Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Office of Regulatory Affairs (ORA)

Funding Opportunity Title

FDA's National Curriculum Standard  Development and Training Delivery and Development (U18) Clinical Trial Not Allowed

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-20-024

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103

Funding Opportunity Purpose

The Food and Drug Administration's (FDA), Office of Regulatory Affairs (ORA), Office of Training, Education, and Development (OTED) is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement.

The goals of this Cooperative Agreement are to continue the development of the Integrated Food Safety System (IFSS) National Curriculum Standard (NCS) curriculum frameworks for regulatory stakeholders with the capacity to expand into other program areas as directed; further work and research on the development and validation of competency statements; and revise, develop and deliver courses to FDA stakeholders nationwide (other federal, state, local, tribal and territorial regulators).  All of these activities are intended to help ensure the appropriate training of regulatory stakeholders.

Under FSMA Section 209, FDA is directed to improve the training of state, local, territorial and tribal food safety officials and set standards and administer training and education programs to ensure a competent work force doing comparable work.

Key Dates

 

Posted Date

February 21, 2020

Open Date (Earliest Submission Date)

February 27, 2020

Letter of Intent Due Date(s)

March 12, 2020

Application Due Date(s)

April 28, 2020, by 11:59 PM Eastern Time.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2020

Advisory Council Review

Not Applicable

Earliest Start Date

July 2020

Expiration Date

April 29, 2020)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

    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


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    The Office of Training, Education, and Development (OTED) in the Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) is announcing the availability of cooperative agreement awards.. FDA can guarantee one year of funding to multiple awardees with the possibility of up to four years of additional, noncompetitive support, dependent on performance and continued availability of federal funds.

    This cooperative agreement funding opportunity is a continuation towards the development of the Integrated Food Safety System (IFSS) National Curriculum Standard (NCS) for the various jobs within the human food, animal food, and laboratory regulatory programs (retail food, human manufactured food, animal food, produce, milk, lab, and shellfish) with the ability to expand into other program areas as directed (pharmaceuticals, medical devices, radiological health, imports, bioresearch monitoring, tobacco, leadership and management or other training programs OTED, is or becomes responsible for); continuation of conducting course deliveries, researching and assessing stakeholder training needs; researching the effectiveness of current training models; development of a curriculum tracking database; and the design, development and/or evaluation of new or existing web and classroom courses, materials, and job aids for classroom or field training as directed.

    FDA has statutory requirements (Public Health Service Act; Food, Drug and Cosmetic Act; Economy Act; and Food Safety Modernization Act) to assist regulators in the prevention and suppression of communicable diseases, aid state and local authorities in the enforcement of federal, state, and local public health regulations, set regulatory standards, and administer training and education programs for regulatory food safety officials. As such, the training and curriculum development for federal, state, local, tribal, and territorial food safety agencies is critically needed to advance public food safety initiatives by fully developing an integrated food safety system (IFSS) for food safety regulators and laboratorians, while simultaneously assisting FDA in meeting the requirements of the Food Safety Modernization Act (FSMA) Section 209 (a)(a) (1-7).

    The Partnership for Food Protection (PFP) was formed to enable the development of the IFSS which represents a seamless partnership among federal, state, local, territorial, and tribal agencies (strategic partners) to achieve the public health goal of a safer food supply. The PFP is comprised of multiple workgroups with specific strategic plan objectives and charges that outline opportunities for mutual reliance by leveraging individual strengths and benefiting the greater food safety community. The PFP’s Training and Credentialing Workgroup is charged with developing the National Curriculum Standard (NCS) in partnership with OTED for the more than 30,000 IFSS human and animal food safety professionals operating in over 2,500 jurisdictions nationwide. The workgroup has spearheaded progress on the development of national curricula standards for IFSS human and animal food safety regulators and laboratory professionals.

    The funding opportunity contains four main sections forth coming: 1. NCS development, 2. course delivery and planning for course offerings and program area, 3. course design, development and evaluation, and 4. facilitation for updating and developing new OTED business processes.

    PART 1, NCS Development:

    A priority project under this cooperative agreement funding opportunity is the continued development of the National Curriculum Standard (NCS). This may include developing human food, animal food, and laboratory program curriculum frameworks, researching job competencies, and behavioral anchors (a matrix providing context to the expectations of the competency). Additional tasks may include but are not limited to, conducting gap analyses with existing course content and resource materials, identifying best practices in competency development, and validating NCS products with the appropriate professional stakeholder groups.

    The National Curriculum Standard curriculum framework outlines the domain topic areas necessary for competency-based training (competency statements, behavioral anchors, and field/class application exercises) spanning multiple professional levels on the curriculum frameworks: entry/basic, mid/advanced, technical/expert, and supervisor/leadership. Following completion of the entry level general education requirements, trainees will continue in the entry level beginning their job specific professional track and will be able to conduct independent activities while continuing their training progression into the mid/advanced levels.

    Awardees are expected to continue developing the IFSS National Curriculum Standard and research best practices towards, among other objectives, identifying competency standards for the various levels of the curriculum frameworks, beginning with the entry/basic level and ascending as lower levels are completed. Subcontractors may be utilized as needed to complete tasks, but their actions are expected to be consistent with OTED NCS development quality standards and policies.

    An overview of the NCS project is to work in collaboration with awardees in:

    1. Complying with FDA/OTED’s NCS development and instructional design approach and standards and SOPs.

    2. Facilitating the lifecycle approach of competency and curriculum frameworks as developed/ updated for the main framework and each program area, utilizing a curriculum database.

    3. Recruiting IFSS human food, animal food, and/or laboratory subject matter experts (SME) skilled in their profession to develop regulatory and laboratory job competencies and behavioral anchors. The awardees maybe requested to fund travel for regulatory, nonfederal SMEs to attend focus group meetings.

    4. Utilizing SME focus groups to develop job competency statements for the following domains:

        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

    5. Developing competency statements representative of course enabling and terminal learning objectives (competencies reverse engineered from course objectives, and then develop the behavioral anchors for that competency).

    6. Validating competency statements with relevant stakeholder groups.

    7. Establishing check points in collaboration with OTED throughout the NCS development process and provide monthly reporting utilizing OTED update forms outlining allocated expenses, funds remaining, initiative progress, and milestone achievement.

    8. Developing annual work and project plans in concert with OTED's work planning outlining NCS initiatives, timelines, review periods, resources utilized, and other criteria as needed.

    9. Providing mid and yearly progress reports to OTED and the Office of Acquisition and Grants Services (OAGS) as directed and required.

    10. Other IFSS NCS activities and initiatives as assigned by OTED.

    For NCS developed content, provide all competencies, behavioral anchors, manuals, presentations, handouts, job aids, resources, etc. in formats request by OTED such as Word, PowerPoint, Excel, Portable Document Format or other formats as required.

    PART 2, Course Delivery and Planning for Course Offerings and Program Area:

    Independent course deliveries for the retail food program continues to be an OTED priority with the capacity to expand training delivery into other regulatory program areas including human manufactured food, animal food, produce, milk, and shellfish (or other OTED program areas as need arise).

    The traditional model for delivering training to state, local, tribal, and territorial regulatory agencies is insufficient to meet the increased stakeholder demand for training. To meet this demand, independent course delivery awardees will work in partnership with OTED to plan, advertise, deliver, and evaluate web and classroom courses and other learning events as directed.

    Independent course delivery may include, participating in identifying cost effective approaches towards, researching and conducting training need assessments, training instructors, identifying and securing training space, printing and shipping course material, evaluating course instructors, conducting course evaluations, and providing recommendations for updating course material based on stakeholder feedback. Subcontractors may be utilized, as needed, but they should carry out their activities consistent with the aforementioned OTED course delivery quality standards and policies.

    The resource goal for delivering FDA courses is efficiency for cost and 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.

    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 travel, lodging and per diem costs, instructor salaries or wages, course materials and supplies, course material shipping expenses, transportation for field trips, training need assessments, course certificates and records, etc.

    Funding is not allocated for course participant travel, lodging, per diem, and salary or wages. Course registration and attendance is free to all federal, state, local, and tribal regulatory stakeholders. Attendance by anyone not identified by OTED as an approved course participant is not permitted.

    An overview of the course delivery initiative tasks should include, but are not limited to:

    1. Complying with FDA/OTED instructor qualifications and course delivery standards.

    2. Recruiting IFSS human and animal food subject matter experts (SME) (or other program areas, as needed) and provide instructor skills training (IST) and other OTED mandated training to SMEs identified as potential course instructors.

    3. Training instructors on how to deliver each individual course, section, unit, activity, exercise, or lecture of a course (Train-the-trainer/course-specific instructor training).

    4. Evaluating instructor performance to assure course content is delivered in compliance with FDA/OTED instructional standards.

    5. Providing recommendations to FDA regarding course material updates based on course instructor and participant feedback in post course reports utilizing OTED report standards.

    6. Maintaining various records such as for course participants, instructors, and training need requests.

    7. Providing monthly reports utilizing OTED’s report form outlining allocated expenses, funds remaining, initiative progress, and milestone achievement.

    8. Developing annual work and project plans in concert with OTED's work planning outlining course delivery initiatives, timelines, review periods, resources utilized, and other criteria as needed.

    9. Providing mid and yearly progress reports to OTED and the Office of Acquisition and Grants Services (OAGS) as directed and required with Part 1, #7 above.

    10. Developing a course delivery schedule (course ID, location and dates) in concert with OTED's work planning.

    11. Other course delivery activities and initiatives as directed by OTED under this section, Part 2.

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

    PART 3, Course Design, Development and Evaluation:

    Additional priorities include the capacity to design and develop content for new or existing classroom and web courses, virtual events, reference resources, job aids, etc. across OTED programmatic areas. This may include the need to secure software licenses, programs, learning management systems, or other tools needed to design and develop engaging regulatory curricula utilizing adult learning principles as well as the development or use of a curriculum database tracking program. 

    The instructional design ideals espoused by FDA's Office of Regulatory Affairs, Office of Training, Education and Development (OTED):

    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, 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: Identifies the instructional objectives and researches 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 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 (e.g.:  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 specific, measurable, achievable, relevant, time-bound (SMART) format.

    Attitude and 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.

    Delivery Approach: Training that is primarily focused on knowledge and comprehension should occur outside of the classroom (e.g.:  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: A course evaluation process should be used to evaluate effective training and training effectiveness (i.e. Kirkpatrick Level 1 and 2, course assessments) of meeting course objectives and use in connection with the analysis to identify and address training gaps.

    Content Development: In collaboration with the sponsor, the awardee will be expected to create course design documents, storyboards, web course templates utilizing Lectora 18 or other designated software (software acquired by awardee(s)), and style guides. OTED will provide the format/layout and design requirements for training content being developed such as web courses, presentations, reading assignments, exercises, manuals (participant and/or instructor), course evaluations, training and/or job aids consistent with FDA's expectations per standards in the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998 (section 508), FOI Act, Privacy Act, Plain Language, and Copyright (Title 17 and Fair Use) laws as applicable.

    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.  The design document and training content development will go through periodic reviews and for 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) to make any final content and/or delivery adjustments.

    An overview of class and web content design and development tasks include, but are not limited to:

    1. Developing or revising course design documents (converting competencies to SMART objectives), storyboards, assessments, knowledge checks, graphics, videos, exercises, instructor, administrator, and participant manuals.

    2. Utilizing OTED course design documents, story boards, web course templates, and/or style guides to develop course content.

    3. Establishing check points (project plan/timeline) in collaboration with OTED throughout the design and development process utilizing the OTED report form format.

    4. Providing monthly reporting utilizing OTED report form outlining allocated expenses, funds remaining, initiative progress, and milestone achievement.

    5. Developing annual work and project plans outlining initiatives, timelines, review periods, resources needed, and other criteria as needed.

    6. Providing mid and yearly progress reports to OTED and the Office of Acquisition and Grants Services (OAGS) as directed and required with Part 1, #7 and Part 2, #9 above.

    7. Reviewing and piloting test classroom course content

    8. Reviewing and piloting test web-based course content (content/functionality testing/508 compliance testing).

    9. Providing OTED all final course source files, unSCORM and SCORM packages, compliance documentation, quality guarantees and assurances, and other documentation and information as requested by OTED. Also, provide all course manuals, presentations, exercises, handouts, job aids, resources, etc. in formats request by OTED such as Word, PowerPoint, Excel, Portable Document Format or other programs

    10. Other class and web-based content design and development activities and initiatives as directed by OTED.

    PART 4, Facilitation for Updating and Developing New OTED Business Processes:

    Provide facilitation services to support OTED's internal business process improvements and initiatives. Facilitators need to have expertise in:

    1. Facilitating focus groups and meetings

    2. The ADDIE instructional design framework (analysis, design, development, implementation and evaluation of training outcomes)

    Section II. Award Information

     

    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for four (4) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

    FDA/ORA intends to fund up to $6,000,000 for fiscal year 2020 in support of this cooperative agreement program.

    It is anticipated that up to 8 awards will be made, not to exceed $1,500,000 in total costs (direct plus indirect), per award.

    Award Budget

    Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

    YR 01: $ $1,500,000

    YR 02: $ $1.500,000

    YR 03: $ $1,500,000

    YR 04: $ $1,500,000

    YR 05: $ $1,500,000

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is (5) years.

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    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)

    Governments

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

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    Foreign Institutions

    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.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • o   NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    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.

    2. Cost Sharing

    This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

    3. Additional Information on Eligibility
    Number of Applications

    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.
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

    Letter of Intent

    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 to:

    Gordana Zuber
    Telephone: 301-348-1747
    Email: Gordana.Zuber@fda.hhs.gov

    A technical session will be held for prospective applicants in March 2020. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process. Participation in the technical session is optional, but strongly encouraged. 

    Page Limitations

    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.

    Instructions for Application Submission

    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.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

    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.
    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

    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:

    • Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information

    When involving FDA-defined 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.

    PHS Assignment Request Form

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

    3. Unique Entity Identifier and System for Award Management (SAM)

    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

    4. Submission Dates and Times

    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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    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. 

    7. Other Submission Requirements and Information

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

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

    For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.

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

    See more tips for avoiding common errors.

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

    Post Submission Materials

    Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review.  Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

    Section V. Application Review Information
    1. Criteria

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

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit.

    Significance (15 Points)

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

    Investigator(s) (25 Points)

           Is the professional experience of the PD(s)/PI(s) and key personnel and staff sufficient for

           continued development and validation the IFSS NCS competencies and curriculum frameworks,

           delivery of courses and the development of classroom and virtual training content? 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? 

    Innovation (25 Points)

           Is the applicant well positioned to represent FDA's human food, animal food, and/or laboratory

           counterparts in the IFSS, working in partnership with other organizations on regulatory public

           health food safety initiatives with the NCS development, course deliveries, and course

           development? Does the applicant's plan of action respond to the scope and complexity of the

           "Funding Opportunity"? 

    Approach (20 Points)

    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?  

           Does the applicant describe how they will assist the FDA in the continued development of the    

           National Curriculum Standard, course deliveries and development? Do the methods proposed in

           the application meet accepted methodology in adult training and education approaches?

    Environment (15 Points)

           Does the association, conference or institution provide adequate program infrastructure,

           organizational resources, administration, professional skill sets, experience and oversight to

           manage their application for this RFA?  

    Additional Review Considerations

    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.

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

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

    Vertebrate Animals

    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.

    Biohazards

    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.

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Select Agent Research

    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).

    Resource Sharing Plans

    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).

    Authentication of Key Biological and/or Chemical Resources:

    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.

    Budget and Period of Support

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

    2. Review and Selection Process

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

    As part of the objective review, all applications:

    • Will receive a written critique.

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

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

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

    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.

    Section VI. Award Administration Information
    1. Award Notices

    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

    2. Administrative and National Policy Requirements

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

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

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

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

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

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

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

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

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

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

    Cooperative Agreement Terms and Conditions of Award

    Expanded authorities do not apply to this cooperative agreement.

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

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

    Submitting quarterly 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 the last month in the calendar quarter.

    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, 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 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, delivery and evaluation of activities within the scope of this cooperative agreement. FDA will be the final approval authority for tasks and will also evaluate courses to assure that instructors are applying the identified instructor competencies and delivering content consistent with the overall purpose of ensuring appropriate training for regulatory stakeholders.

    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 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 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. 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 meetings. 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 quarter (due with quarterly progress report) 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 quarterly 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.

    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.

    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.

    3. Reporting

    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.

    Quarterly progress reports are will be required. 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 the last month in the calendar quarter. A brief quarterly financial summary report 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 will be part of the quarterly progress reports. Report tallies are to include funding totals on a continuous year-to-date and monthly basis against the total award.

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

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. 

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

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

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Suzanne Webb
    Office of Regulatory Affairs (ORA)/Office of Management (OM)
    Telephone:  240-402-3069
    Email:  Suzanne.Webb@fda.hhs.gov

    John Stoll
    Office of Regulatory Affairs (ORA- OTED)
    Telephone: 312-596-4250 
    Email: John.Stoll@fda.hhs.gov

    Kathy Pinkney-Reeves
    Office of Regulatory Affairs (ORA - OTED)
    Telephone:  301-796-4472
    Email:  Kathy.pinkney-reeves@fda.hhs.gov

    Objective Review Contact(s)

    Gordana Zuber
    Office of Acquisitions & Grants Services (OAGS)
    Food and Drug Administration
    Telephone: 301-348-1747
    Email: Gordana.Zuber@fda.hhs.gov

    Financial/Grants Management Contact(s)

    Gordana Zuber
    Office of Acquisitions & Grants Services (OAGS)
    Food and Drug Administration
    Telephone: 301-348-1747
    Email: Gordana Zuber@fda.hhs.gov

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of Section 301(a) of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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