Animal_Generic_Drug_Fee_for_2011--2010-19040.pdf;JSESSIONIDVISTA=cJhWT7HTk3s72jdZfCTp2STJQVc0G4br0xv

Animal_Generic_Drug_Fee_for_2011--2010-19040.pdf;JSESSIONIDVISTA=cJhWT7HTk3s72jdZfCTp2STJQVc0G4br0xv

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45636 Federal Register / Vol. 75, No. 148 / Tuesday, August 3, 2010 / Notices Sheet can be mailed to: Food and Drug Administration, P.O. Box 953877, St. Louis, MO, 63195–3877. If payment is made by wire transfer, send payment to: U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, FDA Deposit Account Number: 75060099, U.S. Department of Treasury routing/transit number: 021030004, SWIFT Number: FRNYUS33. You are responsible for any administrative costs associated with the processing of a wire transfer. Contact your bank or financial institution regarding additional fees. If you prefer to send a check by a courier such as Federal Express (FEDEX) or United Parcel Service (UPS), the courier may deliver the check and printed copy of the cover sheet to: U.S. Bank, Attn: Government Lockbox 953877, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This address is for courier delivery only. If you have any questions concerning courier delivery contact the U.S. Bank at 314– 418–4821. This telephone number is only for questions about courier delivery.) The tax identification number of the Food and Drug Administration is 530196965. (Note: In no case should the payment for the fee be submitted to FDA with the application.) It is helpful if the fee arrives at the bank at least a day or two before the application arrives at FDA’s CVM. FDA records the official application receipt date as the later of the following: The date the application was received by FDA’s CVM, or the date U.S. Bank notifies FDA that your payment in the full amount has been received, or when the U.S. Treasury notifies FDA of receipt of an electronic or wire transfer payment. U.S. Bank and the U.S. Treasury are required to notify FDA within 1 working day, using the PIN described previously. B. Application Cover Sheet Procedures Step One—Create a user account and password. Log on to the ADUFA Web site at http://www.fda.gov/ForIndustry/ UserFees/AnimalDrugUserFee ActADUFA/default.htm and, under Tools and Resources click ‘‘ The Animal Drug User Fee Cover Sheet ’’ and then click ‘‘ Create ADUFA User Fee Cover Sheet. ’’ For security reasons, each firm submitting an application will be assigned an organization identification number, and each user will also be required to set up a user account and password the first time you use this site. Online instructions will walk you through this process. Step Two—Create an Animal Drug User Cover Sheet, transmit it to FDA, and print a copy. After logging into your account with your user name and password, complete the steps required to create an Animal Drug User Fee Cover Sheet. One cover sheet is needed for each animal drug application or supplement. Once you are satisfied that the data on the cover sheet is accurate and you have finalized the cover sheet, you will be able to transmit it electronically to FDA and you will be able to print a copy of your cover sheet showing your unique PIN. Step Three—Send the payment for
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This note was uploaded on 01/01/2012 for the course PHRM 7230 taught by Professor Tackett during the Spring '11 term at University of Georgia Athens.

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Animal_Generic_Drug_Fee_for_2011--2010-19040.pdf;JSESSIONIDVISTA=cJhWT7HTk3s72jdZfCTp2STJQVc0G4br0xv

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