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`RESEARCH
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`APPLICA TION NUMBER:
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`2 1 -976
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`ENVIRONMENTAL ASSESSMENT
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`Johnson & Johnson Pharmaeeutical Research & Development, L.L.C.
`920 ROUTE 202. P.O. BOX- 300. RARI‘I‘AN. new JERSEY 08889-0602
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`ENVIRONMENTAL ASSESSMENT
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`CATEGORICAL EXCLUSION
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`- TMC 114 Enthanolate Tablets (300 mg) -
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`Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) of
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`Raritan, New Jersey, certifies that the above referenced action meets the criteria for
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`categorical exclusion defined in the regulations [21 CFR 25.3l(b)], and that to the
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`knowledge of J&JPRD, no extraordinary circumstances exist. Thus, no environmental
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`assessment needs to be performed.
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` Edward Nowak
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`Director, Global Environmental, Health and Safety
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`Page 1
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`__2_L_ Page(s) Withheld
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`\/ § 552(b)(4) Trade Secret / Confidential
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`§ 552(b)(5) Deliberative Process
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`é § 552(b)(5) Draft Labeling
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`Withheld Track Number: Administrative— I
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