It is critical that applicants follow the Multi-Project (M) Instructions in the 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

Background:

To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) has established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. The FDA established these standards in its rule, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human

Consumption (commonly referred to as the "Produce Safety Rule"), as part of the implementation of the FDA Food Safety Modernization Act. To achieve the requirements of the Produce Safety Rule, a wide-ranging level of cooperation between federal, state, and territory produce regulatory entities is required. Many state and territorial regulatory and food safety agencies plan to align, are in the process of aligning, or have already aligned their produce safety regulatory authority and

practices to reflect the modernized aspects of the Produce Safety Rule. Such alignment requires significant investment to successfully develop and implement multifaceted programs in support of the Produce Safety Rule that are nationally uniform and consistent.

Purpose:

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) is announcing the availability of a cooperative agreement to be awarded under Limited Competition to a national association or organization whose membership includes State, local, territorial, and/or tribal (SLTT) produce safety regulators or SLTT government agencies that are responsible for produce safety.

This cooperative agreement program is intended to assist the FDA in developing, implementing, and improving a nationally consistent system of support which facilitates the implementation of state and territorial produce safety regulatory programs that are modernized and aligned with the standards set forth in the FDA’s rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (commonly referred to as the Produce Safety Rule).

The purpose of this support system will be to assist these agencies, in conjunction with the FDA, in advancing efforts for a nationally integrated food safety system through planning, establishment, and/or enhancement of state and territorial produce safety regulatory programs that encourage the safe production of fresh fruits and vegetables, promote understanding of the Produce Safety Rule and enforce compliance with the Produce Safety Rule's requirements.

Primary Program Objectives of this cooperative agreement are to:

1.) Support the efforts of Federal and State government agencies to build a Produce Safety Integrated Food Safety System.

2.) Assist FDA and States in promoting produce farm understanding of and verifying produce farm compliance with the Produce Safety Rule (21 CFR Part 112) and support state implementation of the Produce Regulatory Program Standards (PRPS) by establishing systems for sharing, promoting, and collaborating on best practices, operating documents, procedures, and other tools to foster consistency in a national produce safety program. 

3.) Support the maintenance and advancement of the Produce Regulatory Program Standards (PRPS).

 

Specific activities to be conducted under this cooperative agreement are:

1.) In collaboration with FDA, establish forums to elicit, discuss, and address topics identified by produce stakeholders relative to the implementation of the Produce Safety Rule by produce farms and the national produce safety programs at large by:

a. Supporting new and existing workgroups that consist of representative members from the FDA and state and territorial produce safety regulatory programs.

b. Developing for each workgroup: a charter, workflow timelines, and summary/recommendation papers.

c. Serving as the project manager providing support to organize, run, and facilitate the forums, workgroups, and subgroups.

d. Maintaining a repository, of all in-progress and final documents created under this cooperative agreement.

e. Having concurrence from the FDA prior to initiating workgroups and charters, charges and timelines identified by the grantee.

2.) Annually updating and conduct continuous review to the Model Produce Safety Implementation Framework. The grantee will review the existing framework and identify areas of improvement, incorporate new information, best practices, and regulatory changes into the framework. Make the document available in print and/or digital form and distribute the updated document at each National Consortium.

3.) Establish and execute mentoring programs between state and territorial produce safety regulatory agencies as it pertains to the Produce Safety Rule and enrolled programs of the Produce Regulatory Program Standards (PRPS). The grantee, in coordination with the FDA, identifies potential mentor and mentee relationships based on program needs, and facilitates the programs in coming to a mutually agreed upon scope for their relationship. The grantee will facilitate the relationships and permit the participating programs to direct the content of the relationship to suit their identified needs. Needs and scope of the mentoring partnerships could include challenges to the application and implementation of the Produce Safety Rule and the Produce Regulatory Program Standards (PRPS).

4.) The grantee will organize, with the FDA’s full participation and collaboration, the annual National Consortium meeting, by supplying project management and support to the process of establishing the planning committee, developing the agenda, organizing the meeting, running the meeting, capturing outcomes, developing timelines/responsibility for action items, and posting meeting information. The grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda developed in conjunction with FDA. Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.

5.) The grantee will update and improve On-Farm Readiness Reviews (OFRR) training manuals and other related documents and activities, as necessary, in conjunction with the FDA and current recipients and future state and territorial produce safety implementation cooperative agreement program grantees and will ensure the OFRR materials reflect the most current PSR requirements. In addition, grantee will maintain the OFRR online data resource site. The site shall contain complete and comprehensive finalized information related to conducting domestic OFRRs. The resources shall be fully accessible to the FDA and to state and territorial produce safety programs funded under the current and future state and territorial produce safety implementation cooperative agreement program. The grantee will gather data from the OFRRs and provide information to FDA.

6.) Research and identify additional training needs and gaps for state and territorial implementation of programs related to the Produce Safety Rule by:

a. Providing collected data to the FDA and training partners for consideration.

b. Working with the FDA and training partners to determine how the gaps can be addressed.

c. Delivery of approved training to state and territorial produce safety regulatory agencies.

7.) Assist the FDA in the implementation, promotion, and maintenance of the Produce Regulatory Program Standards (PRPS). To accomplish this goal, the following sub-objectives are to be accomplished in full coordination with the FDA:

a. Establish a group to support revisions and updates, as necessary, to the Produce Regulatory Program Standards (PRPS) through a process involving the FDA, state and territorial produce regulatory programs, and association stakeholders.

b. Assist the FDA and state and territorial produce regulatory programs in developing, implementing, and recommending changes to the Produce Regulatory Program Standards (PRPS) technical guidance.

c. Share best practices for the Produce Regulatory Program Standards (PRPS).

d. Host at least one annual meeting (face-to-face or virtual), either standalone or in conjunction with other national produce meetings, to assist produce regulatory programs in achieving implementation of the Produce Regulatory Program Standards (PRPS). 

e. Assist FDA in conducting analysis of produce regulatory programs capabilities as needed

The FDA is committed to promoting Diversity, Equity, Inclusion, and Accessibility (DEIA) to achieve the FDA’s mission to protect public health. The grantee is expected to promote diversity among the vendor(s) for goods and services by developing a diversity procurement strategy. The grantee should use their diversity procurement strategy to take all necessary affirmative steps to assure that disadvantaged and women-owned small business concerns, as defined by the U.S. Small Business Administration and outlined in 13 CFR 124-103(b) and 13 CFR 127.200, are solicited for all procurement opportunities whenever there are possible sources. This provision is in support of Federal Acquisition Regulations (FAR) Part 52.219.8 Utilization of Small Business Concerns. The HHS Small Business Office can be solicited for recommendations. The grantee should also consider the diversity efforts of vendors as selection criteria for purchasing goods and services especially when disadvantaged and women-owned small businesses cannot be directly utilized. The grantee may be asked to participate in outreach efforts such as conferences and/or trade shows for the purpose of this provision.

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

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

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

Section 1009 of the Federal Food, Drug and Cosmetic Act, 21 USC 399, legibility to State, local, territorial, and tribal agencies and non-profit training entities that collaborate with 1 or more institutions of higher education. This limited competition award is only available to nonprofit national food safety training associations/organizations that collaborate with 1 or more institutions of higher education.

Applicant associations must hold an information sharing agreement with FDA under 21 CFR 20.88(e) or be able to obtain an agreement prior to the start date of the award. Information sharing is limited to pre-decisional information and only for the purpose outlined in this award.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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, please reference HHS Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

• 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.
  • 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.
  • 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 his/her 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 NIH Grants Policy Statement Section 1.2 Definition of Terms.

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

 

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is 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.

Letter of Intent

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

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Zahara Graves
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration

Email: [email protected]

 

Page Limitations

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

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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 more than $25,000.

The budget justification should also include how resources will be allocated between high and low priority projects.

R&R Subaward Budget

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

A detailed budget and justification must be submitted for each proposed subaward

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

In the research strategy section, the applicant shall address the following:

1. Demonstrate how the applicant will support the efforts of Federal and State government agencies to build a Produce Safety Integrated Food Safety System.

2. Demonstrate how the applicant will assist FDA in the implementation of the Produce Safety Rule and applicable Produce Regulatory Program Standards (PRPS) by establishing systems for sharing, promoting, and collaborating on best practices, operating documents, procedures, and other tools to foster consistency in a national produce safety program.

3. Provide plans to achieve the objectives and activities of the proposed project on time and within budget, and include clearly defined responsibilities, timelines, and milestones for accomplishing project activities.

4. Demonstrate the applicant's relevancy of background, expertise, and administrative experience of key project staff that will direct, manage, and administer the program and/or identify key hires that will be necessary to carry out the program.

5. Demonstrate the applicant's experience and success in leading and coordinating program development, project management, communication strategies, and evaluation activities.

6. Propose clear performance metrics to monitor progress and outcomes of proposed activities.

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

Announcement.

8. Provide a properly detailed budget to meet the project objectives. 

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.

Other Plan(s):

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.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or FDA-defined 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.

PHS Assignment Request Form

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. 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. 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.

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

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

Non-allowable costs:

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

2. Vehicle purchases are not permitted.

3. Cooperative agreement funds may not be utilized for new building construction.

4. Food may not be purchased.

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

Add additional information about funding restrictions. If any of these restrictions become part of the terms of award, that must be stated in Section VI.1.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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 NIH.

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 Center for Scientific Review and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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

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

1. The extent to which the applicant demonstrates how they will support the efforts of Federal and State government agencies to build a Produce Safety Integrated Food Safety System.

2. The extent to which the proposed project demonstrates how the applicant will assist FDA in the implementation of the Produce Safety Rule and applicable Produce Regulatory Program Standards (PRPS) by establishing systems for sharing, promoting, and collaborating on best practices, operating documents, procedures, and other tools to foster consistency in a national produce safety program.

1. The extent to which the project design and management plan demonstrates how the applicant will achieve the objectives and activities of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.

2. The extent and relevancy of background, expertise, and administrative experience of key project staff that will direct, manage, and administer the program and/or identify key hires that will be necessary to carry out the program.

3. The extent to which the applicant proposes clear performance metrics to monitor progress and outcomes of proposed activities.

1. The extent to which the applicant documents strong partnerships and collaborations with produce safety stakeholders, including federal, state, and territorial produce regulatory entities.

2. The extent to which the applicant demonstrates its experience and success in leading and coordinating program development, project management, communication strategies, and evaluation activities.

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

Applications 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 objective review will not be accepted for applications submitted in response to this NOFO.

Applications will compete for available funds with all other recommended applications. 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.

After the objective 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 objective review, and earliest start date.

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.

Section VI. Award Administration Information

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 in the HHS Grants Policy Statement, this FOA, and Notice of Award. 

All FDA grant and cooperative agreement awards include the HHS 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 NIH 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 NIH'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 HHS Grants Policy Statement.
• 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 NIH grants and cooperative agreements except fellowships.

If you wish to add specific award terms and conditions, insert a comment for OER to add and verifying that OPERA has reviewed and approved

Cooperative Agreement Terms and Conditions of Award

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 are anticipated during the performance of the activities. Under the cooperative agreement, FDA’s objective is to support and stimulate the recipient’s activities by involvement in and otherwise working jointly with the award recipient 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 awardee for the project as a whole, although specific tasks and activities may be shared between the awardee and the FDA as defined below:

Project Director/Principal Investigator Rights and Responsibilities:

The Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA/ORA staff being substantially involved as a partner with the PD/PI, as described below.

The PD/PI will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff have the necessary training and clearance to work on this project. This individual will work closely with designated officials within the recipient organization and with partner organizations to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal, regulatory, and organizational requirements.

FDA Responsibilities:

The Grants Project Team may consist of a Grants Management Specialist (GMS), Program Official (PO), Project Manager (PM) and Technical Advisor. The Grants Project Team collaborates to review the progress of the grantee. The Grants Project Team may utilize the grantee’s progress reports, site visits, audit reports and other supporting documentation to determine if the condition of the award was met and satisfactory progress is being made. Each team member works in consultation with each other, as needed, throughout the duration of the project. A description of each team member involved with the program are described below.

An FDA Grants Management Specialist (GMS) will be assigned and named in the Notice of Award. The GMS oversees the administrative, financial, business, and other non-programmatic aspects of the program. These activities include, but are not limited to the following:

• Provides guidance on administrative, business, fiscal aspects of grants management to grantees and FDA program staff
• Monitors and manages applications and required reports on eRA Commons
• Monitors administrative and financial aspects of grantee activities
• Maintains the official grantee file

An FDA Program Official (PO) will be assigned and named in the Notice of Award. The PO is accountable for the programmatic oversight of the grant to include coordination, with the Project Manager, on the technical aspects of the grant. S/he ensures the budget of grantees are reasonable and costs are allowable and allocable. The PO reviews the progress reports to verify the budget proposed includes only allowable expenses that support the project goals and objectives. The PO also assists with post-award monitoring and establishing a corrective action plan, if necessary.

An FDA Project Manager (PM) will be assigned to the program. The FDA PM is the responsible official for the programmatic, scientific, and/or technical aspects of assigned applications and cooperative agreements. The FDA PM will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below.

The PM will have substantial involvement in the design, implementation, and evaluation of program activities, and dissemination of program results and outcomes, above and beyond routine grant monitoring. Substantial involvement by FDA/ORA includes, but is not limited to, the following:

• Provides guidance, direction, and technical assistance in project planning, implementation, and evaluation.
• Provides subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities.
• Actively monitors the supported program via telephone conversations, webinars, e-mails, written correspondence, or periodic site visits.
• Evaluates the supported program, including development of program-level performance measures, consistent data collection, and reporting procedures and protocols.
• Convenes trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing.
• Participates in data analysis, interpretation of findings, and where appropriate, co-authorship of publications.
• Develops programs to meet the FDA mission.
• Provides programmatic technical assistance.
• Performs post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the FDA. 

An FDA Technical Advisor(s) will be assigned to each enrolled program. The Advisor will work cooperatively with the PO to help monitor and report grantee status/progress including sharing of information and historical backgrounds. The FDA Technical Advisor will have programmatic involvement as described below including but not limited to the following:

• Provide guidance, direction, and technical assistance in project planning, implementation, and evaluation.
• Convene trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing.
• Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities.
• Provision of programmatic technical assistance.
• Post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the FDA.

Unless another governance structure is mutually agreed upon, the PO will serve as the primary point of contact for the dissemination of FDA policy and milestones/objectives work planning.

Property rights (if the awardee develops something tangible):

The awardee will retain custody of, and have primary rights to, the data and software (including all source files) developed under these awards, subject to government rights of access consistent with current DHHS, PHS, and FDA policies. In all cases, FDA must be given a royalty-free, nonexclusive, and irrevocable license for the federal government to reproduce, publish, or otherwise use the material and to authorize others to do so for federal purposes. Curriculum and course content developed under this cooperative agreement grant such as objectives, learning outcomes, presentations, manuals, scripts, exercises, handouts, reports, documents, or other tangible materials produced by the awardee must be guaranteed free of copyrights from outside sources and be free domain for use by FDA. Any FDA curriculum or training course content provided by FDA will remain the property of FDA and any proposed changes are not to be made without concurrence from FDA.

Delineation of substantive involvement:

1. FDA will monitor and evaluate the overall performance of the awardee under this cooperative agreement

2. FDA will collaborate and work closely with awardee’s continued development

3. FDA will take any action that may be necessary to ensure compliance with this cooperative agreement

4. FDA may choose not to have significant input or control on some projects and tasks as it may be deemed more suitable for the awardee to lead and control the design, methodology, analysis, development and/or delivery of work.

Monitoring Activities

Periodic program monitoring will be conducted by FDA on an ongoing basis which may include telephone conversations, emails, on-site visits, review of written progress reports, audit assessments, financial reports, etc. The results of these monitoring activities will be recorded in the official cooperative agreement file and will be available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations. Also, the grantee organization shall comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the FDA Staff assigned to the program.

The Project Manager and Technical Advisor conduct the monitoring of the grantee’s performance, provide technical advice and assistance and, when necessary, investigate problems or deficiencies identified during review of reports.

The Grants Project Team (Grant Management Specialist, Program Official, Project Manager and Technical Advisor(s)) reviews the progress report to verify the satisfactory progress is being made toward the project objectives and goals in the project, proposed activities are allowable and within the guidelines of the FOA and budget proposed includes only allowable expenses that support project goals and objectives. When necessary, the Grants Project Team will investigate problems or deficiencies identified during review of reports and determine the corrective actions required.

Performance deficiencies will be addressed by requiring a revised progress report, submission of a corrective action plan, increased reporting requirements, funding restrictions, and other methods, including up to suspension or termination of the award. The Annual Progress Report will be due as part of the Research Performance Progress Report (RPPR) and is due no later than 60 days prior to the start date of the next budget period.]

Additional requirements may be listed in the Notice of Award

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.

• A Data Management and Sharing Plan is not applicable for this NOFO.

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

In addition, completion of a program specific Progress Report Template is due for annual progress reporting. The program specific progress report template is attached to this NOFO and will be provided with the Notice of Award (NOA). The Progress Report Template allows for the recording of progress towards program goals and objectives.

Mid-year and annual progress reports must report against the progress made for each of the objectives and activities outlined in the application.

 

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.

Additionally, progress reports on the diversity procurement strategy for the utilization of disadvantaged and women-owned small businesses should include the following:   

• Indicate the outreach and marketing efforts for procurement activities to solicit goods and services  
• Summarize methods used to distribute the solicitation
• Indicate the small business concerns that applied and received awards
• A Final Summary report is required annually and submitted within 90 days after the expiration date of the project’s period of performance(s) and should include the total diversity spend and count of disadvantaged and women-owned business procurement activities under this provision.

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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Laurie Keppley
Office of Regulatory Affairs (ORA), Office of Management (OM)
Telephone: 240-402-7736
Email: [email protected]

Danielle Head
Office of Regulatory Affairs (ORA), Office of Partnership (OP)
Telephone: 240-377-6624
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 45 CFR Part 75.