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1 2 Preface Executive Summary of the Proposed Rule I Introduction and Summary A Introduction Summary of Costs and Benefits Preliminary Regulatory Impact Analysis A Brief History of Health Ant. If changes are determined to be significant a new formu la number must be assigned Samples submitted Yes No If yes Laboratory Sample or Production Sample INGREDIENTS List each ingredient by weight or percentage and describe ingredient fresh frozen Agent Attention Carol J Haley Director Worldwide Regulatory Strategy 235 East 42 nd Street New York NY 10017 Dear Ms Haley Please refer to your supplemental new drug application dated and received August 28 2009 submitted under section 505b of the F Sections 505o3 and 505o4 and of the F ederal Food Drug and Cosmetic Act FDCA authorize FDA to require holders of approved drug and biological product applications on the basis of new safety information to conduct postmarketing studies and clinical U.S. Department of Health & Human ServicesU.S. Food and Drug Administration FDA Facts: Jerky Pet TreatsDA has been actively investigating consumer complaints about jerky pet treats causing illness in FDA Facts: Drug Shortages in the United States Although FDA cannot directly affect many of the business and economic decisions that contribute to drug shortages, FDA is well positioned to play a si EMPLOYEE($) SIGNATURE DATE ISSUED Lloyd D. Payne, Investigator
Adam c. Hipko, Investigator lt/O'i" SEE REVERSE Jennifer Owens Dowdy, I nvestigator 04/23/2015OF TH IS PAGE Frankli n R. Harris, Inves EMPLOYEE($) SIGNATURE DATE ISSUED Lloyd D. Payne, Investigator
Adam c. Hipko, Investigator lt/O'i" SEE REVERSE Jennifer Owens Dowdy, I nvestigator 04/23/2015OF TH IS PAGE Frankli n R. Harris, Inves Food and Drug Administration Silver Spring MD 20993 TENTATIVE APPROVALVeloxis Pharmaceuticals, Inc.Attention: Michelle A. McGuinness VP Global Regulatory Affairs& Quality Assurance499 Thornall Stre Public Health Serv ice Food and Drug Administration Silver Spring, MD 20993 Sam Boddapati, PhD r. Vice President, Regulatory AffairsOak Pharmaceuticals, Inc.1925 WestField Court, Suite 300 Lake Forest 2015TimothyBaysePEUS Department of the NavyNaval Facilities Engineering CommandLCDRKeithBensonEITUS Department of the NavyNaval Facilities Engineering CommandMeganBlucherPEUnited States Marine CorpsRo Medicare Carriers Manual Centers for Medicare Medicaid Services CMSPart 3 - Claims Process Date MAY 30 2003 CHANGE REQUESTS 2200 2311 HEADER SECTION NUMBERSPAGES TO INSERTPAGES TO DELETE 2049 150 2 1 | Page - Field Services: Client Handbook Mission: To provide quality, efficient, and effective human services, which improve the lives of people. Core Values: Person Centered Care: The unique c 9/21 Page 1 Commissioner : J anet Woodcock, M.D. Department: Department of Health and Human Services (HHS) History & Mission: The Food and Drug Administration dates its origin to June 1906, when Pre Infection Control Advocate & Resident Education. ICARE. Infection Control Advocate and Resident Education. . Preventing Infections in Nursing Home Communities. A sunny afternoon at the Springville Nursing Home....