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 the Commissioner (OC)/Office of the Chief Scientist (OCS)

Funding Opportunity Title

Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Renewal of RFA-FD-16-036

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-18-011

Companion Funding Opportunity

None

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

  93.103

Funding Opportunity Purpose

As part of FDA's Advancing Regulatory Science Initiative, the Office of the Chief Scientist supports innovation aimed at development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.

This funding opportunity will provide support, depending on availability of FDA funding, for one or more of the following existing Centers of Excellence in Regulatory Science and Innovation (CERSIs): Yale University-Mayo Clinic, University of Maryland at College Park and Baltimore and Johns Hopkins University. The CERSI(s) will serve to advance the Agency's regulatory science goals predominantly through cutting-edge collaborative research with FDA; they may also provide training in regulatory science.

Key Dates

 

Posted Date

March 23, 2018

Open Date (Earliest Submission Date)

April 4, 2018

Letter of Intent Due Date(s)

April 16, 2018

Application Due Date(s)

June 4, 2018, 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

June, 2018

Advisory Council Review

Not Applicable

Earliest Start Date

September, 2018

Expiration Date

June 5, 2018

Due Dates for E.O. 12372

Not Applicable

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.


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 the Chief Scientist (OCS) in FDA's Office of the Commissioner (OC) is publishing this Funding Opportunity Announcement (FOA) to provide support for the Agency's Centers of Excellence in Regulatory Science and Innovation (CERSIs). Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. The CERSIs, interacting collaboratively with the FDA, foster robust and innovative approaches to advance the field of regulatory science as follows:

    A. SCIENTIFIC PROGRAMMATIC AREAS

    FDA has identified the following priority areas based on the Agency's current unmet regulatory science needs. As these priorities evolve, the list will be updated periodically. See FDA's Regulatory Science Research Priority Areas for updates.

    1. High priority topics, with needs across product lifecycle and relevant subpopulations (sex, gender, age, race/ethnicity):

    a. Tobacco, including, but not limited to toxicity, addiction, health effects, behavior, and communications.  See link on CTP research priorities for more information.

    b. Reducing healthcare-associated infection:

        i. Better understanding of the effectiveness of sterilization and reprocessing of medical devices

        ii. Further development of pathogen reduction technologies for whole blood and blood components

        iii. Promote development of innovative antimicrobial approaches

    c. Issues related to opioid use, misuse and dependence

    2. Develop and evaluate methods to improve quality and safety of FDA-regulated products for use by patients and consumers, including methods to improve predictive value of nonclinical evaluation

    a. Methodologies for development, manufacturing/quality control of complex generic drugs, biosimilars, biological products and medical devices

    b. Biocompatibility and biological risk evaluation of medical devices and their component  materials

    c. Evaluation of innovative methods such as:

        i. Microphysiological systems (MPS) (organ on a chip)

        ii. Computer modeling and simulation (e.g.,  in silico clinical trials and biocompatibility modeling)

        iii. Discovery and validation of minimally invasive biomarkers particularly for diseases and medical states where few markers exist (such as traumatic brain injury), including predictive microbiome biomarkers and use of current methods such as EEG and bio-imaging.

    3. Develop methods and tools to improve and streamline clinical and post-market evaluation of FDA-regulated products, including

    a. Scientifically valid approaches to incorporating patient input (e.g., patient preference, patient reported outcomes) into regulatory decision-making

    b. Complex adaptive, Bayesian, and other novel clinical trial designs

    c. Approaches to leveraging large, complex data to inform regulatory decision-making, including use of "real world" data sources and mobile technologies

    d. Evaluation of product safety and efficacy in special populations, such as maternal, pregnant and lactating women, perinatal, pediatric, and geriatric individuals

    e. Subpopulation evaluations based on age, sex, gender, race and ethnicity, including evaluation of:

        i. Safety and efficacy

        ii. Effective comprehension and usability of FDA communications

    See links on Office of Women's Health (OWH) Research Roadmap and Office of Minority Health (OMH) Research and Collaboration Program for more information.

    B. FUNDING

    1. Initial CERSI Award: FDA provides funding at the time of initial award of a cooperative agreement for CERSI activities associated with FDA's regulatory science priorities (see Part 2, Section I.A) based on availability of funding and the scope of the applicant's application.

    2. Post-Award Research Projects: In order to accelerate innovation and to address new developments in emerging regulatory science, as well as urgent unmet needs, FDA anticipates funding for additional research projects to be conducted in collaboration with the CERSIs after the initial CERSI award of a cooperative agreement.  These post-award research projects are intended to rapidly and proactively further the regulatory science efforts of FDA in response to public health needs that may not be known or identified at the time of the initial CERSI award. These studies will be conducted collaboratively with FDA. In some cases, FDA will serve in an advisory role for these projects and in other cases, FDA will participate in the projects in hands-on collaboration with the CERSI. In the latter case, internal support for the FDA portion of the project will be provided by the Agency separately from the cooperative agreement support provided for the CERSI. (It is also possible that a CERSI project could be supported, in part, by a third party.)

    Applicants are expected to leverage the funds provided by FDA for the cooperative agreement to expand support for their CERSI activities (e.g., non-FDA federal funds, non-federal funds, CERSI institutional funds, "in-kind" support such as institutional accommodations). 

    C. PROGRAM CHARACTERISTICS

    The CERSIs promote innovation in regulatory science predominantly through cutting-edge scientific research that supports FDA's regulatory needs (see Part 2, Section I.C.2); they may also provide training in regulatory science (see Part 2, Section I.C.3).  An overview of the CERSI program is provided in this section. See Part 2, Section IV.2 on PHS Research Plan for information that should be provided in your application for evaluation by FDA.

    1.   The core program infrastructure provides for effective execution of the CERSI's cooperative agreement, including coordination, management and oversight of program activities, financial transactions, reporting obligations, and interactive meetings.  In some cases, the CERSI partners with another institution working collaboratively on the program (i.e., subaward). The CERSI also interacts collaboratively on projects with FDA and with investigators within the CERSI's institution and sometimes with investigators at other institutions.

    The CERSI is expected to function independently and network with other CERSIs in the program       when possible (e.g., synergizing, collaborating and sharing expertise and program goals). 

    2.   Cutting-edge regulatory science research is the major focus of the CERSI program. Research projects designed to address an unmet regulatory science need at the Agency (see Part 2, Section I.A) are selected and conducted in collaboration with FDA. In some cases, the FDA-CERSI collaborative research projects are conducted with other CERSIs or with partners outside of FDA and the CERSIs. Whether or not FDA directly collaborates in the scientific research, it serves in an advisory role, interacting with the CERSI in project planning, monitoring, and evaluation both to provide scientific input and enhance the utility of the work to meet FDA's public health mission.

    The CERSI program may include exploratory pilot research projects that are aligned with FDA's regulatory science priorities (see Part 2, Section I.A).  These projects are weighed and prioritized in collaboration with FDA against on-going projects that require additional funding. The goal, potential impact and potential for continued funding of an exploratory pilot research project are considered in selecting these projects for the CERSI program.

    FDA-CERSI collaborative research projects are either funded by FDA upon initial CERSI award of a cooperative agreement or funded by FDA post-award. See Part 2, Sections I.B (Funding) and IV.2 (PHS 398 Research Plan) for additional information.

    Initiation of new potential research collaborations are stimulated by scientific exchanges between FDA and the CERSIs. These scientific exchanges can also serve to catalyze newly initiated or on-going collaborative research projects.  Scientific exchanges may involve FDA staff traveling to the CERSI to meet with CERSI program directors and interested researchers and/or spend time learning about new technologies. Funds for FDA staff travel to the CERSI are provided by the Agency separately from the cooperative agreement support provided to the CERSI. Reciprocally, CERSI staff can visit FDA using funds provided by the cooperative agreement.

    3.   Regulatory science training is not mandatory, but may be part of the CERSI program. If included, it should represent a minimal cost component of the program to FDA.

    Training can include proposed courses and other training opportunities for both FDA staff and the CERSIs, as well as broader efforts by the CERSIs to engage other potential partners, domestically and internationally.

    CERSI training in regulatory science may include:

    - Fellowships at the CERSIs, and, when feasible, at FDA for individuals with an advanced degree in a scientific field (e.g., M.D., Ph.D., PharmD, MPH), who participate in an FDA-CERSI collaborative research project

    - Scholar awards (small award/ stipend) at the CERSI for graduate students or postgraduates. It is highly encouraged that these CERSI Scholars participate in an FDA-CERSI collaborative research project, but they could also participate in other regulatory science related research at the CERSI

    - Incorporation of regulatory science (e.g., address scientific question(s) related to medical product development) into CERSI institution's existing coursework that pertains to disciplines currently in demand at FDA (e.g., mathematical modelers, statisticians, medical officers)

    - Courses or mini-courses in regulatory science (in-person or online), in particular, for emerging areas of regulatory science (e.g., patient preference and patient reported outcomes, real world evidence, regenerative medicine)

    - Workshops on topics related to an FDA regulatory science priority that address an unmet Agency need (see Part 2, Section I.A). These workshops may be: 1) collaborative with FDA, 2) collaborative with FDA and other partners, or 3) sponsored by the CERSI on its own. Scientific and educational workshops in partnership with FDA are conducted to bring FDA, CERSI staff, relevant stakeholders and the public together to foster collaborations and stimulate innovation in addressing the Agency's unmet regulatory science needs.

    - Lectures on an FDA-CERSI collaborative research project or related research of the project principal investigator.  They can also be on a topic related to an FDA regulatory science priority (see Part 2, Section I.A).  These lectures may be hosted by the CERSI at their academic institution, at FDA or another venue. Lectures can be in-person or webinars.

    - Competitions for students to stimulate their interest in regulatory science (e.g., America's Got Regulatory Science Talent, regulatory science writing competition)

    - Certificate or degree program in regulatory science

    - Other types of training and professional development opportunities intended to advance excellence in regulatory science and address FDA's unmet needs may be included.

    FDA-CERSI collaborative workshops and lectures are selected for the CERSI program in collaboration with FDA. Any fellowships at FDA are coordinated with FDA to assess the feasibility of having the fellow at FDA and to determine an appropriate mechanism for placing the fellow at FDA.

    It is expected that coursework for which a fee is charged by the CERSI institution should be self-sustaining and require little to no funds from the CERSI cooperative agreement. 

    See Section VIII. Other Information for award authorities and regulations.

    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

    Renewal

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

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s)

    Funds Available and Anticipated Number of Awards

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

    It is anticipated that up to three (3) awards will be made in fiscal year 2018, not to exceed $5,000,000 in total costs (direct plus indirect), per award.

    Because the nature and scope of a proposed CERSI will vary from application to application, it is anticipated that the size of each award will vary. Awards pursuant to this RFA may be funded incrementally throughout the budget period to: 1) support projects proposed in the application but not funded at the time of Initial CERSI Award; 2) continue support for successful projects funded at the time of Initial CERSI Award; or 3) support new projects.

    Award Budget

    Application budgets need to reflect the needs of the proposed program annually (including FDA-CERSI collaborative research projects proposed to be funded at initial CERSI award and those proposed for possible funding post-award) and should not exceed the following in total costs (direct and indirect):

    YR 01: $5,000,000

    YR 02: $5,000,000

    YR 03: $5,000,000

    YR 04: $5,000,000

    YR 05: $5,000,000

    Award Project Period

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

    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.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Eligibility is limited to the Centers of Excellence in Regulatory Science and Innovation (CERSI) at:

     Yale University-Mayo Clinic, Johns Hopkins University, and University of Maryland at College Park and Baltimore

    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) (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.

    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

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

    2. Content and Form of Application Submission

    It is critical that applicants follow the instructions in the Research 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.

    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:

    Shashi Malhotra
    Food and Drug Administration/Office of the Commissioner/Office of Operations/Office of Finance, Budget and Acquisitions/Office of Acquisitions and Grants Services
    Telephone: 240-402-7592
    Email: Shashi.Malhotra@fda.hhs.gov

    A technical session will be held for prospective applicants in April, 2018.  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 exception:

    For this specific FOA, limitations for the PHS 398 Research Plan Components as follows:

              Research Strategy section is limited to 30 pages.

    Note that biographical sketches are limited to 5 pages; use of hyperlinks is permitted and encouraged for citing relevant publications in biosketches and publication lists.

    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.
    • In the narrative justification for the budget, applicants must provide in a tabular format separate budget breakdowns for: 1) each of the FDA-CERSI collaborative research projects proposed for funding and 2) any regulatory science training described in the application in addition to any comprehensive budget provided. FDA-CERSI collaborative research projects that are proposed to be funded at initial CERSI award (up to 8) and those that are proposed to be funded post-award (see Part 2, Sections I.B Funding and IV.2 PHS 398 Research Plan) should be provided in separate sections of the table. Depending on the availability of funding at the time of award, FDA will use this information in conjunction with other information provided in the application to determine the funds that will be provided to the applicant at the time of award.  As indicated elsewhere, FDA-CERSI collaborative research projects are selected for the CERSI program in collaboration with FDA (see Part 2, Sections I.C.2 and IV.2 PHS 398 Research Plan).
    • 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. 

    The Research Strategy Section is limited to 30 pages and should include:

    A proposal for a CERSI program related to FDA's regulatory science priorities (see Part 2, Section I.A).  For the purposes of this FOA, 4 components must be defined:

    1)   Core program infrastructure that describes the organization of the CERSI, including coordination, management and oversight of program activities, financial transactions, reporting obligations, and interactive meetings.  Describe interaction of the CERSI with: 1) FDA, 2) an investigator at another institution that has a subaward with the CERSI (partners with the CERSI), 3) collaborative investigators within the CERSI's institution and any at other institutions and 4) other CERSIs. Provide a diagram(s) depicting the CERSI's organizational structure.

    2)   Cutting-edge regulatory science research proposed for funding at the time of initial CERSI award. Provide a brief (one page) detailed description for each FDA-CERSI collaborative research proposal (up to 8 proposals) that includes: 1) a specific aim(s), 2) its alignment with FDA's regulatory science priorities identified in Part 2, Section I.A, 3) a brief approach including milestones (timeline), and project deliverables, 4) proposed principal investigators, 5) anticipated impacts on FDA and 6) estimated project costs. These proposed collaborative research projects could involve: 1) investigation of new regulatory science priorities (see Part 2, Section I.A) or 2) further investigation of on-going FDA-CERSI collaborative research projects.  Projects will be selected for the CERSI program in collaboration with FDA.

    FDA has developed metrics for the CERSI research program; see FDA's Metrics for Assessment of Impact of CERSI Research. Applicants should consider these metrics for assessment of the anticipated impacts of proposed research projects on FDA.

    Applicants should provide a proposed plan for scientific exchanges between FDA and the CERSI for initiation of new collaborative research projects and also for catalyzing on-going collaborative research projects.

    3)   Cutting-edge regulatory science research proposed for potential funding post-award. Provide a brief (half page) description for each FDA-CERSI collaborative research proposal that includes: 1) a specific aim(s), 2) its alignment with FDA's regulatory science priorities identified in Part 2, Section I.A, 3) a brief approach and 4) anticipated impacts on FDA (see previous item for description of CERSI research program metrics for assessment of anticipated impacts). The applicant needs to present these research projects separately (under separate heading) from the FDA-CERSI collaborative research projects that are proposed for funding at the time of initial CERSI award.  As for FDA-CERSI collaborative research projects funded at the time of initial CERSI award, any FDA-CERSI collaborative research projects funded post-award are selected for the CERSI program in collaboration with FDA.

    4)   Mechanisms for leveraging funds provided by FDA to expand support of CERSI activities (e.g., non-FDA federal funds, non-federal funds, CERSI institutional funds, "in-kind" support such as institutional accommodations). Applicants should describe how they would leverage their CERSI program beyond the funding provided by FDA. Provide letters of support, if applicable.

    In addition, if the CERSI program includes regulatory science training, it should be a minimal cost component of the program to FDA and the applicant must include a description of such training in the application. Training can include proposed courses and other training opportunities for both FDA staff and the CERSIs, as well as broader efforts by the CERSIs to engage other potential partners, domestically and internationally. See Part 2, Section I.C.3 for description of different training options (e.g., fellowships, scholar awards, courses, workshops, lectures, competitions, certificate or degree programs).

    Identify any former FDA or other government employee who is a Senior/Key Person or Project Principal Investigator and their post-employment restrictions.

    CERSI Program Work Plan

    The CERSI Program Work Plan (WP) should describe the CERSI activities to be performed in response to the FOA requirements and include a single Gantt Chart with all activities described in the WP, including core program infrastructure activities. The WP should include a schedule of activities based on an appropriate time scale and should be task linked to the budget. The level of detail necessary in the WP and the corresponding Gantt Chart should be sufficient to successfully manage and execute the cooperative agreement. The WP should:

    Provide measurable outcomes for the overall CERSI program that align with the goals of the cooperative agreement. The application should identify and articulate expected measurable outcomes, and the CERSI is expected to report on progress towards accomplishing these measurable outcomes in the mid-year and annual progress reports. Periodic assessment of the CERSI program's progress will be conducted by FDA. FDA expects outcomes that are highly relevant and significantly impact the Agency's regulatory science priorities (see Part 2, Section I.A) and are supported by infrastructure-related resources and expertise at the CERSI.

    Provide a project management plan documenting how each of the FDA-CERSI collaborative research projects proposed for funding at the time of initial CERSI award of the cooperative agreement (up to 8 proposals) will be executed, managed and monitored.

    Identify appropriate resources such as equipment, facility, and raw materials necessary for the program and how they will be used. In addition, ensure that, when relevant, these resources are included in the budget.

    Provide all relevant letters of commitment that describe how the applicant will commit personnel and/or other resources to the program.

    Past Performance

    An applicant's past performance on their current CERSI cooperative agreement will be considered. The applicant should provide a brief description of their performance within the past two years and may also include any other CERSI activities of significance that occurred more than two years ago. The applicant should identify any problems encountered during the previous two years and explain how they were addressed.

    Other Requirements

    The projects will be a collaborative effort between the awardee and FDA. The applicant must explicitly indicate its willingness to:

    Cooperatively interact with FDA in support of the collaborative research projects and any FDA-CERSI collaborative workshops and lectures or any fellowships at FDA;

    When requested by FDA, provide a detailed collaborative research proposal during the course of the grant award for FDA-CERSI collaborative research projects proposed for funding either at the time of initial CERSI award or post-award so that they can be considered for selection for the CERSI program;

    Work with FDA to arrange meetings that serve to coordinate the efforts of FDA and awardee staff (agenda will be developed in conjunction with FDA), during the course of the grant award;

    Actively seek input from FDA regarding resource needs or expertise needs that may arise during the performance of the project; however, the awardee should be prepared to have the appropriate resources and expertise to successfully complete the project(s) proposed.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information

    The PHS Human Subjects and Clinical Trials Information form replaces the Human Subjects section of the Research Plan form. FOAs that do not allow clinical trials use this form for human subjects.

    When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

     
    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, such as for tobacco-related collaborative research projects that are funded by FDA's Center for Tobacco Products (CTP) in accordance with the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). 

    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 Applying Electronically. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

    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 (25 Points)

    Do the proposed research projects address FDA Center/Office regulatory science priorities? If so, which ones? If the aims of the projects are achieved, what is the projected impact on FDA? Does the CERSI management offer an opportunity to foster meaningful scientific interactions with FDA scientists to advance FDA's regulatory science needs? Has the applicant provided appropriate measurable outcomes for the overall CERSI program?    

    Investigator(s) (15 Points)

    Is the leadership's approach of the governance and organizational structure of the CERSI appropriate for the program? Are the PD(s)/PI(s) of the CERSI effectively managing the resources and the collaborations with FDA? Do the proposed CERSI investigators have good track records of performance and working with FDA or other collaborators?      

    Past Performance (20 Points)

     Have the PD(s)/PI(s) worked collaboratively with FDA? Were the projects conducted by the CERSI well aligned with FDA interests; did they have an impact on FDA? Did they resolve any problems in a timely and appropriate manner?         

    Approach and Innovation (30 Points)

    Does the application include projects that propose novel approaches to addressing FDA regulatory science questions?

    Does the CERSI maximize use of collaborative interactions to execute its CERSI program (e.g.,   with FDA, with an investigator at another institution that is a partner with the CERSI, with   investigators at its institution, with investigators at another institution)?

    Are these collaborative interactions appropriate and beneficial?  If training is included in the CERSI program, is it applicable to FDA's regulatory science interests? Does this training have minimal financial impact  on FDA?

    Does the application provide a plan for scientific exchanges between FDA and the CERSI that is likely to stimulate collaborative interactions?

    Does the application provide plans for leveraging funds provided by FDA (e.g., non-FDA federal funds, non-federal funds, CERSI institution funds and "in-kind" support such as institutional accommodations)? Are these plans likely to be viable?  

    Environment (10 Points)

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

    Additional Review Criteria

    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 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.

    Inclusion of Women, Minorities, and Children

    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.

    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

For Renewals, the committee will consider the progress made within the last two (2) years and any CERSI activities of significance provided by the applicant that occurred more than two (2) years ago.

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 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:

  • Capabilities provided by the overall CERSI program
  • Scientific and technical merit of the proposed projects as determined by objective review.
  • Availability of funds.
  • Relevance of the proposed projects to FDA's unmet regulatory science priorities (see Part 2, Section I.A).
  • Past Performance of the CERSI
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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, FDA's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the program as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

Awardee Responsibilities

The PD(s)/PI(s) (awardee) will have the primary responsibility for the scientific, technical, and programmatic aspects of the grant and for day-to-day management of the program (i.e., FDA-CERSI collaborative regulatory science research projects and any regulatory science training activities). The PD/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff has appropriate clearance (e.g., appropriate Institutional Review Board (IRB) training for human subject related research) and/or background checks to work on this program. This individual will work closely with designated officials within the recipient organization to appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.

The awardee will be required to participate in a cooperative manner with FDA:

The FDA/OCS/ORSI Program Office will be responsible for the normal scientific and programmatic stewardship of the award and an individual from this office will be named in the award notice.

--The awardee is responsible for obtaining approval from the FDA/OCS/ORSI Program Office for the development and design of certain projects (i.e., all FDA-CERSI collaborative research projects, CERSI workshops, lectures, fellowships at FDA and any other regulatory science training for which FDA cooperative agreement funds are to be used) prior to execution. The awardee is also responsible for obtaining approval for any scientific exchanges between the CERSI and FDA; the FDA/OCS/ORSI Program Office will provide funds separate from the cooperative agreement for travel of FDA personnel to the CERSI.

--The awardee is responsible for preparing materials for meetings involving participants from FDA. Some meetings occur at FDA while others are conducted via teleconference;

--The awardee is responsible for maintaining a Web site containing information on the CERSI program, including FDA-CERSI collaborative research projects and publications and any regulatory science training activities;

--The awardee is responsible for submitting mid-year and annual progress reports, when requested, to the FDA/OCS/ORSI Program Office. See Part II, Section VI.3 on Reporting for information on content for these reports;

Data Access/Data Sharing/Resource Sharing/Data Rights

-- The awardee is responsible for timely publication and public release and dissemination of results, Data (under this cooperative agreement, Data is as defined in the HHS Grants Policy Statement to mean recorded information, regardless of the form or media on which it may be recorded, and includes writings, films, sound recordings, pictorial reproductions, drawings, designs or other graphic representations, procedural manuals, forms, diagrams, work flow charts, equipment descriptions, data files, data processing or computer programs (software), statistical records, and other research data) and other products of the study, concordant with an approved plan for making Data and materials available to the scientific community and FDA.  Awardee is requested to provide materials (such as abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this cooperative agreement) for public disclosure to FDA/OCS/ORSI Program Office prior to disclosure or submission for publication so that the Agency can review the material (within an agreed upon timeframe between FDA and the awardee).

-- Publications or oral presentations of work performed under this cooperative agreement will require appropriate acknowledgement of FDA support.  Awardees should use the following language for these acknowledgements: "This work was supported [in part] by a Center of Excellence in Regulatory Science and Innovation (CERSI) grant to [insert name of institution(s)] from the US Food & Drug Administration (insert grant number). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS or FDA."

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;

--Awardees will retain custody of and have primary rights to the Data developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies. Any publications, Data or other copyrightable works developed under this grant may be copyrighted without prior FDA approval. In all cases, whether FDA funded all or part of the project or program resulting in the Data or other copyrightable work, 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.

FDA Responsibilities

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

The responsibilities of the FDA/OCS/ORSI Program Office and other FDA subject matter expert program staff with relevant scientific expertise (FDA SMEs) during conduct of the FDA-CERSI collaborative research projects is above and beyond normal program stewardship for grants.  The FDA/OCS/ORSI Program Office provides FDA oversight for the collaborative research projects and the FDA SMEs provide technical assistance, advice, and/or other assistance activities.  As appropriate, the FDA SMEs may participate in the definition of specific aims and approaches, and in planning, conducting, analyzing, and publishing results, interpretations, and conclusions of FDA-CERSI collaborative research studies.  However, the dominant role and prime responsibility for the activity reside with the awardees(s) for the project as a whole, but not necessarily for each task.

The FDA/OCS/ORSI Program Office, with assistance of FDA SMEs, will be involved in the programmatic coordination and management of any FDA-CERSI collaborative workshops and lectures and any fellowships at FDA. CERSI workshops conducted under this cooperative agreement are not permitted to provide consensus recommendations from the workshop to FDA in accordance with the Federal Advisory Committee Act (FACA) or otherwise provide consensus recommendations to others (e.g., the public) in accordance with Good Guidance Practice (GGP) regulations at 21 CFR 10.115, in particular 21 CFR 10.115(e). 

FDA and Awardee Joint Responsibilities

As relevant, the PDs/PIs (awardee) and FDA SMEs (with oversight of the FDA/OCS/ORSI Program Office) will work collaboratively in evaluating the most appropriate research methods, data quality control strategies, safety issues, study design and implementation, data analysis and interpretation, publication and dissemination of study results. Projects will require FDA/OCS/ORSI Program Office approval prior to implementation/ initiation.

During performance of the award, the FDA/OCS/ORSI Program Office, in consultation with FDA SMEs, may provide appropriate assistance, advice and guidance. The role of the FDA/OCS/ORSI Program Office will be to facilitate and not to direct the activities. It is anticipated that decisions for FDA-CERSI collaborative research projects and any FDA-CERSI collaborative workshops and lectures will be reached by consensus between the PDs/PIs and the FDA/OCS/ORSI Program Office and that FDA SMEs will be given the opportunity to offer input into this process. The FDA/OCS/ORSI Program Office will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services.

Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to a dispute resolution panel composed of three members not involved in the study. One member will be designated by the PDs/PIs, another will be designated by FDA and the third member, who will have expertise in the relevant area of experience, will be chosen by the other two members. 

This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

Non-Federal Funds

The awardee may accept funds from any entity, including an FDA-regulated entity or non-profit organization (participant), to support grant activities such as research projects, training programs, workshops or seminars, so long as federal and non-federal funds are managed in accordance with the HHS Grants Policy Statement and the awardee complies with the terms and conditions in the Notice of Grant Award, including the special terms and conditions described in this section:

I. Assurances to Prevent Conflicts of Interest, and Special Access to, or Undue Influence on FDA, or Their Appearance

  • FDA will not be involved in soliciting funds from outside entities for the grant;
  • FDA staff will abide by federal ethics rules regarding acceptance of gifts, honoraria, travel reimbursement and prospective employment (see 5 C.F.R. §2635 (2015));
  • In accordance with the HHS Grants Policy Statement, all awardees must acknowledge federal funding when issuing statements, press releases, requests for proposals, bid invitations, and other documents describing projects or programs funded in whole or in part with federal funds (see HHS Grants Policy Statement, at II-23);
  • An awardee may not promote itself as having special access to or undue influence on FDA or as having FDA endorsement of the organization, an activity, or a product; however, FDA may co-sponsor events with outside non-federal entities (see HHS Co-Sponsorship Guidance, August 8, 2002). FDA retains the authority to take remedial actions against any awardee or participant determined by the agency not to be in compliance with this requirement;
  • Collaboration activities that include members of FDA-regulated industry, academia, and/or public interest groups will be based on sound scientific evidence and designed to be protective of public health;
  • Costs for meetings must be kept reasonably low. Except where FDA funds are being used to support an activity, FDA will not itself review the relationship of the fees to the costs of the collaboration or whether meeting costs are reasonable in advance of the meeting. If, however, adherence to this assurance is questioned, FDA may take steps to evaluate the relationship of costs and fees to determine whether this assurance has not been adhered to and what action the agency may take in response;
  • Any solicitation by an awardee for outside funding and all funding agreements between the awardee and participants will include a statement that: (a) the contributions will be reasonably related to the costs of the collaboration; (b) the contributions will not result in undue influence on FDA regulatory decisions; (c) the contributions will not result in an endorsement of the participant or any of its products or activities by FDA; (d) the contributions will not provide access to non-public product specific information from FDA; (e) the contribution may be publicly acknowledged by the participant, but the participant may not promote itself as having a relationship with FDA; and (f) the participant understands that FDA staff will abide by federal ethics rules regarding acceptance of gifts, honoraria, travel reimbursement and prospective employment. In particular, any FDA employee who commences employment discussions or otherwise seeks employment with a participant will immediately recuse themselves from official participation in any collaboration involving that participant and from all other particular government matters affecting the financial interests of that participant.

II. Transparency/Equal Access:

  • The awardee must publicize major grant activities with non-federal entity(ies), including summaries of on-going research projects to the extent that publication of the work product and protection of intellectual property would not be compromised, training programs, workshops, scientific exchanges and seminars on a publicly accessible website. The awardee must also publicize on this website a list of the non-federal entities with which it collaborates;
  • The awardee must develop procedures by which any interested party may have the opportunity to provide their views and feedback on grant activities with non-federal entities, without the payment of fees;
  • As with all federally-supported research, the awardee is encouraged to publish or otherwise make publicly available all results, data, and other work-product from the grant activities with non-federal entities, consistent with relevant confidentiality laws and agreements. After the work-product is published, the awardee is encouraged to provide access to the work-product, or a citation to a publication regarding the work-product, on the same website where the awardee has publicized its grant activities.

III. External Advisory Board

The awardee may choose to create an external body of experts to advise them on its grant program

 (e.g., recommendations for research agenda, training programs, workshops or seminars).

  • Any external advisory board must be created and established by the awardee;
  • Any external advisory board must function to provide recommendations on the grant program to the awardee, and not to FDA;
  • FDA must not be a part of the external advisory board, but may attend meetings of the external advisory board on an as needed basis;
  • Organizations may, but are not required to, provide funds to the awardee to participate on the external advisory board. In choosing members of the external advisory board, the awardee may not take into account the willingness of the potential members or their employers to provide funds to underwrite grant activities.

Food and/or Meals

Grant funds may not be used for any food, meals or light refreshments, regardless if certain meals are an integral and necessary part of a meeting (i.e., a working lunch where business is transacted). This does not apply to per diem (for subsistence) that is necessary when travel is required and approved in support of the cooperative agreement.

Non-federal funds obtained from registration fees and sponsors can be used to purchase food for a workshop, conference or training event under the cooperative agreement as long as:

    1. The meal-related portion of registration fees are not collected from federal government staff, including individuals that are paid by the federal government (e.g., contractors, ORISE fellows)

    2. The non-federal funds are held in a separate account and not co-mingled with the grant funds

    3. The food is part of the event (e.g., catered meals) and not purchased individually for attendees.

In accordance with the Standards of Ethical Conduct for Employees in the Executive Branch, HHS Supplemental Standards of Conduct, the criminal conflict of interest statutes (18 U.S.C. §§ 201-209), and the Foreign Gifts and Decorations Act, a federal employee is allowed to accept a gift valued at $20 or less on a single occasion, provided that the total value of gifts from the same source is not more than $50 in a calendar year. Under this cooperative agreement, food provided to federal government staff attending a workshop, conference or training event would be considered a gift.

Terms and Conditions of Award for Collaborative Research Projects Funded by the Center for Tobacco Products (CTP)

Collaborative research projects funded by CTP are subject to the terms and conditions of this cooperative agreement.  In addition, terms and conditions, as follows, also apply to these CTP-funded collaborative research projects. 

ACTIVITIES THAT REQUIRE PRIOR APPROVAL FROM FDA/CTP:

1. PUBLICATIONS, EDUCATIONAL MATERIALS AND PRESS STATEMENTS

The grantee and its employees shall have the right, consistent with academic standards, to publish the results of research performed under this Agreement, provided such publication does not disclose confidential information of the FDA and does not reference, imply or infer any FDA endorsement of regulatory and/or policy changes related to the project.  The FDA reserves the right to request deletion of any trade secret, proprietary, or confidential information, and any inference to FDA endorsement of regulatory and/or policy changes related to the project.

The grantee agrees that, prior to submission of a manuscript, presentation, or abstract with FDA co-author(s) describing the results for publication, the grantee shall forward to the FDA a copy of the manuscript, presentation, or abstract to be submitted and shall allow the FDA 30 calendar days to review for any potential language that might reference, imply or infer any FDA endorsement of regulatory and/or policy changes related to the project.  For publications without a FDA co-author but using FDA/Tobacco User Fee funds to support the grant, a courtesy review of the publication should be shared with FDA to ensure that any potential language that might reference, imply, or infer any FDA endorsement of regulatory and/or policy changes related to the project is not stated.

The grantee shall otherwise be free to submit the manuscript and publish results in any manner consistent with academic standards.

2. CONFERENCES AND TRAVEL

Before a grantee expends any grant funds on newly proposed conference attendance and/or travel that was not previously proposed in the original application submission or subsequent progress reports, they must obtain prior approval from FDA/CTP.  A prior approval request for conference attendance and/or travel must be submitted in writing to the Program Officer and must include the following information:

A.         Title/Topic of Conference

B.         Purpose of Conference

C.         Explanation of how the Conference directly supports the grant's goals and objectives

D.         Dates of Conference

E.         Location of Conference

F.         Detailed breakdown on costs associated with Conference attendance/travel, to include the name of the attendee

3. ADDITIONAL ACTIVITIES THAT REQUIRE PRIOR APPROVAL

The following activities also require prior approval by FDA before being implemented by the grantee, its employees, or designee:

Change in scope or objectives

Change in key personnel

Change in grantee organization

Change in key partner organization(s)

Creation and distribution of promotional items

Any deviation from the terms and conditions of the award

Carryover of unobligated balances

No cost extensions

Any deviation from the approved budget

ALLOWABLE ACTIVITIES/COSTS:

Allowable activities must support CTP activities pursuant to its authorities under the Tobacco Control Act to regulate tobacco products and their manufacture, distribution, and sale in the United States, as described in RFA-FD-18-011.

CONFLICT OF INTEREST:

Financial Conflict of Interest

Recipients and investigators must comply with the requirements of 42 CFR Part 50, Subpart F, "Promoting Objectivity in Research" for which PHS funding is sought. That subpart promotes objectivity in research by establishing standards to ensure that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will not be biased by any conflicting financial interest of an investigator. These requirements do not apply to Phase I of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. Under those requirements the organization must do the following:

  • Have a written and enforced administrative process to identify and manage, reduce, or eliminate conflicting financial interests with respect to research projects for which PHS funding is sought
  • Before spending any PHS funds awarded under a new award, inform the GMO of the existence of any conflicting financial interests it identified of the type covered by 42 CFR 50.605 and assure that the interest been managed, reduced, or eliminated in accordance with the regulations
  • Continue to make similar reports on subsequently identified conflicts within 60 days of identifying them
  • Make additional information available to the OPDIV, upon request, as to how it handled conflicting interests in accordance with the regulations.  As described in the regulations, examples of how financial conflicts of interest might be addressed include the following:
  •  Public disclosure of significant financial interests
  •  Monitoring of research by independent reviewers
  •  Modification of the research plan
  •  Disqualification from participation in all or a portion of the research funded by PHS
  •  Divestiture of significant financial interests                                                                                                                     
  • Severance of relationships that create actual or potential conflicts. Recipients also

must ensure that subawards in the form of consortium agreements address whether the consortium participant's employees will be subject to the financial conflict of   interest requirements of the consortium participant or to those of the recipient.

Some IRBs also consider investigator financial conflict of interest in their deliberations, although they are not required to do so. If an IRB considers the impact of potential financial (or other) conflicts of interest on the research and the protection of human subjects, it should refer to the organization's policies and procedures for identifying and monitoring conflicts of interest. Following are some strategies used by IRBs:

  • Make IRB members aware of the organization's conflict of interest policies and procedures
  • Include a statement in the informed consent form that all investigators comply with the organizational guidelines
  • Ask investigators to complete a short questionnaire about whether they—or any person responsible for the design, conduct, or reporting of research—have an economic interest in or act as an officer or a director of any outside entity whose financial interest could reasonably appear to be affected by the research
  • Instruct IRB members during their orientation on how to identify and respond to a perceived financial, academic, or other conflict of interest.  Suggestions for recipients to consider when implementing the requirements of this regulation are available in an NIH publication, Financial Conflict of Interest–Objectivity in Research: Institutional Policy Review, available on the NIH Web site at http://grants.nih.gov/grants/policy/coi/nih_review.htm.
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.

FDA Evaluation for Non-competing Renewal

Once an award is granted, each year the applicant must submit a Research Performance Progress Report (RPPR) requesting funding for the following year. In considering requests for non-competing renewal of the award, FDA will review the progress of the CERSI program taking into account: 1) overall management and accomplishments of the CERSI program, 2) interactions with FDA, 3) achievement of FDA-CERSI collaborative research project milestones and deliverables, and 4) impact of FDA-CERSI collaborative research projects on FDA.

In addition to the RPPR, awardees are required to submit mid-year and annual progress reports and financial reports for each year of the cooperative agreement. All of these reports should be documented in an agreed upon format between FDA and the CERSI.

  • Regarding the progress reports: the mid-year report should describe progress made during the previous 6 months of the cooperative agreement related to overall management of the core CERSI program infrastructure, FDA-CERSI collaborative research projects and any regulatory science training, while the annual report should describe progress made during the entire past year. These reports should include all FDA-CERSI collaborative research projects, in process and final, accomplishments in all other aspects of CERSI work, issues and concerns encountered, and solutions used to resolve issues. In addition to providing summary information on FDA-CERSI collaborative research projects in progress reports, a separate status report should be provided for each project. These reports should also include a table of grant funds provided and expenditures/remaining funds broken down by categories (e.g., core CERSI program infrastructure, collaborative research projects, regulatory science training, travel, indirect costs). Progress reports beyond the first year of award of a cooperative agreement should include a cumulative accomplishments table listing all the previous achievements of the CERSI program.
  • When a research project is ready for communication to the public (e.g., FDA Internet site, FDA blogs), provide a brief description of the project and its current status using Plain Language Principles.

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 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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

Scientific/Research Contact(s)

Audrey Thomas
Office of the Commissioner
Office of the Chief Scientist
Telephone: 301-796-3520
Email: audrey.thomas@fda.hhs.gov

Objective Review Contact(s)

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: Shashi.Malhotra@fda.hhs.gov

Financial/Grants Management Contact(s)

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: Shashi.Malhotra@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 and 405 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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