It is critical that applicants follow the Research (R) Instructions in How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the HHS Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of 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

 

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 food producers that grow, harvest, pack or hold covered produce.  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 the produce growers throughout the country.  FDA anticipates that produce growers 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 relevant to their regional challenges and practices, and deliverable in an appropriate language or method for their community.

While an initial version of a standardized curriculum has been developed, portions of the FSMA Produce Safety Rule which are still under development and/or review will necessitate that curriculum continue to be updated to reflect current FDA rules and guidance. Additionally, it will be necessary to continually identify and innovate solutions to address the needs of audiences that are not able to access current training offerings (e.g. language, technology, literacy barriers).

The purpose of the opportunity is to fund an entity that will ensure the continued support for a standardized produce safety curriculum, and the support for a robust domestic and international training infrastructure to provide the produce industry and associated groups (e.g., regulators, auditors, extension educators, consumers, etc.) with training and educational opportunities related to current best practices and guidance, and current and future regulatory requirements by maintaining a FSMA alliance for produce safety.

Applicants are also expected to collaborate with the currently established FDA Food Safety Modernization Act (FSMA) Alliances (Preventive Controls Alliance, Local Food Safety Collaborative, Indigenous Food and Agriculture Initiative) and other organizations that deliver FSMA education and outreach (State CAP programs, JIFSAN, Regional Training Centers, USDA, etc.). 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 Produce Safety rule; will help ensure consistency of implementation throughout the United States and internationally; will leverage existing expertise and knowledge; and will ultimately reduce foodborne illness. 

The program will focus on supporting a network of current and future produce safety educators approved to train to a standardized curriculum, helping ensure produce safety growers throughout the country and internationally have access to training opportunities. The program will focus on building an infrastructure to monitor the effectiveness of current trainers, and providing on-going learning opportunities and disseminating up-to-date research and knowledge to help ensure that all produce growers have access to the same high quality, scientifically-based education and technical assistance.

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.

This cooperative agreement is intended to develop and deliver training and outreach; maintain and update (as necessary) FSMA alliance educational materials; identification of additional required technical assistance resources for regulated community; as directed by FDA, facilitate educational summits on produce safety hot topics, grow the network of produce safety educators through a Train the Trainer process and ongoing monitoring of training courses; and help ensure resources are available to facilitate training opportunities for underserved and non-English speaking producers.

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, academic institutions, land grant cooperative extension, industry groups and trade organizations, appropriate NGOs and community-based organizations, as well as federal and state agencies involved in food safety and agricultural preservation/conservation. Target audience includes producers, packers, and shippers of produce.

Development and/or maintenance of a standardized, multi-format, multi-lingual training and education program to assist the produce industry (including growers and packers) and regulatory agencies with the implementation of FDA’s requisite produce safety regulation and in understanding the public health and environmental benefits of co-management and to integrate food safety and environment co-management principles in implementing FDA’s produce safety regulation. Update the standardized curriculum to incorporate published FDA guidance or rulemaking related to produce safety;

Demonstrate the ability to provide training to producers nationwide which are regionally appropriate, and available in more than one language.

Providing educational outreach assistance to fresh produce growers and packers, including grower cooperatives, to increase their understanding of the critical role they play in public health via implementation of on-farm and packing house GAPs, on-farm environmental coordinated management (co-management), and other preventive controls;

Being a repository for and providing easy access to stakeholders of up-to-date scientific and technical information related to FDA’s produce safety regulations and guidance, on-farm produce safety, and on-farm food safety and environment co-management.

Development and/or maintenance of a Train-the-Trainer curriculum to ensure that a national group of qualified instructors is available to deliver the program. Maintain a Lead Training application and review process, and a Trainer of Trainer process, in both English and Spanish

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

Participate in efforts to translate currently available training and outreach materials to reach non-English speaking produce growing communities.

Facilitation of large scale educational summits on topics of importance to the produce industry and the FDA Produce Safety staff.

Work collaboratively to foster an integrated working relationship with the currently established FSMA Alliances; Regional Centers established under the FDA-USDA-NIFA; JIFSAN; other FDA and USDA funded educational partners; Food Safety Outreach Programs; produce safety and preventive controls for human foods stakeholders are all within the target audiences,

Engage with FDA and other partners to advance efforts related to international audiences, including Trainer-of-Trainers trainings and the Lead Trainer application/review process.

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.

Conduct an ongoing formal evaluation of the effectiveness of the training. Conduct research through this evaluation including data collection and analysis to assess the PSA course impact, trainer effectiveness, and need for course modifications to improve participant understanding of the Produce Safety Rule and Good Agricultural Practices, and enhance training based on evaluation findings. Continue to assess the adequacy of existing educational outreach tools, identify gaps, and fill and update as necessary.

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.

Maintain a database of all past and future training information, including a record of all training courses offered (and all course information), training participants, all approved trainers and trainers of trainers, and all evaluation data. This tool will be used to provide data analysis to FDA and other partners, to help identify future needs and/or gaps in training capacity.

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

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

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

Cornell University

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.

• 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.
  • o   Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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 NOFO 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 per 2.3.7.4 Submission of Resubmission Application.  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.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 NOFO. 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 notice of funding opportunity 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.

Not applicable.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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

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.

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:

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:

 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by FDA) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• A Data Management and Sharing Plan is not applicable for this NOFO.

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.

Foreign (non-U.S.) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions.

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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. FDA 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. Applications that miss the due date and time are subjected to the FDA Policy on Late Application Submission.

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 NIH 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.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 FDA and responsiveness by components of participating organizations ,FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

 

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.

For this particular announcement, note the following:

The X01 Resource Access Program invites eligible institutions to seek access to FDA research resources, which are specified in each X01 NOFO. This includes programs where institutions will request access to submit to the resource (e.g., high throughput screening assays) as well as programs where access to a specific FDA research resource is needed to conduct certain research. Important factors in the peer review of X01 applications are the need for, and potential benefit of, gaining access to the resource, specifications for any assays proposed, timelines for completion and plans for follow-on studies.

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

The R21/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An R21/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  Reviewers will assign a single impact score for the entire application, which includes both the R21 and R33 phases.

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

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

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? This criterion will be used to assess the impact of the proposed approach. Elements considered include: the soundness of an evidence-based approach for educational curricula to be used in the project; proposed activities and sequence of activities; trainer recruitment; methodology and limitations of the proposed approach; and expected products and results (e.g. educational approaches including training curriculum, training of trainer curriculum and process, and trainer of trainer process, workshops, meetings, conferences, exhibits, publications, electronic communications, fact sheets, newsletters, social media, webinars, and mass media). In addition, the review criteria should include:

a. Evidence of having successfully participated in national (domestic) and international 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.

b. 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, including training of both produce growers and training of trainers.

c. Evidence of ability to partner with FDA and other produce safety experts to maintain, and update as necessary, a standardized training and education program to assist the produce industry (including growers and packers) and regulatory agencies with the implementation of FDA’s requisite produce safety regulation, and ensure technical accuracy and alignment of training and outreach materials.

d. Evidence that the applicant is considered an authority on FDA’s produce safety regulation, on-farm produce safety, and on-farm food safety and environment co-management by stakeholders for this project, and that training offered under this project would be accepted as an authoritative source of information for the target audience.

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early-Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project? This criterion is used to assess adequacy of key staff, their functions, and their ability to reach producer growers and produce safety educators, capacity to provide training and technical assistance in both English and Spanish, reporting, accounting procedures, and the coordination of collaborative efforts with other federally supported produce safety education alliances and training partners.

Preference will be given to applicants that can demonstrate that key personnel are located across various regions of the United States. Include resumes and/or other documentation that show specific individuals that will work as primary project managers, key developers, and key delivery personnel, including years of direct experience.

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? 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. Innovative program delivery methods to reach desired audience/stakeholders, and expand grower access to training, and grow the network of trained produce safety educators

b. Methods to support, mentor, and provide continuing education to current produce safety educators regarding produce safety and FDA updates, and training delivery.

c. Program evaluation, including data collection and analysis, and communication plans

d. Database development and maintenance to collect and analyze training, participant, and trainer information, and reporting on data trends

e. A documented grower training plan and train the trainer plan, including a timeline to develop training and quality control procedures, any need to adapt or develop current training materials, program delivery methods, and plans to evaluate training efficacy.

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

If the project involves human subjects and/or clinical research, are the plans to address

1) the protection of human subjects from research risks, and

2) 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), justified in terms of the scientific goals and research strategy proposed?

This criterion is used to assess the likelihood that this project will develop and implement 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 a history as an expert/resource for the target audience (both growers and trainers), and ability to collaborate and lead relevant partners that also work with the target audience. Such partners include organizations with expertise in food safety education, such as the FSMA Alliances and regional training centers, as well as federal agencies with a role in food safety such as the USDA. Preference will be given to applicants that have a presence in various regions of the United States, have a demonstrated history of produce safety education and training of trainers, and have an existing network or platform to reach 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 and technical assistance; database development; and for key staff/administration

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? This criterion is used to assess the extent to which the target audience, including both produce growers, packers and shippers, and produce safety educators, will be receptive to this project. Additional consideration will be given to this project's ability to successfully collaborate with existing organizations focused on FSMA education and outreach, both domestically and internationally. Preference will be given to organizations that currently or have recently developed a training support infrastructure for produce safety education in both English and Spanish.

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.

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 Animals 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.

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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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 scientific peer review, all applications:

• Will receive a written critique.

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

Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO will be subject to terms and conditions found on the HHS Grant Policy Statement, this NOFO, and Notice of Award. 

Institutional Review Board or Independent Ethics Committee Approval: 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, 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/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals 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 information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, 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/sex-discrimination/index.html. For information about FDA's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what FDA's expectations are for institutions and the individuals supported on FDA-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws 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 except fellowships.

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 in 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.

Note: The FDA Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the FDA Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the HHS Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

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 HHS Grants Policy Statement.

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 HHS Grants Policy Statement. FDA NOFOs outline intended research 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. See the HHS Grants Policy Statement for additional information on this reporting requirement.

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: https://www.era.nih.gov/need-help (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: [email protected]

Benjamin Marshall
Center for Food Safety and Applied Nutrition
Office of Food Safety
Food and Drug Administration
Telephone: 301-906-8024
Email: [email protected]

Zahara Graves
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: [email protected]

Zahara Graves
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: [email protected]

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

Awards are made under the authorization of Section 1009 of the Federal Food, Drug, and Cosmetic Act (21 USC 399) and under Federal Regulations 42 CFR Part 52, 45 CFR Part 75, and 2 CFR Part 200. ICs should insert IC-specific regulations if applicable.