It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Human Resource Development (DHRD) is announcing the availability of a cooperative agreement to be awarded under a Limited Competition. FDA can guarantee one year of funding with the possibility of up to four years of additional, noncompetitive support, dependent on performance and continued availability of federal funds.

The national associations /organizations eligible to apply for funding under this cooperative agreement must be a national association/organization that represents State and local laboratories that conduct food and/or animal feed testing on behalf of State and local regulatory programs. Organizations as such are well positioned to represent FDA's laboratory counterparts in the IFSS, working together on regulatory, public health and food safety activities.

The awardee will be required to sub award a minimum of 25% of the funds received under this award to at least two different associations in order to meet the goals of the cooperative agreement. One association must represent State manufactured food regulatory officials and the other association must represent State animal feed (food) regulatory officials. Prior approval of the sub awards by FDA is required.

Training for federal, state and local food safety agencies is critically needed to fully develop an integrated food safety system (IFSS) for laboratories and human food and animal feed regulators and assist FDA in meeting the requirements of the Food Safety Modernization Act (FSMA) Section 209 (a)(a)(1-7) and the legal authority of Section 301 of the Public Health Service Act. .

The Partnership for Food Protection (PFP) is the action arm of the IFSS. PFP has representative membership across the country from federal, state, and local regulators and advances the mission of the IFSS. The PFP has multiple workgroups with specific strategic plans and charges. The PFP’s Training and Certification Workgroup is charged to develop the National Curriculum Standard (NCS) for the more than 30,000 IFSS feed and food safety professionals operating in over 2,500 jurisdictions nationwide.

The PFP Training and Certification Workgroup has spearheaded progress on the development of national curricula for IFSS food safety professionals, and to date is developing a national curriculum framework for the jobs conducted by laboratorians working with human and animal food.

PART 1:

The laboratory curriculum framework outlines the domain topic areas necessary for competency (outcome) based training (competency statements, key performance indicators, and field/lab bench application exercises need to be developed to reinforce training and enhance proficiency) spanning five professional levels: entry, mid-level, expert, supervisor/manager, and senior administration (agency specific training content is addressed by each jurisdiction). Following completion of the entry level general education requirements, trainees will continue in the entry level beginning their professional laboratory track and will be able to conduct independent activities while continuing their training and work at the mid-level.

Laboratorians will be expected to continue their research into new and/or improved laboratory methods and training at the expert level and consider continuing through the supervisory/manager and senior administration levels as their desire, proficiency and opportunity enables them to do so.

Awardee is expected to continue developing the IFSS Laboratory National Curriculum Standard research best practices on all five levels of the curriculum framework, beginning with the entry level and ascending as lower levels are completed utilizing the instructional design ideals espoused by FDA’s Office of Regulatory Affairs, Division of Human Resource Development (DHRD) and conduct research analysis for best methods of delivering training:

Course Integrity: Training content is designed utilizing best practices in adult learning to meet course goals, objectives (terminal and enabling) and learning outcomes. Instructional systems specialists and instructional designers work with subject matter experts (SMEs) to align course content with effective and efficient training methods and modalities.

Professional Staff: In the phases of analyzing, researching, designing, developing and evaluating training needs and content, there is an expectation that corresponding professional skill sets are utilized to conduct these activities such as instructional system specialists and designers, SMEs, program/project managers, industrial/organizational psychologists, and psychometricians.

Analysis: Conducts research to identify the instructional objectives, training needs, learning environment, and learner's current knowledge and skill levels. Competencies addressing expectations for the newly acquired behavior, knowledge, and skill should be tied to the requirements for successful job performance. Needs Assessment, Job, task and/or competency analyses may be conducted to provide research to support a foundation and validation of IFSS employee development programs.

Proficiency Levels: Establish course learning outcomes (cognitive, affective, and psychomotor) and learning standards consistent with accepted learning taxonomy (i.e. Bloom’s Taxonomy, Krathwohl's Taxonomy and Harrow's Taxonomy).

Learning Outcomes: Developed consistent with industry accepted practices and standards such as Mager’s Theories on Criterion Referenced Instruction and the use of performance-based learning objectives. Learning outcomes define the competency expectations and provide the specificity of the desired behavior; what will personnel be able to do/demonstrate after completing a specific course and to what level of proficiency? Where practical, objectives are written using the performance, condition and criterion based methodology.

Behaviors: The regulator’s mindset and conduct in carrying out regulatory activities need to be included as a component of the training content and process as behavioral science is an important component to job performance. Grantee should conduct research to ascertain and incorporate current behavioral science as it applies the various components of the laboratorian's job.

Delivery Approach: Training that is primarily focused on knowledge and comprehension should occur outside of the classroom (i.e. online courses or independent reading assignments), while the application and/or demonstration components take place in a classroom setting. Thus in the classroom, lecture is minimized and interactive learning is emphasized. Training occurs over multiple learning events using a blended approach. Reinforcement should be provided to the degree necessary for reaching mastery of the job tasks.

Evaluation: Conduct behavioral research to evaluate effective training and training effectiveness (i.e. Kirkpatrick Level 1 and 2, course assessments) of meeting course objectives.

Legal Requirements: The design and development of training content needs to incorporate and adhere to 508 standards, FOI Act, Privacy Act, Plan Language, and Copyright (Title 17 and Fair Use) laws as applicable.

Content Development: Course design documents, storyboards, web course templates utilizing Lectora 12 (software acquired by awardee(s)), and style guides: DHRD will provide the format/layout and design requirements for all training content being developed such as web courses, presentations, reading assignments, exercises, manuals (participant and/or instructor), course evaluations, training and/or job aids; all course materials are required to conform to the course development templates.

Project Life Cycle: Content development is progressive and systematic, beginning with the design document that includes details such as project title and description, target audience, goals, objectives, learning outcomes, methods and modalities. To assure the design document is followed as the project is developed; periodic reviews are needed such as SME/ISD review of course content and instructional integrity. Where content lies within an online interface, their functionality, technical and instructional reviews will be necessary followed by pilot testing. Classroom courses require a course walk through for further refinements and a pilot (first class offering) in order to make any final content and/or delivery adjustments. Continue research and evaluations with delivery of future courses, both online and classroom to determine effectiveness and/or need for improvements.

An overview of the NCS development status includes, but is not limited to:

1. Adhere to FDA/DHRD’s NCS development and instructional design approach (above)

2. Facilitate the lifecycle approach of competency and curriculum frameworks as developed/updated for the main framework and each program area

3. Competency domain definitions address:

a. Communication: Competencies related to communicating with diverse populations through verbal, written and non-verbal means

b. Core: Competencies that cut across all domains

c. Critical Thinking: Competencies related to objectively assessing information collected from a variety of sources by using a disciplined, analytical, and repeatable thought process while achieving a defensible conclusion

d. Organizational Awareness: Competencies related to the understanding of the regulatory agency’s authority, structure, activities, and mission.

e. Technical: Competencies related to the knowledge, skills, and abilities specifically relating to food and feed regulatory control

4. Develop competency statements down to levels 5. This is a process that takes over arching competencies for a domain area down to sub-competency statements of increasing specificity for each topic or unit under a domain

5. Validate competency statements to a minimum of level 4

6. Use DHRD’s templates for course design documents, story boards, web course templates, and/or style guides to develop course content based on research and analysis of data and findings with SMEs

7. Review and pilot test course content

8. Established check points throughout the NCS development are required for approval prior to continuation of the project

The application must include the following activities:

1. Adhere to FDA's NCS development and instructional design approach (above)

2. Develop annual work plans for continuing the development of the IFSS Laboratory NCS to include areas such as the level, domains, competency statements down to the appropriate level 5 to 7, and key performance indicators (KPI), in conjunction with FDA.

3. Recruit IFSS laboratory subject matter experts (SME) to assist in the NCS development with FDA.

4. Validate competency statements down to the level 4 (equivalent to the terminal learning objective for each unit within a course or domain topic area.

5. Other activities as necessary to develop the IFSS Laboratory NCS.

PART 2:

Develop and/or Deliver Training Meeting the IFSS Laboratory National Curriculum Standard (NCS)

The current model for delivering laboratory training to state and local regulatory agencies is not sufficient to meet the increased demand that now exists under FSMA and IFSS. Web and classroom courses and other learning events being developed and/or delivered must meet the NCS and in cooperation with FDA.

To deliver FDA lab courses, tasks include related activities such as researching and conducting training need assessments for IFSS laboratories, train instructors (instructor skills training course), oversee/audit course instructors, course evaluations and updating courses based on feedback and FDA concurrence. These tasks may utilize subcontractors as needed.

The resource goal for delivering FDA courses is cost efficiency for quality outputs while utilizing the most productive means. Course site selection should find that balance to minimize travel costs between course participants and the instructor cadre. Having the instructor cadre travel to the state or locality reduces travel costs for state/local regulators, whereas which town or city the course is hosted in can impact the instructors travel, lodging and per diem costs. Also, consideration should be given to the state or locality hosting a course if they can provide free government conference/training/lab space or a hotel may provide free or reduced conference room(s) costs with a room block.

Funding is allocated to cover costs on mutually agreed upon projects within the scope of this cooperative agreement such as costs (direct and indirect) associated with course delivery, training instructors ( instructor skills training and course-specific instructor training for each course i.e. LB101, LB102, etc.), instructor travel, lodging and per diem costs for course location, instructor salary or wages, course materials and supplies, shipping course materials/supplies, transportation for field trips, training need assessments, course certificates and records, and/or costs associated with course updates or development.

Funding is not allocated for course participant travel, lodging, per diem, and salary or wages. Course participants are not to be charged a course entrance or registration fee.

The application must include the following activities:

1. Adhere to FDA's NCS development and instructional design approach (above)

2. Recruit IFSS subject matter experts (SME) and provide instructor skills training (IST, general instructor skills that can be utilized in any course) to those SMEs identified as potential instructors.

3. For each instructor that has successfully completed the instructor skills training (IST), also needs to be trained on how to deliver each individual course or section(s) of a course whether an activity, exercise or lecture (course-specific instructor training).

4. Provide oversight of instructors to assure that they are delivering course content as instructed and not deviating from FDA’s intended delivery and utilizing their IST training skills as instructors.

5. Make recommendations to FDA regarding course updates and new developments based on course feedback and training need research and assessments and may assist FDA in carrying out resulting projects with subcontractors as needed.

6. Maintain training records for course participants, instructors and training need requests. Also issue course certificates for those successfully completing training and provide FDA with a copy of training records.

7. Develop annual work plans for designing, developing blended learning courses/events in conjunction with FDA, to include monthly status reports to DHRD POC

8. Develop annual work plans for training needs assessments and a course delivery schedule.

FDA’s Role:

FDA provides SMEs for FDA centric training content (FDA regulations and policy), project oversight, scientific input, content review and programmatic interaction with awardee(s) on activities within the scope of this cooperative agreement grant.

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.

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)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

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.

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the instructions in the Research Instructions for 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:

Allison Mandel
Email: [email protected]

A technical session will be held for prospective applicants in July, 2017. 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.
• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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

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

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

Foreign (non-U.S.) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout 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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

What is the significance and benefit of developing the NCS for IFSS laboratories and subsequent training content and course delivery to have a competent workforce doing comparable work across strategic regulatory partners (federal, state, and local agencies) to achieve the public health mission of a safer food supply under the IFSS?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Is the professional experience of the PD(s)/PI(s) and key personnel and staff sufficient to develop the IFSS National Curriculum Standard (NCS) competency and curriculum frameworks for laboratories, further work on the development and validation of competency statements, develop and deliver laboratory courses meeting NCS?

Does the applicant have previous interactions and accomplishments with state/local food and feed laboratorians related to curriculum development, recruiting subject matter experts (SME) and training programs?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the application challenge the appropriateness and methodologies proposed in curriculum and training course design?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Do the methods proposed in facilitating NCS development process meet accepted methodology in adult training and education approaches?

Does the applicant describe how they will assist the FDA in building out the IFSS National Curriculum Standard and food/feed training programs?

If the project involves human subjects and/or FDA-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the applicant possess the organizational resources, capabilities and experience to manage their application to this RFA?

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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous Objective Review Committee and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

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 Objective Review Committee are adequate and whether substantial changes are clearly evident.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

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

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by an Objective Review Committee using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

Appeals of objective review will not be accepted for applications submitted in response to this FOA.

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

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

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

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

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

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

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

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

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 judgment about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements.

HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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

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

Cooperative Agreement Terms and Conditions of Award

Expanded authorities do not apply to this cooperative agreement grant.

The awardee will be required to sub award a minimum of 25% of the funds received under this award to at least two different associations in order to meet the goals of the cooperative agreement. One association must represent State manufactured food regulatory officials and the other association must represent State animal feed regulatory officials. Prior approval of the sub awards by FDA is required.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when state and local governments are eligible to apply), and other DHHS, Public Health Service (PHS), and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement grant, 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 grant, the FDA purpose is to support and stimulate the awardee’s activities by involvement in and otherwise working jointly with the awardee in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardee for the project as a whole, although specific tasks and activities may be shared among the awardee and FDA as outlined below.

Project Director/Principal Investigator primary responsibilities:

The PD/PI will have the primary responsibility for managing the technical and programmatic aspects of the grant, and for day-to-day management of the project(s)/ tasks, program and subcontractors as needed. 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, as needed, has sufficient clearance and/or background checks to work on this project or program. The PD/PI will work closely with designated officials within the awardee’s organization to prepare justifications, appropriately acknowledge federal support in publications, announcements, news programs, and other media, and ensure compliance with other federal and organizational requirements.

The awardee is also responsible for:

1. Submitting monthly progress reports to the FDA Project Officer (PO). These reports will include an update on all progress made on assignments and monies spent to date against the total award. The report will be due by the 15th of each month.

2. Travel and preparing materials for meetings with FDA personnel in the Washington, D.C. metro area or other designated area.

3. Participating in a cooperative manner with FDA.

4. Timely submission of all training content and/or reviews by subject matter experts (co)authored by members of the grant and/or reviews authored by others working for FDA. Manuscripts are to be submitted to the PO within two weeks of acceptance for publication.

As part of this cooperative agreement grant, the FDA PO and staff will have substantial programmatic involvement that is above and beyond the normal stewardship of grants. The responsibilities of the designated PO and support staff include activities such as technical assistance, advice, coordination, providing subject matter experts (SMEs) for developing and reviewing training content, and/or assisting with other activities that are above and beyond normal grant program stewardship. As appropriate, the PO and support staff will participate in defining the goals, objectives and approaches for planning, analyzing, designing, developing, publishing, delivering and evaluating training and education content. The dominant role and prime responsibility for the projects and activities resides with the awardee for the project as a whole, but not necessarily for each task. As resources permit, FDA will continue to support the cooperative agreement grant with input from FDA staff and other SMEs.

Areas of joint responsibility include:

As relevant, the PD/PI will work collaboratively with the designated PO and support staff in evaluating the most appropriate methods, data quality control strategies and implementation, data analysis and interpretation, publication, and dissemination of project activities and results.

During performance of the award, the PO, with assistance from other FDA program staff who are designated based on their relevant expertise, may provide appropriate assistance, advice, review and guidance. The role of the PO will be to facilitate, not direct the activities. It is anticipated that decisions regarding all activities will be reached by consensus between the awardee and PO, and that selected FDA staff will be given the opportunity to offer input into this process. The PO will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services.

FDA’s role:

FDA provides oversight, scientific, and programmatic interaction with awardee in regard to the design, development, and evaluation of activities within the scope of this cooperative agreement grant. FDA will also evaluate all courses to assure that instructors are applying the identified instructor competencies and delivering content as instructed and not deviating from FDA’s intended delivery modality.

Acknowledgement of federal support:

When issuing statements, press releases, publications, promotional materials, presentations, agendas, and internet postings or printing training content such as course manuals, presentations, web courses, reference material and/or other documents describing projects or programs funded in whole or in part with federal money, the awardee needs to clearly indicate:

*Funding for this (insert appropriate venue, i.e.: conference, training, manuals, presentations, credentials, etc.) was made possible, in part, by the Food and Drug Administration through grant (insert grant number). Views expressed in written materials or publications (where course manuals/publications and presentations have been reviewed and approved by FDA, it may be appropriate to remove in written materials or publications seek input from the PO for appropriate verbiage for each project) and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.*

Property rights:

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.

Other rights, requirements and expectations:

The Government, via the PO, will have access to data generated under this cooperative agreement grant and may periodically review the data, progress reports and/or prepare internal project reports, however awardees will retain custody of and have primary rights to all data developed under these awards.

FDA retains the right to conduct audits and/or request meetings with the awardee management to discuss training programs and other related activities. FDA shall be responsible for funding the travel and travel related costs for FDA personnel (or other federal employees). Any travel cost incurred by the awardee to meet with FDA is the responsibility of the awardee under this grant.

The awardee is expected to remain flexible in support of the overall purpose of the cooperative agreement grant. This may include delivery of training to FDA, state, local, territorial, and tribal regulators as well as academia and regulated industry personnel or the need to reprioritize projects.

Credentials (e.g., certificates, certifications, licenses, continuing education units) should be developed under the appropriate standards such as those found under American National Standards Institute (ANSI).

Exams, assessments and other security related documents developed for ANSI/ISO/IEC 17024 accredited certification related purposes should be maintained by the awardee in accordance with the standard. Curriculum, technical reports (e.g. job/task analysis report) and other non-security related certification and curriculum documentation shall remain free of copyright and be free domain for use by FDA.

The awardee should not previously or presently be involved in legal suits against the federal government.

The awardee will be expected to participate in monthly progress reports. At the discretion of FDA, these meetings may be in person, via conference call, or electronic conferencing. The meetings may involve FDA, other grantees, sub/contractors, subject matter experts, and personnel stipulated by FDA, in addition to the PO, together with awardee personnel knowledgeable of and familiar with the project topic.

The awardee shall provide a brief financial summary report each month (due by the 15th) by categories and/or projects (direct and indirect costs) for funds spent or paid, obligated (but not yet paid for), and remaining funds not yet obligated to a project. Report tallies are to include funding totals on a continuous year-to-date and monthly basis against the total award.

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/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

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.

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons 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 Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

James (Jim) Fear
Office of Regulatory Affairs (ORA))
Telephone: 301-796-4513
Email: [email protected]

Allison Mandel
Office of Acquisitions & Grants Services (OAGS)
Telephone: 240-402-7602
Email: [email protected]

Allison Mandel
Office of Acquisitions & Grants Services (OAGS)
Telephone: 240-402-7602
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.