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Vaccines, Blood & Biologics
Submission Type: BLA Submission ID: 125363/0 Office: OVRR
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Telecon Date/Time: 23-Feb-2012 04:40 PM Initiated by FDA? Yes
Telephone Number: firstname.lastname@example.org; email@example.com
1. Information Request
Author: KIRK PRUTZMAN
Information request for Items 23 and 24a in CR Letter #2
FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN
Non-FDA Participants: JODY GOULD, NORRIS PYLE
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
We have the following Information Request regarding your responses to Item 23 and Item 24a for STN 125363/21 (MenHibrix).
Amendment 21 - Item 23
DBSQC Information Request: In the response to CR Item 23 in m1.11.1 Quality Information Amendment 21, the summary results and cited numbers for the validation reports for MenC-TT and MenY-TT appear to be transposed in that the Validation Report numbers and Ranges tested correspond to MenY-TT and MenC-TT respectively. If our interpretation is correct, please resubmit this table.
Amendment 21 – Item 24a.
DBSQC information request: The response to Item 24a and Validation Report 9000015175RVM001/01 Version 3.0 Section 8.11 does not clearly address the basis for the calculation of recovery of -----(b)(4)----- --- (termed “-----(b)(4)------” in the report) and it is unclear where the cited (b)(4) recovery is reported. Please provide a clear calculation example as to how the stated recovery value has been obtained.
Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
1451 Rockville Pike (WOC2)
Rockville, MD 20857
Phone: (301) 796-2640