Required Application Instructions

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

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

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

The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. FSMA aims to ensure that the U.S. food supply is safe by shifting regulatory focus from responding to contamination to preventing it. The new law results in multiple regulations being developed for human food, animal feed to include preventive controls, imports, produce, sanitary transportation and intentional adulteration.

Instructional Design Approach for Training Content:

Course Integrity: Training content is designed utilizing best practices in adult learning to meet course goals, objectives and learning outcomes. Instructional systems specialists (instructional designers) work with subject matter experts (SMEs) to match course content with appropriate learning 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 (instructional designers, SMEs, program/project managers, industrial/organizational psychologists, and psychometricians.

Analysis: Identifies and clarifies the instructional problems, objectives and training needs, identifies the learning environment, learner's current knowledge and skill levels. Expectations for the newly acquired behavior, knowledge, skills and competencies should be tied to the requirements for successful job performance.

Proficiency Levels: Establish course learning outcomes (cognitive, affective, and psychomotor) and learning standards consistent with industry 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. They 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 shall be written using the Performance, Condition, Criterion methodology.

Attitudes 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 satisfactory job performance.

Delivery Approach: Generally, training that is primarily focused on knowledge and comprehension should occur outside of the classroom (i.e. online courses or readings), while the application and/or demonstration components take place in the classroom setting. Thus in the classroom, lecture is minimized and interactive learning is stressed. Training occurs over multiple learning events using a blended approach and 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) in meeting course objectives.

Legal Requirements: The design and development of training content needs to incorporate and adhere to 508 standards, FOI Act, Privacy Act, and Copyright laws as applicable.

Style Guides: DHRD will provide the format/layout and design requirements for all training content being developed such as web courses, presentations, readings, exercises, manuals (participant, instructor and/or administrative for course delivery instructions), course evaluations, training and/or job aids.

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 being followed as the project is being developed; periodic reviews are needed such as SME review of course content and instructional integrity. Where content lies within an online interface, their functionality, technical and instructional reviews would 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.

Produce:

Update DHRD's Produce Farm Investigations training program to include goals, objectives, learning outcomes and competencies utilizing the instructional design approach outlined in this announcement.

Design and develop DHRD's new FSMA Produce Safety training program to include goals, objectives, learning outcomes and competencies utilizing the instructional design approach outlined in this announcement.

In the course design and develop stages, research existing entities that may have existing content or be developing similar training content on investigations, produce production, good agricultural practices and/or related to the FSMA produce safety rule such as other federal agencies and the Produce Safety Alliance that may be able to supplement DHRD's training program development.

Instructor skills training:

Deliver instructor skills training to those IFSS regulatory subject matter experts on the best practices for instructing and delivering courses on the new FSMA regulations, including FSMA Alliance courses. The instructor skills training would be germane for all instructors (but not how to deliver the particular nuances specific to each unique course).

Design, develop and deliver training for instructors on how to instruct and deliver specific classroom courses being developed under the new FSMA regulations (priority with Preventive Controls for human food and animal feed and address others as feasible). These Courses are designed to enable instructors to deliver and/or facilitate the unique presentations and exercises within each individually titled course. Utilize the instructional design approach outlined in this announcement.

In the course design and develop stages, research existing entities that may have existing content or be developing similar training content relevant to delivering FSMA courses that may be able to supplement DHRD's training program development.

Resources and Funding:

The resource goal for delivering 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.

Funding is allocated to cover costs on mutually agreed upon projects within the scope of this cooperative agreement grant such as costs (direct and indirect) associated with course design, development, and delivery to include travel for SMEs in course design and development, course instructors and course participants (not federal employees), course materials, training venues, course certificates and records and subcontractors as needed.

FDA’s Role:

FDA provides SMEs for FDA centric training content (FDA regulations and policy), oversight, scientific, and programmatic interaction with awardee on activities within the scope of this cooperative agreement grant and evaluating courses to assure that instructors are applying the identified instructor competencies and delivering course content as instructed and not deviating from FDA’s intended delivery.

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

This opportunity is available only to the following entities that are currently being funded under the RFA: Assisting the Integrated Food Safety System's National Food/Feed Training Program (U54), RFA-FD-11-028:

North Carolina State University, Grant# 5U54FD004326-04
University of California at Davis, Grant# 5U54FD004327-04
Auburn University, Grant# 5U54FD004330-04
University of Tennessee, Grant# 5U54FD004331-04
National Environmental Health Association (NEHA), Grant# 5U54FD004325-04
International Food Protection Training Institute (IFPTI), Grant# 5U54FD004324-04
FDA's funding is for the remaining fifth year on RFA-FD-11-028. Competition is limited to these entities for the following reasons: 

The awardees under the current RFA-FD-11-028 are presently familiar with the expectations and business processes DHRD utilizes in applying adult learning best practices in designing, developing and delivering training courses whether online or in the classroom, as well as supporting materials such as student, instructor and administrative course manuals, 508 requirements and job aids. The current grantees possess the necessary subject matter experts necessary to expand training needs under the IFSS for produce safety training and instructor development. The Produce and Instructor Skills Training projects fall within the current award RFA-FD-11-028.

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. Late applications will not be accepted for this FOA.

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

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

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

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

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

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The FDA will not accept duplicate or highly overlapping applications under review at the same time.  This means that the FDA will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

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

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

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

Not Applicable

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

• 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

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

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

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

Part I. Overview Information contains information about Key Dates. 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. 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.

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.

Only the review criteria described below will be considered in the review process. All applications submitted to the FDA in support of this announcement are evaluated for scientific and technical merit through the FDA peer review system.

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? 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 the training application proposal for our nation's regulators 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?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? 

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? Will there be sufficient provision for adequate program infrastructure, administration, and oversight of subcontractors to accomplish the specific aims of the project?

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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.

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 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 on 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 other working for FDA. Manuscripts are to be submitted to the PO within two weeks of acceptance for publication.

As a 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 is 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. However, the dominant role and prime responsibility for the projects and activities reside 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 activity and results.

During performance of the award, the PO, with assistance from other scientific 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 and not to direct the activities. It is anticipated that decisions in 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 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 shall be 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 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 topic project.

Provide a brief financial summary report each month (due on the 15th of each month) 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 conduct 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.

Pre-Award Costs:

According to PHS policy, if pre-award costs are necessary, they may be approved by the authorized institutional official(s).

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements.

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

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

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

Dan Lukash
FDA Grants Specialist
Telephone: 240-402-7596
Email: [email protected]

Dan Lukash
FDA Grants Specialist
Telephone: 240-402-7596
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.