Document text
From: Smith, Michael (CBER) < [email protected] >
Sent: Tuesday, January 25, 2022 11:34 AM
To:Collins, Kathleen Mary Catherine ; Harkins Tull, Elisa
<Elisa.HarkinsTull@pfizer .com >; Devlin, Carmel M <[email protected] >; Mineo, Gosia
Cc:Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >
Subject: [EXTERNAL] STN 125742/45: IR RE EA/CE and FDA form 356
Kate,
The review team has the below Information Requests (IRs) for you. Please submit your
responses in an amendment to STN 125742/45 by February 10, 2022.
1. We noticed that there wa sn’t any information in the supplement regarding
Environmental Assessment (EA) or a claim of categorical exclusion (CE).
As per 21 CFR 25.15(a), all applications requesting agency action require the
submission of an Environmental Assessm ent (EA) or a claim of categorical
exclusion (CE). This includes Biologics License Supplement submissions. Please
submit an EAor a Claim of CE in an amendment to STN 125742/45 in Module 1.12.14.
2. Please submit a revised FDA form 356h t hat includes the information regarding
all establishments and manufac turing facilities (e.g., including the
site).
Regards,
Mike
-Please confirm receipt of this email and let us know if you have any questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & ResearchOffice of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301-796-2640michael.smith2 fda.hhs.gov
g
Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=0014080934, cn=Michael J. Smith -S4 Date: 2022.01.25 11:53:21 -05'00'
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2022-5812-0500313
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS
ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND
PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a
person authorized to deliver the document to the addressee, you are hereby
notified that any review, disclosure, dissemination, copying, or other action
based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender
immediately by e-mail or phone.
FDA-CBER-2022-5812-0500314