UNITED STATES OF AMERICA

BEFORE THE FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

)

)

)

In the Matter of: ) FDA DOCKET: 00N-1571

) DATE: February 25, 2003

Enrofloxacin for Poultry: Withdrawal )

of Approval of Bayer Corporation\'s )

New Animal Drug Application )

(NADA) 140-828 (Baytril) )

)

)

)

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)

Center for Veterinary Medicine\'s Motion to Supplement Document
Submission under 21 CFR §12.85 and Motion to Enter Exhibit G-1799 into
the Evidentiary Record of the Enrofloxacin Hearing

The Center for Veterinary Medicine (\"CVM\" or \"the Center\")
respectfully submits this Motion to supplement its submission pursuant
to 21 C.F.R. 12.85 with an additional document: Exhibit G-1799, a paper
entitled: \"Short and long term mortality associated with foodborne
bacterial gastrointestinal infections: registry based study\" by Morten
Helms, Pernille Vastrup, Peter Gerner-Smidt, and Kare Molbak, published
on February 15, 2003 in the British Medical Journal, a peer-reviewed
journal \[see <http://bmj.com/advice/peer_review.shtml>, copy
attached\]. Dr. Molbak is a witness in this hearing, and the recently
published paper presents some of the same data described in Dr.
Molbak\'s testimony at pages 12-14, paragraphs 36-42, and Tables 7 and
8, which describe mortality associated with *Campylobacter* infections.
The paper was published with a commentary on the epidemiological
methodology used in the paper. This commentary is included in the
proffered Exhibit. CVM received this paper on February 14, 2003, and
believes the paper is relevant to the issues in the hearing, and meets
the requirements of 21 C.F.R. §12.85 (c)[^1].

Moreover, because Exhibit G-1799 was unavailable at the time CVM
submitted its written direct testimony, CVM\'s December 9, 2002, Motion
to Enter Written Direct Testimony and Exhibits and Documents into the
Evidentiary Record could not have included a request to enter this
document. Therefore, CVM is also respectfully requesting that Exhibit
G-1799 be placed on the evidentiary record. CVM provided Bayer\'s
counsel with a copy of this exhibit on February 21, 2003, and is today
providing AHI\'s counsel a copy of the exhibit.

Counsel for Bayer has notified Counsel for CVM that Bayer has no
objection toe the supplementation of the record with this paper,
pursuant to 21 C.F.R. § 12.85, but that Bayer would not concur in the
motion to place G-1799 on the evidentiary record.

Respectfully submitted by:

> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Robert M. Spiller, Jr.

Counsel for the Center for Veterinary Medicine

5600 Fishers Lane (GCF-1)

Rockville, MD 20857

\(303\) 827-1125

UNITED STATES OF AMERICA

BEFORE THE FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

)

In the Matter of: ) FDA DOCKET: 00N-1571

) DATE: February 2003

Enrofloxacin for Poultry: Withdrawal )

of Approval of Bayer Corporation\'s )

New Animal Drug Application )

(NADA) 140-828 (Baytril) )

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
)

**[ORDER]{.underline}**

By its Motion filed February 25, 2003 the Center for Veterinary Medicine
(\"CVM\") seeks to supplement its document submission under 21 C.F.R.
§12.85 and enter Exhibit G**-**1799 into the evidentiary record of this
hearing.

It appearing that Exhibit G-1799: \"Short and long term mortality
associated with foodborne bacterial gastrointestinal infections:
registry based study\" by Morten Helms, Pernille Vastrup, Peter
Gerner-Smidt, and Kare Molbak, published on February 15, 2003 in the
British Medical Journal, and the accompanying published commentary is
plainly relevant and material to the issue of this hearing, and that it
is a recent peer-reviewed publication of some data already testified to
on this Record, the Center for Veterinary Medicine\'s Motion to
Supplement its document submission under 21 C.F.R. §12.85 and to move
Exhibit G-1799 into the evidentiary record of this hearing is HEREBY
GRANTED.

DATED this the \_\_\_\_ day of February, 2003.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Daniel J. Davidson

> Administrative Law Judge
>
> Enrofloxacin Hearing

Docket No: 00N-1571

**CERTIFICATE OF SERVICE**

I hereby certify that an original and one copy of the foregoing Center
for Veterinary Medicine\'s Motion to Supplement its Document Submission
under 21 C.F.R. §12.85 and to enter Exhibit G-1799 into the evidentiary
record of this hearing was hand delivered this 25th day of February,
2003 to:

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane (Room 1061)

Rockville, MD 20852

I also certify that a copy of this motion has been hand delivered and
e-mailed, this 25th day of February, 2003 to:

The Office of the Administrative Law Judge

Food and Drug Administration

Room 9-57, HF-3

5600 Fishers Lane

Rockville, MD 20857

I also certify that a copy of this motion was e-mailed and mailed by
First Class U.S. mail, this 25th day of February, 2003, to:

> Robert B. Nicholas
>
> McDermott, Will & Emery
>
> 600 13th Street, NW
>
> Washington, DC 20005
>
> Kent D. McClure

Animal Health Institute

1325 G Street, NW, Suite 700

Washington, DC 20005

> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Robert M. Spiller, Jr.

Counsel for the Center for

> Veterinary Medicine
>
> 5600 Fishers Lane (GCF-1)

Rockville, MD 20857

> \(301\) 827-1125

[^1]: 21 C.F.R. 12.85(c) provides that: \"Submissions required by
    paragraphs (a) and (b) of this section may be supplemented later in
    the proceeding, with the approval of the presiding officer, upon a
    showing that the material contained in the supplement was not
    reasonably known or available when the submission was made, or\...\"