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

Filing 43

DECLARATION of Amy A. Barcelo in Support re: 40 MOTION for Summary Judgment.. 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, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M)(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.
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 true and correct copy of § 1410.10 of Volume II

of the United States Food and Drug Administration (“FDA”) Staff Manual Guides (the “Staff
Manual Guides”), Delegations of Authority to the Commissioner Food and Drug; and §
1410.503 of Volume II of the Staff Manual Guides, Issuance of Notices, Proposals, and Orders
Relating to New Animal Drugs and Medicated Feed Mill License Applications. A copy of the
entire Staff Manual Guides is available at:
http://www.fda.gov/aboutfda/reportsmanualsforms/staffmanualguides/default.htm.
4.

Attached as Exhibit B hereto is a true and correct copy of FDA Draft Guidance

for Industry #209, The Judicious Use of Medically Important Antimicrobial Drugs in FoodProducing Animals (2010), which is available at:
http://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidanceforin
dustry/ucm216936.pdf.
5.

Attached as Exhibit C hereto is a true and correct copy of Questions and Answers

on FDA’s Draft Guidance on the Judicious Use of Medically Important Antimicrobial Drugs in
Food-Producing Animals, which is available at:
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/u
cm216939.htm.

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6.

Attached as Exhibit D hereto is a true and correct copy of Penicillin-Containing

Premixes; Opportunity for Hearing, 42 Fed. Reg. 43772 (Aug. 30, 1977).
7.

Attached as Exhibit E hereto is a true and correct copy of Tetracycline

(Chlortetracycline and Oxytetracycline)-Containing Premixes; Opportunity for Hearing, 42 Fed.
Reg. 56264 (Oct. 21, 1977).
8.

Attached as Exhibit F hereto is a true and correct copy of Antibiotic and

Sulfonamide Drugs in Animal Feeds; Proposed Statement of Policy, 37 Fed. Reg. 2444 (Feb. 1,
1972).
9.

Attached as Exhibit G hereto is a true and correct copy of Penicillin and

Tetracycline in Animal Feeds Hearing, 43 Fed. Reg. 53827 (November 17, 1978).
10.

Attached as Exhibit H hereto is a true and correct copy of FDA Guidance for

Industry #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their
Microbiological Effects on Bacteria of Human Health Concern (2003), which is available at:
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Guidancef
orIndustry/UCM052519.pdf.
11.

Attached as Exhibit I hereto is a true and correct copy of the November 7, 2011

FDA Final Response to Citizen Petition New Docket No. FDA-1999-P-1286 addressed to Sarah
Klein.
12.

Attached as Exhibit J hereto is a true and correct copy of the November 7, 2011

FDA Final Response to Citizen Petition New Docket No. FDA-2005-P-0007, addressed to
Andrew Maguire.
13.

Attached as Exhibit K hereto is a true and correct copy of Advance Notice of

Proposed Rulemaking, 75 Fed. Reg. 15387 (March 29, 2010).

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14.

Attached as Exhibit L hereto is a true and correct copy of Withdrawal of Notices

of Opportunity for a Hearing; Penicillin and Tetracycline used in Animal Feed, 76 Fed. Reg.
79697 (Dec. 22, 2011).
15.

Attached as Exhibit M hereto is a true and correct copy of 21 C.F.R. § 5.84

16.

Attached as Exhibit N hereto is a true and correct copy of Final Decision of the

(1977).

Commissioner, Withdrawal of Approval of the New Animal Drug Application for Enrofloxacin
in Poultry, Docket No. 2000N-1571 (July 27, 2005).
17.

Attached as Exhibit O hereto is a true and correct copy of Nitrofurans;

Withdrawal of Approved New Animal Drug Applications (Nitrofurans), 56 Fed. Reg. 41902
(Aug. 23, 1991).
18.

Attached as Exhibit P hereto is a true and correct copy of Diethylstilbestrol;

Withdrawal of New Animal Drug Applications (DES), 44 Fed. Reg. 54852 (Sept. 21, 1979).
I declare under penalty of perjury that the foregoing is true and correct.
Dated: New York, New York
January 9, 2012

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

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