Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration (FDA)

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

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

Components of Participating Organizations

Office of Regulatory Affairs (ORA)

Funding Opportunity Title

Revision Applications - FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001 (U18 Clinical Trials Not Allowed)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

March 26, 2020 -Notice of 2nd deadline extension for the 2020 Application Due Date for PAR-20-091 "Revision Applications - FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001 (U18 Clinical Trials Not Allowed)". See Notice NOT-FD-20-021.

March 13, 2020 - Notice of Change in Key Dates for PAR-20-091. See Notice NOT-FD-20-017

Funding Opportunity Announcement (FOA) Number

PAR-20-091

Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.367

Funding Opportunity Purpose

The intended outcome of this program expansion to RFA-FD-18-001 “Flexible Funding Model – Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs” is to advance the efforts for a nationally Integrated Food Safety System (IFSS) by assisting State manufactured food regulatory programs to promote compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (PCHF Rule). PCHF is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States.  This program expansion provides funding to incorporate PCHF activities into the existing human food safety framework being implemented by the grantees under RFA-FD-18-001.

By participating in this program expansion, grantees will develop infrastructure, programs, and trained personnel to support full adoption and implementation of the PCHF Rule, which may include:

  • Establishing a PCHF training coordination/monitoring program for their regulators
  • Developing an inspection and compliance program to conduct full-scope Preventive Control Rule inspections under 21 CFR Part 117,
  • Establishing data information sharing capabilities with FDA and work planning activities promoting an IFSS,
  • Enhancing state regulatory foundations, including regulatory drafting, legislative research, and support for statute modernization
  • Building capacity to support a Preventive Controls program.

For the purposes of this FOA, the term State encompasses all eligible organizations as defined in Section 3

Key Dates
Posted Date

January 16, 2020

Open Date (Earliest Submission Date)

January 24, 2020

Letter of Intent Due Date(s)

March 1, 2020, 2021, 2022

Application Due Date(s)

May 29, 2020, by 11:59 PM Eastern Time.

March 25, 2021, by 11:59 PM Eastern Time.

March 25, 2022, by 11;59 PM Eastern Time.

March 25, 2020, by 11:59 PM Eastern Time.

April 24, 2020, by 11:59 PM Eastern Time.

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

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

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May: 2020, 2021, 2022

Advisory Council Review

Not Applicable

Earliest Start Date

July 1, 2020

Expiration Date

March 26, 2022

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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

    The goal of this funding opportunity is to support activities which advance efforts for a nationally Integrated Food Safety System (IFSS) through the implementation of the PCHF rule.

    The activities funded under this expansion supplement may include legislative research and legal analysis, infrastructure development, establishment of a training program for regulatory staff, development of a Preventive Control Rule inspection and compliance program, establishment of data information sharing capabilities with FDA, and expansion and enhancement of joint work planning activities with FDA.  This expansion supplement is an additional competitive track within the Flexible Funding Model, RFA-FD-18-001, as referenced above.

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

    The goals of this funding opportunity are as follows:

    1. Awardees will incorporate the PCHF rule, 21 CFR Part 117, into their implementation strategy of the MFRPS, including training, inspection, enforcement, auditing, laboratory/testing and outreach programs. 

    2. Manufactured Food regulatory agencies will have training and auditing programs necessary to ensure a sufficient number of staff are qualified to conduct inspections under the PCHF Rule, 21 CFR Part 117 on a risk-based inspection frequency. 

    3. Awardees will build the infrastructure necessary for a manufactured foods regulatory program based upon the PCHF rule. Infrastructure includes qualified personnel, IT resources, and regulatory authorities.

    4. Awardees will adopt regulatory authorities equivalent to the PCHF rule and associated FSMA rules.

    5. Awardees will participate in IT-data exchange development/implementation with FDA to enable necessary information exchange between FDA and state/territory.

    6. Awardees will have the expertise and capacity to perform environmental and product sampling

    7. Utilize best practices for enhanced coordination between FDA and state/territory for information sharing coordination and leveraging of resources for regulatory work conducted under the authority of the PCHF rule, or equivalent state/territorial regulatory authorities.  

    Background

    In the United States, federal and state government agencies ensure the safety of human and animal food. The Food and Drug Administration (FDA) is responsible for ensuring that all human and animal foods moving in interstate commerce, except those under the United States Department of Agriculture (USDA) jurisdiction, are safe, wholesome, and labeled properly. State agencies are responsible for conducting inspections and regulatory activities that help ensure food produced, processed, and distributed within their jurisdictions are safe and in compliance with state laws and regulations. State agencies primarily perform inspections under their own regulatory authority. Some state agencies conduct inspections of food facilities under contract with the FDA. Because jurisdictions may overlap, FDA and states collaborate and share resources to ensure the safety of food supply. To better facilitate a partnership among regulatory authorities, regulatory program outcomes should be equivalent or equivalent in effect.

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

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

    Legislation/Authorities

    National Integrated Food Safety System:

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

    http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/UCM183650.pdf

    Food Safety Modernization Act:

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

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

    Objectives

    The overall objective of this funding opportunity is to advance the adoption and implementation of the PCHF Rule codified at 21 CFR Part 117. This objective is classified into several broad activities to enhance and support PCHF Rule and other human food FSMA related rules implementation:

    Training

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

    The grantee must identify and designate sufficient staff (minimum of 1) to serve as qualified field inspection trainers to provide full scope PCHF field training for staff as necessary to perform full scope PCHF inspections.  Training required for the designated person(s) must be identified and completed. Grantees will conduct the in-field training necessary to ensure staff are qualified to independently conduct PCHF rule inspections and the required sampling (environmental and product).   

    Grantees are also encouraged to serve as instructors for the delivery of training courses (classroom, virtual, and web-based), such as FD 254, and other initiatives to assist with national, regional, and state specific training needs. 

    Grantees will also maintain a sufficient number of trained staff to fully implement the PCHF Rule and provide for continuity in the event of personnel turnover.

    Auditing

    As part of the state contract, the Program is expected to implement and move towards implementation of an audit program to support Phase II and Phase III audits as described in Field Management Directive (FMD)-76.  Grantees will enter, or maintain participation in, Phase III of the food safety inspection contract audit program by the completion of this funding opportunity. State programs that are not currently in Phase II of the audit program as defined by FMD-76 should work with their Division on completing and implementing an Audit Agreement (Appendix H) for participating in the contract audit program in the 2020-2021 contract year.  The Audit Agreement should also be included as an appendix in the grant application.  The Audit Agreement and planning with the Division should transition the state manufactured food regulatory program from Phase II to Phase III of the audit program during the project period. The audit program should include auditing of all inspection types performed by the state manufactured food regulatory program under the food safety inspection contract, including full scope PCHF rule inspections. The grantee should have a minimum of 2 qualified auditors for all inspection types performed by the state agency by the end of the project period.  The auditors should perform audits of inspectors in addition to verification audits according to the requirements of FMD-76, at a minimum.  

    As available, the grantee should collect audit data on full scope PCHF inspections, inspection reports, and sample collections and reports to evaluate general inspector and program data to identify gaps and corrective actions needed.  In collaboration with the Manufactured Food Regulatory Program Alliance, FDA will revise FMD-76 and the audit form (FDA-3610) to incorporate full scope PCHF inspections. Grantees are encouraged to participate in the development and piloting of the audit criteria.  We anticipate a systems-based approach to conducting the PCHF and other manufactured foods inspections will require a comprehensive overhaul of FMD-76 and associated appendices, including the audit form (FDA-3610). 

    Program Improvement and Infrastructure Development

    Grantees will identify and remedy gaps in agency infrastructure necessary to fully adopt and implement the PCHF Rule as a part of the manufactured food regulatory program. Infrastructure needs may include personnel, IT, regulatory foundation, training, updating procedures and records, management programs, and laboratory.  Grantees should also propose how project developed capabilities will be maintained after the conclusion of the project.  

    PC Inspection and Compliance Implementation Strategies

    Grantees will establish inspection and compliance programs which incorporates the requirements of 21 CFR Part 117. Grantees will engage with FDA to participate in workplanning, work-sharing, and data exchange efforts. 

    Before entering Year 2 of the expansion supplement, grantees should have a minimum of 10 - 25% (depending on current MFRPS Tier) of full scope PCHF inspections that are identified for completion by FDA in Fiscal Year 2021 obligated to their human food safety inspection contract. Grantees are strongly encouraged to exceed the minimum as program infrastructure is built. States should also consider the number of full scope PCHF inspections required for each inspector to maintain proficiency. FDA recommends 3 - 5 full scope PCH inspections is conducted annually by each inspector.  Ideally, state regulatory programs are performing ~50% of the PCHF inspections within their state based upon the FSMA risk-based inspection frequency and firm inventory. 

    FDA will continue to emphasize performing full scope PCHF inspections under the food safety inspection contract.  Based upon firm inventory and contract obligations, a reduction in limited scope PC inspections may occur to allow for additional resources to be directed to full scope PCHF inspections.  FDA strongly encourages all states to begin transitioning from limited scope PC inspections to full scope PC inspections in FY 2020.  FDA will work with each state individually to determine the appropriate quantity and type of inspections that should be performed under the food safety inspection contract based upon the inspection priorities of FDA, firm inventory, and state resources.  

    Legislative Research, Rulemaking, and Policy Analysis

    Grantees will determine any necessary activities to adopt, incorporate, reference, or utilize the PCHF Rule. Grantees will take steps to adopt the PCHF Rule or statutory or regulatory language with equivalent effect. Applicants are also encouraged to undertake activities to adopt other rules promulgated under authority of the Food Safety Modernization Act.  The applicant should briefly describe their current status relating to adoption of the PCHF Rule or equivalent authority and evaluate existing statutory and/or regulatory authority related to preventive controls for human foods. If needed, plans to research changes needed to incorporate the PCHF Rule or operate under FDA authority should be described. Applicants may also propose to evaluate other applicable FSMA rules and determine if adoption or updating existing rules and regulations is necessary (e.g. Intentional Adulteration, Sanitary Transport, Foreign Supplier Verification Program, etc.).  The updating of other regulations related to FSMA rules may also require the updating of other procedures and policies to maintain conformance with the MFRPS. 

    Outreach

    Develop an outreach plan (as required in Standard 7) and associated materials related to the PCAF regulation and compliance and other FSMA related rules as part of the state program's overall outreach plan. 

    Joint Workplanning and Enforcement

    FDA and state personnel will meet as necessary to develop and monitor progress in workplanning for manufactured food regulatory facilities under inspection by both parties.  When discussing workplanning, states and FDA should consider the inspection frequency for both high risk and non-high-risk facilities as described in FSMA section 201.  Best Practices, such as those published by the Partnership for Food Protection (PFP), may be used as a resource to guide these meetings. 

    The grantee should evaluate current enforcement tools, strategies, and trends to determine their effectiveness related to full scope PCHF inspections regulatory actions and share findings with FDA. 

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

    Grantees are also encouraged to assist with updating guidance documents and participate in pilot projects to advance joint workplanning, information sharing, firm reconciliation and enforcement actions between the state and FDA.

    Performance Measures

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

    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

    Need help determining whether you are doing a clinical trial?

    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 years contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

    FDA/Office of Regulatory Affairs intends to fund up to $14,400,000, for fiscal year 2020 in support of this grant program. Availability of funding for future Fiscal Years will be contingent upon annual appropriations and program priorities.

    It is anticipated that up to 48 awards will be made, not to exceed $300,000 per award.

    Award Budget

    Application budgets need to reflect the actual needs of the proposed project and should not exceed $300,000 in total costs (direct and indirect):

    YR 01: $300,000

    YR 02: $300,000

    YR 03: $300,000

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is three (3) years.

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Eligibility for this funding opportunity requires that the applicant:

    • Currently holds an award under RFA-18-001 “Flexible Funding Model – Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs” and is satisfactorily meeting the conditions of the award and;
    • Currently is conducting human food inspections under contract with the FDA and maintains a food safety inspection contract in good standing for the duration of the award project period and;
    • Currently conducts food safety inspection audits in Phase II or III of the food contract audit program OR submits a completed Appendix H audit agreement signed by the applicant's agency leadership and Division demonstrating their commitment to be in Phase II of the audit program and to conduct audits under the food safety inspection contract during the first budget period. The grantee should progress from Phase II to Phase III of the audit program by the completion of the project and;
    • Applicants must indicate the number of full-scope PC inspections they plan to conduct, and the number should be commensurate with the firm inventory, during the Federal Fiscal Year 2020 - 2021 contract cycle. All grantees are expected to perform a minimum of the respective percentage (based on the MFRPS funding tier referenced in the next bullet) full-scope PCHF inspections that should be performed based upon the firm inventory and risk-based inspection frequency during the Federal Fiscal Year 2020 - 2021.  For grantees already meeting the minimum of percentage required for the number of full scope PCHF inspections should remain constant or increase.  FDA can provide to each grantee the annualized needs to each state, which outlines an average number of inspections that are required to perform by FDA to meet FSMA inspection frequencies and; 
    •  Performs the respective percentage of full-scope PC inspection based on their MFRPS Tier:
    • Tier 1 - 25%
    • Tier 2 - 15%
    • Tier 3 - 10%
    • For grantees in a state with more than one agency participating in this program, funding will be contingent upon meeting the overall cumulative percentage for the state among the agencies in the Manufactured Regulatory Program Standards.
    Foreign Institutions

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

    Required Registrations

    Applicant Organizations

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

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

    The FDA will not accept duplicate or highly overlapping applications under review at the same time.  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

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

    2. Content and Form of Application Submission

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

    Letter of Intent

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

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

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

    The letter of intent should be sent by email to:

    Daniel Lukash
    Telephone: 240-402-7596
    Email: daniel.lukash@fda.hhs.gov

    A technical session will be held for prospective applicants in January 2020 and as needed for subsequent years.  The conference call information will be provided to prospective applicants that submit a letter of intent.  The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process.  Participation in the technical session is optional, but strongly encouraged. 

    Page Limitations

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

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

    Instructions for Application Submission

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

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

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

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

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Research Strategy (aka Project Plan):

    The research strategy should address several broad areas outlined in the objectives which contribute to the infrastructure necessary to implement the PCHF Rule. The proposal should address how each of the objectives will be accomplished during the project period unless the applicant agency has already accomplished sufficient development in the given element to implement the PCHF Rule. In this case, the applicant should describe the current state of development and its adequacy to support preventive control rule implementation. The areas of infrastructure development are as follows:

    Training 

    Applicants should clearly outline existing training program efforts and how they plan to incorporate preventive controls training into their current staff development programs. The training plan should be designed to train and qualify a sufficient number of personnel to accomplish the number of full-scope PCHF Rule inspections, including performing environmental and product sampling, in the commitment to perform PCHF Rule food safety inspections. This plan should take into account training needs for contingencies related to staff turnover and hiring, including sufficient state capacity to provide required in-field training and on-the-job experience (OJE) for newly-qualified inspectors.  Applicants may also propose serving as course introduce for the delivery of training to meet national, regional, and state specific training needs.  Further, the training plan should take into account training necessary to reach contract audit Phase II or III if the applicant is not already conducting inspection audits under contract.

    Auditing

    Applicants should clearly outline a plan to progress from Phase II to Phase III of the audit program described in FMD-76 by the end of the project period.  The grant application should include an Appendix H for the 2020 - 2021 contract cycle, which outlines the audit plan for Year 1 of this project period.  The plan should take into account training needs (classroom and in-field).  Collaboration with the Division may be required to support accomplishing the training and verification audits.  Applicants should also address how audit findings will be used for continuous improvement of the state manufactured foods regulatory program.  Applicants are strongly encouraged to participate in initiatives to advance the auditing of manufactured foods inspections, especially full scope PCHF. 

    Program Improvement and Infrastructure Development

    Applicants should identify gaps in program infrastructure necessary to fully implement the PCHF rule. The research strategy should propose a process for meeting these infrastructure needs (in accordance with the allowable costs dictated under the HHS Grants Policy) for the Preventive Controls Regulatory Program, including, but not limited to:

    • Information technology (IT)
    • Equipment
    • Supplies

    Proposed infrastructure needs may include personnel or staff resources to be funded by the award. In the case personnel are funded by this award, the sustainability of such investments at the conclusion of the project period, should be addressed. Requests for personnel funds should also include a summary of the staffing and operational financial resources needed annually to operate and provide for long term implementation of an adequate Preventive Controls Regulatory Program within the applicant's jurisdiction.

    PC Inspection and Compliance Implementation Strategies

    Applicants should demonstrate a plan to develop and/or enhance preventive controls regulatory activities within their food safety inspection program, including conducting full scope PCHF inspections under the human food contract. During the first budget period, applicants should perform a minimum of the respective percentage (based on the MFRPS funding tier referenced in the eligibility criteria) of the annualized need of full scope PCHF inspections under the 2020 - 2021 human food contract or maintain current levels if higher.  A plan for continuing to annually increase the number of full scope PCHF inspections performed under the food contract should be included.  The applicant is also strongly encouraged to submit a plan for incorporating full scope PCHF inspections into the states manufactured food inspection program (e.g. non-contract inspections). Applicant should also develop a plan to actively engage with FDA and participate in work planning meetings as deemed appropriate by state management to support quality assurance and continuous improvement. These activities may include:

    • Review and update of policies and procedures to ensure applicable FSMA provisions are referenced and incorporated
    • Review and update of SOPs and protocols for human foods program to reflect the requirements of the PCHF Rule and other FSMA related rules
    • Development of strategies and SOPs for environmental sampling during a PCHF Rule inspection if conditions and/or observations warrant
    • Evaluate internal reporting and documentation processes to ensure compatibility between state and FDA for information exchange needs for state-inspected human food work.
    • Participate in inspection data exchange development/implementation with FDA to enable necessary digital information exchange

    Legislative Research, Rulemaking, and Policy Analysis

    The applicant should briefly describe the current status of adoption of the PCHF Rule or equivalent authority and evaluate existing statutory and/or regulatory authority related to preventive controls for human foods. If needed, plans to research changes needed to incorporate the PCHF Rule or operate under FDA authority should be described. Applicants may also propose to evaluate other applicable FSMA rules and determine if adoption or updating existing rules and regulations is necessary (e.g. Intentional Adulteration, Sanitary Transport, Foreign Supplier Verification Program, etc.). As new regulations are rules are adopted, the applicant should consider the impact to the MFRPS.

    Outreach

    Applicants should outline an outreach plan (as required in Standard 7) and associated materials related to the PCAF regulation and compliance and other FSMA related rules as part of the state program's outreach program.

    Joint Workplanning and enforcement

    The applicant should propose plans for working with the FDA Division to perform workplanning (contract and non-contract) for manufactured food regulatory facilities under inspection by both parties.  When discussing workplanning, consideration should be given to the inspection frequency for both high risk and non-high-risk facilities as described in FSMA section 201 and determined by the state regulatory program under the MFRPS.  Best Practices, such as those published by the Partnership for Food Protection (PFP), may be used as a resource to guide these meetings. 

    The grantee should propose a plan for evaluating current enforcement tools, strategies, and trends to determine their effectiveness related to full scope PCHF inspections regulatory actions and share findings with FDA and other grantees. 

    Grantees should also demonstrate the capability to participate in pilot projects and develop capabilities to share regulatory data with FDA through IT interface Platforms, such as the National Food Safety Data Exchange (NFSDX), and other initiatives.

    Grantees are also encouraged to propose projects that will update guidance documents and participate in pilot projects to advance joint workplanning, information sharing, firm reconciliation and enforcement actions between the state and FDA.

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

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

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    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:

    • Facilities and work reimbursed under the FDA human food safety inspection contract and other funding mechanisms must remain distinct and separate from the cooperative agreement.
    • Vehicle purchases are not permitted.
    • Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.
    • Clothing and uniforms, with the exception of personal protective equipment (PPE).
    • Other items listed in the HHS Grants Policy Statement or Notice of Award.

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

    7. Other Submission Requirements and Information

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

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

    For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

    Post Submission Materials

    Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review.  Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

    Section V. Application Review Information
    1. Criteria

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

    Scored Review Criteria

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

    Training Monitoring and Coordination (20 Points)

    How effectively does the application outline developing a training coordination and monitoring program for PC inspectors? Does the applicant clearly outline training plans (to include Quality Field Inspection Auditors and Quality Field Inspection Trainers) to promote a sustainable training model? If necessary, to what extent has the applicant identified or indicate plans for hiring and/or identifying qualified training staff to implement an internal regulator training and audit program for PC related training requirements? Are there clear plans to collaborate with FDA to determine training needs and requirements?

    Program Improvement and Infrastructure Development (15 Points)

    Are gaps in program infrastructure necessary to fully implement the PCHF rule? Is a process proposed for meeting these infrastructure needs? If personnel funds are requested, does the application include a summary of the staffing and operational financial resources needed?  How well does the applicant address how project developed capabilities will be sustained at the conclusion of the project? 

    Preventive Controls Inspections and Compliance Implementation (20 Points)

    Is the applicant currently conducting Preventive Controls inspections of human food facilities under contract for FDA or have they committed in writing to conduct inspections during Year 1 of this project? Does the applicant have support from their department/agency leadership in the form of a commitment letter? Is the number of full-scope PC inspections to which the applicant has committed commensurate with the amount of funding and resources requested in the application? To what extent does the applicant have a plan to continuously increase the number of full scope PCHF inspections performed (contract and non-contract)?

    Legislative Research, Rulemaking and Policy Analysis (15 Points)

    Does the application describe their current status of adoption of the PCHF Rule or equivalent authority? How effectively does the proposal evaluate existing statutory and/or regulatory authority related to preventive controls for human foods? If needed, are adequate plans to research changes needed to incorporate the PCHF Rule or operate under FDA authority described?

    Outreach  (10 Points)

    Does the application describe effective outreach activities related to the PCHF rule and other FSMA related rules for industry and other stakeholders? 

    Joint Workplanning and Enforcement   (10 Points)

    Does the application outline a strategy to work collaboratively with FDA to perform workplanning (contract and non-contract work)? Will the strategy advance regulatory compliance and public health priorities?  Will the strategy allow each agency to leverage enforcement and regulatory authorities to obtain compliance and protect public health?  How does the application demonstrate how information will be shared between FDA and the State? 

    Investigator, Key Personnel, and Environment  (10 Points)

    Does the application provide justification for hiring new staff, including qualifications, training needs, and new equipment needs? Is there evidence of adequate agency management support, including by the selection of PD/PI(s) for the project?  How well does the application demonstrate the ability to obtain the required resources (personnel, equipment, supplies, regulatory authority, etc.) to meet the objectives of the project?  

    Additional Review Considerations

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

    Resource Sharing Plans

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

    Authentication of Key Biological and/or Chemical Resources:

    Generally not applicable.  Reviewers should bring any concerns to the attention of 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.

    Revisions

    For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project.

    2. Review and Selection Process

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

    As part of the objective review, all applications:

    • Will receive a written critique.

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

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

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

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

    2. Administrative and National Policy Requirements

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

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

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

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

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

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

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

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

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

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

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and FDA grant administration policies.

    FDA Responsibilities

    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 grantee for the project, as a whole, although specific tasks and activities may be shared between the awardee and the FDA as defined below. 

    Substantive involvement by the awarding agency is inherent in the cooperative agreement award.  Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement.

    The Grants Project Team may consist of a Grants Management Specialist, Program Official, Project Manager, and Technical Advisor(s).  The Grants Project team collaborates to review the progress of the grantee, and 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. 

    The Grants Project Team may utilize the grantee's progress reports, site visits, audit reports, FDA human food safety contract data, and other supporting documentation to determine if the terms and conditions of the award are met and satisfactory progress is being made.  Each team member works in consultation with each other, as needed, throughout the duration of the project.  A description of each team member involved with the program are described below.

    An FDA Grants Management Specialist (GMS) will be assigned and named in the Notice of Award.  The GMS oversees the administrative, financial, business and other non-programmatic aspects of the program.  These activities include, but are not limited to the following: 

    • Provides guidance on administrative, business, fiscal aspects of grants management to grantees and FDA program staff,
    • Monitors and manages applications and required reports on eRA Commons,
    • Monitors administrative and financial aspects of grantee activities, and
    • Maintains the official grantee file.

    An FDA Program Official (PO) will be assigned and named in the Notice of Award.  The PO is accountable for the programmatic oversight of the grant to include coordination, with the Project Manager, on the technical aspects of the grant.  S/he ensures the budget of grantees are reasonable and costs are allowable and allocable.  The PO reviews the progress reports to verify the budget proposed includes only allowable expenses that support the project goals and objectives.   The PO also assists with post-award monitoring and establishing a corrective action plan, if necessary.

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

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

    • Provide guidance, direction, and technical assistance in project planning, implementation, and evaluation;
    • Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;
    • Actively monitor the supported program via telephone conversations, webinars, e-mails, written correspondence, or periodic site visits;
    • Evaluate the supported program, including development of program-level performance measures, consistent data collection, and reporting procedures and protocols;
    • Conduct technical sessions with the grantee, as deemed necessary by FDA;
    • 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 Develop programs to meet the FDA mission;
    • Provision of programmatic technical assistance;
    • Monitor project/program performance, including review of progress reports and conducting visits; and
    • Assist in coordinating multi-program pilot projects.

    An FDA Technical Advisor(s) will be assigned to each enrolled program. The Advisor will primarily provide subject matter expertise for program activities and will work cooperatively with the PO and PM to help monitor and report grantee status/progress including sharing of information and historical backgrounds. The FDA Technical Advisor will have programmatic involvement as described below including, but not limited, to the following:

    • Provide guidance and technical assistance in project planning, implementation, and evaluation;
    • Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;
    • Review grantee reports and provide technical comment on progress,
    • Conduct technical sessions with the grantee, as deemed necessary by FDA;
    • Assist in the sharing of information developed by the grantee and collaboration to achieve implementation of the project goals. Examples may include SOPs, MOUs, training programs, and record keeping systems;
    • Assist with trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing; and
    • Assist with development of programs to meet the FDA mission; and
    • Advise on technical aspects of program activities.

    Unless another governance structure is mutually agreed upon, the Project Manager shall serve as the primary point of contact for the dissemination of FDA policy and project planning for milestones/objectives.

    Funding provided under this expansion supplement may be used to fund PCHF Rule-related activities which were previously allocated to the budget under another funding option of the RFA-18-001 award. For reallocations exceeding 10% of the total award, approval is required from the Grants Management Team.

    The purpose of this cooperative agreement is to advance efforts for nationwide implementation of the PCHF Rule. The cooperative agreements will provide funding for additional personnel, equipment, supplies, and training to support activities related to achieving adoption, implementation, and maintenance of the PCHF Rule.

    The grantee must maintain a food safety inspection contract with the FDA throughout the cooperative agreement. Continued funding for this cooperative agreement funding option are subject to the execution and completion of contract work according to the requirements of the contract.

    Applicant organizations must have an executed non-public information sharing agreement under 21 CFR Part 20.88 no later than the start date of the grant award.

    The grantee must agree to participate in mentoring partnerships to develop, advance, share, and implement best practices for regulatory activities.

    Principal Investigator Rights and Responsibilities

    The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, or programmatic aspects of the grant and for day-to-day management of the project or program. The PD/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff has sufficient clearance and/or background checks to work on this project or program. This individual will work closely with designated officials within the recipient organization to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.

    The PD(s)/PI(s) will have the primary responsibility for:

    • Overall management of the study,
    • Agreeing to work cooperatively with FDA, and
    • Developing and implementing systems necessary for communications among the various study organizational components.  All data and samples to be shared freely by methods and within time periods to be specified by the Program Official.

    FDA staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

    • The awardees agree to accept assistance from the designated FDA Project Manager/Technical Advisors. These persons will participate in the monitoring of issues relating to recruitment, follow-up, and adherence to protocols and will assist in the development and/or adjustment of project activity. Additionally, an agency Program Official may be responsible for the normal scientific and programmatic stewardship of the award.
    • The reporting and monitoring activities may include a review of budget modification requests from the grantee. The grantee and any sub-grantees are expected to utilize the approved funding respectively as indicated in the original submitted separate budget and cost estimates. The letter of agreement will be submitted by the grantee, with the aforementioned budget modification request, to the Program Official and Project Manager.
    • Equipment may be loaned by FDA to an awardee pursuant to FDA policy.  Such equipment will remain the property of FDA under loan to the awardee for a specified time period with a review every twelve months. FDA may terminate the loan at any time. Unless approved by ORA/OP, the FDA provided equipment may not be transferred by the awardee to a third party, and the awardee assumes full responsibility and liability for any claims that may arise as a result of operation of this equipment for the period it is in the possession of the awardee.

    Monitoring Activities

    The Program Official and Project Manager/Technical Advisor(s) will monitor award recipients periodically. The monitoring may be in the form of face-to-face meetings, telephone conversations, e-mails, or written correspondence between the Program Official/Grants Management Officer/Technical Advisor(s) and the principal investigator. In addition, periodic site visits with officials of the recipient organization may also occur to assess progress. 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 Program Official and Project Manager/Technical Advisor(s).

    The scope of the recommendation will confirm that:

    (1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements; and (3) if necessary, there is an indication that adequate corrective actions have taken place to address any identified problems.

    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.

    Mid-year reports are required.  The Research Performance Progress Report (RPPR) will be considered the annual program progress report for the budget period. 

    Mid-year and annual progress reports shall contain the elements below as applicable to the grantee proposal and award, but are not limited to, the following:

    1. Detailed progress report on the grantee meeting the project goals detailed in the cooperative agreement and identified in the application;

    2. Status report on the hiring and training of personnel if undertaken as a part of the PCHF funding option;

    3.   Status on the installation and operational readiness of any equipment, including IT, or software purchased; and

    4.  Any programmatic issues or concerns.

    Annual progress reports must contain the elements below as applicable to their application and award, but are not limited to, the following:

    1. Description of program improvements and demonstration of measurable implementation achieved by the funding provided under this expansion supplement;

    2.  An estimate (in total dollars) of in-kind contributions toward accomplishing the goals of the cooperative agreement during the reporting period; and

    3. Report on progress to implement an audit program, including Phase II and III food safety inspection contract audits as described in FDA Field Management Directive 76 (FMD-76), if the program was not already operating in Phase II or III at the start date;

    *NOTE:  Additional Reporting templates may be developed and made available for grantees to use after awards are made, to assist with reporting of progress achieved and/or data elements from the project goals (or outputs) listed in this FOA, and to improve monitoring for the progress and objectives of this Cooperative Agreement.

    The final program progress report must provide full written documentation of the project and summaries of accomplishments and goals, as described in the grant application. The documentation must be in a form and contain sufficient detail such that other state, local, and tribal governments could reproduce the final project. The final program progress report should also detail the strategy, including commitment of personnel, resources, and funding.

    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.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Graham N. Giesen
    Project Manager (Public Health Advisor)
    Office of Partnerships (OP)
    Food and Drug Administration
    Telephone: 214-790-4986
    Email: graham.giesen@fda.hhs.gov

    Laurie Keppley
    Program Official
    Office of Management (OM)
    Office of Regulatory Affairs (ORA)
    Food and Drug Administration
    Telephone: 240-402-7736
    Email: Laurie.Keppley@fda.hhs.gov

    Objective Review Contact(s)

    Daniel Lukash
    Grants Management Specialist
    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)

    Daniel Lukash
    Grants Management Specialist
    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).

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