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

Filing 67

RULE 56.1 STATEMENT. Document filed by Center for Veterinary Medicine, Bernadette Dunham, Margaret Hamburg, Kathleen Sebelius, United States Department of Health and Human Services, United States Food and Drug Administration. (Barcelo, Amy)

PREET BHARARA
United States Attorney for the
Southern District of New York
By: AMY A. BARCELO
Assistant United States Attorney
86 Chambers Street, 3rd Floor
New York, New York 10007
Telephone: [phone]
Fax: [phone]
[e-mail]
UNITED STATES DISTRICT COURT
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.,
Plaintiffs,

11 Civ. 3562 (THK)
ECF Case

v.
UNITED STATES FOOD AND DRUG
ADMINISTRATION; MARGARET
HAMBURG, in her official capacity as
www.fCommissioner, United States Food and
Drug Administration; CENTER FOR
VETERINARY MEDICINE;
BERNADETTE DUNHAM, in her official
capacity as Director, Center for Veterinary
Medicine; UNITED STATES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES; and KATHLEEN
SEBELIUS, in her official capacity as
Secretary, United States Department of
Health and Human Services,
Defendants.
THE GOVERNMENT’S STATEMENT OF UNDISPUTED MATERIAL FACTS
PURSUANT TO LOCAL CIVIL RULE 56.1 IN RESPONSE TO CLAIM SET FORTH IN
PLAINTFFS’ FIRST SUPPLEMETNAL COMPLAINT

Pursuant to Civil Rule 56.1 of the Local Civil Rules of the United States District Court
for the Southern District of New York, Defendants, the United States Food and Drug
Administration (“FDA”), Margaret Hamburg, in her official capacity as Commissioner of Food
and Drugs; Center for Veterinary Medicine; Bernadette Dunham, in her official capacity as
Director, Center for Veterinary Medicine; United States Department of Health and Human
Services; and Kathleen Sebelius, in her official capacity as Secretary, United States Department
of Health and Human Services (collectively, the “Government”), by their attorney, Preet
Bharara, United States Attorney for the Southern District of New York, state that there is no
genuine issue to be tried with respect to the following material facts:
1.

The administrative record of the citizen petitions: (1) filed with FDA on March 9,

1999, by plaintiffs Center for Science in the Public Interest, Food Animal Concerns Trust
(“FACT”), Public Citizen, Inc., and Union of Concerned Scientists, Inc. (“UCS”) and (2) filed
with FDA on April 7, 2005, by plaintiffs FACT and UCS submitted a citizen petition to FDA
(collectively, the “Citizen Petitions”), filed in this action by the Government on March 21, 2012;
under the Certification of Karen Kennard, Division of Dockets Management, executed on March
20, 2012, constitutes the administrative record upon which FDA denied the Citizen Petitions.

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Dated: New York, New York
March 21, 2012
Respectfully submitted,
PREET BHARARA
United States Attorney
Southern District of New York
/s/ Amy A. Barcelo
By: AMY A. BARCELO
Assistant United States Attorney
86 Chambers Street
New York, New York 10007
Tel.: [phone]
Fax: [phone]
Email: [e-mail]
OF COUNSEL:
DAVID J. HOROWITZ
Deputy General Counsel

ELIZABETH H. DICKINSON
Acting Chief Counsel, Food and Drug
Division

ERIC M. BLUMBERG
Deputy Chief Counsel, Litigation

THOMAS J. COSGROVE
Associate Chief Counsel

U.S. Department of Health and Human Services
Office of the General Counsel
White Oak 31 Room 4331
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
(Tel): [phone]

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