriculum developed by the Produce Safety Alliance or the Food Safety Preventive Controls Alliance, would be used as a foundation for customization, where appropriate, to meet local food producer needs.  In addition, the Sprout Safety Alliance will be a resource for existing training materials specific to sprout growers. Customization of these existing training materials, or development of alternate curricula when warranted to address training gaps, would likely address specific needs of the local food producers and processers, regional practices and needs, including addressing specific practices associated with produce farming and food manufacturing/processing relevant to local food stakeholders scale of production and management practices. FDA intends to work with the recipient to ensure that alternate curricula are recognized by FDA. Research to evaluate and assess the impact of education, outreach and technical assistance on addressing training/knowledge gaps of the target audience. The applicant would be expected to collaborate with FDA, USDA and other educational partners as appropriate to complete the program evaluation.

Applicants are also expected to collaborate with the established FDA Food Safety Modernization Act (FSMA) Alliances and other organizations that deliver FSMA education and outreach. Participation in regional and national meetings covering FSMA training and outreach (such as the FDA-USDA FSMA Collaborative Training Forum) is also expected.

This cooperative agreement is beneficial to public health because it will further drive compliance with the final federal preventive controls regulations, especially the Produce Safety and Preventive Controls for Human Food rules; will help ensure consistency of implementation throughout the United States; will leverage existing expertise and knowledge; and will ultimately reduce foodborne illness. 

The program will focus on helping local food producer and processor audiences understand and interpret Federal food safety agricultural production and processing regulations and guidance enacted under FSMA, address challenging topics related to implementation of both the Produce Safety and Preventive Controls for Human Food (e.g., sanitation controls, wash water management, writing a food safety plan) thus enabling them to implement those regulations and guidelines in their respective environments.  The program will provide training, education, and outreach, and build capacity and infrastructure, as well as alternate curriculum development and/or adaptation of the standardized curriculum, in addition to identifying technical assistance resources for local food producer and processor audiences impacted by FSMA regulations and guidance.

The rules issued to implement FSMA are available on FDA's website at http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm, or upon request from the Scientific/Research and Objective Review contacts listed in Section VII.

Program Area Priorities

This cooperative agreement is intended to develop and deliver training and outreach; develop, adapt and provide educational materials using the FSMA Alliance materials as a foundation; support development and delivery of alternate curricula to the FSMA Produce Safety Rule and facilitate identification of appropriate technical assistance resources for local food producers and processors subject to the applicable preventive controls regulations.  The goal of developing and delivering this training, educational materials and outreach is to enhance the fundamental knowledge of food safety and especially on-farm good agricultural practices of local food producer stakeholders subject to applicable FSMA regulations.

Applications must address all of the following:

Demonstrate an ability to reach the target audience and an ability to collaborate and lead relevant partners that also work with the target audience on applicable areas. Partners include appropriate NGOs and community-based organizations, academic institutions, land grant cooperative extension, as well as federal agencies involved in food safety and agricultural preservation/conservation. Target audiences include diversified, sustainable, organic, identity-preserved agricultural operations, beginning and socially disadvantaged farmers, small-scale processors, and direct and intermediate supply-chain participants.

Demonstrate an ability to collaborate and support organizations interested in developing and disseminating alternate curricula to the FSMA Produce Safety Rule for local producers and processors.

Demonstrate an ability to develop and implement a training plan that includes project goals that shall significantly advance local food producer and manufacturer/processor understanding of on-farm produce and food manufacturing/processing food safety, taking into account existing materials and also regional- and management-specific practices, and ultimately increase understanding of the requirements of the Produce Safety and Preventive Controls for Human Food rules to facilitate and support compliance.

Develop science-based, management practice-appropriate training and educational materials and outreach tools, around the FDA preventive controls regulations, especially the Produce Safety and Preventive Controls for Human Food rules. Targeted training and educational materials should be based upon existing produce and human food safety training and educational materials (e.g., FSMA Alliances) to the extent practicable and will be adaptable to specific (documented and itemized) local and regional food sector needs, where appropriate, while otherwise providing for national uniformity. 

Identify culturally appropriate delivery vehicles for the training, outreach, and educational materials, as well as mechanisms to connect with technical assistance resources.

Address FSMA training needs and gaps for local food producers and processers such as those identified through needs assessments or other surveys, as previously conducted by FDA and USDA funded organizations.

Work collaboratively to foster an integrated working relationship with the FSMA Alliances (Produce Safety Alliance, Food Safety Preventive Controls Alliance and Sprout Safety Alliance), Regional Centers established under the FDA-USDA-NIFA, other FDA and USDA funded educational partners  Food Safety Outreach Program and produce safety and preventive controls for human foods stakeholders within the target audiences, including diversified, sustainable, organic, identity-preserved agricultural operations, beginning and socially disadvantaged farmers, traditional farmers (e.g., plain farmers), novel approaches to farming (e.g., urban farming), small-scale processors, and direct and intermediate supply-chain participants.

Collaborate with FDA, USDA and educational partners as appropriate to complete an evaluation on the impact of education, outreach and technical assistance provided, including coordination with partners on metrics and consideration of additional training needs or gaps;

Evaluate education, outreach and technical assistance for best practices, challenges, and lessons learned for this target population. Ensure that educational efforts can be scalable and/or adopted by other organizations.

Identify proven education methods to help local food producers and food manufacturers/processors decide how to select appropriate, cost-effective short-term and long-term FSMA compliance strategies while maximizing the effectiveness of their food safety risk management.

Identify and conduct outreach opportunities relative to these overall priorities to be delivered so that local food producers and food manufacturers/processors are aware of the availability of training, educational materials and technical assistance opportunities.

Evaluate the training curricula and delivery to ensure that the target audience is provided with adequate information to increase understanding of the requirements of the Produce Safety and Preventive Controls for Human Food rules.

Identify opportunities to institutionalize food safety resources (e.g., educational materials, trainers) for the benefit of the target population beyond the lifecycle of this award.

Other Requirements

Demonstrate the ability to develop and provide a range of educational tools for local food producer and food manufacturer/processor stakeholders relative to the FDA preventive controls regulations, especially the Produce Safety Rule and Preventive Controls for Human Food rule.

Demonstrate the ability to understand the perspectives of and organizations that represent local food producers and processors at a national, state and local level. Demonstrate the ability to engage with and work collaboratively with national and regional local food stakeholder leaders (individuals and organizations), colleges and universities and related extension programs, regional and local food sector organizations, grassroots outreach and education organizations, and the established FSMA Alliances, as well as the USDA-NIFA Regional Centers and other educational partners in order to leverage and advance understanding of the FSMA requirements among the target audiences.

Demonstrate the ability to extensively cooperate and coordinate with FDA CFSAN and other FDA program offices, and FDA’s FSMA partners at USDA in order to further enhance an integrated food safety system.

Demonstrate the availability of adequately trained personnel that will be providing training, education and outreach, and resources for technical assistance to local food producer stakeholders. Communicate the criteria and ability to hire and/or train personnel to meet the deliverables of the cooperative agreement.

Provide a properly detailed budget (one for each year funding is available) that is intended to advance the training and education program and outreach, including identification of technical assistance resources, understanding, and compliance with the Produce Safety and Preventive Controls for Human Food rules.  Each year's budget must include sufficient detail reflecting any/all subcontracts that support this work.

Demonstrate the ability to satisfy the reporting requirements outlined in Section VI.3 of this announcement.

Provide justification for hiring new staff, including qualifications, and training needs.

Applications demonstrating an ability to sustain the progress made beyond the duration of this cooperative agreement are encouraged.

Post Award Program Management

In addition, this cooperative agreement opportunity has common programmatic conditions in order to execute a seamlessly collaborative program between FDA and the awardee:

A steering committee, composed of FDA, USDA and Cooperative Agreement recipient representatives, as well as other partnering or relevant organizations, will be established to provide guidance, input and oversight of this cooperative agreement and its deliverables.   Subcommittees, such as technical committees, may also be formed to provide input and guidance or to accomplish specific deliverables throughout the project and may include other partnering or relevant organizations. 

Develop a plan to manage the solicitation, review and selection of projects to be funded under this award, including methods for awarding subcontracts and providing fiscal oversight.

Develop a project plan to monitor progress of subcontractors (e.g., deliverables, timelines, milestones, progress); Subcontractors should be evaluated (e.g., on a semi-annual basis) for impact on target audience and to determine whether funding should be continued.

Applicants will develop a communication plan to ensure consistent, transparent and open communication channels among the FDA, USDA, and FSMA Alliances, as well as other relevant organizations. It should involve communication at a regular frequency through various mechanisms such as teleconferences, webinars, and other forms of communication. The plan will also include one face-to-face meeting each year of the project period, a written, quarterly progress report, and monthly teleconferences between FDA and the awardee.

The communication plan must include sharing of all appropriate information, such as data pertinent to the activities conducted by the applicant, along with the appropriate information regarding the compiled contacts and collaborator activities.

The Project Director will be responsible for managing all technical and programmatic aspects of the cooperative agreement and will be responsible for appropriately acknowledging FDA support in publications, announcements, news programs, and other media.

The Project Director and members of the project team will be responsible for attending an annual meeting with FDA where they will provide updates on project progress, and any other significant programmatic outputs.

Funds allocated to this cooperative agreement are intended to be utilized to develop and deliver the specific training, educational materials and outreach as noted here within.

See Section VIII. Other Information for award authorities and regulations.

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

National Farmers Union Foundation

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.

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) 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.
• o   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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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 application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) 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.

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 30 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, with the following additional requirements:

• For field 4. a. Federal Identifier - The Federal Identifier is required.  Include only the IC and serial number of the previously assigned award number (e.g., use FD006921 from 5U01FD006921-02).
• For field 8. TYPE OF APPLICATION - applicant must mark 'RENEWAL'.

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:

• 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.
• 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 agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
• Funds should be requested in the budget for key project personnel to travel to meetings, on-site visits, and audits with FDA program staff to discuss the project. A portion of budgeted travel funds should also be set aside for key personnel to attend an annual face-to-face meeting (as determined by FDA/OP), conferences and committee meetings supporting this project. Training needs should also be anticipated and budgeted for accordingly.

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 requirements:

Research Strategy: The Research Strategy should include a brief Progress Report that summarizes Progress to Date and accomplishments achieved during the current funding period. The Progress Report should include a summary of the specific aims of the previous project period and the importance of the findings, progress made towards achievements, explanation on any significant changes to the specific aims and any new directions.

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:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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 and time. 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 and 45 CFR 75.

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

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 How to Apply Application Guide. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 

Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

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/technical merit.

This criterion is used to assess the impact of the proposed approach.  Elements considered include: soundness of an evidence-based approach for educational curricula to be used in the project; proposed activities and sequence of activities; participants and, if applicable, trainer recruitment; methodology and limitations of the proposed approach; and expected new products and results (e.g., educational approaches including training curricula, alternate curricula (to include train the trainer programs), workshops, meetings, conferences, exhibits, publications, electronic communication, fact sheets, newsletters, social media, and mass media).  In addition, the review criteria should include:

a. Evidence of having successfully engaged and collaborated with both national and regional training, education and, if applicable, technical assistance-related projects with a range of local food stakeholders. Including developers of alternate curriculum.

b. Evidence of having successfully participated in national or regional projects that included extensive cooperation and coordination with other Federal or State Government agencies or public-private partners on the topic of food safety/FSMA to reach the target audience.

c. Evidence of having successfully developed and delivered training, education and outreach as well as identification of appropriate technical assistance resources on the topic of food safety/FSMA for the target audience.

d. Evidence of and/or established partnerships with experienced food safety educational personnel that work with the target audience. 

This criterion is used to assess adequacy of key staff, their functions and their ability to reach local food producer and food manufacturer/processor audiences, reporting, accounting procedures (for funds used by the parent organizations and local sites), the coordination of collaborative efforts with local and/or community partners, and key staff of known subcontractors involved in the project. Include r sum’s and/or other documentation that shows specific individuals that will work as primary project managers and key developers and key delivery personnel, including years of experience.

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

a. Methods to identify and target desired audience/stakeholders, and potential partners or subcontractors (if applicable);

b. Program evaluation, including data collection and analysis, and communication plans;

c. A documented training plan including a proposed training schedule and the proposed number of sessions with adequate detail related to utilizing existing materials, the need for adapting or developing materials, program delivery methods, and identified specific practices for incorporation in regard to local food producers and manufacturers/processors.

d. A training and education curriculum to include alternate curriculum and train the trainer programs, trainer qualifications, and all related materials (lesson plans, speaker notes, handouts, stakeholder take-away materials, etc.) that addresses specific practices, procedures and conditions that may be adapted and connected to the existing materials

e. A range of training tools that address specific issues, with details on how each would be developed and implemented.

f. Approaches to institutionalize food safety resources within the target audience.

This criterion is used to assess the likelihood that this project will develop and implement a food safety training, education, extension, and outreach program with core competencies to address FSMA regulations, guidance and protocols as well as facilitate identification of appropriate technical assistance resources; demonstrate an ability to reach the target audience and an ability to collaborate and lead relevant partners that also work with the target audience on relevant areas. Such partners include associations dedicated to diversified, sustainable, organic, identity-preserved agricultural operation, beginning and socially disadvantaged farmers, small-scale processors, and direct and intermediate supply chain participants. Additional partners should include organizations with expertise in food safety education, such as the FSMA Alliances, as well as federal agencies with a role in food safety such as the USDA; subcontracts are encouraged. Preference will be given to applicants that either directly have or partner with organizations who have a presence in the various regions of the United States, have a demonstrated track record of working with the target audience on the topic of FSMA and food safety, and have an existing network or platform to reach the target audience.

This criterion would also assess the likelihood that this project will support the development and delivery of alternate curriculum for the target audience.

Elements considered include: a clear statement of the project goal(s) and supporting objectives of the proposed activities; body of knowledge, preliminary data and other past activities used to substantiate the need for the proposed project; justification and criteria used to select the population groups to be served; innovation; and the degree to which the project will reach the target audience and evaluate the project's impact to advance awareness, understanding, and implementation of new FSMA regulations and guidelines among the target audience.

Include a detailed budget for each of the years funding is available that includes the costs for education, outreach and training programs and materials, and resources for technical assistance; and for key staff/administration. Also include a project timetable that outlines all important phases as a function of time, year by year, for the entire project, including periods beyond the cooperative agreement funding period. Include plans for managing the solicitation, review and selection of subawards as well as the approach for developing a project/monitoring plan to oversee work done by subcontractors. Describe approach to monitor, report progress and evaluate subcontractors (e.g., deliverables, timelines, milestones, progress);

This criterion is used to assess the extent to which the target audience, including both local producers and processers as well as associations dedicated to diversified, sustainable, organic, identity-preserved agricultural operation, beginning and socially disadvantaged farmers, small-scale processors, and direct and intermediate supply chain participants will be receptive to this project. Additional consideration will be given to this project's ability to successfully collaborate with existing organizations working with local food producers and processers to provide FSMA education and outreach and to develop and delivery alternate curricula. Preference will be given to organizations that currently or have recently successfully worked with the local producer and processor community addressing the topic of food safety and FSMA through education and outreach at the national level and across the various regions in the United States, such as community-based organizations or grassroot organizations. 

As applicable for the project proposed, reviewers will evaluate the following additional items but will not give separate scores for these items and should not consider them in providing an overall score.

For research that involves human subjects but does not involve one of the 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 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.

When the proposed project involves human subjects and/or 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 individuals of all ages (including children and older adults) 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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not applicable

For Renewals, the committee will consider the progress made in the last funding period.

Not applicable

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate 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 objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

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 recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions and in the Notice of Award. 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, this FOA, and Notice of Award.

Institutional Review Board or Independent Ethics Committee Approval: For projects that involve Human Subjects and/or Clinical Trials Research, Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.

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

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency.  Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment.  Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about FDA's commitment to supporting a safe and respectful work environment, and what FDA's expectations are for institutions and the individuals supported on FDA-funded awards, please see https://www.fda.gov/science-research/about-science-research-fda/fda-sexual-harassment-policy-concerning-extramural-research.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws.  Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions.  Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.  

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. 

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements.

FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.

Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the peer-reviewed scientific publication resulting from research supported in whole or in part with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.

Termination provisions in 2 CFR 200.340 (a) (1-4) are applicable to awards issued under this Notice of Funding Opportunity.

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

Reporting Requirements: All FDA grants require both Financial and Performance reporting.

Financial Reporting:

A. Cash Transaction Reports

The Federal Financial Report (FFR) has a dedicated section to report Federal cash receipts and disbursements. For recipients, this information must be submitted quarterly directly to the Payment Management System (PMS) using the web-based tool. Quarterly reports are due 30 days following the end of each calendar quarter. The reporting period for this report continues to be based on the calendar quarter. Questions concerning the requirements for this quarterly financial report should be directed to the PMS.

B. Financial Expenditure Reports

A required Federal Financial Report (FFR) must be submitted annually. All annual FFRs must be submitted electronically using the Federal Financial Report (FFR) system located in the eRA Commons. This includes all initial FFRs being prepared for submission and any revised FFRs being submitted or re-submitted to FDA. Paper expenditure/FFR reports will not accepted.

Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. If a grant is under expanded authorities, the grantee must indicate the carryover amount in Section 12. Remarks of the annual FFR.

Performance Progress Reporting:

When multiple years (more than one budget period) are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually as required in the Notice of Award. Annual RPPRs must be submitted using the RPPR module in eRA Commons.  The annual RPPR must include a detailed budget.  Annual RPPRs are due no later than 60 days prior to the start of the next budget period.

Failure to submit timely reports may affect future funding. Additional Financial and Performance Progress reports may be required for this award. Any additional reporting requirements will be listed under Section IV Special Terms and Condition of the Notice of Award.

Salary Caps:

None of the funds in this award shall be used to pay the salary of an individual at a rate in excess

of the current Executive Level II of the Federal Executive Pay Scale.

Certificates of Confidentiality 42 U.S.C. 241(d)

Awardees are responsible for complying with all requirements to protect the confidentiality of identifiable, sensitive information that is collected or used in biomedical, behavioral, clinical, or other research (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs) funded wholly or in part by the Federal Government.  See 42 U.S.C. 241(d).  All research funded by FDA, in whole or in part, that is within the scope of these requirements is deemed to be issued a Certificate of Confidentiality through these Terms and Conditions. Certificates issued in this manner will not be issued as a separate document. 

Awardees are expected to ensure that any investigator or institution not funded by FDA who receives a copy of identifiable, sensitive information protected by these requirements, understand they are also subject to the requirements of 42 U.S.C. 241(d).  Awardees are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).

Acknowledgment of Federal Support:

When issuing statements, press releases, publications, requests for proposal, bid solicitations and other documents --such as tool-kits, resource guides, websites, and presentations (hereafter statements )--describing the projects or programs funded in whole or in part with FDA federal funds, the recipient must clearly state:

1. the percentage and dollar amount of the total costs of the program or project funded with federal money; and,

2. the percentage and dollar amount of the total costs of the project or program funded by non-governmental sources.

When issuing statements resulting from activities supported by FDA financial assistance, the recipient entity must include an acknowledgement of federal assistance using one of the following statements.

If the FDA Grant or Cooperative Agreement is NOT funded with other non-governmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with 100 percent funded by FDA]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

If the FDA Grant or Cooperative Agreement IS partially funded with other nongovernmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with XX percentage funded by FDA/HHS and $XX amount and XX percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

The federal award total must reflect total costs (direct and indirect) for all authorized funds (including supplements and carryover) for the total competitive segment up to the time of the public statement.  Any amendments by the recipient to the acknowledgement statement must be coordinated with FDA.  If the recipient plans to issue a press release concerning the outcome of activities supported by FDA financial assistance, it should notify FDA in advance to allow for coordination.

Additional prior approval requirements pertaining to Acknowledgement of Federal Support, publications, press statements, etc. may be required, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Prior Approval:

All prior approval requests must be submitted using the Prior Approval module in eRA Commons.  Any requests involving budgetary issues must include a new proposed budget and a narrative justification of the requested changes. If there are any questions regarding the need or requirement for prior approval for any activity or cost, the grantee is to contact the assigned Grants Management Specialist prior to expenditure of funds.

For grant awards not covered under Expanded Authorities, Carryover and No Cost Extension (NCE) requests will require prior approval.  All Carryover and NCE requests should be submitted using the Prior Approval module in eRA Commons.  ****Please review the section on Expanded Authorities to determine if this award is covered/not covered under Expanded Authorities and whether prior approval is needed for carryover and no cost extension requests.****

The following activities require prior approval from FDA on all awards:

1.         Change in Grantee Organization

2.         Significant Rebudgeting

3.         Change in Scope or Objectives

4.         Deviation from Terms and Conditions of Award

5.         Change in Key Personnel which includes replacement of the PD/PI or other key personnel as specified on the NoA.

6.         Disengagement from the project for more than three months, or a 25 percent reduction in time devoted to the project, by the approved PD/PI. No individual may be committed to more than 100% professional time and effort. In the event that an individual's commitment exceeds 100%, the grantee must make adjustments to reduce effort. For FDA-sponsored projects, significant reductions in effort (i.e., in excess of 25% of the originally proposed level of effort) for the PD/PI and key personnel named on named on this Notice of Award must receive written prior approval from FDA.

Additional prior approval requirements may be required for this award, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Audits and Monitoring:

Audit Requirements:

1.         Recipients of Federal funds are subject to annual audit requirements as specified in 45 CFR 75.501 (https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=8040c4036b962cc9d75c3638dedce240&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1501). Grantees should refer to this regulation for the current annual Federal fund expenditure threshold level which requires audit.

2.         Foreign recipients are subject to the same audit requirements as for-profit organizations (specified in 45 CFR 75.501(h) through 75.501(k).

3.         For-profit and foreign entities can email their audit reports to AuditResolution@hhs.gov or mail them to the following address:

U.S. Department of Health and Human Services
Audit Resolution Division, Room 549D
Attention: Robin Aldridge, Director
200 Independence Avenue, SW
Washington, DC 20201

Monitoring:

Recipients are responsible for managing the day-to-day operations of grant-supported activities using their established controls and policies, as long as they are consistent with Federal, DHHS and FDA requirements. However, to fulfill their role in regard to the stewardship of Federal funds, FDA monitors our grants to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the recipient, audit reports, site visits, and other information available to FDA.

1.         Desk review: FDA grants monitoring specialists will periodically reach out to recipients to request information for the completion of desk reviews. Requested information may include:

• Policies and procedures
• List of grant expenditures
• Accounting records
• Supporting documents (e.g., invoices, receipts, paystubs, timesheets, contracts, etc.)
• Financial statements
• Audit reports
• Other related documentation

2.         Site visits: FDA will conduct site visits when necessary and will notify the recipient with reasonable advance notice of any such visit(s).

3.         Foreign entities: All Foreign entities are subject to the same monitoring requirements as domestic entities.  Foreign entities covered under immunity Executive Orders will provide supporting documents for monitoring requirements unless such an action is a violation of the Executive Orders. Recipients may discuss with the FDA to come up with an alternate approach to satisfy the award monitoring requirements.

All recipients will make reasonable efforts to resolve issues found, including audit findings. Successful

resolutions to issues are important as they are part of the grant performance review. All recipients are responsible for submitting all requested information in an expeditious manner.  Failure to submit timely reports and/or respond to inquiries from FDA may affect future funding or enforcement actions, including withholding, or conversion to a reimbursement payment method.

Financial Conflict of Interest (FCOI):

This award is subject to the Financial Conflict of Interest (FCOI) regulation at 42 CFR Part 50 Subpart F.

Closeout Requirements (when applicable):

A Final Research Performance Progress Report (FRPPR), Final Federal Financial Report SF-425, Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 120 days after the expiration date of the project period.  All closeout documents must be submitted electronically in eRA Commons.

The Final FFR must indicate the exact balance of unobligated funds and may not reflect unliquidated obligations. There must be no discrepancies between the Final FFR expenditure data and FFR cash transaction data in the Payment Management System (PMS). The expended funds reported on the Final FFR must exactly match the disbursements reported on the grantee's report to the Payment Management System and the charge advances in PMS.  It is the recipient's responsibility to reconcile reports submitted to PMS and to the FDA.

Program Income:

The grantee is 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.

Examples of Program Income include (but 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.

Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee will be treated as identified below.

Treatment of Program Income:

Prohibition on certain telecommunications and video surveillance services or equipment:

(a) As described in CFR 200.216, recipients and subrecipients are prohibited to obligate or spend grant funds (to include direct and indirect expenditures as well as cost share and program) to:

(1) Procure or obtain,

(2) Extend or renew a contract to procure or obtain; or

(3) Enter into contract (or extend or renew contract) to procure or obtain equipment, services, or systems that use covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. As described in Pub. L. 115-232, section 889, covered telecommunications equipment is telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities).

i. For the purpose of public safety, security of government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities).

ii. Telecommunications or video surveillance services provided by such entities or using such equipment.

iii. Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise, connected to the government of a covered foreign country.

Other:

This award is subject to the requirements of 2 CFR Part 25 for institutions to maintain an active registration in the System of Award Management (SAM). Should a consortium/subaward be issued under this award, a requirement for active registration in SAM must be included.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts with cumulative total value greater than $10,000,000 must report and maintain information in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently the Federal Awardee Performance and Integrity Information System (FAPIIS)). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75.

You must administer your project in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/providerobligations/index.html and  https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

You must take reasonable steps to ensure that your project provides meaningful access to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals, see https://www.hhs.gov/civilrights/for-individuals/special-topics/limited-english-proficiency/fact-sheetguidance/index.html and https://www.lep.gov.

For information on your specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and taking appropriate steps to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sexdiscrimination/index.html.

For guidance on administering your project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscienceprotections/index.html and https://www.hhs.gov/conscience/religiousfreedom/index.html.

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 Part 75, 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 of 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 the FDA as defined below.

a. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for and dominant role in planning, directing, and executing the proposed project, with the FDA staff being substantially involved as a partner with the PI. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.

b. FDA Responsibilities

An FDA Program Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The program officer will monitor the grantee periodically. The monitoring may be in the form of telephone conversations, emails, or written correspondence between the project officer/grants management officer and the Principal Investigator.  Periodic site visits with officials of the grantee organization may also occur.  The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request, consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the grant, including those that state that future funding will depend on recommendations from the project officer. In addition,

a. FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee.

b. FDA will be directly involved in the guidance and development of the program.

c. FDA scientists will participate, with the grantee, in determining and carrying out scientific and technical activities. Collaboration will also include data analysis, interpretation of findings and, where appropriate, co-authorship of publications.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the terms and conditions of award and the HHS Grants Policy Statement. FDA FOAs outline intended goals and objectives. Post award, FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Marion V. Allen, FAC COR II, P/PM II
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 240-402-1584
Email: marion.allen@fda.hhs.gov

Kiara Farmer
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-3099
Email: Kiara.Farmer@fda.hhs.gov

Kiara Farmer
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-3099
Email:  Kiara.Farmer@fda.hhs.gov

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement, 45 CFR 75 and Notice of Award.

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.