Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 91

DECLARATION of Jennifer A. Sorenson in Support re: 89 Memorandum of Law in Opposition,. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I)(Sorenson, Jennifer)

EXHIBIT F
TO THE THIRD DECLARATION
OF JENNIFER A. SORENSON

UNITED STATES OF AMERICA
BEFORE THE FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

1
1
1

In the Matter of :

)
)
)
1
)
1
1
1
>

Enrofloxacin for Poultry: Withdrawal
Of Approval of New Animal Drug
Application
NADA 140-828

FDA DOCKET: OON-1571
DATE: April lo,2002

ORDER

The proposed schedule of pre-hearing and hearing requirements filed April 5, 2002
provides for an unduly prolonged process that would extend this proceeding well into the
year 2004. Two areas of the proposed schedule appear to require the most significant
amounts of time. One is from June to November of 2002. It provides for discovery
proceedings in addition to that embodied in 2 1 CFR 8 12.85. The other extends from May
through December 2003 and contemplates two-stage evidentiary submissions and oral.
hearings for the purposes of cross-examination. Accordingly the proposed schedule h&
been modified, inter ah, in an attempt to minimize the time needed to complete the;
hearing stage of this proceeding.
Schedule of Due Dates

1.

Motions to Modify issues for hearing:

2.

Responses to Motions to Modify for hearing:

Pre-Hearing
3.

4/15/02

Exchange:

Participant’s submission of 12.85 documents:
--Bayer Submission:
--AHI’s Submission:

4/22/02
5/6/02

z

4.

5.

6.

Submission of additional 12.85 material if Motion
to Modify issues for hearing is granted

5/20/02

Exchange of Witness Lists, CV’s, and
Prior Statements:

5/20/02

Objection to witnesses based on qualifications:

6/03/02

Additional

Discovery:

During the period between June and September 2003 the participants are free to
conduct additional discovery. The office of the Administrative Law Judge will not be
involved unless there are disputes that requiring a formal ruling.
7.

8/3 O/O2

Discovery Completed:

Stipulations:
8.

Exchange of Proposed Stipulations:

g/09/02

9.

Submission of Joint Stipulations:

9/l 6102

Testimony/Exhibits,

Cross Examinations,

Dispositive Motions:

10.

Submission of Written Direct Testimony/Exhibits:

12/09/02

11.

Motions to Strike Testimony/Exhibits and/or
Permission to Conduct Cross-examination:

l/27/03

Responses to Motions to Strike Testimony/Exhibits
and/or Permission to Conduct Cross-examination:

2/l O/O3

Submission of numbered findings of fact, with record references,
based on that which each participant believes the evidence has
established.

3/l 7/03

Submission of correspondingly numbered critiques of other
participants’ numbered findings of fact.

4/l 4/03

Cross Examination of Witnesses:

4/28/03-5/09/03

12.

13.

14.

15.

A schedule for rebuttal, if necessary, and/or the Post-Hearing briefs will be
established at the conclusion of the oral phase of the hearing.
Dated this

b??

day of

I#-+‘(

,2002.
SO ORDERED:

Rm. 9-57, HF-3
5600 Fishers Lane
Rockville, MD 20857
Telephone: [phone]
FAX: [phone]