Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al
Filing
42
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: (212) 637-6559
Fax: (212) 637-2730
amy.barcelo@usdoj.gov
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
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 (“HHS”); 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.
In 1977, FDA’s Bureau of Veterinary Medicine issued two notices of opportunity
for hearing that generally proposed to withdraw approval of penicillin and tetracycline in animal
feed because of safety concerns related to those uses (collectively, the “1977 NOOHs”). See
Penicillin-Containing Premixes; Opportunity for Hearing, 42 Fed. Reg. 43772 (Aug. 30, 1977)
(the “Penicillin NOOH”), attached as Exhibit D to Barcelo Decl.; Tetracycline (Chlortetracycline
and Oxytetracycline)-Containing Premixes; Opportunity for Hearing, 42 Fed. Reg. 56264 (Oct.
21, 1977) (the “Tetracycline NOOH”), attached as Exhibit E to the Barcelo Decl.
2.
The Tetracycline NOOH included a series of important exceptions, through which
the use of tetracycline feeds would remain approved for certain “subtherapeutic conditions of
use.” Tetracycline NOOH, 42 Fed. Reg. at 56287.
3.
In response to the 1977 NOOHs, approximately 20 drug firms, agricultural
organizations and individuals requested hearings on BVM’s proposals as set forth in the 1977
NOOHs. See Penicillin and Tetracycline in Animal Feeds Hearing, 43 Fed. Reg. 53827, 53828
(Nov. 17, 1978), attached as Exhibit G to the Barcelo Decl.
2
4.
On November 9, 1978, the Commissioner granted these requests, announcing that
“there w[ould] be a formal evidentiary public hearing on these proposals,” and that a date for the
hearing would be set “as soon as practicable.” See Penicillin and Tetracycline in Animal Feeds
Hearing, 43 Fed. Reg. at 53828.
5.
In the late 1970s and early 1980s, Congress requested that FDA conduct further
studies and hold in abeyance the implementation of the 1977 NOOHs pending the outcome of
these studies. See H.R. Rep. No. 95-1290, at 99-100 (1978) (report by the House Committee on
Appropriations “recommend[ing]” that FDA conduct research regarding “whether or not the
continued subtherapeutic use of [the NOOH Products] would result in any significant human
health risk” before revoking such approval); H.R. Rep. No. 96-1095, at 105-06 (1980) (report by
the House Committee on Appropriations requesting FDA to “hold in abeyance any
implementation” of the proposed revocation pending further research); S. Rep. No. 97-248, at 79
(1981) (report by the Senate Committee on Appropriations making the same request); see also
FDA Draft Guidance for Industry #209, The Judicious Use of Medically Important Antimicrobial
Drugs in Food-Producing Animals (2010) at 6, attached as Exhibit B to the Barcelo Decl.
6.
No hearing has been held in connection with the 1977 NOOHs. See Withdrawal
of Notices of Opportunity for a Hearing; Penicillin and Tetracycline used in Animal Feed, 76
Fed. Reg. 79697, 79698 (Dec. 22, 2011), attached as Exhibit L to Barcelo Decl.
3
7.
On December 16, 2011, FDA withdrew the 1977 NOOHs. See 76 Fed. Reg.
79697.
Dated: New York, New York
January 9, 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.: (212) 637-6559
Fax: (212) 637-2730
Email: amy.barcelo@usdoj.gov
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): (301) 796-8613
4
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?