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

Filing 65

DECLARATION of Amy A. Barcelo in Support re: 63 MOTION for Summary Judgment on Plaintiffs' First Supplemental Complaint.. 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. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D (part 1 of 6), # 5 Exhibit D (part 2 of 6), # 6 Exhibit D (part 3 of 6), # 7 Exhibit D (part 4 of 6), # 8 Exhibit D (part 5 of 6), # 9 Exhibit D (part 6 of 6), # 10 Exhibit E (part 1 of 8), # 11 Exhibit E (part 2 of 8), # 12 Exhibit E (part 3 of 8), # 13 Exhibit E (part 4 of 8), # 14 Exhibit E (part 5 of 8), # 15 Exhibit E (part 6 of 8), # 16 Exhibit E (part 7 of 8), # 17 Exhibit E (part 8 of 8), # 18 Exhibit F, # 19 Exhibit G, # 20 Exhibit H, # 21 Exhibit I)(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
Commissioner, 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.
SECCOND DECLARATION OF AMY A. BARCELO
Amy A. Barcelo, pursuant to the provisions of 28 U.S.C. § 1746, declares, under penalty
of perjury, as follows:

1.

I am Assistant United States Attorney in the office of Preet Bharara, United States

Attorney for the Southern District of New York, attorney for defendants in this case. I am the
attorney assigned to the defense of this matter.
2.

I submit this declaration in support of the defendants’ motion for summary

judgment.
3.

Attached as Exhibit A hereto is a copy of Center for Veterinary Medicine,

Program Policy and Procedure Manual, Voluntary Compliance, which is available at:
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/PoliciesPro
ceduresManual/ucm046435.pdf. 4.
4.

Attached as Exhibit B hereto is a Fed FDA Regulatory Procedures Manual, § 4-1-

1, which is available at:
http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176870.htm
5.

Attached as Exhibit C hereto is FDA Investigations Operations Manual, § 2.6.1,

which is available at: http://www.fda.gov/ICECI/Inspections/IOM/ucm122514.htm
6.

Attached as Exhibit D hereto is the citizen petition submitted by plaintiffs Center

for Science in the Public Interest, Food Animal Concerns Trust (“FACT”), Public Citizen, Inc.,
and Union of Concerned Scientists, Inc. (“UCS”) submitted citizen petition to FDA on March 9,
1999 (the “1999 Petition”). This document is included in the Administrative Record of the
citizen petitions: (1) filed with FDA on March 9, 1999, by plaintiffs Center for Science in the
Public Interest, FACT, Public Citizen, Inc., and UCS submitted citizen petition to FDA, and (2)
filed with FDA on April 7, 2005, by plaintiffs FACT and UCS, filed by the defendants in this
action on March 21, 2012, under the Certification of Karen Kennard, Division of Dockets
Management, executed on March 20, 2012 (the “Administrative Record”).

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7.

Attached as Exhibit E hereto is the citizen petition submitted by plaintiffs FACT

and UCS to FDA on April 7, 2005 (the “2005 Petition”). This document is included in the
Administrative Record.
8.

Attached as Exhibit F hereto is FDA’s tentative response to the 1999 Petition,

dated February 28, 2001. This document is included in the Administrative Record.
9.

Attached as Exhibit G hereto is FDA’s tentative response to the 2005 Petition,

dated October 4, 2005. This document is included in the Administrative Record.
10.

Attached as Exhibit H hereto is the slip opinion in Chaney v. Schweiker, No. 81-

2265 (D.D.C. Aug. 30, 1982).
11.

Attached as Exhibit I hereto is an excerpt from the 1947 Attorney General’s

Manual on the Administrative Procedure Act consisting of pages 8-17 of that Manual.
12.

The documents attached as Exhibits B, H, I, and J to my declaration dated January

9, 2012 in this action are included in the Administrative Record.
I declare under penalty of perjury that the foregoing is true and correct.
Dated: New York, New York
March 21, 2012

/s/ Amy A. Barcelo
AMY A. BARCELO
Assistant United States Attorney

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