Record of Telephone Conversation, April 3, 2014 - RAGWITEK

RECORD OF TELEPHONE CONVERSATION
 Submission Type: BLA Submission ID: 125478/0 Office: OVRR
 Product:
 Short Ragweed Pollen Allergen Extract
 Applicant:
 Merck Sharp & Dohme Corp.
 Telecon Date/Time: 03-Apr-2014 02:57 AM Initiated by FDA? Yes
 Telephone Number: Via E-mail
 Communication Categorie(s):
 1. Information Request

Author: DEBORAH TROUT
 Telecon Summary:
 Request for justification for the ---(b)(4)---- acceptance criterion of ---(b)(4)--- for cleaning the ---(b)(4)----.
 FDA Participants: Deborah Trout
 Non-FDA Participants: Scott Greenfeder
 Trans-BLA Group: No

Telecon Body:
 Deborah Trout e-mailed Scott Greenfeder concerning BLA section 3.2.A.1 Facilities and Equipment page 48 to request that he provide a justification for the ---(b)(4)------ acceptance criterion of ---(b)(4)----- for cleaning the ---(b)(4)----.
