Vaccines, Blood & Biologics
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Request for Categorical Exclusion Memo - MenHibrix
MEMORANDUM – Environmental Assessment Review
To: STN: 125363/0
From: LCDR Sean R. Byrd, Dir. Reg. Rev. Ofc., OCBQ/DMPQ/BI, HFM-675
Through: Carolyn Renshaw, Chief, OCBQ/DMPQ/BI, HFM-675
Applicant: GlaxoSmithKline Biologicals S.A., License# 1617
Product: Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine [MenHibrix®]
Subject: Review of request for categorical exclusion from preparation of an Environmental Assessment under 21 CFR 25.31(c).
Recommended Action:
Based on review of the information provided, I conclude that the request for categorical exclusion from preparation of an Environmental Assessment under 21 CFR 25.31(c) is justified.
Summary:
GSK requested in Section 1.12.14 of their submission that the requirement for an Environmental Assessment be waived. Under 21 CFR 25.31(c), the requirement for an environmental impact assessment is categorically waived for applications to market biological products containing substances that occur naturally in the environment when a regulatory action does not significantly alter the concentration or distribution of the substance, its metabolites or degradation products in the environment.
GSK believes these conditions apply to MenHibrix® because there is no knowledge of any extraordinary circumstances that might cause its manufacture to have a significant affect on the quality of the human environment.
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LCDR Sean Byrd Date
Director, Regulatory Review Officer
Division of Manufacturing and Product Quality
Concurrence:
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John A. Eltermann, Jr., R.Ph. Date
Director
Division of Manufacturing and Product Quality
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