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's (FDA), Center for Food Safety and Applied Nutrition (CFSAN), is announcing the availability of a limited competition Cooperative Agreement. The estimated amount of funds available for support of this Cooperative Agreement is $750,000 (direct and indirect costs) for fiscal year 2016. It is anticipated that at least an additional two (2) years of support will be available, ($625,000 for fiscal year (FY)-2017 and $500,000 for FY-2018), depending on annual appropriations and successful performance.

The intent of this cooperative agreement is to fund entities that have active working relationships with Native American tribes and/or organizations that have demonstrated experience developing and providing science-based, culturally specific food safety training, education, outreach, and technical assistance for tribes, tribal businesses, and/or tribal members, with an emphasis on agricultural production and human food manufacturing/processing. Subcontracts to organizations that meet the intent noted above are encouraged. It is expected that applicants will specifically include collaboration between and among national and regional tribal stakeholder leaders, relevant tribal organizations, tribal colleges and universities and associated national organizations; as well as land grant cooperative extension programs, and other organizations and partners involved in national food safety efforts, in order to reach the intended audience. In addition, applicants are expected to collaborate with the established FDA Food Safety Modernization Act (FSMA) Alliances. Extensive cooperation and coordination with FDA CFSAN and other FDA program offices, the National Coordination and Regional Centers (established under the National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program ), and FDA’s FSMA partners at the U.S. Department of Agriculture (USDA) and other Federal organizations that have a vested interest in food safety among tribal stakeholders is also expected.

The primary objective of this cooperative agreement is to develop and provide training, education, outreach, and facilitate identification of appropriate technical assistance resources to produce farming and food manufacturing/processing members of federally recognized tribes related to the applicable federal regulations under FSMA, especially the Produce Safety and Preventive Controls for Human Food rules. In addition, consideration should be given to tribal stakeholders not currently subject to the regulatory requirements but that have conveyed an interest in or have identified economic incentives to comply (i.e., marketplace requirements to comply or business growth outlooks) with such regulations. This agreement focuses primarily on the standards for Produce Safety and Preventive Controls for Human Food rules; however, more broadly all regulations under FSMA should be considered by the applicant, as any may apply to tribal members based on their specific operation.

FSMA was signed into law in 2011 and provided FDA with a legislative mandate to require comprehensive, prevention-based controls across the food supply along with other prevention-focused tools in order to create substantial improvements in the Agency’s approach to food safety. Standards that FDA is directed to issue under FSMA include requirements for hazard analysis and risk-based preventive controls for both human food and animal food and standards for produce safety, among other rulemaking and guidance development activities. The regulations include requirements for training and employee qualifications.

Additionally, FSMA calls for enhanced partnerships and integration with FDA’s food safety Federal, State, local, tribal and territorial partners in order to achieve public health goals. To this end, the Agency has been working with such partners to develop and implement an integrated food safety system. To be successful, an integrated national food safety system must build upon the work currently being done by FDA and our regulatory and public health partners. Additional work is needed in terms of active communication, coordination, and support. One important step towards implementing an integrated national food safety system will entail training, education, outreach and understanding technical assistance needs for tribal members that grow, harvest, pack or hold produce, or process foods. Among other roles, it is FDA’s role and responsibility to collaborate with other food regulatory agencies, but to also assist through incentives or other means state, local and tribal regulatory and public health programs working to meet these standards.

To build an integrated national food safety system, new training related to FSMA will need to be available to tribal produce farmers, packers and food manufacturers/processors. FDA anticipates that federally recognized tribes will need food safety education and training that addresses the regulatory requirements of the applicable FSMA rules and also encompasses specific cultural practices associated with produce farming and food manufacturing/processing within tribes relevant to their status as sovereign nations. Additionally, these tribal stakeholders frequently have limited access to adequate and affordable food safety training, education, outreach, and technical assistance. FDA will engage in a cooperative agreement with one or more collaborators that will develop and implement food safety training, education, outreach and identification of technical assistance resources for key tribal stakeholders, including farmers, packers and manufacturers/processors that grow, harvest, pack and hold produce and process food impacted by FSMA. It is expected that existing training materials, such as the standardized curriculum developed by the Produce Safety Alliance or the Food Safety Preventive Controls Alliance, would be used as a foundation for customization, where appropriate, to meet tribal needs. In addition, the Sprout Safety Alliance will be a resource for existing training materials specific to sprout growers. Customization of these existing training materials would likely address regional practices and needs, including addressing specific tribal practices associated with produce farming and food manufacturing/processing. FDA intends to work with the recipient to ensure that alternate and customized curricula are recognized by FDA.

This cooperative agreement is beneficial to public health because it would further drive compliance with the final federal preventive controls regulations, especially the Produce Safety and Preventive Controls for Human Food rules; would help ensure consistency of implementation throughout the United States; would leverage existing expertise, knowledge, and enforcement authorities of tribal regulatory staff; and ultimately reduce foodborne illness.

The program will focus on helping tribal audiences understand and interpret new Federal food safety agricultural production and processing regulations and guidance enacted under FSMA, thus enabling them to implement those regulations and guidelines in their respective environments. The program will begin with assessing needs, capacity and infrastructure, building and evolving to curriculum development and/or adaptation delivering training, education and outreach as well as identifying technical assistance resources for tribal audiences impacted by the new food safety regulations and guidance.

The other preventive controls rules are available on FDA's website at http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm, or upon request.

This cooperative agreement is intended to develop and deliver training and outreach, develop and provide educational materials using the FSMA Alliance materials as a foundation, and facilitate identification of appropriate technical assistance resources for tribes subject to the applicable preventive controls regulations. The goal of developing and delivering this training, educational material and outreach is to: enhance the fundamental knowledge of food safety and especially on-farm good agricultural practices of tribal stakeholders subject to applicable FSMA regulations.

Applications must address all of the following:

• Demonstrate an ability to reach the target audience and an ability to collaborate and lead relevant partners that also work with the target audience on relevant areas. Such partners include tribal academic institutions, tribal governments, land grant cooperative extension, federally-recognized tribal extension agents, tribal NGOs and community-based organizations, and federal agencies with a role in food safety such as the USDA, Centers for Disease Control and Prevention, and the Indian Health Service;
• Demonstrate an ability to develop and implement a training plan that includes project goals that shall significantly advance tribal stakeholders understanding of on-farm produce and food manufacturing/processing safety, taking into account existing materials and also specific cultural practices within tribes and regions, and ultimately increase understanding of the requirements of the Produce Safety and Preventive Controls for Human Food rules as well as other federal preventive controls standards to facilitate and support compliance;
• Conduct a training, education, and technical assistance needs assessment so that training, education, and outreach can be prioritized within the scope of this cooperative agreement and appropriate resources for technical assistance can be identified;
• Develop science-based, culturally appropriate training, outreach and educational materials and tools, around the FSMA regulations, especially the Produce Safety rule and Preventive Controls for Human Food rule, for federally recognized tribes. Targeted training and educational materials will be based upon existing produce and human food safety training and educational materials (e.g., FSMA Alliances) to the extent practicable and will address specific (documented and itemized) regional needs where appropriate while otherwise providing for national uniformity;
• Identify culturally appropriate delivery vehicles for the training, outreach, and educational materials as well as mechanisms to connect with technical assistance resources for federally-recognized tribes;
• Identify and quantitatively characterize the top 20%, but no more than 50 total, of tribes that engage in commercial production of covered produce under the Produce Safety rule as well as the top 20%, but no more than 50 total, of tribes engaged in commercial production of food covered under the Preventive Controls for Human Foods rule; and include within this group, identification of tribes with mixed-type operations;
• Foster and/or strengthen an integrated working relationship between the Federally-Recognized Tribes Extension Program extension educators, 1994 tribal land-grant colleges and universities, FDA and other partners including the FSMA Alliances (Produce Safety Alliance, Food Safety Preventive Controls Alliance and Sprout Safety Alliances), the FDA National Coordination Center and FDA/USDA Regional Centers established under the National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program;"
• Identify and provide contacts for future tribal food safety engagement as applicable to this cooperative agreement and subsequent related activity;
• Identify and characterize existing education and training programs within federally recognized tribes related to on-farm produce and food manufacturing/processing safety;
• Identify and conduct outreach opportunities relative to these overall priorities so that tribal member produce growers and food manufacturers/processors are aware of the availability of training, educational materials and technical assistance opportunities;
• Work collaboratively to foster an integrated working relationship with the various FSMA alliances (Produce Safety Alliance, Food Safety Preventive Controls Alliance and Sprouts Safety Alliance).
  Evaluate the training curricula and delivery to ensure that the target audience is provided with adequate information to increase understanding of the requirements of the Produce Safety and Preventive Controls for Human Food rules.

Other Requirements:

• Demonstrate the ability to develop and provide a range of educational tools for tribal stakeholders relative to FSMA regulations, especially the Produce Safety rule and Preventive Controls for Human Food rule, for federally recognized tribes.
• Demonstrate the ability to engage with and work collaboratively with national and regional Native American organization leaders (individuals and organizations), Native American colleges and universities as well as other national organizations, land grant university extension programs, the established FSMA Alliances as well as the National Coordination and Regional Centers in order to leverage and advance understanding of the FSMA requirements among the target audience.
• Demonstrate the ability to extensively cooperate and coordinate with FDA CFSAN and other FDA program offices, and FDA’s FSMA partners at USDA in order to further enhance an integrated food safety system.
• Demonstrate the availability of adequately trained personnel that will be providing training, education and outreach to tribal stakeholders. Communicate the criteria and ability to hire and/or train personnel to meet the deliverables of the cooperative agreement.
• Provide a properly detailed budget (one for each of the 3 years) that is intended to advance the training and education program, outreach including identification of technical assistance resources, to advance understanding of the Produce Safety and Preventive Controls for Human Food rules.
• Demonstrate the ability to satisfy the reporting requirements outlined in section VI.3 of this announcement.
• Provide justification for hiring new staff, including qualifications, and training needs.
• Applications demonstrating an ability to sustain the progress made beyond the duration of this cooperative agreement are encouraged.

In addition, this cooperative agreement opportunity has common programmatic conditions in order to execute a seamlessly collaborative program between FDA and the awardee:

• An executive committee, composed of FDA and Cooperative Agreement recipient representatives as well as other partnering or relevant organizations, will be developed to provide guidance and oversight of this cooperative agreement (for example, in the development of specific deliverables and timelines). Broader committees, such as steering and technical committees, may also be formed to provide input and guidance throughout the project and may include other partnering or relevant organizations.
• Applicants will develop a communication plan to ensure consistent, transparent and open communication channels among the FDA, USDA, and FSMA Alliances as well as other relevant organizations; it should involve communication at a regular frequency through various mechanisms such as teleconferences, webinars, and other forms of communication; it will also include one face-to-face meeting each year of the project period, a written, quarterly progress report, and monthly teleconferences between FDA and the awardee.
• The communication plan must include sharing of all the appropriate information, such as data, to the activities conducted by the applicant, along with the appropriate information regarding the compiled contacts, and collaborator activities.
• The Project Director will be responsible for managing all technical and programmatic aspects of the cooperative agreement and will be responsible for appropriately acknowledging FDA support in publications, announcements, news programs, and other media; and
• The Project Director and members of the project team will be responsible for attending an annual meeting with FDA where they will provide updates on project progress, and any other significant programmatic outputs.
• Funds allocated to this cooperative agreement are intended to be utilized to develop and deliver the specific training, educational materials and outreach as noted here within.

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 in response to this FOA.

• Community-Based Organizations
• Grassroots Organizations that advance the sustainability of agriculture, food systems, natural resources, and rural communities
• 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)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession
• Native American Small Business

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:

Lisa Ko
Grants Management Officer
Food and Drug Administration
Email: [email protected]

A technical session will be held for prospective applicants in March 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 Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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.

This criterion is used to assess the likelihood that this project will develop and implement food safety training, education, and outreach, with core competencies to address FSMA regulations as well as facilitate identification of appropriate technical assistance resources; demonstrate an ability to reach the target audience and an ability to collaborate and lead relevant partners that also work with the target audience on relevant areas. Such partners include tribal academic institutions, tribal governments, land grant cooperative extension, federally-recognized tribal extension agents, tribal NGOs and community-based organizations. Additional partners should include organizations with expertise in food safety education, such as the FSMA Alliances, as well as federal agencies with a role in food safety such as the USDA, and Centers for Disease Control and Prevention and the Indian Health Service; subcontracts are encouraged. Elements considered include: a clear statement of the project goal(s) and supporting objectives of the proposed activities; body of knowledge, preliminary data and other past activities used to substantiate the need for the proposed project; justification and criteria used to select the population groups to be served; innovation; and the degree to which the project will reach the target audience and evaluate the project’s impact to advance awareness, understanding, and implementation of new FSMA regulations and guidelines among the target audience.

This criterion is used to assess the soundness of the proposed approach. Elements considered include: soundness of an evidence-based approach for educational curricula to be used in the project; proposed activities and sequence of activities; participant and, if applicable, trainer recruitment; methodology and limitations of the proposed approach; project timeline; and expected new products and results (e.g., educational approaches including training curricula, workshops, meetings, conferences, exhibits, publications, electronic communication, fact sheets, newsletters, social media, and mass media). In addition, the review criteria should include:

a. Evidence of having successfully engaged and collaborated with national or regional training, education and, if applicable, technical assistance-related projects with a range of tribal stakeholders.

b. Evidence of having successfully participated in national or regional projects that included extensive cooperation and coordination with other Federal or State Government agencies or public-private partners.

c. Evidence of having successfully developed and delivered training, education and outreach as well as identification of appropriate technical assistance resources.

d. Evidence of and/or established partnerships with experienced food safety educational personnel.

e. Resume and/or other documentation that shows specific individuals that will work as primary project managers and key developers and key delivery personnel, including years of experience.

This criterion is used to assess the adequacy of the proposed recruitment, training, education and outreach plan and how the training, education and outreach methodology will be evaluated. Elements considered include: stakeholder identification methods, training programs and educational methods, data collection, analysis, and communication plans; and the strengths and limitations of the proposed evaluation approach.

Explicitly state the procedures or methodology you will apply to the proposed effort. This section should include but not necessarily be limited to, descriptions of:

a. A documented training plan including a proposed training schedule and the proposed number of sessions with adequate detail related to utilizing existing materials, the need for adapting or developing materials, program delivery methods, and identified specific practices for incorporation in regards to tribal stakeholders.

b. A training and education curriculum, and all related materials (lesson plans, speaker notes, handouts, stakeholder take-away materials, etc.) that addresses culturally/regionally specific practices, procedures and conditions that may be adapted and connected to the existing materials.

c. A range of training tools that address culturally/regionally specific issues, with details on how each would be developed and implemented.

d. Identified personnel to develop training, education and outreach programs as well as identification of appropriate technical assistance resources.

e. Identified personnel to deliver training, education and outreach programs.

f. The number of training sessions held across tribal communities nationwide utilizing a variety of culturally appropriate delivery vehicles.

g. A detailed budget for each of the 3 years that itemizes the costs for the education and training program, educational and outreach materials and as well as identification of appropriate technical assistance resources.

h. Documented, detailed methodology for the assessment and evaluation of the training, education and outreach programs, of review and improvement, and collaboration necessary to accomplish the work, as described in this announcement, and methodology to ensure program sustainability.

This criterion is used to assess the adequacy of proposed project management, including key staff, their functions and their ability to reach tribal audiences, reporting, accounting procedures(for funds used by the parent organizations and local sites), and coordination of collaborative efforts with local and/or community partners.

Project Timetable: The proposal should outline all important phases as a function of time, year by year, for the entire project, including periods beyond the grant funding period.

This criterion is used to assess the extent to which the total budget adequately supports the objectives, is appropriate to the project objectives being proposed, and is cost effective. Elements considered include: the necessity and reasonableness of costs to carry out project activities and achieve project objectives; the appropriateness of budget allocations between the applicant and any collaborating organization(s); and appropriateness of the budget relative to time committed to the project by key project personnel. Provide documentation of and justification for hiring new staff, including qualifications, and training needs.

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

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 Wide Association Studies (GWAS)/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.

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.

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 Part 75, and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an acquisition mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, 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.

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

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

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

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

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

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: [email protected]

Scarlett Salem
Consumer Safety Officer
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 240-402-2080
Email: [email protected]

Lisa Ko
Grants Management Officer
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: [email protected]

Lisa Ko
Grants Management Officer
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: [email protected]

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.