Notice Number: NOT-HD-13-009
Update: The following update relating to this announcement has been issued:
- September 20, 2013 - See Issusance of PAR-13-358 (U01) and PAR-13-357 (X02)
Key Dates
Release Date: July 25, 2013
Estimated Publication Date of Announcement: September 2013
First Estimated Application Due Date: November 20, 2013
Earliest Estimated Award Date: November 2014
Earliest Estimated Start Date: November 2014
PAR-13-029
Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Purpose
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and other participating NIH Institutes and Centers intend to re-affirm NIH’s commitment to support collaborative translational research projects between extramural (non-NIH) investigators and internal (intramural) NIH investigators that utilize the resources of the NIH Clinical Center and announce some changes in the application process for next year’s competition.
Two companion FOAs are expected to be published in Fall 2013. These FOAs will utilize the U01 Research Project Cooperative Agreements activity code and the X02 Pre-application activity code. Details of the planned FOAs are provided below.
Research Initiative Details
The goal of this program is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. It encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers
Specifically, the program seeks to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators (i.e., those conducting research within the labs and clinics of the NIH) and extramural investigators (i.e., those conducting research in labs outside the NIH), and by providing support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting research projects in collaboration with NIH intramural investigators. In order to be eligible for this program, the application must include at least one intramural scientist as Principal Investigator/Co-investigator, and at least some of the research must be conducted at the NIH Clinical Center.
Through this collaboration, external researchers may gain access to the NIH Clinical Center (CC) and leverage the diverse CC resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with the potential for advancing disease diagnosis, treatment and prevention. The NIH Clinical Center is a hospital exclusively dedicated to clinical research, thus research is the culture and research studies are routine. Its mission includes the support of clinical studies that are considered intellectually challenging and risky but with the potential of high reward with new breakthroughs in medicine.
The special environment of the Clinical Center can support studies that may not be readily supported elsewhere and includes:
- A host of special resources, such as a good manufacturing practices (GMP) facility for new biological or clinical products, specialized clinical phenotyping facilities (including a metabolic and other units), the manufacturing and use of newly designed PET ligands for imaging studies, the availability of blood products for special research studies.
- Collaborative opportunities on clinical protocols on unique pharmaceutical agents and/or other modes of therapy, or extraordinarily rare diseases with investigators that are known experts (http://clinicalstudies.info.nih.gov/).
- The ability to support long-term clinical studies at minimal cost to patients and their families.
- On-campus amenities (e.g., Family Lodge and Children’s Inn) to support patients and families in supportive, home-like environments as they leave their own homes to participate in clinical research.)
- More details on the unique resources available at the CC may be found at: http://www.cc.nih.gov/researchers/resources.shtml
A Funding Opportunity Announcement (FOA), PAR-13-029, was published in 2012 encouraging U01 cooperative agreement applications on due dates in 2013, 2014, and 2015 for possible funding consideration in FY2014, FY2015 and FY2016, respectively. NIH will continue to accept applications for possible funding in FY2015 and FY2016, but following revised procedures, as described below.
Application Process for FY2015 and FY2015 Awards
Reissue of U01 Funding Opportunity Announcement (FOA): The previous U01 FOA (PAR-13-029) will expire and be reissued this fall. A companion X02 FOA will also be issued at that time.
New U01 Funding Opportunity Announcement (FOA)
The new U01 FOA will have a new number and revised instructions, but the due dates for 2014 and 2015 will remain the same (March 20, 2014 for possible funding in FY 2015 and March 20, 2015 for possible funding in FY2016).
New X02 Funding Opportunity Announcement (FOA)
A new companion FOA will also be published in the fall using the X02 pre-application mechanism that will run in parallel with the reissued U01 FOA. The X02 pre-application will be the first step in submitting an application for the U01 award. No awards will be made in response to the X02 FOA; instead applicants of X02 pre-applications that are found meritorious and programmatically relevant will be notified of the opportunity to submit a full application in response to the U01 FOA.
Resubmissions
Applicants who had applied in response to PAR-13-029 but were not funded are encouraged to apply to the X02 FOA; the X02 application would be a new application. If they subsequently apply to the companion reissued U01 FOA, their U01 application would be considered a resubmission.
New Applications
Applicants who had not applied in response to PAR-13-029 are also encouraged to submit a new application in response to the X02 FOA. If they subsequently apply to the companion reissued U01 FOA, their U01 application would also be considered a new application.
Summary of Key Dates
FY2015 Funding Consideration
Publication of X02 FOA and reissued U01 FOA: September 2013
Pre-application webinar: October 2013
Due date for X02 pre-application: November 20, 2013
Evaluation of X02 pre-applications: December 2013-January 2014
Notification of Opportunity to submit U01 application: January 20, 2014
Due date for reissued U01 FOA: March 20, 2014
Scientific peer review of U01 applications: June-July 2014
Second-level review by relevant Institute/Center Advisory Council: October 2014
Start date for awarded U01 grants: November-December 2014
FY2016 Funding Consideration
Publication of X02 FOA and reissued U01 FOA: September 2013
Pre-application webinar: October 2013
Due date for X02 pre-application: November 20, 2014
Evaluation of X02 pre-applications: December 2014-January 2015
Notification of Opportunity to submit U01 application: January 20, 2015
Due date for reissued U01 FOA: March 20, 2015
Scientific peer review of U01 applications: June-July 2015
Second-level review by relevant Institute/Center Advisory Council: October 2015
Start date for awarded U01 grants: November-December 2015
Additional information about the program
To assist extramural (non-NIH) investigators in identifying opportunities for collaboration, NIH has created a web site for Investigator Access to the NIH Clinical Center. This website includes information about Clinical Center resources, a searchable database of intramural investigators, and guidance about intramural policies, requirements, and other considerations when implementing intramural-extramural collaborations and conducting research at the NIH Clinical Center. Potential applicants are also encouraged to contact staff at the appropriate NIH Institute/Center.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Inquiries
Please direct all inquiries to:
Questions about the NIH Clinical Center:
Pat Piringer, RN, MSN
Special Assistant to the Director
NIH Clinical Center
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov
Questions about extramural grants:
Eugene G. Hayunga, PhD
Director, Office of Extramural Policy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
Telephone: 301-435-6856
Email: ehayunga@mail.nih.gov
and Human Services (HHS)
