Required Application Instructions

It is critical that applicants follow the 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), Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Safety) is announcing the availability of a cooperative agreement to be awarded under Limited Competition. Only one national association/organization will be selected for funding under this cooperative agreement.

CFSAN's Office of Food Safety (OFS) shall work cooperatively with a national organization/association to increase partnerships and collaboration with our regulatory partners at local health departments, as well as state health and agriculture departments that represent city and county health departments. We endeavor to identify best practices and innovative approaches used to implement the FDA Food Code and Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) and continue to examine the impact they have on the reduction of foodborne illness risk factors. The organization must have:

1. The expertise needed to conduct research;

2. The expertise to manage complex projects;

3. The expertise to provide expert advice and recommendations to FDA that can be shared and used by multiple local health departments, as well as state health and agriculture departments, to help reduce the risk of foodborne illness in retail and food service settings; and

4. The expertise to identify best practices and highlight them through different media formats (e.g., recorded webinars, podcasts, vodcasts, infographics) such that retail food regulatory programs can learn from this information and apply it in their jurisdiction.

5. The expertise to manage a peer mentorship program for retail food regulatory programs.

6. The expertise to answer questions from retail food regulatory programs about the relationship between the Retail Program Standards and Public Health Accreditation

This cooperative agreement will address information gaps experienced by FDA, enhance enrollment and implementation of the Retail Program Standards, enhance adoption and implementation of the Food Code and enhance the effectiveness / ability of retail food regulatory programs. Possible areas for research and collaboration with FDA including the following objectives and activities:

Objective 1: Collaborate with an organization to enhance and expand an existing peer mentoring program that pairs local health department officials who have experience successfully implementing the Retail Program Standards with those who have experienced difficulty implementing the standards or are just beginning to implement the Retail Program Standards. This Cooperative Agreement will also enable FDA to explore and implement other models of mentorship that may assist enrolled jurisdictions achieve conformance with the Retail Program Standards, such as mentorship for state health and state agriculture retail food regulatory programs, and mentorship between state and local retail food regulatory programs. Findings from the mentorship program can also be used to identify opportunities to provide or facilitate additional training opportunities and share best practices for the Retail Program Standards.

Objective 2: Conduct research on how regulatory authority is exercised at the local level (e.g., identify regulatory programs that exercise regulatory authority directly and / or via delegation or contractual agreements.)

Objective 3: Conduct research on how retail food regulatory programs categorize / inspect establishments by risk (e.g., identify different approaches that retail food regulatory programs are using to categorize establishments, learn more about inspection frequency employed in local health departments, and share best practices).

Objective 4: Conduct research to learn more about how the Retail Program Standards are used as a tool for interacting with and fostering continuous improvement among local health departments and state agencies. From this research, identify and share best practices.

Objective 5: Conduct research to learn more about the roles local health departments are playing on regulatory policy issues such as menu labeling regulations, food defense, food donations, food banks, cottage foods and how food safety interfaces with these issues. From this research, identify best practices to share with local health departments.

The cooperative agreement will provide resources to the organization needed to manage and support the mentorship program, conduct additional research projects among local and state health departments, to participate in meetings with the local health departments that participate in this project, analyze data and findings, and produce reports on findings and recommendations from research projects, including disseminating and making findings and recommendations available to local health departments, and convene, at a minimum, bi-weekly calls with the FDA project officer to ensure regular communication and elicit input and feedback on the work conducted under the cooperative agreement.

CFSAN regulates $417 billion worth of domestic food, $49 billion worth of imported foods, and over $60 billion worth of cosmetics sold across state lines. This regulation takes place at any point from the products' point of U.S. entry or processing to their point of sale. There are over 377,000 registered food facilities (including approximately 154,000 domestic facilities and 223,000 foreign facilities) that manufacture, process, pack, or hold food consumed by humans or animals in the United States and several thousand cosmetic firms. However, these figures do not include restaurants, institutional food service establishments, or supermarkets, grocery stores, and other food outlets over which FDA has jurisdiction but which are traditionally primarily regulated by almost 3,000 state, local, and tribal agencies. FDA strives to promote the application of science-based food safety principles in retail and food service settings to minimize the incidence of foodborne illness. FDA assists regulatory agencies and the industries they regulate by providing a model Food Code, Retail Program Standards, scientifically-based guidance, training, program evaluation, and technical assistance. This cooperative agreement will further FDA's ability to work collaboratively with a national organization to strengthen and promote the role of the agencies responsible for retail food safety regulation.

The CFSAN/OFS/ Retail Food Protection Staff works to promote the sharing of best practices, including those regulatory and industry interventions that are targeted at improving the management of food safety practices in the retail setting. CFSAN/OFS desires to work cooperatively with a national organization to increase partnerships and collaboration with our regulatory partners at local health departments, as well as state health and agricultural departments that represent city and county health departments, to identify and help agencies implement innovative food safety approaches including adoption of the FDA Food Code and Retail Program Standards and continue efforts to promote the impact they have on the reduction of foodborne illness risk factors.

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

This opportunity is only available to the following nonprofit organizations/associations:

National organization/associations whose membership includes, but is not necessarily limited to, State, local, territorial, and/or tribal retail food safety regulators.

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

1. National organizations and associations with membership that includes, but is not necessarily limited to, State, local, territorial, and/or tribal retail food regulatory jurisdictions will have the relationships and communication systems to effectively promote and support the mentorship program and research needed under this cooperative agreement. Therefore, a strong communications platform to both educate potential applicants and receive feedback will be critical to the success of this project.

2. These national organizations and associations have a vested interest in retail food safety and share FDA’s visions to advance the FDA’s Food Code and Retail Program Standards and improve public health at the retail level. They are also knowledgeable of the Retail Program Standards and the requirements to achieve conformance. These national organizations can best collaborate with FDA on the mentorship program and conduct needed research projects to increase FDA’s knowledge and understanding on other retail food safety-related areas.

3. These national organizations and associations can provide a platform for sharing information about the implementation of the retail food safety projects pursued by the mentorship participants and the additional research projects through national and regional meetings, web site, listervs, and other communications to retail food regulatory programs. Most national associations/organizations also have committees that may further advance the projects conducted under this cooperative agreement.

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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

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

The letter of intent should be sent via electronic mail as a PDF file with the FOA Number and the Institution's Name in the message subject heading to:

Bryce Jones
Grants Management Specialist
Food and Drug Administration
Email: bryce.jones@fda.hhs.gov

A technical session will be held for prospective applicants in May 2016. 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.

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

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report 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.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. 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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have a major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

The proposed strategies and approach to meet the intended objectives and outcomes of the cooperative agreement are well-reasoned, appropriate and complete.

Demonstration of effectiveness in working cooperatively with federal, state, local, territorial and/or tribal regulatory jurisdictions on retail food safety issues that positions the applicant to successfully implement the intended objectives and outcomes of the cooperative agreement.

Demonstration that the PI/PD, collaborators and other key personnel are well-suited to the project with the appropriate experience and training.

Demonstration of adequate organization program infrastructure and resources to accomplish the intended objectives and outcomes of the cooperative agreement, including providing adequate administration and oversight to subawards/contracts issued.

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 six 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 six 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.

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 children 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 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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. 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. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

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 CFSAN 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 Parts 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), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role of activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the FDA as defined below.

The intended outcomes of this FOA are to: enhance and expand an existing mentorship program that pair local health department officials who have experience implementing the Retail Program Standards with those who have struggled or are just beginning the process; consider expanding the mentorship program to include state - state mentorship or a regional or state wide mentorship program to assist states enrolled in the Retail Program Standards who want to make progress; and conduct research tasks in several areas described above to address knowledge gaps that will improve FDA's and local and state agencies understanding of retail food protection issues.

It is anticipated that approximately 50% of the cooperative agreement funds will be devoted to the mentorship program and related activities.

A.1. Principal Investigator Rights and Responsibilities

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

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

A.2. FDA Responsibilities

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

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

a. FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee.

b. FDA will be directly involved in the guidance and development of the program. The Project Officer, and representatives from FDA/CFSAN's Retail Food Policy Team and the National Retail Food Team will monitor and provide expertise needed for the different objectives of the cooperative agreement as members of a Project Advisory Group. The group will meet at least quarterly to discuss progress and provide advice as needed with the grantee.

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

In addition, work proposed and conducted under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts or grants or other funding mechanisms. Projects proposed and conducted under this cooperative agreement must remain distinct and separate from other projects and funding sources.

Additional funding restrictions may be part of 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.

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

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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 submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

Peter Salsbury
Food and Drug Administration
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 240-402-1655
Email: Peter.Salsbury@fda.hhs.gov

Bryce Jones
Food and Drug Administration (FDA)
Office of Acquisitions and Grants Services
5630 Fishers Lane, Rm 2026, HFA 500
Rockville, MD 20857
Telephone: 240-402-2111
Email: bryce.jones@fda.hhs.gov

Bryce Jones
Food and Drug Administration (FDA)
Office of Acquisitions and Grants Services
5630 Fishers Lane, Rm. 2026, HFA 500
Rockville, MD 20857
Telephone: 240-402-2111
Email: bryce.jones@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 Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.