Notice Number: NOT-HD-12-025

Key Dates
Release Date: July 26, 2012
Estimated Publication Date of Announcement: October 2012 
First Estimated Application Due Date: January 2013
Earliest Estimated Award Date: September 2013
Earliest Estimated Start Date: September 2013

Related Notices
NOT-OD-12-005

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Notice is to announce the intention of NIH to issue a Funding Opportunity Announcement (FOA) to solicit applications from teams of extramural (non-NIH) investigators and internal (intramural) NIH investigators to conduct collaborative translational research projects that are aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. This opportunity is specifically to provide extramural (non-NIH) investigators a mechanism to establish collaborations with NIH intramural investigators and to take advantage of the unique research opportunities available at the NIH Clinical Center and work in collaboration with NIH intramural scientists: (http://www.cc.nih.gov/translational-research-resources/index.html).

This Notice incorporates the input provided in response to the RFI: To Solicit Input on Partnerships between Extramural and NIH Intramural Investigators Utilizing the NIH Clinical Center (NOT-OD-12-005) and provides links to the information sources necessary to explore potential partnerships and collaborations recommended in the response received. This notice is being provided to allow potential applicants sufficient time to review these resources and to develop meaningful extramural-intramural collaborations and responsive projects. 

The FOA is expected to be published in Fall 2012 with expected receipt dates in January 2013 and thereafter.

This FOA will utilize the U01 (cooperative agreement) activity code. Details of the planned Funding Opportunity Announcement (FOA) are provided below.

Background

While translating basic research into clinical practice is increasingly difficult, time consuming, and expensive, translational research is crucially important in converting basic scientific discoveries into new diagnostics and therapies for patients.  As such, this FOA intends to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science.

The cooperative agreement grant mechanism will promote collaborative research projects between extramural and intramural NIH investigators. Through this collaboration, external researchers also 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 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 in the context of state of the art medical care. 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 supports 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 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 who are known experts. 
• The ability to support longitudinal 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 while they are away from their own homes to participate in clinical research.

Research Initiative Details

Research projects submitted in response to this FOA must have a collaborating Principal Investigator/Co-Investigator in the NIH Intramural Program and must describe a research plan that will take advantage of the special resources and opportunities afforded by the NIH Clinical Center.  Collaborating research teams supported by this program will have at least one intramural and one extramural (non-NIH) investigator.

Applications may request a budget of up to $500,000 (direct costs) per year for a period up to 3 years.  In order to be eligible, the application will need to include at least one intramural scientist as Principal Investigator/Co-investigator, and the proposed collaborative project will need approval by the intramural Scientific Director of the relevant NIH Institute/Center and the Director of the Clinical Center, who will assure clinical resource availability.

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: (http://www.cc.nih.gov/translational-research-resources/index.html). 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 address questions about the NIH Clinical Center to:

Pat Piringer, RN, MSN
Special Assistant to the Director
NIH Clinical Center
tel: 301-496-4121
E-mail: ClinicalCtrPartner@mail.nih.gov

Please address questions about extramural grants to:

Eugene G. Hayunga, Ph.D.
Director, Office of Extramural Policy
Eunice Kennedy Shriver National Institute of Child Health
   and Human Development (NICHD)
National Institutes of Health
6100 Executive Boulevard, Room 2C01
Bethesda, Maryland 20892-7510
   (courier use: Rockville, MD 20852)
tel: 301-435-6856
email: ehayunga@mail.nih.gov