SUP Bayer Corporation Vol by FDADocs

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									                                                             A Partnership Including       Boston
                                                             Professtonal Corporations     Chicago
                                                             600 Thirteenth Street, N.W.   London
                                                                                           Los Angeles
                                                             Washington, D.C. 20005-3096   Miami
                                                             202-756-8000                  Moscow
                                                             Facsmde 202-756-8087          New York
                                                             www.mwe.com                   Orange County
                                                                                           Silicon Vallev
                                                                                           Vilnius       d
                                                             Robert B. Nicholas            Washington, D.C
                                                             Attorney at Law
                                                             rnicholas@mwe.com
                                                             202-756-8170
   MCDERMOTT,                 WILL     & EMERY


                                                    August 22,2002


   Dockets Management Branch (HFA-305)
   Food and Drug Administration
   5630 Fishers Lane (Room 1061)
   Rockville, Maryland 20852

                        Re:         In the Matter of Notice of Hearing: Proposal to Withdraw
                                    Approval of New Animal Drug Application for Enrofloxacin
                                    for Poultry (“Enrofloxacin Hearing)
                                    FDA Docket: OON-1571
                                    SUBMISSION OF DISCOVERY DOCUMENTS


   Dear Sir/Madam:

          Enclosed for filing to docket number OON-1571, please find two copies of Respondent
                                                                               s
   Bayer Corporation’ (“Bayer”) discovery documents in response to CVM’ Request for
                     s
   Production and Interrogatories. As a courtesy, we have also enclosed an index of these
   documents.

               Please call with any questions.




       Enclosures




       WDC99 642846-2.048250.0013

OSAL            671
                                          DOCKET     INDEX

Exhibit                      Contents

B-l 163              Documents in Response to CVM Request for Production # 1

B-l 164              Documents in Response to CVM Request for Production # 2

B-l 165              Documents in Response to CVM Request for Production # 5

B-l 166              Documents in Response to CVM Request for Production # 12, 13 & 14

B-l 167              Documents in Response to CVM Interrogatory # 6

B-l 168              Documents in Response to CVM Interrogatory # 7

B-l 169              Documents in Response to CVM Interrogatory # 16




WDC99 642846-2.048250.0013
                                    CERTIFICATE        OF SERVICE

                                                                                               s
        I hereby certify that a copy of the transmittal letter for Respondent Bayer Corporation’
Submission of Discovery Documents was sent via e-mail and via first-class mail, postage pre-
paid this 22nd day of August 2002, to:

Nadine R. Steinberg, Esquire
Food and Drug Administration
Office of General Counsel (CGF-1)
5600 Fischers Lane, Room 7-77
Rockville, MD 20857

           and was mailed, via first-class mail, postage pre-paid to:

Kent D. McClure
Animal Health Institute
1325 G Street, N.W., Suite 700
Washington, D.C. 20005

          and was hand delivered this 22nd day of August 2002, to:

Dockets Management Branch (HFA - 305) - FDA
5630 Fishers Lane
Room 1061
Rockville, Maryland 20857




WDC99 642846-2.048250.0013

								
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