FAQs About RFA-HD-14-022: CPCCRN Clinical Sites (UG1)

RFA-HD-14-022: Collaborative Pediatric Critical Care Research Network (CPCCRN) (UG1)

  1. What is the UG1 mechanism and how is it different than the U10 mechanism used in the previous CPCCRN funding cycle?
    • A UG1 is a Clinical Research Cooperative Agreement – Single Project.  It is used to support single project applications conducting clinical evaluation of various methods of therapy and/or prevention (in specific disease areas).  Substantial federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of the award. 
    • NOTE: The UG1 is the single-component companion to the U10 which is used for multi-project applications only (the U10 is used to support clinical evaluation of various methods of therapy and/or prevention in specific disease areas).  These represent cooperative programs between sponsoring institutions and participating principal investigators, and are usually conducted under established protocols).
  1. How is a UG1 different from an R01?
    • The UG1 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 UG1 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.
  1. 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.
  1. I am a current member of CPCCRN and am applying for renewal.  Because the mechanism has changed from a U10 to a UG1, do I submit as a renewal application, or as a new application?
    • You may submit as a renewal application.  Now that U10s are defined as multi-project grants, the UG1 was created to allow for a single project that would have been U10 before the change.  In this situation, if the applicant is submitting a renewal of an earlier U10, then his/her UG1 may be a renewal application.
  1. Can the Multiple 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 PDs/PIs 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 Clinical Site Director, as each site is only allowed one vote in the Steering Committee.
        1. Are resubmission (A1) applications allowed?
          • No, resubmission applications are not allowed for this RFA.  This is a one-time-only submission.
        1. 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.
        1. 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:
        1. 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
        1. Can two or more institutions join together to submit one application as a consortium site?
          • Yes, multiple sites may submit a single application to perform as a consortium site within the network.
          • PDs/PIs at different institutions may collaborate on the development of a multiple PD/PI application.  However, a single application should be submitted from one institution that identifies all PDs/PIs, including those from institutions other than the applicant institution.  The institution submitting the application will be considered the lead institution.  The Contact PD/PI must be associated with the institution submitting the application.  In the case of a consortium, there will be one PD/PI who will serve on the Steering Committee and represent the other consortium sites.
          • If funded, NIH will issue a single award to the applicant institution which will administer the award using the traditional subcontract approach to the other collaborating sites. No additional base funds will be provided beyond the base budget request of $172,000.
        1. My area of scientific interest is not listed in the RFA.  Can I still submit an application?
          • Yes.  The subject areas listed in the RFA are examples of research appropriate for the FOA, but applicants are not limited to those subject areas. 
        1. The FOA says that NICHD “intends to commit approximately $1.8 million in fiscal year 2015 to fund up to 7 Clinical Site awards.”  Is the indicated dollar amount for each award, or is it for all of the awards?  Does the amount include indirect costs?  Does the amount span the entire 5 years of the award?
          • The dollar amounts indicated in each FOA represent the committed funds for fiscal year 2015 to cover all awards for that FOA, including direct plus indirect (facilities and administrative) costs.  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. 
          • An applicant for a Clinical Site may request a budget for direct costs up to $172,000 per year.  CPCCRN patient and protocol costs, and support for required monitoring, Data and Safety Monitoring Boards, and Advisory Board meetings are administered through the Data Coordinating Center that supports the CPCCRN.
          • An applicant for a Clinical Site may request a project period of 5 years.
        1. What would a typical budget be for this FOA, and how much money should I ask for?
          • An applicant for a Clinical Site may request a budget for direct costs up to $172,000 per year.  Key components of the application base budget are located in the RFA under Section IV.2 Content and Form of Application Submission/R&R or Modular Budget.
        1. Is the “concept proposal” part of the 12-page Research Strategy section page limit?
          • Yes, the concept proposal is just a part of the research strategy section and is meant to provide peer reviewers and the NICHD an idea of the investigators’ capabilities to participate in the development and design of common protocols.  The concept proposal should be described briefly (2-5 pages maximum). 
        1. Should I include a budget for my “concept” proposal?
          • No, the only budget that should be included in the application is the base budget for the Clinical Site.  There is no assurance that concepts presented by successful applicants will be carried out by the network. 
        1. The RFA for the last funding cycle required biosketches for all intensivists in our department.  The new RFA does not seem to ask for that information.  What biosketches are needed?
          • Biosketches for all pediatric intensivists at the site do not need to be included.  The only biosketches required include the PI(s), Alternate Clinical Site Director (formerly, “Alternate PI”) and other key personnel.  It is up to each site to determine who constitutes Key Personnel.  However, a discussion of staffing at each clinical site is required in the application per Section IV.2.PHS 398 Research Plan/Pediatric Critical Care Staffing and Available Expertise.
        1. The last RFA required applicants to name an Alternate Principal Investigator.  This RFA does not request an Alternate PI, but rather an Alternate Clinical Site 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 Clinical Site 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 Clinical Site Director, and the formerly titled “Alternate PI” will be designated as the Alternate Clinical Site Director.  If the multi-PI option is used, the contact PI will be designated as the Clinical Site Director, and another PI (most frequently the second PI) will be designated as the Alternate Clinical Site Director.
          • The Alternate Clinical Site Director may be a pediatric intensivist, or, if appropriate to the expertise and research expertise at an applicant site, a pediatric surgical investigator (pediatric trauma, burn, neurological or general pediatric surgery).  
        1. 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.
        1. 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.
        1. Will the applications be reviewed in a standing NIH study section?
          • This FOA will be reviewed in a Special Emphasis Panels convened by the review staff of NICHD, with reviewer expertise focused on the applications received in response to the FOA.
        1. 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.
        1. Who should I contact for more information?
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