Notice Number: NOT-RR-06-001

Key Dates
Release Date: October 12, 2005

Issued by
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)

Today NIH published an RFA for Institutional Clinical and Translational Science Awards (RFA-RM-06-002). This new Clinical and Translational Science Award (CTSA) program, which NCRR is leading on behalf of the NIH Roadmap for Medical Research, will transform and advance clinical and translational science as a distinct discipline within a definable academic home. Since the RFA will be issued annually, a cademic health centers, including those with GCRCs, can build on their existing resources and transform into this new integrated program over a period of years. Also, a one-time planning grant RFA has been announced to give institutions more time to prepare to apply for a CTSA (RFA-RM-06-001). The CTSA program will build on existing programs by reconfiguring, and adding to, certain NIH awards (NCRR GCRC [M01], K12, K30, and Roadmap T32 and K12) held by the applicant institution and its affiliates.

As part of this process, NCRR will modify procedures for GCRCs as follows:

• General Clinical Research Center or GCRC (M01) applications submitted in 2006 and beyond are to prepare the M01 application in accordance with the September 2005 Guidelines for the General Clinical Research Centers Program (M01) posted at http://www.ncrr.nih.gov/clinical/DCRRGuidelines2005/GCRC_Guidelines_September2005.pdf. The Clinical Research Review Committee will review these applications without conducting a site visit.

• Applications that already have a scheduled submission date will continue to be accepted. Those that are successful through the review process will receive a 3-year M01 award.

• New and amended GCRC applications will continue to be accepted through January 1, 2007.

• Competing continuation GCRC applications will be accepted through June 1, 2007.

• GCRCs with a project period end date in 2008 may request a 1-year extension of support for their M01 grant in lieu of a competing renewal application.

Institutions with GCRCs that are applying for a CTSA should be aware of the following:

• An institution may not simultaneously hold both a CTSA and a GCRC award. As specified in RFA RM-06-002, successful applicants for CTSAs will relinquish their GCRC grants when the CTSA is awarded because M01 funds will be reconfigured to become part of the CTSA. While institutions may hold more than one GCRC award, they may only hold, or participate in, one CTSA.

• In 2006, institutions may submit an M01 grant application and a CTSA Planning Grant application. However, they may submit either an M01 grant application or a CTSA grant application, but not both.

• Applicants with a GCRC (M01) grant who are unsuccessful in obtaining a CTSA will retain their current GCRC grant for the awarded project period.

NCRR anticipates that the competitive process that will transform GCRC (M01) grants to CTSAs will be complete by September 30, 2010. NCRR will work flexibly on a case-by-case basis with GCRCs during this transition period to give them time to plan and apply for a CTSA award.

Inquiries

Anthony R. Hayward, M.D., Ph.D.
Division for Clinical Research Resources
National Center for Research Resources
6701 Democracy Boulevard Room 906 - MSC 4874
Bethesda , MD 20892-4874
Telephone: (301) 435-0790
FAX: (301) 480-3661
Email: haywarda@mail.nih.gov