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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Con., January 26, 2011 - Adenovirus 

Submission Type: BLA Submission ID: 125296/0 Office: OVRR

Product: Adenovirus Vaccine Live Oral Type 4 and Type 7

Applicant: Teva Women's Health, Inc.

Telecon Date/Time: 26-Jan-2011 04:07 PM Initiated by FDA? Yes

Communication Category: Information Request

Author: Helen Gemignani

Telecon Summary: Request for Categorical Exclusion

FDAParticipants: Helen Gemignani

Non-FDA Participants: Valerie Mulligan

Telecon Body: Please submit a formal request for Categorical Exclusion from an Environmental Assessment (in Section 1.12.14 Environmental Analysis) for your product under 21 CFR 25.31.