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

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP) is announcing the availability of a cooperative agreement to be awarded under a Limited Competition. FDA can guarantee one year of funding with the possibility of up to two years of additional, non-competitive support, dependent on performance and continued availability of federal funds. Only National Associations/Organizations representing State food regulatory programs as a primary purpose are eligible to apply for this funding opportunity.

A primary goal of the FDA/ORA's Cooperative Agreement Program is to facilitate long-term improvements to the national food safety system by strengthening interagency collaboration, improving States' regulatory and surveillance protection programs for manufactured foods, conducting research, and promoting the Manufactured Food Regulatory Program Standards (MFRPS). The FDA Food Safety Modernization Act (FSMA) gave FDA a new public health mandate. The law applies to human food as well as to food for animals, including pets. It directed FDA to establish standards for adoption of modern food safety prevention practices by those who grow, process, transport, and store food. Congress recognized that the more than 3,000 state, local, and tribal government agencies involved in food safety which must be fully integrated in FDA’s work to fulfill FSMA’s mandate that consumers be protected by a food safety system based on prevention and risk. This National Integrated Food Safety System will ensure the quality, consistency, and effectiveness of local, state, and federal efforts to protect the food supply.

Effective leveraging of resources and harmonization of efforts will require extensive cooperation and coordination with FDA, national organizations and initiatives, State and local regulatory programs, and other food safety stakeholders.

The Manufactured Food Regulatory Program Standards establish a uniform foundation for the design and management of State programs responsible for the regulation of food plants. The elements of the program standards describe best practices of a high-quality regulatory program. Conformance with these program standards will help Federal and State agencies better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods.

The primary objectives of this cooperative agreement are:

1) Assist FDA in meeting provisions of the FDA Food Safety Modernization Act;

2) Support the efforts of Federal, State, and local government agencies to build a National Integrated Food Safety System;

3) Establish systems for sharing, promotion, and collaboration of best practices, guidance documents, sampling plans, procedures, memorandums of understanding, and other tools to foster mutual reliance between Federal, State and local, manufactured food regulatory programs and public health agencies;

4) Assist FDA in the identification, development, delivery, promotion, and/or attendance of food safety and defense training programs to support conformance with the MFRPS, training and stakeholder support provisions of FSMA;

5) Support the advancement of the MFRPS and the Manufactured Food Regulatory Program Alliance (Alliance).

Specific activities of this cooperative should be:

1) Building an on-line program portal to serve as a learning exchange, subject matter expert registry, topical index of regulatory guidance, regulatory updates, and other information that impacts manufactured food regulatory programs.

2) Building a user community and support data management and exchange between FDA and state regulatory agencies to promote conformance with human and animal food regulatory program standards.

3) Providing forums to elicit, discuss and address concerns identified by State manufactured food regulatory programs relative to the MFRPS, food safety inspection contract, training, FSMA, and other activities impacting Federal-State relations.

4) Updating and continuous improvement of a web-based directory of State and local food protection officials for use by Federal, State, local, tribal and territorial regulatory agencies. Continuous improvement activities include expanding the directory to include new agencies and individual roles. The directory should be maintained in an electronic format that is publicly available. A system for maintaining the accuracy of the data should be developed and maintained. At minimum, semi-annual verification of data and updates is anticipated.

5) Providing support to the Manufactured Food Regulatory Program Alliance and other initiatives that advance an integrated public health system by:

- Supporting a committee structure environment and encouraging involvement from State food program managers to assist in technical guidance solutions, implementing changes, and increasing sharing of best practices for the Manufactured Food Regulatory Program Standards.

- Scheduling and hosting meetings (in-person and remote), establishing workgroups, recruiting members, recording meeting minutes, and other duties necessary to support the goals of the Alliance.

- Maintaining the official repository of all documents created by the Alliance, such as meeting minutes, by-laws, governance structure, suggested changes to the MFRPS, and position statements.

- Hosting of at least one annual face-to-face meeting (minimum of 3 days) to assist State and local manufactured food regulatory programs in achieving conformance with the MFRPS, including scheduling, meeting facilities, invitations, registration, materials, and AV needs and support. Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda. Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.

- Providing administrative support to the Rapid Response Teams (RRT) Program’s annual face to face meeting (minimum of 3 days), including scheduling, meeting facilities, invitations, registration, materials, AV needs, and on-site support during the meeting. Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda developed by the RRT Face to Face Meeting Planning Committee. Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.

6) Providing administrative support to other meetings the grantee identifies that will support the advancement of an integrated food safety system, including scheduling, meeting facilities, invitations, registration, materials, AV needs, and on-site support during the meeting. Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda developed in conjunction with FDA. Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.

7) Providing administrative support to other meetings the grantee identifies, such as those of the Partnership for Food Protection (PFP) and Food Protection Task Force Alliance, that will support the advancement of an integrated food safety system, including scheduling, meeting facilities, invitations, registration, materials, AV needs, and on-site support during the meeting. Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda developed in conjunction with FDA. Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.

8) Supporting the training needs for State and local regulatory program’s conformance with regulatory standards and best practices in human and animal food by:

• Identifying, developing, delivering, and/or promoting food safety and defense training programs to support conformance with the MFRPS and provisions of FSMA.
• Providing financial assistance to State and local food regulatory programs to attend manufactured food training courses and other meetings, as needed.
• Conducting research in the form of surveys of State and local food regulatory programs and performing data analysis to determine the capabilities and capacity of an Integrated National Food Safety System. The research should aim to quantify State and local food safety efforts, such as surveillance activities, regulatory actions pursued, and outbreak and emergency response activities. Information on the infrastructure of State and local manufactured food programs may also be collected and studied, such as program resources, funding streams, regulatory structures and authorities, IT support, licensing protocols, use of general funds, and training requirements. The grantee should anticipate performing at least 1 national survey including State and local food regulatory programs per budget period. This information will be important for establishing an Integrated Food Safety System that is better able to control foodborne disease.
• Developing task-oriented guidelines to address issues that can be adopted or referenced by manufactured food regulatory programs.

9) In support of FSMA, working with FDA to establish, participate, and promote operational partnerships that assist in building an Integrated National Food Safety System. Operational partnerships may include other national associations, alliances (such as the Seafood HACCP Alliance and Preventative Controls Alliance), PFP, and Food Protection Task Forces (FPTF).

10) Providing financial support for manufactured food regulatory programs to develop, host, or attend training courses, meetings, conferences, and other events that support building an integrated food safety system. Examples include the MFRPA meeting, RRT meeting, Seafood HACCP Alliance, and training courses that support conformance with the MFRPS. An application and approval process for subawarding of funds must be performed in collaboration with and approved by FDA.

11) Provide support and outreach to colleges and universities to promote career paths and experiential learning in regulatory affairs and sciences.

12) Provide support for advanced training or fellowship programs to promote experiential learning, applied research and mentorship in manufactured food regulation.

13) Establish a system for continuous improvement of all activities being performed under this cooperative agreement. The grantee should actively request feedback from State manufactured food programs on activities being performed under this cooperative agreement. The feedback solicited should then be used to identify future activities.

Other program objectives may be supported upon mutual agreement between FDA and the grantee.

Applicants are strongly encouraged to identify additional activities that will support the goals and objectives of this cooperative agreement. Baseline data, targets and performance measures for each activity should be included in the application. The applicant should also suggest the reporting criteria for each activity.

Historically, the food supply has encountered risks and emergencies of significant national concern. To provide safe food to consumers, efforts have been undertaken at all levels, including consumers, industry, regulators, and even international organizations, to identify and implement improvements to the food safety system.

- National Integrated Food Safety System

FDA continues to work with its partners to create a national, fully integrated food safety system that is characterized by effective communication and efficient processes among federal, state, and local partners in the food safety system.

Various initiatives, such as the Food Safety Task Force Program, Innovative Food Defense Program, and federal cooperative agreements, work to engage partners across multiple sectors of the food safety system to collaborate and identify means to improve and optimize the nation’s food safety system.

-The Partnership for Food Protection (https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives/partnership-food-protection-pfp) is a major driving force in the establishment of a national integrated food safety system.

- FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to protect public health by strengthening the food safety system. FSMA allows FDA to focus on the prevention of foods safety problems by providing new enforcement authorities and risk-based food safety standards. The expanded enforcement authorities include: mandatory recalls, expanded administrative detention, suspension of facility registration, enhanced product tracing abilities, and additional recordkeeping requirements for high-risk foods. FSMA also gives FDA new tools to hold imported foods to the same standards as domestic foods.

FSMA directs FDA to build an integrated national food safety system in partnership with State and local authorities, explicitly recognizing that all food safety agencies need to work together to achieve national public health goals. FSMA identifies some key priorities in working with partners in areas, such as: reliance on Federal, State, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and local food safety and defense capacities.

Full text of the law: http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

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.

• Nonprofits Other Than Institutions of Higher Education
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

This opportunity is only available to the following nonprofit food safety training entities that collaborate with 1 or more institutes of higher education:

National organization/associations whose membership includes, but is not necessarily limited to, state, local, territorial, and/or tribal regulatory manufactured food professionals or government agencies and who collaborate with one or more institutions of higher education as defined in 21 USC 399(b).

Competition is limited to these national organizations/associations for the following reasons:

National organizations/associations with membership that includes, but is not necessarily limited to, SLTT regulatory manufactured food safety professionals or government agencies will have the relationships and communication systems to effectively promote the objectives established under this cooperative agreement.

These national organizations/associations have a vested interest and share FDA’s visions to advance safety of manufactured foods and improve public health outcomes. These national organizations/associations can best collaborate with FDA.

These national organizations/associations can provide a platform for sharing information and national implementation of the projects through national and regional meetings, web sites, listservs, and other communications. Most national associations/organizations also have committees that may further advance the projects pursued by the subawardees.

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

Applicant Organizations

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

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

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

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

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

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

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

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

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

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

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.

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 to:

Gordana Zuber
Telephone: 301-348-1747
Email: [email protected]

A technical session will be held for prospective applicants in March 2021. 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.

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.

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.

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.

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

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.

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

This award may only be used for activities associated with achieving the goals and objectives of the cooperative agreement and work proposed by the grantee. Work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under this cooperative agreement must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures.

Non-allowable costs:

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

2. Vehicle purchases are not permitted.

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

4. Food may not be purchased.

Additional funding restrictions may be part of the Notice of Award

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

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

Significance (25 Points)

Does the project help support and enhance manufactured food regulatory programs, specifically through the activities of an association that will offer trainings, workshops, meetings, and other educational resources; conducting surveys; prepare best practices and other guidance manuals; and other activities to support manufactured food programs?

Investigator(s) (25 Points)

Are the PD(s)/PI(s), collaborators, and other key personnel well suited to the project? Do they have previous experience implementing effective training programs, hosting effective national meetings, communicating with state and local regulatory programs, experience with the MFRPS, and experience with advancing a national integrated food safety system and other integration efforts with Federal, state, and local regulatory programs?

Approach (25 Points)

Is the overall strategy appropriate to support and enhance manufactured food safety activities? Does the rationale and design meet the goals of the cooperative agreement?

Environment (25 Points)

Will the environment in which the work will be done contribute to the probability of success? Has the applicant demonstrated the ability to effectively work with Federal and State partners to implement the goals and objectives of the cooperative agreement?

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Not Applicable.

Not Applicable.

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.

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.

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

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

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

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

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

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

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

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

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

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

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

Reporting Requirements:

All FDA grants require both Financial and Performance reporting.

Financial Reporting:

A. Cash Transaction Reports

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

B. Financial Expenditure Reports

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

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

Performance Progress Reporting:

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

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

Salary Caps:

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

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

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

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

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

Acknowledgment of Federal Support:

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

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

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

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

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

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

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

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

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

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

Prior Approval:

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

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

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

1. Change in Grantee Organization

2. Significant Rebudgeting

3. Change in Scope or Objectives

4. Deviation from Terms and Conditions of Award

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

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

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

Audits and Monitoring:

Audit Requirements:

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

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

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

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

Monitoring:

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

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

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

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

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

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

Financial Conflict of Interest (FCOI):

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

Closeout Requirements (when applicable):

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

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

Program Income:

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

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

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

Treatment of Program Income:

Prohibition on certain telecommunications and video surveillance services or equipment:

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

(1) Procure or obtain,

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

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

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

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

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

Other:

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

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

Other:

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

Additional Reporting Requirements:

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

Financial

• A summary of funds awarded to State, local, territorial, and tribal attendees to attend, develop, or host manufactured foods training courses, meetings, and other initiatives to support Federal, State, and local integration efforts must be included with each mid-year and annual progress report.

Performance

• Mid-Year interim performance progress reports are required for this award. The interim performance progress reports should be submitted via email to the listed Grants Management Specialist and Program Official by October 31, for each budget period.

The interim mid-year performance progress report should include:

1. Data, analysis, and response rates of surveys conducted of State manufactured foods programs to date in the performance period.

2. A narrative of the progress made for each of the objectives and activities outlined in the application and agreed upon by the grantee and FDA in the preceding six months

3. Financial assistance provided to State, local, territorial, and tribal attendees to attend, develop, or host manufactured foods training courses, meetings, and other initiatives to support Federal, State, and local integration efforts.

All progress reports shall contain certain elements as applicable to their approved cooperative agreement and award. These elements include, but are not limited to, the following:

• Content, usage, and improvements to the on-line Manufactured Food State Program Manager’s portal and other collaboration sites, including the subject matter expert registry, topical index of regulatory guidance, regulatory updates, etc. statistics on baseline and current of these systems and feedback received should be included.
• Summary of issues elicited related to the implementation of MFRPS, FSMA, contracts, training and other issues impacting State and local manufactured food regulatory programs.
• Impact and recommendations from forums to address concerns identified by State and local manufactured food regulatory programs relative to the MFRPS, FSMA, MQSA, and other activities impacting Federal-State relations.
• Improvements and updates made to the web-based directory of State and local food protection officials for use by Federal, State, local, tribal and territorial regulatory agencies. The directory shall be maintained in an electronic format easily accessible to all interested parties and updated at least semi-annually. Statistics on baseline and current use of these systems should be provided. Feedback and opportunities for improvement should be identified.
• Status updates on the MFRPA and associated committees, including involvement from State and local food regulatory program managers, technical guidance provided, best practices shared, and changes recommended for the MFRPS. Updates should include meetings held, participants, summaries of issues discussed, decisions made, action items, and responsible parties.
• Summaries, outcomes, and evaluations of meetings (in-person and remote) held to support the goals of the Alliance and building an integrated food safety system, such as the annual MFRPA, PFP, and RRT meetings. The feedback solicited should be used to improve the quality of future meetings.
• Content, usage, and improvements to the MFRPA portal (or other platform for storing the official records generated for the MFRPA). Statics on baseline and current usage should be provided. Feedback and opportunities for improvement should be identified.
• Summary on the identification, development, and/or delivery of food safety and defense training programs to support conformance with the MFRPS and provisions of FSMA.
• Financial assistance provided to State, local, territorial, and tribal attendees to attend, develop, or host manufactured foods training courses, meetings, and other initiatives to support Federal, State, and local integration efforts.
• Data, analysis, and response rates of surveys conducted of State manufactured foods programs.
• Development and distribution of task-oriented guidelines to address issues that can be adopted or referenced by manufactured food regulatory programs.
• Support, outreach and involvement in operational partnerships that assist in building an Integrated Food Safety System.
• Mid-Year and Annual progress reports must report against the progress made for each of the objectives and activities outlined in the application and agreed upon by the grantee and FDA. The grantee and FDA will determine the specific progress reporting requirements within 90 days of the award.

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

The administrative and funding instrument used for this program will be the cooperative agreement, an assistance mechanism (rather than an acquisition mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, FDA’s objective is to support and stimulate the recipient’s activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role of activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardee for the project as a whole, although specific tasks and activities may be shared between the awardee and the FDA as defined below.

A. Cooperative Agreement--Project Director/Principal Investigator Rights and Responsibilities:

The Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA/ORA staff being substantially involved as a partner with the PD/PI, as described below.

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

B. Cooperative Agreement--FDA Responsibilities:

An FDA Program Official (PO) and an FDA Project Manager/Technical Advisor will be assigned and named in the Notice of Award. The FDA Program Official and Project Manager/Technical Advisor will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below:

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

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

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

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

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

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

7. Development of programs to meet the FDA mission;

8. Provision of programmatic technical assistance;

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

C. Monitoring Activities:

Periodic program monitoring will be conducted by FDA on an ongoing basis which may include telephone conversations and site visits between the Principal Investigator and FDA Staff assigned to the program. Monitoring also includes the review of written reports. The results of these monitoring activities will be recorded in the official cooperative agreement file and will be available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations. Also, the grantee organization shall comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the FDA Staff assigned to the program.

The scope of the recommendation shall confirm that:

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

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

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

The grantee of this cooperative agreement program will include FDA in the dissemination of all information, documents, processes, and procedures created under this agreement. Any information gathering activities conducted under this cooperative agreement program should be conducted in coordination with FDA, and the results of information gathering should be shared with the FDA.

Additional requirements may be listed in the Notice of Award.

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.

All progress reports shall contain certain elements as applicable to their approved cooperative agreement and award. These elements include, but are not limited to, the following:

• Content, usage, and improvements to the on-line Manufactured Food State Program Manager’s portal and other collaboration sites, including the subject matter expert registry, topical index of regulatory guidance, regulatory updates, etc. Statics on baseline and current of these systems and feedback received should be included.
• Summary of issues elicited related to the implementation of MFRPS, FSMA, contracts, training and other issues impacting State and local manufactured food regulatory programs.
• Impact and recommendations from forums to address concerns identified by State and local manufactured food regulatory programs relative to the MFRPS, FSMA, MQSA, and other activities impacting Federal-State relations.
• Improvements and updates made to the web-based directory of State and local food protection officials for use by Federal, State, local, tribal and territorial regulatory agencies. The directory shall be maintained in an electronic format easily accessible to all interested parties and updated at least semi-annually. Statistics on baseline and current use of these systems should be provided. Feedback and opportunities for improvement should be identified.
• Status updates on the MFRPA and associated committees, including involvement from State and local food regulatory program managers, technical guidance provided, best practices shared, and changes recommended for the MFRPS. Updates should include meetings held, participants, summaries of issues discussed, decisions made, action items, and responsible parties.
• Summaries, outcomes, and evaluations of meetings (in-person and remote) held to support the goals of the Alliance and building an integrated food safety system, such as the annual MFRPA, PFP, and RRT meetings. The feedback solicited should be used to improve the quality of future meetings.
• Content, usage, and improvements to the MFRPA portal (or other platform for storing the official records generated for the MFRPA). Statics on baseline and current usage should be provided. Feedback and opportunities for improvement should be identified.
• Summary on the identification, development, and/or delivery of food safety and defense training programs to support conformance with the MFRPS and provisions of FSMA.
• Financial assistance provided to State, local, territorial, and tribal attendees to attend, develop, or host manufactured foods training courses, meetings, and other initiatives to support Federal, State, and local integration efforts.
• Data, analysis, and response rates of surveys conducted of State manufactured foods programs.
• Development and distribution of task-oriented guidelines to address issues that can be adopted or referenced by manufactured food regulatory programs.
• Support, outreach and involvement in operational partnerships that assist in building an Integrated Food Safety System.
• Mid-year and annual progress reports must report against the progress made for each of the objectives and activities outlined in the application and agreed upon by the grantee and FDA. The grantee and FDA will determine the specific progress reporting requirements within 90 days of the award.

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

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

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

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

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

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

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

Suzanne Webb
Office of Regulatory Affairs (ORA)
Office of Management
Telephone: 240-402-3069
Email: [email protected]

Gerald J. Berg
ORA/Office of Partnerships
Telephone: 612-758-7183
Email: [email protected]

Gordana Zuber
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 301-348-1747
Email: [email protected]

Gordana Zuber
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 301-348-1747
Email: [email protected]

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

Awards are made under the authorization of section 1009 of the Federal Food, Drug, and Cosmetic Act (21 USC 399) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.