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 cooperative agreements to be awarded under Limited Competition to State, local, territorial, or tribal retail food regulatory programs. The intended outcome of the FOA is to advance efforts for a nationally integrated food safety system through the conformance with an advancement of the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS or Retail Program Standards). The VNRFRPS apply to the operation and management of a retail food regulatory program that is focused on the reduction of risk factors known to contribute to foodborne illness and the promotion of industry action to achieve active managerial control of these risk factors. The Retail Program Standards include nine individual Program Standards. Each Program Standard has one or more corresponding worksheets, forms and guidance documents.

While the Retail Program Standards represent a model of the effective, focused food safety program, they begin by providing a foundation and system upon which all regulatory programs can build through a continuous improvement process. The Retail Program Standards encourage regulatory agencies to improve and build upon existing programs. Further, the Retail Program Standards provide a framework designed to accommodate both traditional and emerging approaches to food safety. The Retail Program Standards are intended to reinforce proper sanitation (good retail practices) and operational and environmental prerequisite programs while encouraging regulatory agencies and industry to focus on the factors that cause and contribute to foodborne illness, with the ultimate goal or reducing the occurrence of those factors.

BACKGROUND

This funding opportunity furthers FDA's support of state, local, territorial, and tribal retail food safety programs. The purpose of this support system will be to assist these agencies in advancing efforts for a nationally integrated food safety system through research, planning, establishment, and/or enhancement of state and territorial retail food regulatory programs.

Recent legislative and strategic initiatives have addressed FDA's relationship with state, local, territorial and tribal authorities in retail food protection activities. Please visit http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/default.htm for more information.

a. Retail Food Safety Initiative

Announced in October 2010, the Retail Food Safety Initiative is part of the Food and Drug Administration’s overall prevention-based, farm-to-table food safety strategy to reduce foodborne illness. The FDA actions in this initiative are prompted by a 10-year study of more than 800 retail food establishments to determine compliance with five key risk factors in nine types of retail operations.

FDA's partnerships with the retail food industry; state, local, territories and tribal authorities; and other government agencies are a foundational building block of the initiative and key to its success in four action areas:

• Make the presence of certified food protection managers common practice.
• Strengthen active managerial controls at the retail level and ensure better compliance.
• Encourage widespread, uniform, and complete adoption of the FDA Food Code.
• Create an enhanced local regulatory environment for retail food operations.

To help create an enhanced local regulatory environment for retail food operations, FDA is committed to:

(1) Promoting wider implementation by state, local and tribal regulatory programs of the FDA Voluntary National Retail Food Regulatory Programs Standards;

(2) Ensuring universal participation by local regulators in consistent, high-quality training through increased access and increased portability and transferability of FDA courses; and

(3) Seeking increased multi-year funding for the state, local and tribal programs as part of an integrated food safety system.

b. Food and Drug Administration Amendments Act of 2007 (FDAAA)

Under section 1004 of FDAAA (21 U.S.C. 2104), the Secretary of the Department of Health and Human Services (which includes FDA) is required to work with the states to improve food safety.

Section 1004(a) of FDAAA (21 U.S.C. 2104(a)) states that the Secretary shall provide assistance to encourage states to:

(1) Establish, continue, or strengthen state food safety programs, especially with respect to the regulation of retail commercial food establishments; and

(2) Establish procedures and requirements for ensuring that processed produce under the jurisdiction of state food safety programs is not unsafe for human consumption.

This assistance to plan, develop, and implement such a food safety program may include:

(1) Advisory assistance;

(2) Technical assistance, training, and laboratory assistance; and

(3) Financial and other assistance (21 U.S.C. 2104(b)).

c. FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. It also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. These include authorities such as mandatory recall, expanded administrative detention, and suspension of facility registration. FSMA also gives FDA important 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 in an integrated way 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.

OBJECTIVES

When first enrolling in the Retail Program Standards, retail regulatory programs are encouraged to conduct a comprehensive self-assessment to identify program needs and then establish priorities to maximize the effectiveness of resources.

Post self-assessment, cooperative agreement funds shall be used to enhance or establish systems to:

a. Address gaps identified through the self-assessment process to achieve greater conformance with the Retail Program Standards;

b. Complete a risk factor study (or track routine inspection data) to identify the foodborne illness risk factors most in need of priority attention; and/or

c. Implement intervention strategies to reduce the occurrence of foodborne illness risk factors (Intervention strategies are defined as a comprehensive set of activities, initiatives, or specific tools implemented on the part of industry and/or regulators that are designed to bring about immediate and/or long-term control of foodborne illness risk factors).

The cooperative agreements that will be funded through this FOA are intended to develop, implement, and continuously improve the infrastructure and effectiveness of retail food programs using the VNRFRPS. Under the resulting cooperative agreements, state, local, territorial, or tribal jurisdictions will implement a continuous program improvement/enhancement strategy (action plan) using the VNRFRPS. The action plan will identify activities, timeframes, personnel and other resources required for implementation of the improvement/enhancement strategy. Funds may be utilized for a variety of activities and those allowable expenses are listed in Section IV.

OUTCOMES

The intended outcomes of the work provided under the resulting cooperative agreements are as follows:

1. Retail food regulatory programs demonstrate increased conformance by meeting part or all of standards criteria within the Retail Program Standards;

2. Retail food regulatory programs complete a risk factor study (or track routine inspection data) to identify the foodborne illness risk factors most in need of priority attention;

3. Retail food regulatory programs develop and implement intervention strategies to reduce the occurrence of foodborne illness risk factors in need of priority attention;

4. Retail food regulatory programs develop and implement training programs to ensure staff is adequately trained, able to train others, and/or standardized, in conformance with the Retail Program Standards;

5. Retail food regulatory programs develop and implement an action plan that justifies the need for resources including, but not limited to, equipment, personnel, or software to address gaps identified in the Program Standards self-assessment; and/or

6. Retail food regulatory programs leverage other jurisdictions and/or organizations to assist in achieving conformance with one or more standards, conduct risk factor studies (or track routine inspection data), develop and implement intervention strategies, develop/deliver training programs, or otherwise build capacity to more effectively prevent foodborne illness and/or more effectively and efficiently respond to foodborne illness outbreaks, should they occur.

Only state, local, territorial, and tribal agencies with primary regulatory responsibilities for retail food establishments, or those government agencies with substantial involvement and control over such agencies are eligible to apply. In addition, the retail food regulatory agency must be enrolled in the VNRFRPS and have completed a current self-assessment against all nine (9) Retail Program Standards.

Upon submission of the completed enrollment form, FDA will add the jurisdiction to its on-line Listing of Jurisdictions Enrolled in the Voluntary National Retail Food Regulatory Program Standards. The on-line listing will be reviewed to confirm registration.

PERFORMANCE MEASURES

Consistent with an increased focus on performance accountability as required by the Uniform Guidance 2 CFR 200, an emphasis will be placed on the applicant’s ability to measure progress and track its performance using objective, proven, and measurable data. As such, applicants should carefully consider the Scored Review Criteria listed in Section V of this announcement when submitting their application. Each applicant is encouraged to identify performance measures, baseline data, and targets for activities listed in the objectives and outcomes sections of this announcement as appropriate and feasible.

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.

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

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.
• o 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.

The funds provided by this cooperative agreement are available to applicants only to the extent that that the applicant funds its food safety program independently of any grant issued pursuant to this FOA in each year of the grant at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in kind, fairly evaluated, including plant, equipment, or services.

The funds provided by this cooperative agreement shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities carried out pursuant to this cooperative agreement.

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.

Additionally, the applicant must submit:

(A)an assurance that the eligible entity has developed plans to engage in the types of activities described in this FOA.

(B)a description of the types of activities to be funded by the grant;

(C)an itemization of how grant funds received under this section will be expended;

(D)a description of how grant activities will be monitored; and

(E)an agreement by the eligible entity to report information required by the Secretary to conduct evaluations under this section.

To the extent that any of these requirements conflict with the Research (R) Instruction in the SF424 (R&R) Application Guide, these requirements prevail.

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)
• Date of most recent self-assessment
• Number and title of this funding opportunity

The letter of intent should be sent to:

Kiara Fowler
Telephone: 240-402-3099
Email: Kiara Fowler@fda.hhs.gov

A technical session will be held for prospective applicants in February 2020. 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.

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:

Research Strategy:

In the application, the applicant must:

1) Certify that it is enrolled in the Retail Program Standards with FDA.

2) Provide a completed, current self-assessment of all nine (9) Retail Program Standards

3) Demonstrate the ability to develop and implement an action plan that identifies actions, timeframes, personnel and other resources required to implement the retail program improvement/enhancement strategy to advance one or more retail program standard.

4) Demonstrate the action plan will improve the applicants retail program within the Retail Program Standards related to risk factor studies, intervention strategies, training programs, infrastructure and/or capacity building. The information shall document how the action plan relates to the specific Retail Program Standard(s) that will be met.

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

6) Provide a detailed budget for one year that is intended to advance the conformance with the Retail Program Standards in relation to the action plan of the applicant.

7) Provide justification for hiring new staff, including qualifications, training needs and new equipment needs. Justifications shall relate to the specific Retail Program Standard(s) that will be advanced.

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.

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.

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.

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

The FDA will provide one year of funding. Application budgets are limited to $70,000 (direct and indirect costs) of funding requested and must reflect the actual needs of the proposed activities.

Allowable cost include but are not limited to:

1. Audio/visual materials such as videotapes, DVDs, public service announcements, etc.

2. Consultant services

3. Employee salaries, wages and fringe benefits

4. Rental, purchasing, calibration, and maintenance of supplies and equipment, including investigational, GPS interface, communication, and laboratory

5. Indirect costs

6. Registration fees

7. Purchase or development of IT equipment, software, and support

8. Shipping and mailing of equipment and supplies

9. Travel

10. Speaker fees

11. Training programs, including the development, delivery, and attendance

12. Subcontracting to third parties (other than local/county/tribal agencies).

Non-allowable costs:

1. Facilities, work, and training reimbursed under other cooperative agreements, grants, contracts, and other funding mechanisms shall remain distinct and separate from the cooperative agreement.

2. Vehicle purchases are not permitted.

3. Cooperative agreement funds may not be utilized for new building construction or remodeling of existing facilities.

4. Cooperative agreement funds may not be utilized for uniforms or clothing except Personal Protective Equipment (PPE).

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.

Does the project rationale and design meet the objectives and projected outcomes of this FOA to advance conformance to the Retail Program Standards and/or reduce the occurrence of foodborne illness risk factors? Are the overall strategy, methodology and evaluations well-reasoned and appropriate to accomplish the specific aims of conformance to the Retail Program Standards and/or reduction in the occurrence in foodborne illness risk factors? Does the project address gaps found in the Retail Program Standards self-assessment? Are potential problems, alternative strategies and benchmarks for success presented?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Is the leadership approach, governance and organizational structure appropriate for the project?

Are potential problems, alternative strategies, and benchmarks for success presented? Does the project provide a likelihood that capabilities developed can be sustained after the project period?

Does the application provide justification for hiring new staff, including qualifications, training needs, and new equipment needs?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to advance conformance to the Retail Program Standards and/or reduce the occurrence of foodborne illness risk factors? Does the application document a method for measuring their advancement of the Retail Program Standards and/or reducing the occurrence of foodborne illness risk factors? Have adequate resources (including staff and infrastructure) been proposed to meet the objectives of the FOA? If not, has the ability to obtain the needed resources been demonstrated? Is there adequate demonstration of effectiveness in working with federal, state, and local partners and other appropriate organizations to implement the goals of the cooperative agreement? Does the application define the applicant’s ability to measure progress and track its performance using objective, proven, and measurable data?

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.

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

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

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

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 grantee’s business official.

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

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

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

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

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

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

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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

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

Monitoring Activities

The Project Official, ORA Project Manager, and Technical Advisor will monitor award recipients periodically. The monitoring may be in the form of face-to-face meetings, telephone conversations, e-mails, or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the recipient organization will occur, including program assessments and audits.

The results of these monitoring activities will be recorded in the official cooperative agreement file and will be made 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 Project Officer and Technical Advisor.

The scope of the recommendation will confirm that:

(1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA

regulatory requirements; and (3) if necessary, there is an indication that corrective action has taken place.

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

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

Mid-year progress and end of year reports shall contain the elements below as applicable to the application and award, including but not limited to, the following:

1) Provide an updated action plan that identifies actions, timeframes, completed activities, personnel and other resources required to implement the retail program improvement/enhancement strategy to advance one or more retail program standard.

2) Provide a narrative demonstrating how the action plan has improved the grantees Retail Program Standards related to intervention strategies, training programs, infrastructure and/or capacity building. The information should include a full description of achievements with conformance to the Retail Program Standards and the associated activities completed during the reporting period.

3) Status report on the hiring and training of food program personnel during the reporting period. If training is part of the action plan, please provide the total number of employees trained, classes or work trained on, and the connection to the Retail Program Standards.

4) Provide a detailed budget of funds expended to date.

The final program progress report shall provide a complete written narrative covering the entire project and summaries of accomplishments and goals, as described in the grant application. The final program progress report shall include a final action plan, an updated current self-assessment for the Retail Program Standard areas advanced during the project period. The report shall detail the strategy to continue advancing conformance with the Retail Program Standards. The documentation shall be in a form and contain sufficient detail such that other agencies could reproduce the final project.

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: support@grants.gov

Suzanne Webb

Office of Regulatory Affairs (ORA), Office of Management (OM)

Food and Drug Administration

Telephone: 240-402-3069

Email: suzanne.webb@fda.hhs.gov

Maribeth G. Niesen

Office of Regulatory Affairs (ORA), Office of Partnerships

Food and Drug Administration

Telephone: 513-679-2704

Email: maribeth.niesen@fda.hhs.gov

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

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

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

Awards are made under the authorization of section 1009 of the Federal Food, Drug, and Cosmetic Act21 USC 399) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75