Modified Receipt and Decision Process for PAR-11-344 (X01)

Notice Number: NOT-NS-11-025

Release Date: September 21, 2011

(PAR-11-344)

National Institute of Neurological Disorders and Stroke (NINDS))

The purpose of this Notice is to inform the community that the National Institutes of Health is implementing an alternate plan for receipt and review of X01 applications seeking access to the NeuroNEXT infrastructure to conduct clinical trials in neurological diseases: PAR-11-344, NeuroNEXT Infrastructure Resource Access (X01).

This alternate receipt and review plan is not applicable to PAR-11-343, NeuroNEXT Clinical Trials (U01) or PAR-11-345, NeuroNext Small Business Innovation in Clinical Trials (U44). Interested parties should look at those announcements for the applicable receipt dates.

Processing and Review Schedule: Applications for PAR-11-344, NeuroNEXT Infrastructure Resource Access (X01), may be submitted at any time and will be reviewed no later than 120 days after receipt.  Because of the need to assign an Advisory Council date, the following schedule will be followed.  However, applications may be moved to earlier Councils as timing permits. 

Schedule for Assignment to Advisory Council Rounds

Council Round	Receipt Window
May	November 13 - March 12
October	March 13 - July 12
January	July 13 - November 12

D. Elizabeth McNeil, MD MSc
6001 Executive Boulevard, MSC 9520
Rockville, MD 20852
Phone: 301-496-9135
Fax: 301-480-1080
Email: [email protected]