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

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

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

An intergovernmental organization, FAO has 191 Member Nations, two associate members and one member organization (the European Union). FAO's stated goals include achieving food security for all, to make sure people have regular access to enough high-quality food to lead active, healthy lives. FAO's stated mandate is to raise levels of nutrition, improve agricultural productivity, better the lives of rural populations and contribute to the growth of the world economy.

FAO's stated activities comprise four main areas:

Putting information within reach: FAO represents that it serves as a knowledge network. The organization indicates that it uses the expertise of its staff - agronomists, foresters, fisheries and livestock specialists, nutritionists, social scientists, economists, statisticians and other professionals - to collect, analyze and disseminate data that aid development.

Sharing policy expertise: FAO represents that it lends its years of experience to member countries in devising agricultural policy, supporting planning, drafting effective legislation and creating national strategies to achieve rural development and hunger alleviation goals.

Providing a meeting place for nations: As a neutral forum, experts from around the globe convene at headquarters or in field offices to forge agreements on major food and agriculture issues.

Bringing knowledge to the field: FAO represents that it provides the technical know-how and mobilizes and manages millions of dollars provided by industrialized countries, development banks and other sources to make sure the projects achieve their goals.

Capacity Development is a core function highlighted in FAO s new strategic framework. Member Countries place strong emphasis on FAO enhancing delivery in this area as the Member Countries recently approved the Corporate Strategy on Capacity Development. FAO indicates that the Strategy was developed in consultation with Member Countries and all FAO units worldwide. FAO further indicates that taking a corporate approach to Capacity Development allows FAO to learn from its collective efforts and to support Member Countries in their own Capacity Development activities. FAO represents that the new FAO Capacity Development framework will guide FAO staff and their partners in analyzing capacities in Member Countries and identifying the appropriate intervention(s) for fostering sustainable development.

FAO represents that it supports member countries in developing their capacities to effectively manage food safety and quality as well as land and water as a key step to safeguarding the health and well-being of people as well as to accessing domestic, regional and international markets. Capacity Development in Food Safety and Quality and Land and Water is the process through which relevant stakeholders from farm to table (including government agencies, food enterprises, academia and consumers) are able to better perform their functions and to assume their responsibilities in ensuring safety and quality of food for domestic consumption and export.

For the Food Safety and Quality Unit (AGN) within FAO, the stated overall goal is to improve systems of food safety and quality management, based on scientific principles, that lead to reduced foodborne illness and support fair and transparent trade, thereby contributing to economic development, improved livelihoods and food security. FAO states that this unit:

1 - Provides independent scientific advice on food safety and nutrition which serves as the basis for

international food standards

2 - Develops institutional and individual capacities for food control and food safety management in

many countries, including the management of food safety emergencies

3 - Supports processes for the development of food safety policy frameworks

4 - Facilitates global access to information and encourages and supports the development of food

safety/quality networks.

While the specific projects to be undertaken under this cooperative agreement will be determined following the agreement entering into force, examples of the types of food safety projects of interest to FDA that could be undertaken by the FAO include the following: Development of policy support tools to guide planning and investment in national food control systems; provision of technical advice for the development and improvement of integrated and modern food control systems; enhancement of effective participation in the work of the Codex Alimentarius Commission and other international fora; addressing emerging food safety issues; and development of technical tools and guides related to various technical and managerial aspects of food control. In addition to the aforementioned types of projects, FDA would also be interested in supporting nutrition projects through this Agreement. Examples of such projects include the FAO’s Nutrition Education and Communication (NEAC) project focusing on professional education, as well as assistance with countries seeking to develop effective food-based dietary guidelines.

With an increasingly diverse and complex global food supply, FDA’s interest is to strengthen food safety systems globally to prevent food safety problems rather than merely reacting to problems after they occur. FDA recognizes that it can t do this alone. By leveraging other WTO member countries and partnering with the FAO, the FDA can broaden the reach of food safety capacity building efforts.

This Cooperative Agreement will allow FDA to deepen its international food safety capacity building partnerships, provide a wider scope of impact than exists currently and leverage resources with other countries.

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

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

Eligibility is limited to the Food and Agriculture Organization (FAO).

Competition is limited to the FAO because, as a global organization with a well-established, trusted presence, access to 191 member nations and an ability to coordinate capacity building programs at a regional and international level, FAO is uniquely qualified to further the global food safety capacity building objectives of this cooperative agreement. This ability to advance the objectives of this cooperative agreement through Member Country engagement and leveraging is a requisite for success.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

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

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

Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed.

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

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

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.

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.

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

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

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

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

• For field 4. a. Federal Identifier - The Federal Identifier is required. Include only the IC and serial number of the previously assigned award number e.g., use FD005037 from 5U01FD005037-10).
• For field 8. TYPE OF APPLICATION - applicant must mark 'RENEWAL'

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

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

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

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

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
• Indirect/F&A costs under grants to foreign and international organizations will be funded at a fixed rate of 8 percent of modified total direct costs (MTDC), exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. (With the exception of the American University of Beirut and the World Health Organization, which are eligible for full F&A cost reimbursement). Awards to domestic organizations with a foreign or international consortium participant may include 8 percent of MTDC, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

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

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

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

Research Strategy: The Research Strategy should include a brief Progress Report that summarizes Progress to Date and accomplishments achieved during the current funding period. The Progress Report should include a summary of the specific aims of the previous project period and the importance of the findings, progress made towards achievements, explanation on any significant changes to the specific aims and any new directions.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

Foreign (non-U.S.) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions.

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

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

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

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

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

This initiative is not subject to intergovernmental review.

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement and 45 CFR 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

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

Does the project address an important problem or a critical issue? If the aims of the project are achieved, how will scientific knowledge and technical capability be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the collaborators and their staff well suited to the project? Do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative, do the collaborators have complementary and integrated expertise? Is their leadership approach, governance and organizational structure appropriate for the project?

Does the application challenge and seek to shift current paradigms by utilizing novel concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel in a limited sense or novel in a broad sense? Is a refinement, improvement, or new application of concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the collaborators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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.

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

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

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

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

Not Applicable

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

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

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

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

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

As part of the objective review, all applications:

• Will receive a written critique.

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

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

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

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

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: For projects that involve Human Subjects and/or Clinical Trials Research, Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.

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

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

Should the applicant organization successfully compete for an award, 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 (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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

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

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

Termination provisions in 2 CFR 200.340(a)(1-4) are applicable to awards issued under this Notice of Funding Opportunity.

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

Reporting Requirements:

All FDA grants require both Financial and Performance reporting.

Financial Reporting:

A. Financial Expenditure Reports

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

Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. If a grant is under expanded authorities, the grantee must indicate the carryover amount in Section 12. Remarks of the annual FFR.

Performance Progress Reporting:

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

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

Salary Caps:

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

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

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

Recipients 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.

Recipients 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). Recipients are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).

Acknowledgment of Federal Support:

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

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

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

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

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

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

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

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

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

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

Prior Approval:

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

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

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

1. Change in Grantee Organization

2. Significant Rebudgeting

3. Change in Scope or Objectives

4. Deviation from Terms and Conditions of Award

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

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

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

Audits and Monitoring:

Audit Requirements:

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

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

3. For-profit and foreign entities can email their audit reports to AuditResolution@hhs.gov or mail them to the following address:

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

Monitoring:

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

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

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

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

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

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

Financial Conflict of Interest (FCOI):

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

Closeout Requirements (when applicable):

A Final Research Performance Progress Report (FRPPR), Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 120 days after the expiration date of the project period. All closeout documents must be submitted electronically in eRA Commons.

The Final Federal Financial Report (FFR SF-425), must be submitted in PMS and indicate the exact balance of unobligated funds and may not reflect unliquidated obligations. There must be no discrepancies between the Final FFR expenditure data and FFR cash transaction data in the Payment Management System (PMS). The expended funds reported on the Final FFR must exactly match the disbursements and the charge advances in PMS. It is the recipient's responsibility to reconcile reports submitted to PMS and to the FDA.

Program Income:

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

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

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

Treatment of Program Income:

Prohibition on certain telecommunications and video surveillance services or equipment:

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

(1) Procure or obtain,

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

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

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

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

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

Other:

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

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

You must administer your project 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 (including gender identity, sexual orientation, and pregnancy). This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/providerobligations/index.html and https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

• You must take reasonable steps to ensure that your project provides meaningful access to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals, see https://www.hhs.gov/civilrights/for-individuals/special-topics/limited-english-proficiency/fact-sheetguidance/index.html and https://www.lep.gov.
• For information on your specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and taking appropriate steps to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sexdiscrimination/index.html.
• For guidance on administering your project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscienceprotections/index.html and https://www.hhs.gov/conscience/religiousfreedom/index.html.

FDA acknowledges that, as a specialized agency of the United Nations, FAO is not subject to any national restrictions or prohibitions on procurement, including U.S. prohibitions on procurement of 'covered telecommunications and video surveillance services or equipment' as referred to in Section III, and its procurement activities are carried out impartially and without any form of discrimination to support the best interests of the Organization .

1. In recognition of FAO’s status as an international organization, FAO shall be responsible for administering the Notice of Award (NOA) in accordance with its rules and regulations. The parties acknowledge the existence of the terms and conditions set forth in Section III -- TERMS AND CONDITIONS U01FD005037 above in the Notice of Award (NoA). Without prejudice to its status as international organization and to its privileges and immunities, FAO will undertake all reasonable efforts to accommodate the terms and conditions set forth in Section III above in the NoA. Notwithstanding the foregoing, in case of conflict or overlap between Section III and Section IV of the NoA, Section IV shall prevail.

2. Should FDA or FAO become aware of any conflicts between FAO’s administration of the funds and the applicable grant regulations issued by the US Department of Health and Human Services (HHS) and/or U.S. laws, the parties shall notify one another and make reasonable efforts to find a mutually acceptable compromise solution.

3. Payment under this award will be made through the U.S. Department of Health and Human Services Payment Management System (DHHS). Recipient should request funds based on immediate disbursement requirements and disburse funds as soon as possible to minimize the Federal cash on hand in accordance with the policies established by the U.S. Treasury Department. FDA is not responsible for reimbursing the recipient for expired funds due to lack of periodic submission of voucher/invoices for payment. Future recommended support will be dependent on successful performance, and the availability of funds.

4. Cooperative Agreement: The administrative and funding mechanism used for this program is cooperative agreement, an "assistance" mechanism in which substantial FDA programmatic involvement with the recipients is anticipated during the performance of the activities.

5. Under the cooperative agreement, FDA's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project, although specific tasks and activities may be shared among the recipients and FDA as defined below.

a. All recipients are required to participate in a cooperative manner with FDA.

6. Principal Investigator(s) (PI)/Program Director (PD) will have primary responsibility for the following:

7. The Principal Investigator (PI)/Program Director (PD) will have responsibility for the scientific, technical, and 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. This individual will work closely with designated officials within the recipient organization to prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other organizational requirements.

8. The recipient is responsible for submitting interim progress reports (e.g. at specified intervals), when requested, to the FDA Project Officer (PO) and the Grants Management Specialist (listed as contacts on the Notice of Grant Award) including summary data on progress to date.

9. The recipient is responsible for obtaining approval for the development and design of FDA projects prior to execution.

10. The FDA, through the PO, will have access to methodologies and training tools, as well as report cleared for public dissemination, generated under this Cooperative Agreement and may periodically review these as well as progress reports two times a year. The FDA PO may use information obtained from these for the preparation of internal reports on the activities of the award.

11. An FDA PO with scientific/technical expertise and other members of the FDA staff will be closely associated with the implementation of the activities funded under this award, as described below:

a. The responsibilities of the PO include consultation during conduct of the activity, including on methodological approaches.

b. FDA program staff will arrange to have professional scientific and administrative personnel working in collaboration with the recipient as agreed with the Principal Investigator/Program Director.

12. Collaborative Responsibilities:

a. As relevant, the PD/PIs and the PO will work collaboratively in evaluating the most appropriate research topics, methods, data quality control strategies, safety issues, study design and implementation, data analysis and interpretation, publication and dissemination of study results. Projects require FDA approval prior to implementation/initiation.

b. During performance of the award, the PO, with assistance from other scientific program staff, designated by FDA based on their relevant expertise, may provide appropriate assistance, advice and guidance. The role of the PO will be to facilitate and not to direct the activities.

c. As appropriate, the FDA will work collaboratively with FAO to identify and coordinate training, professional development and training-related scientific exchange opportunities.

13. Dispute Resolution Process:

a. Any dispute between FDA and FAO arising out of the interpretation or execution of this award shall be settled by mutual consultations between the Parties, and shall be governed by general principles of law, to the exclusion of any single national system of law.

14. Intellectual Property Rights:

All intellectual property rights, including copyright, in work performed and outputs produced under projects pursuant to this Arrangement will be vested in FAO, including, without any limitations, the right to use, publish, translate, sell and distribute, distribute, privately or publicly, any item or part thereof. FAO supports the principle of open access publishing and undertakes to ensure the immediate and maximum dissemination of information and publications produced under projects pursuant to this Arrangement. FDA will have the right to use and distribute any item or part thereof for public and non-commercial purposes, provided that such use is compliant with the terms and conditions applicable to peer-reviewed publications and other such products referred to in Progress Reports section of this Special Programmatic Terms and Conditions. Information and publications emanating from specific projects that involve third party intellectual or financial contributions may be subject to separate publishing agreements. Neither FAO nor FDA will use the emblem or logos of the other Party without that Party’s prior written consent.

15. Cost Principals:

a. Facilities and Administrative (F&A) Costs. With the exception of American University of Beirut and the World Health Organization, full F&A costs will not be allowed. However, FDA provides limited F&A costs (8 percent of total direct costs less only equipment) to foreign institutions and international organizations to support the costs of compliance with FDA requirements. Some examples of FDA compliance requirements are the protection of human subjects (including the required education in the protection of human research participants), animal welfare, and invention reporting, other post-award reporting requirements, financial conflict of interest and research misconduct. Note, these are just a few representative examples of compliance requirement; this list is not all inclusive. FDA will not support the acquisition of, or provide for depreciation on, any capital expenditures, or support the normal, general operations of foreign and international organizations. These expenses should not be requested as a Direct Cost budget expense. Note the reference to capital expenditures for the purposes of allowable F&A costs do not include purchases of equipment. Equipment is still allowable as a direct cost. Since the F&A costs are intended for compliance costs only, other items normally considered an F&A cost can be requested as a direct cost, e.g. rent.

b. Within the total budget, 7 (seven) percent of the total direct costs may be spent on administrative costs incurred by FAO.

16. Data Sharing:

a. In addition to sharing data and research resources with the research community, upon request of the FDA, the recipient also must provide a copy of documents or a sample of any material developed under an HHS grant award as long as such material is cleared for public distribution. The recipient may charge a nominal fee to cover shipping costs for providing this material.

17. Income earned from these charges must be treated as program income.

18. Organizations that believe they will be unable to comply with these requirements should promptly contact the Grant Management Office (GMO) to discuss the circumstances, obtain information that might enable compliance, and reach an understanding in advance of an award.

19. Audit and Records:

a. The recipient agrees to furnish the U.S. Government (USG) with a final report on activities carried out under the award, including accounting for award funds in sufficient detail to enable the U.S. Food and Drug Administration (USFDA) to liquidate the award. The report must be submitted to the address specified in the award.

b. It is understood that financial records, including documentation to support entries on accounting records and to substantiate charges against the award, will be maintained in accordance with the recipient’s usual accounting procedures, which must follow generally accepted accounting practices. The recipient must maintain such financial records for at least three years after the recipient’s final disbursement of funds under the award.

c. FDA and the recipient confirm that the award account will be audited applying established procedures under appropriate provisions of the financial regulations and rules of the Food and Agriculture Organization of the United Nations and that the audit requirements set out in 45 CFR Part 75 are not applicable. The recipient agrees to make available these audit reports to the USG and other related Information as agreed upon by the parties. In exceptional circumstances, at USFDA's request, FAO shall request its Finance Committee to request its External Auditor to perform a special examination of the accounts, records, and statements of a project covered by the award, of such scope as FAO, in consultation with USFDA, shall specify, provided that the costs of such special examination are covered by USFDA or the project itself.

20. Allowable Costs:.

a. Without prejudice to the privileges and immunities enjoyed by FAO, the recipient will be reimbursed for costs incurred in carrying out the purposes of this award, which are reasonable, allocable, and allowable.

(1) Reasonable means those costs that do not exceed those that would ordinarily be incurred by a prudent person in the conduct of normal business.

(2) Allocable means those costs that are reasonable and allocable, and that conform to any limitations set forth in this award.

(3) Allowable means those costs that are reasonable and allocable, and that conform to any limitations set forth in this award.

b. The recipient is encouraged to obtain the FDA PO’s written determination as to whether the cost will be allowable before incurring a questionable or unique cost.

21. Budget Control: Recipients must be able to compare actual expenditures or outlays with the approved budget.

22. Cash Management:

a. Recipients must have procedures for minimizing the time elapsing between the transfer of any advance payments of funds under the award and disbursement of the funds for direct program costs and the proportionate share of any allowable indirect or facilities and administrative costs. Recipients must ensure that the timing and amount of any payments to sub-recipients under the award conform to this standard.

23. Refunds:

a. If the recipient earns interest on Federal advances before expending the funds for program purposes, the recipient must remit the interest annually to FDA through the same way as paid. Interest amounts up to $250 per year may be retained by the recipient for administrative expenses.

b. Funds obligated by FDA but not disbursed to the recipient before the award expires or is terminated will revert to FDA, except for funds committed by the recipient to a legally binding transaction applicable to this award.

c. If, at any time during the life of the award, or as a result of final audit, it is determined, in consultation with the recipient, that FDA funds provided under this award have been expended for purposes not in accordance with the terms of this award, the recipient must refund such amount to FDA.

24. Progress Reports:

a. Each recipient (parent and sub-recipients) must submit progress reports by the due dates and/or frequency as jointly agreed with the PO. A performance progress report must compare actual to planned performance and indicate the progress made in accomplishing each assistance award task. The report should include relevant details for assessing the progress made, as well as any specific tasks which are not progressing according to plan; the reasons for the difficulty; specific recommendations for remedial action; and the associated costs. Recipients must relate financial information to performance data and compare costs against budgeted amounts. FDA will accept estimates based on available documentation. Requests for extensions of reporting deadlines may be granted by the Grants Officer when the report(s) cannot be furnished in a timely manner for reasons legitimately beyond the control of the recipient.

b. An annual Non-Competing Continuation Progress Report is due with (or incorporated into the PHS 2590 application) no later than three (3) months prior to the next budget period start date. The report should provide information on all project activity outcomes in the current budget period. The PHS-FORM-2590/Non-competing Type-5 applications is available at http://grants2.nih.gov/grants/funding/2590/2590.htm

25.Financial Reporting:

a. Financial Expenditure Reports

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

Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended; the FFR should be submitted no later than December 30. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. Failure to submit timely reports may affect future funding.

The final FFR report is due 120 days after the end date of the project; for this award, the submission date is December 30.

Performance Progress Reporting:

a. Annual progress reports are required. The Annual Progress Report will be due as part of the Research Performance Progress Report (RPPR).

b. Grants with Multiple Years: When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR).

26. Sub-recipient reporting:

Each recipient is to determine their specific sub-recipient reporting requirements. Recipients are responsible for managing and monitoring each project, program, sub-award, function or activity supported by the award. Recipients must monitor sub-awards to ensure that sub-recipients have met the audit requirements as delineated in award.

27. Monitoring:

Recipients are responsible for monitoring sub-recipient activities and provide for their training needs, tracking progress toward objectives, and identifying challenges during the project period.

28. Procurement:

All procurements shall be made in accordance with FAO regulations, which shall conform to generally accepted principles of good procurement practice, and which shall include safeguards against corrupt and illegal practice. FAO shall include in the solicitations for equipment and services an assessment of potential sources of supply in the recipient country and other relevant developing countries. No offer, gift, consideration, payment or benefit of any kind, which would or could be construed as an illegal or corrupt practice may be accepted, either directly or indirectly, as an inducement or reward for the award or execution of procurement contracts. To this end, FAO shall ensure that it applies and enforces its relevant rules regarding corrupt and illegal practices.

FDA acknowledges that, as a specialized agency of the United Nations, FAO is not subject to any national restrictions or prohibitions on procurement, including U.S. prohibitions on procurement of 'covered telecommunications and video surveillance services or equipment' as referred to in Section III, and its procurement activities are carried out impartially and without any form of discrimination to support the best interests of the Organization

29. All formal correspondence reports regarding the grant should be signed by an authorized institutional official and the Principal Investigator and should be sent to the attention of the grants management specialist/officer, with a copy to the Project Officer via scanned electronic copy.

30. Modification and Termination:

a. FDA and FAO shall promptly inform each other of any event or situation which might affect the implementation of the Project and which may necessitate a modification or alteration of the scope, implementation, the agreed budget or other aspects of the award. In case any change occurs in the schedule or implementation of the project, FAO shall promptly inform the FDA Project Officer (PO).

b. Failure to comply with the above Standard Terms and Conditions could result in the suspension or termination of this grant project.

c. FDA may at any time, by providing upon three-month written notice given to FAO, terminate this award if major deviations from mutually approved plans and budgets occur or if reasonable doubt arises with regard to the proper use of funds under this award; if the project’s main objectives are endangered; if reports, information or records are not delivered as agreed and as set forth in Article 24 and 25; or if any circumstances occur which, in the opinion of FDA, impair significantly on the value of the project. FDA and FAO will consult on measures to resolve the problem and possible courses of action. In such an event, FDA may also modify or terminate its financial contribution to any project under this award. Before taking such a decision, FDA shall consult with FAO to rectify the shortfalls and take corrective actions in line with project. In the event of termination, the obligations already assumed by either Party shall remain in force to the extent necessary to permit orderly withdrawal of personnel, funds and assets, the settlement of accounts between the Parties and the settlement of any liability incurred by FAO for the activities covered by this award. FAO shall promptly remit any remaining funds after the settlement of accounts between the Parties to FDA.

31. Nothing in this Notice of Grant or in any document relating thereto, shall be construed as constituting a waiver of privileges or immunities of FAO, or as its acceptance of the jurisdiction of the courts of any country over disputes arising out of this Agreement.

32. The present Notice of Grant and any document or arrangement relating thereto shall be governed by general principles of law, to the exclusion of any single national system of law. Such general principles of law shall include the UNIDROIT General Principles of International Commercial Contracts 2016.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an acquisition mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the FDA as defined below.

1. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for and dominant role in planning, directing, and executing the proposed program, with the FDA staff being substantially involved as a partner with the PI.

The Principal Investigator will have primary responsibility for the financial management of program funds to adhere to the mission of the program as determined by the bilateral partnership.

Awardees will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.

1. A.2. FDA Responsibilities

An FDA Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The program project officer will monitor the grantee periodically. The monitoring may be in the form of telephone conversations, emails, or written correspondence between the project officer/grants management officer and the Principal Investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request, consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the grant, including those that state that future funding will depend on recommendations from the project officer. In addition,

a. FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee, as well as any collaborative structure between FAO and any other entities.

b. FDA will be directly involved in the guidance and development of the program and the collaborative structure for the program.

c. FDA scientists will participate, with the grantee, in determining and carrying out scientific and technical activities. Collaboration will also include data analysis, interpretation of findings and, where appropriate, co-authorship of publications.

Areas of Joint Responsibility include:

• No additional joint responsibilities, apart from those described above. All responsibilities are divided between awardees and FDA staff as described above.

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

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. FDA FOAs outline intended goals and objectives. Post award, FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR 75.301 and 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable 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 the threshold.

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

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

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

Finding Help Online: https://grants.nih.gov/support/index.html(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

Eric Stevens
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 240-402-3534
Email: Eric.Stevens@fda.hhs.gov

Kevin Robinson
Center for Food Safety and Applied Nutrition (CFSAN)
Division of Acquisition Support and Grants
Telephone: 240-402-2131
Email: kevin.robinson@fda.hhs.gov

Kiara Farmer
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-3099
Email: Kiara.Farmer@fda.hhs.gov

Kiara Farmer
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-3099
Email: Kiara.Farmer@fda.hhs.gov

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement, Notice of Award, and 45 CFR 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions .

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.