Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

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

Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
  • February 16, 2017 - FDA Will Not Be Receiving Applications in 2017 for the Collaborating Centers of Excellence in Regulatory Science and Innovation Funding Opportunity Announcement. See Notice NOT-FD-17-002.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

RFA-FD-16-036

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 for one or more Centers of Excellence in Regulatory Science and Innovation (CERSIs), which will serve to advance the Agency's regulatory science goals through cutting-edge research, state-of -the-art training/educational programs and collaborative interactions including scientific exchanges, workshops and seminars.

This Funding Opportunity Announcement (FOA) will provide support, depending on availability of FDA funding, for: 1) competing continuation of existing CERSIs and 2) establishment of one or more new CERSIs.

Key Dates
Posted Date

April 20, 2016

Open Date (Earliest Submission Date)

April 29, 2016

Letter of Intent Due Date(s)

May 13, 2016

April 06, 2017

April 06, 2018

April 08, 2019

April 06, 2019

Application Due Date(s)

June 28, 2016, by 11:59 PM Eastern Time.

May 22, 2017, by 11:59 PM Eastern Time.

May 22, 2018, by 11:59 PM Eastern Time.

May 22, 2019, by 11:59 PM Eastern Time.

May 22, 2020, by 11:59 PM Eastern Time.

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

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

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2016,

June 2017, 2018, 2019, 2020

Advisory Council Review

Not Applicable

Earliest Start Date

September 2016, 2017, 2018, 2019, 2020

Expiration Date

May 23, 2020

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.



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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 announcing this FOA to provide support for the Agency's Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI). 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 foster an innovative and thematically coherent approach to advance the field of regulatory science as follows:

A. SCIENTIFIC PROGRAMMATIC AREAS

FDA's overarching Strategic Plan for Regulatory Science, accessible at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm :

1. Modernize Toxicology to Enhance Product Safety

2. Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes

3. Support new approaches to improve product manufacturing and quality

4. Ensure FDA readiness to evaluate innovative emerging technologies

5. Harness diverse data through information sciences to improve health outcomes

6. Strengthen social and behavioral science to help consumers and professionals make informed

decisions about FDA regulated products

7. Implement a new prevention-focused food safety system to protect public health

8. Facilitate development of medical countermeasures to protect against threats to the U.S. and global health and security

9. Strengthening the global product safety net.

FDA's medical product centers and offices have also issued announcements, as follows, that represent their Center's/Office's specific regulatory science priorities:

1. The Center for Drug Evaluation and Research's (CDER's) Priorities and Topic Areas:

a. Critical Path Program, accessible at http://wcms.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/UCM077258.pdf

b. Generic Drugs Program, accessible at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM469453.pdf

c. Safety Research Interest Group, accessible at http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM438138.pdf

 

2. The Center for Devices and Radiological Health's (CDRH's) Priorities and Research Programs, accessible at http://www.fda.gov/MedicalDevices/ScienceandResearch/ucm467550.htm and http://www.fda.gov/MedicalDevices/ScienceandResearch/ResearchPrograms/default.htm, respectively.

3.The Center for Biologics Evaluation and Research's (CBER's) Priorities, accessible at http://www.fda.gov/downloads/BiologicsBloodVaccines/ScienceResearch/UCM303542.pdf

4. The Office of Minority Health (OMH) Priorities, accessible at http://www.fda.gov/ForConsumers/ByAudience/MinorityHealth/ucm412588.htm

5. Office of Health Informatics (OHI) Priorities, accessible at http://www.fda.gov/ScienceResearch/HealthInformatics/ucm474551.htm

6. Office of Women's Health (OWH) Priorities and Funded Projects, accessible at http://www.fda.gov/downloads/scienceresearch/specialtopics/womenshealthresearch/ucm479681.pdf and http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm134809.htm, respectively



B. FDA Funding:

1. At Time of Award: FDA provides funding at the time of award of a cooperative agreement for CERSI activities associated with FDA's regulatory science priorities described in section I.A above based on the scope of the applicant's application.

2. Post-Award Supplemental Projects: In order to accelerate innovation and to address new developments in emerging regulatory science, as well as urgent, novel unmet needs, FDA anticipates additional projects to be conducted in collaboration with the CERSIs.  These Post-Award Supplemental Projects are intended to rapidly and proactively further the regulatory science efforts of the CERSI program in response to public health needs that may not yet be known or identified at the time of the original CERSI awards. In some cases, these projects may be conducted by the CERSIs in hands-on collaboration with investigators from the Agency. In this case, internal support for the FDA portion of the project will be provided separately from the external support. (It is also possible that some of the projects will be supported, in part, by a third party.)

C. Program Characteristics:

The CERSIs promote innovation in regulatory science through state-of-the-art training/educational programs, cutting-edge scientific research, and collaborative interactions including scientific exchanges, workshops and seminars (CERSI activities). 

1. State-of-the-art regulatory science training/educational programs for FDA staff and other scientists. This 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.

Training/educational programs may include regulatory science:

- Coursework that is part of a certificate or degree program

- Mini-courses

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

- Fellowships for graduate students and post-doctoral students at the CERSIs, FDA and/or industry (e.g., FDA staff can serve as mentors for fellows, fellows can participate in research activities at the CERSI, FDA, or industry)

- Opportunities for qualified FDA staff to participate in clinical experience or provide training at the CERSIs and their affiliates (e.g., hospitals associated with CERSI's academic institution).

Specific proposals should be provided for the above, as well as other suggested types of training and professional development opportunities intended to advance excellence in regulatory science.

2. Cutting-edge regulatory science research with high public health impact, including an infrastructure for collaboration to enable and support such work.  The CERSI may carry out agreed upon specific regulatory science research projects on its own or collaboratively, which could include other partners both within and outside of FDA and the CERSI. It is anticipated that whether or not FDA directly collaborates in scientific activities, it will interact with the CERSI in project planning and evaluation both to provide scientific input and enhance the utility of the work for FDA’s public health mission. Please also refer to the section for Post-Award Supplemental Projects below, section 5. While Post-Award Supplemental Projects will be discussed after award of the cooperative agreement, the regulatory science research described in this section will be evaluated pre-award, thus, short descriptions of proposed research projects (approximately a half page each) are requested at the time of submission of the application.

3. Collaborative interactions should serve to stimulate regulatory science interest and accelerate progress in areas of high priority to FDA.

Collaborative interactions may include:

- Scientific exchanges such as a visiting scientist program. FDA staff visit a CERSI to provide regulatory science lectures and/or participate in workshops, spend time learning about new technologies or how to use new instrumentation and meet with CERSI program directors and interested students, professors, and researchers.  Reciprocally, CERSI staff can visit FDA to provide regulatory science lectures and/or participate in workshops, spend time in FDA research laboratories and meet with FDA staff. These discussions often conceive or catalyze new collaborations/interactions between FDA and the CERSI.

- Workshops on regulatory science topics. These workshops should engage FDA and CERSI staff, other partners and the public. These workshops may be co-sponsored with FDA or with FDA and other partners, or sponsored by the CERSI on its own. FDA will communicate workshop topics, of interest and importance to the FDA mission, to the CERSIs periodically.  Scientific and educational workshops in partnership with FDA may be proposed for horizon scanning for emerging fields or timely public health issues to bring relevant stakeholders together and to accelerate the understanding of the fields.

- Seminars on regulatory science topics.  These seminars may be hosted by the CERSI at its academic institution, at FDA or another venue.

Applicants need to demonstrate their ability to accomplish the collaborative interactions provided above, as well as propose other types of interactions that would further regulatory science communications.

4. Core program support infrastructure at the CERSI. The application needs to justify the configuration and numbers of components (see Research Plan section for a description of components) proposed and to demonstrate that the proposed center infrastructure would facilitate effectively the achievement of the desired level of integration and synergy. The center mechanism is not appropriate to support a set of complex unitary investigations that would be best supported as individual R01s. Applicants should explicitly discuss the integration of work in the CERSI in the introductory section of the application.  Further, it is expected to be demonstrated that the use of the research center mechanism is essential to accomplishing the scientific aims set forth in the application. In addition to a narrative, evidence of the components' interdependency should be summarized in a table. The CERSI's organizational structure should be summarized in a table and a diagram.

Applicants are expected to not only function as an independent CERSI but also to network with other CERSIs in the program (e.g., synergizing, collaborating and sharing expertise and program goals).  Applicants should include plans and business models describing how their CERSI would network with other CERSIs in the program. Applicants should also include plans and business models which describe how they would leverage their CERSI program beyond the funding provided by FDA.

5. Post-Award Supplemental Projects. As previously described in section I.B.2, in order to accelerate innovation and to address new developments in emerging regulatory science, as well as urgent, novel unmet needs, FDA anticipates that the Agency may have additional funds to support CERSI activities associated with FDA's regulatory science priorities described in section I.A above.  These Post-Award Supplemental Projects are intended to rapidly and proactively further the regulatory science efforts of the CERSI program in response to public health needs that may not yet be known or identified at the time of the original CERSI awards. In some cases, these projects may be conducted by the CERSIs in hands-on collaboration with investigators from the Agency. It is also possible that some of the projects will be conducted in collaboration with a third party.

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

New

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations, availability of funding and awardee performance.

It is anticipated that up to six (6) awards will be made in fiscal year 2016, not to exceed $5,000,000 in total costs (direct plus indirect), per award.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will vary. Although the financial plans of the FDA provide support for this program, awards pursuant to this RFA may be funded incrementally throughout the budget period to support projects proposed in the application but not funded at the time of initial award, to continue support for successful projects funded at the time of initial award or to support new projects not included in the application.

Award Budget

Application budgets need to reflect the actual needs of the proposed project annually 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

Higher Education Institutions

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

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (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

Applicants must obtain 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.

2. Content and Form of Application Submission

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.

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/OCS 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), address(es), and telephone number(s) of the PD(s)/PI(s) and Participating institution(s)
  •      Number and title of this funding opportunity

The letter should be sent via electronic mail as a Word or PDF file to Eric Bozoian at eric.bozoian@fda.hhs.gov with "RFA-FD-16-036 Letter of Intent" and the Institution's Name in the message subject heading.

A technical session will be held for prospective applicants in May 2016, April 2017, April 2018, April 2019, April 2020.  The conference call information will be provided to prospective applicants that submit a letter of intent.  The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process.  Participation in the technical session is optional, but strongly encouraged. 

Page Limitations

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

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

Research Strategy section is limited to 20 pages.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

  • Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
  • In the narrative budget justification applicants must provide in a table format separate budgets broken down for each of the projects (e.g., research, education/training, collaborative interactions) described in the application in addition to any comprehensive budget provided. 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 projects that will be funded at the time of award.
  • 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 with the following additional instructions:

The Research Strategy Section is limited to 20 pages and should include:

A proposal for a CERSI program related to FDA's mission of protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, and products that emit radiation.  For the purposes of this FOA, 5 components must be defined: 1) core program support infrastructure, 2) regulatory science training/educational programs, 3) collaborative interactions to foster regulatory science communications including scientific exchanges, workshops and seminars 4) regulatory science research with high public health impact, and 5) mechanisms for acquisition of non-federal funding to leverage FDA funding and support the CERSI program, including letters of support, if applicable. Applications should include: 1) specific aims for the regulatory science research projects, educational/training programs and collaborative interactions and 2) the research strategies proposed for the regulatory science research projects.

Clear benchmarks or milestones indicating progress. The guiding principle of milestone driven research is to focus on a well-defined goal, thus achieving that goal with greatest efficiency. The use of milestones provides clear indicators of a project’s continued success or emergent difficulties. Milestones are different from specific aims. The milestones must provide objectives and quantitative outcomes by which to justify advancing the project. The application must include a strong rationale for the choice of models, parameters, and quantitative go/no-go decisions to be made by those involved in the project, based upon accepted practices in the specific field. Once an application is granted, each year the applicant must submit a Research Performance Progress Report (RPPR) requesting funding for the following year.  These benchmarks/milestones will be reviewed and evaluated by FDA in considering such requests as part of the non-competing award process.

Research Project Work Plan

The Research Project Work Plan (WP) should describe the activities to be performed in response to the FOA requirements and include a single Gantt Chart with all activities described in the WP. 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:

Include a well-defined project scope that aligns with the goals of the FOA. Provide all relevant letters of commitment that must describe how the applying institution will benefit from the project and will commit personnel and/or other resources if the proposal is funded, including a letter from the institution’s training/professional development director.

Identify appropriate resources such as equipment, facility, and raw materials necessary for the project

and how they will be used in the project. In addition, ensure that these resources are appropriately

aligned in the budget.

Provide a project management plan documenting how each project will be executed, monitored, and controlled. The management plan must include a project schedule with sufficient detail of all proposed major tasks, events, or actions that are required to fulfill the goal of the FOA.

Measurable Outcomes

As a component of the cooperative agreement, the applicant will be required to document measurable outcomes that align with the goal of the grant. The application should identify and articulate expected measurable outcomes, and the CERSI is expected to periodically report on progress towards accomplishing measurable outcomes that should, at a minimum, be detailed in the mid-year and annual progress reports and final report. The cooperative agreement is milestone-driven and funding is expected to occur in phases at completion of major milestones. Periodic assessment of progress will be conducted by FDA Subject Matter Experts (SMEs). FDA expects outcomes from CERSI that are highly relevant and significantly impact the Agency's critical public health missions, and are supported by infrastructure-related resources and expertise at the CERSI.

Past Performance

An applicant's past performance on their current CERSI cooperative agreement will be considered, if applicable. In addition, the applicant may provide information from any other relevant grant, contract, and/or cooperative agreement of similar size and complexity that involves similar or related programs, held within the past three years. Past performance information shall contain the names and phone numbers of the contracting officer or grants management official who can verify past performance information, the performance location, award number (if available), a brief description of the work performed (including as part of a team or joint venture), and a point of contact list with current telephone numbers. If past performance questionnaires were completed for these grants, contracts, and/or cooperative agreements, indicate the date(s) when they were completed. (FDA will only discuss past performance information directly with the prospective prime or sub-contractor that is being reviewed.) Past performance information on work for State and local governments, private sector clients, and subcontracts that is similar to the Government requirement will be evaluated equally with similar Federal grants, contracts, and/or cooperative agreements.

Other Special Performance Requirements

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

Work with FDA to arrange for meetings that serve to coordinate the efforts of FDA and awardee staff

(agenda will be developed and approved with FDA), during the course of the grant award;

Cooperatively interact with FDA in support of the research projects and other activities;

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 expertise to successfully complete the project(s) proposed; and

Provide a CERSI monitoring plan for all activities proposed along with specific measurable outcomes.

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 Inclusion Enrollment Report

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

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 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA's electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

Additional funding restrictions may be part of the Notice of Award.  

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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 (20 Points)

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved to address critical regulatory science needs and issues? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or processes that help FDA meet its mission? More specifically, do the training/educational programs and collaborative interaction plans and research proposals address important needs and areas of regulatory science? If the project aims are achieved, how will technological advances, FDA regulatory practices, and/or public health be impacted? Will a new approach/methodology have a competitive advantage over existing approaches? Do proposed research projects address unmet areas of regulatory science? 

Investigator(s) (20 Points)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Do they have sufficient experience and knowledge in regulatory science and in program coordination to lead the program and establish new partnerships with investigators within the institution and with other stakeholders outside their organization? If Early Stage Investigators or those 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? More specifically, does the applicant have the necessary ability to address regulatory science issues? Do project team members and/or associated collaborators have prior experience and/or necessary qualifications to successfully execute and implement the proposed regulatory science research including, where appropriate, the ability to partner and collaborate with other scientists or organizations? Is there clear commitment, experience and capacity in the area of scientific/professional development, training and scientific exchanges? Are the relationships of the key personnel to the applicant organization and, if applicable, to other partnering organizations (e.g., Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), academic laboratories, clinical sites and/or strategic partners) appropriate for the work?  

If past performance information was provided for the applicant, were the examples both recent (i.e., completed within the past three years) and relevant (i.e., similar in size, scope, complexity, dollar cost, and grant/contract type to that in this application)? If involved in past team efforts, how well did the applicant perform with respect to the entire team, e.g., consortia, joint venture members, and proposed sub-award organizations, as applicable? Based on the information provided, did the applicant: 1) complete progress and final reports, outcomes, and milestones in a timely manner; 2) comply with previous contract/grant requirements and produce accurate and technically excellent outcomes; 3) have significant and exceptional technical achievements; 4) encounter few, if any, significant problems, and/or resolve problems in an appropriate manner; 5) provide effective management and behave in a cooperative and proactive manner with the contracting officer or grants management official; and 6) have appropriate cost controls in place and perform within budget? Does the available past performance information suggest that the applicant will have a high probability of success in meeting the requirements of this cooperative agreement?

Innovation (20 Points)

Does the application challenge and seek to shift current regulatory science 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 regulatory science research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Does the research outcome have the potential to solve the identified problem and create significant value in informing FDA-regulated product evaluation and the regulatory decision-making process? Are there clear public health benefits that would accrue from success of the program? Are the technologies or experimental approaches state of the art? 

Approach (20 Points)

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

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?  

Environment (20 Points)

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? Is the applicant organization concentrating on its core competencies to maximize its chances of success? Has the applicant established alliances/collaborative partnerships where they are appropriate or needed to facilitate achievement of the research goals?  Has the applicant provided an adequate plan and business model for leveraging their CERSI program beyond the funding provided by FDA?  

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

Not Applicable

Revisions

Not Applicable 

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the objective review, all applications:

  • Will receive a written critique.

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

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

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

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

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

Additional terms and conditions regarding FDA regulatory and 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 project as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, and programmatic aspects of the grant and for day-to-day management of the project or program. 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 and/or background checks to work on this project or program. This individual will work closely with designated officials within the recipient 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.

All applicants will be required to participate in a cooperative manner with FDA:

--The awardee is responsible for submitting mid-year progress reports, when requested, to the FDA Project Scientist;

--The awardee is responsible for preparing materials for the meetings involving participants from the FDA, to occur in the Washington, DC Metro area;

-- The awardee is responsible for timely publication and public release and dissemination of

results, 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 for public disclosure to FDA Project Scientist 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);

--The awardee is responsible for maintaining a Web site containing information on the CERSI program,

including training/educational programs, scientific research and publications, workshops and seminars;

--Awardees 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.

--The awardee is responsible for obtaining approval for the development and design of FDA projects, such as research projects and workshops, prior to execution

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 Project Scientist include involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities that is above and beyond normal program stewardship for grants.  As appropriate, the FDA Project Scientist will participate in the definition of objectives and approaches, and in planning, conducting, analyzing, and publishing results, interpretations, and conclusions of their 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.

In addition to the FDA Project Scientist, a separate FDA Program Official (PO) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Government, via the FDA PO, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. The FDA PO may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards.

The FDA will be involved in the programmatic coordination and management of training, professional development and training-related scientific exchanges through mechanisms such as Fellowships. The responsibilities of FDA include involvement in identifying and developing training as well as developing and coordinating mechanisms for professional development and training-related scientific exchanges.

Areas of Joint Responsibility include:

As relevant, the PDs/PIs and the FDA Project Scientist in collaboration with FDA PO 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 Project Scientist approval prior to implementation/initiation.

During performance of the award, the FDA Project Scientist, with assistance from other scientific program staff who are designated based on their relevant expertise, may provide appropriate assistance, advice and guidance. The role of the FDA Project Scientist 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 PDs/PIs, the FDA Project Scientist and FDA PO and that the FDA staff will be given the opportunity to offer input into this process. The FDA Project Scientist will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services.

The PDs/PIs will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Cooperative Agreement.  Intended public disclosures shall be submitted to FDA Project Scientist, so the Agency can review them (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. The PDs/PIs will be responsible for timely publication of major findings.

The FDA and CERSI will work collaboratively to identify and coordinate training, professional development and training related scientific exchange opportunities.

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 themself  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.
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.

Awardees are required to submit mid-year and annual progress reports, monitoring plans, 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 research projects, educational/training programs and collaborative interactions, while the annual report should describe progress made during the entire past year. These reports should include preliminary and final research project outcomes, accomplishments in all aspects of CERSI work, progress in meeting performance metrics, issues and concerns encountered, and solutions used to resolve issues. In addition, 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.

--Regarding the monitoring plans: the mid-year and annual monitoring plans, which can be a section in the progress reports, should include a timeline (or Gantt chart) showing the dates and status of accomplishing expected outcomes.

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. 

Cash Transaction Reports

The Federal Financial Report (FFR) has a dedicated section to report Federal cash receipts and disbursements. For recipients this information must be submitted quarterly directly to the Payment Management System (PMS) using the web-based tool. Quarterly reports are due 30 days following the end of each calendar quarter. The reporting period for this report continues to be based on the calendar quarter. Questions concerning the requirements for this quarterly financial report should be directed to the PMS.

Financial Expenditure Reports

A required Federal Financial Report (FFR) must be submitted annually.

FDA now requires all financial expenditure reports to be submitted electronically using the Federal Financial Report (FFR) system located in the eRA Commons. This includes all initial FFRs being prepared for submission and any revised FSR/FFRs being submitted or re-submitted to FDA. Paper expenditure/FFR reports will not accepted.

Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. Failure to submit timely reports may affect future funding.

Regarding the financial reports: in addition to the requirement for the annual financial statement at the end of each year, awardees are required to submit mid-year and annual financial reports  (on an agreed upon date between FDA and the awardee) to the Grants Management Specialist, FDA Project Scientist and FDA Project Manager.

Closeout Requirements (when applicable): A Final Program Progress Activity Report, Final Federal Financial Report SF-425, Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428, and Statement of Disposition of Equipment (if applicable) must be submitted within 90 days after the expiration date of the project period. All forms can be found at: https://grants.nih.gov/grants/forms.htm.

A non-Federal entity that expends $750,000 or more during the non-Federal entity's fiscal year in Federal awards must have a single or program-specific audit conducted for that year in accordance with the provisions of 45 CFR 75, Subpart F-Audit Requirements.  Audits must be completed and submitted electronically to the Federal Audit Clearinghouse (FAC) within 30 days after receipt of the auditor's report(s), or 9 months after the end of the audit period, i.e., the end of the organization's fiscal year, whichever is earlier. If you need information on your organization’s obligations, please visit the following website: http://harvester.census.gov/sac/. Valuable information is included under the “Frequently Asked Questions” section of that website.

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: https://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 CenterTelephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

York Tomita
Office of the Commissioner,
Office of the Chief Scientist
Telephone: 301-796-9624
Email: OC-OCS-Grants@fda.hhs.gov

Objective Review Contact(s)

Eric Bozoian
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration (FDA)
5630 Fishers Lane
Rockville, MD  20857
Telephone: 240-402-7623
Email: eric.bozoian@fda.hhs.gov

Financial/Grants Management Contact(s)

Eric Bozoian
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration (FDA)
5630 Fishers Lane
Rockville, MD 20857
Telephone: 240-402-7623
Email: eric.bozoian@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 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.

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