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

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

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

The 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).

The FDA hosts the CERSI Program to foster robust and innovative approaches to advance regulatory science, and the goal is for the CERSIs to advance regulatory science individually and synergistically, under the CERSI Program led by the Office of Regulatory Science and Innovation, through collaborative interactions with the FDA scientific experts and funding offices. We aim for that to be accomplished through the framework described below.

Regulatory science is the science of developing tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products, which include medical devices, drugs, biologics, combination products, veterinary medicine, food, cosmetics, dietary supplements, and tobacco products.

In addition to the product areas that FDA regulates, FDA also aims to target cross-cutting areas that have the potential to transform how FDA-regulated products are developed, evaluated, surveilled and used, such as digital health, artificial intelligence, data science, alternative methods, One Health, patient-centered outcomes, and behavior change/ social science.

Moreover, FDA aims to target innovation in regulatory science that advances the health of the following demographic groups and populations with clinical characteristics which may frequently preclude their participation in clinical research: racial & ethnic minorities, sex and gender minorities, women, children and adolescents, older adults, persons from rural geographies, persons who are immunocompromised, persons who are pregnant and lactating, persons with HIV infection, persons receiving gender-affirming medical interventions, persons with disabilities, persons with cancer, persons with rare diseases, and populations that include patients from multiple groups, like persons with rare cancers.

A. REGULATORY SCIENCE FRAMEWORK

The goal of the framework is to harness regulatory science outcomes to accomplish the following three charges, directly aligning with FDA’s mission, to:

I. Modernize Development and Evaluation of FDA-Regulated Products

II. Strengthen Post-market Surveillance and Labeling of FDA-Regulated Products

III. Invigorate Public Health Preparedness and Response of the FDA, Patients and Consumers

These three charges are foundational to FDA’s mission, and thus are not expected to change. We have designated areas to target regulatory science efforts that support the FDA’s mission for each charge, which are expected to change with the evolution of science, technologies, and public health needs. These areas that FDA are targeting with this FOA are defined in each of the lettered lists in Sections I through III below. Moreover, the cross-cutting areas are identified as those regulatory science areas that impact a majority of product areas across all three charges.

I. Harness regulatory science to modernize development and evaluation of FDA-regulated products

This charge is relevant for the following FDA-regulated product areas: devices, drugs, biologics, combination products, veterinary medicine, food, cosmetics, dietary supplements, and tobacco products.

Moreover, the following charge is applicable to these demographic groups, and populations with clinical characteristics which may preclude their participation in clinical research: racial & ethnic minorities, sex and gender minorities, women, children and adolescents, older adults, persons from rural geographies, persons who are immunocompromised, persons who are pregnant and lactating, persons with HIV infection, persons receiving gender-affirming medical interventions, persons with disabilities, persons with cancer, persons with rare diseases, and populations that include patients from multiple groups, like persons with rare cancers.

Furthermore, the cross-cutting areas have the potential to transform how FDA-regulated products are developed and evaluated: digital health, artificial intelligence, data science, alternative methods, One Health, patient-centered outcomes, and behavior change/ social science.

The following areas of regulatory science are identified to accomplish Charge I, modernize development and evaluation of FDA-regulated products:

A. Alternative methods to animal studies (e.g., microphysiological systems)

B. Advanced manufacturing approaches

C. Analytical and computational methods

D. Biomarkers tools (e.g., imaging)

E. Clinical outcome assessment surveys/tools (e.g., patient-reported outcomes, clinician-reported outcomes, performance outcomes)

F. Complex, adaptive, Bayesian, and other novel clinical trial designs, (e.g., methods for considering different endpoints; approaches for utilizing and validating artificial intelligence, machine learning, and natural language processing)

G. Methods for assessing behavioral, economic, or human factors

H. Approaches to incorporate patient and consumer input (e.g., patient and consumer preferences)

I. Methodologies to assess whether real-world data (RWD) (e.g., data derived from electronic health records (EHRs), registries, observational data, data gathered from digital health technologies) are fit-for-purpose to serve as real-world evidence (RWE)

J. Methodologies to enable and improve data source interoperability

II. Harness regulatory science to strengthen post-market surveillance and labeling of FDA-regulated products

This charge is relevant for the following FDA-regulated product areas: devices, drugs, biologics, combination products, veterinary medicine, food, cosmetics, dietary supplements, and tobacco products.

Moreover, the following charge is applicable to these demographic groups, and populations with clinical characteristics which may preclude their participation in clinical research: racial & ethnic minorities, sex and gender minorities, women, children and adolescents, older adults, persons from rural geographies, persons who are immunocompromised, persons who are pregnant and lactating, persons with HIV infection, persons receiving gender-affirming medical interventions, persons with disabilities, persons with cancer, persons with rare diseases, and populations that include patients from multiple groups, like persons with rare cancers.

Furthermore, the cross-cutting areas have the potential to transform how FDA-regulated products are surveilled and labeled: digital health, artificial intelligence, data science, alternative methods, One Health, patient-centered outcomes, and behavior change/ social science.

The following areas of regulatory science are identified to accomplish Charge II, strengthen post-market surveillance and labeling of FDA-regulated products:

A. Approaches for assessing viability, reliability (fit-for-purpose), and relevance of RWD

(e.g., data derived from electronic health records (EHRs); medical claims and billing data; data from product, disease registries, and registry networks; patient-generated health data, including from in- home-use settings; and data gathered from other sources that can inform on health status, such as mobile devices, wearables, or other digital heath technologies) to support regulatory decision-making

B. Methods or utilizing and validating artificial intelligence approaches (e.g., machine learning, deep learning, natural language processing)

C. Novel statistical and epidemiologic methods

D. Automated reporting tools for adverse events and active surveillance

E. Approaches for assessing behavioral, economic, or human factors

F. Methods to improve communication about risk to patients and consumers (e.g., safety recalls for medical products, food safety recalls), and support patient decision-making (e.g., patient-specific labeling, patient decision aids)

G. Approach to expand data capacity, and increase data quality and utilization

H. Efforts to harmonize existing data standards

III. Harness regulatory science to invigorate public health preparedness and response of the FDA, patients, and consumers

This charge is relevant for the following FDA-regulated product areas: devices, drugs, biologics, combination products, veterinary medicine, food, cosmetics, dietary supplements, and tobacco products.

Moreover, the following charge is applicable to these demographic groups, and populations with clinical characteristics which may preclude their participation in clinical research: racial & ethnic minorities, sex and gender minorities, women, children and adolescents, older adults, persons from rural geographies, persons who are immunocompromised, persons who are pregnant and lactating, persons with HIV infection, persons receiving gender-affirming medical interventions, persons with disabilities, persons with cancer, persons with rare diseases, and populations that include patients from multiple groups, like persons with rare cancers.

Furthermore, the cross-cutting areas have the potential to transform how FDA-regulated products are surveilled and labeled: digital health, artificial intelligence, data science, alternative methods, One Health, patient-centered outcomes, and behavior change/ social science.

The following areas of regulatory science are identified to accomplish Charge III, invigorate public health preparedness and response of the FDA, patients, and consumers:

A. Reinforce Medical Countermeasures Initiative (MCMi) and increase preparedness and response for emerging public health threats

B. Mitigate Antimicrobial resistance

C. Strengthen Patient and consumer engagement and communication

D. Understand substance use and minimize misuse

E. Apply population approaches to Precision Medicine

F. Expand One Health approaches

G. Identify and harness relevant emerging technologies

H. Strengthen global product safety net

1. Medical product shortages

2. Food safety surveillance in global market

3. Import operations

4. Global vaccine production

5. Global supply chain

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 Framework (see Part 2, Section I.A) based on availability of funding and the scope of the applicant's application.

2. Post-Award Research Projects: To accelerate innovation and address developments in emerging regulatory science, as well as urgent unmet needs, FDA anticipates providing funding for additional research projects to be conducted in collaboration with the identified CERSI institution 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 harness their CERSI platform 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 science needs (see Part 2, Section I.C.2); they may also provide regulatory science information sharing opportunities (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 FDA’s evaluation.

1. The core program infrastructure supports the 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 other institutions working collaboratively on the program (i.e., subaward). These partnerships may be formed to fill unmet needs and complement the regulatory science infrastructure of the CERSI institution. (e.g., increase access to diverse demographic populations and investigators who are members of demographic populations that are historically underrepresented in clinical research or who predominantly serve diverse populations, harmonize globally on regulatory science areas important to other regulatory agencies).

The CERSI is expected to function independently but is encouraged to network with other CERSIs in the program when possible (e.g., synergize on areas of regulatory science, collaborate and share expertise and program goals, regulatory science competitions for students, scholars' program).

2. Cutting-edge regulatory science research is the major focus of the CERSI program. Research projects designed to address regulatory science needs 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 FDA directly collaborates in the scientific research, it remains in an advisory role. FDA identifies subject matter experts within the Agency to provide scientific input and enhance the utility of the work to meet FDA's public health mission and also participates in project planning, monitoring, and evaluation.

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 is stimulated by interactions and scientific discussions between FDA and the CERSIs, which 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 information sharing opportunities are not mandatory but are encouraged to be part of the CERSI program. If included, it should represent a minimal cost component of the program to FDA as compared to the funding proposed for research projects.

The CERSIs may propose a range of regulatory science information sharing 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 regulatory science information sharing opportunities 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
• Lectures, bootcamps, mini-courses, and 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, digital health, clinical trial diversity) as well those identified in the Regulatory Science Framework (see Part 2, Section I.A).
• Workshops on topics related to the Regulatory Science Framework (see Part 2, Section I.A). These workshops may be: 1) collaborative with FDA or 2) collaborative with FDA and other partners. 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.
• Competitions for students to stimulate their interest in regulatory science

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

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

Higher Education Institutions

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

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

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

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)

Local Governments

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

Other

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

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 allowed.

Applicant Organizations

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

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • 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.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed. Institutions interested in involving multiple offices/departments (within their institution) should internally coordinate and choose one (1) entity to apply.

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.

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

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

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
Email: [email protected]

A technical session will be held for prospective applicants on November 10, 2022. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process. Participation in the technical session is optional, but strongly encouraged.

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

For this specific FOA, the Research Strategy section is limited to 30 pages.

Note that biographical sketches are limited to 5 pages each; use of hyperlinks is permitted and encouraged for citing relevant publications in biosketches and publication lists. Biographical sketches only need to be included for CERSI program directors, project principal investigators and key personnel. Identify any former FDA or other government employee who is a Senior/Key Person or Project Principal Investigator and their post-employment restrictions.

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

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

For Renewal Applications Only:

• For field 4. a. Federal Identifier - The Federal Identifier is required. Include only the IC and serial number of the previously assigned award number (e.g., use FD005938 from 5U01FD005938-07).
• For field 8. TYPE OF APPLICATION - applicant must mark 'RENEWAL'

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

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

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

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

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
• Indirect/F&A costs under grants to foreign and international organizations will be funded at a fixed rate of 8 percent of modified total direct costs (MTDC), exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. (With the exception of the American University of Beirut and the World Health Organization, which are eligible for full F&A cost reimbursement). Awards to domestic organizations with a foreign or international consortium participant may include 8 percent of MTDC, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.
• 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 information sharing opportunities 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).

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

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

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

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.

Research Strategy:

The CERSI program aims to complement FDA’s scientific knowledge, expertise, and infrastructure to target research areas outlined in the Regulatory Science Framework (see Part 2, Section I.A) that enable FDA to advance its mission.

The Research Strategy Section is limited to 30 pages and should include a proposal for the scope and focus of the CERSI program related to FDA's regulatory science priorities, along with the CERSI Work Plan and summary of past performance, if applicable.

For the purposes of this Notice of Funding Opportunity announcement, 4 components must be defined in the research strategy:

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 a) FDA, b) collaborative investigators within the CERSI's institution, c) investigators at partner institution that have a subaward with the CERSI, if applicable, d) investigators at other institutions and e) other CERSIs. A diagram(s) depicting the CERSI's organizational structure may be provided.

2) Cutting-edge regulatory science research proposed for funding at the time of the initial CERSI award. Provide a one-page description, up to 8, for each FDA-CERSI collaborative research proposal that targets an area outlined in the Regulatory Science Framework. Each one-page description should include a) a specific aim(s), b) alignment with FDA's regulatory science framework identified in Part 2, Section I.A, c) a brief approach including milestones (timeline), and project deliverables, d) proposed principal investigators, e) anticipated outcomes, and f) estimated project costs. Note that modifications to the project proposals may be proposed by FDA prior to selection of funding.

FDA has developed Outcomes of Interest for Regulatory Science Research Projects, which will be used to assess the contributions/impact of the CERSI program.. Applicants should consider these when planning, proposing, and communicating about CERSI research projects.

Applicants should also propose a plan for how they envision scientific discussions and interactions between FDA and the CERSI for initiation of new collaborative research projects, and also for how they aim to interact with FDA staff for ongoing collaborative research projects.

3) Cutting-edge regulatory science research projects proposed for potential funding post-award. Provide a half-page description for each project and include a) a specific aim(s), b) alignment with FDA's regulatory science framework identified in Part 2, Section I.A, c) a brief approach, d) anticipated outcomes, and e) estimated budget.

Applicants should provide proposals that highlight the strength and breadth of the CERSIs potential contribution to work alongside FDA to advance regulatory science.

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. Projects may be selected for the CERSI program in collaboration with FDA after the initial award.

4) Proposed mechanisms for how the CERSI program directors aim to harness their platform 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) beyond the funding provided by FDA. Provide letters of support, if applicable.

5) (optional) If the CERSI program includes regulatory science information sharing opportunities (see Part 2, Section I.C.3), it should be a minimal cost component of the program to FDA and the applicant must include a description of such opportunities in the application.

6) (optional) Diversity plan

Describe plans to:

• Include investigators who are members of demographic populations that are historically underrepresented in clinical research or who predominantly serve diverse populations
• Enhance diversity in studies involving human subjects by increasing the participation of individuals from diverse backgrounds, including those from underrepresented groups (e.g., underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women)
• Enhance diversity in participation in regulatory science information sharing opportunities

Where applicable, applicants should describe the success of previous strategies to enhance diversity in the planning and implementation of the above. Describe any organizational partnerships with institutions and organizations serving historically underserved communities such as: Historically Black Colleges and Universities (HBCUs); Minority Serving Institutions (MSIs); Hispanic-Serving Institutions; Tribal Colleges and Universities; Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander-Serving Institutions (AANAPISIs); Women s Colleges and Universities; Organizations serving veterans, individuals with disabilities, LGBTQIA+ individuals, economically disadvantaged; etc.

CERSI Program Work Plan

The work plan (WP) should include 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 areas outlined in the Regulatory Science Framework (see Part 2, Section I.A) and are supported by infrastructure-related resources and expertise at the CERSI.

The work plan should also include a description of how each of the FDA-CERSI collaborative research projects proposed for funding at the time of initial CERSI award of the cooperative agreement or funded later will be executed, managed, and monitored. For example, specify whether project management support will be provided by core CERSI program staff who manage and monitor all projects in the CERSI portfolio or on a case-by-case basis by an individual in the awarded PIs laboratory/group. If the latter, please describe how communication between CERSI program directors and the awarded PIs will be handled to ensure consistency between management of projects and that CERSI program directors stay abreast of the project status. Please also describe plans for ensuring timeliness and adequacy of project deliverables, including manuscripts/publications, for projects and activities conducted under the cooperative agreement.

Identify appropriate resources such as equipment, facility, and raw materials necessary for the program and how they will be used. Additionally, 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 or challenges encountered during the previous past grant cycles and explain how they were addressed.

Other Requirements

The applicant must explicitly indicate its willingness to:

• Cooperatively interact with FDA in support of the collaborative research projects and regulatory science information sharing opportunities
• When requested by FDA, provide a detailed collaborative research proposal during 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 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

Appendix:

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

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.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement and 45 CFR 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

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).

All research projects involving human subjects will have a restriction on use of funds for activities involving active recruitment of human subjects until both IRB approvals and FDA Human Subject Protection determinations have been completed.

Similarly, all research projects involving animals will have restrictions on use of funds for activities involving active animal research until Institutional Animal Care and Use Committee (IACUC) review has been completed for the project. There should be a formal written understanding that addresses responsibility for animal care and use, animal ownership, and IACUC review and oversight.

For some projects additional agreements and approvals (e.g., material transfer agreements, Paperwork Reduction Act (PRA) clearance) may be required before the study can proceed.

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier 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 are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

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

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

Do the proposed CERSI management, infrastructure, expertise, and partnerships offer an opportunity to foster meaningful interactions with FDA scientists to advance FDA's regulatory science needs that will lead to meaningful public health impact?

Have relevant cross-cutting areas been identified in the core award proposal?

If the aims of the projects are achieved, will there be significant anticipated impacts on regulatory science according to Outcomes of Interest for Regulatory Science Research Projects?

Has the applicant provided appropriate measurable outcomes for the overall CERSI program?? ??

Are there clear public health benefits that would accrue from success of the program?

Is the CERSI’s proposed leadership and approach of the governance and organizational structure of the CERSI appropriate for the program?

Does the background and expertise of the PD(s)/PI(s), collaborators, and other researchers make them well-suited to support the CERSI program?

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 the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise?

Does the information provided demonstrate a track record of success for the investigators to achieve relevant regulator science outcomes?

Are the technologies or experimental approaches proposed cutting-edge and aim to fill gaps in FDA expertise and resources?

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

Does the application provide viable plans for fully utilizing funds provided by FDA?

Does the application provide viable plans for gaining addition funding from sources beyond FDA (e.g., non-FDA federal funds, non-federal funds, CERSI institution funds and "in-kind" support such as institutional accommodations?

Is there a sound approach for managing projects and accountability, ensuring smooth communication between FDA and CERSI PIs and monitoring project timelines and deliverables?

Does the proposed approach lay out mechanisms to harness 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 the collaborative interactions appropriate and beneficial to the CERSI and FDA?

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

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

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?

Will the management of the CERSI program in the proposed scientific environment be appropriate for successful completion of the projects?

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?

Has the applicant established alliances/collaborative partnerships to facilitate achievement of the proposed research goals??

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.

If applicable, included

• 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?

• If applicable, included
• How well does the diversity plan demonstrate efforts to enhance diversity by increasing the participation of individuals from diverse backgrounds, including those from underrepresented groups?

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

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

Not Applicable

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

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

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

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

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

As part of the objective review, all applications:

• Will receive a written critique.

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

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

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

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

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

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions and in the Notice of Award. 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, this FOA, and Notice of Award.

Institutional Review Board or Independent Ethics Committee Approval: For projects that involve Human Subjects and/or Clinical Trials Research, Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.

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

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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. For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about FDA's commitment to supporting a safe and respectful work environment, and what FDA's expectations are for institutions and the individuals supported on FDA-funded awards, please see https://www.fda.gov/science-research/about-science-research-fda/fda-sexual-harassment-policy-concerning-extramural-research.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 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.

Termination provisions in 2 CFR 200.340 (a) (1-4) are applicable to awards issued under this Notice of Funding Opportunity.

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

Reporting Requirements:

All FDA grants require both Financial and Performance reporting.

Financial Reporting:

A. Financial Expenditure Reports

A required Federal Financial Report (FFR) must be submitted annually. All annual FFRs must be submitted electronically using the Payment Management System (PMS). This includes all initial FFRs being prepared for submission and any revised 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. If a grant is under expanded authorities, the grantee must indicate the carryover amount in Section 12. Remarks of the annual FFR.

Performance Progress Reporting:

When multiple years (more than one budget period) are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually as required in the Notice of Award. Annual RPPRs must be submitted using the RPPR module in eRA Commons. The annual RPPR must include a detailed budget. Annual RPPRs are due no later than 60 days prior to the start of the next budget period.

Failure to submit timely reports may affect future funding. Additional Financial and Performance Progress reports may be required for this award. Any additional reporting requirements will be listed under Section IV Special Terms and Condition of the Notice of Award.

Salary Caps:

None of the funds in this award shall be used to pay the salary of an individual at a rate in excess

of the current Executive Level II of the Federal Executive Pay Scale.

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

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

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

Acknowledgment of Federal Support:

When issuing statements, press releases, publications, requests for proposal, bid solicitations and other documents --such as tool-kits, resource guides, websites, and presentations (hereafter statements )--describing the projects or programs funded in whole or in part with FDA federal funds, the recipient must clearly state:

1. the percentage and dollar amount of the total costs of the program or project funded with federal money; and,

2. the percentage and dollar amount of the total costs of the project or program funded by non-governmental sources.

When issuing statements resulting from activities supported by FDA financial assistance, the recipient entity must include an acknowledgement of federal assistance using one of the following statements.

If the FDA Grant or Cooperative Agreement is NOT funded with other non-governmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with 100 percent funded by FDA]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

If the FDA Grant or Cooperative Agreement IS partially funded with other nongovernmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with XX percentage funded by FDA/HHS and $XX amount and XX percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

The federal award total must reflect total costs (direct and indirect) for all authorized funds (including supplements and carryover) for the total competitive segment up to the time of the public statement. Any amendments by the recipient to the acknowledgement statement must be coordinated with FDA. If the recipient plans to issue a press release concerning the outcome of activities supported by FDA financial assistance, it should notify FDA in advance to allow for coordination.

Additional prior approval requirements pertaining to Acknowledgement of Federal Support, publications, press statements, etc. may be required, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Prior Approval:

All prior approval requests must be submitted using the Prior Approval module in eRA Commons. Any requests involving budgetary issues must include a new proposed budget and a narrative justification of the requested changes. If there are any questions regarding the need or requirement for prior approval for any activity or cost, the grantee is to contact the assigned Grants Management Specialist prior to expenditure of funds.

For grant awards not covered under Expanded Authorities, Carryover and No Cost Extension (NCE) requests will require prior approval. All Carryover and NCE requests should be submitted using the Prior Approval module in eRA Commons. ****Please review the section on Expanded Authorities to determine if this award is covered/not covered under Expanded Authorities and whether prior approval is needed for carryover and no cost extension requests.****

The following activities require prior approval from FDA on all awards:

1. Change in Grantee Organization

2. Significant Rebudgeting

3. Change in Scope or Objectives

4. Deviation from Terms and Conditions of Award

5. Change in Key Personnel which includes replacement of the PD/PI or other key personnel as specified on the NoA.

6. Disengagement from the project for more than three months, or a 25 percent reduction in time devoted to the project, by the approved PD/PI. No individual may be committed to more than 100% professional time and effort. In the event that an individual's commitment exceeds 100%, the grantee must make adjustments to reduce effort. For FDA-sponsored projects, significant reductions in effort (i.e., in excess of 25% of the originally proposed level of effort) for the PD/PI and key personnel named on named on this Notice of Award must receive written prior approval from FDA.

Additional prior approval requirements may be required for this award, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Audits and Monitoring:

Audit Requirements:

1. Recipients of Federal funds are subject to annual audit requirements as specified in 45 CFR 75.501 (https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=8040c4036b962cc9d75c3638dedce240&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1501). Grantees should refer to this regulation for the current annual Federal fund expenditure threshold level which requires audit.

2. Foreign recipients are subject to the same audit requirements as for-profit organizations (specified in 45 CFR 75.501(h) through 75.501(k).

3. For-profit and foreign entities can email their audit reports to [email protected] or mail them to the following address:

U.S. Department of Health and Human Services
Audit Resolution Division, Room 549D
Attention: Robin Aldridge, Director
200 Independence Avenue, SW
Washington, DC 20201

Monitoring:

Recipients are responsible for managing the day-to-day operations of grant-supported activities using their established controls and policies, as long as they are consistent with Federal, DHHS and FDA requirements. However, to fulfill their role in regard to the stewardship of Federal funds, FDA monitors our grants to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the recipient, audit reports, site visits, and other information available to FDA.

1. Desk review: FDA grants monitoring specialists will periodically reach out to recipients to request information for the completion of desk reviews. Requested information may include:

• Policies and procedures
• List of grant expenditures
• Accounting records
• Supporting documents (e.g., invoices, receipts, paystubs, timesheets, contracts, etc.)
• Financial statements
• Audit reports
• Other related documentation

2. Site visits: FDA will conduct site visits when necessary and will notify the recipient with reasonable advance notice of any such visit(s).

3. Foreign entities: All Foreign entities are subject to the same monitoring requirements as domestic entities. Foreign entities covered under immunity Executive Orders will provide supporting documents for monitoring requirements unless such an action is a violation of the Executive Orders. Recipients may discuss with the FDA to come up with an alternate approach to satisfy the award monitoring requirements.

All recipients will make reasonable efforts to resolve issues found, including audit findings. Successful resolutions to issues are important as they are part of the grant performance review. All recipients are responsible for submitting all requested information in an expeditious manner. Failure to submit timely reports and/or respond to inquiries from FDA may affect future funding or enforcement actions, including withholding, or conversion to a reimbursement payment method.

Financial Conflict of Interest (FCOI):

This award is subject to the Financial Conflict of Interest (FCOI) regulation at 42 CFR Part 50 Subpart F.

Closeout Requirements (when applicable):

A Final Research Performance Progress Report (FRPPR), Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 120 days after the expiration date of the project period. All closeout documents must be submitted electronically in eRA Commons.

The Final Federal Financial Report (FFR SF-425), must be submitted in PMS and indicate the exact balance of unobligated funds and may not reflect unliquidated obligations. There must be no discrepancies between the Final FFR expenditure data and FFR cash transaction data in the Payment Management System (PMS). The expended funds reported on the Final FFR must exactly match the disbursements and the charge advances in PMS. It is the recipient's responsibility to reconcile reports submitted to PMS and to the FDA.

Program Income:

The grantee is required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the grantee s Federal Financial Report (FFR) SF-425.

Examples of Program Income include (but are not limited to): fees for services performed during the grant or sub-grant period, proceeds from sale of tangible personal or real property, usage or rental fees, patent or copyright royalties, and proceeds from the sale of products and technology developed under the grant.

Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee will be treated as identified below.

Treatment of Program Income:

Prohibition on certain telecommunications and video surveillance services or equipment:

(a) As described in CFR 200.216, recipients and subrecipients are prohibited to obligate or spend grant funds (to include direct and indirect expenditures as well as cost share and program) to:

(1) Procure or obtain,

(2) Extend or renew a contract to procure or obtain; or

(3) Enter into contract (or extend or renew contract) to procure or obtain equipment, services, or systems that use covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. As described in Pub. L. 115-232, section 889, covered telecommunications equipment is telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities).

i. For the purpose of public safety, security of government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities).

ii. Telecommunications or video surveillance services provided by such entities or using such equipment.

iii. Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise, connected to the government of a covered foreign country.

Other:

This award is subject to the requirements of 2 CFR Part 25 for institutions to maintain an active registration in the System of Award Management (SAM). Should a consortium/subaward be issued under this award, a requirement for active registration in SAM must be included.

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 with cumulative total value greater than $10,000,000 must report and maintain information 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 the Federal Awardee Performance and Integrity Information System (FAPIIS)). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75.

You must administer your project in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/providerobligations/index.html and https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

• You must take reasonable steps to ensure that your project provides meaningful access to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals, see https://www.hhs.gov/civilrights/for-individuals/special-topics/limited-english-proficiency/fact-sheetguidance/index.html and https://www.lep.gov.
• For information on your specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and taking appropriate steps to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sexdiscrimination/index.html.
• For guidance on administering your project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscienceprotections/index.html and https://www.hhs.gov/conscience/religiousfreedom/index.html.

Additional Reporting Requirements:

All FDA grants require annual financial and performance progress reporting. This award has additional performance reporting requirements as outlined below.

Mid-Year interim performance progress reports are required for this award. The interim performance progress reports should be submitted via email to the listed Grants Management Specialist and Program Official in February of each year.

Mid-year and annual reports shall contain the elements below as applicable to the grantee proposal and award, but are not limited to, the following:

1. Mid-year reports: 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 information sharing opportunities.

2. Annual reports: describe progress made during the entire past year. A grant closeout report will also be required at the end of the overall grant project period.

3. Both mid-year and annual reports should summarize all FDA-CERSI collaborative research projects and activities, 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.

4. 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.

5. Project final reports and project closeout meeting will be required.

All reports will be reviewed by ORSI and FDA collaborators/ subject matter experts (SMEs) to ensure accuracy of the information provided and that timeline/ deliverables are being met.

Center for Tobacco Products (CTP) performance progress reports:

For CTP-funded CERSI research projects, a CTP-specific final report is required to be submitted. The report is due within 90 days of the end date of the research project. The report needs to document project outcomes and grant expenditures made with tobacco user fees. The report is used to facilitate closeout of the CTP-specific award of the research project and support return of any unspent tobacco user fees back to CTP. CTP CERSI Research Project Final Reports will be submitted via email to the assigned CTP Program Office Project Lead and the grant program official in FDA/OCS/ORSI Program Office.

Office of Women’s Health (OWH) Expenditure Report

For projects funded by OWH, an expenditure report is required for the time period of September-March each budget period.

Other:

When a research project is ready for communication to the public (e.g., FDA Internet site, FDA blogs), a brief description of the project should be provided using Plain Language Principles.

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, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the program, although specific tasks and activities may be shared among the awardees and the FDA as defined below.

Awardee Responsibilities

The Program Director(s)/Principal Investigator(s) (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., ensuring timeliness and adequacy of project deliverables for all research projects and activities conducted under the cooperative agreement). The awardee 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 as described in Section VI (see Acknowledgement of Federal Support); 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.

a. The awardee is responsible for obtaining approval from the FDA/OCS/ORSI Program Office in communication with the funding office for the development and design of certain projects (i.e., all FDA-CERSI collaborative research projects, regulatory science information sharing opportunities 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

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

c. The awardee is responsible for maintaining a Web site containing information on the CERSI program, including an up-to-date list of active FDA-CERSI collaborative research projects, publications and any regulatory science information sharing opportunities.

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 must provide FDA co-authored materials (such as press releases, abstracts, manuscripts and reviews 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 and clear the material (within an agreed upon timeframe between FDA and the awardee). For materials without an FDA co-author, the awardee should provide the materials to FDA/OCS/ORSI Program Office prior to public disclosure or submission for publication to allow FDA a courtesy review of 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. See Section VI (Acknowledgement of Federal Support) for language that needs to be used for this acknowledgement.
• 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 identified by FDA provide technical assistance, assistance with obtaining FDA Human Subject Protection determinations and other necessary approvals or agreements, 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.

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).

Fellowships at the FDA require use of an established mechanism (ORISE fellow, guest worker, visitor, student volunteer) for hosting the CERSI fellow at the Agency; some mechanisms are applicable to all of FDA, while others are only applicable to certain Centers and Offices. In addition, completion of a successful background investigation by the Office of Personnel Management (OPM) is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

Areas of Joint Responsibility include:

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. For human subject research studies, compensation of participants is limited to their time and effort and travel expenses.

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 information sharing opportunities 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 research projects, as 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. General Terms and Conditions

• The awardee understands that FDA will not be involved in soliciting funds from outside entities;
• The awardee understands that FDA staff will abide by federal ethics rules regarding acceptance of gifts, honoraria, travel reimbursement and prospective employment and will act consistently with these rules (see 5 C.F.R. Part 2635);
• The 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);
• Collaborative activities 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 routinely review the relationship of the fees to the costs of the collaboration or whether meeting costs are reasonable in advance of the meeting. However, 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 the following statements: (a) contributions must be reasonably related to the costs of the collaboration; (b) the participant may publicly acknowledge its contribution but may not promote itself as having a relationship with FDA related to the contribution; and (c) the participant understands that (i) contributions will not result in undue influence on FDA regulatory decisions, (ii) contributions will not result in an endorsement of the participant or any of its products or activities by FDA, (iii) contributions will not provide access to non-public product specific information from FDA, and (iv) FDA staff will abide by federal ethics rules regarding acceptance of gifts, honoraria, travel reimbursement, and prospective employment.

II. Transparency/Equal Access:

• The awardee must publicize major grant activities with non-federal entity(ies) on a publicly accessible website, 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) and regulatory science information sharing opportunities 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 major grant activities with non-federal entities, without the payment of fees;
• 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);
• 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, regulatory science information sharing opportunities).

• 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 will not be a member of the external advisory board, but may attend meetings of the external advisory board on an as needed basis;
• Members of the advisory board may, but are not required to, provide funds to the awardee. 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 of whether 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 workshops or conferences 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 or conference 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.

A. 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. FDA shall not review for stylistic, grammar, readability, and format. Should any comments/edits concerning potential language that might reference, imply or infer any FDA endorsement of regulatory and/or policy changes related to the project need to be addressed between grantee and FDA, the maximum review time shall not exceed 60 calendar days from the date of initial submission. Unless for reasons of potential language that might reference, imply or infer any FDA endorsement of regulatory and/or policy changes related to the project, the grantee is free to move forward with the publication consistent with academic standards, once 60 calendar days from the initial submission to FDA has lapsed.

B. For publications without an 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. FDA shall not review for stylistic, grammar, readability, and format. Should any comments/edits concerning potential language that might reference, imply or infer any FDA endorsement of regulatory and/or policy changes related to the project need to be addressed between grantee and FDA, the maximum review time shall not exceed 30 calendar days from the date of initial submission. Unless for reasons of potential language that might reference, imply or infer any FDA endorsement of regulatory and/or policy changes related to the project, the grantee is free to move forward with the publication consistent with academic standards, once 30 calendar days from the initial submission to FDA has lapsed.

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 key personnel for CTP projects
• Change in key partner organization(s)
• Any deviation from the approved budget

4. 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 and RFA-FD-21-017.

5. 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 Grants Management Officer (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

6. CTP CERSI Research Project Final Report

After a CTP-funded CERSI research project ends, the grantee will submit a CTP-specific final report within 90 days of the end date of the research project. This written report needs to document project outcomes and grant expenditures made with tobacco user fees. The report is used to facilitate closeout of the CTP-specific award of the research project and support return of any unspent tobacco user fees back to CTP. CTP CERSI Research Project Final Reports will be submitted via email to the assigned CTP Program Office Project Lead and the grant program official in FDA/OCS/ORSI Program Office.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award.

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 continuation 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.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the terms and conditions of award and the HHS Grants Policy Statement. FDA FOAs outline intended goals and objectives. Post award, FDA will review, and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Rebekah Zinn, PhD
Office of the Commissioner (OC)/ Office of the Chief Scientist (OCS)
Food and Drug Administration
Telephone: 301-796-9495
Email: [email protected]

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: [email protected]

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: [email protected]

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement, Notice of Award, and 45 CFR 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions .

Awards are made under the authorization of Section 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 and 2 CFR Part 200.