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)

Funding Opportunity Title

Revision Applications - Manufactured Food Flexible Funding Model Compliance and Enforcement Expansion Supplement (U18) [Clinical Trials Not Allowed]

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

NOT-OD-22-018 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available

NOT-OD-21-181 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients

NOT-OD-21-169 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022

NOT-OD-21-170 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements

NOT-OD-21-109 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel

Funding Opportunity Announcement (FOA) Number

RFA-FD-22-019

Companion Funding Opportunity

RFA-FD-18-001 - Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U18)

PAR-20-105 - Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed

Assistance Listing Number(s)

93.103

Funding Opportunity Purpose

The goal of this cooperative agreement is to advance public health by building the capacity and capability of grantees to take the appropriate action in response to confirmed and potentially violative samples identified as part of the Laboratory Flexible Funding Model (LFFM) cooperative agreement.

By participating in this program expansion, the capabilities of the laboratory and regulatory programs will be integrated to ensure a comprehensive approach to the prevention, identification, containment, and removal of adulterated, contaminated, or mislabeled products in the marketplace.

Key Dates
Posted Date

January 20, 2022

Open Date (Earliest Submission Date)

February 1, 2022

Letter of Intent Due Date(s)

February 15, 2022

Application Due Date(s)

April 4, 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

May 2022

Advisory Council Review

Not Applicable

Earliest Start Date

July 2022

Expiration Date

April 5, 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) outlines a new approach to food safety that is risk-informed and preventive in focus. Recognizing that sample testing can play a greater role in helping the Agency and our regulatory partners prevent contaminated product from reaching consumers, understand risks, and assess the value of strategies to control those risks, Food and Drug Administration has begun the process of rethinking how the agency deploys its resources.

In order to develop prevention-based systems, data and other information are needed to help identify and address hazards. This data generated by laboratories can be leveraged by state, tribal, and territorial food safety agencies to ensure the food supply is safe and wholesome.

 

Goals

The goals of this funding opportunity are as follows:

1. Awardees will apply their Manufactured Food Regulatory Program Standards (MFRPS) response, enforcement and regulatory framework to conduct follow-up inspections, investigations (including traceback/forward), and enforcement actions (including embargos, recalls, warning letters, and closures) to positive and violative samples identified as part of the LFFM cooperative agreement. Coordination with the RRT and activation, if applicable, is required for grantees also awarded the RRT track.

Awardees will commit to coordinating response and compliance follow-up on LFFM samples with the FDA in real-time, to include sharing findings and compliance actions or other follow-up activities discussing regulatory/compliance strategy with the FDA.

If a potentially violative LFFM sample comes to a MFRPS program but is outside of the MFRPS program’s regulatory authority/jurisdiction, the MFRPS program agrees to identify and notify the appropriate state/federal agencies with jurisdiction, and to notify the FDA.

Potentially violative LFFM samples may come to the MFRPS program from any laboratory participating in the LFFM Human Food Product Testing track for microbiology or chemistry. This includes – samples collected by LFFM laboratories within the same state as the MFRPS program (may or may not be the primary servicing laboratory for MFRPS); samples collected by other states/analyzed by other LFFM laboratories where the potentially violative product is traced back to the MFRPS program’s state. 

2. Manufactured food regulatory agencies will have training and auditing programs necessary to ensure a sufficient number of staff are qualified to conduct regulatory and compliance activities in response to violative laboratory samples.

a. Staff must be able to conduct traceback investigations of products related to consumer complaints, adverse events, recalls, and other reports indicating significant health and safety problems associated with the products. The tracebacks will attempt to identify the domestic or foreign source (origin) of the implicated product(s) and will ensure appropriate additional investigational or compliance activities.

b. The awardee will engage in discussions with the FDA Division and other FDA Offices during the LFFM HAF Product Testing Track planning process (annual) to outline a mutually agreeable regulatory and compliance strategy for proposed LFFM sampling to occur in the upcoming year. If there is not a pre-agreed upon regulatory/compliance strategy with the FDA for a particular potentially violative sample, the MFRPS program will promptly engage in discussions with the FDA Division to determine the appropriate approach after receiving notification of said sample(s).

c. Awardees will have the expertise and capacity to perform product sampling and compliance and regulatory response.

d. Awardees will collect samples at the manufacturer, and other locations, in accordance with the collection instructions for each hazard-commodity pair on the approved LFFM sample plan, as needed.

3. Awardees will build the necessary regulatory and compliance response infrastructure to investigate and respond to violative samples, including qualified personnel, IT resources, and regulatory authorities.

4. Awardees will expand upon the LFFM goals to participate in IT-data exchange development/implementation with the FDA to enable necessary information exchange between the FDA and state/territory. This will set best practices for enhanced coordination between the FDA and state/territory for information sharing coordination and leveraging of resources for regulatory work.

5. To increase the use of best practices for enhanced coordination between the FDA and state/territory for information sharing, coordination, and leveraging of resources for regulatory work, awardees will participate in IT-data exchange development/implementation with the FDA to enable information exchange between FDA and state/territory. This includes collaborating with LFFM laboratories to ensure all sample collection information is complete and meets ORA DX requirements, for LFFM samples to be submitted via ORA DX, including FEI and product code fields.

Objectives

Advance the efforts for a nationally Integrated Food Safety System (IFSS) by assisting state manufactured and food regulatory programs to enhance regulatory and compliance response when a potential violative sample is identified in the lab. This objective is classified into several broad activities to enhance and support analogous cooperative agreements and other human and animal food related laboratory and response activities:

Training

Recipient programs will ensure sufficient technical training in the scientific basis, procedures, and legal requirements of the collection of samples, and compliance and response follow-up for testing of human and animal food for analysis in a LFFM lab. This allows for the equivalent and consistent application of the requirements across the United States. The program training plan (as required by the MFRPS) must be updated to include sampling and technical compliance follow-up, coursework and field training required and completed. The state program training plan for sampling and compliance follow-up must satisfy the training elements in MFRPS. The training plan will provide a foundation for evidence collection and development, and data acceptability for potentially violative samples. An evaluation of the program training plan using data from inspections, samples, and regulatory actions must be performed to determine if the training program needs to be updated to support advisory/regulatory action under your own authorities or by the FDA, when necessary. The evaluation shall identify and document any improvements (such as updates, modifications, or additions) to the program training plan that are needed to promote evidence collection and support possible regulatory actions. The training required to conduct product sampling, traceback investigations, recalls, and recall audit checks must also be incorporated into the training program. The program must consult with their assigned the FDA Division staff, as appropriate, to conduct the evaluation and develop the improvements.

Grantees must maintain sufficient trained staff to perform sample collections and maintain response capability to violative samples, recalls, and compliance actions.

Program Improvement and Infrastructure Development

Grantees will identify and remedy gaps in agency infrastructure necessary to fully identify, respond to and initiate potential compliance actions on violative samples. Infrastructure needs may include personnel, IT, regulatory foundation, training, updating procedures and records, management programs, and laboratory.  Grantees should also propose how project developed capabilities will be maintained after the conclusion of the project.

Compliance Implementation Strategies

Grantees will incorporate expanded regulatory, response, and compliance programs as outlined in MFRPS Standard 6 to ensure enhanced capabilities to work in conjunction with laboratory operations.

Grantees will engage with the FDA to participate in work planning, work-sharing, procedures, and data exchange efforts.

Awardees will collaborate with LFFM participating laboratories within their state to review and concur with the annual sample plan prior to final submission of the plan to the FDA.  Special attention should be given to the collection location (firm type), sampling techniques, and compliance follow-up required for each hazard-commodity pair.

Applicants must hold an information sharing agreement with the FDA under 21 CFR 20.88 or be able to obtain an agreement prior to the start date of the award.

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

Revision

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.

The FDA/ORA intends to commit up to $1,500,000 in FY 2022 to fund 15 awards.

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: $100,000

Award Project Period

Applicants may request support for 1 year, not to exceed the remaining number of years on the parent grant. The parent grant must be active when the application is submitted. If a no-cost extension is needed on the parent grant, it must be in place before the revision application is submitted.

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

Governments

  • State Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • U.S. Territory or Possession

This opportunity is only available to State, Tribal or Territorial feed/animal food safety programs which meet the following criteria:

  • Currently holds an award under RFA-FD-18-001 “Flexible Funding Model – Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs” and is satisfactorily meeting the conditions of the award; and
  • Currently is conducting human food inspections under contract with the FDA and maintains a food safety inspection contract in good standing for the duration of the award project period; and
  • Collaborates with one or more human food testing laboratories currently holding an award under PAR-20-105 "Laboratory Flexible Funding Model (LFFM) and participating in the Human Food Product Testing Track(s) - Micro or Chem" with the LFFM lab in the same state as the FFM CAP program.
  • Applicants must hold an information sharing agreement with the FDA under 21 CFR 20.88 or be able to obtain an agreement prior to the start date of the 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

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

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

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

 

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 to:

Gordana Zuber, Grant Management Specialist

Gordana.zuber@fda.hhs.gov

 

A technical session will be held for prospective applicants in February/March 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 12 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, with the following additional requirements:

  • For field 4. a. Federal Identifier - The Federal Identifier is required.  Include only the IC and serial number of the previously assigned award number (e.g., use FD006420 from 5U18FD006420-04).
  • For field 8. TYPE OF APPLICATION - applicant must mark 'REVISION'.
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:

  • 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.
  • Indirect/F&A costs under grants to foreign and international organizations will be funded at a fixed rate of 8 percent of modified total direct costs (MTDC), exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. (With the exception of the American University of Beirut and the World Health Organization, which are eligible for full F&A cost reimbursement). Awards to domestic organizations with a foreign or international consortium participant may include 8 percent of MTDC, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.
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, with the following additional requirements. 

 

Research Strategy: The research strategy should address the broad goals and objectives outlined above which contribute to the applicant's ability to investigate, mitigate, and control the public health impact of violative food samples.

Areas to address include the following:

Existence and status of compliance and investigational procedures

Applicants should clearly describe their current procedures and processes for evaluating and investigating violative sample findings and describe any enhancements planned with the proposed award

Information technology capacity to share data with the applicant's servicing lab, the FDA, and other public health partners

Applicants should outline their ability to receive and transmit sample, analyte, manufacturer, and trace forward/back data necessary for regulatory investigation of violative samples

Laboratory Collaboration

Applicants should describe current practices and planned enhancements in coordinating with food testing servicing laboratories. This should include processes for coordinating with LFFM participating laboratories within the applicant's state to develop and implement the annual LFFM Human or Animal Food Product Testing Track sampling plan(s) and follow-up to positive or violative samples.  

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.

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 the 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.  The 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/technical merit.

Significance (40 Points)

Does the project address an important problem or a critical barrier to regulatory follow-up to violative sample findings? If the aims of the project are achieved, how will technical capability and/or regulatory practice be improved?

Investigator(s) (10 Points)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Is the leadership approach, governance and organizational structure appropriate for the project?   

Approach (40 Points)

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in existing compliance and enforcement programs? Are potential problems, alternative strategies, and benchmarks for success presented? Is the proposed work likely to enhance public health protection?

 

Environment (10 Points)

Will the environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the regulatory program, or collaborative arrangements?   

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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous objective review group are adequate and whether substantial changes are clearly evident.

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 the 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 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all FDA grants and cooperative agreements.

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

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

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

Additional terms and conditions regarding FDA regulatory and 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 Budget changes

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

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 reports are required for this award. The Research Performance Progress Report (RPPR) will be considered the annual program progress report for the budget period. Reports for this expansion supplement must be included as a component of the reports required by RFA-FD-18-001.

The mid-year performance progress report should be submitted via email to the listed Grants Management Specialist and Program Official by January 30, 2023. 

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. Detailed progress report on the grantee meeting the project goals detailed in the cooperative agreement and identified in the application;

2. A comprehensive list of violative samples referred by the collaborating food testing laboratory

3. A summary of investigative actions undertaken in response to violative sample referrals from the food testing laboratory, including a summary of findings, and all compliance and enforcement activities conducted (advisory, administrative, and/or judicial).

4. Any programmatic issues or concerns

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.

FDA Responsibilities

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, 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 grantee for the project, as a whole, although specific tasks and activities may be shared between the awardee and the FDA as defined below. 

Substantive involvement by the awarding agency is inherent in the cooperative agreement award.  Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement.

The Grants Project Team may consist of a Grants Management Specialist, Program Official, Project Manager, and Technical Advisor(s).  The Grants Project team collaborates to review the progress of the grantee, and 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. 

The Grants Project Team may utilize the grantee's progress reports, site visits, audit reports, FDA human food safety contract data, and other supporting documentation to determine if the terms and conditions of the award are 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, and

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;

Conduct technical sessions with the grantee, as deemed necessary by FDA;

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 Develop programs to meet the FDA mission;

Provision of programmatic technical assistance;

Monitor project/program performance, including review of progress reports and conducting visits; and

Assist in coordinating multi-program pilot projects.

An FDA Technical Advisor(s) will be assigned to each enrolled program. The Advisor will primarily provide subject matter expertise for program activities and will work cooperatively with the PO and PM 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 and technical assistance in project planning, implementation, and evaluation;

Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;

Review grantee reports and provide technical comment on progress,

Conduct technical sessions with the grantee, as deemed necessary by FDA;

Assist in the sharing of information developed by the grantee and collaboration to achieve implementation of the project goals. Examples may include SOPs, MOUs, training programs, and record keeping systems;

Assist with trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing; and

Assist with development of programs to meet the FDA mission; and

Advise on technical aspects of program activities.

Unless another governance structure is mutually agreed upon, the Project Manager shall serve as the primary point of contact for the dissemination of FDA policy and project planning for milestones/objectives.

The grantee must maintain a food safety inspection contract with the FDA throughout the cooperative agreement. Continued funding for this cooperative agreement funding option are subject to the execution and completion of contract work according to the requirements of the contract.

Applicant organizations must have an executed non-public information sharing agreement under 21 CFR Part 20.88 no later than the start date of the grant award.

The grantee must agree to participate in mentoring partnerships to develop, advance, share, and implement best practices for regulatory activities.

Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, or programmatic aspects of the grant and for day-to-day management of the project or program. The PD/PI(s) will 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 will 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.

The PD(s)/PI(s) will have the primary responsibility for:

Overall management of the study,

Agreeing to work cooperatively with FDA, and

Developing and implementing systems necessary for communications among the various study organizational components.  All data and samples to be shared freely by methods and within time periods to be specified by the Program Official.

FDA staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The awardees agree to accept assistance from the designated FDA Project Manager/Technical Advisors. These persons will participate in the monitoring of issues relating to recruitment, follow-up, and adherence to protocols and will assist in the development and/or adjustment of project activity. Additionally, an agency Program Official may be responsible for the normal scientific and programmatic stewardship of the award.

The reporting and monitoring activities may include a review of budget modification requests from the grantee. The grantee and any sub-grantees are expected to utilize the approved funding respectively as indicated in the original submitted separate budget and cost estimates. The letter of agreement will be submitted by the grantee, with the aforementioned budget modification request, to the Program Official and Project Manager.

Equipment may be loaned by FDA to an awardee pursuant to FDA policy.  Such equipment will remain the property of FDA under loan to the awardee for a specified time period with a review every twelve months. FDA may terminate the loan at any time. Unless approved by ORA/OP, the FDA provided equipment may not be transferred by the awardee to a third party, and the awardee assumes full responsibility and liability for any claims that may arise as a result of operation of this equipment for the period it is in the possession of the awardee.

Monitoring Activities

The Program Official and Project Manager/Technical Advisor(s) will monitor award recipients periodically. The monitoring may be in the form of face-to-face meetings, telephone conversations, e-mails, or written correspondence between the Program Official/Grants Management Officer/Technical Advisor(s) and the principal investigator. In addition, periodic site visits with officials of the recipient organization may also occur to assess progress. 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 Program Official and Project Manager/Technical Advisor(s).

The scope of the recommendation will confirm that:

(1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements; and (3) if necessary, there is an indication that adequate corrective actions have taken place to address any identified problems.

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.

Mid-year reports are required.  The Research Performance Progress Report (RPPR) will be considered the annual program progress report for the budget period. Reports for this expansion supplement must be included as a component of the reports required by RFA-FD-18-001.

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. Detailed progress report on the grantee meeting the project goals detailed in the cooperative agreement and identified in the application;

2. A comprehensive list of violative samples referred by the collaborating food testing laboratory

3. A summary of investigative actions undertaken in response to violative sample referrals from the food testing laboratory, including a summary of findings, and all compliance and enforcement activities conducted (advisory, administrative, and/or judicial).

4. Any programmatic issues or concerns

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

Scientific/Research Contact(s)

James Betz
Office of Regulatory Affairs (ORA)
Telephone: 843-642-6190
Email: james.betz@fda.hhs.gov

Jocelyn Ramos
Office of Regulatory Affairs (ORA)
Telephone: 510-337-6894
Email: jocelyn.ramos@fda.hhs.gov

Aaron Dagres
Office of Regulatory Affairs (ORA)
Telephone:  513-322-0607
Email: aaron.dagres@fda.hhs.gov

Objective Review Contact(s)

Gordana Zuber
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 301-308-1747
Email: gordana.zuber@fda.hhs.gov

 
Financial/Grants Management Contact(s)

 

Gordana Zuber
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 301-308-1747
Email: gordana.zuber@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 U.S.C. § 399) and under Federal Regulations 45 CFR Part 75 and 2 CFR Part 200.

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