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

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

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

 

This cooperative agreement is intended to support the Manufactured Food Regulatory Program Standards (MFRPS), Food Protection Task Force (FPTF) programs, Dietary Supplement (DS) programs, as well as MFRPS Special Projects. Applicants must refer to the Eligibility Section of this NOFO to determine which funding track they should apply for: MFRPS Development or MFRPS Maintenance. Within each track, applicants applying for more than one funding option add-on should include activities supporting each funding add-on, as outlined below. Further information on eligibility for each of the funding options, maximum budget per program area and other administrative considerations can be found in this document below.

A schematic outlining the two funding tracks and the associated funding option add-ons available for each track is below:

Base Funding	Optional Add-Ons			Potential Award
MFRPS (Development)	Food Protection Task Force	Dietary Supplements	Special Projects
Flat rate: $300,000/year/grantee	Flat rate: $15,000/year/grantee	N/A	N/A	$315,000
Base Funding	Optional Add-Ons			Potential Award
MFRPS (Maintenance phase-variable funding)	Food Protection Task Force	Dietary Supplements	Special Projects
Level 1: $150,000	Flat rate: $15,000/year/grantee	Flat rate: $50,000/year/grantee	*Will fund at a limited amount based on the project innovation proposed in the application	$215,000 + special projects track amount
Level 2: $225,000	Flat rate: $15,000/year/grantee	Flat rate: $50,000/year/grantee		$290,000 + special projects track amount
Level 3: $300,000	Flat rate: $15,000/year/grantee	Flat rate: $50,000/year/grantee		$365,000 + special projects track amount

 

Background:

In the United States, federal and state government agencies ensure the safety of human and animal food. The Food and Drug Administration (FDA) is responsible for ensuring that all human and animal foods moving in interstate commerce, except those under the United States Department of Agriculture (USDA) jurisdiction, are safe, wholesome, and labeled properly. State agencies are responsible for conducting inspections and regulatory activities that help ensure food produced, processed, and distributed within their jurisdictions are safe and in compliance with state laws and regulations. State agencies primarily perform inspections under their own regulatory authority. Many state agencies conduct inspections of food facilities under contract with the FDA. Partnerships amongst the FDA and state regulatory authorities are important because jurisdictions often overlap and consistency in inspectional approach and capabilities enhances the IFSS.

The FDA Food Safety Modernization Act (FSMA) provides further support for developing an IFSS. FSMA was signed into law in January 2011 and calls for enhanced partnerships and integration with federal, state, local, tribal, and territorial partners. The enhanced partnerships and integration directed under the law allow the FDA to rely on inspections and data collected by other agencies, to support regulatory activities and further the build on the idea of an IFSS.

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food Regulation 21 CFR Part 117 ('Preventive Controls Rule') is intended to ensure safe manufacturing/processing, packing, and holding of food products for human consumption in the United States. Implementation of Preventive Controls Rule across state and territorial governments will help advance a risk-based vision of food safety.

The Manufactured Food Regulatory Program Standards (MFRPS) allows for the development and maintenance of risk-based food safety programs by establishing a uniform basis for measuring and improving the performance of state manufactured food regulatory programs in the United States.

For more information on the MFRPS Program, please visit http://www.fda.gov/ForFederalStateandLocalOfficials/ProgramsInitiatives/RegulatoryPrgmStnds/ucm475064.htm

For the purpose of this funding opportunity, conformance means the fulfillment of a requirement of the MFRPS specifically a state program is using and can demonstrate the use of a particular element, system, or program listed in the MFRPS (most recent version).

Goals:

Although individual year outcomes may vary among programs, the overall goals of the work provided under this cooperative agreement are as follows:

(1) Recipients will achieve and maintain conformance with the MFRPS (most recent version, https://www.fda.gov/media/131392/download?attachment) which is recognized as a critical element to creating a national, fully integrated food safety system.

(a) If conformance is not achieved by the conclusion of the cooperative agreement, the recipient will develop and implement a strategic improvement plan to reach conformance.

(b) Recipients will develop strategies and resources for achieving and maintaining conformance with the MFRPS that can be shared and duplicated on a national basis including: performing self-assessments, participating with the FDA assessments/audits, identifying continuous improvement projects, and maintaining an up-to-date strategic improvement plan.

(2) Recipient will provide the FDA the foundation for the improvement in quality of contracts, coordination of inspections, investigations and enforcement to effectively and efficiently protect public health to further the (IFSS).

(a) Recipients will contribute to the continuous improvement of the MFRPS through attendance at an annual face-to-face meeting, active participation in committees, and other initiatives that contribute to the improvement in regulatory activities in the IFSS.

(b) Recipient will maintain the FDA inspectional contract in good standing by completing all agreed upon inspectional work, audits, and associated compliance and regulatory activities.

(3) Recipient will establish inspection and compliance programs which incorporates a regulatory framework and authority to facilitate the IFSS, including engaging with the FDA to participate in work planning, work sharing, and data exchange efforts.

(a) To facilitate this continued development of an IFSS, the FDA and state personnel will meet as necessary to develop and monitor progress in work planning, work sharing, and data exchange efforts.

(b) When discussing work planning, states and the FDA should consider the inspection frequency for both high risk and non-high-risk facilities as described in FSMA section 201. Best Practices, such as those published by the Partnership for Food Protection (PFP), may be used as a resource to guide these meetings.

(4) Recipients will identify gaps in agency infrastructure necessary to fully adopt and implement the Preventive Controls Rule or statutory and/or regulatory authority with equivalent effect as a part of the manufactured food regulatory program.

(a) Infrastructure needs may include personnel, IT, regulatory foundation, training, updating procedures and records, management programs, and laboratory.

(b) The recipients should briefly describe their current status and evaluate existing statutory and/or regulatory authority related to the Preventive Controls Rule. If needed, plans to research changes needed to incorporate the Preventive Controls Rule or operate under the FDA authority should be described. Applicants may also propose to evaluate other applicable FSMA rules and determine if adoption or updating existing rules and regulations is necessary (e.g. Intentional Adulteration, Sanitary Transport, Foreign Supplier Verification Program, etc.). The updating of other regulations related to FSMA rules may also require updating procedures and policies to maintain conformance with the MFRPS.

(c) Recipients are encouraged to participate in pilot projects and develop capabilities to share regulatory data with the FDA through IT platforms, such as the National Food Safety Data Exchange (NFSDX), as opportunities are available.

(d) Recipients should also propose how novel capabilities will be maintained after the conclusion of the project.

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

(6) If recipients are a part of the Laboratory Flexible Funding Model (LFFM) they will apply their MFRPS response, enforcement and regulatory framework to conduct follow-up inspections, investigations (including traceback/forward), and enforcement actions (including embargos, recalls, warning letters, and closures) to positive and violative samples identified as part of the LFFM cooperative agreement. Coordination with the Rapid Response Team (RRT) and activation, if applicable, is required for recipients also participate in that award (RFA-FD-23-019).

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

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

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

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

(e) Recipients will build the necessary regulatory and compliance response infrastructure to investigate and respond to violative samples, including qualified personnel, IT resources, and regulatory authorities.

This funding track provides funding for the purpose of supporting activities of a food protection task force, as described in the Coalition of Food Protection Task Forces Best Practices Manual: https://web-dfsr.s3-us-gov-west-1.amazonaws.com/OP/assets/File/FPTF-Best-Practices-FINAL-1-12-21-508-version.pdf.

Task forces shall establish and annually update a vision & mission statement, organizational governance documentation, and a logic model that depicts the task force’s focus, inputs, activities, outputs (measurable/quantifiable program activities), and outcomes (qualitative and tangible benefits).

Task forces focuses can include: 1) Enhancement of partnerships for an IFSS; 2) Gathering, analyzing, and synthesizing input on proposed laws and regulations; 3) Education of stakeholders on new laws, rules, and regulations; 4) Providing technical assistance; 5) Educating consumers; 6) Enhancing human and animal food emergency response preparedness; 7) Discussing food safety issues related to emerging food trends; and 8) Promoting implementation of intervention strategies.

For applicants that do not currently operate or fund Food Protection Task Force(s) within their jurisdiction, objectives relating to the FPTF Project are allowed via subaward to active task force(s) within their jurisdiction.

 

Example of activities can include, but not limited to:

• Inspection/investigation strategic coordination and process improvement;
• Prevention activities such as after action reviews, hot washes, etc. to identify areas for improvement and for stakeholder training, education, and outreach;
• Intervention activities such as coordination of compliance, enforcement, and voluntary corrections;
• Multi-agency response activities and process improvement;
• Discussion and development of replicable resources and materials regarding effectively establishing and maintaining an Integrated Food Safety System.

Yearly Goals for FPTF:

1) Convene at least one task force meeting each year with the explicit purpose of informing, educating, and soliciting input from external stakeholders on items relevant to executing an effective Integrated Food Safety System at all levels within the respective state.

2) Convene at least one governance meeting with diverse membership to update the vision & mission statement, organizational governance documentation, and the logic model depicting the focus and measurable impact of the Food Protection Task Force.

3) Annually report quantified metrics and measurements demonstrating the various integration and task force activities conducted by the task force directly and as an indirect result of the task force to demonstrate overall impact of this funding track.

4) Submit copies of FPTF presentations, job aids, educational resources and other materials developed in part by this funding to the Office of Partnerships annually.

Objectives:

The objective of this funding track is to advance the adoption and implementation of the cGMPs for Dietary Supplements Rule codified at 21 CFR Part 111. This objective is classified into several broad activities to enhance and support cGMPs for Dietary Supplements rule implementation:

Training:

Technical training in the scientific basis, procedures, and legal requirements of the cGMPs for Dietary Supplements Rule allows for the equivalent and consistent application of the cGMPs for Dietary Supplements Rule across the United States. The program training plan (as required by the MFRPS) must be updated to include dietary supplement coursework and field training for inspectors engaging in these types of inspections. The state program training plan for dietary supplements should satisfy the training elements in the MFRPS. The training plan will provide a foundation for evidence collection and development, and data acceptability for dietary supplement inspections. An evaluation of the program training plan using data from inspections, samples, and regulatory actions should be performed to determine if the training program needs to be updated to support advisory/regulatory action under your own authorities or by the FDA, when necessary. The program should consult with their assigned FDA division staff, as appropriate when conducting the evaluation and shall identify and document any improvements (such as updates, modifications, or additions) to the program training plan that are needed to promote evidence collection and support possible regulatory actions.  The training required for conducting environmental and product sampling to support dietary supplement inspections should also be incorporated into the training program, as appropriate. Fully trained staff should conduct a minimum of 3 - 5 dietary supplement inspections annually to maintain proficiency. 

The recipient must identify and designate sufficient staff (minimum of 1) to serve as qualified field inspection trainers to provide dietary supplement training for staff as necessary to perform dietary supplement inspections.  Training required for the designated person(s) must be identified and completed. Recipients will conduct the in-field training necessary to ensure staff are qualified to independently conduct dietary supplement inspections and any required sampling (environmental and product).  Recipients can work with their assigned the FDA Field Division office for assistance with training. 

Auditing:

As part of the state contract, the state program is expected to move towards implementation of an audit program to support the dietary supplement inspection program. Once implemented, the audit program should include auditing of dietary supplement inspections. As available, the recipient should collect audit data on dietary supplement inspections, inspection reports, and sample collections and reports to evaluate general inspector and program data to identify any gaps and corrective actions needed.

Compliance Implementation Strategies:

Recipients will establish inspection and compliance programs which incorporates the requirements of 21 CFR Part 111. Programs will analyze their existing regulatory authority and identify strategies to address any gaps in existing laws and regulations. Programs will analyze their existing enforcement capabilities for dietary supplements and identify gaps in existing procedures. Recipients will work towards development of enforcement strategies appropriate for a dietary supplement inspection program including identifying critical observations, methods for monitoring chronic violators and chronic violations in conformance with Standard 6 of the MFRPS.

Program Improvement and Infrastructure Development:

Recipients will identify and provide the framework to address the gaps in agency infrastructure necessary to fully adopt and implement the cGMPs for Dietary Supplements Rule as a part of the manufactured food regulatory program. Infrastructure needs may include personnel, IT, regulatory foundation, training, updating procedures and records, management programs, and laboratory. Recipients should consider information sharing capabilities with the FDA in this assessment, as appropriate. Recipients should also propose how project developed capabilities will be maintained after the conclusion of the project. 

Other Outreach Activities:

Develop an outreach plan (as required in Standard 7) and associated materials related to dietary supplement regulation and compliance as part of the state program's overall outreach plan. Recipients should consider outreach to industry, including presentations at conferences, Food Protection Task Force meetings, website updates and/or other outreach efforts as appropriate.

Joint Work Planning and Enforcement:

The FDA and state personnel will meet as necessary to develop and monitor progress in work planning for dietary supplement facilities under inspection by both agencies to ensure mutually beneficial results. When discussing work planning, best practices, such as those published by the Partnership for Food Protection (PFP), may be used as a resource to guide these meetings. The recipient should evaluate current enforcement tools, strategies, and trends to determine their effectiveness and share findings with the FDA. Recipients are also encouraged to assist with updating guidance documents and participate in pilot projects to advance joint work planning, information sharing, firm reconciliation and enforcement actions between the state and the FDA, as necessary.

The FDA will consider providing funding for special projects that support innovation and integration in a nationally Integrated Food Safety System (IFSS) using the MFRPS framework. State programs will be expected to complete the special project within the proposed project period. All project deliverables and resources developed must be made available to other programs. The proposal will be evaluated to determine whether or not the project meets one or more of the following criteria:

(a)  Exceeds criteria in MFRPS program elements.

(b)  Addresses an IFSS issue or problem.

(c)  Is based on the most current public and environmental health and regulatory science and data available.

(d)  Introduces an innovative approach (a new method, idea, protocol, tool/resource).

(e)  Produces outcome data and/or a product and lessons learned that can be shared with the FDA and other stakeholders.

(f)   Reflects and promotes inter-agency communication, collaboration, coordination, accountability, transparency and sharing of information.

(g)  Supports the FDA’s mission and vision for building mutual reliance in an IFSS under FSMA.

(h)  Focuses on prevention, intervention or response activities.

(i)  Supports national or external (outside of applicant's State) capacity/capability development for prevention, intervention or response.

Examples of special projects include but are not limited to:

Development of a new inspections or investigations course, such as for a specific commodity, investigation technique, industry, or new rule.

Development of a new environmental sampling methodology to enhance efficiency.

Development of a system to collaborate with the FDA and other agencies through IT information sharing.

Development of an electronic risk-based modeling program that can demonstrate increased efficiency and effectiveness.

Development of a new foodborne illness prevention and/or intervention strategy designed for a specific targeted population.

Development of best practices or piloting of innovative approaches/technology/tools related to inter-agency data sharing, communication and coordination during prevention, intervention, and response.

Evaluates, summarizes, and shares lessons learned from using nationally recognized tools such as PFP guidance documents and Best Practices Manual with other state programs and stakeholders.

Legislation/other references of authority

National Integrated Food Safety System:

http://www.fda.gov/ForFederalStateandLocalOfficials/ProgramsInitiatives/default.htm

Food Safety Modernization Act:

http://www.fda.gov/Food/GuidanceRegulation/FSMA/

Full text of the law: http://www.fda.gov/food/guidanceregulation/fsma/ucm247548.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.

Governments

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

This opportunity is only available to the following State, Tribal or Territorial food safety programs:

Manufactured food regulatory programs with current the FDA food safety inspection contracts (providing funding to state agency food protection regulatory programs), or those that meet the eligibility requirements and agree to enter into a food safety inspection contract with the FDA at the earliest possible date, are eligible to apply for funding under this cooperative agreement. Competition is limited to state, tribal and territorial manufactured food regulatory programs because the foundational work conducted under the current FDA food safety inspection contracts is necessary for the completion of significant improvements in an IFSS.

Applicants will be categorized under one of two funding tracks: MFRPS Development or MFRPS Maintenance (see eligibility criteria below). Within each funding track, an applicant may apply for additional funding options for which they meet the eligibility criteria (below).

The applicant must hold a long-term food nonpublic information sharing agreement with the FDA pursuant to 20 CFR 20.88 ( 20.88 agreement ) or agree to enter into a 20.88 agreement with the FDA by the end of grant year one (June 30, 2025).

Applicants are encouraged to apply for cooperative agreement assistance that reflects their jurisdiction’s needs both in terms of amounts of funding and number of project years.

To ascertain an applicant's tier’s funding level, please consult Section II. Award Information.

State programs are eligible for Funding Track 1 if they have received less than five (5) years funding under a past MFRPS cooperative agreement or have never received a MFRPS cooperative agreement.

Applicants may request up to $300,000/year for this funding option.

State programs will move to MFRPS Maintenance funding levels in the sixth year of funding under MFRPS cooperative agreements. Applicants with less than five (5) years funding under a past MFRPS cooperative agreement may elect to count years of MFRPS enrollment under the FDA Food Inspection Contract towards the five (5) years MFRPS funding eligibility requirement when determining the entry date for Funding Track 2 (MFRPS Maintenance).

2018-19 MFRPS Cooperative Agreement Recipients (RFA-FD-18-001): State programs who began receiving MFRPS cooperative agreement funding in 2018 and/or 2019 are not eligible for Funding Track 1 of this cooperative agreement. These state programs must request funding under Funding Track 2 (MFRPS Maintenance).

2020 MFRPS Cooperative Agreement Recipients: State programs who began receiving MFRPS cooperative agreement funding in 2020 are only eligible to receive funding under Funding Track 1 (MFRPS Development) for year 1 of this two-year cooperative agreement.

2021-22 MFRPS Cooperative Agreement Recipients: State programs who began receiving MFRPS cooperative agreement funding in 2021 and/or 2022 are eligible to receive funding under Funding Track 1 for years 1 and 2 of this cooperative agreement.

See section titled, "MFRPS Funding Track 2" for variable funding levels and additional funding options.

Programs who meet the eligibility requirements for Funding Track 1 (MFRPS Development):

• Are also eligible to apply for a FPTF option.
• Are not eligible to apply for Dietary Supplements or Special Projects funding options.

State programs are eligible for Funding Track 2 if they have received five (5) years funding under a past MFRPS cooperative agreement. Applicants with less than five (5) years funding under a past MFRPS cooperative agreement may elect to count years of MFRPS enrollment under the FDA Food Inspection Contract towards the five (5) years MFRPS funding eligibility requirement when determining the entry date for Funding Track 2 (MFRPS Maintenance).

When a state program transitions from Funding Track 1 to Funding Track 2 during the course of the two-year cooperative agreement, that state program also becomes eligible for the additional funding opportunities available under Funding Track 2 (such as: Dietary Supplements and Special Projects).

If the state program is not currently deemed to be in conformance (as documented in the most recent assessment by the FDA/ORA/OHAFO/Audit Staff), then the program must submit a strategic improvement plan as part of the application.

Potential applicants have been classified into three (3) funding levels based on a variety of factors. Applicants may apply for funding levels up to, but not exceeding, the levels identified below. Each jurisdiction is unique and must not apply for funding exceeding these levels.

MFRPS Level 1 $150,000	MFRPS Level 2 $225,000	MFRPS Level 3 $300,000
Arkansas	Alabama	California - Health
Mississippi	Alaska	Florida
Nebraska	Colorado	Illinois
Nevada	Connecticut	Michigan
Rhode Island	Georgia	New Jersey
South Carolina - Agriculture	Indiana	New York
South Carolina - Health	Iowa	North Carolina
Vermont	Kansas	Ohio
West Virginia -Agriculture	Kentucky	Pennsylvania
West Virginia - Health	Maryland	Texas
Wyoming	Massachusetts	Washington
Delaware*	Minnesota	Wisconsin
Hawaii*	Missouri
New Hampshire*	Tennessee
North Dakota*	Utah
Oklahoma*	Virginia
South Dakota*	Arizona*
	California - Agriculture*
	Idaho*
	Louisiana*
	Maine*
	Montana*
	New Mexico*
	Oregon*
	Puerto Rico*

* State program's eligibility to enter the MFRPS Maintenance Funding Track depends on date of first receiving a MFRPS Cooperative Agreement - see eligibility narrative for further details.

MFRPS Level 1

• $150,000

MFRPS Level 2

• $225,000

MFRPS Level 3

• $300,000

Data sources used to determine eligibility:

Criteria	Range	Value
Total Non-Contract Inspections (NCI)	<885 firms (<33% percentile)	1 point
	>885-1980 firms (>33-66% percentile)	2 points
	>2142 firms (>66% percentile)	3 points
# of High Risk Inventory	<122 firms (<33% percentile)	1 point
	>179-383 firms (>33-66% percentile)	2 points
	>603 firms (>66% percentile)	3 points
Total FSMA Count by FEI	<704 firms (<33% percentile)	1 point
	>1004-1757 firms (>33-66% percentile)	2 points
	>1948 firms (66% percentile)	3 points
FSMA High Risk Inventory	<190 firms (<33% percentile)	1 point
	>212-595 firms (>33-66% percentile)	2 points
	>793 firms (>66% percentile)	3 points
Total Weighted Contract Inspection Cost	<$1217.4 (<33% percentile)	1 point
	>$1253.05-1930.59 (>33-66% percentile)	2 points
	>$1962.41 (>66% percentile)	3 points
Population based on 2020 Census	>3.011M population (<25% percentile)	1 point
	>3.012 - 6.177M population (>25-75% percentile)	2 points
	>6.178M population (>75% percentile)	3 points

Programs who meet the eligibility requirements for Funding Track 2 (MFRPS Development):

• Are also eligible to apply for a FPTF option.
• Are also eligible to apply for a Dietary Supplements funding option.
• Are also eligible to apply for a Special Projects funding option.

Food Protection Task Force (FPTF) eligibility requirements:

• Applicants may request up to $15,000/year for this funding option
• State programs are eligible to apply for this option for both Funding Track 1 (MFRPS Development) and Funding Track 2 (MFRPS Maintenance).
• States with an existing Food Protection Task Force, as well as States that are developing a new Food Protection Task Force are both eligible to apply for this funding option.
• To apply for this funding option, a task force must provide a forum for all the stakeholders of the food protection system regulatory agencies, academia, industry, consumers, State legislators, Boards of Health and Agriculture, and other interested parties to improve food safety and defense.
• Only one award is allowed per state/territory. Jurisdictions interested in involving multiple state/territory entities (within their jurisdiction) are required to internally coordinate and choose one (1) entity to apply.

Dietary Supplements (DS) eligibility requirements:

• Applicants may request up to $50,000/year for this funding option.
• Applicants must have DS as an elective option in their FDA food state contract and to conduct DS contract inspections

Special Project eligibility requirements:

• Applicants will be reviewed, and funding levels will be determined based on the budget justification and amount proposed. This option may have limited availability for funding.

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

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

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

Applicant Organizations

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

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

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 2.3.7.4 Submission of Resubmission Application. This means that the FDA will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

 

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Applicants must download the application package associated with the Track (MFRPS Maintenance or MFRPS Development) they are applying for by referencing the COMPETITION ID field. The COMPETITION ID field will state:

• MFRPS Development
• MFRPS Maintenance

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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

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

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

The letter of intent should be sent to:

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: [email protected]

A technical session will be held for prospective applicants in March 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.

Available Components	Component Type for Submission	Page Limit	Required/Optional	Minimum	Maximum
Overall	Overall	6	Required	1	1
Core	Core	12	Required	1	1
Projects	Project	12 (each Project)	Optional	0	3

The following section supplements the instructions found in the How to Apply Application Guide , and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Core: required
• Projects: optional

When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form, with following additional instructions:

•      Descriptive Title of Applicant's Project: Applicants must include the Track Name (MFRPS Maintenance or MFRPS Development) and State Organization Name/Abbreviation in the Project Title.  

Follow standard instructions.

Follow standard instructions.

Project Narrative: Required. Project narrative is required for the Overall component.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

 

Specific Aims: Describe the overall objective of the proposed multi-project application, and how the individual projects contribute to the overall objective.    

Research Strategy: Focusing on the project as a whole, describe the strategy to accomplish the overarching aims of the overall project. This should include how your personnel, resources, and organizational infrastructure are well suited to meet the goals of the project through appropriate training and experience.

Letters of Support: Not required.

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 NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

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

When preparing your application, use Component Type Core.

• One Core is required. A Core is either MFRPS Development or MFRPS Maintenance.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (must include the Track Name (MFRPS Maintenance or MFRPS Development) and State Organization Name/Abbreviation in the Project Title)   
• Proposed Project Start/Ending Dates

Typically, not applicable for this NOFO.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

• 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.
• Budgets should take into consideration sending Key personnel (minimum of two) to attend an annual face-to-face meeting (as determined by the FDA OP) as a condition of the award.

Research Strategy: The application should detail how the following will be achieved:

(1) Defining how applicant will achieve and maintain conformance with the MFRPS or continue to maintain conformance with the MFRPS (most recent version).

(a) Identifying if conformance is not achieved, they will develop and implement a strategic improvement plan to reach conformance.

(b) Expand upon established strategies and resources for achieving and maintaining conformance with the MFRPS that can be shared and duplicated on a national basis including examples which may be: performing self-assessments, participating with the FDA assessments/audits, identify continuous improvement projects as well as maintain an up to date strategic improvement plan.

(2) Providing the foundation for the improvement in quality of contracts, coordination of inspections, investigations and enforcement to effectively and efficiently protect public health to further the Integrated Food Safety System (IFSS).

(a) Maintaining standards through the attendance at an annual face-to-face meeting, active participation in committees, and other initiatives that contribute to the improvement in regulatory activities in the IFSS.

(b) Maintaining an the FDA inspectional contract in good standing by completing all agreed upon inspectional work, audits, and associated compliance and regulatory activities.

(3) Facilitating the establishment and improvement of in place inspection and compliance programs which incorporates a regulatory framework and authority to facilitate the IFSS, including engaging with the FDA to participate in work planning, work sharing, and data exchange efforts.

(a) Describing opportunities to expand opportunities for the FDA and state personnel to meet as necessary to develop and monitor progress in work planning, work sharing, and data exchange efforts.

(4) Describe gaps in agency infrastructure necessary to fully adopt and implement the Preventive Controls Rule or statutory and/or regulatory authority with equivalent effect as a part of the manufactured food regulatory program and describe plans for implementation.

(a) Infrastructure needs may include personnel, IT, regulatory foundation, training, updating procedures and records, management programs, and laboratory.

(b) The applicant should briefly describe their current status and evaluate existing statutory and/or regulatory authority related to the Preventive Controls Rule. If needed, plans to research changes needed to incorporate the Preventive Controls Rule or operate under the FDA authority should be described. Applicants may also propose to evaluate other applicable FSMA rules and determine if adoption or updating existing rules and regulations is necessary (e.g. Intentional Adulteration, Sanitary Transport, Foreign Supplier Verification Program, etc.). The updating of other regulations related to FSMA rules may also require the updating procedures and policies to maintain conformance with the MFRPS.

(c) Describe plans to participate pilot projects and develop capabilities to share regulatory data with the FDA through IT platforms, such as the National Food Safety Data Exchange (NFSDX), as opportunities are available.

(5) Applicants will describe their information sharing agreement with the FDA under 21 CFR 20.88 status and if one does not happen describe plan to be able to obtain an agreement prior to the start date of the award.

(6) If applicants are a part of the Laboratory Flexible Funding Model (LFFM) they will detail their MFRPS response, enforcement and regulatory framework to conduct follow-up inspections, investigations (including traceback/forward), and enforcement actions (including embargos, recalls, warning letters, and closures) to positive and violative samples identified as part of the LFFM cooperative agreement.

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 NOFO.

Appendix: Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When preparing your application, use Component Type Project.

• Projects are optional. Projects include FPTF, Dietary Supplements, or Special Project.  Please review Section III Eligibility Information, to see which project(s) you are eligible to apply for.  The applicant must prepare a separate Component for each proposed project by adding a new Component Type 'Project' for each project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant
• Descriptive Title of Applicant’s Project (must include Project Name (FPTF, Dietary Supplements, or Special Project) and State Organization Name/Abbreviation in the Project Title)   
• Proposed Project Start/Ending Dates

Typically, not applicable for this NOFO.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Application guide states that Project Narrative is required.  However it is only required for the Overall component. 

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

• 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.
• Please review and adhere to all budget requirements for each project.

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 NOFO.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. 

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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH 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 NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 and 45 CFR 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Awards issued under this NOFO will be incrementally funded awards for each budget period. NIH and FDA will not issue any awards under this NOFO for a single budget period for multiple years.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA.

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

See more tips for avoiding common errors.

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

 

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

Post-submission materials are those submitted after submission of the grant application but prior to scientific peer 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 scientific peer 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.

PERFORMANCE MEASURES:

Consistent with the Uniform Guidance, codified at 2 CFR Part 200, an emphasis will be placed on the applicant’s ability to measure progress and track performance using objective, proven, and measurable data.  As such, applicants will propose how they will develop and implement a performance measurement system, plan, and/or process and will carefully consider the Scored Review Criteria listed in Section V of this announcement when submitting their application. 

As a part of your application, applicants should explain how they intend to measure performance if their application is funded. This should include Acceptable Quality Levels as well as Public Health Measures that are SMART:

Specific (specific, sensible, significant)

Measurable (meaningful, motivating)

Achievable (agreed, attainable)

Relevant (reasonable, realistic and resourced, results-based)

Time-Bound (time-based, time limited, time/cost limited, timely, time sensitive)

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

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

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

Does the applicant demonstrate the ability to develop or implement a comprehensive approach that results in the program reaching conformance within three (3) years of receiving funding (Development Funding Track 1) or maintaining conformance with the MFRPS (Maintenance Funding Track 2), including new versions? Have potential obstacles to achieving and maintaining conformance been identified, along with approaches to overcome these obstacles? For applicants located in a state with a supporting laboratory that receives funding under an active the FDA cooperative agreement for expanding capacity for analysis of human food, including maintaining ISO 17025 accreditation, does the project outline a sampling plan to support laboratory capacity development and product surveillance?

Are the overall strategy, methodology, and analyses well-though out and appropriate to accomplish the specific goals of the project? Have adequate resources (including staff and infrastructure) been proposed in the application budget to meet the objectives of the cooperative agreement? Is there adequate demonstration of effectiveness in working with federal, state, and local partners and other appropriate organizations to implement the goals of the cooperative agreement?

Is the proposed budget relevant and impactful towards achieving the goals of the cooperative agreement? Does the application provide justification for hiring new staff, or maintaining existing staff, including qualifications, training needs, and new equipment needs, or maintenance of equipment? Is there at least one dedicated full-time employee/equivalent (FTE) to lead day-to-day oversight of this project, such as a MFRPS Coordinator? Is there adequate agency management support, as evidenced by the selection of PD/PI(s) for the project? Have the agencies previously experienced issues with carryover, offsets, or lack of agency support to adequately fulfill the goals of the program?

Does the applicant demonstrate the ability to fully participate in initiatives supporting the cooperative agreement? Does the applicant outline strategies to maintain conformance with the MFRPS?

Does the applicant propose new innovations or improvement of current systems using the MFRPS that contribute to the advancement of the IFSS, or DMR?

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.

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

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

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

FPTF:

Task force mission and objectives are clearly identified and address one of the following: routine communication between FPTF stakeholders, topics of concern to stakeholders, training, improving inspections/investigations, foodborne illness prevention, intervention and/or response, working together to achieve compliance with food regulations/laws.

Dietary Supplements:

Does the project list milestones and key support staff responsible for the program? 

Will the organization monitor and trend to determine their effectiveness related to dietary supplement regulatory actions and appropriate evidence for violation? 

Organization evaluates existing regulatory authority and identifies program gaps with existing enforcement capabilities or develop enforcement strategies appropriate for a dietary supplement inspection program (i.e. identifying critical observations, methods for monitoring chronic violators and analyze compliance and enforcement program).

Special Projects:

Does the project address support innovation and integration in a nationally Integrated Food Safety System (IFSS) using the MFRPS framework? Does the project exceed the criteria in MFRPS program elements? Does this project initiate or drive system improvements?

FPTF:

Program addresses how communication and collaboration with key stakeholders (including but not limited to regulatory agencies, academia, industry, consumers, State legislators, Boards of Health and Agriculture, and other interested parties) will support an integrated food safety system.

Dietary Supplements:

Does the proposed project describe the infrastructure of the entire project with reasonable timeframes to meet expected goals? Does the proposal include development of protocols or written procedures to support a comprehensive Dietary Supplement inspection program? Does the proposal include methods of identifying and categorizing inventory based on risk? Does the proposal include analyzing current regulatory authorities and identifying gaps in compliance and enforcement authorities?

Proposals are adequate to address possible variables and factors that will prepare the agency to handle non-compliance issues or products that pose a public health risk. If certain program areas are established, does the project lists improvement or alternative strategies for maintaining a Dietary Supplement inspection program and explains the benchmarks for success? If the project is in the early stages of development, will the strategy establish feasibility?

Special Projects:

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific goals of the project? Can the project be completed within the proposed timeframe? If pertinent to the proposed project, have relationships with appropriate partner organizations been established?

FPTF:

Is the proposed budget relevant and has a major effect towards achieving the goals of the cooperative agreement?

Dietary Supplements:

Is the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Does the project explain the success of the program, program benefits for the agency, consumers, or public health?

Does the program have a structure in place for adequate management of the project to meet the overall objectives?  Does the organization explain the best use of funds, materials and staff in order to function effectively?

Does the proposed project include a plan to develop a training curriculum, including field training, for dietary supplement inspectors? Does the proposed project include determining appropriate training for non-inspectors with a role in the Dietary Supplement program (e.g. supervisors, compliance officers, laboratory personnel, etc.)?

To achieve appropriate experience and training, detailed activities should be provided.  Some activities may include:  conducting inspections, understanding case development for noncompliant products, documenting inspectional observations for evidence development and report writing, collecting samples, analyzing noncompliant products, and/or reviewing evidence and reports to support regulatory actions.

Special Projects:

Is the proposed budget relevant and impactful towards achieving the goals of the cooperative agreement?

FPTF:

Demonstrate the ability to bring together the FPTF stakeholders for a meeting/forum, including: Food Regulatory, Academia, and Industry. Promote the concept of integrated Food Safety System (IFSS), such as: Collaborate on integration projects and share innovative outcomes nationally; Include plans to collaborate with other FPTF's on integration; Work with stakeholders to adopt and implement the appropriate regulations (Food Code, CFR, FSMA etc.); Work on current projects that benefit public health including prevention, intervention, response, and post-response.

Does the applicant plan to share or otherwise make available any developed resources, materials

or information to all stakeholders (including other FPTFs) for them to access and use/replicate?

Dietary Supplements:

Does the proposed program describe the resources, IT systems/processes, equipment and other support (i.e. staff or physical resources) needed to make this a successful program?  Does the proposal describe in detail how the organization ensures the program is adequately resourced?  Does it list the challenges and weaknesses the organization may face in attempting to develop or maintain this program?

The proposal specifies how the organization effectively communicates with key personnel and their assigned the FDA division staff, as appropriate when conducting evaluations, work planning, identify improvements (such as updates, modifications, or additions) to the program or training plan that are needed to promote evidence collection and support possible regulatory actions. In addition, the organization should consider information sharing capabilities.

Special Projects:

Will project outcomes, data, or lessons learned be shared with the FDA and other State programs to improve their capabilities/capacity?

FPTF:

Does the applicant propose new innovations or improvement of current system or process?

Dietary Supplements:

Does the applicant propose new innovations or improvement of current system or process?

Special Projects:

Does the project introduce an innovative or an improved method?

Applications will be evaluated for scientific and technical merit by (an) appropriate scientific peer review committee convened by the FDA, using the stated review criteria.

As part of the scientific peer review, all applications:

• Will receive a written critique.

Appeals of scientific 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:

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

After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

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.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients 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.

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see  https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about FDA's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what FDA's expectations are for institutions and the individuals supported on FDA-funded awards, please see FDA's Anti-Harassment and Inappropriate Conduct Policy.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.  

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. 

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award (NOA). All progress reports shall contain certain elements as applicable to their approved cooperative agreement and award.

All the FDA grants require annual performance progress reporting. This award has additional performance reporting requirements as outlined below.

Additional Terms and Conditions for MFRPS Funding track: 

Key personnel (minimum of two) must attend an annual face-to-face meeting (as determined by the FDA OP) as a condition of the award.

State manufactured food regulatory programs in the MFRPS Development funding track are expected to achieve conformance with the MFRPS before year 6 under this or any other combination of cooperative agreements funding the MFRPS program.

State manufactured food regulatory programs in the MFRPS Maintenance funding track are expected to maintain conformance with the MFRPS throughout the duration of the award.

The recipient must maintain a food safety inspection contract in satisfactory standing with the FDA throughout the cooperative agreement.

If a recipient of multiple the FDA awards (cooperative agreements, grants, contracts), the State must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, under those funding mechanisms and this cooperative agreement.

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

Additional Terms and Conditions for FPTF funding track (as applicable): 

All conference material (promotional materials, agenda, publications and internet sites) related to this project must include an acknowledgement of the FDA grant support and a disclaimer stating the following: Funding for this conference was made possible [in part] by [insert grant number] from [insert the FDA name]. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

Task Forces funded under this grant must establish and maintain organizational governance documentation (mission statement, vision statement, charter) and have a clearly defined resource-development and educational focus, quantifiable outputs, and measurable public health impact/outcomes.

Additional Terms and Conditions for Special Projects funding track (as applicable) 

The FDA reserves a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use for federal purposes any copyrighted works that are outcomes from these funding tracks, including curriculum, course content, objectives, learning outcomes, presentations, manuals, scripts, exercises, handouts, reports, documents or other tangible materials produced by the recipient. The FDA may authorize others to reproduce, publish, or otherwise use such works for Federal purposes.

A review will be conducted after each progress report is submitted and State programs will be placed in special conditions if review of the most recent audit assessment, strategic improvement plan, the FDA Office of Partnerships/Division of Standards Implementation (OP/DSI) visit and progress report indicate the program is at risk of not meeting the goals of this cooperative agreement.

Applicants should develop a sustainability plan when designing projects proposed under this cooperative agreement to maximize the longevity of resulting outcomes, resources, and program infrastructure beyond the end of the project period.

Consistent with the HHS 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 45 CFR Part 75.301 and 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 NIH 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 NIH Grants Policy Statement for additional information on this reporting requirement.

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

Aaron Dagres
Office of Regulatory Management Operations (ORMO)
Food and Drug Administration
Email: [email protected]

Nicola Areshenko, Project Manager
Office of Regulatory Affairs
Office of Partnerships (OP), Division of Partnership Investments and Agreements
Food and Drug Administration
Email: [email protected]

Jocelyn Ramos
Office of Regulatory Affairs
Office of Partnerships (OP), Division of Partnership Investments and Agreements
Food and Drug Administration
Email: [email protected]

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: [email protected]

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

 

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..