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

Filing 91

DECLARATION of Jennifer A. Sorenson in Support re: 89 Memorandum of Law in Opposition,. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (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)(Sorenson, Jennifer)

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IN THE UNITED STATES DISTRICT COURT FOR THE 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, ) ) 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. ) 11 CIV 3562 (THK) ECF Case THIRD DECLARATION OF JENNIFER A. SORENSON I, Jennifer A. Sorenson, declare as follows: 1. I serve as counsel for plaintiffs in this proceeding. I am a member in good standing of the bar of the State of California, and I am admitted to practice pro hac vice in this action. I have personal knowledge of the facts stated herein. 2. Attached as Exhibit A is a true and correct copy of a Letter from Amy A. Barcelo to Hon. Theodore H. Katz (Nov. 7, 2011). 3. Attached as Exhibit B is a true and correct copy of the Corrected Transcript of Proceedings held before Hon. Theodore H. Katz, Magistrate Judge, on February 23, 2012. 4. Attached as Exhibit C is a true and correct copy of Emergence of the Superbug: Antimicrobial Resistance in the United States, Hearing before the S. Comm. on Health, Education, Labor, and Pensions, S. Hrg. No. 110-989 (2008). 5. Attached as Exhibit D is a true and correct copy of Center for Veterinary Medicine (CVM), Annual Report, Fiscal Year 2003. 6. Attached as Exhibit E is a true and correct copy of CVM, Annual Report, Fiscal Year 2004. 7. Attached as Exhibit F is a true and correct copy of In re: Enrofloxacin for Poultry, FDA Dkt. No. 00N-1571 (Apr. 10, 2002) (order). 8. Attached as Exhibit G is a true and correct copy of FDA, Update: FDA’s Proposed Withdrawal of Approval of Poultry Fluoroquinolones. I downloaded this document in May 2012, using the following URL: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ RecallsWithdrawals/ucm042012.htm. 9. Attached as Exhibit H is a true and correct copy of the results of a search of the Department of Health and Human Services’ (HHS’s) online employee directory, http://directory.psc.gov/employee.htm, for employees of CVM’s Office of New Animal Drug Evaluations (ONADE). I performed this search in May 2012 by entering “CVM/ONADE” in the “Other org.” field and selecting “contains” from the corresponding pull-down menu. For the line reading “Return no more than ___ rows,” I entered “500.” 2 10. Attached as Exhibit I is a true and correct copy of the results of a search of HHS’s online employee directory, http://directory.psc.gov/employee.htm, for employees of CVM’s Office of Research (OR). I performed this search in May 2012 by entering “CVM/OR” in the “Other org.” field and selecting “contains” from the corresponding pull-down menu. For the line reading “Return no more than ___ rows,” I entered “500.” I declare under penalty of perjury that the foregoing is true and correct, to the best of my knowledge, information, and belief. Executed on May 25, 2012, at San Francisco, California. s/ Jennifer A. Sorenson Jennifer A. Sorenson 3

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