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Accordance with 21 CFR 720) Read Instruction Booklet Before Completing. Type entries in CAPITAL LETTERS. Expiration Date: April 30, 2014. See Burden Statement on Reverse of Part I. ORIGINAL AMENDED FOR FDA USE ONLY ON ORIGINAL SUBMISSIONS FDA CPIS NO. FILING DATE F NOTE: This report is authorized by Public Law 21 U.S.C. 371(a); 21 CFR 720. While you are not required to respond, your cooperation is needed to make the results of this voluntary program comprehensive, accurate, and timely. I.

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