Notice Number: NOT-RM-10-012

Update: The following update relating to this announcement has been issued:

• March 31, 2011 - See Notice NOT-RM-11-013 Cancellation of the Remaining Receipt Dates for PAR-09-027.

Key Dates
Release Date: August 17, 2010

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Purpose

The purpose of this Notice is to update potential applicants regarding changes to scope of PAR-09-027 (http://grants.nih.gov/grants/guide/pa-files/PAR-09-027.html). The changes are effective beginning with the September 15, 2010 receipt date.

• When a lead recombinant protein or monoclonal antibody has been selected and proposed for preclinical development, applicants may request the following services, in addition to those listed in the Available Services section of PAR-09-027 (http://grants.nih.gov/grants/guide/pa-files/PAR-09-027.html#SectionI):
• Synthesis
• Scale-up production
• Development of analytical methods
• Development of suitable formulations
• Manufacture of clinical trial supplies
• NIH-RAID resources under PAR-09-027 (http://grants.nih.gov/grants/guide/pa-files/PAR-09-027.html) are no longer available when a lead therapeutic agent has not yet been selected and proposed for preclinical development. Only applications pertaining to the development of a lead therapeutic agent should be submitted in response to PAR-09-027(http://grants.nih.gov/grants/guide/pa-files/PAR-09-027.html).
• Formal product development plans are no longer available through PAR-09-027 (http://grants.nih.gov/grants/guide/pa-files/PAR-09-027.html). Successful X01 applicants may still receive informal product development guidance and advice in IND preparation from NIH staff if their application is deemed meritorious.

All other aspects of the FOA remain unchanged.

Inquiries

Interested parties may contact:

Tony Jackson
NIH-RAID Program
6001 Executive Boulevard, Room 2141
Bethesda, MD 20892
EXPRESS/COURIER: Rockville, MD 20852
Phone: (301) 594-4660
Email: [email protected]