`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`22-350
`
`ENVIRONMENTAL ASSESSMENT
`
`
`
`.
`
`'
`
`3... dawn 4".
`
`3'
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`
`‘51,”-
`
`I
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`Public Health Service
`
`
`Food and Drug Administration
`CDER, Office of New Drug Quality Assessment
`Mail Room 2562
`
`10903 New Hampshire Ave.
`Silver Spring, Maryland 20993
`(301) 796-1679
`(301) 796-9747 (FAX)
`
`MEMORANDUM
`
`DATE:
`
`25-JUN-2009
`
`FROM:
`
`John C. Hill, Ph.D., CMC Reviewer
`
`THROUGH: Ali Al-Hakim, Ph.D., Chief, DPA—I
`
`TO:
`
`File, NDA 22-350
`
`SUBJECT: Environmental Assessment (EA) waver
`
`The applicant has provided calculations indicating that they are in compliance with the
`following section of the CFR.
`
`21 CFR§25.31(b) Action on an NDA, abbreviated application, or a supplement to
`such applications, or action on an OTC monograph, if the action increases the
`use of the active moiety, but the estimated concentration of the substance at
`the point of entry into the aquatic environment will be below 1 part per billion.
`
`This statement is satisfactory, the claim for exemption from the requirement for an EA
`(21 CFR§25.15) is granted.
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`John C. Hill
`6/25/2009 11:01:32 AM
`CHEMIST
`
`Ali Al-Hakim
`
`6/25/2009 04:31:49 PM
`CHEMIST
`
`
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