FAQs About RFA-HD-14-020: CPCCRN Data Coordinating Center (DCC)

RFA-HD-14-020: Data Coordinating Center (DCC) for the Collaborative Pediatric Critical Care Research Network (CPCCRN)

1. What is the grant activity code/mechanism for this Request for Application (RFA)?
   • Applicants for this RFA are competing for a single U01 award.  The U01 mechanism is used to support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his specific interest and competencies.

2. How is a U01 different from an R01?
   • The U01 is similar to the R01, insofar as investigators are free to propose specific aims that they believe to be appropriate for their research.  However, the U01 code is used for cooperative agreement awards, which formalize a partnership role for NIH staff in assisting or coordinating the funded research.  Terms for the cooperative agreement, which focus primarily on potential coordination of research among awardees, are indicated in text of the FOA.

3. What is a Cooperative Agreement?
   • A Cooperative Agreement is a financial assistance instrument under which substantial involvement is anticipated between the federal agency and the recipient during performance of the contemplated project or activity.  These agreements are similar to grants, but federal staff have substantial scientific or programmatic involvement.

4. Can the Multiple Principal Investigator (PI) option be used for this application/award? 
   • Yes, multi-PI applications may be used for this award.  Refer to the NIH website http://grants.nih.gov/grants/multi_pi/faq.htm for more information on applying with Multiple PIs.  Information is also included in the SF424 application instructions.
   • When a multi-PD/PI option is used, all PD(s)/PI(s) have equal responsibility and accountability for leading and directing the project.  The structure and interaction of the PD/PI team will be left up to the PDs/PIs and the applicant institution.  All PDs/PIs must be qualified to serve as PD/PI and will share responsibility for the project.  Although the PDs/PIs may identify a leader of the project or a coordinator of the overall team, that is not a role that NIH formally acknowledges.  For the purposes of CPCCRN administrative functioning, the contact PI will assume the role of DCC Director, as the DCC is allowed only one vote in the Steering Committee.

5. Are resubmission (A1) applications allowed?
   • No, resubmission applications are not allowed for this RFA.  This is a one-time-only submission.

6. Is a letter of intent (LOI) required? When is the LOI due? Why do you want an LOI?
   • 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 allow NICHD staff to estimate the potential review workload and plan the review.
   • The LOI is due by May 2, 2014.

7. What information should be included in the LOI?
   • Descriptive title of proposed activity
   • Name(s), address(es), and telephone numbers of the PD(s)/PI(s)
   • Names of other key personnel
   • Participating institution(s)
   • Number and title of this funding opportunity announcement (FOA)
   • The letter of intent should be sent to:

8. Where should the LOI be sent?
   • Valerie Maholmes, Ph.D., C.A.S.
     Email: maholmev@mail.nih.gov
     Mail: 6100 Executive Blvd. Rm 8B07A, Bethesda, MD 20892* (*for courier/FedEx, replace with Rockville, MD 20852)
     Telephone: 301-496-1514
     Fax: 301-480-0230

9. The FOA says that NICHD “intends to commit $2.5 million in fiscal year 2015 to fund one award.”  What is the distribution of these funds?  Does the amount include indirect costs?  Does the amount span the entire 5 years of the award?
   • The dollar amount indicated in this FOA represents the committed funds for fiscal year 2015 to cover this FOA.  Because future budget years have yet to be approved by Congress, the amounts only represent funds for the initial award year.  However, as with other NIH FOAs, the expectation is that comparable funding will be available for the non-competing years of each award.
   • There are two financial components of this award: 
     1. The base award for the DCC,  and
     2. The patient and protocol funds for distribution to the CPCCRN Clinical Sites, and for support for required monitoring, a Data and Safety Monitoring Board (as needed), and for Advisory Board support. 
   • The base award includes direct plus indirect (facilities and administrative) costs.  An applicant for the DCC may request a budget for direct costs up to $800,000 per year.  The applicant should not include patient and protocol funds in the budget pages of the application.
   • An applicant for the DCC may request a project period of 5 years.

10. The last funding cycle RFA required the DCC applicant to submit a concept proposal.  Is that still required?
    • No, there is no concept proposal required for applications for the DCC; however, applicants should be prepared to describe expertise in the design, execution, and analysis of pediatric research.

11. The last RFA required applicants to name an Alternate PI.  This RFA does not request an Alternate PI, but rather an Alternate DCC Director.  Are they the same thing?
    • Yes, the term “Alternate PI” was used during the previous funding cycle to designate the qualified individual who could provide leadership in the absence of the PI.  It is a functional title within the administrative structure of the CPCCRN Steering Committee. While the role stays the same, the title has been changed to “Alternate DCC Director,” as NIH does not officially recognize the “Alternate PI” term. 
    • For the purposes of the administrative functioning of the CPCCRN, the PI will be designated the DCC Director, and the formerly titled “Alternate PI” will be designated as the Alternate DCC Director.  If the multi-PI option is used, the contact PI will be designated as the DCC Director, and another PI (most frequently the second PI) will be designated as the Alternate DCC Director.

12. Where does the RFA discuss the need for an Alternate DCC Director?
    • In Section IV.2 Content and Form of Application Submission/R&R or Modular Budget, the RFA states that “the designated Alternate DCC Director will commit up to 3.6 person months (30 percent) effort.”
    • The following statement was inadvertently left off of the RFA:  Section III.1.Eligible Applicants/Eligible Individuals (Program Director/Principal Investigator)/Minimum Requirements – “The application must identify a qualified Senior/Key individual to serve as Alternate DCC Director who can provide leadership in the absence of the DCC Director.  The individual may be one of the named PD(s)/PI(s) on a multi-PI application.”  This correction will be published in the NIH Guide as soon as possible, prior to the Earliest Submission Date.

13. What are the page limits for this application?
    • Page limitations may be found in the SF424 Application Guide and the Table of Page Limits (http://grants.nih.gov/grants/forms_page_limits.htm#other)
    • Page limitations must be strictly followed.
      1. Specific Aims = 1
      2. Research Strategy = 12
      3. Biographical Sketch = 4
    • NIH has the authority to withdraw an application from review and funding consideration for egregious cases in which the Appendix or certain section of the applications are used to circumvent page limits or include inappropriate material in the application.

14. Can supplemental material be submitted after the application receipt date, but prior to the initial peer review?
    • The NIH policy on post-submission application materials (those submitted after the initial grant application submission but prior to peer review) specifies that, for the majority of applications, the only post-submission materials that the NIH will accept are those resulting from unforeseen administrative issues, an option to be used when an unexpected event such as the departure of a participant, natural disaster, etc. has occurred, not to correct oversights/errors discovered after submission of the application. 
    • Adding materials to reviewer workload may be counterproductive, so applicants should carefully consider the need to send post-submission materials. 
    • Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

15. Will the applications be reviewed in a standing NIH study section?
    • The FOAs will be reviewed in Special Emphasis Panels convened by the review staff of NICHD, with reviewer expertise focused on the applications received in response to each FOA.

16. When will the Pre-Application Technical Assistance Meeting be held?
    • The pre-application meeting/webinar for will occur on April 25, 2014, from 1 p.m. to 5 p.m. Visit NOT-HD-14-013 for more detailed information.
    • Interested applicants may either attend in person or via webinar. The meeting will be recorded and available for applicants to access at their convenience.

17. Who should I contact for more information?
    • The primary contacts for this RFA are: Dr. Valerie Maholmes (maholmev@mail.nih.gov) and Ms. Tammara Jenkins (tjenkins@mail.nih.gov).