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)
Center for Veterinary Medicine (CVM)

Funding Opportunity Title

Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed

Activity Code

U18 Research Demonstration Cooperative Agreements

Announcement Type

New

Related Notices
  • March 30, 2020 - Notice to extend the 2020 Application Due Date for PAR-20-132. See Notice NOT-FD-20-023.
Funding Opportunity Announcement (FOA) Number

PAR-20-132

Companion Funding Opportunity

None

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

93.103

Funding Opportunity Purpose

The intended outcome of this Funding Opportunity Announcement (FOA) is to advance efforts for a nationally integrated animal food safety system by assisting State animal food regulatory programs to achieve and maintain full implementation of the Animal Feed Regulatory Program Standards (AFRPS), and to provide optional funding for State animal food regulatory programs to perform regulatory work and promote compliance with the Preventive Controls for Animal Food (PCAF) regulation.

Key Dates
Posted Date

March 11, 2020

Open Date (Earliest Submission Date)

March 12, 2020

December 1, 2020

December 1, 2021

Letter of Intent Due Date(s)

April 2, 2020;

December 15, 2020;

December 15, 2021

Application Due Date(s)

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

February 15, 2021 by 11:59 PM Eastern Time.

February 15, 2022, 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

June 2020; April 2021; April 2022

Advisory Council Review

Not Applicable

Earliest Start Date

September 2020; July 2021; July 2022

Expiration Date

February 16, 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.


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 Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships and Operational Policy (OPOP), Office of Partnerships (OP), is announcing the availability of up to $11,375,000 in FY 2020 to be awarded under Limited Competition to State animal food regulatory programs. The intended outcome of this FOA is to advance efforts for a nationally integrated animal food safety system through the implementation and advancement of the Animal Feed Regulatory Program Standards (AFRPS) by State animal food regulatory programs, and to enhance State animal food regulatory programs and work related to 21 CFR Part 507 CGMP and PC regulations. Applicants must refer to the Eligibility section of this FOA to determine which funding track they should apply for: AFRPS Development or AFRPS Maintenance. Within each track, eligible applicants applying for the Preventive Controls Initiative funding option should include activities supporting the funding option, as outlined below. Further information on eligibility for the funding option, maximum budget per program area, and other administrative considerations can be found in this document below.

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

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 AFRPS allows for the development of risk-based animal food safety programs by establishing a uniform basis for measuring, evaluating, and improving the performance of State animal food regulatory programs in the Unites States. By achieving and maintaining implementation of these program Standards, Federal and State food regulatory programs can better direct their regulatory activities toward preventing animal food safety hazards, that can cause illness or injury to animals or humans, in facilities that manufacture, process, pack, or hold animal food materials/supplies. Consequently, the safety and security of the United States animal food supply and protection of human public health will improve.

The AFRPS are comprised of eleven Standards (See link below in Program Goals Section) which establish foundations for the critical elements that serve as an objective framework to evaluate and improve components of a State animal food program. These elements cover the State animal food program's regulatory foundation, training, inspection program, auditing, animal food-related illness or death and emergency response, enforcement program, outreach activities, planning and resources, laboratory services, sampling program, and assessment and improvement of Standard implementation.

Achieving and maintaining implementation of the program Standards will require comprehensive self-assessment on the part of a State program and will encourage continuous improvement and innovation. FDA recognizes that the time required for achieving full implementation of the AFRPS will vary between States. However, all State animal food regulatory programs will be expected to implement improvement plans to ensure continuous improvement and demonstrate that they are moving towards full implementation. State animal food regulatory programs receiving funds under this cooperative agreement will be expected to achieve and maintain full implementation by the conclusion of the cooperative agreement.

Grantees will achieve and maintain implementation with the AFRPS (most recent published version).

For the purpose of this funding opportunity, "full implementation" is defined as the State animal food

regulatory program having all elements, systems, and programs, as required in the Program Elements and Documentation sections of the AFRPS; and can demonstrate the use of those elements, systems, or programs. If implementation is not achieved by the conclusion of the cooperative agreement or at the end of funding year 5 (whichever comes first), the State program will provide a detailed improvement plan on how the remaining AFRPS elements and documentation requirements will be fully implemented and demonstrated. The improvement plan will include: A detailed timeline including what needs to be accomplished to implement the element and/or documentation requirement, and when the work will be completed.

The outcomes of the work provided under this cooperative agreement are as follows:

1. State animal food regulatory programs will achieve and maintain implementation of the AFRPS, which is recognized as a critical element to creating a national, fully integrated food safety system.

2. State animal food regulatory programs will contribute to the continuous improvement of the AFRPS through attendance at an annual face-to-face meeting, active participation in committees, and other Initiative supporting the AFRPS.

3. Develop strategies for achieving and maintaining implementation of the AFRPS that can be replicated or leveraged across state programs to promote national consistency.

4. Provide a foundation for supporting advisory/regulatory action based upon findings of regulatory activities conducted by State animal food regulatory programs.

5. Research and coordinate with FDA to identify and implement best practices for State animal food regulatory work performed under the scope of 21 CFR Part 507 CGMP and PC regulations, as well as other related FSMA provisions, which may be incorporated as elements for future versions of the Animal Feed Regulatory Program Standards.

Only the following State animal food programs will be eligible to apply:

State animal food regulatory programs with current FDA animal food safety inspection contracts (providing funding to State animal food regulatory programs) and are also enrolled in the AFRPS, or those that apply for an FDA animal food safety inspection contract and enroll in the AFRPS, are eligible to apply for funding under this cooperative agreement. An animal food safety inspection contract must be executed prior to this cooperative agreement being awarded. A condition of the award will be maintaining a current FDA animal food safety inspection contract in satisfactory condition throughout the cooperative agreement project period. Additional eligibility requirements for the Preventive Controls Initiative Funding Option can be found in Section III. Eligibility Information below in this Funding Opportunity Announcement.

The FDA will provide one year of funding with the possibility of up to four years of additional non-competitive support, contingent on performance and continued availability of federal funds for the FDA animal food safety inspection contract. For AFRPS, it is anticipated that full implementation of the AFRPS will be achieved within 5 total funding years under an AFRPS Cooperative Agreement, based on a verification audit of your program to ensure the elements have been implemented.

Background

In the United States, Federal and State government agencies ensure the safety of 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 jurisdiction, are safe, wholesome, and labeled properly. State agencies are responsible for conducting inspections and regulatory activities that help ensure animal 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 animal food facilities under contract with the FDA. Because jurisdictions may overlap, FDA and States collaborate and share resources to ensure the safety of the animal food supply. To better facilitate a partnership among regulatory authorities, regulatory program outcomes should be equivalent or equivalent in effect.

The Partnership for Food Protection (PFP) supports maximizing resources between FDA and its regulatory partners to develop an Integrated Food Safety System (IFSS). An IFSS promotes mutual reliance between federal, state, local, and territorial partners and enables them to rely on each other to conduct inspections, share data, and ensure actions are taken to remove adulterated food from the market quickly. The FDA and the Association of American Feed Control Officials (AAFCO) are members of the PFP and have been working together to develop model programs to promote consistency in animal food regulation across the U.S. One of the foundational principles of an IFSS is the implementation and uniform application of model standards so that regulatory partners conduct inspections under the same set of standards. Standards provide a consistent, underlying foundation that is critical for uniformity across State and Federal agencies to ensure the credibility of all programs under an IFSS.

The FDA Food Safety Modernization Act (FSMA) provides further support for developing an IFSS. FSMA was signed into law in January 2011 and calls for enhanced partnerships and integration with Federal, State, local, tribal, and territorial partners. A major component of FDA s implementation of the enhanced partnership provisions of FSMA was the development and implementation of the AFRPS. The enhanced partnerships and integration called for by FSMA allow FDA to rely on inspections and data collected by other agencies, such as those who have implemented and maintain AFRPS, to support regulatory activities and further the build on the idea of an IFSS.

In 2011, FDA and AAFCO entered into a partnership to develop the AFRPS. The AFRPS was first published and States began implementation within their programs in 2014. These Standards are designed to promote uniformity and consistency among animal food regulatory programs. This is consistent with the principles of FSMA and the fundamental goal of AAFCO and FDA to provide a mechanism for developing and implementing uniform and equitable regulations, and standards to enhance the protection of the nation's animal food supply.

FSMA also required FDA to develop new prevention-oriented standards for animal food, which were published in the final PCAF regulation in 2015. FDA and state partners recognized that harmonization and mutual reliance efforts are needed to successfully implement the PCAF regulation at both the federal and state level. FDA partnered with the National Association of State Departments of Agriculture (NASDA) and AAFCO to develop a framework that state animal food programs can utilize to update, modernize, or transform their programs to implement a prevention-oriented program, with the PCAF regulation as a foundation. The NASDA PCAF Framework document was published in 2018 and outlines various program functions a state will need to assess or build into their existing program to successfully implement a prevention-oriented regulatory program. The State's animal food regulatory programs need to develop and incorporate a risk-based approach to animal food safety that is utilized when assessing a facility's implementation of requirements found in the PCAF regulation for Current Good Manufacturing Practice (CGMP), hazard analysis, and risk-based preventive controls.

Objectives

Animal Feed Regulatory Program Standards (AFRPS)

All applicants must specifically address how they will achieve each of the following objectives in the cooperative agreement.

1. Demonstrate the ability to develop and/or maintain implementation of a comprehensive improvement plan that will result in full implementation of the AFRPS and continued maintenance of the AFRPS when the cooperative agreement ends.

2. Demonstrate the ability to fully participate in Initiative supporting the AFRPS, such as a required annual face-to-face meeting and any required training for this project (as determined by FDA/OP), committees, OP/AFRPS conference calls, sharing of best practices, annual visits, and verification audits

3. Demonstrate the availability of adequately trained staff and the criteria and ability to hire and/or train personnel to meet the goals and outputs of the cooperative agreement

4. Provide a properly detailed budget (one for each of the five years) that is intended to achieve implementation and subsequent maintenance of full implementation of the AFRPS. For applicants that choose to support ISO/IEC 17025 Accreditation or expansion for a primary servicing laboratory, a separate budget is required. The applicant must consult with the primary servicing laboratory they choose to support for ISO/IEC 17025 Accreditation or expansion, when developing a separate budget to include for this purpose

5. Demonstrate the ability to satisfy the reporting requirements outlined in section VI.3 of this announcement

6. Outline a detailed methodology for program assessment, improvement, and collaboration to accomplish the work, as described in this announcement, and ensure program sustainability.

7. Provide justification for hiring new staff to complete work under this FOA, including qualifications, training needs, and new equipment needs

8. Estimate capacities and identify capabilities for animal food sample collection and analysis for chemical and microbiological hazards for emergency response and surveillance and compliance efforts - an annual estimate of capacity and capability should be provided for sample collection for chemical and microbiological testing, based on recent sample data from the program and laboratory included with the estimate

9. Provide an approved exit strategy for maintenance of the AFRPS by the fifth year of funding under an AFRPS cooperative agreement to address sustainability of program accomplishments including commitment of personnel, resources and funding to sustain full conformance with the AFRPS.

Preventive Controls Initiative (Funding Option)

All applicants should specifically address the ability to achieve the following objectives in the cooperative agreement:

1. Build the following capabilities and capacities as needed to perform CGMP and PC regulatory work activities within your State program:

  • Demonstrate the availability of staff to complete training required to perform regulatory operations, including CGMP and PC inspections under 21 CFR Part 507, as well as the ability to develop and implement a training plan to build training capacity in order to independently perform CGMP and PC regulatory work by Funding Year 2.
  • Review State provisions to conduct regulatory activities under State authority for provisions equivalent or equivalent-in-effect to 21 CFR Part 507.
  • Demonstrate the ability and commitment to coordinate, develop, and implement plans and strategies with FDA and other state animal food regulatory programs to support joint Initiative for animal food regulatory programs. Such plans may include, but are not limited to:
  • Conducting annual meetings with FDA program staff (such as technical advisors for this cooperative agreement, State Liaisons, and appropriate Compliance Officers) to review enforcement tools and trends to improve enforcement strategies that utilize State and Federal resources more efficiently
  • Gathering and sharing animal food facility information and data (including risk categorization data) with FDA to provide essential data for a shared, up-to-date firm inventory, either through manual or automated data exchange
  • Conducting annual workplanning sessions with FDA program divisions to perform and monitor contract and non-contract inspections and samples, based on program capacities and capabilities
  • Participating in mentoring partnerships to develop, advance, share, and implement best practices for regulatory activities

2. Provide an approved exit strategy, by year 5, to address sustainability of the program accomplishments from this project beyond the funding provided by this Cooperative Agreement. The exit strategy for Animal Food CGMP and PC regulatory work as part of the State's comprehensive animal food safety inspection program should detail strategies for:

  • Maintenance of staff competencies
  • Outreach materials/presentations to external stakeholders
  • Regulatory work activities in line with achievements made during the life of this cooperative agreement.
Program Goals:

Animal Feed Regulatory Program Standards (AFRPS) Development Phase Track

The project outputs provided below are based on new programs enrolling in the AFRPS, or existing AFRPS enrollees which have not reached full implementation and have received less than 5 years of funding under an existing Cooperative Agreement. The project outputs are applicable to all such applicants. The FDA recognizes that achieving full implementation of the AFRPS will vary by program based on multiple factors, such as previous enrollment in the AFRPS and current level of implementation. Applicants should adjust their project goals to reflect their previous accomplishments and current implementation level with the AFRPS. A maximum of 5 total years of cooperative agreement funding is expected to reach full implementation of the AFRPS. Programs entering this cooperative agreement that have had a previous award to implement the AFRPS must begin completing work for the year following the funding year completed in the previous award, and continue to plan to reach full implementation of the AFRPS within 5 years of their initial start date for the original project. Once a State animal food regulatory program has completed 5 years of total funding, it should transition to completing the goals for maintenance, according to the schedule under the maintenance phase track below, and its continued funding level will be determined by the funding criteria for the maintenance phase track under this cooperative agreement.

Year 1:

1. If not under a current animal food safety inspection contract, the State animal food program must apply for an animal food safety inspection contract with the FDA, at the earliest possible date. An animal food safety inspection contract must be executed prior to the cooperative agreement being awarded. A current animal food safety inspection contract must be maintained in satisfactory condition throughout the cooperative agreement project period, as agreed upon by the State and FDA during contract negotiations.

2. Participation in a visit consisting of key personnel from the State animal food regulatory program and FDA to discuss the implementation of program elements of the AFRPS. Participation includes providing meeting space, accessibility of key State animal food regulatory program management and staff, and access to records, databases, and other materials supporting AFRPS implementation.

3. Attendance and participation of key State animal food program managers and staff in an annual face-to-face meeting, committee meetings, and other Initiative supporting national and program specific implementation of the AFRPS.

4. Conduct a comprehensive baseline self-assessment/baseline evaluation, as required in

Standard 9 of the AFRPS.

5. Following the baseline evaluation, develop improvement plan(s) that will result in implementation of the AFRPS by the completion of Year 5 of the cooperative agreement. Review and update improvement plan(s) on an annual basis. Documentation related to the evaluation and improvement plan(s) must be maintained.

Improvement plan(s) must include the following, at a minimum:

a. The individual element or documentation requirement for the Standard that was not fully met.

b. Improvements needed to fully implement the program element or documentation requirement(s) of the Standard.

c. Lists of individual tasks that will be used to address the needed improvement(s).

d. A projected completion date and actual completion date (once completed) for each task.

6. If the grantee is located in a state with a supporting laboratory that receives funding under an active FDA cooperative agreement for animal food sample analyses or other purposes (e.g., Laboratory Flexible Funding Model), the regulatory program grantee will support the collection of samples (FDA regulated animal food only) to support laboratory capacity development and product surveillance. The applicant must also demonstrate the ability to perform appropriate enforcement or other follow-up activities based on sample results. Sampling plans will be developed in cooperation with the laboratory to support the objectives of both programs.

Year 2:

1. Participation in a verification audit conducted by FDA/ORA/OHAFO Audit Staff. Participation includes providing meeting space, accessibility of key State animal food program management and staff, and access to records, databases, and other materials supporting AFRPS implementation. Nonconformities identified in the audit should be addressed in the subsequent self-assessment and improvement plan.

2. Participation in a visit consisting of key personnel from the State animal food regulatory program and FDA to discuss the implementation of program elements of the AFRPS. Participation includes providing meeting space, accessibility of key State animal food regulatory program management and staff, and access to records, databases, and other materials supporting AFRPS implementation.

3. Attendance and participation of key State animal food regulatory program managers and staff in a required annual face-to-face meeting and any required training, committee meetings, and other Initiative supporting national and program specific implementation of the AFRPS.

4. Implementation of the improvement plan(s). The improvement plan(s) should be updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve full implementation of the AFRPS. Progress achieved should indicate that full implementation of the AFRPS can be expected by the completion of Year 5.

5. Review and updated improvement plan(s) on an annual basis. Documentation related to the evaluation and improvement plan(s) must be maintained. The improvement plan(s) must include the following, at a minimum:

a. The individual element or documentation requirement for the Standard that was not fully met.

b. Improvements needed to fully meet the program element or documentation requirement(s) of the Standard.

c. Lists of individual tasks that will be used to address the needed improvement(s).

d. A projected completion date and actual completion date (once completed) for each task.

6. If the grantee is located in a state with a supporting laboratory that receives funding under an active FDA cooperative agreement for animal food sample analyses or other purposes (e.g., Laboratory Flexible Funding Model), the regulatory program grantee will support the collection of samples (FDA regulated animal food only) to support laboratory capacity development and product surveillance. The applicant must also demonstrate the ability to perform appropriate enforcement or other follow-up activities based on sample results. Sampling plans will be developed in cooperation with the laboratory to support the objectives of both programs.

Year 3:

1. Participation in a verification audit conducted by FDA/ORA/OHAFO Audit Staff (may be scheduled for year 4, based on State and audit staff availability). Participation includes providing meeting space, accessibility of key State animal food regulatory program management and staff, and access to records, databases, and other materials supporting AFRPS implementation. Nonconformities identified in the audit should be addressed in the subsequent self-assessment and improvement plan.

2. Participation in a visit consisting of key State animal food regulatory program and FDA personnel to

discuss the implementation of program elements of the AFRPS. Participation includes providing meeting space, accessibility of key State animal food regulatory program management and staff, and access to records, databases, and other materials supporting AFRPS implementation.

3. Attendance and participation of key State animal food regulatory program managers and staff in a required annual face-to-face meeting and any required training, committee meetings, and other Initiative supporting national and program specific implementation of the AFRPS.

4. Implementation of the improvement plan. The improvement plan should be updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve full implementation of the AFRPS. Progress achieved should indicate that implementation of the AFRPS can be expected by completion of Year 5.

5. Review and update improvement plan(s) on an annual basis. Documentation related to the evaluation and improvement plan(s) must be maintained. The improvement plan must include the following, at a minimum:

a. The individual element or documentation requirement for the Standard that was not fully met.

b. Improvements needed to fully meet the program element or documentation requirement(s) of the Standard.

c. Lists of individual tasks that will be used to address the needed improvement(s).

d. A projected completion date and actual completion date (once completed) for each task.

6. If the grantee is located in a state with a supporting laboratory that receives funding under an active FDA cooperative agreement for animal food sample analyses or other purposes (e.g., Laboratory Flexible Funding Model), the regulatory program grantee will support the collection of samples (FDA regulated animal food only) to support laboratory capacity development and product surveillance. The applicant must also demonstrate the ability to perform appropriate enforcement or other follow-up activities based on sample results. Sampling plans will be developed in cooperation with the laboratory to support the objectives of both programs.

Year 4:

1. Participation in a visit consisting of key personnel from the State animal food regulatory program and FDA to discuss the implementation of program elements of the AFRPS. Participation includes providing meeting space, accessibility of key State animal food regulatory program management and staff, and access to records, databases, and other materials supporting AFRPS implementation.

2. Attendance and participation of key State animal food regulatory program managers and staff in a required annual face-to-face meeting and any required training, committee meetings, and other Initiative supporting national and program specific implementation of the AFRPS.

3. Implementation of the improvement plan. The improvement plan should be updated to accurately reflect when specific objectives and tasks have been met, and when new objectives and tasks are identified to achieve full implementation of the AFRPS. Progress achieved should indicate that full implementation of the AFRPS can be expected by completion of Year 5.

4. Review and update improvement plan(s) on an annual basis. Documentation related to the evaluation and improvement plan(s) must be maintained. The improvement plan must include the following, at a minimum:

a. The individual element or documentation requirement for the Standard that was not fully met.

b. Improvements needed to fully meet the program element or documentation requirement(s) of the Standard.

c. Lists of individual tasks that will be used to address the needed improvement(s).

d. A projected completion date and actual completion date (once completed) for each task.

5. If the grantee is located in a state with a supporting laboratory that receives funding under an active FDA cooperative agreement for animal food sample analyses or other purposes (e.g., Laboratory Flexible Funding Model), the regulatory program grantee will support the collection of samples (FDA regulated animal food only) to support laboratory capacity development and product surveillance. The applicant must also demonstrate the ability to perform appropriate enforcement or other follow-up activities based on sample results. Sampling plans will be developed in cooperation with the laboratory to support the objectives of both programs.

Year 5:

1. Participation in a verification audit by the FDA/ORA/OHAFO Audit Staff of the State animal food program to verify implementation status of the AFRPS. Participation includes providing meeting space, accessibility of State key animal food program staff, and access to records, databases, and other materials supporting the State program's implementation of the AFRPS. Nonconformities identified in the audit should be addressed in the subsequent self-assessment and improvement plan.

2. Participation in a visit consisting of key personnel from the State animal food regulatory program and FDA to discuss the implementation of program elements of the AFRPS. Participation includes providing meeting space, accessibility of key State animal food regulatory program management and staff, and access to records, databases, and other materials supporting AFRPS implementation.

3. Attendance and participation of key State animal food regulatory program managers and staff in a required annual face-to-face meeting and any required training, committee meetings, and other Initiative supporting national and program specific implementation of the AFRPS.

4. Development of a plan identifying personnel, funding, and resources necessary to sustain implementation of the AFRPS.

5. If the grantee is located in a state with a supporting laboratory that receives funding under an active FDA cooperative agreement for animal food sample analyses or other purposes (e.g., Laboratory Flexible Funding Model), the regulatory program grantee will support the collection of samples (FDA regulated animal food only) to support laboratory capacity development and product surveillance. The applicant must also demonstrate the ability to perform appropriate enforcement or other follow-up activities based on sample results. Sampling plans will be developed in cooperation with the laboratory to support the objectives of both programs.

Exit Strategy for Sustainability (Development Track):

State animal food programs are expected to achieve full implementation of the AFRPS by the completion of year 5 of funding under a cooperative agreement(s) and must develop and submit an Exit Strategy for Sustainability (ESS) with the mid-year report for their 5th year of funding, for FDA review and approval. The ESS will outline the State program's plans to maintain implementation of the AFRPS and ensure progress continues within their agency to achieve full implementation of the AFRPS.

The ESS must detail:

  • Strategy to sustain AFRPS implementation, including identifying personnel/FTEs, current funding sources for these personnel, and plans to sustain those personnel using grantee resources to the best of the grantee's ability, based on the data below
  • Animal food program data including (all data should be pulled from a recent 12-month period):
  • Number of trained animal food inspectors (FTE)
  • Number of animal food facilities in inventory
  • Number of routine animal food inspections conducted
  • Number of animal food-related emergency response events investigated
  • Number of animal food compliance actions taken (embargo, disposal, emergency closures, re-inspections and fines issued)

Animal Feed Regulatory Program Standards (AFRPS) Maintenance Phase Track

The project goals provided below are based on programs previously enrolled in the AFRPS which have received up to 5 years of Cooperative Agreement funding and have implemented the AFRPS and are applicable to all such applicants. The FDA recognizes that achieving full implementation (as previously defined) of the AFRPS will vary by program based on multiple factors, such as previous enrollment in the AFRPS and current level of implementation. Applicants should adjust their project goals to reflect their previous accomplishments and current implementation level with the AFRPS. A maximum of 5 total years of cooperative agreement funding is expected to reach full implementation of the AFRPS. Once a State animal food regulatory program has completed 5 years of total funding, it should transition to completing the goals for maintenance, according to the schedule under the track below, and its continued funding level will be determined by the funding criteria for the maintenance phase track under this cooperative agreement.

For more information on the AFRPS program, please visit https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/regulatory-program-standards/animal-feed-regulatory-program-standards-afrps

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

1. A current animal food safety inspection contract must be maintained in satisfactory condition throughout the cooperative agreement, as agreed upon by the State and FDA during contract negotiations, throughout the cooperative agreement project period.

2. Grantees will achieve and maintain implementation with the AFRPS (most recent version). If implementation is not achieved and maintained upon award and throughout the cooperative agreement, the state will develop and use an improvement plan to reach implementation. Improvements are expected to be completed as expediently as possible.

3. Grantees will participate in regularly scheduled visits consisting of key personnel from the State animal food regulatory program and FDA to discuss the implementation of program elements of the AFRPS. Participation includes providing meeting space, accessibility of key State animal food regulatory program management and staff, and access to records, databases, and other materials supporting AFRPS implementation.

4. Grantees will contribute to the continuous improvement of the AFRPS through attendance at an annual face-to-face meeting, active participation in committees, and other Initiative.

5. Grantees will develop strategies and resources for achieving and maintaining implementation with the AFRPS that can be shared and duplicated on a national basis.

6. Grantees will provide the FDA the foundation for pursuing regulatory action based upon the findings of State Animal Food regulatory programs. Grantees will provide the FDA the foundation to improve quality of contracts, coordination of inspections, investigations and enforcement to effectively and efficiently protect public health.

7. If the grantee is located in a state with a supporting laboratory that receives funding under an active FDA cooperative agreement for animal food sample analyses or other purposes (e.g., Laboratory Flexible Funding Model), the regulatory program grantee will support the collection of samples (FDA regulated animal food only) to support laboratory capacity development and product surveillance. The applicant must also demonstrate the ability to perform appropriate enforcement or other follow-up activities based on sample results. Sampling plans will be developed in cooperation with the laboratory to support the objectives of both programs.

8. Grantees will participate in scheduled verification audits by the FDA/ORA/OHAFO Audit Staff of the state animal food program to verify implementation status of the AFRPS. Participation includes providing meeting space, accessibility of state key animal food program staff, and access to records, databases, and other materials supporting the state program's implementation of the AFRPS. Nonconformities identified in the audit should be addressed in the subsequent self-assessment and improvement plan.

Preventive Controls Initiative (PC Funding Option)

The project goals provided below are intended to develop and enhance integrated program operations and best practices for new programs enrolling in the AFRPS or those that are considered to be in their maintenance phase of AFRPS. These project goals are applicable to those applicants that meet the eligibility requirements and choose to enroll in the Preventive Controls funding option.

Year 1:

1. An animal food safety inspection contract must be executed prior to the cooperative agreement being awarded. A current animal food safety inspection contract must be maintained in satisfactory condition throughout the cooperative agreement, as agreed upon by the State and FDA during contract negotiations, throughout the cooperative agreement project period. Continued funding for this cooperative agreement funding option is subject to the execution and completion of contract work according to the terms and conditions for this cooperative agreement.

States must be performing comprehensive animal food safety inspections (under the scope of 21 CFR Part 507), no later than the 24 months after the initial award date of this cooperative agreement. As they build capacities and capabilities from this project, states are expected to increase the amount of comprehensive inspections performed under the FDA animal food safety contract or under the State’s authority, progressively throughout this cooperative agreement.

2. Define, identify, and provide a list of all active animal food facilities, including the facility's risk categorization, in the State animal food facility inventory and provide the list to the FDA. Designated State animal food regulatory program staff must work with appropriate FDA personnel to reconcile firms between the State and FDA facility inventories (common facilities, duplicate facilities, inactive facilities, out-of-business facilities, not official establishment facilities, etc.)

3. Identify and designate at least 2 people intended to complete (or who have previously completed) all required FDA training for Animal Food Preventive Controls Inspections (by the end of funding year 2). The program training plan (as required by the AFRPS) must be updated to include CGMP and PC coursework and field training required and completed.

4. Identify and designate at least 1 person as a qualified field inspection trainer to provide CGMP and PC field training (not CGMP and PC coursework training) for field program staff as necessary to perform Animal Food CGMP and PC inspections. Training required for the designated person(s) must be identified and completed.

5. Develop outreach plan (as required in Standard 7) and associated materials related to the PCAF regulation and compliance as part of the State program's overall outreach plan.

6. Identify the element(s) of the State program training plan which satisfy AFRPS element 2.3.2.2.8 to provide a foundation for evidence collection and development, and data acceptability for CGMP and PC inspections. Conduct an evaluation of the program training plan using data from CGMP and PC inspections, samples, and regulatory actions to determine if the training needs to be updated, modified, or created to support evidence developed 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 program shall consult with their assigned FDA Division staff as appropriate, to conduct the evaluation and develop the improvements.

7. Identify and collect data, that can be used in the state audit program, on CGMP and PC inspections, inspection reports, and samples to evaluate general inspector and program data to identify gaps and corrective actions needed. In addition, as part of the State contract, the Program is expected to implement and move towards implementation of an audit program to support Phase 2 and 3 audits as described in Field Management Directive (FMD)-76.

8. Coordinate with FDA Division personnel and other appropriate FDA staff. FDA and State personnel will meet as necessary to develop and monitor progress in workplanning for animal 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, may be used as a resource to guide these meetings.

9. Evaluate current enforcement tools, strategies, and trends to determine their applicability to CGMP and PC regulatory actions and share findings with FDA.

10. Participate 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.

Year 2:

1. An animal food safety inspection contract must be executed prior to the cooperative agreement being awarded. A current animal food safety inspection contract must be maintained in satisfactory condition throughout the cooperative agreement, as agreed upon by the State and FDA during contract negotiations, throughout the cooperative agreement project period. Continued funding for this cooperative agreement funding option is subject to the execution and completion of contract work according to the terms and conditions for this cooperative agreement.

States must be performing comprehensive animal food safety inspections (under the scope of 21 CFR Part 507), no later than 24 months after the initial award date of this cooperative agreement. As they build capacities and capabilities from this project, states are expected to increase the amount of comprehensive inspections performed under the FDA animal food safety contract or under the State’s authority, progressively throughout this cooperative agreement.

2. Maintain and coordinate animal food facility data and inventory with FDA, including risk categorization data.

3. Identify and designate sufficient program staff assigned to complete (or who have previously completed) required training for Animal Food CGMP and PC Inspections and perform inspections. Due to the complexity and length of CGMP and PC inspections, programs are strongly encouraged to maintain a minimum of 2 trained staff available to perform the inspections. The program training plan (as required by the AFRPS) must be updated to include CGMP and PC coursework and field training required and completed.

3. Assign designated qualified field inspection trainer(s) to train additional field program staff as necessary to perform Animal Food CGMP and PC inspections. At least 1 state staff member is expected to be available and utilized as qualified field inspection trainers, for CGMP and PC field inspection training (not CGMP and PC Coursework Training).

4. Identify and perform outreach activities according to outreach plan which are related to the PCAF regulation and compliance, including applicable evaluations of outreach activity events.

5. The State program must evaluate and provide any improvements to the program training plan to ensure evidence developed for Animal Food Regulatory actions for CGMP and PC inspections and samples can support advisory/regulatory action under your own authorities or by FDA, when necessary. Improvements to the training plan must be developed and documented as identified from the evaluation. The program shall consult with their assigned FDA Division staff as appropriate, to conduct the evaluation and develop the improvements.

6. Identify and collect data, that can be used in the state audit program, on CGMP and PC inspections, inspection reports, and samples to evaluate general inspector and program data to identify gaps and corrective actions needed. In addition, as part of the State contract, the Program is expected to implement and move towards implementation of an audit program to support Phase 2 and 3 audits as described in Field Management Directive (FMD)-76.

7. Coordinate with FDA Division personnel and other appropriate FDA staff. FDA and State personnel will meet as necessary to develop and monitor progress in workplanning for animal 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.

8. Develop and/or begin use of enforcement tools and strategies to support CGMP and PC regulatory actions. Share and communicate the tools, strategies, and trends with FDA and state programs to improve enforcement strategies between regulatory authorities.

9. Participate 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.

Years 3-5:

1. Maintain and coordinate animal food facility data and inventory with FDA, including risk categorization data.

2. Ensure training program provides sufficient program staff and qualified field inspection trainers needed to perform State and FDA Animal food CGMP and PC inspections.

3. Identify and perform outreach activities according to the outreach plan which are related to the PCAF regulation and compliance, including applicable evaluations of outreach activity events. Modify and update the outreach plan and outreach activities if determined necessary based on the results of the evaluation(s).

4. The State program must evaluate and provide any improvements to the program training plan to ensure evidence developed for Animal Food Regulatory actions for CGMP and PC inspections and samples can support advisory/regulatory action under State authorities or by FDA, when necessary. The state program should consider whether additional improvements to the training plan are needed to support evidence developed during comprehensive animal food inspections. Improvements to the training plan must be developed and documented as identified from the evaluation. The program shall consult with their assigned FDA Division staff as appropriate, to conduct the evaluation and develop the improvements.

5. Identify and collect data, that can be used in the state audit program, on CGMP and PC inspections, inspection reports, and samples to evaluate general inspector and program data to identify gaps and corrective actions needed. States are expected to implement an audit program, including phase 2 and 3 audits as described in FMD-76 for state contract inspections, within 5 years or less of total funding under an AFRPS cooperative agreement, or according to the implementation schedule for their improvement plan for the AFRPS.

6. Coordinate with FDA Division personnel and other appropriate FDA staff. FDA and State personnel will meet as necessary to develop and monitor progress in workplanning for animal 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.

7. Utilize established enforcement tools and strategies to support CGMP and PC regulatory actions. Evaluate these tools and strategies to determine their effectiveness periodically and make improvements, as needed. Share and communicate the tools, strategies, and trends with FDA and state programs to improve enforcement strategies between regulatory authorities. This may be conducted in conjunction with the annual evaluation of enforcement strategies as required by Standard 6 in the AFRPS.

8. Participate 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.

9. Develop and implement a plan to incorporate CGMP and PC animal food inspections into comprehensive animal food inspections that include inspection for compliance with the PCAF regulation and other relevant animal food safety requirements, such as those found in regulations for Bovine Spongiform Encephalopathy (BSE),, medicated feed CGMP, Veterinary Feed Directive (VFD), Sanitary Transportation, or Foreign Supplier Verification Programs (FSVP). The State program should begin conducting comprehensive animal food inspections by the completion of year 5 of this agreement. The State program can use FDA's Compliance Program Guide Manual (CPGM) for comprehensive animal food inspections once that CPGM is available.

Exit Strategy for Sustainability (PC Option):

State animal food programs are expected to sustain resources, program development and implementation, and advances in CGMP and PC animal food regulatory work matching (or exceeding) achievements made during the life of this Cooperative agreement. Grantees must develop and submit an Exit Strategy for Sustainability (ESS) with the mid-year report for their 5th year of funding, for FDA review and approval. The ESS will outline the State program's plans to sustain implementation of CGMP and PC regulatory work and resources within their State programs and ensure progress continues within their agency for program improvement.

The ESS must detail:

  • Strategy to sustain incorporation of the State program's CGMP and PC regulatory work as part of their comprehensive animal food inspection program, including identifying personnel, current funding sources for these personnel, and plans to sustain those personnel using grantee resources to the best of the grantee's ability, based on the data below
  • Animal food program data as it pertains to implementation of the CGMP and PC regulatory work for animal food facilities within their State (all data should be pulled from a recent 12-month period):
  • Number of trained CGMP and PC animal food inspectors (FTE)
  • Number of animal food facilities that are subject to the PCAF regulation in their inventory
  • Number of CGMP and PC animal food inspections conducted
  • Number of animal food-related emergency response events investigated

Number of animal food CGMP and PC-related compliance actions taken (embargo, disposal, emergency closures, re-inspections, fines issued, or other administrative or enforcement agency actions)

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

New

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 four (4) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

FDA/ORA intends to fund up to $11,375,000 in fiscal year 2020 in support of this grant program. Funding for future Fiscal Years will be contingent upon annual appropriations and program priorities.

It is anticipated that up to 24 awards will be made, not to exceed $600,000 in total costs (direct plus indirect), per award per year.

AFRPS base funding: It is anticipated that up to 24 awards will be made, not to exceed $300,000 in total costs (direct plus indirect), per award per year.

PC Animal Food Funding Option: It is anticipated that up to 19 awards will be made, not to exceed $300,000 in total costs (direct plus indirect), per award per year.

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):

The below application budget limits are the same for all five (5) years of the cooperative agreement. See Award Project Period, directly below:

Funding Track 1: AFRPS Development:

AFRPS Development Base

PC Funding Option

Potential Total Award (Up to)

$300,000

$300,000

$600,000

Funding Track 2: AFRPS Maintenance

Level

AFRPS Maintenance Base

PC Funding Option

Potential Total Award (Up to)

1

$150,000

$300,000

$450,000

2

$225,000

$300,000

$525,000

3

$300,000

$300,000

$600,000

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is five (5) years.

The anticipated Project Period for awards made in FY20 will be 9/1/2020 - 6/31/2025 with the below annual Budget Periods:

Year 1: 9/1/2020-6/30/2021

Year 2: 7/1/2021-6/30/2022

Year 3: 7/1/2022-6/30/2023

Year 4: 7/1/2023-6/30/2024

Year 5: 7/1/2024-6/30/2025

Awards made in future Fiscal Years will follow a similar project period cycle.

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

AFRPS Development Phase and Maintenance Phase Tracks

Governments

  • State Governments

This opportunity is only available to the following State animal food safety programs:

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

Applicants will be categorized under one of two funding tracks: AFRPS Development or AFRPS Maintenance (see eligibility criteria below). Within each funding track, an applicant may apply to the Preventive Controls Initiative funding option, provided they meet the funding option eligibility criteria (below).

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

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

Funding Track 1: AFRPS Development Phase

Applicants must have received less than five (5) years of funding under a past AFRPS cooperative agreement, or have never received an AFRPS cooperative agreement. Applicants may request up to $300,000 per year for this funding track. State programs will move to AFRPS Maintenance funding levels in the sixth year of funding under AFRPS cooperative agreements. Applicants with less than five (5) years of funding under a past AFRPS cooperative agreement may elect to count years of AFRPS enrollment under the FDA Animal Food Safety Inspection Contract toward the five (5) years AFRPS funding eligibility requirement when determining the entry date for Funding Track 2 (AFRPS Maintenance Phase), and may elect to move to Funding Track 2 (AFRPS Maintenance Phase) for the award year after full implementation of the AFRPS has been achieved (as determined by an FDA verification audit).

See below for AFRPS Funding Track 2 (AFRPS Maintenance Phase) variable funding levels. Eligible AFRPS Funding Track 1 (AFRPS Development Phase) applicants are also eligible to apply for the Preventive Controls Initiative Funding Option.

Funding Track 2: AFRPS Maintenance Phase

Applicants must have received five (5) years of funding under a past AFRPS cooperative agreement. Applicants with less than five (5) years funding under a past AFRPS cooperative agreement may elect to count years of AFRPS enrollment under the FDA Animal Food Safety Inspection Contract toward the five (5 years AFRPS funding eligibility requirement when determining the entry date for Funding Track 2 (AFRPS Maintenance Phase), and may elect to move to Funding Track 2 (AFRPS Maintenance Phase for the award year after full implementation of the AFRPS has been achieved (as determined by an FDA verification audit). If the state program is not currently deemed to be in full implementation and their corrective actions are still pending (as documented in the most recent verification audit by FDA/ORA/OHAFO/Audit Staff), then the program must address the corrective actions in their strategic improvement plan submitted as part of the application.

Applicants have been classified into three (3) levels of funding ceilings based on a variety of factors unique to that jurisdiction (See data sources below). This approach establishes funding ceilings proportional to the applicant's jurisdictional work volume for this program area. To determine which funding level is applicable to your program, please consult the table below. 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.

AFRPS Maintenance Level 1

$150,000

AFRPS Maintenance Level 2

$225,000

AFRPS Maintenance Level 3

$300,000

Connecticut

Alabama**

Iowa

Louisiana

California

Kansas

New Jersey

Colorado

Minnesota

New Mexico

Florida

Missouri

South Carolina*

Georgia

Nebraska

West Virginia

Kentucky

Texas

Michigan*

North Carolina

Pennsylvania

Tennessee

Washington

*May not be eligible to select the AFRPS Maintenance Funding Track in Year 1 of the cooperative agreement (Funding Track 2); State program’s eligibility to enter the AFRPS Maintenance Funding Track depends on date of first receiving an AFRPS Cooperative Agreement see eligibility narrative for further details.

**May not be eligible to select the AFRPS Maintenance Funding Track until Year 5 of the cooperative agreement (Funding Track 2); State program’s eligibility to enter the AFRPS Maintenance Funding Track depends on the date for first receiving an AFRPS Cooperative Agreement see eligibility narrative for further details.

Eligible AFRPS Development Phase Track applicants are also eligible to apply for the Preventive Controls Initiative Funding Option.

Data Sources used to determine eligibility (see table below for further details):

  • FY19 FDA Animal Food Safety Inspection Contract Data and Inspection Time Projections
  • FY19 FDA firm inventory data (as of 4/15/2019)
  • OP will maintain a copy of the funding algorithm and supporting data used to place State programs into funding levels. If you would like to obtain the data set specific to your State program, please email Isaiah.Isakson@fda.hhs.gov

Preventive Controls Initiative (PC Funding Option)

Applicants must be enrolled in the AFRPS with a funding award under either the AFRPS Development Phase Track or the AFRPS Maintenance Track in order to be eligible to receive funding for the PC Funding Option.

1. An animal food safety inspection contract must be executed prior to the cooperative agreement being awarded. A current animal food safety inspection contract must be maintained in satisfactory condition throughout the cooperative agreement, as agreed upon by the State and FDA during contract negotiations, throughout the cooperative agreement project period.

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

Overlapping Cooperative Agreements

  • If an applicant is the recipient of a current AFRPS cooperative agreement with a project period extending beyond August 2020 and the applicant applies for this cooperative agreement under either Funding Track 1 or Funding Track 2, the pre-existing AFRPS cooperative agreement will be subject to termination, pending determination of awards funded under Funding Track 1 or 2 of this Cooperative Agreement instead of through a previous cooperative agreement award.

Applicant organizations may not submit more than one 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 via electronic mail as a PDF file with the FOA Number and the Institution's Name in the message subject heading to:

Gordana Zuber
Telephone: 301-348-1747
Email: gordana.zuber@fda.hhs.gov

A technical session will be held for prospective applicants in April 2020 and as needed for future out 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.

15 Pages for AFRPS (Development or Maintenance)

15 Pages for Preventive Controls Initiative Funding Option

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.
  • Applicants must project their eligibility and interest in the funding option over the five (5) year cooperative agreement, as options to expand participation in the funding option after the award is made will be limited.
  • Each of the funding tracks/options selected by the applicant must have a detailed budget justification for each year in which funding is 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.
  • Applicants may also apply for personnel, training, and surveillance sample analysis if they have the necessary equipment and it will be available for these projects.
  • Where personnel costs are requested, documentation must be provided to associate these costs with the specific goals and objectives
  • Funds should be requested in the budget for key project personnel to travel to meetings, on-site visits, assessments and audits with FDA program staff to discuss the State self-assessment and implementation of the AFRPS, and for training and coordination for regulatory and project work for Animal Food Preventive Controls Initiative (only applicable if applying for the funding option) with appropriate State and FDA staff. All anticipated meetings for attendance should be listed and referenced by name in the application.
  • A portion of budgeted travel funds should also be set aside for key personnel (a minimum of 2) to attend required annual face-to-face meeting and any required training (as determined by FDA/OP) and committee meetings supporting the AFRPS, and the Preventive Controls Initiative (only applicable if applying for the funding option).
  • All anticipated meetings and trainings, to include required annual meeting(s) and required training, for attendance should be listed and referenced by name in the application.
  • Funding Plan: Grantees whose State human or animal food regulatory program receives funding from an FDA Rapid Response Team (RRT) cooperative agreement are required to participate in the RRT and should ensure that their efforts to meet the program elements of the AFRPS Standard 5 are aligned/integrated with the existing RRT and their participation therein. Funds from the AFRPS Cooperative Agreement are to be used for the program elements indicated under each Standard. RRT-specific activities support the program elements under Standard 5, but it is not a requirement of Standard 5.
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):

Page one of the Research Strategy must be a cover sheet with the following table indicating funding track(s) and funding option (if applicable) selected for each of the five (5) years of the cooperative agreement. For each year, list the amount requested under each option, and the total award amount for each year.

  • Identify specific personnel responsible for implementation of each funding track/option selected in the application (e.g. AFRPS Development or Maintenance, and PC Funding Option). These personnel may be different from the Principal Investigator (PI) on the overall cooperative agreement
  • For the AFRPS Development or Maintenance Funding Tracks, there must be at least one dedicated full-time employee/equivalent (FTE) to lead day-to-day oversight, such as an AFRPS Coordinator
  • Demonstrate the availability of adequately trained staff and the ability to hire and/or train personnel to meet the outputs of this cooperative agreement. This should include a description of training needs to support AFRPS implementation and Regulatory work for Animal food CGMP and PC inspections, as well as requirements of the FDA animal food safety inspection contract (allowable expenses under this cooperative agreement)
  • Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs.
  • Demonstrate the ability to satisfy the reporting requirements outlined in section VI.3 of this announcement
  • Demonstrate the ability to fully participate in Initiative supporting this cooperative agreement, such as annual face-to-face meetings (as determined by FDA), committees, conference calls, sharing of data and best practices, coordination and planning events (such as for workplanning and enforcement, if applicable), on-site visits, and verification audits.
  • For applicants enrolled in the AFRPS for a minimum of twelve (12) months, a copy of the program self-assessment, improvement plan, and a description of the progress and accomplishments of the program in achieving implementation of the AFRPS must be included in the application. The program self-assessment and improvement plan should be included as appendices following the directions in the SF-424 Guide.
  • An Improvement Plan means a type of improvement plan that includes the following information: (1) the individual element or documentation requirement of the standard that was not met, (2) improvements needed to meet the program element or documentation requirement of the standard, (3) projected completion dates for each task, and (4) date completed.
  • Describe any identified or potential obstacles in achieving and maintaining implementation with the AFRPS and approaches to overcome these obstacles.
  • If the applicant is located in a state with a supporting laboratory that receives funding under an active FDA cooperative agreement for analysis of animal foods, the applicant must demonstrate the ability to provide for the collection of samples (FDA regulated animal food only) to support laboratory capacity development and product surveillance. The applicant must also demonstrate the ability to perform any enforcement or other follow-up activities based on sample results. Sampling plans will be developed in cooperation with the laboratory to support the objectives of both programs.
  • Outline a detailed methodology to accomplish the work, as described in this announcement.

There must be a separate and distinct methodology section for each funding option included in the application. See page limitations (Section IV of the FOA).

Additional items to be included in AFRPS Development Phase Funding Track (Funding Track 1) and AFRPS Maintenance Phase Funding Track (Funding Track 2) Applications:

  • Demonstrate the ability to implement a comprehensive improvement plan that results in the program achieving and maintaining implementation with the AFRPS, including new versions.
  • Submit your most recent verification audit report provided by the Audit Staff as an appendix following the directions in the SF-424 Guide.

Additional items to be included in the Preventive Controls Initiative Funding Option:

  • Identify specific personnel responsible for overseeing implementation of the PC Funding Option. These personnel may be different from the Principal Investigator (PI) on the overall cooperative agreement and the personnel responsible for implementation of the AFRPS Funding Track 1 or 2.
  • Outline plans and resources/assistance needed (if any) to incorporate provisions equivalent or equivalent-in-effect to 21 CFR Part 507. Funding requested for this purpose should also be detailed in the budget, as appropriate.
  • Describe plans to perform state and/or FDA contract CGMP and PC inspections under federal or state authority

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.

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.

Selected list of allowable costs that have limitations specific to this announcement (including but not limited to):

1) Audiovisual materials such as videotapes, DVDs, public service announcements, etc. when identified as a necessary expense that directly impacts the goals and deliverables of this award.

2) Travel and per diem to trainings, exercises and meetings with AFRPS members (other State agencies, local agencies, FDA Divisions and Districts), FDA Headquarters, and annual AFRPS meetings.

3) Subcontracting to third parties (other than local/county/tribal agencies conducting work on behalf of the State animal food regulatory agency) is allowed but limited to 25% of each year's award.

Non-allowable costs:

1) Pre-award costs are not allowable for this announcement.

2) Facilities, work, and training reimbursed under the FDA animal food safety inspection contract and other funding mechanisms must remain distinct and separate from the cooperative agreement. The State must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, as well as sub-contractor and/or primary servicing laboratory expenditures, under the animal food safety inspection contracts and other funding mechanisms and these cooperative agreements.

3) Vehicle purchases are not permitted.

4) 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.

Only primary servicing laboratories are eligible to receive funds through the awardee, in order to help the State animal food regulatory program to implement the AFRPS. Primary servicing laboratories are defined as State funded regulatory laboratories, funded by the same State as the State animal food regulatory program, which perform 51% or more of the analyses on all samples collected by the State animal food regulatory program. Grantees may provide no more that 25% of annual award funds from the AFRPS track funding to primary servicing laboratories for the purpose of achieving or expanding accreditation for animal feed analyses under the current version of ISO/IEC 17025.

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.

Animal Food Regulatory Program Standards (Development and Maintenance Phase Tracks)

Rationale and Design (40 Points)

Demonstrates ability to achieve the goals of the cooperative agreement and project proposed.

Cooperation (20 Points)

Demonstration of effectiveness in working with federal, State, and local partners and other appropriate organizations to implement the goals of the cooperative agreement.

Sustainability and Integration (20 Points)

Demonstration of plans to facilitate the incorporation and sustainability of project developed capabilities into the entity’s animal food safety system. Expected challenges are documented and addressed.

Resources (20 Points)

Demonstration of adequate program resources (including staff) and infrastructure, or the ability to obtain the resources necessary, to complete the project and sustain the project beyond the 5 year project period.

Preventive Controls Initiative (PC Funding Option)

Research Activities (10 Points)

Demonstration the application clearly outlines plans to conduct research into legislation, rule-making, etc. If the applicant has already adopted the PCAF Regulation, demonstration that they plan to conduct research to ensure no other changes are necessary to implement their inspection and compliance program.

Quality System Development (20 Points)

The applicant clearly outlines plans to conduct research into PCAF focused coordinated regulatory efforts to determine where changes need to be made to ensure acceptance of work product by FDA and state program needs for acceptance of data from FDA. The applicant clearly outlines how PCAF research activities will be incorporated into their existing AFRPS framework and program. The applicant describes the capability, commitment and availability of program staff to work with FDA and other agencies to conduct future revisions to the AFRPS, which will include researching, identifying and incorporating PCAF related best practices for regulatory programs and quality improvement elements (such as training plan, inspection protocol elements, audit criteria, etc.) into the existing AFRPS framework.

Infrastructure Development (20 Points)

Demonstration the PI has the education and experience commensurate with the scope of the project and adequate personnel have been identified to support the project. Demonstration the equipment and materials are reasonable and necessary for this scope of work. The application addresses retention issues and provides a strategy to ensure sustainable staffing for program activities.

Training Program Development (20 Points)

Application clearly outlines development of a training program for CGMP and PC inspectors. Demonstration applicant's existing training plan that promotes a sustainable training model. Demonstration of plans for hiring qualified training staff to implement a regulator training program. Demonstration of plans to collaborate with FDA to determine coursework or other training needs and requirements. Demonstration of plans to develop an audit program.

Animal Food CGMP and PC Inspection and Compliance Program Coordination and Development (30 Points)

Demonstration that the program has provisions equivalent or equivalent-in-effect to 21 CFR Part 507, and specific plans (if any) for conducting CGMP and PC inspections under State authority. The applicant demonstrates they are conducting CGMP and PC inspections of animal food facilities under contract for FDA, at levels that indicate significant commitment to perform and build capacity for CGMP and PC regulatory work under 21 CFR Part 507, and especially for FDA animal food safety contract CGMP and PC inspections. Or if not, have they committed in writing to conduct inspections by the end of funding year 2 of this cooperative agreement, and beyond, at levels appropriate to the facility inventory and workload for CGMP and PC inspections for the state/FDA ORA Division. (For example, by then end of funding year 2, the state program plans to perform enough CGMP and PC animal food inspections under the FDA contract to equal at least 10% of the annual FDA workplan for animal food, for the ORA division. Then after funding Year 2, the state program plans to perform enough CGMP and PC animal food inspections under the FDA contract to equal at least 15% of the annual FDA workplan for animal food, for the ORA division.)

Demonstration that adequate personnel been identified to receive training, or have already received training, and conduct CGMP and PC inspections of animal food facilities. Demonstration the applicant has support from their department/agency leadership. Is an appropriate portion of the award funds planned to hire new/existing personnel for the purposes of CGMP and PC training and inspection work?

Demonstration the applicant is committed to evaluating and improving regulatory activities to ensure actionable work products. Demonstration the applicant is committed to sharing work planning information and collaborating with FDA for inspections, including firm inventory and risk categorization data.

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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) 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, this FOA, and Notice of Award.

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

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 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 awardee 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. Substantive involvement may include, but is not limited to, the following:

The Grants Project Team may utilize the grantee's progress reports, site visits, audit reports, FDA animal 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
  • 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;
  • FDA hosting annual face-to-face meetings for programs enrolled in the AFRPS, and participating in the meetings with awardees.
  • FDA conducting 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 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 conducting visits and verification audits to verify grantee progress in achieving implementation of the AFRPS; and
  • FDA assistance in coordinating multi-program pilot projects.

An FDA Technical Advisor(s) will be assigned to each enrolled program. The Advisor will work cooperatively with the PO 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;
  • Actively monitor the supported program via telephone conversations, webinars, e-mails, written correspondence, or periodic site visits;
  • FDA hosting annual face-to-face meetings for programs enrolled in the AFRPS, and participating in the meetings with awardees.
  • FDA conducting technical sessions with the grantee, as deemed necessary by FDA.
  • FDA hosting monthly (or at a frequency chosen by FDA) conference calls/webinar meetings with all programs enrolled in the AFRPS.
  • FDA assistance in the sharing of information developed by the grantee and collaboration to achieve implementation of the AFRPS with other programs enrolled in the AFRPS in addition to FDA and other federal agencies. Examples may include SOPs, MOUs, training programs, and record keeping systems.
  • Convene trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing;
  • Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;
  • 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 conducting visits and verification audits to verify grantee progress in achieving implementation of the AFRPS; and
  • FDA assistance in coordinating multi-program pilot projects.

Additionally, other FDA Operational Divisions or Centers (such as the ORA program division assigned to the region for the awardee) are expected to have program involvement as described below including but not limited to the following:

  • FDA in coordination with the participating State agency will schedule an annual meeting(s) (or more frequently if needed) to discuss (PC Funding Option only):
  • Work planning as it relates to CGMP and PC regulatory activities,
  • Enforcement strategies,
  • Classifying risk assessments and sharing inventories for CGMP and PC facilities, and
  • Auditing of State personnel under Phase 2 or 3 as defined in FMD-76.
  • FDA in coordination with the participating State agency will schedule one additional meeting during the second or third quarter of the performance period as mentioned and discussed above during the annual meeting to review the progress and ensure outputs are being satisfactorily met.

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.

The purpose of this cooperative agreement is to advance efforts for a nationally integrated animal food safety system by assisting State animal food regulatory programs to achieve and maintain full implementation of the AFRPS. The AFRPS are intended to ensure that State animal food regulatory programs develop and maintain best practices for a high-quality regulatory program. The cooperative agreements will provide funding for additional personnel, equipment, supplies, and training to support activities related to achieving implementation of the AFRPS.

The grantee must maintain an animal food safety inspection contract with the FDA throughout the cooperative agreement. Key personnel (minimum of 2) will attend a required annual face-to-face meeting and any required training (as determined by FDA/OP) as a condition of the award. Facilities, work, and training reimbursed under the FDA animal food safety inspection contract and other funding mechanisms must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, as well as sub-contractor and/or primary servicing laboratory expenditures, under the animal food safety inspection contracts and other funding mechanisms and these cooperative agreements. Future funding will be dependent on recommendations from the Project Officer. The scope of the recommendation will confirm that acceptable progress has been made in achieving implementation of the AFRPS, continued compliance with all FDA regulatory requirements, and, if necessary, a corrective action plan has been implemented.

If the grantee is located in a state with a supporting laboratory that receives funding under an active FDA cooperative agreement for animal food sample analyses or other purposes (e.g., Laboratory Flexible Funding Model), the regulatory program grantee will provide for the collection of samples (FDA regulated animal food only) to support laboratory capacity development and product surveillance. The applicant must also demonstrate the ability to perform appropriate enforcement or other follow-up activities based on sample results. Sampling plans will be developed in cooperation with the laboratory to support the objectives of both programs. Ideally the primary servicing laboratory will support the awardee with report data to demonstrate progress in achieving the project goals listed, as applicable. Continued funding may be subject to adequate program support toward other FDA Cooperative agreements that support laboratory accreditation, testing, method development, and/or other relevant Initiative.

To apply for this Cooperative Agreement PC Funding Option, the State animal food program must be performing Animal Food CGMP and PC inspections under the FDA animal food safety inspection contract, by the end of funding year 2 of this Cooperative Agreement.

Continued funding for this cooperative agreement funding option for awards for funding years 3, 4, and 5 are subject to the execution and completion of contract work according to the terms and conditions of this cooperative agreement.

States are strongly encouraged to begin or increase the amount of inspections performed under the state's authority once their contract has reached 15-20% of the planned FDA Animal Food PC inspections for their State.

Award and Continued funding for the PC funding option under this cooperative agreement is subject to the condition that 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 and agree to work cooperatively with FDA.

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

Reporting

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 animal food program personnel.

3. Certification of current State appropriation funding levels for the State animal food regulatory program.

4. Submission of the following documents in the most current version of the AFRPS. These documents must be current and fit for use.

Appendix 1.1 or alternate form that is equivalent

Appendix 2.1 or alternate form that is equivalent

Appendix 3.1 or alternate form that is equivalent

Appendix 4.1, 4.3, 4.6, 4.8, 4.10, 4.11 or alternate forms that are equivalent

Appendix 5.1 or alternate form that is equivalent

Appendix 6.1 or alternate form that is equivalent

Appendix 7.1 or alternate form that is equivalent

Appendix 8.1 or alternate form that is equivalent

Appendix 9.1, 9.2, and 9.3 or alternate forms that are equivalent

Appendix 10.1 or alternate form that is equivalent

Appendix 11.1 or alternate form that is equivalent

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

1. An improvement plan that accurately reflects when specific objectives and tasks have been, or will be, completed and/or implemented and when new objectives and tasks are identified to achieve full implementation of the AFRPS. Progress achieved should indicate full implementation of the AFRPS can be expected by completion of Year 5. Review and update improvement plan(s) on an annual basis. Documentation related to the evaluation and improvement plan(s) should be maintained.

Submission of an improvement plan will include the following at the minimum to demonstrate program advancement in achieving implementation of the AFRPS:

  • The individual element or documentation requirement for the Standard that was not fully met.
  • Improvements needed to fully meet the program element or documentation requirement(s) of the Standard.
  • Lists of individual tasks that will be used to address the improvement
  • Projected and actual completion dates for each task

Note: For programs with less than 12 months of enrollment in the AFRPS, this information will be required after 12 months of enrollment in the AFRPS, with the annual progress report.

2. Description of program improvements and demonstration of measurable implementation of the AFRPS.

Note: For programs with no previous enrollment in the AFRPS, this information will not be required until Year 2.

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

Additional reporting requirements: For programs with less than 12 months of enrollment in the AFRPS, submission of the baseline self-assessment, including applicable appendices, worksheets, and other documents required for each Standard, or equivalent alternate forms, and an improvement plan is required to be submitted after 12 months of enrollment in the AFRPS, with the first annual progress report.

PC Funding Option: For programs awarded under the PC funding option, the following reporting elements must be submitted with the Annual report, and progress on all outputs and objectives of this funding option must be summarized in the mid-year and annual progress reports:

1. List of all active animal food facilities, including the facility's risk categorization

2. Copy of the improvements (identified during the evaluation) to the program training plan to address data acceptability issues and evidence development

3. Report on progress to implement an audit program, including Phase 2 and 3 audits under FMD-76

*NOTE: Additional Reporting templates may be developed and made available for grantees to use after awards are made, in order 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, to sustain implementation of the AFRPS (current and future versions). An independent audit of the program by FDA should verify the program is in implementation of the AFRPS.

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.

The evaluation of performance includes, but is not limited to: technical meeting and annual face-to face meeting attendance and participation, implementation progress of the AFRPS according to the work and schedules identified in the application and improvement plan submissions, verification of implementation progress through FDA verification audits, responsiveness to FDA, conference call participation, and the general progress of the cooperative agreement deliverables as determined by FDA. Continued funding each funding year is subject to implementation status based on review of program reports and documentation, and verification audit findings.

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 animal food program personnel.

3. Certification of current State appropriation funding levels for the State animal food regulatory program.

4. Submission of the following documents in the most current version of the AFRPS. These documents must be current and fit for use.

Appendix 1.1 or alternate form that is equivalent

Appendix 2.1 or alternate form that is equivalent

Appendix 3.1 or alternate form that is equivalent

Appendix 4.1, 4.3, 4.6, 4.8, 4.10, 4.11 or alternate forms that are equivalent

Appendix 5.1 or alternate form that is equivalent

Appendix 6.1 or alternate form that is equivalent

Appendix 7.1 or alternate form that is equivalent

Appendix 8.1 or alternate form that is equivalent

Appendix 9.1, 9.2, and 9.3 or alternate forms that are equivalent

Appendix 10.1 or alternate form that is equivalent

Appendix 11.1 or alternate form that is equivalent

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

1. An improvement plan that accurately reflects when specific objectives and tasks have been, or will be, completed and/or implemented and when new objectives and tasks are identified to achieve full implementation of the AFRPS. Progress achieved should indicate full implementation of the AFRPS can be expected by completion of Year 5. Review and update improvement plan(s) on an annual basis. Documentation related to the evaluation and improvement plan(s) should be maintained.

Submission of an improvement plan will include the following at the minimum to demonstrate program advancement in achieving implementation of the AFRPS:

  • The individual element or documentation requirement for the Standard that was not fully met.
  • Improvements needed to fully meet the program element or documentation requirement(s) of the Standard.
  • Lists of individual tasks that will be used to address the improvement
  • Projected and actual completion dates for each task

Note: For programs with less than 12 months of enrollment in the AFRPS, this information will be required with the annual progress report.

2. Description of program improvements and demonstration of measurable implementation of the AFRPS.

Note: For programs with no previous enrollment in the AFRPS, this information will not be required until Year 2.

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

Additional reporting requirements: For programs with less than 12 months of enrollment in the AFRPS, submission of the baseline self-assessment, including applicable appendices, worksheets, and other documents required for each Standard, or equivalent alternate forms, and an improvement plan is required to be submitted with the first annual progress report.

PC Funding Option: For programs awarded under the PC funding option, the following reporting elements must be submitted with the Annual report, and progress on all outputs and objectives of this funding option must be summarized in the mid-year and annual progress reports:

1. List of all active animal food facilities, including the facility's risk categorization

2. Copy of the improvements (identified during the evaluation) to the program training plan to address data acceptability issues and evidence development

3. Report on progress to implement an audit program, including Phase 2 and 3 audits under FMD-76

*NOTE: Additional Reporting templates may be developed and made available for grantees to use after awards are made, in order 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, to sustain implementation of the AFRPS (current and future versions). An independent audit of the program by FDA should verify the program is in implementation of the AFRPS.

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)

Isaiah Isakson
Food and Drug Administration (FDA)
Telephone: 406-465-9363
Email: isaiah.isakson@fda.hhs.gov

Objective Review Contact(s)

Gordana Zuber
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 301-348-1747
Email: gordana.zuber@fda.hhs.gov

Financial/Grants Management Contact(s)

Gordana Zuber
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 301-348-1747
Email: gordana.zuber@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 1004 of the Food and Drug Administration

Amendments Act of 2007 (21 USC 2104), Section 301(a) of the Public Health Service Act as amended (42 USC 241), and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.