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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, January 15, 2013 - Novoeight

 

From:                    Pracht, Leigh
Sent:                      Tuesday, January 15, 2013 4:22 PM
To:                         CDCA (Cindy Cao)
Subject:                 STN 125466/0 Information Request as discussed earlier today
 
Importance:           High
Cindy,
 
Regarding the first three of six documents under section 5.3.5.4.25.2.1 being submitted in a readable hard copy format, this approach will not work. To this point, your entire submission has been electronic and is required to remain in an electronic format. Please submit these documents electronically under section 5.3.5.4.25.2.1 in a format with larger text so that when it is printed, it is readable.
 
 
Thank you,
 
Leigh A. Pracht
Regulatory Project Manager
FDA/CBER/OBRR/DBA
WOC1; RM 572N; HFM-380
1401 Rockville Pike
Rockville, MD 20852
Telephone: 301-827-6116
Fax: 301- 827-2857
Leigh.Pracht@fda.hhs.gov