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

Filing 78

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, # 5 Exhibit E, # 6 Exhibit F)(Barcelo, Amy) (Additional attachment(s) added on 5/2/2012: # 6 Exhibit 6) (jfe).

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.
THIRD 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 United States Food and Drug

Administration (“FDA”) Draft Guidance for Industry #209, The Judicious Use of Medically
Important Antimicrobial Drugs in Food-Producing Animals.
4.

Attached as Exhibit B hereto is a copy of FDA Draft Guidance for Industry #213,

New Animal Drugs and New Animal Drug Combination Products Administered in or on
Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209.
5.

Attached as Exhibit C hereto is a copy of the Draft Text for Proposed Regulation

entitled Veterinary Feed Directive; Draft Text for Proposed Regulation, for inclusion in 21
C.F.R. Part 558, issued by FDA on April 11, 2011.
6.

Attached as Exhibit D hereto is a true and correct copy of a Press Release dated

March 1, 2011, by Pfizer Inc., entitled “Pfizer Completes Acquisition of King Pharmaceuticals,
Inc.,” which is available at:
http://www.businesswire.com/news/home/20110301006102/en/Pfizer-Completes-AcquisitionKing-Pharmaceuticals.
7.

Attached as Exhibit E hereto is a true and correct copy of an excerpt from the

website of the American Farm Bureau Federation, which is available at:
http://www.fb.org/index.php?action=about.home.

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8.

Attached as Exhibit F hereto is a true and correct copy of a statement issued by

the American Health Institute on April 11, 2012, which is available at:
http://www.ahi.org/archives/2012/04/ahi-statement-on-fda-guidance-documents-and-draftcodified-language-on-antibiotics/.
I declare under penalty of perjury that the foregoing is true and correct.

Dated: New York, New York
April 16, 2012

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

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