Frequently Asked Questions (FAQs) for RFA-DE-19-001 and RFA-DE-19-002

Administrative and Resource Center (U19 Clinical Trial Required) RFA-DE-19-001

Coordinating Center (U01 Clinical Trial Required) RFA-DE-19-002

This webpage for FAQs pertaining to RFA-DE-19-001 and RFA-DE-19-002 will be updated periodically. Potential applicants are encouraged to check this website for up-to-date information. If you have a question that is not addressed here, please email it to DentalPBRN@nidcr.nih.gov.

Updated 4/16/2018

  1. Question/Answer: A Notice of correction (NOT-DE-18-017) was recently published to RFA-DE-19-001.
  2. Question/Answer: A Notice of correction (NOT-DE-18-018) was recently published to RFA-DE-19-002.
  3. Question: As a follow-up to Question 19 (posted 3/22/2018), if studies funded through the future FOA for investigator-initiated studies justified the need for additional salary support for Node Coordinators (study-specific activities that are not part of the functions described in the RFAs as role/responsibilities of the Administrative and Resource Center or Coordinating Center), could that support come through the FOA for investigator-initiated studies?
    Answer: Yes, additional salary support for Node Coordinators could come through a FOA for investigator-initiated studies, provided that the activities are not part of the functions described in RFA-DE-19-001 or RFA-DE-19-002.

Updated 4/04/2018

  1. Question: Can ARC or DCC pay for licenses needed to enable efficient and HIPAA compliant communication software/tools?
    Answer: Yes, however justification should be provided for the purchase.
  2. Question: There appears to be a broken link in both RFAs: https://www.nidcr.nih.gov/GrantsAndFunding/PoliciesandGuidance/ClinicalResearch/NIDCRClinicalTermsofAward.
    Answer: Thank you for bringing this to our attention. The link has been fixed.
  3. Question: Are letters of support from the regional directors expected or required for the applications?
    Answer: Letters of support from Node Directors are not expected or required for the applications. As stated in RFA-DE-19-001Section IV. Application and Submission Information, 2. Content and Form of Application Submission, Administrative Core, Budget (Administrative Core), Node (Consortium) PD(s)/PI(s) must be identified as Key Personnel.
  4. Question: Is a letter of support from the current PBRN national director expected or required for the coordinating center application? Is a letter of support from the current coordinating center expected or required for the administrative and resource center application?
    Answer: No, a letter of support from the PBRN National Director is not expected or required for the Coordinating Center application, and a letter of support from the Coordinating Center is not expected or required for the Administrative and Resource Center application. Further, as stated in RFA-DE-19-001, a Collaboration Plan must be included as an Other Attachment in the Overall component of the U19 application. The Collaboration Plan must not name any proposed national DPBRN Coordinating Center institution/entity or personnel to prevent the potential for bias during peer review. As stated in RFA-DE-19-002, a Collaboration Plan must be included as an Other Attachment in the U01 application. The Collaboration Plan must not name any proposed national DPBRN Administrative and Resource Center institution/entity or personnel to prevent the potential for bias during peer review.

Updated 3/28/2018

  1. Question: The FAQs page regarding the RFA clarifies that the funding amounts
    ($3.2 million for the Administrative and Resource Center (ARC) and $2.2 million for the Coordinating Center (CC)) for FY 2019 are total amounts (rather than direct amount). It further states that application budgets are limited to the said amounts in total costs per year and that they must reflect the actual needs of the project. Is it correct to interpret these sentences to mean that the institute has not committed funds yet for years 2 through 7, but that the stated total budgets ($3.2 million for the ARC and $2.2 million for CC as maximum amounts per year) are guidelines for how budgets should be handled for years 2 through 7 in the application (while keeping in mind that they must reflect the actual needs of the project)? Or are there other guidelines for how years 2-7 should be handled in the application budget, budget justification etc.?
    Answer: Yes, the institute has not yet committed funds for years 2 through 7, but the stated total budgets are guidelines for how budgets should be handled for years 2 through 7 in the application. There are no other guidelines for how years 2-7 should be handled in the application budget, budget justification, etc.
  2. Question: Funding is indicated to be for FY2019, but the earliest funding date is April 1, 2019. Does that mean that the first year is from April 1, 2019 to Dec 31, 2019 or from April 1, 2019 to March 31, 2020?
    Answer: The first year is from April 1, 2019 to March 31, 2020.
  3. Question: The RFA states "Prior to initiating the Development and Implementation Phases of approved network studies, a project work scope and timeline will be finalized. ..." In this context, does "approved" mean approved after peer review, or approved by the network to be developed into an application?
    Answer: For research study funds available through the U19 award, “approved” means approved by NIDCR after having been recommended by the Executive Committee and then submitted to the NIDCR for evaluation. For investigator-initiated clinical research studies to be solicited through a future national DPBRN-specific funding opportunity announcement, “approved” means grants awarded by NIDCR after having undergone peer review. Specifically, RFA-DE-19-001 and RFA-DE-19-002 state the following: “During the Conceptual Phase of each potential new network study, the National DPBRN Administrative and Resource Center in collaboration with the National Coordinating Center will be responsible for… Providing information necessary to the potential applicants as they apply for NIDCR funding (e.g., review study concept and schedule of activities, create project work scope and timeline, ensure the feasibility of the proposed research to be implemented in the network, assess availability and extent of network resources required to implement the research study).”
  4. Question: Can ARC or DCC pay for software for practitioners and/or patients?
    Answer: It is unclear what is meant by software, but justification should be provided for the purchase.

Posted 3/22/2018

  1. Question: May a potential applicant arrange a meeting or phone call with an NIDCR Program Official to discuss the RFAs and obtain clarification of instructions?
    Answer: To ensure that all potential applicants have access to the same information, queries about the RFAs must be directed to DentalPBRN@nidcr.nih.gov. All questions received by NIDCR will be answered on this FAQ webpage.
  2. Question: RFA-DE-19-001 (U19) cites an annual award amount of $3.2 million. Is this a total cost amount or direct cost amount?
    Answer: The NIDCR intends to commit up to approximately $3,200,000 in total costs in FY2019 to fund one U19 award. Application budgets are limited to $3,200,000 in total costs per year and must reflect the actual needs of the project.
  3. Question: RFA-DE-19-002 (U01) cites an annual award amount of $2.2 million. Is this a total cost amount or direct cost amount?
    Answer: The NIDCR intends to commit up to approximately $2,200,000 in total costs in FY2019 to fund one U01 award. It is expected that application budgets will be limited to $2,200,000 in total costs per year and will reflect the actual needs of the project.
  4. Question: For applications in response to RFA-DE-19-001 (U19), may an institution submit more than one application?
    Answer: Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. Refer to Part I. Overview Information and Section III.3 for additional information.
  5. Question: For applications in response to RFA-DE-19-002 (U01), may an institution submit more than one application to one of the RFAs?
    Answer: Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. Refer to Part I. Overview Information for additional information.
  6. Question: Must an applicant responding to either RFA have current or previous involvement with NIDCR-supported Practice-Based Research Networks?
    Answer: No, this is an open competition. It is not limited to applicants with prior experience in the NIDCR-supported Practice-Based Research Networks.
  7. Question: Can a Program Director/Principal Investigator (PD/PI) for an application in response to one of the RFAs be a co-investigator or subcontract (Consortium) PD/PI for an application in response to the other RFA?
    Answer: Both RFAs state that a PD/PI for an application in response to one RFA may not be a PD/PI for an application in response to the companion RFA. There are no restrictions for co-investigators or subcontract (Consortium) PDs/PIs.
  8. Question: Can an applicant organization submit an application for both RFA-DE-19-001 and RFA-DE-19-002?
    Answer: Yes, an applicant organization may submit separate applications in response to each of the RFAs. Note that there is no requirement that applicant organizations submit applications for both RFAs.
  9. Question: Is a Letter of Intent required for either RFA?
    Answer: For either RFA, a Letter of Intent is not required, is not binding and does not enter into the review of a subsequent application. The information that a Letter of Intent contains assists staff in estimating the potential review workload and is requested to be submitted by June 17, 2018. Refer to Section IV.2 for additional information.
  10. Question: What is a companion award and how will it work?
    Answer: NIH defines companion Funding Opportunity Announcements (FOAs) as a set of FOAs that share a unified theme or initiative. These FOAs may use different activity codes. They are typically (but not always) published concurrently. To ensure success of the dental practice-based research network (DPBRN), there must be strong communication and collaboration between the DPBRN Administrative and Resource Center and the DPBRN Coordinating Center.
  11. Question: For applications in response to RFA-DE-19-001 (U19), what must be included in the Collaboration Plan? How can detail be provided if we cannot identify who the collaborators may be?
    Answer: A Collaboration Plan must be included as an Other Attachment in the Overall component of the U19 application. The Collaboration Plan must describe communication and collaboration interactions between the national DPBRN Administrative and Resource Center and the national DPBRN Coordinating Center. Further, the Collaboration Plan must describe the distribution of activities and division of tasks and responsibilities pertaining to management of the DPBRN infrastructure and research studies conducted through the DPBRN and must include a conflict resolution plan. The page limit for the Collaboration Plan is 4 pages.
    The Collaboration Plan must not name any proposed national DPBRN Coordinating Center institution/entity or personnel to prevent the potential for bias during peer review.
  12. Question: For applications in response to RFA-DE-19-002 (U01), what must be included in the Collaboration Plan? How can detail be provided if we cannot identify who the collaborators may be?
    Answer: A Collaboration Plan must be included as an Other Attachment in the U01 application. The Collaboration Plan must describe communication and collaboration interactions between the national DPBRN Administrative and Resource Center and the national DPBRN Coordinating Center. Further, the Collaboration Plan must describe the distribution of activities and division of tasks and responsibilities pertaining to management of the DPBRN infrastructure and research studies conducted through the DPBRN and must include a conflict resolution plan. The page limit for the Collaboration Plan is 4 pages.
    The Collaboration Plan must not name any proposed national DPBRN Administrative and Resource Center institution/entity or personnel to prevent the potential for bias during peer review.
  13. Question: Must the PD/PI for an application in response to one RFA illustrate previous collaboration with the PD/PI of the companion application?
    Answer: No, previous collaboration is not required. Applications must describe the vision for a future collaboration between the DPBRN Administrative and Resource Center and the DPBRN Coordinating Center, including a plan for communication between the entities and the distribution and division of tasks related to management of administrative and research activities.
  14. Question: For applications in response to RFA-DE-19-001 (U19), what is the page limit for the Research Strategy section of the application?
    Answer: In the U19 application, there are 3 required sections or “components,” each of which includes a Research Strategy section. The page limit for the Research Strategy section in the Overall component is 12 pages. The page limit for the Research Strategy section in Administrative Core (Node Organizational Structure) is 12 pages. The page limit for the Research Strategy section in DPBRN Elements Core (required DPBRN components) is 6 pages. All 3 components must be included in the grant application.
  15. Question: For applications in response to RFA-DE-19-002 (U01), what is the page limit for the Research Strategy section of the application?
    Answer: The RFA states that all page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. The page limit for the Research Strategy section of a U01 application is 12 pages.
  16. Question: For either RFA, what information may be included in the Appendix?
    Answer: The Appendix Policy specifies the only allowable Appendix materials, and applications submitted with Appendix materials not specified in the Appendix Policy will be withdrawn as noncompliant. It is recommended not to include any appendix materials in applications submitted to either RFA since the allowable materials are research study-specific, and applications submitted to these RFAs do not request study-specific details.
  17. Question: For applications in response to RFA-DE-19-001 (U19), why am I instructed to respond “yes” to the 4 questions in the Clinical Trials Questionnaire if I am not proposing a clinical trial in the grant application?
    Answer: The grant application must demonstrate that the proposed network has the capacity to develop and implement clinical trials. A Study Record must be entered as an example of how a clinical trial would be implemented in the network. Some of the information needed to demonstrate capacity is located in the FORMS-E Study Record: PHS Human Subjects and Clinical Trials Information form. To access the required data entry fields in the Study Record, the applicant must do the following:

    In the Overall component

    1. In SF424 (R&R) Other Project Information (Overall), indicate “Yes” to the question “Are Human Subjects Involved?”
    2. Add an attachment to Other Requested Information to cross-reference Study Record information across components. This attachment should indicate that all components (Overall component, Administrative Core, and DPBRN Elements Core) will contribute towards development and implementation of clinical trials in the network.
    3. Complete a Study Record: PHS Human Subjects and Clinical Trials Information form. Indicate “Yes” to the 4 questions of the Clinical Trials Questionnaire (Section 1.4), which will allow access to certain data entry fields needed to demonstrate the network’s capacity to develop and implement clinical trials. (As indicated in the RFA instructions, complete the following fields only: 1.1, 1.2, 1.3, 1.4, 2.1, 2.4, 2.5, 3.1, 3.2, 3.3, 4.7.)
    4. Do not enter a Delayed Onset Study Record in the Overall component.

    In the Administrative Core

    1. In SF424 (R&R) Other Project Information (Administrative Core), indicate “Yes” to the question “Are Human Subjects Involved?”
    2. Add an attachment to Other Requested Information to cross-reference Study Record information across components. This attachment must indicate that the Study Record details, which demonstrate the network’s capacity to develop and implement clinical trials, are included in the Overall component.
    3. Do not enter a Study Record in the Administrative Core.
    4. Enter a Delayed Onset Study Record in the Administrative Core. Note the following additional instructions, which were inadvertently omitted from RFA-DE-19-001 (A Notice to clarify the omission will be published):
      The grant application must include one or more developmental/exploratory, pilot (feasibility), and/or survey delayed onset studies to be funded through this award. The delayed onset study(ies) represent future studies funded through the U19 grant to be conducted through the national DPBRN and should not provide specific details about the proposed clinical studies. Enter the delayed onset study(ies) in the Administrative Core only. Per the instructions, multiple delayed onset studies can be grouped in a single record, and the justification attachment can represent all delayed onset studies grouped in a single record. The justification should indicate that the delayed onset clinical studies will be submitted to the NIDCR as study concepts, which will undergo evaluation and future implementation in the DPBRN.

    In the DPBRN Elements Core

    1. In SF424 (R&R) Other Project Information (DPBRN Elements Core), indicate “Yes” to the question “Are Human Subjects Involved?”
    2. Add an attachment to Other Requested Information to cross-reference Study Record information across components. This attachment must indicate that the Study Record details, which demonstrate the network’s capacity to develop and implement clinical trials, are included in the Overall component.
    3. Do not enter a Study Record in the DPBRN Elements Core.
    4. Do not enter a Delayed Onset Study Record in the DPBRN Elements Core.
  18. Question: For applications in response to RFA-DE-19-002 (U01), why am I instructed to respond “yes” to the 4 questions in the Clinical Trials Questionnaire if I am not proposing a clinical trial in the grant application?
    Answer: The grant application must demonstrate that the proposed Coordinating Center has the capacity to support clinical studies to be conducted within the DPBRN. A Study Record must be entered as an example of how a clinical trial would be supported. Some of the information needed to demonstrate capacity is located in the FORMS-E Study Record: PHS Human Subjects and Clinical Trials Information form. To access the required data entry fields in the Study Record, the applicant must do the following:
    1. In SF424 (R&R) Other Project Information, indicate “Yes” to the question “Are Human Subjects Involved?”
    2. Complete a Study Record: PHS Human Subjects and Clinical Trials Information form. Indicate “Yes” to the 4 questions of the Clinical Trials Questionnaire (Section 1.4), which will allow access to certain data entry fields needed to demonstrate the Coordinating Center’s capacity to support clinical trials. (As indicated in the RFA instructions, complete the following fields only: 1.1, 1.2, 1.3, 1.4, 2.1, 2.4, 3.1, 3.2, 3.3, 3.5, 4.7.)
    3. Do not enter a Delayed Onset Study Record.
  19. Question: The RFAs mention a funding opportunity announcement (FOA) planned for later that will fund investigator-initiated studies. Can you tell U19/U01 applicants what budget items that FOA will fund? For example, would the investigator-initiated RFA fund salary support for the Study PI and Investigator(s), practitioner payments, and patient payments? Will that FOA fund other items, such as investigator travel costs, node coordinator travel costs, study-specific publication costs, consultant costs, and any other items? This would help applicants draw the line where study-specific budgets end and infrastructure budgets begin.
    Answer: Since a future FOA will solicit applications for research studies to be conducted in the dental practice-based research network, expenditures that are necessary and reasonable to develop and implement future studies would be included in applications responding to a future FOA. The U19/U01 applications should budget for study-specific expenditures described as roles/responsibilities/functions of the Administrative and Resource Center or Coordinating Center stated in the RFAs. For example, in RFA-DE-19-001 (U19), personnel within the Node Organizational Structure are responsible for functions such as “engaging practitioners in study participation,” “participating on study teams to provide oversight of network resources and advising study teams about network operations,” “working collaboratively with study teams to develop clinical research training procedures and materials for practitioners,” “assuring that practitioners are appropriately trained,” etc. Similarly, in RFA-DE-19-002 (U01), functions of the Coordinating Center include “providing biostatistical support to study teams for study design and protocol development…,” “assisting study teams in the preparation of study protocols, case report forms, and other study-related documents,” “establishing and maintaining a data management system needed for study data collection and storage…,” etc. In RFA-DE-19-002 (U01), see Section IV. 2 R&R or Modular Budget for additional information about activities to be budgeted.
  20. Question: When will a future funding opportunity announcement be published that will solicit applications for research studies to be conducted in the dental practice-based research network? Would this be possibly in a few months, or only after the U19/U01 awards have been made? This is relevant to planning how U19 and U01 budgets might be affected by the timing of large-scale study launches.
    Answer: Information about timing of a future FOA is not available at this time. Applicants should propose budgets and network activity timelines based upon when it is expected that the network will have the capacity to launch large-scale clinical studies.
Last Reviewed on
March 2018