EXPIRED
U.S. Food and Drug Administration (FDA)
NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.
The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.
Center for Drug Evaluation and Research (CDER)
Development of Standard Core Clinical Outcomes Assessments (COAs) and Endpoints (UG3/UH3 Clinical Trial Optional)
Reissue of RFA-FD-19-006
None
RFA-FD-21-004
None
93.103
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for UG3/UH3 cooperative agreements to support the development of a publicly available core set(s) of COAs and their related endpoints for specific disease indications or for disease impacts that span multiple rare diseases of similar phenotypes.
The UG3/UH3 Phase Innovation Award Cooperative Agreement involves 2 phases. The UG3 phase will provide funding for 1 to 2 years to conduct planning activities. The UH3 phase will provide funding for 3 to 4 years to projects that successfully complete the planning activities and reach the projected milestones set in the UG3 phase. UH3 phase awards will be awarded after administrative review of eligible UG3 phase awards that have met the scientific milestone and feasibility requirements necessary for UH3 phase implementation. The number of awards is dependent on the availability of funds. The UG3/UH3 application must be submitted as a single application, and applicants should note specific instructions for each phase in this FOA. The total award project period will not exceed 5 years.
July 9, 2020
July 14, 2020
August 21, 2020
October 14, 2020, by 11:59 PM Eastern Time.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date.
Late applications will not be accepted for this FOA.
Not Applicable
November 2020
Not Applicable
December 2020
October 15, 2020
Not Applicable
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
This RFA was first issued in 2019 and 3 projects were funded. With this reissue, FDA is seeking to expand the program. Information on the grants funding in 2019 can be found here.
FDA considers the use of patient input an important part of drug development that can foster innovation and the availability of safe and effective drugs. Patient input can help inform the therapeutic context for regulatory review. Patient input also can inform the selection of clinical outcomes, ensure the appropriateness of instruments used to collect trial data, and help ensure that investigations of the effect of treatments are assessing outcomes that are meaningful to patients. If methodologically-sound data collection instruments are developed and used within clinical trials of an investigational therapy, patient input can provide a direct source of evidence regarding the benefits and risks of a drug.
As part of FDA's commitments under the 21st Century Cures Act and the sixth authorization of the Prescription Drug User Fee Act, FDA is publishing a series of patient-focused drug development methodological guidance documents intended to provide FDA’s current thinking about methods that could be used to bridge from important early-stage efforts to gain patients narrative perspectives on the therapeutic context to development and use of methodologically-sound data collection instruments in clinical trials. A primary component of this guidance series is to provide a patient-focused outcome measurement approach to clinical outcome assessment (COA) selection and/or development for clinical trials.
COAs are often primary, co-primary, or pre-specified secondary endpoints in clinical trials used to support drug approval and labeling claims or other communications regarding clinical benefit. Clinical benefit is defined as a positive clinically meaningful effect of an intervention on how an individual feels, functions, or survives. The demonstration of clinical benefit and how that benefit is measured is an important aspect of drug development. FDA uses COAs to determine whether a drug has been shown to provide clinical benefit to patients. Tolerability of risk and safety can also be measured by COAs. Understanding what is most important to patients can help to develop and/or select tailored COAs to adequately collect meaningful patient input.
The development of a COA that is fit-for-purpose for its intended use in drug development is a lengthy, rigorous, and resource-intensive process. There are different approaches and methods to develop or modify and select COAs.[1] FDA believes that these efforts can be improved through coordination across or within disease areas and is seeking to optimize long-term sustainability by facilitating a collaborative, multi-stakeholder approach to the development, modification and/or selection of COAs within specific disease area(s) that incorporates input from patients and care partners, drug developers, researchers, regulators, payers, and other decision
makers.
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for UG3/UH3 cooperative agreements to support the development of a publicly available standard core set(s) of COAs and their related endpoints for specific disease indications. The standard core set(s) can include different types of COAs (i.e. patient-reported outcome [PRO], clinician-reported outcome [ClinRO], observer-reported outcome [ObsRO], performance outcome [PerfO] instruments) and their related endpoints that assess a minimum list of impacts that matter most to patients, are likely to demonstrate change (including differences in trial arms related to disease burden, treatment burden, and if applicable, physical function) and should be reported in a clinical trial. A standard core set might be relevant across several disease populations or subgroups or be focused on attributes of a specific disease (a disease-specific or generic instrument that can adapted and applied more broadly across disease areas or across age groups).
A UG3/UH3 cooperative agreement has two phases: a milestone-driven planning phase (UG3) and an implementation phase (UH3). Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to an implementation phase of up to four years (UH3).
Only UG3 projects that have met the scientific milestones and feasibility requirements necessary for UH3, may transition to the UH3 implementation phase. An administrative review will determine whether the milestones and requirements have been met for a project to transition to the UH3 implementation phase. It may be the case that not all funded UG3 projects will transition to the UH3 phase. The number of awards is dependent on the availability of funds. The UG3/UH3 application must be submitted as a single application, and applicants should note specific instructions for each phase in this FOA. The total award project period will not exceed 5 years.
Under the UG3/UH3 phases, applicants will conduct a well-managed, transparent, and methodologically-sound process following a core set development strategy and protocol. FDA is interested in the identification of modifiable disease and treatment impacts that matter most to people living with a disease or condition. To minimize ambiguity and uncertainty for both regulatory decision makers and drug developers, FDA is not only interested in the high-level concepts related to those impacts but also in the set of specific instruments, and endpoints for a given disease or condition.
The core set development work pursued under the cooperative agreement should be informed by FDA guidance documents (e.g., patient-focused drug development methodological guidances), the COA compendium, drug development tools qualification guidelines, a review of the literature (including a gap analysis to evaluate the use of existing instruments), and current knowledge of the disease area.
To ensure the development of coordinated and quality core set(s) in or across disease states, existing publicly available COAs and available outcome sets can be leveraged to pursue development of a core set. A core set could include publicly available COAs that have already been evaluated against standards outlined in the FDA Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims and related documents and undergone sufficient psychometric testing to provide evidence that demonstrates they are fit-for-purpose for regulatory use. For disease areas such as rare diseases, where there may not be existing COAs, de novo instrument development or testing available COAs in new populations may be necessary. Given this understanding, proposed activities in both phases will depend on the specific condition of interest and research strategy proposed by the applicant (e.g., proposed outcomes of interest, type of COA, expressed aim).
Since the UG3/UH3 cooperative agreement is a phased approach, FDA understands that, depending on the proposal, the information generated early in the UG3 phase may be at an early proof-of concept stage. However, it is expected that all work products, including de novo or modified COAs and additional COA supportive evidence generated through both the UG3 and UH3 phases of this FOA are currently or will be publicly available by the end of the grant period, at no cost or nominal cost. In addition, it will be important to ensure that identified concepts, COAs, and endpoints reflect what is most important and relevant in stakeholder decision making. To facilitate this, stakeholders including patients, care partners, FDA reviewers, drug developers, as well as other government and academic researchers, health care providers, health technology assessors and health payers, will ideally be engaged at key milestones via public meetings. The scope of this cooperative agreement will cover all aspects of planning (e.g., protocol development, literature review, gap analysis), implementation (e.g., execution of plan, active stakeholder engagement, development of work products) and other tasks necessary to support the objectives specified.
For this cooperative agreement, development of a standard core set(s) of instruments, and their related endpoints may either focus on specific disease indications or on disease impacts that span multiple rare diseases of similar phenotypes. Differences in language and culture should the considered when developing a standard core set(s) of instruments in order to be useful in global trials.
FDA is particularly interested in applications focusing on the following areas for the development of standard core set(s) under this FOA:
Birth to three years of age
Three to six years of age
Six to twelve years of age
Twelve to eighteen years of age
For awards made under this FOA the projects will be funded as phased awards. Contingent on continued availability of funds, this would include one to two years in the planning phase (UG3) and three to four years in the implementation phase (UH3). Funds will be awarded to applicants pursuing development of a single core set for a disease area and/or multiple core sets. Applicants must clearly specify in the application whether they will be pursuing development of a single or multiple core set(s) for a disease area. Outlined below are activities that should generally be included in each phase.
Applications must include clearly defined and measurable goals and milestones for the UG3 phase of the research. The goals specified will be used to evaluate the success of the UG3 phase.
A UG3 cooperative agreement may include a review of the literature and current work, including a gap analysis, to determine if there are instruments which assess outcomes of importance to patients and meet FDA evidentiary standards. It may also propose what additional work would be necessary to conduct during the UH3 period to ensure the instruments meet FDA evidentiary standards.
During the UG3 or planning phase, activities will generally include, but are not limited to:
The objective of the three-to-four-year UH3 implementation phase is to conduct standard core set(s) development, in accordance with activities planned in UG3 phase. In addition to proposing a well-defined set of milestones for the UG3 planning phase, an application must also propose key milestones for the UH3 implementation phase. It is understood that the proposed milestones for the UH3 phase may be revised as activities start during the UG3 planning phase. In the event of an award, FDA staff will negotiate a list of milestones and planned activities (e.g., public workshops) for each year of support.
At the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition request for the UH3 implementation phase. To transition to the UH3 implementation phase, applicants must submit a complete package, including any needed protocols, updated terms for intellectual property considerations including updated letter(s) of support, statistical analysis plans (SAPs), analysis data, identified concepts, sample size information, stakeholder engagement plan, and a detailed plan outlining work to be conducted under UH3. A UH3 transition request will undergo an administrative review to determine whether the milestones have been met. It may be the case that not all funded UG3 projects will transition to the UH3 phase.
Prospective applicants should note that funding of UG3/UH3 Phased cooperative agreement does not guarantee support of the UH3 implementation phase. Transition to the UH3 phase of the project will occur only if an administrative review process recommends that the UG3 activities have been successful and the implementation project (UH3) can proceed with confidence of success, and if funds are available.
Implementation activities will depend on the disease area /disease area impact being addressed, but in general the following goals should be achieved:
Note: Lack of an ongoing clinical trial in a given disease area should not preclude the development of a core set of COAs and their related endpoints for that given disease area.
Sharing Research Resources: Rights in Data
The ultimate goal of this funding award is to support the development of a publicly available core set(s) of COA and their related endpoints for specific disease indications. Recipients of awards are encouraged to identify and foster relationships with potential licensing and commercialization partners early in the COA instrument development process, to identify any potential issues that may impact the public availability of any resulting COA instruments. The PD/PI(s) are expected to work closely with technology transfer officials at their institution to ensure that royalty agreements, patent filings, and all other necessary intellectual property arrangements are completed in a timely manner and that plans are developed and updated over the course of the project. FDA seeks to ensure that the products and materials resulting from FDA’s support, are free to the public or made available to the public at nominal cost.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
New
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s)
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for four (4) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.
FDA/CDER intends to commit up to $4,200,000 total for fiscal year 2021 to fund up to three (3) awards in support of this grant program.
Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):
UG3 (up to 2 years):
Combined years: up to $1,400,000 total costs/per award
It is up to the applicant to determine the number of years and budget for the UG3 phase. The application should provide justification for the number of years and budget split among the years if the UG3 phase is anticipated to take more than 1 year.
UH3 (up to 4 years):
Combined years: up to $2,700,000 total costs/award
It is up to the applicant to determine the number years and budget for the UH4 phase. The application should provide justification for the number of years for the UH3 phase and budget split among the years.
The scope of the proposed project should determine the project period. The UG3 phase is limited to up to two years and the UH3 phase can request up to four years of support. The total project period for an application submitted in response to this FOA may not exceed five (5) years.
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
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are 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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:
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:
The letter of intent should be sent to:
Shashi Malhotra
Telephone: 240-402-7592
Email: Shashi.Malhotra@fda.hhs.gov
A technical session will be held for prospective applicants in September of 2020. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow FDA to provide responses to the questions received regarding the application process. Prospective applicants will participate in the technical session in listening mode only. All questions must be submitted as part of the letter of intent. 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.
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:
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:
To clearly distinguish between the two phases, applicants should specify separate UG3 and UH3 information in each subsection (Specific Aims and Research Strategy) of the PHS398 Research Plan as appropriate.
In preparing the application, investigators should consider the fact that the applications will be assigned a single impact score for both UG3 and UH3 phases.
Specific Aims: Each submitted application should address one specified disease or disease impact area. If applicants are submitting more than one application, each application should be scientifically distinct. Applicants should include separate aims for each phase (UG3/UH3) and delineate the planned work to be conducted during the funding period, separately for each phase (UG3/UH3). All information should be summarized within the designated page limit.
Research Strategy:
Within the Research Strategy, applicants should first describe the UG3 Phase and then the UH3 Phase with a clear demarcation of the UG3 and UH3 phases of the application. It is not necessary to repeat background information or details of methods in the UH3 portion that were provided in the UG3 portion. The UG3 and UH3 Phases must be described in sufficient detail to permit reviewers to assess the proposed work and the strength of the proposed design and methods. An application should identify key decision elements for core set(s) development for the targeted disease or disease impact area. The application should describe details about the proposed core set development plan and how each plan component is suitable for the development of COAs for regulatory purposes. The application should also describe how the standard core set COAs and endpoints development process will accommodate variability across geographic regions/countries, subpopulations, cultures, and regional technology and infrastructure.
The application should describe the approach to ensure key stakeholder (multiple authorities and decision makers) engagement at key milestones in the core set development. The application must provide a description of the infrastructure and the expertise available to develop core set(s) COAs and endpoints. The application should also describe the approach to ensure the core set and the supportive information to aid use in regulated environments are publicly available for minimal or no cost.
Applicants must describe their willingness to comply with policies, guidelines, and practices developed by the PD/PI(s), and to work with FDA, Science Policy Board, and the Program Steering Committee in providing relevant information and materials when needed.
Applicants must not propose work that duplicates efforts already funded or underway. Although novel theoretical approaches and methodologies may be needed and de novo development may be necessary, when possible applicants should leverage existing instruments and/or modify existing instruments.
The following sections should be included under the Research Strategy following the guidelines in Section V. Application Review Information
1. Rationale
2. Infrastructure and Resources
3. Investigator(s)
4. Approach
5. Significance
Rationale:
The Rationale section of the Research Strategy should be framed within context, detailing how the proposed project fits within more current knowledge of the disease and measurement area(s) and the likelihood that the forthcoming standard core set(s) of COAs and endpoints will facilitate drug development to address an unmet medical need in a disease and measurement area(s) or substantially contribute to market approval of product(s). This subsection should include:
Research Team and Member's Roles/Responsibilities (without duplicating information already requested/provided in the bio sketches):
The Investigator section of the Research strategy should also include a subsection with the heading, "Research Team and Member Roles/Responsibility." This subsection should reflect the research strategy and approach outlined by the applicant and include the following:
Milestones:
Both the UG3 and UH3 phases of the Research Strategy must have a section of proposed milestones, which should be well described, quantifiable, and scientifically justified to allow an assessment of progress. For UG3 milestones, applications should delineate what they propose to achieve in order to proceed to the UH3 phase. The milestones should also include a timeline, a discussion of the suitability of the milestones assessing success in the UG3 phase, and a discussion of the implications of successful completion of these milestones for the proposed UH3 phase. The application should also identify key milestones for periodic engagement with external stakeholders. Annual milestone for the UH3 phase should also be included in the application, although it is understood that timelines and milestones for implementation in the UH3 phase that are proposed in the application will evolve as activities in the UG3 phase progress, if an Award is made.
Letters of support: Applicants should include a letter of support from consultants, contractors, and collaborators. Letters of support should be uploaded to line item 9. Letters of Support on the PHS 398 Research Plan form.
Additional Information:
Governance: The awards funded under this FOA will be cooperative agreements (See Section VI.
Cooperative Agreement Terms and Conditions). Close interactions between the FDA and the awardee
will be required to accomplish the goals of this program. The governance of this award will include
programmatic insight by a Program Steering Committee and Scientific
Policy Board. The Scientific Policy Board may include US regulatory and health authorities, other government regulatory staff, and other key stakeholders as deemed necessary by FDA for the specific project of interest.
The Program Steering Committee will function as the advisory board of all grants awarded under this RFA. The Program Steering Committee will include one representative from each award and will include FDA Scientific and Program Officer(s). All members are expected to actively participate in all Steering Committee activities.
It is expected each awardee PD/PI will establish an External Technical Advisory Committee specific to their award with external experts to advise and assist with facilitating the overall goals of this program and implementing the guidance and insight provided via the Scientific Policy Board and Scientific Program Steering Committee.
Data Sharing Plan: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan https://www.fda.gov/ScienceResearch/AboutScienceResearchatFDA/ucm433459.htm.
Individuals are required to provide primary data to FDA for regulatory review similar to the level of data expected to be submitted to support FDA pre-market review of a New Drug Application or Biologics Licensing Application. This includes person level data, transcripts, interview guides, and other documents similar to what is submitted as part of the submission to the FDA COA DDT qualification program.
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:
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, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
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.
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 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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Post-submission materials 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 merit.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA:
Is the need for a core set of COAs and endpoints and area of unmet need in the proposed disease/impact area clearly defined? Is the need for a core set of COA(s) and endpoints in the proposed disease/impact area well supported by information presented in the application (e.g., evidence from the literature, review of previous trials, etc.)? Does the applicant outline efforts that will strategically build on previous work in the current space and add a unique contribution to the field, above and beyond what is currently available? Does the application demonstrate that a core set(s) of analysis-ready clinical trial endpoints (not only outcome measurement instruments) will be developed for a given disease area or condition? Will the UG3 and UH3 activities and resulting core set(s) of COAs advance the science, development and utilization of core set(s) of COAs and endpoints for in the proposed disease/impact area?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA:
Do the PD/PIs have the expertise, operational management skills, and training needed for core set development as demonstrated in their biographical sketches and CVs? Do the PD/PI(s) and other key personnel (e.g., project management team) have sufficient content area expertise in the disease and/or condition, including knowledge and experience with the specific population and/or subpopulation of interest? Do the PD/PI(s) and key personnel have expertise in qualitative and quantitative methods necessary for core set COA development (e.g., qualitative and quantitative methods required for de novo instrument development, modification of existing instruments; this also includes expertise necessary for the psychometric evaluation of COAs)? Do the PD/PI(s) and key personnel have expertise in data standards related to the core set COAs to aid regulatory submission? Do the PD/PI(s) have extensive experience in performing proposed UG3 phase activities? Do they have expertise in study coordination, data management, and statistics? What is the likelihood that all PD/PI(s) will be able to collaboratively work together to complete the proposed work?
Does the application represent sound approaches or methodologies, instrumentation, or interventions for core set development? Are the concepts, approaches or methodologies, instrumentation, or interventions in relation to enhancing the current understanding of a specific disease or disease impact supported by this application? Is there a critical barrier or important knowledge gap in the current drug development paradigm this proposed project will address? Does the proposed project provide essential data needed for drug development? For a given context of disease and subpopulation, does the project address specific limitations in patient population which may impact core set development?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or FDA-defined clinical research, are the plans to address
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA:
Does the application identify key decision points and milestones for core set development? Does the proposal describe methods for achieving consensus among all key US and multinational stakeholder groups on which concepts, measures and endpoints should be included in the core set? Does the approach ensure key stakeholder engagement (e.g., with multiple authorities and decision makers, patients, and key opinion leaders in the core set(s) development? Does the project include innovative approaches to overcoming barriers and challenges? Does the plan propose work that complements (in part or whole) efforts already funded or underway? What differentiates the proposed work from what has already been done? Does the application provide an adequate plan to leverage existing instruments? Is the plan to develop/modify instruments reasonable, and could the proposed instruments and trial endpoints be developed for use in regulatory decision-making using the plan that is described? Is there an adequate plan to test the validity, reliability, and responsiveness to change of the instruments and endpoints? Is there an adequate plan to evaluate the feasibility of using the COAs and endpoints in clinical trials? Does the project ensure the inclusion of input from patients and other key stakeholders as part of the core set development strategy? Does the proposed approach incorporate steps to reduce respondent (patient and other informant's) burden? Is there an adequate plan to minimize users' cost burden? Is there an adequate plan to determine the applicability of core set(s) developed in one region/country to patient populations in other countries/regions of the world? Does the approach adequately discuss sustainability beyond the proposed timeline? Will proposed UG3 activities and proposed milestones allow for implementing UH3 activities? Is the proposed approach for maintenance and minimal cost accessibility reasonable? Will the approach allow FDA to receive documents and data that will be necessary for the instruments and endpoints in the core set(s) to be evaluated by FDA reviewers as part of a regulatory review process to inform regulatory decision making?
In addition, for applications proposing clinical trials:
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Will the organizational infrastructure 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 organization infrastructure and resources, subject populations, or collaborative arrangements?
Specific to this FOA:
If proposal includes multiple PD/PI, what specific resources or infrastructure elements does each provide to facilitate success of the project? What capabilities are available to support maintenance and lifecycle considerations of the project? What capabilities are available to support the availability of the core set(s) in the public domain? If IT application or systems will be used, is support available organizationally to ensure the needs for patient engagement, training and/or testing of software are met appropriately? How will applicability and operability across regions, subpopulation differences, variations in culture, and regional technology and infrastructure differences will be accounted for in the development of the core set? If proposal includes use of existing instruments for inclusion within a core set(s) of COAs, are infrastructure and resources available to support intellectual property, licensing, or technology transfer concerns which may arise with the existing instruments or measures of interest? Does the letter of support address technology transfer, intellectual property concerns, and collaborations with private entities?
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.
Milestones
Are the steps and milestones clearly defined? Are the proposed milestones well described, feasible, and quantifiable with regards to specific goals and accomplishments? Are adequate criteria provided for the UG3 phase that will be utilized in determining milestone completion before proceeding to the next phase of the project? Are UH3 milestones appropriate for the next phase of the project?
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.
Ability to Foster Public Availability of Core Set Development Efforts:
The reviewers will comment on the appropriateness and adequacy of the proposed approach to manage intellectual property, data sharing, and software sharing as applicable amongst multiple entities with the aim of ensuring core set development aligns with the overall aim of being publicly available.
Does the proposed approach ensure public availability of preliminary and final project research deliverables? Is there an appropriate mechanism to incorporate feedback from the Program Steering Committee and other key stakeholders during development? Does the proposed software and/or data sharing aspects of the project approach ensure public availability?
Ability to Advance the Current Field
The reviewers will comment on the ability of the project to advance current research paradigms towards future drug development and to exert a significant influence on drug development. The reviewers will evaluate the following:
Study Timeline
Specific to applications proposing clinical trials:
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 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 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
Not applicable
Not applicable
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic 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:
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:
Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found in the HHS Grants Policy Statement, this FOA, and Notice of Award.
The following Standard Terms and Conditions will apply:
Reporting Requirements:
All FDA grants require both Financial and Performance reporting.
Financial Reporting:
A. Cash Transaction Reports
The Federal Financial Report (FFR) has a dedicated section to report Federal cash receipts and disbursements. For recipients, this information must be submitted quarterly directly to the Payment Management System (PMS) using the web-based tool. Quarterly reports are due 30 days following the end of each calendar quarter. The reporting period for this report continues to be based on the calendar quarter. Questions concerning the requirements for this quarterly financial report should be directed to the PMS.
B. Financial Expenditure Reports
A required Federal Financial Report (FFR) must be submitted annually. All annual FFRs must be submitted electronically using the Federal Financial Report (FFR) system located in the eRA Commons. This includes all initial FFRs being prepared for submission and any revised 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.
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. The following activities require prior approval from FDA:
1. Carryover of Unobligated Balances
2. No Cost Extensions
3. Change in Grantee Organization
4. Significant Rebudgeting
5. Change in Scope or Objectives
6. Deviation from Terms and Conditions of Award
7. Change in Key Personnel which includes replacement of the PD/PI or other key personnel as specified on the NoA.
8. 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 AuditResolution@hhs.gov 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:
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 Federal Financial Report SF-425, 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 90 days after the expiration date of the project period. All closeout documents must be submitted electronically in eRA Commons.
The Final FFR must 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). 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:
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.
All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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.
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 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements.
FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.
Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the peer-reviewed scientific publication resulting from research supported in whole or in part with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.
Additional terms and conditions regarding FDA regulatory and CDER programmatic requirements may be part of the Notice of Award.
Cooperative Agreement Terms and Conditions of Award
All references to the Program Steering Committee and Scientific Policy Board are in accordance as defined below.
Program Steering Committee: The Program Steering Committee will function as the advisory board of all grants awarded under this RFA. The Program Steering Committee will include one representative from each award and will include FDA Scientific and Program Officer(s). Additional people relevant to the program aims and goals may be invited to attend meetings and participate in working groups by action of the Program Steering Committee or FDA.
Scientific Policy Board: The scientific policy board will consist of representatives from US regulatory and health authorities (e.g., FDA, NIH) and representatives from other regulatory and health authorities (e.g., European Commission/European Medicines Agency, Health Canada, Japanese Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency) to facilitate the program goals and objectives. Other stakeholders may be identified and included as needed. The Scientific Policy Board will be appointed by the FDA. The Scientific Policy Board will meet at least twice each year in conjunction with the Program Steering Committee. A schedule for subsequent meetings will be discussed and prepared during the project kick-off meeting. Other FDA staff may be invited to attend Scientific Policy Board meetings when their expertise is required for a specific discussion. 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 (HHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and FDA grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an assistance mechanism (rather than an acquisition mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, FDA's purpose is to support and stimulate the recipients activities by involvement in and otherwise working jointly with the award recipients in a partnership role; 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 project as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.
2.A.1. Principal Investigator Rights and Responsibilities
The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, or programmatic aspects of the cooperative agreement and for day-to-day management of the project or program. The PD(s)/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 have 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 create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.
Sharing Research Resources: Rights in Data
The ultimate goal of this funding award is to support the development of a publicly available core set(s) of COA and their related endpoints for specific disease indications. Recipients of awards are encouraged to identify and foster relationships with potential licensing and commercialization partners early in the COA instrument development process, to identify any potential issues that may impact the public availability of any resulting COA instruments. The PD/PI(s) are expected to work closely with technology transfer officials at their institution to ensure that royalty agreements, patent filings, and all other necessary intellectual property arrangements are completed in a timely manner and that plans are developed and updated over the course of the project. FDA seeks to ensure that the products and materials resulting from FDA’s support, are free to the public or made available to the public at nominal cost.
Additionally, PD/PIs will:
1. Participate in site visits or attend meetings as requested by the FDA. A portion of the budget should be reserved for such travel.
2. FDA may also request data be made available through speaking engagements and publications, presentations at scientific symposia and seminars, while making sure that confidentiality and privacy of the data is protected.
3. The awardees will provide FDA any data obtained from investigations if requested by FDA.
4. 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.
5. For publications without an FDA co-author but using FDA funds to support the grant, a courtesy review of the publication should be shared with FDA to ensure that any potential language that might reference, imply, or infer any FDA endorsement of regulatory and/or policy changes related to the project is not stated.
The PD(s)/PI(s) will have the responsibilities for:
2. A.2. FDA Responsibilities
An FDA Program Official (PO) will have substantial programmatic involvement as described below. The PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO’s responsibilities include, but are not limited to, post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the Grants Management Officer (GMO). The PO and the GMO work as a team in many of these activities.
Additionally, an agency program official will be responsible for the scientific and programmatic stewardship of the award and will be named in the award notice.
FDA will provide technical monitoring and/or direction of the work, including monitoring of data analysis, interpretation of analytical findings and their significance.
FDA will assist and approve (as deemed appropriate) the substance of publications, co-authorship of publications and data release.
In addition to the FDA responsibilities described above, FDA staff have substantial programmatic involvement that is above and beyond normal stewardship in awards, as described below: One or more designated FDA program staff will have substantial involvement in the Standard Core Clinical Outcomes Assessments and Endpoints Program as part of the Scientific Policy Board and Program Steering Committee.
The specific roles of the involved FDA program staff members include the following activities:
The institution/organization specific program oversight committee will make decisions on project continuation with input from FDA staff and/or any established committee, based on:
2.A.3. Dispute Resolution:
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 Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Program Steering Committee chosen without FDA staff input, one FDA designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. 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 Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award.
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.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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: http://grants.nih.gov/support/ (preferred
method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Robyn Bent
Center for Drug Evaluation and Research (CDER)
Telephone: 301-796-9171
Email: robyn.bent@fda.hhs.gov
Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: Shashi.Malhotra@fda.hhs.gov
Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: Shashi.Malhotra@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 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.
[1] COA Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. U.S. Food and Drug Administration Center of Drug Evaluation and Research Office of New Drugs https://www.fda.gov/downloads/drugs/developmentapprovalprocess/drugdevelopmenttoolsqualificationprogram/ucm370174.pdf