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

Renewal - Integrated Food Safety System Online Research and Collaboration Development (U18) Clinical Trials Not Allowed

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-20-023

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103  

Funding Opportunity Purpose

The Office of Regulatory Affairs is soliciting a Renewal application to support the development, support, and promotion of innovative information sharing and research tools hosted on the Integrated Food Safety System (IFSS) collaboration/research portal, which serves as a critical federal-state collaboration portal to advance food safety and public health.     

Key Dates
Posted Date

January 16, 2020

Open Date (Earliest Submission Date)

January 24, 2020

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

March 25, 2020, 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 2020

Advisory Council Review

Not Applicable

Earliest Start Date

September 2020

Expiration Date

March 26, 2020

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
Background

Together with our federal, state, local, tribal, and territorial public health partners, the U.S. Food and Drug Administration (FDA) continues its plan to implement an inspection and enforcement program that will ensure high rates of compliance with the Agency’s food safety standards.  FDA intends to establish a fully integrated national food safety system built on collaboration with all these partners. This system will continue to encompass inspections, laboratory testing, and outbreak response and will place priority on collaboration with state and federal partners preventing foodborne illness, in both food for humans and animals. This collaboration will result in better ability to assess potential risk at domestic food facilities and greater and more consistent inspectional coverage of these facilities across the entire food supply chain, 2) greater food surveillance through integration of food facility inspection and testing information, and 3) improved rapid response capacity and efficiency. 4) better transparency between state and federal partners leading towards mutual reliance of food safety objectives.

FDA is awarding this cooperative agreement under its authority in section 1009 of the Federal Food, Drug, and Cosmetic Act of 2011 (FSMA).  Specifically, section 1009(a)(5) authorizes FDA to make grants to eligible entities to take appropriate action to protect the public health in response to a notification under section 1008 of the FD&C Act, or a recall of food under the FD&C Act.  As set forth in section 1009(b)(1), entities eligible for grants under section 1009 are States, localities, territories, Indian tribes, and nonprofit food safety training entities.  Specifically, only food safety programs that are either State, local, tribal, territorial, or non-profit food safety training entities that collaborate with one or more institutions of higher learning are eligible to apply for this cooperative agreement.

The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system.  It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur.  It also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention and risk-based food safety standards, and to better respond to and contain problems when they occur. 

FSMA directs FDA to build an integrated national food safety system in partnership with state, local, territorial and tribal authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals.  FSMA further identifies key priorities in working with partners in areas such as reliance on federal, state and local agencies for inspections, improving foodborne illness surveillance, and leveraging and enhancing state and local food safety and defense capabilities. In addition, FSMA specifically directs grants be made available to state, local, territorial, tribal and nonprofit food safety training entities that collaborate with one or more institutions of higher education to enhance food safety.

This funding opportunity will support implementation of training, standards, emergency response, laboratory capacity, produce rule implementation and other FSMA related priorities as authorized under this grant authority through a national communications and information sharing data platform, such as the IFSS online research and collaboration platform.

To be fully successful, the national food safety system must be maintained with continuous input from FDA’s regulatory and state and federal public health partners. Efforts shall facilitate information sharing, regulatory program and trend research and communication/cooperation among all partners and include infrastructure for a national electronic information-sharing mechanism. These actions will result in a national food safety system that identifies sources of risk throughout the system and reduces time to detect and respond to foodborne outbreaks.  A public health driven, collaborative, and leveraged approach to food safety activities and responsibilities will be reflected in improved public sector resource utilization at a national level, which provides additional capacity for ensuring a safe and secure food supply.

An IFSS electronic portal, dedicated to Food and Agriculture Sector professionals, serves as a critical federal-state-local-tribal-territorial collaboration and research tool enabling the planning and implementation of a collaborative Online Integrated Food Safety System.  An IFSS portal should allow for research, collaboration, and information sharing across Federal, State, local, territorial, and tribal agencies and other public health partners.  The public health partners of FDA participate in multiple initiatives to advance an integrated food safety system, such as Manufactured Foods Regulatory Program Standards (MFRPS), Animal Food Regulatory Standards (AFRPS), Produce Regulatory Program Implementation, Voluntary National Retail Food Regulatory Program Standards, and other multiagency initiatives. Public health partners also participate in the Rapid Response Teams (RRTs) to prepare, respond, coordinate, and contain multi-state foodborne illness outbreaks, recalls, natural disasters, and other emergencies. 

Therefore, the ability to share information with various levels of security is necessary to protect public health and build strong regulatory programs.  The IFSS portal allows for leveraging of resources by all food safety partners, such as best practices, risk factor studies, outbreak information, and training materials, to advance food safety and protect public health.  A central location for publicly available information on food protection issues, tools, events, jobs, and resources promotes efficient leveraging of resources. Secure portals  for members only of specific workgroups allows agencies to share non-public information related to emergency response activities, agency policies and procedures, best practices, and training.  This enhanced collaboration has resulted in greater awareness of potential vulnerabilities, the creation of more effective prevention programs, new surveillance systems, and the ability to respond more quickly to outbreaks of foodborne illness. 

Objectives

The Office of Regulatory Affairs (ORA) is soliciting a renewal application to support the support, innovation, and promotion of an online, electronic IFSS portal for critical federal-state collaboration. The application should outline the continued development and operations of collaborative online tools involving a range of stakeholders including, but not limited to, federal, state, tribal and local regulatory and public health bodies for the purposes of information sharing to advance building an integrated food safety system and protect public health.

The application should include a list of collaborators and their roles.  The grantee will be expected to work directly with state, local, territorial, and tribal (SLTT) users for the continuous improvement and expansion of the IFSS portal, including soliciting proposals for new projects, obtaining feedback, and promoting usage. 

The application should describe the methodology that will be utilized to develop an interagency process for continuous improvement of the IFSS portal.  Ideally, an interagency workgroup is established to identify innovative projects that will enhance information sharing with SLTT regulatory and public health agencies and promote the IFSS portal usage. 

The application should detail how the following will be achieved:

1.  Soliciting proposed projects from stakeholders (specifically state, local, territorial, and tribal agencies). 

2.  Selecting projects based upon the priorities and input of stakeholders.

3.  Collaborating with lead users during project development and execution.

4.  Soliciting and responding to feedback from users.

5.  Identifying and resolving barriers to using the IFSS portal.

6.  Promote widespread usage and adoption of the IFSS portal for use by SLTTs .

The application should also provide a detailed plan for initiating, improving, and/or leveraging collaborative virtual partnerships to address projects.  SLTT currently use a wide range of online collaborative tools, such as:

I.          Rapid Response Team Capability Assessment Tool

The Rapid Response Team (RRT) Capability Assessment Tool (CAT) is an online capability assessment tool used by RRTs to assist with their requirement to report their yearly milestones and assessments.  The data is used to research and measure each state’s capability, capacity and infrastructure development and performance.  It also serves as a tool that allows state partners to share best practices and assist each other in their performance goals.

II.         After Action Exchange (AAX)

The After Action Exchange (AAX) provides a searchable database of After Action Reports/Improvement Plans (AARs/IPs) from food and feed contamination events and training exercises.  AARs/IPs are contributed by federal, state, local and tribal public health and regulatory agencies with authority to respond to food and feed contamination events, and access to the AAX is limited to these regulatory partners.  With this information, users are able to research, study and learn from past events and exercises, suggest future preventive measures, and identify mutual training needs.  Furthermore, AAX assists all cooperating regulatory partners in efforts involved in responding to food and feed contamination events and allows them to thoroughly summarize the events and prepare for effective cooperative responses to these events.

III.       State Task Force Websites

State Task Force Websites provides comprehensive, content management system based websites for state food protection task forces to provide public information about projects, initiatives, and activities.  Task Force Websites greatly improve communication among state regulatory partners and allow for information sharing state to state and from each state to the FDA by enabling the Task Forces to communicate and push out real-time information and research data via mobile applications and network website portals.

IV.        Shopper Card Database

The Shopper Card Database was designed as a collaboration and research tool, used to assist federal, state, tribal and local regulatory partners in foodborne illness outbreaks.  A critical part of multi-state foodborne illness outbreaks is working with retail chains to obtain information about purchases made by ill persons during specific timeframes of interest. This allows investigators to identify common food consumption patterns among ill persons and can lead to identification of the vehicle (specific food) that caused the outbreak.  Shopper Card requests have been identified as a response activity that would benefit from best practices and other tools/resources that could be leveraged by regulatory and public health authorities to increase the efficiency and chances of success in making these requests to retail chains. To that end, a National Shopper Card Initiative was established to identify and address barriers and opportunities surrounding shopper loyalty card data usage for public health purposes.

V.         Resource Library

The resource library was created to organize, and index research data used by state, federal, tribal and local regulatory partners.  The IFSS portal holds a growing volume of research/regulatory data and collaborative resources created by various state partners, researchers, and working groups.  The resource library allows state partners and collaborators to research and analyze trends to understand activity, analyze trends, identify information gaps, and prioritize regulatory efforts.  Furthermore, the resource library allows users to group, quantify and promote research materials in a secure environment.

VI.  Communication tools

Secure and non-secure resources, such as the food and agriculture sector contact directory, lin06ks to web resources, public discussion forums, conference management, secure file sharing, and on-demand and live trainings.

VII. New Tools

The applicant should actively seek input from state, local, territorial, and tribal users to continuously improve and promote the IFSS portal usage to advance building an integrated food safety system.    

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

Renewal

Clinical Trial?

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

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 four (4) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance

FDA/ORA intends to fund up to $1,200,000 for fiscal year 2020 in support of this grant program.

It is anticipated that one award will be made, not to exceed $1,200,000.00 in total costs (direct plus indirect), per 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: $1,200,000

YR 02: $1,200,000

YR 03: $1,200,000

YR 04: $1,200,000

YR 05: $1,200,000

Award Project Period

The total project period for an application requesting support may not exceed 5 years.  Recommended support beyond the first year will depend on the availability of funds and approved performance.

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

 Eligibility is limited to University of Minnesota

 
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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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 not submit more than one 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.

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, with the following additional instructions: 

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

  • 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 FDA-defined 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.

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

Funds are not to be utilized for new building construction.

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):

Audiovisual materials such as videotapes, DVDs, public service announcements, etc.

Consultant services

Employee salaries, wages and fringe benefits

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

Indirect costs

Recruitment costs for hiring new employees

Registration fees

Purchase or development of IT equipment, software, and support

Shipping and mailing of equipment and supplies

Travel (shall not exceed coach class fare)

Speaker fees

Non-allowable costs:

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. The State shall be able to account separately for fund expenditures, including employee salaries, wages, and benefits, under the food safety inspection contract, the feed safety inspection contract and other funding mechanisms and this cooperative agreement.

Vehicle purchases are not permitted.

Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.

Clothing (with the exception of PPE) purchases are not permitted.

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 public health be improved? How will successful completion of the aims improve the regulatory programs and coordination between State, local, territorial, and tribal agencies and other stakeholders?  

Investigator(s) (20 Points)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project and managed similar projects? How have investigators and other key personnel demonstrated an ongoing record of accomplishments that have advanced online tools, collaboration, and communication?

Innovation (20 Points)

How does the application and seek to develop innovate and effective approaches to communications and collaboration, especially between State, local, territorial, and tribal agencies and other public health partners?

Approach (20 Points)

Is 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 any potential problems that may be encountered?

Environment (20Points)

Will the environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, knowledge, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment and 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 FDA-defined 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

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

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 grantee’s business official.

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

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

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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.

HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 “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.

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).

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

Awardees shall retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies.

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, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 $25,000. 

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 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 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Mid-year progress and end of year reports shall contain the elements below as applicable to the application and award, including but not limited to, the following:

1.  Detail progress report on the grantee meeting the project milestones detailed in the cooperative agreement, proposal, strategic plan, conditions of the award, etc. Goals and objectives should be broken out and specific progress reported. 

2. Status report on the hiring and training of cooperative agreement funded personnel.

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.

4.  Status reporting on the purchasing, development, and operational readiness of any equipment, computers, or software purchased.

5.  Identifying any pending issues or concerns that may affect accomplishing the objectives and goals of the cooperative agreement.

6. A corrective action plan must be submitted if the objectives and goals of the cooperative agreement are not being met. The corrective action plan must detail the tasks, responsible personnel, and updated timeframes to ensure satisfactory performance and meet the deliverables required under the grant.

7.  Summary of grant expenditures and obligations during the current budget period.

8.  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, analysis, and recommendations.

9.  Status report on the support and identification of any pilot projects implemented. 

10.  Status report on meetings, networking activities, collaboration with the FDA, best practices, studies, technical assistance and outreach and reports shared with FDA and other stakeholders. 

FDA and the grantee will identify key project activities and reporting requirements based upon the application submitted and project goals identified.  Reporting requirements may be revised annually. 

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)

Ronald Winter
Food and Drug Administration (FDA)
Office of Partnerships (OP)
Telephone:  303-236-9695
Email: ronald.winter@fda.hhs.gov

Suzanne Webb
Food and Drug Administration (FDA)
Office of Management (OM)
Telephone:  240-402-3069
Email:  suzanne.webb@fda.hhs.gov

Objective Review Contact(s)

Daniel Lukash
Food and Drug Administration (FDA)
Office of Acquisitions & Grants Services (OAGS)
Telephone: 240-402-7596
Email: daniel.lukash@fda.hhs.gov

Financial/Grants Management Contact(s)

Daniel Lukash
Food and Drug Administration (FDA)
Office of Acquisitions & Grants Services (OAGS)
Telephone: 240-402-7596
Email: daniel.lukash@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.

Authority and Regulations

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

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.