Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Office of the Commissioner (OC), Office of the Chief Scientist (OCS), FDA is announcing this FOA to provide continuing support for two existing Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI) at the University of Maryland, and Georgetown University. Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. The CERSI’s will continue to foster an innovative and thematically coherent approach to advance the field of regulatory science (including laboratory, population, behavioral and manufacturing sciences, as well as other scientific programmatic areas, including those outlined in FDA's Strategic Plan for Regulatory Science, accessible at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm) toward more effective and efficient product development and evaluation. CERSI efforts will focus on promoting innovation in support of the development and evaluation of safe and effective products through training, collaborative cutting-edge scientific research, professional development and scientific exchanges.

Program Characteristics:

1. Scientific exchanges and training for participating FDA and CERSI scientists. This can include proposed training interactions and opportunities for representatives from both institutions as well as broader efforts by the institutions to engage other potential partners. This may involve, for example, providing opportunities for FDA staff to participate in professional development activities offered by CERSI and for CERSI members and other stakeholders to participate in research activities at FDA as fellows.

This may include opportunities for FDA and CERSI scientists to spend time at each other's institutions in scientific training and collaboration exchanges working on projects of importance to FDA's public health mission (see 2 below). Opportunities for graduate students and Fellows from participating universities may be provided by FDA for training and joint projects and mentorship at the FDA. Continuing clinical and teaching opportunities for qualified FDA staff at participating academic institutions and their affiliates are desirable. Specific proposals should be provided for the above and other suggested types of scientific and professional development opportunities including public workshops and other activities intended to advance excellence in regulatory science both generally and in at least 2 of the following specific areas of emphasis for FDA's Science and Innovation Strategy:

• Improving pre-clinical assessments of safety and efficacy
• Improving clinical studies and evaluation
• Supporting new approaches to improving product manufacturing and quality
• Ensuring readiness to evaluate innovative and emerging technologies
• Harnessing diverse data through information sciences to improve health outcomes
• Strengthening social and behavioral science to help consumers and professionals make informed decisions about FDA regulated products
• Development of a new prevention-focused food safety system
• Development of a medical countermeasures structure to protect against threats.

2. Creation of new opportunities for collaborative regulatory science research with high public health impact, including both an infrastructure for collaboration to enable and support such work, with a proposal for candidate specific scientific work. In addition to support for training (see 1 above), CERSI may carry out agreed upon specific regulatory science research projects collaboratively, which could include other partners both within and outside of FDA and CERSI. It is anticipated that whether or not FDA directly collaborates in scientific activities, it will interact with the CERSI in project planning and evaluation both to provide scientific input and enhance the utility of the work for FDA’s public health mission. Please also refer to the section for Supplemental Research Projects below, section 4. While Supplemental Research Projects will be discussed post-award, the collaborative regulatory science research described in this section will be evaluated pre-award, thus, short descriptions of proposed projects (approximately a half page each) are requested at the time of submission of the application.

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

Applicants should include plans and business models describing how their CERSI networks with other CERSIs in the program (e.g., synergizing, collaborating and sharing expertise and program goals). Applicants should also include plans and business models which describe: 1) how they would leverage their CERSI program beyond the funding provided by FDA and 2) how their CERSI program would continue its role and function as an FDA-partnering center of excellence in regulatory science beyond the funding provided with this CERSI mechanism.

4. In order to accelerate innovation and to address new developments in emerging regulatory science, as well as urgent, novel unmet needs, FDA anticipates that it may have additional funds to support a limited number of Supplemental Research Projects throughout the award period.  These Supplemental Research Projects are intended to rapidly and proactively further the regulatory science research efforts of the CERSI program in response to public health needs that may not yet be known or identified at the time of the award.  In some cases, Supplemental Research Projects may be conducted in hands-on collaboration with investigators from FDA. In this case, internal support for the FDA portion of the research will be provided separately from the external support. (It is also possible that some of the projects will be supported in part by a third party.)

The Supplemental Research Projects will be identified, reviewed and funded post-award.  To initiate the process, potential Supplemental Research Projects will be identified by either FDA or the CERSI and the proposed projects will be reviewed first by the CERSI.  FDA will conduct a programmatic review and has the final authority to determine whether or not to fund a Supplemental Research Project based on the CERSI s recommendations, the FDA review, project merit, programmatic priorities and availability of funds.  Applicants should not submit research project descriptions or a budget for the Supplemental Research Projects at the time of this application; these projects will only be considered for funding post-award. On the other hand, any planned research projects proposed at the time of submission should be included under the Research Plan section of this application.

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

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

The University of Maryland and Georgetown University

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

Applicant Organizations

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

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

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

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

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

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

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement. However, awardees are encouraged to share in the costs of a project through contributions. If contributing a share of the costs, the application budgets and budget justifications should include the projected commitments of the contributions for the entire performance period and include the letter of commitment.  Inclusion of funds from cost sharing should be discussed in the narrative section of the Research Plan and reported on the Federal Financial Report, making it clear which funds are federal and which are from cost sharing. However, lack of supporting documentation at the time of application submission will not exclude the application from competitive review.

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

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

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

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

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

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

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:

PHS 398 Research Plan Components

• Introduction is limited to 1 page
• Specific Aims is limited to 1 page
• Research Strategy section is limited to 12 pages

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

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

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

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

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

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

• 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'.
• 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 the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed.  MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract.  MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.

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

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

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

The Research Strategy section is limited to 12 pages and should include:

Clear benchmarks or milestones indicating progress

For the purposes of this FOA, 3 components must be defined: core program support infrastructure, scientific exchanges/training for participating FDA and academic scientists and creation of new opportunities for collaborative regulatory scientific research with high public health impact. The guiding principle of milestone-driven research is to remain focused on a well-defined goal, thus achieving that goal with greatest efficiency. The use of milestones provides clear indicators of a project’s continued success or emergent difficulties. Milestones are different from specific aims. The milestones must provide objectives and quantitative outcomes by which to justify advancing the project. The application must include a strong rationale for the choice of models, parameters, and quantitative go/no-go decisions to be made by those involved in the project, based upon accepted practices in the specific field. Once an application is granted, each year the applicant must submit a PHS 2590 Non-Competing Continuation Progress Report requesting funding for the following year. These benchmarks/milestones will be reviewed and evaluated by FDA in considering such requests as part of the non-competing award process.

Research Work Plan

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

• Include a well-defined project scope that aligns with the goals of the FOA.
• Provide all relevant letters of commitment that must describe how the inscribing institution will benefit from the project and will commit personnel and/or other resources if the proposal is funded, including a letter from the institution’s training/professional development director.
• Identify appropriate resources such as equipment, facility, and raw materials necessary for the project and how they will be used in the project. In addition, ensure that these resources are appropriately aligned in the budget.
• Provide a project management plan documenting how the project will be executed, monitored, and controlled. The management plan must include a project schedule with sufficient detail of all proposed major tasks, events, or actions that are required to fulfill the goal of the FOA.

Measurable Outcomes and Deliverables

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

Past Performance

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

Other Special Performance Requirements

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

• Work with FDA to arrange for meetings that serve to coordinate the efforts of FDA and awardee staff (agenda will be developed and approved with the FDA), during the course of the grant award;
• Cooperatively interact with FDA in support of the project and activities;
• Actively seek input from FDA regarding resource needs or expertise needs that may arise during the performance of the project; however, the awardee should be prepared to have the appropriate expertise to successfully complete the project(s) proposed; and
• Provide a CERSI monitoring plan for all activities proposed along with specific measurable outcomes (see third section above entitled "Measureable Outcomes and Deliverables").

Applications should address the FDA mission of protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. Applications should include: specific aims for the research projects and educational/training programs, research strategies proposed for research projects, plans for obtaining additional funds from external sources to support and sustain CERSI activities over an extended period, and letters of support, if applicable.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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

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

See more tips for avoiding common errors.

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

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

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

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

Significance (20 points)

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved to address critical regulatory science needs and issues? How will successful completion of the aims improve the concepts, methods, technologies, treatments, services, or processes that help FDA meet its mission? Do the training, professional development and research proposals address important needs and areas of regulatory science? If the project aims are achieved, how will technological advances, regulatory practice, and/or health be impacted? Will the new approach/methodology have a competitive advantage over existing/alternate approaches? Does the proposed research address an unmet area in regulatory science?

Investigator(s) (20 points)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Do they have sufficient experience and knowledge in regulatory science and in program coordination to lead the program and establish new partnerships with investigators within the institution and with other stakeholders outside of their organization? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the applicant have the necessary ability to address regulatory issues? Do project team members and/or associated collaborators have prior experience and/or necessary qualifications to successfully execute and implement the proposed research including, where appropriate, the ability to partner and collaborate with other scientists or organizations? Is there clear commitment, experience and capacity in the area of scientific/professional development, training and scientific exchanges? Are the relationships of the key personnel to the applicant organization and, if applicable, to other partnering organizations (e.g., Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), academic laboratories, clinical sites and/or strategic partners) appropriate for the work?

Innovation and Approach (20 points)

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the research outcome have the potential to solve the identified problem and create significant value in informing the product evaluation pathway and regulatory decision-making process? Does the

project develop or employ novel concepts, approaches, methodologies, tools, or technologies? Are there clear health benefits that would accrue from success of the program?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Are the technologies or experimental approaches state of the art?

Environment (20 points)

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the applicant organization concentrating on its core competencies to maximize its chances of success? Has the applicant established alliances/collaborative partnerships where they are appropriate or needed to facilitate achievement of the research goals?

Past Performance (20 points)

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

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall score.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

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

As part of the objective review, all applications:

• Will receive a written critique.

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

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

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

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

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

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

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

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, a "collaborative" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, FDA's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The scientific, technical, and programmatic aspects of the grant and for day-to-day management of the project or program. The PD/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff has sufficient clearance and/or background checks to work on this project or program. This individual will work closely with designated officials within the recipient organization to prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.

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

• The awardee is responsible for submitting quarterly progress reports,to the FDA Project Scientist (PS) including summary data on progress to date.
• The awardee is responsible for preparing material for the meetings involving participants from the FDA.
• The awardee is responsible for timely publication and public release and dissemination of results, data and other products of the study, concordant with the study protocol and governance and the approved plan for making data and materials available to the scientific community and FDA. Awardee will work with the appropriate FDA staff to develop and implement an appropriate rapid data release policy that ensures wide accessibility of the findings. Awardee is requested to provide materials for public disclosure to FDA Project Scientist (PS) prior to disclosure or submission for publication so that the Agency can review the material (within an agreed upon timeframe between FDA and the awardee).
• The awardee is responsible for maintaining a Web site containing information on the CERSI program, including training/educational programs, scientific research and publications, workshops and seminars.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies.

An FDA Project Scientist (PS) and other members of the FDA staff, like the FDA Training/Exchange Liaison and Subject Matter Experts (SMEs), will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The responsibilities of the PS include involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities that is above and beyond normal program stewardship for grants.

As appropriate, the PS will participate in the definition of objectives and approaches, and in planning, conducting, analyzing, and publishing results, interpretations, and conclusions of their studies.

However, the dominant role and prime responsibility for the activity reside with the awardees(s) for the project as a whole, but not necessarily for each task.

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

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

Areas of Joint Responsibility include:

As relevant, the PD/PIs and the PS in collaboration with PO will work collaboratively in evaluating the most appropriate research methods, data quality control strategies, safety issues, study design and implementation, data analysis and interpretation, publication and dissemination of study results.

During performance of the award, the PS, with assistance from other scientific program staff who are designated based on their relevant expertise, may provide appropriate assistance, advice and guidance. The role of the PS will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus between the PI and the PS, PO and that the FDA staff will be given the opportunity to offer input into this process. The PS will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services.

The PD/PIs will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Cooperative Agreement. Intended public disclosures shall be submitted to FDA PS, so the Agency can review them (within an agreed upon timeframe between FDA and the awardee). Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of FDA support. The PD/PIs will be responsible for timely publication of major findings.

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

Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to a dispute resolution panel composed of three FDA staff members not involved in the study. One member will have voting rights, and the other two FDA designees will have expertise in the relevant area of experience. If a decision is unable to be reached, the first member may be chosen by the individual awardees.

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.

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

Awardees are required to submit quarterly progress reports, monitoring plans, and financial reports at the end of each quarter during each full year of the cooperative agreement.  All of these reports should be documented in an agreed upon format between FDA and the CERSI. 

--Regarding the progress reports:  the first, second and third quarterly reports should describe progress made during each respective quarter related to research projects and educational and training programs, while the fourth quarterly report should be an annual progress report describing progress made during the entire past year.  These reports should include preliminary and final research project outcomes, accomplishments in all aspects of CERSI work, progress in meeting performance metrics, issues and concerns encountered, and solutions used to resolve issues. 

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

--Regarding the financial reports:  in addition to the requirement for the annual financial statement at the end of each year, awardees are required to submit a quarterly financial report at the end of each quarter (on an agreed upon date between FDA and the awardee).

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

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

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

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

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

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

Kimberly Pendleton Chew
Office of Acquisition & Grants Services (OAGS)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20857
Telephone: 240-402-7610
Email: Kimberly.Pendleton@fda.hhs.gov

Kimberly Pendleton Chew
Office of Acquisition & Grants Services (OAGS)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20857
Telephone: 240-402-7610
Email: Kimberly.Pendleton@fda.hhs.gov

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

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