It is critical that applicants follow the Research (R) Instructions in How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
- Use the NIH ASSIST system to prepare, submit and track your application online.
- Use an institutional system-to-system (S2S) solution to prepare and submit your application
to Grants.gov and eRA Commons to track your
application. Check with your institutional officials regarding availability.
- Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your 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.
- Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see HHS Grants Policy Statement ).
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
- 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.
- 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.
- Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.
- All applicants planning research (funded or conducted in whole or in part by FDA) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
- A Data Management and Sharing Plan is not applicable for this NOFO.
- Will receive a written critique.
- Scientific and technical merit of the proposed project as determined by objective review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
- FDA review and approval of task-oriented guidelines and other documents developed under the award.
- FDA assistance and coordination in the sharing of information to federal, state, and territorial agencies and other stakeholders.
- FDA review and approval of publications, web applications, or any revisions to existing systems.
- FDA review and approval of subawards made using cooperative agreement funds. FDA has discretion when making final subaward decisions, and may approve changes to funding amount, priority, and other aspects to ensure the subaward meets the FDA’s intended goals.
- Other assistance or collaboration as requested by associations and state or territorial agencies.
- Minimum of one (1) meeting per year with the Program Office to review grantee progress and discuss cooperative agreement goals and objectives.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Purpose
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships is announcing the availability of a cooperative agreement to be awarded under Limited Competition to one (1) non-profit food safety training association or organization that collaborates with one or more institutions of higher education, whose membership includes but may not be limited to state or territorial employees, who work in either the manufactured food regulatory program, the Grade A Milk Safety program, or the National Shellfish Sanitation regulatory program. Only national associations or organizations representing state or territorial food regulatory programs as a primary purpose are eligible to apply for this funding opportunity.
The purpose of this NOFO is two-fold:
1. To facilitate long-term improvements to the national food safety system by strengthening interagency collaboration, improving the states' regulatory and surveillance protection programs for manufactured foods, conducting research, and promoting the Manufactured Food Regulatory Program Standards (MFRPS) [Hereinafter referred to as "NOFO Purpose #1"]; and
2. The continued development, implementation, management, and support of a funding system for those state and territorial agencies that have primary responsibility for regulating Grade A milk or molluscan shellfish (or both). Such agencies may apply and be subawarded funds to facilitate training, equipment purchases, or provide for other priorities needed to implement the Grade "A" Milk Safety program and the National Shellfish Sanitation Program (NSSP) within their respective jurisdictions [Hereinafter referred to as "NOFO Purpose #2"].
The cooperative agreement includes one (1) year of funding with up to two (2) years of additional non-competitive support, dependent on performance and continued availability of funds. The funds that will be subawarded under this NOFO will be through a funding system developed by the grantee.
The following are the overarching goals of this cooperative agreement:
1. Assist FDA in meeting provisions of the FDA Food Safety Modernization Act (FSMA).
2. Support the efforts of federal, state, local, tribal, and territorial government agencies to build a national Integrated Food Safety System (IFSS).
In addition to the two (2) goals above, the following three (3) goals are for accomplishment of NOFO Purpose #1 and to facilitate long-term improvements to the national food safety system, and to promote the Manufactured Food Regulatory Program Standards:
3. Establish systems for sharing, promoting, and collaborating of best practices, guidance documents, sampling plans, procedures, memorandums of understanding, and other tools to foster domestic mutual reliance between federal, state, local, tribal, and territorial public health agencies that are mandated to regulate the nation’s manufactured food industry.
4. Assist FDA in the identification, development, delivery, promotion, and/or attendance of food safety and defense training programs to support conformance with the Manufactured Food Regulatory Program Standards (MFRPS), training and stakeholder support provisions of FSMA.
5. Support the advancement of the MFRPS and the Manufactured Food Regulatory Program Alliance (MFRPA).
In addition to the five (5) goals above, the following four (4) goals are for accomplishment of NOFO Purpose #2 and to support state and territorial Grade "A" Milk Safety and National Shellfish Sanitation regulatory programs:
6. Support the training needs of state and territorial Grade A Milk Safety and National Shellfish Sanitation Programs thereby permitting them to participate in technical training, including FDA/Office of Training, Education and Development (OTED)-supported Grade A Milk training courses, FDA/OTED-supported Shellfish training courses, Milk or Shellfish seminars, Laboratory Evaluation Officer (LEO) milk or LEO shellfish training courses; and
7. Support the equipment needs thereby assisting the states and territories with their implementation of the Grade "A" Milk Safety program and/or National Shellfish Sanitation Program (NSSP).
8. Support the state and territorial agencies through the performance of special projects to investigate emerging concerns involving the Grade A Milk program and/or NSSP.
9. Support state and territorial Grade A Milk Safety and National Shellfish Sanitation programs to participate in their biennial conferences, i.e. National Conference on Interstate Milk Shipments (NCIMS) and Interstate Shellfish Sanitation Conference (ISSC), respectively. During the biennial conferences, amendments to the Pasteurized Milk Ordinance (PMO) and NSSP, respectively, are recommended, considered, debated, and voted upon by the state conferees.
To support the goals related to NOFO Purpose #1, the specific objectives to be performed under this cooperative agreement are the following:
1. Building an on-line program portal to serve as a learning exchange, subject matter expert registry, topical index of regulatory guidance, regulatory updates, and other information that impacts manufactured food regulatory programs.
2. Building a user community and support data management and exchange between FDA and state, local, tribal, and territorial (SLTT) regulatory agencies, the principle purpose of which is to promote state, local, tribal, and territorial conformance with human and animal food regulatory program standards.
3. Providing forums to elicit, discuss and address concerns identified by state manufactured food regulatory programs relative to the MFRPS, food safety inspection contract, training, FSMA, and other activities impacting federal-state relations.
4. Updating and continuous improvement of a web-based directory of SLTT public health officials for use by federal and SLTT agencies. The directory should be maintained in an electronic format that will be available to the public. A system for maintaining the accuracy of the SLTT directory will also need to be developed and maintained.
5. Providing support to the Manufactured Food Regulatory Program Alliance (MFRPA) and other initiatives that advance an integrated public health system by:
a. Supporting a committee structure environment and encouraging involvement from state food program managers to assist in technical guidance solutions, implementing changes, and increasing sharing of best practices for the MFRPS.
b. Scheduling and hosting meetings (in-person and/or remote), establishing workgroups, recruiting members, recording meeting minutes, and other duties necessary to support the goals of the MFRPA.
c. Maintaining the official repository of all documents created by the MFRPA, such as meeting minutes, by-laws, governance structure, suggested changes to the MFRPS, and position statements.
d. Hosting of at least one annual face-to-face meeting (minimum of 3 days) to assist state manufactured food regulatory programs to achieve conformance with the MFRPS, including scheduling, meeting facilities, invitations, registration, materials, and AV needs and support.
e. Providing administrative support to the Rapid Response Teams (RRT) Program’s annual face-to-face meeting (minimum of 3 days), including scheduling, meeting facilities, invitations, registration, materials, AV needs, and on-site support during the meeting.
6. Supporting the training needs for SLTT regulatory program’s conformance with regulatory standards and best practices in human and animal food by:
a. Identifying, developing, delivering, and/or promoting food safety and defense training programs to support conformance with the MFRPS and related provisions of FSMA.
b. Providing financial assistance to state food regulatory programs to attend manufactured food training courses and other meetings, as needed.
c. Conducting research in the form of surveys of SLTT food regulatory programs and performing data analysis to determine the capabilities and capacity of a national IFSS.
d. Developing task-oriented guidelines to address issues that can be adopted or referenced by manufactured food regulatory programs.
7. In support of FSMA, working with FDA to establish, participate, and promote operational partnerships that assist in building a national IFSS. Operational partnerships may include other national associations, alliances (such as the Seafood HACCP Alliance and Preventative Controls Alliance), Partnership for Food Protection (PFP), and Food Protection Task Forces (FPTF).
8. Providing administrative support to other meetings needed to support the advancement of a national IFSS, including scheduling, meeting facilities, invitations, registration, materials, AV needs, and on-site support during the meeting.
9. Providing financial support for manufactured food regulatory programs to develop, host, or attend training courses, meetings, conferences, and other events that support building an IFSS. Examples include the MFRPA meeting, RRT meeting, Seafood HACCP Alliance, and training courses that support conformance with the MFRPS.
10. Providing support and outreach to colleges and universities to promote career paths and experiential learning in regulatory affairs and sciences.
11. Providing support for advanced training or fellowship programs to promote experiential learning, applied research and mentorship in manufactured food regulation.
12. Establishing a system for continuous improvement of all activities being performed under the cooperative agreement. The grantee should seek feedback from state manufactured food programs on activities performed under the cooperative agreement. The feedback solicited should then be used to identify future activities.
13. Providing support for the continued use of the legacy IT systems currently in use by those state agencies, until such time the IT systems currently in development are ready to be implemented.
Applicants are strongly encouraged to identify additional activities that will support the goals and objectives of this cooperative agreement. Baseline data, targets and performance measures for each activity should be included in the application. The applicant should also suggest the reporting criteria for each activity.
To support the goals related to NOFO Purpose #2, the grantee will perform the following specific objectives:
14. Ensures the cooperation, coordination, and continuous involvement of the FDA, including Milk and Shellfish Specialists, National Milk and Shellfish Teams, Milk and Shellfish Steering Committees, OTED, Office of State Cooperative Programs (OSCP), Office of Partnerships (OP), and the Center for Food Safety and Applied Nutrition (CFSAN).
15. Establishes a joint advisory group (JAG) including the grantee, FDA, and other stakeholders to establish priorities and ensure the goals of the cooperative agreement are achieved.
16. Contains a communications strategy that includes marketing and advertising of the availability of funds, projects funded, and project goals.
17. Describes in detail the process for selecting subawardees that includes active, direct involvement of the FDA Milk and/or Shellfish Specialists and other FDA stakeholders. Also, describes a clear process or management with unbiased methods for solicitation/recruitment of applications, review of submissions, and selection of subawardees to ensure distribution of funds over a wide range of state and territorial regulatory jurisdictions in keeping with FDA program priorities.
18. Establishes a system for monitoring the progress of subawardees to include the periodic verification of project goals and reporting of the project results/goals to FDA.
19. Establishes a system for the management, distribution, and verification of the use of funds subawarded to state and territorial Grade "A" milk and/or molluscan shellfish regulatory agencies, including providing a software program to manage and track awards.
20. Establishes a system for development of corrective action plans when subawardees are not completing the projects proposed or using the funds appropriately.
21. Ensures, through working cooperatively with FDA, that the projects proposed by subawardees have not been reimbursed under other cooperative agreements, grants, contracts, and other funding mechanisms.
22. Establishes a system for determining the states and territories future training and equipment needs, to include both short term and long-range needs. Since several states and territories may have similar need for specific training courses, such a system should also include recommendations for the most efficient dates and locations for conducting the training courses, seminars, workshops, and conferences.
23. Establishes a system for determining the impact and effectiveness of training received pursuant to a subaward. Such a system should collect information from the subawardees on the various operational activities, regulatory or administrative actions, recalls, and related public health outcomes that were the result of training received by state employees pursuant to a subaward.
24. Establishes a system for determining the impact and effectiveness of equipment purchased pursuant to a subaward. Such a system should collect information from the subawardees on the various operational activities, regulatory or administrative actions, recalls, and related public health outcomes that were the result of equipment purchased by the states pursuant to a subaward.
Subawarded funds are to be made available by the grantee in support of state and territorial needs related to training, equipment, special projects, and biennial conferences:
In support of NOFO Purpose #2, projects proposed by the subawardees should target support of training in Grade A Milk Safety and National Shellfish Sanitation programs including FDA/OTED-supported Grade A Milk Safety training courses, FDA OTED supported Shellfish training courses, Milk or Shellfish Seminars, Lab Evaluation Officer (LEO) Milk or LEO Shellfish training and equipment to assist in the implementation of the Grade "A" Milk Safety Program and/or NSSP. Programs applying for subawards shall submit a proposal detailing the use and goals of the funds requested and a progress report at the conclusion of the project.
The types of projects proposed by the subawardees may include FDA/OTED-supported Grade A Milk or Shellfish training courses, Milk or Shellfish seminars, LEO Milk or LEO Shellfish training, etc., which are all specifically needed by employees and staff for program implementation. Likewise, equipment proposals may consist of tools and/or related devices needed to conduct program work except for non-allowable proposals, cited in Sec IV.6 - Funding Restrictions. Proposals for special project subawards may be supported upon mutual agreement between FDA and the grantee. Biennial conference support may be provided during the year when the respective conferences are held.
The FDA is committed to promoting Diversity, Equity, Inclusion, and Accessibility (DEIA) to achieve the FDA’s mission to protect public health. The grantee is expected to promote diversity by developing a diversity procurement strategy. The grantee should use their diversity procurement strategy to take all necessary affirmative steps to assure that disadvantaged and women-owned small business concerns, as defined by the U.S. Small Business Administration and outlined in 13 CFR 124-103(b) and 13 CFR 127.200, are solicited for all procurement opportunities whenever there are possible sources. This provision is in support of Federal Acquisition Regulations (FAR) Part 52.219.8 Utilization of Small Business Concerns. The HHS Small Business Office can be solicited for recommendations. The grantee should also consider the diversity efforts of vendors as selection criteria for purchasing goods and services especially when disadvantaged and women-owned small businesses cannot be directly utilized. The grantee may be asked to participate in outreach efforts such as conferences and/or trade shows for the purpose of this provision
Other program objectives may be supported upon mutual agreement between FDA and the grantee.
Background
Historically, the food supply has encountered risks and emergencies of significant national concern. To
provide safe food to consumers, efforts have been undertaken at all levels, including consumers, industry, regulators, and even international organizations, to identify and implement improvements to the food safety system.
1. National Integrated Food Safety System
FDA continues to work with its partners to create a national, fully integrated food safety system that is
characterized by effective communication and efficient processes among federal, state, and local partners in the food safety system.
Various initiatives, such as the Food Safety Task Force Program, Innovative Food Defense Program, and federal cooperative agreements, work to engage partners across multiple sectors of the food safety system to collaborate and identify means to improve and optimize the nation’s food safety system.
The Partnership for Food Protection (https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives/partnership-food-protection-pfp) is a major driving force in the establishment of a national integrated food safety system.
2. Federal Food, Drug, and Cosmetic Act
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.
3. FDA Food Safety Modernization Act
The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to protect public health by strengthening the food safety system. FSMA allows FDA to focus on the prevention of foods safety problems by providing new enforcement authorities and risk-based food safety standards. The expanded enforcement authorities include mandatory recalls, expanded administrative detention, suspension of facility registration, enhanced product tracing abilities, and additional recordkeeping requirements for high-risk foods. FSMA also gives FDA new tools to hold imported foods to the same standards as domestic foods.
FSMA directs FDA to build an integrated national food safety system in partnership with state and local authorities, explicitly recognizing that all food safety agencies need to work together to achieve national public health goals. FSMA identifies some 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 capacities.
Full text of the law: http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm
See Section VIII. Other Information for award authorities and regulations.
HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Nonprofits Other Than Institutions of Higher Education
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Eligibility is further limited to a non-profit food safety training association or organization that collaborates with one or more institutions of higher education, and whose membership includes but may not be limited to state or territorial employees, who work in either the manufactured food regulatory program, the Grade A Milk Safety program, or the National Shellfish Sanitation regulatory program. Only national associations or organizations representing state or territorial food regulatory programs as a primary purpose are eligible to apply for this funding opportunity.
Competition is limited to these national organizations/associations for the following reasons:
These national organizations/associations will have the relationships and communication systems to effectively promote the objectives established under this cooperative agreement.
These national organizations/associations have a vested interest and share FDA’s visions to advance food safety vcm,h7 and improve public health outcomes. These national organizations/associations can best collaborate with the FDA.
These national organizations/associations can provide a platform for sharing information and national implementation of the projects through national and regional meetings, web sites, listservs, and other communications. Most national associations/organizations also have committees that may further advance the projects pursued by the subawardees.
Applicant associations must hold an information sharing agreement with FDA under 21 CFR 20.88(e) or be able to obtain an agreement prior to the start date of the award. Information sharing is limited to pre-decisional information and only for the purpose outlined in this award.
Pursuant to 21 USC 399(a)(1)(B) & (2), applicants must submit to FDA: (A) an assurance that it has developed plans to engage in the types of activities described in throughout this RFA; (B) a description of the types of activities to be funded by the grant; (C) an itemization of how grant funds received will be expended; (D) a description of how grant activities will be monitored; and (E) an agreement by the eligible entity to report information required by the Secretary to conduct evaluations as required by 21 USC 399(f)(1).
Manual Chapter 4204-204a- Requirements for Maximum Competition under Assistance Programs
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference HHS Grants Policy Statement for additional information.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for FDA support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.
The funds provided under this cooperative agreement shall be available to an eligible entity that receives a grant under this section only to the extent such entity funds the food safety programs of such entity independently of any funds provided under this cooperative agreement in each year of the grant at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.
Grant funds received under this section shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this section.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The FDA will not accept duplicate or highly overlapping applications under review at the same time per HHS Grants Policy Statement . This means that the FDA will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Research (R) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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:
The letter of intent should be sent to:
Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov
A technical session will be held for prospective applicants in April 2024. 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.
All page limitations described in the How to Apply Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
For this specific NOFO, the Research Strategy section is limited to 30 pages.
The following section supplements the instructions found in the How to Apply Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - 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 How to Apply - Application Guide , with the following modification:
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
How to Apply - Application Guide
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
How to Apply - Application Guide
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .
When involving human subjects research, clinical research, and/or FDA-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Foreign (non-U.S.) organizations must follow policies described in the HHS Grants Policy Statement, and procedures for foreign organizations.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA’s electronic system for grants administration. FDA and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the HHS Grants Policy Statement .
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 How to Apply Application Guide.
This initiative is not subject to intergovernmental review.
All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Pre-award costs are allowable only as described in the HHS Grants Policy Statement
This award may only be used for activities associated with achieving the goals and objectives of the
cooperative agreement and work proposed by the grantee. Work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under this cooperative agreement must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures.
Pursuant to NOFO Purpose #1, the grantee will establish a program for subawarding of funds to food (human and animal) regulatory programs for attending and delivery of courses related to the Preventive Controls Rules (human and animal food) and other FSMA-related rules.
Pursuant to NOFO Purpose #2, for subawards and contracts to third parties, a minimum of 35% of the cooperative agreement funds shall be subawarded to state and territorial regulatory agencies with primary responsibility for the Grade A Milk Safety regulatory program or the National Shellfish Sanitation program, or to agencies with substantial control and responsibility over such agencies. Substantial control and responsibility include conducting standardization and training, promulgating regulations, providing significant funding, or directing the activities of agencies with primary responsibility over the Grade "A" Milk or National Shellfish Sanitation regulatory programs.
In support of NOFO Purpose #1 and #2, expectations for the subaward program include:
1. The applicant will provide in detail the process for subawardees and how they plan to use the funds.
2. The applicant should provide in detail the process for selecting subawardees that includes active, direct involvement with FDA.
3. The applicant will create a communication strategy that includes advertising the availability of funds and training courses.
4. The applicant will establish a system for verification the course was successfully completed by the attendee or other project goals were met.
5. The applicant will establish a process for reimbursing the sub-awardees for any approved expenses, including registration fees, course materials, and travel expenses, including transportation, hotel, meals, and other reasonable expenses, equipment, and supplies.
Non-allowable costs:
1. Facilities, work, training, and other expenses reimbursed under other cooperative agreements, grants, contracts, and other funding mechanisms shall remain distinct and separate from this cooperative agreement.
2. Vehicle purchases are not permitted.
3. Cooperative agreement may not be utilized for new building construction or remodeling of existing facilities.
Additional funding restrictions may be part of the Notice of Award
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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 FDA 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 are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.
Only the review criteria described below will be considered in the review process.
Applications submitted to the FDA in support of the HHS mission are evaluated for scientific and technical merit through the FDA objective review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project support the national food safety system, the Manufactured Food Regulatory Program Standards (MFRPS), and the Grade A Milk Safety and National Shellfish Sanitation regulatory programs? More specifically, does the project support the activities that will: 1) strengthen interagency collaboration, improve the states' regulatory and surveillance protection programs for manufactured foods, and promote the MFRPS; and 2) provide continued support towards a funding system to facilitate training, purchase of equipment, and provide for other priorities needed to implement the Grade "A" Milk Safety and National Shellfish Sanitation regulatory programs?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Do they have previous, successful experience with: 1) establishing systems for sharing, promoting, and collaborating of best practices, guidance documents, and other tools to foster domestic mutual reliance between federal, state, local, tribal, and territorial public health agencies that are mandated to regulate the nation’s food industry; 2) identifying, developing, delivering, and promoting training programs to support conformance with the Manufactured Food Regulatory Program Standards (MFRPS), the Grade A Milk Safety Program, and the National Shellfish Sanitation Program; and 3) establishing systems for the management, distribution, and verification of the use of funds subawarded to state and territorial food regulatory agencies.
Does the rationale and design of the application meet the goals of the cooperative agreement? Is the overall strategy appropriate to support and enhance manufactured food safety activities, and the Grade A Milk Safety and National Shellfish Sanitation regulatory programs? Are the proposed systems and approach to meet the goals of the cooperative agreement well-reasoned, appropriate, and complete?
Is the overall strategy appropriate to support and enhance the Integrated Food Safety System? Does the approach foster the advancement of an Integrated Food Safety System and the Grade A Milk Safety and National Shellfish Safety Programs? Do the timelines, methods, and resources support the goals of the cooperative agreement?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or 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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
Not Applicable
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
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).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Committee convened by the FDA}, using the stated review criteria. Assignment to a Objective Review Group will be shown in the eRA Commons.
As part of the scientific objective review, all applications:
Appeals of objective peer review will not be accepted for applications submitted in response to this NOFO.
Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. The following will be considered in making funding decisions:
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.
Information regarding the disposition of applications is available in the HHS Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this NOFO will be subject to terms and conditions found in the HHS Grants Policy Statement.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.
All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
HHS recognizes that FDA research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.
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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. FDA will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements except fellowships.
Cooperative Agreement (U) Awards
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, FDA’s objective is to support and stimulate the recipient’s activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role of activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardee for the project as a whole, although specific tasks and activities may be shared between the awardee and the FDA as defined below.
A. Cooperative Agreement--Project Director/Principal Investigator Rights and Responsibilities:
The Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA/ORA staff being substantially involved as a partner with the PD/PI, as described below.
The PD/PI will maintain general oversight for ensuring compliance with the financial and administrative
aspects of the award, as well as ensuring that all staff have sufficient clearance and/or background checks to work on this project. This individual will work closely with designated officials within the recipient organization and with partner organizations to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal, regulatory, and organizational requirements.
B. Cooperative Agreement--FDA Responsibilities:
An FDA Program Official (PO) and an FDA Project Manager/Technical Advisor will be assigned and named in the Notice of Award. The FDA Program Official and Project Manager/Technical Advisor will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below:
1. Provide guidance, direction, and technical assistance in project planning, implementation, and
evaluation;
2. Provide subject matter expertise, programmatic assistance, and evaluation services to support
program studies and activities;
3. Actively monitor the supported program via telephone conversations, e-mails, written
correspondence, or periodic site visits;
4. Evaluate the supported program, including development of program-level performance measures,
consistent data collection, and reporting procedures and protocols;
5. Convene trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration
and information sharing;
6. Participate in data analysis, interpretation of findings, and where appropriate, co-authorship of
publications;
7. Development of programs to meet the FDA mission;
8. Provision of programmatic technical assistance;
9. 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.
C. Monitoring Activities:
Periodic program monitoring will be conducted by FDA on an ongoing basis which may include telephone conversations and site visits between the Principal Investigator and FDA Staff assigned to the program. Monitoring also includes the review of written reports. The results of these monitoring activities will be recorded in the official cooperative agreement file and will be available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations. Also, the grantee organization shall comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the FDA Staff assigned to the program.
The scope of the reports shall confirm that:
1. There has been acceptable progress on the project as measured by mutually agreed upon performance measures;
2. There is continued compliance with all FDA regulatory requirements; and
3. If necessary, there is an indication that corrective action has taken place.
Support will be in the form of a cooperative agreement. Substantial 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 and subawards funded by the cooperative agreement, including participating, guiding, coordinating, and participating in project activities.
Substantive involvement includes, but is not limited to, the following:
The grantee of this cooperative agreement program will include FDA in the dissemination of all information, documents, processes, and procedures created under this agreement. Any information gathering activities conducted under this cooperative agreement program should be conducted in coordination with FDA, and the results of information gathering should be shared with the FDA.
The recipient is required to submit their RPPR and financial reports as required in the Notice of Award (NoA). The program specific progress report template is attached to this Notice of Funding Opportunity (NOFO) at the link below and will also be provided with the NoA. The progress report template allows for the recording of SMART goals and performance metrics mentioned in Section IV Application and Submission Information - Research Strategy. All progress reports shall contain certain elements as application to their approved cooperative agreement and award.
Pursuant to NOFO Purpose #2, state or territorial Grade A Milk Safety and/or National Shellfish Sanitation regulatory programs may apply and be subawarded funds to support training including but not limited to FDA/OTED-supported Grade A Milk training courses, FDA/OTED-supported Shellfish training courses, Milk or Shellfish seminars, and LEO Milk or LEO Shellfish training courses, which are all specific needs of staff for program implementation. Equipment shall be the tools needed to conduct the programs.
A minimum of 35% of the cooperative agreement funds awarded shall be subawarded to state or territorial regulatory agencies to assist with implementation of the Grade "A" Milk Safety Program or the National Shellfish Sanitation Program.
The FDA program management officer, FDA grants management officer, FDA technical advisors, FDA Milk Specialists, FDA Shellfish Specialists, FDA National Milk and Shellfish Teams, FDA Milk and Shellfish Steering Committees, FDA Office of State Cooperative Program Directors, FDA/Office of Partnerships Milk and Shellfish Specialists, and representatives from other components within FDA will monitor the recipient and subawardees. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the FDA and the principal investigator. Periodic site visits from representatives of ORA with officials of the recipient organization or subawardees may also occur. There may be other regular meetings with the recipient and subawardees to assist in fulfilling the requirements of the cooperative agreement.
Initial, mid-year, and annual reports are required. The Research Performance Progress Report (RPPR) will be considered the annual program progress report for the budget period.
Link to report template:
https://www.fda.gov/media/176564/download?attachment
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 proposal. Goals and objectives should be itemized and reported accordingly.
2. Status report on the hiring and training of any personnel.
3. Status report on the purchasing and operational readiness of any equipment, computers, or software purchased.
4. Summary of funding requests received and subawards issued with the following information, at a minimum: name and contact information of agency, summary project proposed, funds requested, funding decision, and progress of the projects or subawards selected for funding.
5. Identify any pending issues or concerns that may affect accomplishing the objectives and goals of the cooperative agreement, including any subawards made. If the objectives and goals of the cooperative agreement are not being met, then a corrective action plan shall be submitted. The corrective action plan should detail the tasks, responsible personnel, and updated timeframes to ensure satisfactory performance and meet the deliverables required under the grant.
6. Detailed program budget demonstrating that a minimum of 35% of funds are subawarded to state or territorial regulatory agencies with primary responsibility for regulating Grade A Milk products and Molluscan Shellfish in their respective jurisdictions, or to agencies with substantial control and responsibility for such agencies.
7. Summary of the analyses of emerging concerns and trends within the states' and territories' Grade A Milk Safety Program and National Shellfish Sanitation Program.
8. Summary of the analyses of the states and territories future training and equipment needs, to include both short term and long-range needs. For example, several states and territories may have similar need for specific training courses, thus such a system should also include recommendations for the most efficient dates and locations for conducting future training courses, seminars, workshops, and conferences.
9. Summary of the impact and effectiveness of training received pursuant to a subaward. Such a summary should provide information on the various operational activities, regulatory or administrative actions, recalls, or related public health outcomes that were the result of training received by state or territorial employees pursuant to the receipt of subawards.
10. Summary of the impact and effectiveness of equipment purchased pursuant to a subaward. Such a summary should provide information on the various operational activities, regulatory or administrative actions, recalls, and/or related public health outcomes that were the result of equipment purchased by the states or territories pursuant to the receipt of subawards.
The final program progress report shall provide full written documentation of the project and summaries of accomplishments and goals, as described in the grant application. The documentation shall be in a form and contain sufficient detail such that other entities could reproduce the final project.
In addition, work proposed and conducted under this cooperative agreement, including subawards issued, may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed and conducted under this cooperative agreement and the funding provided shall remain distinct and separate from other projects and funding sources. The grantee shall be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.
Additional requirements may be listed in the Notice of Award.
Consistent with the 2023 FDA Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the HHS Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the HHS Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement. FDA NOFOs outline intended research goals and objectives. Post award, FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the HHS Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help
(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Suzanne Webb
FDA/ORA/Office of Regulatory Management Operations
Telephone: 240-402-3069
Email: suzanne.webb@fda.hhs.gov
Jenice Butler
FDA/ORA/Office of Partnerships
Telephone: 301-337-5538
Email: jenice.butler@fda.hhs.gov
Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov
Recently issued trans-FDA policy notices may affect your application submission. A full list of policy notices published by FDA is provided in the Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
and Human Services (HHS)
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