Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Office of the Commissioner (OC)

Funding Opportunity Title

Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional

Activity Code

P50 Research Program Projects and Centers

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-23-024

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.103

Funding Opportunity Purpose

The intended goal of this FOA is to facilitate the development, production, and distribution of pediatric medical devices.  Although the FOA is issued by the FDA's Office of Orphan Products Development, the grant application is intended to encompass devices for all pediatric diseases and conditions, not just those that are rare.  Applicants will request funding to serve as a nonprofit consortium to provide expert advising and support services to innovators of pediatric medical devices.  The advising and services will focus on the total product life cycle for medical devices from concept, through pre-market development, to commercialization, and replacement by subsequent generations of devices.  In addition, consortia should also provide expertise on evidence generation, including use of real-world evidence (RWE), for pediatric device development.  As the consortia execute their mission, they are encouraged to collaborate with each other and the broader community and to maintain a commitment to health equity, diversity, and inclusion to foster innovation, development, and improve access to medical devices for all pediatric patients.

Pediatric medical devices treat or diagnose diseases and conditions in individuals who are 21 years of age or younger (that is, up to but not including the 22nd birthday) at the time of diagnosis or treatment (21 CFR 814.3(s)).

Key Dates

Posted Date

January 18, 2023

Open Date (Earliest Submission Date)

January 25, 2023

Letter of Intent Due Date(s)

February 16, 2023

Application Due Date(s)

March 29, 2023, by 11:59 PM Eastern Time.

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

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

 

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2023

Advisory Council Review

Not Applicable

Earliest Start Date

August 2023

Expiration Date

March 30, 2023

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

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

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

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

     

    Section I a. Background and Objectives

    Pediatric medical device development and innovation for pediatric patients continues to lag behind the advances made for adult devices.  Pediatric medical device development faces unique challenges as children often differ from adults in size, growth, development, body chemistry, and disease propensity.  Due in part to these issues, only a small number of medical devices approved are labeled for pediatric use, of which, some are designed specifically for children and others are adapted from adult applications.  The Food and Drug Administration's (FDA) Pediatric Device Consortia (PDC) Grants Program was first established by Congress in the Pediatric Medical Device Safety and Improvement Act of 2007.  The act requires the department of Health and Human Services (HHS) to provide demonstration grants to nonprofit consortia to promote pediatric device development.  Recent passage of the Food and Drug Omnibus Reform Act of 2022 continues to support of the PDC grants program for fiscal years 2023 through 2027. 

    The goal of the FDA PDC Grants Program is to address this medical need by facilitating the development of pediatric medical devices through funding of nonprofit consortia.  These nonprofit consortia will provide a platform of experienced regulatory, business planning, and device development services (such as but not limited to intellectual property advising; prototyping; engineering; laboratory and animal testing; grant-writing; and clinical trial design) to help foster and guide the advancement of medical devices for pediatric patients.  The advising and services will focus on the total product life cycle for pediatric medical devices such as understanding the evolution of medical device development from concept, through pre-market development, to commercialization, and replacement by subsequent generations of devices.

    In addition to providing advice and/or assistance on all the above, the consortia may provide funding to directly advance pediatric device projects ("Direct Device Funding").  The activities supported by funding may include, but are not limited to, activities such as prototyping, testing (laboratory and animal), modeling, etc. 

    Furthermore, the FDA is working to broaden and improve opportunities to leverage real-world evidence for regulatory evaluation of medical devices across their total product lifecycle.  The consortia are encouraged to submit real-world evidence demonstration project proposal(s) in the pediatric space that develop, verify, and operationalize methods of evidence generation and data use, and demonstrate scalability across the healthcare system.

    The consortia will utilize their expertise to identify challenges and gaps in pediatric medical device development and develop strategic solutions to address these issues, including improving pediatric medical device clinical trial infrastructure at their local institutions (such as, advising services, IRB consultive services, development of process related templates).  The consortia will accomplish their mission by working collaboratively with the other consortia (such as, combined events, cross referrals based on expertise and site resources) and with the broader community (such as, forming partnerships, augmenting resources).  These extended collaborations will establish a national PDC network, improving access to this critical resource for pediatric medical device development.  The consortia will maintain a commitment to diversity, equity, and inclusion to include innovative ideas and distinct perspectives from a variety of stakeholders to advance pediatric medical device development and support pediatric labeling for all pediatric patients. 

    The grants are available to any domestic, public or private, nonprofit entity (including State and local units of government).  Federal agencies may not apply.

    Funds are not intended to be used for general consortium "academic educational" initiatives including but not limited to university curriculum development, educational videos, or undergraduate, graduate, or fellowship classes.

    The pediatric population for medical devices is defined as individuals who are 21 years of age or younger (that is, up to but not including the 22nd birthday) at the time of diagnosis or treatment (21 CFR 814.3(s)).  The following ranges of pediatric subpopulations can be used as a guide for the development of pediatric medical devices:

        Newborn (neonate) - from birth to 1 month of age

        Infant - greater than 1 month to 2 years of age

        Child - greater than 2 to 12 years of age

        Adolescent - greater than 12 through 21 years of age

    The FDA recognizes, however, that the descriptions are somewhat arbitrary and that, in fact, the subject’s weight, body size, physiological development, neurological development, and neuromuscular coordination may often be more appropriate indicators than chronological age.  The consortia will use their judgment when providing advice and/or assistance to pediatric device innovators regarding the potential benefits of addressing an unmet need in the pediatric population.

    Section 1b. Core Attributes of Pediatric Device Consortia

    The consortia shall demonstrate their ability to perform the following:

    • Encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;
    • Mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing;
    • Connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology;
    • Assessing the scientific and medical merit of proposed pediatric device projects;
    • Providing assistance and advice on business development, personnel training, prototype development, postmarket needs, and other activities consistent with the purposes of this section;
    • Providing regulatory consultation to device sponsors in support of the submission of an application (e.g., pre-submission, investigational device exemption, premarket notification [510(k)], premarket approval, humanitarian device exemption, etc.) for pediatric devices;
    • Identifying and addressing challenges associated with pediatric medical device development, including improving clinical trial infrastructure at the PDC institutions;
    • Collaborating with the other funded consortia and the broader community to form partnerships, augment resources, and develop a national PDC network;
    • Demonstrating a commitment to diversity, equity, and inclusion to include innovative ideas and perspectives from all stakeholders to optimize pediatric medical device development for all pediatric patients.

    The consortia are expected to provide counsel on how to access various Federal and non-Federal funding resources.

    The consortia are expected to be knowledgeable and provide advice on leveraging real-world evidence within the pediatric medical device ecosystem to pediatric device innovators.  FDA has published guidance on "Use of real-world evidence to support regulatory decision-making for medical devices."  This guidance can be found at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf.

    The consortia are expected to track the type of assistance that is requested by pediatric device innovators and monitor the progression of the pediatric device development with routine data requests to the innovator.

    The consortia are expected to track the device projects that receive Direct Device Funding and monitor the progress of the funded tasks.  

    The consortia are expected to be up to date and knowledgeable with news and updates surrounding the regulatory decision-making for medical devices such as guidance documents, webinars, programs, etc.  Similarly, the consortia are expected to attend and participate, if needed, at meetings or workshops convened by or involving the FDA regarding pediatric devices.

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

    Section II. Award Information

    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    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.

    Clinical Trial?

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. 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 recipient performance.

    FDA/Office of Orphan Products Development intends to commit up to $6,750,000, for fiscal year 2023 in support of this grant program including consortia advising and support services and projects.  Of the estimated $6,750,000, approximately $1,000,000 may be used for RWE Demonstration Project Funding (subject to review of merit).

    RWE Demonstration Project Funding shall not exceed $335,000 in total costs per consortia.

    It is anticipated that up to five (5) awards will be made in FY 2023.

    Award Budget

    Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect) and is contingent upon availability of Federal funds:

    YR 01: $1,485,000

    YR 02: $1,485,000

    YR 03: $1,485,000

    YR 04: $1,485,000

    YR 05: $1,485,000

    Direct Device Funding

    Up to 25% of a consortium’s base budget ($1,150,000) may be used for Direct Device Funding. 

    Device project activities supported by funding may include, but are not limited to, activities such as prototyping, testing (laboratory and animal), modeling, etc. 

    Not more than 25% of total Direct Device Funding can be used to advance a consortium's internally developed device projects.

    The maximum amount allotted to any device receiving Direct Device Funding shall not exceed $50,000 per year, per consortium and $100,000 per consortium during the 5-year grant period, except where Direct Device Funding pertains to real-world evidence generation and has been discussed and cleared in advance through OOPD.

    The maximum total amount allotted to any device receiving Direct Device Funding shall not exceed $500,000 during the 5-year grant period.

     

    Combined Direct Device Funding:

    A Combined Direct Device Funding award is when more than one consortium collaborates to review and select a highly promising device to receive Direct Device Funding from all participating consortia (i.e., Direct Device Funding that is provided simultaneously from each of the collaborating consortia for the same device).

    The consortia may elect to consolidate a portion of their Direct Device Funds to be used for Combined Direct Device Funding (up to $50,000 per consortium, per year) to award highly promising and significantly impactful devices. The total Combined Direct Device Funding shall not exceed $250,000 per award, per year (the consortia may award a maximum of $250,000 in Combined Direct Device Funds per year; they may elect to award a single $250,000 Combined Direct Device Funding award or multiple, smaller Combined Direct Device Funding awards).

    While more than one consortium may collaborate to simultaneously award Combined Direct Device Funding to one device, each of the participating consortium must fund unique device projects; as each collaborating consortium will be responsible for reviewing, selecting, and monitoring the progress of the funded tasks (device projects).    

    Once a device receives a Combined Direct Device Funding award that same device will still be eligible for Direct Device Funding from any consortium to a maximum of $100,000 per consortium over the 5-year period. The maximum total amount allotted to any device receiving Direct Device Funding shall not exceed $500,000 during the 5-year grant period.

    Once a device receives a Combined Direct Device Funding award, that same device will not be eligible for another Combined Direct Device Funding award for the remainder of the 5-year grant funding period (regardless of the total amount received).

    As Combined Direct Device Funding is a form of Direct Device Funding, the same rules described for the use and monitoring of Direct Device Funding also apply to Combined Direct Device Funding.  

    RWE Demonstration Projects:

    For RWE Demonstration Project Funding, the maximum amount requested shall not exceed $335,000 in total cost per year.  As with the overall application, it is expected that the time and scope of the project is reflected in the budget request and will be reviewed annually by the program.

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is five (5) years, contingent upon performance during the preceding year, compliance with regulatory requirements (if applicable), and availability of Federal funds.

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

    Section III. Eligibility Information

    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    Local Governments

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

    Other

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

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

    Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

    Required Registrations

    Applicant Organizations

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

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

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

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

     

    Section IV. Application and Submission Information

    1. Requesting an Application Package

    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.

    2. Content and Form of Application Submission

    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.

    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA staff to estimate the potential review workload and plan the review.

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    • Descriptive title of proposed activity
    • Name(s), email address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity

    The letter of intent should be sent via electronic mail as a PDF file with the FOA Number and the Institution's Name in the message subject heading to:

    Shashi Malhotra
    Grants Management Specialist
    Shashi.Malhotra@fda.hhs.gov

    Page Limitations

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

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

    For all P50 applications submitted in response to this RFA, the standard PHS 398 instructions are modified.

    In particular, Research Plan (Research Strategy [Item 3] per Revision 3/2016 of the PHS 398 Table of Contents is altered as follows:

    • Standard item 3 of the PHS 398 Research Plan is replaced by Sections 1, 2, 3 and 4 below.
    • The PHS 398 standard page limit for item 3 is replaced by a new limit of 12 pages for Section 1, 8 pages for Section 2, 5 pages for Section 3, and 5 pages for Section 4.
    • Other sections of the standard PHS 398 Research Plan remain unchanged and must be completed following the PHS 398 instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
    • The Biographical Sketch section of PHS 398 application should be used to highlight the relevant pediatric device development experience of the consortia leaders and key members. For consortia leaders or key members with a background in business, regulatory, or law, Sections C (Contributions to Science) and D (Additional Information: Research Support and/or Scholastic Performance) should be replaced with a description of practical experiences related to pediatric or medical device development.
    Instructions for Application Submission

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

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

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

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

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

     

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

    • Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    Research Strategy

    Section 1:  Overall Description of the Consortium and Accomplishments (maximum of 12 pages)

    Overall Description of the Consortium

    This section should present both the overall vision and specifics for the consortium as it relates to the goal of the PDC Grants Program such as regulatory, business planning, and other pediatric device developmental services that the consortium can provide to pediatric device innovators.  This section should contain the long- and short-term objectives, including how activities supported by the consortium will advance pediatric device development.  Resources available to the consortium should be described.

    Of importance is a discussion of the business, regulatory, and medical/scientific expertise of the consortium leaders and members.  Established relationships between the consortium and manufacturers and academic institutions should be explained.  Relevant background information on the consortium leadership’s accomplishments pertinent to the goals of pediatric medical device development should be described.

    The consortium’s method and approach to evaluating Direct Device Funding (which also applies to Combined Direct Device Funding) should be explained and how funds will be distributed to each of their pediatric device projects.  The consortium should explain the individuals or groups involved and why they have specific experience and/or knowledge to make such strategic recommendations.  Also, the consortium will need to explain how it plans to monitor the spending and activities of the recipients Direct Device Funding and the methods by which they plan to hold recipients accountable to conduct the funded tasks.

    The consortium’s familiarity with the Federal system and obtaining funding through Federal and non-Federal sources should be described.

    Accomplishments

    The applicant should describe any relevant experience with managing projects for pediatric medical device development and provide a brief summary highlighting their accomplishments.  Additionally, please explain any achievements specifically related to successfully guiding a pediatric medical device(s) to market or into clinical trials or animal testing.  This summary should at a minimum include the advice/strategy provided and how it was relevant to the success of the pediatric device project.

    Section 2:  Consortium's Ability to Identify Challenges, Provide Solutions, and Advise Innovators Regarding Pediatric Medical Device Development (maximum of 8 pages)

    The applicant should specifically address their ability to advise and assist pediatric device innovators who request strategic guidance from the consortium regarding pediatric medical device development at any stage of the total product life cycle.  The applicant should include a discussion regarding the challenges and difficulties that pediatric device innovators may encounter and develop a strategic plan to address these challenges, thus aiming to narrow the gap in pediatric medical device development.

    The applicant should explain the process for how they would assist pediatric device innovators. The applicant should explain how they evaluate specific issues brought to them by pediatric device innovators and how they will provide strategic and technical guidance to navigate the regulatory processes for marketing approval and subsequent reimbursement planning.

    The applicant should describe a scenario with an innovator who has a pediatric device at the concept stage and explain how the consortium will work with the innovator to facilitate bringing the device to market.  The applicant should explain the analysis and advice provided (i.e., business, regulatory, and medical/scientific expertise) at each stage of device development, including the regulatory process, marketing, and reimbursement stages.  The applicant should also describe how the advice provided is intended to overcome the noted challenges.

    The applicant should also describe how the consortium will improve clinical trial infrastructure for pediatric medical devices at their local institution (such as, advising services, IRB consultive services, development of process related templates).  Appropriate pediatric medical device clinical trial infrastructure is critical for pediatric medical device development and reflects the consortium's ability to identify challenges and provide solutions.

    Section 3: Consortium's Plan to Foster Collaboration, Diversity, Equity, and Inclusion to Create a National Network Benefiting All Pediatric Patients (maximum of 5 pages)

    The applicant should provide a 5-year plan to foster collaboration among the other consortia, the community (local and national), and key stakeholders to support pediatric medical device development.  The plan should include short term and long term aims, rationale, areas for collaboration, identification of key stakeholders, as well as anticipated obstacles and a plan to address them.  Collaborations may be as simple as cross referrals to other consortia based on site expertise, augmenting consortium resources through various partnerships, or more complex collaborations such as hosting recurring consortia events (events designed to foster synergy among innovators across the technology development ecosystem focusing on pediatric topics geared towards advancing pediatric medical device development).

    The plan will bring together stakeholders from diverse backgrounds to include their perspectives, increase racial, ethnic, and minority participation in the process to optimize pediatric medical device development.  The applicant should identify the underrepresented and underserved groups in the pediatric medical device field and develop a strategy to encourage the participation of these groups.  The applicant should describe how the proposed strategy will foster scientific innovation, enhance global competitiveness, improve the quality of research, advance the likelihood that underserved, or health disparity populations participate in, and/or benefit from pediatric medical device research and development.

    Bringing these concepts together, the applicant will illustrate how the consortium will collaborate to develop a national network of services to be utilized by a diverse group of device innovators for the benefit of all pediatric patients.    

    Section 4: RWE Demonstration Project(s) (maximum of 5 pages)

    The applicant is encouraged to propose a clearly defined RWE Demonstration Project(s) that will have significant impact in pediatric medical device development and pediatric labeling.  A well-described summary description of the project should be provided that clearly defines the purpose, aim(s) and overall goal(s) of the project.  The applicant should provide a race and ethnic diversity plan as part of the development process for the RWE Demonstration Project(s) that promotes inclusion, engagement and participation of diverse and inclusive populations.  The project(s) should include an explanation of how it will contribute to the field of real-world evidence, and specifically within the pediatric medical device ecosystem.  The project(s) can range in size and scope but should develop, verify and operationalize methods of evidence generation and data use, and demonstrate scalability across healthcare systems, device types, and manufacturers.  The proposed project(s) must all be designed to obtain results that are directly relevant and useful in clinical practice and in advancing pediatric device development and pediatric medical device labeling.  The RWE Demonstration Projects will be reviewed annually to ensure continued funding.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information

    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.

    PHS Assignment Request Form

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

    3. Unique Entity Identifier and System for Award Management (SAM)

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

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

    7. Other Submission Requirements and Information

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

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

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

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

    Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review.  Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

    Section V. Application Review Information

    1. Criteria

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

    Responsive applications will be reviewed and evaluated by a panel of experts with relevant expertise, such as pediatrics, regulatory, and device development.  In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed consortium will have a substantial impact on pediatric device development.  By submitting an application in response to this RFA, applicants understand and agree that members of the objective review panel of experts may be provided access to non-public information contained in the grant application, as necessary for evaluation of the application and subject to necessary restrictions on the further disclosure of the information.

    A combined score with a maximum of 100 points will be assigned to each application based on the scientific/technical review criteria (sections 1-4).  All applications will be ranked based on the scores of sections 1, 2, and 3 to identify those with the highest scores.  These applications will be considered for awards.  Section 4 (RWE projects) will be scored with the other sections but ranked independently from the top-ranking applications (based on the scores for sections 1, 2 and 3) of which the top scoring RWE projects will be considered for funding.

    The review panel may advise OOPD about the appropriateness of the proposal as it relates to the goals of the PDC grants program and may suggest funding modifications.  The following criteria are used by reviewers to assign scores.

    Scored Review Criteria

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

    1) Overall Description of the Consortium and Accomplishments (35 points)

    In evaluating the overall description of the consortium and their ability to accomplish the goals of promoting pediatric device development, as demonstrated to include but are not limited to the following, reviewers will provide a score to reflect their assessment of the consortium:

    a) The consortium’s organization and approach to facilitate the development of pediatric          devices;

    b) The consortium's leadership, membership, and affiliations;

    c) The consortium's ability to integrate and convey scientific, business, and regulatory considerations and strategic guidance to the pediatric device innovator;

    d) The consortium's ability to serve as a resource for pediatric device innovators and what       capabilities and affiliations exist to assist with pediatric device development;

    e) The consortium's relevant regulatory experience and how its current membership has          provided strategic guidance to device development along with knowledge of the regulatory         process for navigating the total product lifecycle;

    f) The consortium's plan for Direct Device Funding; and

    g) The consortium's ability to successfully guide pediatric device(s) through the total product life cycle.

    Reviewers will consider the consortium leadership and membership, how the consortium will achieve the goals of advancing pediatric device development, the budget proposal, and the resources available to the consortium.  The reviewers will consider whether the consortium membership includes the expertise that is needed for pediatric device development and not be required to seek significant external assistance outside the membership of the consortium.  When evaluating the consortium's accomplishments relevant to medical device development, it is important to consider the quality and potential impact of the examples provided, rather than focusing solely the quantity of examples provided.  Prior accomplishments do not need to be in the setting of a pediatric device consortium, the focus is on the applicant's accomplishments and ability to facilitate pediatric medical device development.

    2) Consortium's Ability to Identify Challenges, Provide Solutions, and Advise Innovators Regarding Pediatric Medical Device Development (30 points)

    Reviewers will consider and evaluate the consortium's ability to:

    a) Clearly and effectively advise and assist pediatric device innovators who request strategic guidance from the consortium regarding pediatric device development across the total product life cycle, at each stage of the device development;

    b) Provide training, subject matter expertise, and relevant assistance to pediatric medical device innovators and not be required to seek significant external assistance outside the membership of the consortium;

    c) Identify challenges and difficulties that the pediatric medical device innovators may encounter and provide the advice, guidance, tools and resources to overcome these challenges; and

    d) Improve clinical trial infrastructure for pediatric medical device development at their local institution.

    3) Consortium's Plan to Foster Collaboration, Diversity, Equity, and Inclusion to Create a National Network Benefiting All Pediatric Patients (20 points)

    Reviewers will evaluate the consortium's plan to foster collaboration among the consortia, the community (local and national), and key stakeholders.  Reviewers will assess the impact of these collaborations on developing a sustainable network of resources to advance and drive pediatric medical device innovation and development.  Reviewers will consider how effectively the plan will bring together stakeholders from diverse backgrounds to include their perspectives, increase racial, ethnic, and minority participation in the process to establish a national network to be utilized by a diverse group of device innovators for the benefit of all pediatric patients.   

    4) RWE Demonstration Projects (15 points)

    Reviewers will consider the significance on whether the project(s) contributes to pediatric device real-world evidence.  Reviewers will consider the approach of the real-world evidence to determine its impact to advance the development of pediatric medical devices, particularly, how the RWE project will obtain results that are directly relevant and useful in clinical practice and in advancing pediatric device development and pediatric medical device labeling.  The reviewers will consider the consortia's plan to develop, verify, and operationalize methods of evidence generation and data use, as well as their ability to demonstrate scalability across the healthcare system.  Reviewers will gauge the likelihood of success depending on leadership, resources, and soundness of the proposed project along with the ability to complete the project during the funding period.  The reviewer will consider the inclusion of a race and ethnic diversity plan as part of the development process for the RWE Demonstration Project(s).

    RWE Demonstration Projects will be reviewed annually for continued funding.

    Additional Review Considerations

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

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the  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.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

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

    Vertebrate Animals

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

    Biohazards

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

         Resubmissions

           Not Applicable.

         Renewals

           Not Applicable.

         Revisions

           Not Applicable.

    Select Agent Research

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

    Resource Sharing Plans

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

    Authentication of Key Biological and/or Chemical Resources:

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

    Budget and Period of Support

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

    2. Review and Selection Process

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

    As part of the objective review, all applications:

    • Will receive a written critique.

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

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

    • Scientific and technical merit of the proposed project as determined by objective review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    • Relevance of RWE Demonstration Projects to FDA priorities regarding Real-World Evidence
    3. Anticipated Announcement and Award Dates

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

    Section VI. Award Administration Information

    1. Award Notices

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

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

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

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

    2. Administrative and National Policy Requirements

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

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

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

    HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.  For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

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

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

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

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

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

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

    Standard Terms and Conditions of Award

    Reporting Requirements:

    All FDA grants require both Financial and Performance reporting.

    Financial Reporting:

    A. Financial Expenditure Reports

    A required Federal Financial Report (FFR) must be submitted annually. All annual FFRs must be submitted electronically using the Payment Management System (PMS). This includes all initial FFRs being prepared for submission and any revised FFRs being submitted or re-submitted to FDA. Paper expenditure/FFR reports will not accepted.

    Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. If a grant is under expanded authorities, the grantee must indicate the carryover amount in Section 12. Remarks of the annual FFR.

    Performance Progress Reporting:

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

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

    Salary Caps:

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

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

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

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

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

    Acknowledgment of Federal Support:

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

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

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

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

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

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

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

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

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

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

    Prior Approval:

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

    For grant awards not covered under Expanded Authorities, Carryover and No Cost Extension (NCE) requests will require prior approval.  All Carryover and NCE requests should be submitted using the Prior Approval module in eRA Commons. 

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

    1.         Change in Grantee Organization

    2.         Significant Rebudgeting

    3.         Change in Scope or Objectives

    4.         Deviation from Terms and Conditions of Award

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

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

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

    Audits and Monitoring:

    Audit Requirements:

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

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

    3.         For-profit and foreign entities can email their audit reports to 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:

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

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

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

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

    Financial Conflict of Interest (FCOI):

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

    Closeout Requirements (when applicable):

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

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

    Program Income:

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

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

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

    Treatment of Program Income:

    Prohibition on certain telecommunications and video surveillance services or equipment:

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

    (1) Procure or obtain,

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

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

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

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

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

    Other:

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

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts with cumulative total value greater than $10,000,000 must report and maintain information in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently the Federal Awardee Performance and Integrity Information System (FAPIIS)). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75.

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

    Special Terms and Conditions of Award

    A semi-annual report is required and should be emailed to your Program Officer and Grants Specialist 30 days after the first 6 months of each budget year.

    The Semi-Annual Report should include:

    1. A completed and clear discussion on how the consortium has facilitated the development, production, and distribution of pediatric medical devices with emphasis on pediatric device development, translation to market, and clinical access to pediatrics. Additionally, the consortium should provide specific and detailed examples related to key achievements of the consortium related device development, translation to market, and clinical access.

    2. A summary on Pediatric Device Development which includes: device projects, intellectual property, device design, pre-clinical milestones, external funding, collaborations with stakeholders and outreach

    2a. Include a clear device description that conveys why that device is a medical device and that the device is eligible for PDC support.

    2b. Confirm that the consortium supported only US sponsors/companies (confirm they have a U.S. subsidiary.)

    3. A summary on Transition to Market which includes: regulatory strategy and requirements, clinical evidence, business development and manufacturing

    4. A summary on Clinical Access which includes: marketing regulatory decision, commercialization and patient access, post market, and Real World evidence

    5. Publications/ Presentations (list and available reprints)

    6. A detailed progress update on the Real World Evidence projects (if applicable)]

    7. Confirm that no more than 25% of a consortium’s base budget ($1,150,000) was used for direct device funding.

    8. Confirm that no more than 25% of direct device funding supported internal devices.

    9. Confirm the consortium submitted appropriate IRB approval form and send a copy of the IRB approval form to OOPD, if applicable.

    10. Confirm the consortium is not conducting clinical trials (if yes, additional information will be required). 

    Direct Device Award Terms (including Combined Direct Device Awards):

    1. Each consortium involved in an award must review and agree to grant the award for the device project.

    2. Each consortium granting an award will fund a specific device project, review the budget for the funded project and will be responsible for monitoring the progress of the funded project.

    3. Each consortium involved in an award will issue their own award for their specific funded device project .

    3. Reporting

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

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

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

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

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

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

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Erika Torjusen
    FDA/ Office of Orphan Products Development (OOPD)
    Telephone: 301-796-2278
    Email: Erika.Torjusen@fda.hhs.gov

    Objective Review Contact(s)

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

    Financial/Grants Management Contact(s)

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

     

    Section VIII. Other Information

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

     

    Authority and Regulations

    Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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