Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Office of Regulatory Affairs (ORA)

Center for Veterinary Medicine (CVM)

Center for Food Safety and Applied Nutrition (CFSAN)

Funding Opportunity Title

Building an Integrated Information Technology Infrastructure for State Regulatory Programs (U2F) [Clinical Trial Not Allowed]

Activity Code

U2F Food Safety Capacity and Infrastructure Building

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-22-021

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

One application per eligible entity

Assistance Listing Number(s)

93.103

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement is to build an integrated information technology (IT) data management system and user community to be utilized by state, local, territorial, and tribal (SLTTs) regulatory and public health partners for their human and animal food regulatory and public health programs. This cooperative agreement is intended to establish a robust IT infrastructure to assist SLTT regulatory and public health partners to better manage high quality regulatory programs and advance conformance with the regulatory standards.  The IT infrastructure will be designed with the capability to integrate with FDA data exchange systems, which supports information sharing between states as well as between FDA and state regulatory and public health partners.  The data management system and user community will support continuing efforts in achieving a national integrated food supply system (IFSS), promoting One Health, supporting domestic mutual reliance (DMR) initiatives and implementing the New Era of Smarter Food Safety Blueprint.

Key Dates
Posted Date

December 22, 2021

Open Date (Earliest Submission Date)

December 23, 2021

Letter of Intent Due Date(s)

January 20, 2022

Application Due Date(s)

February 22, 2022 by 11:59 PM Eastern Time.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

 

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2022

Advisory Council Review

Not Applicable

Earliest Start Date

May 2022

Expiration Date

February 23, 2022

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

The FDA Food Safety Modernization Act (FSMA), signed into law in January 2011, lays the strategic groundwork for fostering coordination and collaboration of food safety efforts across federal and state, local, tribal, and territorial regulatory and public health partners (SLTT partners) to establish a fully integrated food safety system (IFSS).  In coordinated efforts with the Food and Drug Administration's (FDA) strategic partners, the IFSS operations continue to implement risk-based inspections and investigations, ensure consistent and meaningful laboratory data and practices, establish national standards to ensure consistency across all jurisdictions, and improve response capabilities to foodborne illness outbreaks, recalls, and food emergencies.    

FDA continues to work towards achieving a national IFSS in addition to promoting One Health and supporting domestic mutual reliance (DMR) initiatives to protect the food supply for both humans and animals and advance public health. 

DMR is a seamless partnership that enables FDA and states with comparable regulatory public health systems, as trusted partners, to rely on, coordinate with, and leverage one another's work, data, and actions to meet the public health goal of a safe national food supply. One of the critical operations to advance these efforts is to have seamless and robust, high-quality data integration and information sharing mechanisms among our SLTT partners. Data management systems are also critical for states to implement and maintain conformance with the regulatory program standards, which is a foundational piece for FDA to rely upon state data.

As the work of FDA and SLTT partners requires us across local, regional, national, and global levels to achieve optimal health outcomes, we are also recognizing the interconnection between people, animals, plants, and their shared environment. FDA recognizes and supports a One Health approach to collaborate with stakeholders across disciplines and sectors using science, technology, and innovation to achieve optimal public health outcomes.  One Health is a collaborative, multisectoral, and transdisciplinary approach. As FDA and SLTT partners consider how to exchange data to support our work on human and animal food safety, we also need to consider how to share essential information, including epidemiological and laboratory data, across all public health sectors to effectively detect, respond, and prevent outbreaks of foodborne illness and to promote food safety.

Objectives

The Office of Regulatory Affairs (ORA) is soliciting a new application to support the planning, development, implementation, operation, and maintenance of a data management system to be utilized by our SLTT partners in both human and animal food programs. The grantee would need to have substantial involvement with SLTT partners to establish an integrated information technology infrastructure that enables data management, data exchange, and information sharing between and among SLTT partners and FDA. The grantee will ensure the projects have the maximum benefit to our regulatory and public health partners in advancing technologies to integrate regulatory data into a nation-wide repository as well as addressing the public health administrative functions such as licensing. 

The application should include a list of collaborators and their roles and responsibilities. The grantee will be expected to work directly with the user community involving a range of stakeholders including, but not limited to federal and SLTT partner agencies for the development and continuous improvement of the data management system.

This data management system should include the following capabilities and features:

  • Perform firm search and firm history
  • Store and share inspection and investigation reports, lab data, complaints, recalls, and enforcement actions.
  • Promote early identification and response to food emergencies by supporting product traceability and identifying trends in the supplier chain.
  • Support implementation and conformance to regulatory program standards with features to assist with risk-based categorization of firms, work-planning, tracking enforcement actions and compliance follow-up in response to violative findings, and tracking consumer complaints.

Once the data management system and ORA Data Exchange capabilities are fully developed, FDA will aim to establish data exchange capabilities between SLTT programs and FDA under separate agreements and in line with FDA's information sharing authorities.

Utilizing this data management system for the above components will increase efficiency and reliability of regulatory data shared amongst our SLTT partners to advance public health and promote regulatory compliance. The system will assist our SLTT partners to better manage high quality regulatory programs and advance implementation and conformance with the regulatory program standards by enhancing the management of regulatory records including firm inventory, inspection reports (for SLTT conducted inspections and FDA contract inspections), inspection frequencies, laboratory results, consumer complaints, recalls, and enforcement actions. The system will also strengthen collaborations across relevant public health sectors to prepare, detect, respond, and prevent future public health emergencies, such as foodborne illness outbreaks or infectious disease. Supporting a One Health approach includes sharing pertinent information such as complaint investigation and laboratory data.

The application should detail how the following will be achieved:

 

User Community

A. Defining, establishing, and identifying the needs of the stakeholders and user community.

B. Develop and maintain contracts, memorandum of understanding (MOUs), or other agreements with participating users. The agreements should encompass such provisions including but not limited to, establishing a non-public information sharing matrix with the user community, projected cost of each user for the development, continuous maintenance and improvement of the project, roles and responsibilities of each party, liability conditions, and obtaining consensus on user requirements. The grantee must collaborate with lead users and FDA during project development and execution.  

C. Promote widespread usage and adoption of the data management infrastructure by conducting outreach to recruit users across the human and animal food regulatory community. 

D. Develop a continuous improvement framework to be sustained by the user community, including implementation of a cost sharing model for all system users throughout the development, maintenance, and improvement phases of the project.  The cost sharing model should enable the grantee and users to support the maintenance, continuation, and long-term sustainability of the database after the project period. Provide a forum for soliciting user feedback and making system improvements.

E. Determine participation criteria of SLTT partners to align with the scope of this project. This data management system may support non-FDA programs based upon user needs and requests using non-FDA funds.  The grantee should identify and ensure those costs are incurred by the users or other funding sources as FDA grant funds may only be used to support programs directly related to the mission and regulatory responsibilities of FDA.

F. Collaborate with user community to seek innovative approaches to support the One Health concept by leveraging the data management system

Technology and policies

A. As the data management system is developed, an aim of this project will be to support implementation of data integration, i.e., integrate with ORA Data Exchange (DX), a bidirectional unified platform to securely share information between regulatory partners and FDA. Capabilities of the ORA DX include sharing of FDA data such as firm inventory to state partners and streamlining inspection and lab sample data submissions from state partners to FDA. The ORA DX encompasses component applications for inspection, lab sample, and firm inventory data exchange capabilities including a website portal called the ORA Partners Portal (ORAPP) and a system-to-system web service application programming interface (API) called the National Food Safety Data Exchange (NFSDX). It also includes a downloadable XML-based Enhanced DX Client application for sample data submissions from state labs to FDA. In addition, the ORA DX integrates with other FDA systems including the ORA Field Accomplishments and Compliance Tracking System (FACTS) and the Electronic State Access to FACTS (eSAF), as well as planned future integration with the Automated Laboratory Information System (ALIS). The ORA DX is managed by the ORA Office of Information Systems Management (OISM) and Office of Information Management and Technology (OIMT) in close collaboration with stakeholders across FDA and state regulatory partners. The grantee shall provide development, maintenance, and support for the data management system using processes that facilitate coordination and interoperability with the ORA DX, including but not limited to:

  • Continuously enhance the data management system with new and updated capabilities to ensure ongoing interoperability and feature parity with FDA updates to the ORA DX, as well as interoperability with related FDA systems such as FACTS, eSAF, and ALIS, on a timeframe and release schedule agreed to by the grantee and OISM/OIMT stakeholders.
  • Utilize software development methodologies to ensure long-term sustainability and ease of use and maintenance by state regulatory partners during and after the cooperative agreement period of performance, as well as reduced duplication of effort for development of data exchange systems across the grantee, FDA, and state regulatory partners (including but not limited to open-source development of the data management system for use by FDA and any state regulatory partner, shared application frameworks, publishing standards and documentation, and API management)
  • Develop and implement contingency plans to ensure data are available and maintained during and after unforeseen events.
  • Coordinating with OISM/OIMT stakeholders on software architecture, design, and management processes to increase adoption of the ORA DX by current and future state regulatory partner users of the data management system, including continuous system enhancements and process improvements to reduce the time and resources required to onboard, upgrade, and troubleshoot and fix integration issues between the ORA DX and the data management system as well as integration issues with related FDA systems such as FACTS, eSAF, and ALIS.
  • Support and provide activities to monitor and maintain availability of state regulatory partner integrations between the ORA DX and the data management system as well as its related FDA systems such as FACTS, eSAF, and ALIS. This includes end-to-end system reliability, testing, quality assurance, and timely resolution of outages and bug fixes.

Grantee will need to ensure IT vendor(s) and/or other supportive vendors enter into non-public information disclosure agreements with the participating SLTT partners as necessary to protect state and FDA regulatory information. In order to promote appropriate information sharing, the applicant must have 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.

B. Leverage and adopt technologies, tools, and approaches in supporting New Era of Smarter Food Safety Blueprints.  For example:

  • Ensure the data management system is designed to be interoperable with other systems to monitor and share data between stakeholders on accelerated tracebacks and traceforwards
  • Advance New Era Blueprint core element 2.3 (Domestic Mutual Reliance), to further develop and enhance the mechanisms for appropriate data and information sharing to enable FDA and states with comparable regulatory and public health systems to more fully rely on, coordinate with, and leverage one another’s work, data, and actions

C. Leverage and adopt technologies, tools, and approaches in supporting Domestic Mutual Reliance in collaboration with the FDA and user community.  For example:

  • Ensure the data management system is designed to be interoperable with other systems to share data and advance an integrated approach to work-planning and risk prioritization/categorization including inspection frequency mandates, comparison/reconciliation of inventories, and sample collection
  • Support future advancements of a Food Safety Information Network to enable FDA to work closely with state regulatory human and animal food safety programs to extend efforts to protect public health; collaborate with states to develop and sustain a highly trained workforce and build quality management systems and the infrastructure needed to meet national regulatory program standards

D. Leverage and adopt technologies, tools, and approaches in supporting a One Health approach. For example:

Ensure the data management system is designed to be operable with other systems to support cross-jurisdictional coordination and information sharing to address localized environmental contamination in agricultural/farm production, such as produce outbreaks linked to the environment

E. Protect and ensure compliance with applicable regulations on data security, privacy, and usage

F. Identify and address barriers to using the data management system

G. Provide documentation on policies for data retention, records management, and security within the repository

 

Resources

A. Indicate how the project will be monitored and managed, frequency of oversight, and by whom (e.g., titles, roles). Additionally, determine how the project will support seamless user migration from existing data management systems to the new system.  

B. Ensure project team have adequate resources and knowledge to ensure project timelines are met.

C. Provide, or has a mechanism for others to provide, quality assurance to improve the accuracy and integrity of datasets and metadata.

D. Ensure administrative, technical, and physical safeguards are employed to comply with applicable confidentiality, risk management, and continuous monitoring requirements for sensitive data.

E.  Implement procurement practices and a strategy that accomplishes the objectives of the cooperative agreement and promotes diversity. FDA is committed to promoting Diversity, Equity, Inclusion and Accessibility (DEIA) to achieve 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 US 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 48 CFR 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.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New  

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for two (2) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

FDA /ORA intends to commit up to $6,000,000 in FY 2022 to fund one award.

Award Budget

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $6,000,000

YR 02: $6,000,000

YR 03: $6,000,000

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is three (3) years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations
  • Nonprofits Other Than Institutions of Higher Education
  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

This opportunity is only available to the following nonprofit food safety training entities that collaborate with 1 or more institutes of higher education:

National organization/associations whose membership includes, but is not necessarily limited to, state, local, territorial, and/or tribal food safety regulatory professionals or government agencies and who collaborate with one or more institutions of higher education as defined in 21 USC §399(b).

Competition is limited to these national organizations/associations for the following reasons:

These national organizations/associations must have the knowledge and understanding of the following but are not limited to state unique regulatory program data management requirements; data sharing initiatives between SLTT and federal partners; state needs and procurement requirements; regulatory program standards and the requirements to achieve conformance. These national organizations/associations have a vested interest and share FDA’s visions to improving food safety and public health outcomes.  They strive to lead other initiatives to advance building an integrated food and public health safety system.

National organizations/associations can provide a platform for sharing information and national implementation of the projects through national and regional meetings, web sites, listservs, and other communications. They have relationships and communication systems to effectively promote the objectives established under this cooperative agreement. 

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.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM)– 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

If the sentence above is not true, and the Number of Applications field in the first table states that only one application is allowed, IC must insert a comment to change the sentence above to “Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.”Applicant organizations may not submit more than one application. Only one application per organization is allowed.

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

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

 

Section IV. Application and Submission Information
1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 FDA 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), email 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 via electronic mail as a PDF file with the FOA number and the Institution's Name in the message subject heading to:

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

A technical session will be held for prospective applicants in February 2022. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process.  Participation in the technical session is optional, but strongly encouraged. 

Page Limitations

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

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R 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 in excess of $25,000.
  • Funds should be requested in the budget for key project personnel to travel to meetings, on-site visits, and audits with FDA program staff to discuss the project. A portion of budgeted travel funds should also be set aside for key personnel to attend an annual face-to-face meeting (as determined by FDA/OP), conferences and committee meetings supporting this project. Training needs should also be anticipated and budgeted for accordingly.
R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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

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

Appendix:

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

PHS Human Subjects and Clinical Trials Information

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.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA’s electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

A decrease in the amount of the non-competitive segment may occur if there is an unobligated balance from the prior year, in which case prior year funds can be used as an offset for the current year award.

Appropriated funds shall not be used to purchase promotional items when they are not a necessary expense.

Continued funding of a non-competitive segment is contingent upon satisfactory progress as determined by the FDA program/technical staff, the receipt of a non-competing continuation application, submission of an acceptable annual report and the availability of Federal funds.

Allowable costs (including but not limited to):

1. Subawards/contracts to third parties for the scope of this project

2. Audiovisual materials

3. Consultant services for the scope of this project

4. Employee salaries, wages and fringe benefits

5. Rental, purchasing, calibration, and maintenance of supplies and equipment

6. Indirect costs based on a signed, current federal indirect cost rate agreement

7. Recruitment costs for hiring new employees

8. Registration fees

9. Purchase or development of IT equipment, software, and support

10. Shipping and mailing of equipment and supplies

11. Travel (shall not exceed coach class fare)

12. Speaker fees

Non-allowable costs:

1. Facilities, work, and training reimbursed under the FDA food safety inspection contract, the FDA feed safety inspection contract and other funding mechanisms shall remain distinct and separate from the cooperative agreement.

2. Vehicle purchases are not permitted.

3. Cooperative agreement funds may not be utilized for new building construction or remodeling of existing facilities.

4. Cooperative agreements funds may not be utilized for uniforms or clothing except Personal Protective Equipment (PPE).

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

7. Other Submission Requirements and Information

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.

 

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

 

See more tips for avoiding common errors.

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

 

Post Submission Materials

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.

Section V. Application Review Information
1. Criteria

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit.

Significance (20 Points)

How does the project address an important problem or a critical barrier to progress in the field? How does previous work support the proposed project? If the aims of the project are achieved, how will collaboration and coordination between SLTT partners and FDA be improved? How does the project address the utilization of specified small business concerns to achieve the aims? How will successful completion of the aims improve the regulatory standard programs, support One Health and advance toward an integrated public health system? Does the proposed IT infrastructure have the potential to be widely adopted by the relevant regulatory and public health partners?

Investigator(s) (20 Points)

Do the PD/PI(s) and key personnel have the expertise, experience, and ability to coordinate, manage, and implement the proposed integrated data management system to meet project milestones and timelines? Do the PD/PI(s) provide adequate leadership approach, governance and organizational structure appropriate for the project. How have the PD/PI(s) and key personnel demonstrated the ability to collaborate with regulatory and public health agencies in support of the proposed integrated information technology infrastructure?

Innovation (20 Points)

How does the application seek innovative technology to support its intended use and purposes? Is the proposed data management infrastructure capable of supporting continuous innovative technology and ideas to further advance an integrated public health system, New Era of Smarter Food Safety, and Domestic Mutual Reliance and to support One Health approach? 

Approach (20 Points)

Is the overall strategy, planning, and analyses well-reasoned and robust to ensure the project supports user needs, primarily in the FDA regulated programs? Does the approach for purchasing goods and services support the utilization of specified small business concerns? If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Are the procedures for data management and quality control of data standardized and adequate for each user?

Sustainability and Integration (20 Points)

Demonstration of feasible plans to facilitate the implementation of continuous data exchange and   integration, long-term sustainability of the system and engagement of user community during and after the cooperative agreement period of performance. Demonstration of adequate program resources and infrastructure, or the ability to obtain the resources necessary, to complete the project and sustain the system beyond the project period. 

Additional Review Considerations

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

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan 
 

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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable   

Select Agent Research

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).

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the objective review, all applications:

  • Will receive a written critique.

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

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

  • Scientific and technical merit of the proposed project as determined by objective review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

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
1. Award Notices

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

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions and in the Notice of Award. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found in the HHS Grants Policy Statement, this FOA, and Notice of Award.   

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

2. Administrative and National Policy Requirements

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

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

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

 

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

 

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 2000.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all FDA grants and cooperative agreements.

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

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

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

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

Standard Terms and Conditions of Award

Reporting Requirements:

All FDA grants require both Financial and Performance reporting.

Financial Reporting:

A. Cash Transaction Reports

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

B. Financial Expenditure Reports

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

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

Performance Progress Reporting:

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

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

Salary Caps:

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

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

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

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

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

Acknowledgment of Federal Support:

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

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

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

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

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

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

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

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

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

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

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

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

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

1. Change in Grantee Organization

2. Significant Rebudgeting

3. Change in Scope or Objectives

4. Deviation from Terms and Conditions of Award

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

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

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

Audits and Monitoring:

Audit Requirements:

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

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

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

U.S. Department of Health and Human Services

Audit Resolution Division, Room 549D

Attention: Robin Aldridge, Director

200 Independence Avenue, SW

Washington, DC 20201

Monitoring:

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

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

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

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

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

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

Financial Conflict of Interest (FCOI):

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

Closeout Requirements (when applicable):

A Final Research Performance Progress Report (FRPPR), Final Federal Financial Report SF-425, Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 90 days after the expiration date of the project period. All closeout documents must be submitted electronically in eRA Commons.

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

Program Income:

The grantee is required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the grantee’s Federal Financial Report (FFR) SF-425.

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

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

Treatment of Program Income:

Prohibition on certain telecommunications and video surveillance services or equipment:

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

(1) Procure or obtain,

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

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

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

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

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

Other:

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

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

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

Special Terms and Conditions of Award

Grantee shall have an established detailed work agreement with each subaward and contractor for each budget period.

The grantee must have 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.  The grantee must ensure any subcontractors or other key personnel can also enter into the required information sharing agreements with the grantee, FDA and SLTT partners.

Additional Reporting Requirements:

All FDA grants require annual financial and performance progress as stated in Section III.  This award has additional performance reporting requirements as outlined below.

Performance

Mid-year interim performance progress reports are required for this award.  The interim performance progress reports should be submitted via email to the listed Grants Management Specialist and Program Official by October 30th.

The Research Performance Progress Report (RPPR) will be considered the annual program progress report for the budget period.

Mid-year and annual progress reports shall contain the elements below as applicable to the grantee proposal and award, but are not limited to, the following:

1. Detail progress report on the grantee meeting the project milestones detailed in the cooperative agreement, strategic plan, conditions of the award, etc.  Goals and objectives should be separately identified, and specific progress reported.  Provide forecast project completion.

2. Summary of funding requests received and subawards issued with the following information, at a minimum: name and contact information of vendor, summary project proposed, funds requested, funding decision, and progress of projects/sub awardees selected for funded.

3. Contributions of personnel, especially employees receiving salary and/or benefits through the cooperative agreement or identified as key personnel, towards the goals of the cooperative agreement should be reported against. Contributions should be directly related to the objectives of the funding agreement. Additionally, status report on the hiring and training of funded personnel will need to be provided.

4. Summary of major changes approved by stakeholders in the reporting period.

5. Identify pending risks and issues that may affect accomplishing the objectives and goals of this project. If the objectives and goals are not being met, then a corrective action plan shall be submitted to include, at minimum, the following details: tasks, responsible personnel, and updated timeframes to ensure satisfactory performance and meet the deliverables of this project.

6. Summary report on surveys, field testing, assessments, and other activities conducted in support of the cooperative agreement goals, including evaluation of effectiveness, response rates, impact, and recommendations. Provide trend analysis, including analysis of past performance.

7. Status report on contracts and/or other agreements with current participating users and pending eligible users including detailed cost-sharing model agreements.

8. Status report on outreach and involvement with user community including the following:

  • Conduct outreach to promote widespread usage and adoption of the data management system
  • Solicit user feedback for system process improvements
  • Develop strategies to promote best practices for cost sharing, system utilization and information sharing  

9. Status report on the purchasing and operational readiness of any equipment, computers, and/or software purchased in the reporting period.

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

In addition, work proposed and conducted under this cooperative agreement, including subawards issued, may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed and conducted under this cooperative agreement and the funding provided shall remain distinct and separate from other projects and funding sources. The grantee shall be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.

The grantee and FDA will determine any additional specific progress reporting requirements within 90 days of the award. 

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR 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 the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) shall have the primary responsibility for the scientific, technical, and programmatic aspects of the grant and for day-to-day management of the project or program.  The PD/PI(s) shall maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff has sufficient clearance and/or background checks to work on this project or program. This individual shall work closely with designated officials within the recipient organization 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 and organizational requirements.

FDA and participating users shall retain custody of and have primary rights to the applicable data and software developed under this award, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies.

Additionally:

1. The PD(s)/PI(s) will host at minimum quarterly virtual meetings with FDA staff to check-in on project progress and discuss items that necessitate FDA feedback or guidance.

2. The PD(s)/PI(s) will host at minimum quarterly virtual meetings with FDA staff and all stakeholders to discuss project progress and address process improvement obtained from user community feedback.

FDA Responsibilities:

The Grants Project Team may consist of a Grants Management Specialist, 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:

  • -Provide guidance, direction, and technical assistance in project planning, implementation, and evaluation;
  • -Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;
  • -Actively monitor the supported program via telephone conversations, webinars, e-mails, written correspondence, or periodic site visits;
  • -Evaluate the supported program, including development of program-level performance measures, consistent data collection, and reporting procedures and protocols;
  • -Convene trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing;
  • -Participate in data analysis, interpretation of findings, and where appropriate, co-authorship of publications;
  • -Development of programs to meet the FDA mission;
  • -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.

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 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.

3. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. 

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

Program Official Contact(s)

Shannon Lowe
Office of Management (OM)
Office of Regulatory Affairs (ORA)
Telephone: 214-253-5304
Email: shannon.lowe@fda.hhs.gov

Project Manager/Technical Advisor Contact(s)

Anh Lac
Office of Partnerships (OP)
Office of Regulatory Affairs (ORA)
Telephone: 240-641-3052
Email: anh.lac@fda.hhs.gov

Objective Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

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 and 45 CFR Part 75 and 2 CFR Part 200.

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