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

Filing 59

DECLARATION of Mitchell S. Bernard in Support re: 56 MOTION for Summary Judgment on Plaintiffs Third Claim for Relief.. 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)(Bernard, Mitchell)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF NEW YORK
NATURAL RESOURCES DEFENSE
COUNCIL, INC.; CENTER FOR SCIENCE
IN THE PUBLIC INTEREST; FOOD
ANIMAL CONCERNS TRUST; PUBLIC
CITIZEN, INC.; and UNION OF
CONCERNED SCIENTISTS, INC.,

)
)
)
)
)
)
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Plaintiffs,
)
)
v.
)
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UNITED STATES FOOD AND DRUG
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ADMINISTRATION; MARGARET
)
HAMBURG, in her official capacity as
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Commissioner, United States Food and Drug )
Administration; CENTER FOR
)
VETERINARY MEDICINE; BERNADETTE )
)
DUNHAM, in her official capacity as
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Director, Center for Veterinary Medicine;
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UNITED STATES DEPARTMENT OF
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HEALTH AND HUMAN SERVICES; and
)
KATHLEEN SEBELIUS, in her official
)
capacity as Secretary, United States
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Department of Health and Human Services,
)
)
Defendants.
)

11 CIV 3562 (THK)
ECF Case

DECLARATION OF
MITCHELL S. BERNARD

I, Mitchell S. Bernard, declare as follows:
1.

I serve as counsel for plaintiffs in this proceeding. I am a member in good

standing of the bar of the State of New York and am admitted to practice before this Court. I
have personal knowledge of the facts stated herein.
2.

Attached as Exhibit A is a true and correct copy of the U.S. Food and Drug

Administration’s (FDA’s) Final Response to Citizen Petition, New Dkt. No. FDA-1999-P-1286
(Nov. 7, 2011).

3.

Attached as Exhibit B is a true and correct copy of FDA’s Final Response to

Citizen Petition, New Dkt. No. FDA-2005-P-0007 (Nov. 7, 2011).
4.

Attached as Exhibit C is a true and correct copy of the Comments of the Animal

Health Institute on FDA Draft Guidance No. 209, Document No. FDA-2010-D-0094-0403 (Aug.
27, 2010).
5.

Attached as Exhibit D is a true and correct copy of the Comments of Alpharma,

LLC, on FDA Draft Guidance No. 209, Document No. FDA-2010-D-0094-0392 (Aug. 25,
2010).
6.

Attached as Exhibit E is a true and correct copy of the Comments of the American

Farm Bureau Federation on FDA Draft Guidance No. 209, Document No. FDA-2010-D-00940386 (Aug. 26, 2010).

I declare under penalty of perjury that the foregoing is true and correct, to the best of my
knowledge, information, and belief.
Executed on February 21, 2012, at New York, New York.

s/ Mitchell S. Bernard
Mitchell S. Bernard

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