Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Center for Food Safety and Applied Nutrition (CFSAN)
Office of Regulatory Affairs (ORA)

Funding Opportunity Title

State and Territory Produce Safety Implementation Program Expansion for Entrance into Competition B of PAR-16-137 (U18)

Activity Code

 U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-19-017

Companion Funding Opportunity

PAR-16-137, Research Demonstration – Cooperative Agreements

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

93.103

Funding Opportunity Purpose

This program expansion FOA provides a mechanism for organizations receiving only Competition A funding under PAR-16-137 to apply for Competition B funding. Only those states/territories currently receiving funding for only Competition A under PAR-16-137 are eligible to apply.

Key Dates
Posted Date

October 2, 2018

Open Date (Earliest Submission Date)

October 15, 2018 for December 15, 2018 due date.

November 1, 2018 for March 1, 2019 due date.

November 1, 2019 for March 1, 2020 due date.

Letter of Intent Due Date(s)

Not applicable

Application Due Date(s)

 December 15, 2018, March 1, 2019, March 1, 2020  

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

 Not Applicable

Scientific Merit Review

January 2019, April 2019, April 2020

Advisory Council Review

Not Applicable

Earliest Start Date

February 1, 2019, July 1, 2019, July 1, 2020

Expiration Date

March 2, 2020

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

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

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

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Successful applicants will focus on Inspectional Program Development and be prepared to conduct inspections of farms as the compliance dates become effective and inspections are implemented per FDA’s regulation “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (commonly referred to as the Produce Safety Rule).   Successful applicants will provide clear plans to implement an inspectional program during the first year of activity and any subsequent years.

    The goals listed below are designed to complement Competition A activities under PAR-16-137. Many activities will need to be revisited to include inspectional and enforcement components for already completed deliverables (e.g. Jurisdictional Self-Assessment, Multi-Year Strategic Plan, Performance Measurement System). Inspections of covered farms are to be conducted beginning in 2019 (and subsequent years) per established compliance dates for the Produce Safety Rule and FDA communications.

    BACKGROUND:

    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, meaning fruits and vegetables grown for human consumption. FDA established these standards as part of the implementation of the FDA Food Safety Modernization Act. To achieve the realities contemplated by this new legislation, a new level of cooperation between Federal, State, and Territorial regulatory and food safety produce entities is required.

    FDA recognizes that State and Territory regulatory and food safety agencies may wish to align their produce regulatory authority and practices to reflect the modernized aspects of the FDA Produce Safety Rule. Such alignment will require significant investment to successfully develop and implement multi-faceted administrative programs in support of the Produce Safety Rule. This cooperative agreement is intended to offer one such opportunity for produce infrastructure investment at the State and Territory level.

    PURPOSE:

    The purpose of this cooperative agreement is to advance efforts for a nationally integrated food safety system through the planning, establishment, and/or enhancement of State and Territory Produce Safety Programs that encourage the safe production of fresh fruits and vegetables and to promote understanding and compliance with the requirements of the Produce Safety Rule.

    Awardees are encouraged to evaluate their jurisdiction's unique produce safety landscape, prioritizing commodities regulated by the Produce Safety Rule, and then develop programs to address the specific and unique needs of their jurisdiction. 

    Achieving alignment with the Produce Safety Rule will require comprehensive self-assessment on the part of a State/Territory program and will encourage continuous improvement and innovation. FDA recognizes that the time required for implementation of a produce safety program will vary between jurisdictions, and FDA intends to be a permanent source of funding, subject to the availability of funds. All applicants shall be expected to implement multi-year, strategic plans (if applying for multiple years of funding) to ensure continuous improvement and demonstrate that they are moving towards the goals of improved produce safety and high rates of compliance with the Produce Safety Rule.

    OVERARCHING PROGRAM GOALS:

    The goals of the overall program (including the original PAR-16-137, and this expansion cooperative agreement) are to provide awardees with the resources to:

    Assess their produce landscape, with a focus upon produce covered under the Produce Safety Rule, and available resources to determine the necessary size and scope of their jurisdiction's Produce Safety Program

    Establish a process to develop and maintain a produce farm inventory

    Provide resources for, and invest in, their program's infrastructure

    Develop specific mechanisms to coordinate with other local, state, territory, and federal agencies for produce safety activities

    Formulate a multi-year plan to implement a new or enhanced produce safety system

    Develop a performance measurement system, plan and/or process system to measure the progress towards the goals of this cooperative agreement using analytical processes including quantitative and qualitative data.

    Evaluate the need for new or updated produce legislative or regulatory authority

    Develop and/or provide education, outreach, and technical assistance, prioritizing farming operations covered by the rule

    Develop and/or provide education, outreach, and technical assistance to the jurisdictional produce safety regulators

    Design and implement a compliance program for applicable produce safety regulations at the jurisdictional level.

    PERFORMANCE MEASURES:

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

    COMPETITIONS:

    The FDA recognizes that jurisdictions currently have different levels of infrastructure regarding produce safety. PAR-16-137 provided an opportunity for states/territories to apply for either Competition A, or Competitions A&B. If an organization previously applied for only Competition A, and is receiving funding for only Competition A under PAR-16-137, then an application may be submitted under this FOA for Competition B funding.

    All budget allocations have been formulated to help provide applicants with guidance on how to optimally budget money for each required activity. While applicants are free to set their own budget percentages based on their jurisdiction’s need, any significant deviation from the suggested percentages (a difference equal or greater than + or – 15 percentage points) shall be accompanied by explanatory justifications.

    Note: Applicants who have no plans to adopt the FDA Produce Safety Rule in its entirety or pursue inspections though jurisdiction’s employees with an FDA commission are not eligible for Competition B funding.  To be eligible for Competition B funding, applicants shall submit a letter (uploaded as an appendix) with their application expressly confirming their jurisdiction’s intent to adopt the FDA Produce Safety Rule in its entirety or pursue inspections though jurisdiction employees with an FDA commission.

    Applicants applying for Competition B shall specifically address in the application the ability to achieve the following objectives in the cooperative agreement over the course of the project period:

    1. Develop and/or provide education, training, and technical assistance to jurisdictional produce regulators

    2. Design and implement a compliance program for applicable produce safety regulations through standardized regulatory inspections to begin during the first and subsequent budget periods under this announcement

    Note: It is expected that many overlapping activities will have been completed during work under Competition A of PAR-16-137. Substantially duplicative activities should not be included under this application for Competition B.

    Competition B Inspection, Compliance, and Enforcement Project Goals:

    Applications must include the following:

    Updating your Strategic Multi-Year Plan

    A multi-year strategy that outlines the jurisdiction’s plan to:

    a. Provide education, outreach, and technical assistance to the regulator community within the jurisdiction to promote understanding and appropriate application of the provisions of the Produce Safety Rule;

    b. Provide for inspections and an inspection program as a verification tool to ensure compliance with and understanding of the regulation.

    c. Conduct inspections during the first and each subsequent budget period in accordance with compliance dates and FDA communications.

    Education and Outreach and Technical Assistance (Suggested funding – 30% of Competition B Tier Allotment)

    1. Ensure regulatory jurisdiction personnel are trained utilizing the curriculum and materials developed by the FDA for regulators and have the knowledge and skills needed to perform the various functions of their positions as they relate to the Produce Safety Program

    2. Develop and implement a continuing education program to keep regulators and other food safety personnel current on best practices, available resources, updates to policy (e.g., guidance documents) and changes in the industry as they apply within your jurisdiction

    3. Establish ties with FDA’s Produce Safety Network and FDA’s Technical Assistance Network to ensure that any questions or issues are raised, and that state/territory regulators receive any necessary technical assistance

    Inspectional Program Development: (Suggested funding – 70% of Competition B Tier Allotment)

    1. Research, design, and implement a compliance program for applicable produce safety regulations at the jurisdictional level. The compliance program shall have standardized regulatory surveillance inspections with an emphasis on education to promote compliance. Such a program shall include, but not be limited to, the following attributes:

    a. Conduct inspections, collecting a common set of data elements in a standardized format to facilitate sharing with FDA and other regulatory partners

    b. Collaborate regularly with FDA and other regulatory personnel from other jurisdictions to identify the risk criteria and models that would be recommended for use to prioritize and identify specific farms for inspection

    c. Collaborate regularly with FDA and other regulatory personnel to develop recommendations for the number/percentage/frequency of full inspections and the number/percentage of targeted inspections to be conducted

    d. Develop an annual work plan/inspection plan for conducting inspections that would be shared with other regulatory entities

    e. Collaborate with federal, state, and territory regulatory entities to develop and utilize information technology (IT) systems that shall facilitate sharing inspectional reports by capturing data in discrete data fields which can be mapped to XML standards for data sharing purposes (Note common data fields for collection shall be decided in cooperation with the FDA)

    f. When appropriate, initiate a compliance action on a farm or in a packing house (facility)

    g. Collaborate with federal, state, and territory regulatory entities to establish common data elements and collection tools that shall facilitate the aggregation of data and data analysis efforts

    h. Consult with FDA when situations involving policy interpretation are needed

    Recommended length: 1-5 pages. Present the purpose of the funding opportunity in paragraph form, addressing all of the items below. Please keep in mind that readers will appreciate clarity and brevity.

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

    Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for up to two (2) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

The total amount of funding that the FDA expects to award through this announcement is approximately $405,000 in FY2019; the anticipated number of awards will be up to four (4) with an undetermined amount of awards in subsequent years depending on current and future Competition A participation under PAR-16-137.

Application budgets are based on Competition B funding tier levels in PAR-16-137 described in the FOA and assigned per the table listed below in "Award Budget."

The length of support will be for the remainder of the grantees' project period in PAR-16-137 under noncompetitive continued support which will depend on performance during the preceding year and availability of Federal funds. Support for this activity will terminate in 2021.

It is anticipated that up to four (4) awards will be made, not to exceed funding caps for their respective tier and budget period in the table below (Award Budget) per award, in 2019. Future awards will be based on availability of funds and take into consideration the number of eligible entities.

Award Budget

Application budgets need to reflect the actual needs of the proposed project. Only Competition B funding may be requested in this application. 

Grantees applying for the 2018 application date will be funded a maximum of 50% of the 2018-2019 Competition B funding for their respective Tier. Successful applicants under the 2018 application date will be eligible for the maximum funding for their respective tier in subsequent years (i.e. 50% of funding is only for the 2018 budget period to adjust for 6 months of work under Competition B for that year).

Grantees applying for funding in the 2019 and future application dates can be awarded up to the maximum funding level under their respective Tier and budget period in PAR-16-137 and per the table listed below.

Grantees may apply for Competition B funding at the funding levels below.  Duration of award is limited to the awarded project period for the grantee's project work under PAR-16-137 and their current budget period (years listed below) in the project.

Award Budget

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

2018-2019

Total Funding Available for Inspection, Compliance And Enforcement (Competition B)

Tier 2

 $400,000

Tier 3

 $290,000

Tier 4

 $180,000

Tier 5

 $110,000

2019-2020

Total Funding Available for Inspection, Compliance And Enforcement (Competition B)

Tier 2

 $425,000

Tier 3

 $310,000

Tier 4

 $195,000

Tier 5

 $115,000

2020-2021

Total Funding Available for Inspection, Compliance And Enforcement (Competition B)

Tier 2

 $775,000

Tier 3

 $560,000

Tier 4

 $300,000

Tier 5

 $200,000

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is dictated by the remaining project period dates for the grantee's grant project activities awarded under PAR-16-137. The project end date shall not exceed the project end date of the grantee's PAR-16-137 Notices of Award.

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

This opportunity is available only to state/territory government food agencies with actual or potential regulatory oversight and responsibility over their respective jurisdiction’s commodities regulated in FDA's “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” rule.

Only institutions with an active FDA funded program awarded for Competition A under PAR-16-137 are eligible to apply for Competition B under this FOA. Eligible organizations include: Any state/territory currently enrolled and performing work under Competition A of PAR-16-137 at the time of the application for Competition B. The level of Competition B funding will be at the funding levels for the current budget period the applicant is participating in under PAR-16-137 per the included tiered funding table and the project period will terminate when completing the project period for activities under PAR-16-137.

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.

Potential applicants have been classified into 5 tiers of funding ceilings based on the number of farms growing covered produce within the jurisdiction. (Data furnished by the United States Department of Agriculture’s National Agricultural Statistics Survey).

This tiered system establishes funding ceilings proportional to the applicant’s jurisdictional produce volume. Applicants are only eligible to receive the level of funding associated with their current Tier level under their grant project activities awarded under PAR-16-137.

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

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

Foreign Institutions

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

Required Registrations

Applicant Organizations

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

  •    Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  •    Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

For this specific FOA, the Research Strategy section is limited to 12 pages.

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

  • Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
  • If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission.  This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
  • If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed.  MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract.  MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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:

  • Applicants who have no plans to adopt the FDA Produce Safety Rule in its entirety or pursue inspections though jurisdiction’s employees with an FDA commission are not eligible for Competition B funding.  To be eligible for Competition B funding, applicants shall submit a letter (uploaded as an appendix) with their application expressly confirming their jurisdiction’s intent to adopt the FDA Produce Safety Rule in its entirety or pursue inspections though jurisdiction employees with an FDA commission.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

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

Program funds may not be used for any purpose other than those directly tied to the goals of the cooperative agreement.  

Non-allowable costs:

1) Vehicle purchases are not permitted.

2) Cooperative agreement funds may not be utilized for new building construction or remodeling.

3) 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. 

Additional funding restrictions may be part of the Notice of Award.

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. 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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

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

Scored Review Criteria

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

Program Design (40 Points)

This criterion is used to assess the rationale and program design to meet the goals and project milestones of the cooperative agreement to operate a Produce Safety Program within the State’s jurisdiction.

Has the application successfully demonstrated or described a program with the ability to:

-Develop communication mechanisms for sharing produce safety activities with local, state and federal partners

-Outline a multi-year strategic plan

-Formulate methods of evaluation, including the use of performance measures that are clearly related to the intended outcomes of this cooperative agreement and shall produce quantitative and qualitative data where possible

-Promote produce safety regulatory authority

-Identify resources to develop, provide and prioritize education, outreach and technical assistance to regulators

-Design and implement a produce safety compliance program

-Provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes

Implementation (20 Points)

This criterion is used to assess the likelihood that a Produce Safety program can be effectively implemented. 

Demonstration that proposed plan has the ability to:

-Achieve long-term educational programs and resources

-Monitor and improve the processes and incorporate best practices

-Anticipate and address expected challenges

Environment (10 Points)

This criterion is used to assess if different sectors of the covered produce industry and their unique needs for education, outreach, and technical assistance are addressed.

Has the applicant successfully described a strategy to recognize, consider and address:

-Cultural, economic and geographical variables, such as local and regional practices and conditions

-Agricultural commodity-specific variables

-Diverse educational levels and language barriers

Key Personnel and Project Management (10 Points)

This criterion is used to assess adequacy of proposed project management, including key staff, their functions and their ability to reach targeted audiences, reporting, accounting procedures, and coordination of collaborative efforts with key partners involved in the project.

Has the applicant successfully demonstrated the ability to:

-Engage and collaborate with national or regional training, education and/or technical assistance-related projects with a range of stakeholders

-Participate in national or regional projects that included extensive cooperation and coordination with other Federal or State Government agencies

-Develop and deliver training, education, and outreach

-Identify appropriate technical assistance resources, including development of IT systems

-Partner with experienced food safety educational personnel specifically in academia (especially extension), industry, and other stakeholder groups  

Communication (20 Points)

This criterion is used to assess the adequacy of the proposed communication and collaboration efforts among Federal, State regulatory partners as well as industry stakeholders in relation to the Produce Safety regulation.

Proposal outlines a plan of action for the dissemination and sharing of ideas, techniques and solutions with relevant parties, including:

-Working with existing food safety programs to maximize efficiency and cohesiveness within a safety structure

-Utilizing novel methods of outreach to ensure effective communication of safety activities to stakeholders

-Establishing relationships with other regulatory entities

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items, but will not give separate scores for these items and should not consider them in providing an overall score.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

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

Select Agent Research

Generally not applicable. Reviewers should bring any concerns to the attention of the assigned Grants Management Specialist.

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

Generally not applicable. Reviewers should bring any concerns to the attention of the assigned Grants Management Specialist

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the objective review, all applications:

  •   Will receive a written critique.

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

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

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

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

Section VI. Award Administration Information
1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. 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. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

The 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 Project Officer (PO) will be assigned and named in the NoA. The FDA PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and cooperative agreements. The FDA PO will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below.

The PO will have substantial involvement in the design, implementation, and evaluation of program activities, and dissemination of program results and outcomes, above and beyond routine grant monitoring. Substantial involvement by FDA/ORA includes, but is not limited to, the following:

Provide guidance, direction, and technical assistance in project planning, implementation, and evaluation;

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

Actively monitor the supported program via telephone conversations, e-mails, written correspondence, or periodic site visits;

Evaluate the supported program, including development of program-level performance measures, consistent data collection, and reporting procedures and protocols;

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

Participate in data analysis, interpretation of findings, and where appropriate, co-authorship of publications;

Development of programs to meet the FDA mission;

Provision of programmatic technical assistance;

Post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the FDA. 

Unless another governance structure is mutually agreed upon, the PO will serve as the primary point of contact for the dissemination of FDA policy and milestones/objectives work planning.

Monitoring Activities

The FDA project officer shall monitor grantees periodically.  The monitoring may be in the form of, but not limited to, telephone conversations, e-mails, or written correspondence between the project program office/grants management office and the principal investigator.  Periodic site visits with officials of the funding recipient organization may also occur.  The results of these monitoring activities shall be recorded in the official grant file and shall be available to the funding recipient upon request consistent with applicable disclosure statutes and with 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 project officer.  The scope of the recommendation shall confirm that: (1) there has been acceptable progress on the project as measured by mutually agreed upon performance measure; (2) there is continued compliance with all FDA regulatory requirements; (3) if necessary, there is an indication that corrective action has taken place.

Additional requirements may be listed in the Notice of Award.

3. Reporting

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

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

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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 submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

Scientific/Research Contact(s)

Alicia Schroder
Office of Regulatory Affairs (ORA)
Office of Partnerships
Telephone: 425-582-3148
Email: Alicia.Schroder@fda.hhs.gov

Objective Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement .

Authority and Regulations

Awards are made under the authorization of Section 317R of the Public Health Service Act (42 USC 247b-20), and Section 1004 of the Food and Drug Administration Amendments Act (21 USC 2104) and under Federal Regulation 45 CFR Part 75.


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