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

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

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

To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) has established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce raw agricultural commodities grown for human consumption. FDA established these standards in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, referred to as the Produce Safety Rule under 21 CFR Part 112, as part of the implementation of the FDA Food Safety Modernization Act (FSMA). Additionally, FSMA explicitly recognizes that all food safety agencies need to work together in an integrated way to achieve our public health goals.

FDA initiated a partnership with state and territory agencies in 2016 through June 2021 via the cooperative agreements under PAR-16-137. That Cooperative Agreement Program provided technical and financial assistance to state and territorial agencies to develop and implement multi-faceted Produce Safety Programs that support implementation of the Produce Safety Rule and the FDA Food Safety Modernization Act (FSMA).

Grantee agencies of this cooperative agreement program (CAP) will establish and maintain a Produce Safety Program within their jurisdiction with the overarching purpose to enhance produce safety and achieve high rates of compliance with the FDA’s Produce Safety Rule. The objectives of this CAP are holistically intended to guide grantee Produce Programs that are focused on quality and national consistency.

Grantees are to choose one of three Program Path options. The Program Path selected by the grantee primarily distinguishes how they choose to accomplish a Produce Safety regulatory program.

Objectives are outlined according to Program Path.

Objectives for Assessment and Planning; Program Administration; Education, Outreach, and Technical Assistance; and Farm Inventory are applicable to all grantees, as outlined.

All applicants MUST choose only one Program Path (A, B, or C)

PATH A: Jurisdictions that will not conduct produce safety inspections (non-regulatory programs) but will complete other applicable program objectives. Path A grantees are responsible for completing all items under Program Objectives 1, 2, 3, and 4.

PATH B: Jurisdictions that will conduct produce safety inspections under FDA’s authority and will complete other applicable program objectives. Path B grantees are responsible for completing all items under Program Objectives 1, 2, 3, 4, 5, 6, and 7.

PATH C: Jurisdictions that will conduct produce safety inspections under their own authority and will complete other applicable program objectives. Path C grantees are responsible for completing all items under Program Objectives 1, 2, 3, 4, 5, 6, and 7.

Assessment and planning activities are essential with respect to program development, maintenance, and longevity. The intention of Project Plan and Assessment documents are to guide the development of the grantee’s program.

a. Project Plan Document: The Project Plan must be a written document. The Project Plan will document plans, progress, accomplishments, and setbacks in achieving each program objective. The Project Plan must track timelines, responsibilities, and key milestones according to the documented plan for accomplishing each applicable program objective. Version controls must be used for changes to the document; all changes must be tracked and explained. This is expected to be a living document and is required for all paths.

b. Assessment Document: The Assessment must be a written document. The original Assessment must be completed by the Year 1 annual report submission date. The Assessment must provide complete jurisdiction information related to each item below under Produce Landscape, Produce Program Resources, and Produce-Related Response. Version controls must be used for changes to the document; all changes must be tracked and explained. This is expected to be a living document and is required for all paths.

Produce Landscape Assessment

1. Identify covered produce commodities that are common to your jurisdiction

2. Identify common farming conditions and practices in your jurisdiction

3. Identify unique farming conditions and practices in your jurisdiction

4. Review farm inventory data using estimated data (2017 National Agricultural Statistics Service (NASS) Data or other justified source) and compare it to your jurisdiction’s verified number of farms in inventory, specifically for, but not limited to:

a. Covered Farms (Conducting Covered Activities on Covered Produce):

i. Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $500,000

ii. Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $250,000 but not more than $500,000 (small businesses)

iii. Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $25,000 (as adjusted for inflation), but no more than $250,000 (very small businesses)

b. Farms that are eligible for a qualified exemption

c. Farms where all covered produce is eligible for processing exemption

d. Farms that have an average annual value of produce sold during the previous three-year period of $25,000 (as adjusted for inflation), or less

e. Farms that exclusively grow, harvest, pack or hold produce commodities that are identified by FDA as Rarely Consumed Raw

Produce Program Resource Assessment

1. Develop an organizational structure and infrastructure needed to fulfill CAP objectives.

2. Identify partners and collaborators that support your produce program, such as other regulatory programs, other governmental non-regulatory programs, audit programs, educational programs, industry organizations, commodity groups, and other stakeholders (e.g., coalitions, subject matter experts). Identify potential additional opportunities for collaboration and partnership.

Produce-Related Event Response Assessment

1. Assess your state or territories capabilities (authorities, roles, staffing, policies, and procedures) to respond to produce related events within the jurisdiction. Additionally, identify where existing federal funding is provided to conduct such capabilities.

Produce-related events may include the following associated with Raw Agricultural Commodities grown in a grantee state or territory associated with:

a. A local, single-state, multi-state or international foodborne illness outbreak or death(s) due to human pathogens.

b. A positive food (produce) product sample positive for human pathogens

c. A voluntary intra-state or interstate commerce food (produce) recall due to human pathogens

d. Natural and man-made events that may adulterate produce

e. Reportable Food Registry Reports

Capabilities may include:

A. Incident Response

• For-cause Investigation capacity and capability
• For-cause sampling capabilities (product and environmental) including, laboratory support to analyze for-cause samples
• Traceback investigation capabilities
• Root cause investigations capabilities. Including investigations of related operations (compost suppliers, packing sheds) and adjacent land (CAFOs, dairies, livestock farming operations, etc.)
• Communications Capabilities ability to develop and publish consumer advisories
• State jurisdictional authority that provide the capability for incident response (e.g. actions, and capabilities).
• State compliance and enforcement capabilities for farm level incident response; (e.g. stop sale, embargo, etc.)

B. Recall

• Conduct recall-related activities

i. Effectiveness checks capabilities

ii. Audit checks; potentially leading to further follow-up activities capabilities.

This objective is intended to establish the foundational resources, including, but not limited to, personnel, supplies, training, authority, and agreements, needed to fulfill the grantee’s project plan.

a. Maintain program staff and partners to accomplish the implementation, oversight, monitoring and reporting of program objectives (See Program Reporting section of this Funding Opportunity Announcement).

b. Identify training needs for positions to fulfill program objectives. Provide program personnel with

appropriate training and resources commensurate with work duties.

c. Develop a plan for succession within the jurisdiction s program.

d. Provide for key program personnel to attend and participate in the Annual National Consortium for Produce Safety and other initiatives supporting program implementation.

e. Establish and maintain FDA Commissions for key personnel in the program and 21 CFR 20.88 information sharing agreements with FDA.

f. PATH B Grantees shall maintain FDA pocket credentials (with produce endorsement) for staff conducting Produce Safety Rule inspections.

g. PATH C Grantees shall adopt all Subparts of the Produce Safety Rule (21 CFR Part 112) in their entirety, by statute or administrative regulation; with exceptions as follows: grantees may omit any, or all, of the following:

• Subpart M (Sprouts);
• Subpart P (Variances);
• Subpart Q (Compliance and Enforcement), provided the grantee agency has compliance and enforcement authority, or such authority will be obtained before conducting inspections.

Additionally, PATH C grantees are responsible for ensuring that their statute or administrative regulation is updated to reflect applicable changes to the Produce Safety Rule resulting from FDA rule-making. Changes resulting from FDA rulemaking must be incorporated into the grantee’s statute or administrative regulation no later than the compliance date that is applicable to the rulemaking.

This objective is intended to provide opportunities for education, outreach, and technical assistance on the Produce Safety Rule and the jurisdiction’s produce regulatory program to produce farms, prioritizing covered farms.

a. Utilize data from the jurisdiction’s Assessment, verified farm inventory, and inspection program to create a plan to provide opportunities for education, outreach, and technical assistance on the Produce Safety Rule and the jurisdiction’s produce regulatory program to produce farms, prioritizing covered farms. Document the annual education, outreach, and technical assistance plan in the Project Plan.

Farms conducting covered activities on covered produce are eligible to receive education, outreach, and technical assistance regardless of produce sales or exemption status.

b. Provide education utilizing the existing curriculum and materials recognized by FDA and training partners; these may include but are not limited to curriculum and materials developed by the Produce Safety Alliance and the Sprout Safety Alliance, and Regional Centers.

c. Provide outreach and technical assistance that focuses on the requirements of the Produce Safety Rule and your jurisdiction’s produce regulatory program; incorporating local and regional practices and conditions and sharing information on best practices.

d. Technical assistance may be provided pre- and/or post- inspection through the optional activity of On-Farm Advisory/Readiness Reviews (OFRRs) or other remote or on-farm educational programs.

e. Funded education, technical assistance, and outreach activities must be tracked in the Project Plan to include: a clear description of the activity; the host of the activity; number of participating farms/stakeholders; measure of how the activity will improve produce safety and enhance compliance with the Produce Safety Rule. Activities may be grouped by categories (OFRRs/PSA grower trainings/etc.); however, each activity must be accounted for in reporting.

Education activities may include formal dissemination of established curriculum and materials. Technical Assistance may include individual assistance to interpret and apply the regulation to a specific situation. Outreach activities may include one-time or short -duration contact to provide information. These accomplishments should be documented according to the established plan for conducting such activities.

f. An educational needs assessment is required to be completed prior to the development of any new trainings and/or materials. The grantee should inform their FDA Project Manager before initiating an educational needs assessment.

Farm inventory data is the basis for program planning at the national level and at the grantee level. The USDA National Agricultural Statistical Services (NASS) 2017 Census of Agriculture is the current source for estimating the number of Produce farms in the U.S. The objective is intended for grantees to establish a complete and accurate inventory of produce farms, which can be used to implement corresponding objectives of this CAP.

a. Develop a verified, usable inventory that captures at least the required data elements in the Farm Inventory Data Elements Catalog (SEE APPENDIX G) for all Produce Farms with Produce Sales.

• The grantee’s plan to develop a complete farm inventory should aim to achieve 100% the number of Produce Farms with Produce Sales from the National Agricultural Statistical Services (NASS) 2017 Census of Agriculture data; and should include justification for deviations from the 2017 NASS data.
• Verified refers to data collected directly from the farmer (e.g., collected through direct mailing, phone, informational visit, inspection, voluntary online registration, or other direct interaction with farmer).

b. When appropriate, coordinate with FDA and other state or local agencies for farm inventory activities.

c. By the end of year 1, grantees should maintain farm inventory data in a manner that will facilitate retrieval and reporting of required aggregate inventory data (See APPENDIX D) in a system that is capable of exporting in an excel format.

d. PATH A grantees are responsible for developing a comprehensive farm inventory to provide to FDA monthly, or as needed. The Grantee shall submit verified farm information in the ORAPP (See APPENDIX F). By the end of year 1, grantees should establish and utilize written procedures for conducting farm inventory verification activities. After the grantee submits verified farm information in ORAPP, the FDA will maintain and update the farm inventory. FDA will share any updated inventory information with the respective Grantee to support the Grantee s outreach, education and technical assistance efforts.

e. PATH B and PATH C By the end of year 1, grantees should establish and utilize written procedures for farm inventory verification and maintenance activities, including identifying FDA and state required data elements, frequency for maintenance activities, and mechanisms for updating information, including updating information during regulatory activities.

FDA established the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, referred to as the Produce Safety Rule under 21 CFR Part 112, as part of the implementation of the FDA Food Safety Modernization Act (FSMA). Additionally, FSMA explicitly recognizes that all food safety agencies need to work together in an integrated way to achieve our public health goals. In effort to support an IFSS, inspection regulatory programs should be focused on quality and national consistency. This objective is applicable to grantee agencies that will conduct produce safety rule inspections funded by this CAP.

a. Conduct inspections according to written procedures that should align with the Standardized Approach to Produce Farm Inspections (APPENDIX H).

1. PATH B grantees are expected to conduct inspections according to the most current FDA Produce Safety Inspections Assignment (and attachments) and pertinent FDA guidance or operating instructions for conducting produce safety inspection.

2. PATH C grantees are encouraged to conduct inspections according to the current FDA Produce Safety Inspections Assignment (and attachments) and pertinent FDA guidance for conducting produce safety inspection.

b. Implement and execute a produce safety inspection calibration program, in coordination with FDA, to ensure the consistent understanding, application, and communication of Produce Safety Rule requirements during inspections.

c. Utilize an electronic system for maintaining inspection data and inspection data elements; the system should be capable of extracting data into an .xml file format and facilitate reporting of required aggregate inspection-related data elements (See APPENDIX E).

d. When appropriate, coordinate with FDA and other state or local agencies when multi-jurisdiction inspections are identified.

e. Establish an annual inspection work plan using the following Inspection Frequency and Risk-Based Prioritization according to the following:

Inspection Frequency:

• At a minimum, grantees should conduct routine inspections on 20% of the jurisdiction’s non-exempt covered farms annually. If your jurisdiction chooses to do more inspections than 20% of your covered inventory annually, that is allowed but will not be considered for regulatory band funding.
• Each non-exempt covered farm should receive an initial inspection by June 30, 2026.
• Annual funding is also allocated for compliance-based inspections, estimated at 20% of all routine inspections conducted.

Funding is allocated to conduct the number of inspections identified in Appendix B. Unless otherwise justified, the expectation is based on National Agricultural Statistical Services (NASS) 2017 Census of Agriculture data.

• If the jurisdiction has completed an initial inspection of all non-exempt covered farms, the grantee may transition to an inspection frequency as the top 30% (higher priority) inspected on a three-year cycle; and the lower 70% (lower priority) inspected on a five-year cycle.

Inspection Prioritization:

• Grantees shall utilize a risk-based prioritization model for planning inspections.
• PATH B grantees shall prioritize inspections according to the current Produce Safety Inspections Assignment (and attachments) and pertinent FDA guidance or operating instructions for produce safety inspection prioritization and work planning.
• PATH C grantees are encouraged to prioritize inspections according to the current Produce Safety Inspections Assignment (and attachments) and pertinent FDA guidance or operating instructions for produce safety inspection prioritization and work planning.
• The Produce Decision Analysis Tool (PDAT) prioritization tool (posted at ProduceDAT.org) developed by FDA would meet this requirement. If a different model is used, FDA should be provided an opportunity to review and provide feedback on any grantee’s models that vary from the PDAT tool, to ensure prioritization is happening in a relatively consistent manner across the country.
• The grantees annual work plan may include routine, for-cause, or compliance-based inspections, as determined by the grantee’s prioritization or through coordination with other federal, state, or local agencies.

5.1 Sprout Inspections (if applicable)

a. Grantees conducting inspections under Subpart M of the Produce Safety Rule, will conduct these inspections jointly with FDA, in coordination with the FDA, and at the discretion of FDA. Inspections completed must be reported on the Aggregate Inspection Data Table.

b. Compliance and enforcement activities related to inspections under Subpart M of the Produce Safety Rule shall be in coordination with the FDA.

c. Personnel must complete FDA required training courses to conduct inspection-related activities.

d. No additional funding will be provided for sprout inspection activities other than through this FOA.

This objective is applicable to grantee agencies that will conduct produce safety rule inspections funded by this CAP. It is expected that both PATH B and PATH C grantees establish compliance and enforcement programs tailored to their chosen program path. In any event, it is recommended that all programs coordinate with local/state/federal agencies to utilize the compliance and enforcement action(s) that will result in greatest protection of public health. In effort to support an IFSS, compliance and enforcement regulatory programs should be focused on quality and national consistency.

a. PATH B Grantees should establish internal procedures for, and conduct, the preliminary review of inspection documentation. Grantees will coordinate with FDA on any compliance and enforcement activities according to the most current Produce Safety Inspections Assignment (and attachments) and pertinent FDA guidance or operating instructions. In most compliance cases, Path B grantees will need to provide their inspection documentation to FDA, and FDA would determine the compliance status and perform the enforcement action(s). PATH B grantees may need to conduct any follow-up inspections as determined by the FDA.

b. PATH C Grantees should utilize written procedures for conducting compliance and enforcement activities that establish:

• A risk-based process to determine when a directed investigation, follow-up, or re-inspection is needed;
• A framework for compliance and enforcement progressive actions, utilizing the current compliance and enforcement guidance available.

Each jurisdiction should have the capability to systematically detect, investigate, mitigate, document and analyze produce related incidents to stop, control and prevent hazards that are likely to result in a produce related illness, injury or outbreak. These capabilities can reside and be funded by other offices or agencies in the jurisdiction or may be headed by the produce program funded under this Cooperative Agreement. The expectation is that there is coordination across multiple offices and departments within a jurisdiction and there is not duplication of efforts or redundant funding allocated to have these capabilities.

Under Objective 1b of this Agreement, all grantees must complete the Assessment for Produce-Related Event Response. As part of the Assessment, the grantee will identify the organization within their jurisdiction, if any, that has the responsibility and capabilities to conduct the various response activities. The assessment will also cover how the produce program is coordinating or integrating with other offices or agencies conducting produce response activities.

a. If the jurisdiction’s capabilities are complete, this should be identified clearly in the grantee’s Assessment.

b. If the jurisdiction’s capability does not exist or the grantee has identified gaps requiring further development, the grantee will document a plan to develop the capability/capabilities within the jurisdiction; this plan will be documented in their Project Plan (See Objective 1a Project Plan).

1. The plan should identify potential gaps in your jurisdiction’s capability to effectively conduct a produce-related response activity. Potential gaps may include lack of or inadequate:

• Written processes or procedures to conduct consistent and actionable response activities
• Formal coordination of relevant agencies
• Efficient communication amongst relevant agencies
• Clear authority to conduct response activity
• Material and/or human resources (supplies, training, personnel)

2. The plan should identify the resources required, timeframe for implementation, and specific expected outcomes.

3. The plan should consider the following:

i. The need for additional funding for response capacity. Additional funding for response capacity can be requested on a case by case basis via a future companion Notice of Funding Opportunity. Please note the following:

• A comprehensive assessment, gap analysis, and plan to develop response capabilities must be complete before applying for additional funding.
• Duplicate federal funding will not be awarded for multiple agencies in the same jurisdiction to do the same body of work.
• MOUs and other similar arrangements should be utilized and considered when requesting funding for this work

ii. Subawards to other agencies are encouraged to develop capabilities, as appropriate.

iii. There may be Rapid Response Teams and other cross operational coordination groups established in a jurisdiction to do some of this work and it is expected that those entities would still lead this.

iv. Fully integrated response cooperation as an operating principle to benefit public health outcomes. Grantees should collaborate with FDA and/or other state and local agencies in identifying, coordinating, and implementing response activities.

v. Response information is expected to be shared with all applicable partners to facilitate an informed and harmonized approach when conducting response activities.

Table A1. Regulatory Bands; range of farms is based on 2017 NASS Data Number of Farms Covered

Regulatory Band	Range of Covered Farms	Band Funding	State Authority Funding
1	20000 +	$ 7,500,000	$ 675,000
	14501-19999	$ 7,000,000	$ 640,000
	12001-14500	$ 5,500,000	$ 464,000
	8001-12000	$ 4,500,000	$ 384,000
	3001-8000	$ 3,000,000	$ 256,000
2	1601-3000	$ 1,100,000	$ 85,000
3	1001-1600	$ 705,000	$ 50,000
4	701-1000	$ 500,000	$ 30,000
5	500-700	$ 430,000	$ 20,000
6	261-499	$ 350,000	$ 12,500
7	201-260	$ 300,000	$ 8,000
8	121-200	$ 265,000	$ 5,500
9	61-120	$ 250,000	$ 3,500
10	1-60	$ 220,000	$ 1,500

Table A2. Education & Inventory Bands; reference 2017 NASS Data. The range of farms were primarily based on Number of Farms Covered, Qualified Exempt; and Micro Exempt (Sales up to $25,000); additionally, funding is also included based on Total Produce Farms.

Education & Inventory Band	Range of Farms	Band Funding
1	30001 +	$ 4,000,000
	20001-30000	$ 3,000,000
	10001-20000	$ 2,000,000
	8001-12000	$ 1,000,000
2	6001-8000	$ 830,000
3	4001-6000	$ 630,000
4	2501-4000	$ 475,000
5	1501-2500	$ 330,000
6	1001-1500	$ 270,000
7	501-1000	$ 185,000
8	1-500	$ 130,000

Table B1. Target Expectations outline the estimated total number of farms to be verified in inventory by the end of the project period; estimated total number farms to receive education and/or outreach by the end of the project period; and the estimated number of annual inspections.

	Target Expectations for Education & Inventory Bands		Target Expectations for Regulatory Bands
Jurisdiction	Total Farms Verified in Inventory by Jun 30, 2026	Total Farms Receiving Education and/or Outreach by Jun 30, 2026	Total Farms for Routine Inspection Annually (Jul 1 - Jun 30)	Total Follow-up Inspections Annually (Jul 1 - Jun 30)
Alabama	3293	2113	58	12
Alaska	344	312	3	1
American Samoa
Arizona	1878	1666	53	11
Arkansas	1367	1073	28	6
California	38265	37538	4210	842
Colorado	1732	1469	46	9
Connecticut	1253	1149	33	7
Delaware	247	156	13	3
Florida	8680	7341	508	102
Georgia	7822	2909	123	25
Guam
Hawaii	4150	3380	111	22
Idaho	1633	930	24	5
Illinois	2112	1602	54	11
Indiana	2088	1773	54	11
Iowa	1912	1685	44	9
Kansas	886	762	16	3
Kentucky	3390	3017	55	11
Louisiana	1619	1162	22	4
Maine	2254	2053	65	13
Maryland	1318	1126	49	10
Massachusetts	2201	1800	77	15
Michigan	5372	4666	281	56
Minnesota	3628	2152	62	12
Mississippi	2066	1595	47	9
Missouri	2698	2332	61	12
Montana	795	708	15	3
Nebraska	709	608	14	3
Nevada	184	171	7	1
New Hampshire	907	856	17	3
New Jersey	1995	1825	104	21
New Mexico	4001	2335	29	6
New York	5791	5226	292	58
North Carolina	5705	4315	165	33
North Dakota	317	167	2	0
Commonwealth Northern Mariana Islands
Ohio	4348	3736	107	21
Oklahoma	2384	678	13	3
Oregon	6344	5244	311	62
Pennsylvania	6214	5294	263	53
Puerto Rico
Rhode Island	288	263	9	2
South Carolina	2977	2111	60	12
South Dakota	304	276	6	1
Tennessee	3085	2722	54	11
Texas	8147	4773	164	33
US Virgin Islands
Utah	1140	1011	28	6
Vermont	1131	1066	27	5
Virginia	3283	2750	101	20
Washington	6869	6325	528	106
Washington DC
West Virginia	1647	1445	24	5
Wisconsin	4697	3342	122	24
Wyoming	169	144	3	1

See website for 2017 NASS Data.

Elements are included as a reference and are subject to minor changes.

# Verified Farms

# Farms verified conducting covered activities on covered produce

# Farms conducting covered activities on FDA identifies national priority commodities (updated annually)

# Farms growing covered produce

# Farms harvesting covered produce

# Farms packing covered produce

# Farms holding covered produce

# Farms processing covered produce

# Farms retailing covered produce

Elements are included as a reference and are subject to minor changes.

# Total farms inspected

# Total inspections

For reporting period:

# Inspections

# Inspections with observations on the Form FDA 4056 or state equivalent

# Inspections at farms that handle priority commodities

# Farms with improved inspection classification from previous inspection

# Inspections where egregious conditions were observed

# Observations corrected during inspection

Inspection classification for each inspection by inspection type

# Farms having previous educational visits/food safety audits/Produce Safety Alliance training

# Observations by Produce Safety Rule Citation

# Inspections resulting in compliance actions

# Farms inspected resulting in compliance actions and by compliance action taken

# Recalls and volume of product recalled

# Compliance follow up inspections/#farms and by improved classification

See website for ORAPP Instructions.

Elements are included as a reference and are subject to minor changes.

State Farm Unique ID

Farm Data Source

Verification Method

Farm Name

Business Address Line 1

Business Address City

Business Address State Code

Business Address Zip Code

Business Address Country Code

Farm Phone

Farm Size based on Average Produce Sales

Covered Produce

Seasonal Growing Period

Point of Contact Role

Point of Contact First Name

Point of Contact Last Name

Point of Contact Phone

See website Standardized Approach to Produce Farm Inspections document.

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 FOA.

Funding by Program Path (All Applicants)

Each eligible applicant may apply for up to their maximum annual eligible funding, which is assigned based on band assignments for each Program Path as outlined in TABLE 1. The National Agricultural Statistical Services (NASS) 2017 Census of Agriculture data tables (APPENDIX C) were used to determine preliminary funding bands (APPENDIX A). Band assignments are based on the anticipated workload of each grantee. Band assignments are subject to change on an annual basis, particularly in the regulatory band assignments, and will be based on the grantee’s verified inventory and work plan. For each jurisdiction, the Target Expectations (APPENDIX B) are outlined for: the total number of farms to be verified in inventory by the end of the entire project period, total number of farms to receive education and/or outreach by the end of the entire project period, and the number of annual inspections expected for each project period. If the actual number of farms and the corresponding workload are different than NASS estimates, grantees of this program may be moved into different funding bands.

TABLE 1: Program Path Funding; maximum eligible funding (total costs (includes direct and indirect costs)) per path and band assignment based on National Agricultural Statistical Services (NASS) 2017 Census of Agriculture data tables.

First Time Applicant Funding (Eligible applicants: IL, SD, WY, AS, CNMI, GU, USVI, DC, PR)

First Time Applicant funding is for entities that did not receive funding under PAR-16-137 to establish regulatory programs. It is one-time funding (not annual) that will be in addition to the Program Path funding explained above and outlined in TABLE 1. First Time Applicant Funding should be utilized for activities specified below and will be funded based on the applicant’s Program Path, as follows:

• PATH A: No additional First Time Applicant funding will be awarded.
• PATH B: First Time Applicant funding to establish an electronic based system for inventory and inspections.
• PATH C: First Time Applicant funding to establish an electronic based system for inventory and inspections and to establish the legal authority for produce farm inspections and enforcement.

TABLE 2: First Time Applicant Funding

Eligible Applicants	Program Path	Maximum Eligible Funding
IL, SD, WY, AS, CNMI, GU, USVI, DC, PR	PATH A	No Additional Funding
	PATH B	$250,000
	PATH C	$335,000

Governments

• State Governments
• U.S. Territory or Possession
• American Samoa (AS)
• Commonwealth of the Northern Mariana Islands (CNMI)
• Guam (GU)
• Puerto Rico (PR)
• Virgin Islands (VI)
• Washington District of Columbia (DC)

This opportunity is available only to state and territory government agencies with actual or potential regulatory oversight and responsibility over their respective jurisdiction’s farms, produce commodities, and activities covered under FDA's Produce Safety Rule (21 CFR Part 112).

Only one application is allowed per state or territory. Jurisdictions interested in involving multiple state or territory entities within their jurisdiction are required to internally coordinate and choose one entity to apply

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

Only one application is allowed per state/territory. Jurisdictions interested in involving multiple state/territory entities (within their jurisdiction) are required to internally coordinate and choose 1 entity to apply. This organization shall list their plans to sub-award funds (up 40% of entire award) to other entities within their jurisdiction in their application.

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

Applicants must download the application package associated with the PROGRAM PATH they are applying for by referencing the COMPETITION ID field. The COMPETITION ID field will state:

PATH A

PATH B

PATH C

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

A letter of intent is not required. However, to be invited to the technical session, please send the following via electronic mail to [email protected] and [email protected] by the date listed in Part 1. Overview Information.

Email Subject: State Abbreviation (e.g. California - CA) State Produce CAP Technical Session Request

• Requestor Name
• Requestor Email
• Requestor’s Participating Institution

Technical session(s) will be held for prospective applicants in March 2021. Subsequent technical sessions for future application due dates will be held as necessary. 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 SF424 Application Guide and the Table of Page Limits must be followed with the following exceptions or additional requirements:

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

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

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

11. Descriptive Title of Applicant's Project: Applicants must include the PATH Name and State Organization Name/Abbreviation in the Project Title.

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

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

The Project Summary/Abstract must:

a. Confirm the applicant’s Program PATH (A, B, or C).

b. PATH B or C Applicants intending to conduct sprout inspection under Subpart M of the Produce Safety Rule under this FOA, must include a confirmation statement.

c. All PATH C Applicants must provide a weblink (or attach a copy) of the applicable state law(s) that pertain to produce safety inspection and compliance authority. The applicant must also include a statement confirming the jurisdiction’s inspection and enforcement authority and confirmation that the state law adopts the FDA’s Produce Safety Rule (21 CFR Part 112) in its entirety.

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

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

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested. The budget and justification for the first budget year should be detailed and reflect costs that accurately and realistically portrays the work that will be completed within the first budget year While, we do not expect your budget to predict perfectly how you will spend your money five years down the road, we do expect a reasonable approximation of what you intend to spend. Be thorough enough to convince the reviewers that you have a good sense of the overall costs. A detailed budget justification must be submitted for each proposed subaward (see R&R Subaward Budget section).
• 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.

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

• A detailed budget and justification must be submitted for each proposed subaward.

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

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

Specific Aims: The Specific Aims document should list succinctly the goals for each applicable objective and summarize the expected outcome(s).

Research Strategy: As part of the research strategy the applicant must submit a Project Plan. The Project Plan must include timelines, responsibilities, and key milestones for accomplishing each applicable Program Objective. The Project Plan must address the jurisdiction’s Target Expectations in APPENDIX B, which identifies the estimated total number of farms to be verified in inventory by the end of the project period; total number farms to receive education and/or outreach by the end of the project period; and (for PATH B and PATH C only) the number of annual inspections.

Appendix: Applicants must include an organizational structure to accomplish the implementation, oversight, monitoring and reporting of program objectives. Roles and responsibilities must be outlined and must directly relate to accomplishing the applicable Program Objectives. This organizational structure must be uploaded as Appendix #1.

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

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

Appendix:

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

Applicants must attach as Appendix #1, an organizational structure to accomplish the implementation, oversight, monitoring and reporting of program objectives. Roles and responsibilities must be outlined and must directly relate to accomplishing the applicable Program Objectives.

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.

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

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

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

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 Part 75.

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.

Cooperative Agreement funds may not be used to fund activities or work beyond the scope of this funding opportunity announcement; this includes activities or work relating to requirements added to state laws that are not included in the Produce Safety Rule.

Subcontracting to third parties is limited to 40% of each year's award. Subcontracting with these award funds to awardees receiving funding under cooperative agreement program RFA-FD-16-030 Limited Competition for Revision Applications for National Research Project to Assess State Agricultural Laws, Regulations and Resources Related to Produce Safety is prohibited during the entirety of the project period.

Non-allowable costs:

1. Facilities and work covered under current contracts, cooperative agreements/grants, partnership funds, and other sources cannot be counted towards the fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures other sources of FDA funding and these cooperative agreements.

2. Vehicle purchases are not permitted.

3. Cooperative agreement funds may not be utilized for new building construction.

4. Food may not be purchased.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post-submission materials 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.

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

As part of the research strategy the applicant must submit a Project Plan. Does the project plan must include timelines, responsibilities, and key milestones for accomplishing each applicable Program Objective? Does the Project Plan address the jurisdiction’s Target Expectations in APPENDIX B, which identifies the estimated total number of farms to be verified in inventory by the end of the project period; total number farms to receive education and/or outreach by the end of the project period; and (for PATH B and PATH C only) the number of annual inspections?

Does the application demonstrate the agency’s ability to implement and maintain a Produce Safety Program that supports implementation of the Produce Safety Rule through the cooperative agreement program?

The applicant must provide an organizational structure to accomplish the implementation, oversight, monitoring and reporting of program objectives. Does the application outline roles and responsibilities that directly relate to accomplishing the applicable Program Objectives?

The applicant must provide a properly detailed budget for the Year 1 budget period. A detailed budget justification must be submitted for each proposed subaward. Does the proposed budget align with the applicant s Project Plan, proposed organizational structure, and relevant towards achieving the objectives of the cooperative agreement?

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

As part of the objective review, all applications:

• Will receive a written critique.

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

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

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

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.

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.

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

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

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

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

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please 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. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about FDA's commitment to supporting a safe and respectful work environment and what FDA's expectations are for institutions and the individuals supported on FDA-funded awards, please see https://www.fda.gov/science-research/about-science-research-fda/fda-sexual-harassment-policy-concerning-extramural-research.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please 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 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements.

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

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

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

Reporting Requirements:

All FDA grants require both Financial and Performance reporting.

Financial Reporting:

A. Cash Transaction Reports

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

B. Financial Expenditure Reports

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

Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter.

Performance Progress Reporting:

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

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

Salary Caps:

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

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

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

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

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

Acknowledgment of Federal Support:

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

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

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

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

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

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

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

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

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

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

Prior Approval:

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

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

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

1. Change in Grantee Organization

2. Significant Rebudgeting

3. Change in Scope or Objectives

4. Deviation from Terms and Conditions of Award

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

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

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

Audits and Monitoring:

Audit Requirements:

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

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

3. For-profit and foreign entities can email their audit reports to [email protected] or mail them to the following address:

U.S. Department of Health and Human Services
Audit Resolution Division, Room 549D
Attention: Robin Aldridge, Director
200 Independence Avenue, SW
Washington, DC 20201

Monitoring:

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

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

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

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

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

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

Financial Conflict of Interest (FCOI):

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

Closeout Requirements (when applicable):

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

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

Program Income:

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

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

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

Treatment of Program Income:

Prohibition on certain telecommunications and video surveillance services or equipment:

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

(1) Procure or obtain,

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

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

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

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

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

Other:

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

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

Restrictions:

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.

Cooperative Agreement funds may not be used to fund activities or work beyond the scope of this funding opportunity announcement; this includes activities or work relating to requirements added to state laws that are not included in the Produce Safety Rule.

Subcontracting to third parties is limited to 40% of each year's award. Subcontracting with these award funds to awardees receiving funding under cooperative agreement program RFA-FD-16-030 Limited Competition for Revision Applications for National Research Project to Assess State Agricultural Laws, Regulations and Resources Related to Produce Safety is prohibited during the entirety of the project period.

Non-allowable costs:

1. Facilities and work covered under current contracts, cooperative agreements/grants, partnership funds, and other sources cannot be counted towards the fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures other sources of FDA funding and these cooperative agreements.

2. Vehicle purchases are not permitted.

3. Cooperative agreement funds may not be utilized for new building construction.

4. Food may not be purchased.

Additional Reporting Requirements:

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

Financial

Grantees are expected to report current budgetary information for monitoring activities (annual reports, mid-year reports, and monitoring calls), including funds expended (total and by category), planned expenses (total and by category), and funds remaining.

Performance

Annual and Mid-Year performance progress reports and interim data reports are required for this award. Reports should be submitted via email to the listed Grants Management Specialist and Program Official as follows:

i. Project Plan: with mid-year and annual report.

ii. Assessment: with mid-year and annual report.

iii. Cumulative Aggregate Inventory Data submitted on Dec. 1; Feb. 1; May 1; and Sept. 1

iv. PATHS B & C, only Aggregate Inspection Data submitted on:

• Dec. 1 includes data for Jul 1 - Oct 31
• Feb. 1 includes data for Jul 1 - Dec 31
• May 1 includes data for Jul 1 - Mar 31
• Sept. 1 includes data for Jul 1 - Jun 30

v. PATH A, only Comprehensive Farm Inventory Data submitted through ORAPP monthly, or as needed by FDA.

Other:

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

2. Tribal farms should not be the target audience of activities funded by this cooperative agreement.

3. FDA anticipates that Produce Safety Program Standards will be developed. The Produce Safety Program Standards will identify the best practices of a produce regulatory program. Elements of the Produce Safety Program Standards are expected to include regulatory authority, training, inspection and compliance, emergency response, laboratory, and outreach. When the Produce Safety Program Standards are complete, jurisdictions produce programs receiving funding under this cooperative agreement are expected to prepare to conform to the Produce Safety Program Standards, by first conducting a gap analysis and then developing a plan for implementation. FDA expects that full conformance to the Produce Safety Program Standards will extend beyond the project period of this cooperative agreement. No additional funding will be provided to grantees of this program for Produce Safety Program Standards implementation.

4. PATH B and C: FDA will not routinely request detailed inspection reports and farm inventory records. However, in for cause situations, FDA may request these documents.

5. Under PATH B, FDA is responsible for processing public records requests for inspection records for work conducted under FDA authority (i.e., when FDA credentials are used by the state). All requested records must be provided to FDA by the grantee within 5 business days of the request for records.

6. Under PATH C, grantees are responsible for processing public records requests for inspection records for work conducted under state authority under this agreement.

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 recommendation shall confirm that:

a. there has been acceptable progress on the project as measured by mutually agreed upon performance measures;

b. there is continued compliance with all FDA regulatory requirements;

c. if necessary, there is an indication that corrective action has taken place.

The grantee of this cooperative agreement program will include FDA in the dissemination of all information, documents, processes, and procedures created under this agreement, to ensure mutual transparency on messaging, both between the grantee and FDA, and to states and territories and to state and territory extension personnel, particularly those funded under the current or future State Cooperative Agreement to Enhance Produce Safety. FDA will be invited, either as participant or as an observer, to all meetings (in person or electronic) involving grantees of the current or future State Cooperative Agreement to Enhance Produce Safety that discuss any aspects of either cooperative agreement.

The grantee shall ensure that technical assistance provided to state and territorial produce safety programs is not counter to the FDA's laws, regulations, policies, procedures, and program guidance, and that is does not inhibit or counter FDA's ability to perform its required grant and program management requirements and responsibilities, including management of the current or future State Cooperative Agreement to Enhance Produce Safety.

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.

Additional requirements may be listed in the Notice of Award.

a. A mid-year and annual performance reports are required under this cooperative agreement.

b. The following items must be complete and submitted to your Project Manager:

i. Project Plan: with mid-year and annual report.

ii. Assessment: with mid-year and annual report.

iii. Cumulative Aggregate Inventory Data submitted on Dec. 1; Feb. 1; May 1; and Sept. 1

iv. PATHS B & C, only Aggregate Inspection Data submitted on:

• Dec. 1 includes data for Jul 1 - Oct 31
• Feb. 1 includes data for Jul 1 - Dec 31
• May 1 includes data for Jul 1 - Mar 31
• Sept. 1 includes data for Jul 1 - Jun 30

v. PATH A, only Comprehensive Farm Inventory Data submitted through ORAPP monthly, or as needed by FDA.

c. PATH B and C: FDA will not routinely request detailed inspection reports and farm inventory records. However, in for cause situations, FDA may request these documents.

d. PATH B: If FDA receives a Freedom of Information Act request for records created using FDA authority, records will be requested and must be provided to FDA in a timely manner. See also Special Terms and Conditions of Award.

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the terms and conditions of award and the HHS Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Laurie Keppley
Office of Regulatory Affairs (ORA)
Office of Management
Telephone: 240-402-7736
Email: [email protected]

Alicia Schroder
Office of Regulatory Affairs (ORA)
Office of Partnerships
Telephone: 425-582-3148
Email: [email protected]

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

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

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

Awards are made under the authorization of Section 1004 of the Food and Drug Administration Amendments Act (21 USC 2104) and under Federal Regulation 45 CFR Part 75.