It is critical that applicants follow the Research (R) Instructions in How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of 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

 

Purpose:

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) is announcing the availability of a cooperative agreement to be awarded under Limited Competition for national associations/organizations to support awardees under the Laboratory Flexible Funding Model (LFFM) cooperative agreement program as well as unfunded laboratories within the Food Emergency Response Network (FERN). Nonprofit national associations/organizations that represent human and/or animal food testing laboratories have the membership, resources, structure, and expertise necessary to build national consensus amongst state and local agencies on key human and animal food safety and laboratory issues.

The intended outcome of this funding opportunity is to advance the national food safety system by supporting and enhancing state human and animal food testing laboratories tasked with surveillance and emergency response testing, including investigations of foodborne disease outbreaks. The resulting cooperative agreement will provide the additional support to these laboratories through the activities of an association that will conduct research on national testing capability and capacity; develop best practices and other guidance manuals; offer trainings, workshops, meetings, and other

educational resources; support ISO/IEC 17025 laboratory accreditation for non-accredited laboratories; create and manage whole genome workforce development opportunities; and other activities to support human and animal food testing laboratories.

Program Goals:

State and local laboratories play a critical role in the identification, containment, and prevention of foodborne illness. The FDA is committed to assisting these laboratories in building laboratory capacity and capability, maintaining and expanding the scope of ISO/IEC 17025 accreditation, and supporting

the groundbreaking work achieved through the GenomeTrakr network. Effective leveraging of resources and harmonization of efforts will require extensive collaboration with relevant initiatives, including those of federal partners, associations/organizations, and state and local partners.

The goal of this funding opportunity is to assist laboratories with building laboratory capacity and capability, workforce development, and assisting the FDA in the development of trainings, workshops, educational materials, and meetings in support of LFFM and unfunded laboratories conducting testing of human and animal food samples.

This cooperative agreement is only available to nonprofit national associations/organizations that represent state and local laboratories that conduct food and/or animal feed testing on behalf of state and local regulatory programs and that collaborate with one or more institutions of higher education.

Project Objectives (progress assessed semi-annually):

1. Research into the development and implementation of trainings, workshops, and other educational materials and resources for use by laboratories in the LFFM, in addition to unfunded laboratories.

Provide training for laboratories, including but not limited to the following areas, those seeking to achieve, maintain, and enhance ISO/IEC 17025 accreditation, whole genome sequencing, GOOD Test Portions, and GOODSamples. Specific areas of need include effective workshops, seminars, and reference materials on laboratory procedures, data transfer (to NCBI and FDA data systems), metadata standardization, document control, quality management systems, continuous improvement, sample collection, state laboratory and regulatory collaborative/coordinated trainings for planned surveillance and emergency response testing, and risk assessment.

Existing training should be leveraged (e.g., FDA FERN courses). If existing training materials do not exist, develop new trainings in partnerships with state and FDA subject matter experts (SMEs); build and deliver trainings based on available training needs assessments data. Work performed under this deliverable should be distinguishable from work performed under the FDA Office of Training, Education, and Development (OTED) cooperative agreement program for the national laboratory curriculum framework development and other initiatives.

Activities would include identifying host locations, working with the FDA to identify SMEs/trainers, coordinating/organizing logistics, managing registration, supporting travel of non-LFFM labs, and issuing course evaluations. Determine which courses to hold based on review with the FDA using previous or additional training needs assessments and gap analyses. Priority of course offerings based on discipline are (1) radiochemistry, (2) chemistry, and (3) microbiology

Methods of delivery for trainings could include webinars, teleconferences, workshops, on-site

technical sessions, face-to-face meetings, and information sharing through web-based resources.

Both individual laboratory and broad-based training needs should be considered and met by the grantee. The FDA will have significant involvement in the training programs including pre-review and approval of the content prior to delivery. The FDA will periodically assess the effectiveness of courses by reviewing the course assessments and evaluations completed by students (individual and aggregated data).

2. Plan and host annual meetings, including scheduling, agenda planning, invitations, on-site logistics (meeting facilities and AV needs and support), poster sessions, trainings or workshops during the meeting, registration, materials, and follow-up evaluations, for:

a. The LFFM Face-to-Face Meeting (in-person)

b. The GenomeTrakr Face-to-Face Meeting (in-person)

c. NARMS Public Meeting Hybrid (virtual and in-person)

Meeting agendas and materials shall be pre-reviewed and approved by the FDA prior to distribution and execution.

3. Collaborate with FDA Whole Genome Sequencing (WGS) SMEs on workforce development in the field of bioinformatics. Workforce development efforts involve:

• Y1: Collaborate with SMEs to develop a program to recruit and train qualified individuals in bioinformatics to prepare them to pursue a career in public health.
• Y2/Y3: Onboarding of individuals will be conducted in collaboration with host laboratories, the awardee, and the FDA as additional funding sources become available.

The outcome of workforce development entails enhanced technical and non-technical knowledge, skills, and abilities among public health laboratory professionals in diverse settings. The workforce development resources are expected to be informed by FDA SMEs, competency guidelines, and appropriate data. Work must include participation in implementation, support, and monitoring efforts at least quarterly for any funded recipients of workforce development efforts.

4. Provide direct technical assistance to FERN labs seeking ISO/IEC 17025 accreditation. This should also include support to FERN labs facing challenges or needing assistance with scope expansion.

5. Provide Laboratory Information Management System (LIMS) and ORA Data Exchange (DX) implementation support to laboratories building sample data sharing capabilities. Provide coordination and support for states implementing LIMS with a focus on identifying gaps, creating resources and best practices to improve integration with FDA LFFM data reporting mechanisms, including ORA DX and FERN Portal quarterly sample data submissions. Activities associated include integrating FDA training modules into existing training programs when appropriate, creating and managing LIMS group forums, and assessing and providing ways to strengthen the completeness, accuracy and defensibility of data originating from a variety of electronic systems.

6. Collaborate with the FDA on laboratory projects that have a national scope including the following:

• Support efforts toward data compilation, evaluation, and analysis of the FDA National Laboratory Network project.
• Support state input on the FDA State Human and Animal Food Laboratory Partnerships Strategic Plan and associated activities by identifying staff from state laboratories to provide input and coordinating state laboratory review and feedback on strategic plan deliverables and activities, as requested by the FDA.
• Partner with the FDA NARMS Program in efforts to reduce the burden of salmonellosis in meat commodities at retail.
• Aiding with identifying sources of isolates or helping states build collaborations with isolate sources to support GenomeTrakr.
• Promote GenomeTrakr and LFFM accomplishments by working with states to create and publish success stories.

7. Collaborate with the FDA to compile state partner feedback and input on topics identified by the FDA.

8. Collaborate with the Partnership for Food Protection IT Workgroup (PFP IT WG) to assist in data system transition activities. Collaborate with the PFP Laboratory Workgroup (PFP Lab WG) and lead efforts to update the most recent PFP Lab Best Practices Manual. Communicate regularly with the FDA on progress and needs.

9. Manage committees that collaborate with SLTT, federal, and relevant association partners regarding FDA funded work in areas that include but are not limited to human and animal foods and food chemistry. Ensure continued coordination with AFDO, AAFCO, NASDA, and other relevant association partners.

10. Provide travel scholarships to laboratory individuals for trainings, meetings, and conferences. Eligible travel scholarships awardees may include non-FDA funded state laboratories, additional attendees (above the FDA cooperative agreement requirement) for LFFM or GenomeTrakr face-to-face meetings, and LFFM state laboratory members to committee meetings such as the APHL food safety and chemistry committees.

11. The FDA is committed to promoting Diversity, Equity, Inclusion, and Accessibility (DEIA) to achieve the FDA’s mission to protect public health. The grantee is expected to promote diversity among the vendor(s) for goods and services by developing a diversity procurement strategy. The grantee should use their diversity procurement strategy to take all necessary affirmative steps to ensure that disadvantaged and women-owned small business concerns, as defined by the U.S. Small Business Administration and outlined in 13 CFR 124-103(b) and 13 CFR 127.200, are solicited for all procurement opportunities whenever there are possible sources. This provision is in support of Federal Acquisition Regulations (FAR) Part 52.219.8 Utilization of Small Business Concerns. The HHS Small Business Office can be solicited for recommendations. The grantee should also consider the diversity efforts of vendors as selection criteria for purchasing goods and services especially when disadvantaged and women-owned small businesses cannot be directly utilized. The grantee may be asked to participate in outreach efforts such as conferences and/or trade shows for the purpose of this provision

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 NOFO.

Nonprofits Other Than Institutions of Higher Education

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

This opportunity is only available to non-profit, food safety training entities that are national associations/organizations that represent State and local laboratories that conduct food and/or animal feed testing on behalf of State and local regulatory programs and collaborate with one (1) or more institutions of higher education. The applicant is required to hold an information sharing agreement with the FDA under 21 CFR 20.88(e) or be able to obtain the agreement at the earliest possible date after the award.

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.

• 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.
• o   Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

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

This NOFO 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 per 2.3.7.4 Submission of Resubmission Application.  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.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

 

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 NOFO. 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 notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

For this specific NOFO, 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 NOFO.

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:

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 NOFO.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

The research strategy submitted should include specific project milestones and metrics for each objective. In developing the research strategy, the applicant shall specifically address the ability to achieve the following objectives in the cooperative agreement

1. Demonstrate the ability to research, develop, and deliver trainings, workshops, meetings, and other educational materials and resources, including any online courses and in-person workshops or seminars. This shall include:

a. Evidence of technical knowledge of the Whole Genome Sequencing (WGS) specifically under the GenomeTrakr network; ISO/IEC 17025 accreditation; as well as sample collection and analysis of human and animal foods.

b. Experience in planning and hosting meetings and conferences with 100-200 attendees, including agenda planning, on-site logistics management, and the distribution and assessment of follow-up evaluations.

c. Process for researching, developing, and distributing best practices documents, protocols, and standard operating procedures, meeting materials and other project communications, in collaboration with the FDA.

2. Show evidence of technical knowledge of ISO/IEC 17025 accreditation requirements, including the ability to assess and assist accreditation for achieving, maintaining, and expanding ISO/IEC 17025 accreditation.

• Include efforts to research, design, develop, document, deliver, manage, and implement support programs for ISO/IEC 17025 accreditation in non-FDA funded laboratories. Monitoring of the selected laboratories to ensure that they are on track and determination of solutions to common barriers shall also be included in the plan.

3. Demonstrate the ability to develop and implement a workforce development program including identifying host laboratories, assistance with the development of program eligibility requirements, curriculum, and candidate submission process.

4. Demonstrate the ability to assist states with ORA DX and/or LIMS support including but not limited to integration of existing FDA training modules into training programs offered by association or organization as appropriate. Indicate the ability to coordinate and support states implementing LIMS with a focus on developing LIMS group forums; identifying gaps and creating resources and best practices to improve integration with FDA LFFM data reporting mechanisms; and aiding in the development of a mock laboratory environment for data submission demonstration.

5. Outline the plan, resources available, and qualifications of the personnel that will support this project.

6. Demonstrate the ability to satisfy the reporting requirements outlined in Section VI.3 of this Announcement.

7. As a part of your application, applicants should explain how they intend to measure performance if their application is funded. This should include Acceptable Quality Levels as well as Public Health Measures that are SMART:

Specific (specific, sensible, significant)

Measurable (meaningful, motivating)

Achievable (agreed, attainable)

Relevant (reasonable, realistic and resourced, results-based)

Time-Bound (time-based, time limited, time/cost limited, timely, time sensitive)

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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. FDA 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 NOFO.

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.

Vehicle purchases are not permitted.

Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.

Clothing and uniforms except for personal protective equipment (PPE). PPE is defined as protective clothing or other outerwear required to mitigate a defined workplace hazard.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

 

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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. The FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

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

Reviewers will consider each of the review criteria below in the determination of scientific/technical merit and give a separate score for each.

Does the project help support and enhance human and animal food testing laboratory activities, specifically through the activities of an association that will offer trainings, workshops, meetings, and other educational resources; conduct research and data evaluation/compilation for national projects and for feedback from state partners; prepare best practices and other guidance manuals; support ISO/IEC 17025 laboratory accreditation for non-accredited laboratories; provide workforce development opportunities; and other activities to support human and animal food testing laboratories?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Do they have previous, successful experience implementing effective training and workforce development programs, implementing effective national meetings, communicating, and working with state and local laboratories, aiding with ISO/IEC 17025 accreditation and scope expansion, developing aspects of WGS/bioinformatics and the GenomeTrakr network?

Is the overall strategy appropriate to support and enhance human and animal food testing laboratory activities? Does the rationale and design meet the goals of the cooperative agreement? Do the timelines, methods, and resources support the goals of the cooperative agreement?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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.

When the proposed project involves human subjects and/or 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 Animals 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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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 scientific peer review, all applications:

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

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

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

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO will be subject to terms and conditions found in the AHHS Grants Policy Statement, this NOFO, and Notice of Award. 

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

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

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

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

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). The 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 the FDA. Please see the FDA Public Access Policy.

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

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

Reporting Requirements:

All FDA grants require both Financial and Performance reporting.

Financial Reporting:

A. Financial Expenditure Reports

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

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

Performance Progress Reporting:

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

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

Salary Caps:

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

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

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

Awardees are responsible for complying with all requirements to protect the confidentiality of identifiable, sensitive information that is collected or used in biomedical, behavioral, clinical, or other research (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs) funded wholly or in part by the Federal Government. See 42 U.S.C. 241(d). All research funded by the 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 the FDA who receives a copy of identifiable, sensitive information protected by these requirements, understand they are also subject to the requirements of 42 U.S.C. 241(d). Awardees are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).

Acknowledgment of Federal Support:

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

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

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

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

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

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

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

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

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

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

Prior Approval:

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

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

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

1. Change in Grantee Organization
2. Significant Rebudgeting
3. Change in Scope or Objectives
4. Deviation from Terms and Conditions of Award
5. Change in Key Personnel which includes replacement of the PD/PI or other key personnel as specified on the NoA.
6. Disengagement from the project for more than three months, or a 25 percent reduction in time devoted to the project, by the approved PD/PI. No individual may be committed to more than 100% professional time and effort. In the event that an individual's commitment exceeds 100%, the grantee must make adjustments to reduce effort. For FDA-sponsored projects, significant reductions in effort (i.e., in excess of 25% of the originally proposed level of effort) for the PD/PI and key personnel named on named on this Notice of Award must receive written prior approval from FDA.

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

Audits and Monitoring:

Audit Requirements:

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

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

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

U.S. Department of Health and Human Services

Audit Resolution Division, Room 549D

Attention: Robin Aldridge, Director

200 Independence Avenue, SW

Washington, DC 20201

Monitoring:

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

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

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

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

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

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

Financial Conflict of Interest (FCOI):

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

Closeout Requirements (when applicable):

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

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

Program Income:

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

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

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

Treatment of Program Income:

Prohibition on certain telecommunications and video surveillance services or equipment:

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

(1) Procure or obtain,

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

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

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

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

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

Other:

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

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

You must administer your project in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/providerobligations/index.html and https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

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

Cooperative Agreement Terms and Conditions of Award

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

Project Director/Principal Investigator Rights and Responsibilities:

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

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

FDA Responsibilities:

The Grants Project Team may consist of a Grants Management Specialist, Program Official (PO), Project Manager (PM) and Technical Advisor. The Grants Project Team collaborates to review the progress of the grantee. The Grants Project Team may utilize the grantee’s progress reports, site visits, audit reports and other supporting documentation to determine if the condition of the award was met and satisfactory progress is being made. Each team member works in consultation with each other, as needed, throughout the duration of the project. A description of each team member involved with the program are described below.

An FDA Grants Management Specialist (GMS) will be assigned and named in the Notice of Award. The GMS oversees the administrative, financial, business and other non-programmatic aspects of the program. These activities include, but are not limited to the following:

• Provides guidance on administrative, business, fiscal aspects of grants management to grantees and FDA program staff
• Monitors and manages applications and required reports on eRA Commons
• Monitors administrative and financial aspects of grantee activities
• Maintains the official grantee file

An FDA Program Official (PO) will be assigned and named in the Notice of Award. The PO is accountable for the programmatic oversight of the grant to include coordination, with the Project Manager, on the technical aspects of the grant. S/he ensures the budget of grantees are reasonable and costs are allowable and allocable. The PO reviews the progress reports to verify the budget proposed includes only allowable expenses that support the project goals and objectives. The PO also assists with post-award monitoring and establishing a corrective action plan, if necessary.

An FDA Project Manager (PM) will be assigned to the program. The FDA PM is the responsible official for the programmatic, scientific, and/or technical aspects of assigned applications and cooperative agreements. The FDA PM will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below.

The PM will have substantial involvement in the design, implementation, and evaluation of program activities, and dissemination of program results and outcomes, above and beyond routine grant monitoring. Substantial involvement by FDA/ORA includes, but is not limited to, the following:

• Provides guidance, direction, and technical assistance in project planning, implementation, and evaluation;
• Provides subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;
• Actively monitors the supported program via telephone conversations, webinars, e-mails, written correspondence, or periodic site visits;
• Evaluates the supported program, including development of program-level performance measures, consistent data collection, and reporting procedures and protocols;
• Convenes trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing;
• Participates in data analysis, interpretation of findings, and where appropriate, co-authorship of publications;
• Develops programs to meet the FDA mission;
• Provides programmatic technical assistance;
• Performs post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the FDA.

An FDA Technical Advisor(s) will be assigned to each enrolled program. The Advisor will work cooperatively with the PO to help monitor and report grantee status/progress including sharing of information and historical backgrounds. The FDA Technical Advisor will have programmatic involvement as described below including but not limited to the following:

• Provide guidance, direction, and technical assistance in project planning, implementation, and evaluation;
• Convene trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing;
• Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;
• Provision of programmatic technical assistance;
• Post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the FDA.

Unless another governance structure is mutually agreed upon, the PO will serve as the primary point of contact for the dissemination of FDA policy and milestones/objectives work planning.

Property rights (if the awardee develops something tangible):

The awardee will retain custody of, and have primary rights to, the data and software (including all source files) developed under these awards, subject to government rights of access consistent with current DHHS, PHS, and FDA policies. In all cases, FDA must be given a royalty-free, nonexclusive, and irrevocable license for the federal government to reproduce, publish, or otherwise use the material and to authorize others to do so for federal purposes. Curriculum and course content developed under this cooperative agreement grant such as objectives, learning outcomes, presentations, manuals, scripts, exercises, handouts, reports, documents, or other tangible materials produced by the awardee must be guaranteed free of copyrights from outside sources and be free domain for use by FDA. Any FDA curriculum or training course content provided by FDA will remain the property of FDA and any proposed changes are not to be made without concurrence from FDA.

Delineation of substantive involvement:

1. FDA will monitor and evaluate the overall performance of the awardee under this cooperative agreement grant

2. FDA will collaborate and work closely with awardee s continued development

3. FDA will take any action that may be necessary to ensure compliance with this cooperative agreement grant

4. FDA may choose not to have significant input or control on some projects and tasks as it may be deemed more suitable for the awardee to lead and control the design, methodology, analysis, development and/or delivery of work.

Monitoring Activities:

Periodic program monitoring will be conducted by FDA on an ongoing basis which may include telephone conversations, emails, on-site visits, review of written progress reports, audit assessments, financial reports, etc.

The Project Manager and Technical Advisor conduct the monitoring of the grantee’s performance, provide technical advice and assistance and, when necessary, investigate problems or deficiencies identified during review of reports.

The Grants Project Team (Grant Management Specialist, Program Official, Project Manager and Technical Advisor(s)) reviews the progress report to verify the satisfactory progress is being made toward the project objectives and goals in the project, proposed activities are allowable and within the guidelines of the NOFO and budget proposed includes only allowable expenses that support project goals and objectives. When necessary, the Grants Project Team will investigate problems or deficiencies identified during review of reports and determine the corrective actions required.

Performance deficiencies will be addressed by requiring a revised progress report, submission of a corrective action plan, increased reporting requirements, funding restrictions, and other methods, including up to suspension or termination of the award. The Annual Progress Report will be due as part of the Research Performance Progress Report (RPPR) and is due no later than 60 days prior to the start date of the next budget period.

Reporting Activities:

The program specific progress report template is attached to this NOFO and will be provided with the Notice of Award (NOA). The progress report template allows for the recording of SMART goals and performance metrics mentioned in Section IV. Application and Submission Information Research Strategy. All progress reports shall contain certain elements as applicable to their approved cooperative agreement and award. The template reporting elements include:

1. Development status and projected completion timeline of any trainings, workshops, meetings, and other educational materials and resources. Include activities related to:

a.Trainings, workshops, and other educational materials and resources for ISO/IEC 17025 accreditation, whole genome sequencing, GOOD Test Portions, and GOODSamples. Examples include workshops and seminars on laboratory procedures, data transfer (to NCBI and FDA data systems), document control, quality management systems, continuous improvement, sample collection, and risk assessment.

b. Lab trainings for (in order of priority): (1) radiochemistry, (2) chemistry, (3) microbiology.

c. Support provided to both LFFM and non-LFFM FERN labs.

2. Description of planning, hosting, and follow-up activities for the annual LFFM Face-to-Face and GenomeTrakr meetings and the NARMS meeting.

3. Description of the workforce development for whole genome sequencing and GenomeTrakr work. Include planning and collaboration efforts, program development steps, recruitment efforts, program details, outcomes of workforce development program, and reporting mechanisms from host labs and trainees.

4. Description of support being provided to laboratories to obtain, maintain, expand scope, and enhance ISO/IEC 17025 accreditation requirements. This includes a summary of the monitoring activities, assistance to labs facing challenges, and progress of the laboratories directly being supported through any consultant services offered under this award.

5. Description of assistance provided to states with LIMS and ORA DX support. Include activities related to:

a. Integrating FDA-provided ORAPP or ORA DX training modules into existing training programs offered by the association as appropriate or other resources developed or utilized.

b. Managing LIMS group forums; coordination and support for states implementing LIMS with a focus on integration with FDA LFFM data reporting mechanisms such as spreadsheets.

c. Strengthening state data submissions.

6. Description of collaboration with the FDA on laboratory projects that have a national scope including:

a. Supporting efforts toward data collection, evaluation, and analysis of the National Laboratory Network project.

b. Supporting state input on the FDA State Human and Animal Food Laboratory Partnerships Strategic Plan and associated activities.

c. Partnering with FDA NARMS in efforts to reduce the burden of salmonellosis in meat commodities at retail.

d. Aiding the identification of isolate sources or helping states build collaborations with isolate sources to support GenomeTrakr.

e. Promoting GenomeTrakr and LFFM accomplishments by working with states to create and publish success stories.

7. Description of collaboration with the FDA to evaluate and compile state partner feedback and input on topics identified by the FDA.

8. Description of collaborative work with the Partnership for Food Protection IT Workgroup (PFP IT WG) and Partnership for Food Protection Laboratory Workgroup (PFP Lab WG) including assisting in data system transition activities, collaborating with the PFP Laboratory Workgroup (PFP Lab WG), and updating the most recent PFP Lab Best Practices Manual.

9. Description of collaborative work for committees such as the Human and Animal Foods Committee and Food Chemistry Committee regarding FDA funded work in areas that include but are not limited to human and animal foods and food chemistry. Description of coordination with AFDO, AAFCO, NASDA, and other relevant association partners.

10. Summary of travel scholarships awarded to laboratorians for trainings, meetings, and conferences. Include the organization name, the number of scholarships awarded and the associated amounts of the scholarships.

11. Updates on the diversity procurement strategy for the utilization of disadvantaged and women-owned small businesses should include the following: outreach and marketing efforts for procurement activities to solicit goods and services, summary of methods used to distribute the solicitation; small business concerns that applied and received awards, and total diversity spend and count of disadvantaged and women-owned business procurement activities under this provision and other efforts to promote diversity, equity, inclusion and accessibility.

Not Applicable

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

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

Finding Help Online: https://www.era.nih.gov/need-help (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

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

Food and Drug Administration
Telephone: 240-402-7736
Email: Laurie.Keppley@fda.hhs.gov

Christina Chrysogelos

Office of Regulatory Affairs (ORA), Office of Partnerships (OP)

Food and Drug Administration

Telephone: 708-205-3185

Email: Christina.Chrysogelos@fda.hhs.gov

Kimberly Pendleton

Office of Acquisitions & Grants Services (OAGS)

Food and Drug Administration

Telephone: 240-402-7610

Email: Kimberly.Pendleton@fda.hhs.gov

Kimberly Pendleton

Office of Acquisitions & Grants Services (OAGS)

Food and Drug Administration

Telephone: 240-402-7610

Email: Kimberly.Pendleton@fda.hhs.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Section 1009 of the Federal Food, Drug, and Cosmetic Act (21 USC 399) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.