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DOCKETS ENTERED on 4/08/03
Docket Number - Title
78N-036L OTC Laxative
*
95N-0304 Ephedrine Alkaloids: Reports of Adverse
Events; Availability*
96N-0417 CGMP in Mfg. Packing or Holding Dietary
Supplements*
00N-1484 Safety Reporting Requirements Human
Drug/Biological Products*
00N-1571 Enrofloxacin for Poultry: Opportunity for
Hearing *
02D-0103 Draft Revised Compliance Policy Guide; Male
Condom Defects*
02D-0526 Guidance for drug Chemistry, Manufacturing,
Control Info.*
02N-0204 Bar Code Label Requirements for human drug
products*
03P-0140 Refrain from Approving ANDAs for Topical
Mupirocin Ointment*
RPT 16 The Purdue Frederick, Co. Vol#: 124
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
C 3907 Metabolife International, Inc. Vol#: 338
C 3908 Form Letter count 6 Vol#: 339
C 3909 Form Letter count 28 Vol#: 340
C 3910 Form Letter count 11 Vol#: 341
C 3911 Karen Masterson Koch CN Vol#: 342
C 3912 Acupuncture & Chinese Herbal Medicine Vol#: 342
C 3913 Jamaica Plain Acupuncture and Herbal Med Vol#: 342
C 3914 Council for Resonsible Nutrition Vol#: 342
C 3915 Dr. Albert M Fleischner Vol#: 342
C 3916 illegible Vol#: 342
C 3917 High Falls Gardens Vol#: 342
C 3918 Alkemists Pharmaceuticals et al Vol#: 342
C 3919 Maury Silverman Vol#: 342
C 3920 Congress of the United States Vol#: 342
C 3921 Universiyt of Kansas, School of Medicine Vol#: 343
C 3922 American Academy of orthopaedics Surgeon Vol#: 342
C 3923 Circadian Technologies, Inc. Vol#: 342
C 3924 American Herbalists Guild Vol#: 342
C 3925 American Academy of Family Physicians Vol#: 342
C 3926 Congress of the United States Vol#: 344
C 3927 AARP Vol#: 344
C 3928 American Herbal Products Association Vol#: 344
C 3929 Brian E Pfeiffer Vol#: 344
C 3930 Karina Kdeniytseia Vol#: 344
C 3931 Marcelina Villanneva Vol#: 344
C 3932 Shirley Kollinberg Vol#: 344
C 3933 Nutraceutical Corporation Vol#: 344
C 3934 Congress of the United States, Vol#: 344
C 3935 Center for Science in the Public Interes Vol#: 344
EMC 278 Number not used Vol#: 345
EMC 279 Number not used Vol#: 345
EMC 280 Number not used Vol#: 345
EMC 281 Number not used Vol#: 345
EMC 282 Number not used Vol#: 345
EMC 283 Number not used Vol#: 345
EMC 284 Number not used Vol#: 345
EMC 285 Number not used Vol#: 345
EMC 286 Number not used Vol#: 345
EMC 287 Number not used Vol#: 345
EMC 288 Number not used Vol#: 345
EMC 289 Number not used Vol#: 345
EMC 290 Number not used Vol#: 345
EMC 291 Diana Dai Vol#: 345
EMC 292 Gladys Krinke Vol#: 345
EMC 293 Beth Hooper Vol#: 345
EMC 294 Number not used Vol#: 345
EMC 295 Dennis Mizer Vol#: 345
EMC 296 Brian Carter Vol#: 345
EMC 297 M Berry Vol#: 345
EMC 298 Koni Seaberg Vol#: 345
EMC 299 Amy Matton L.Ac. Vol#: 345
EMC 300 Rhonda Koon Vol#: 345
EMC 301 Wanda Lake Vol#: 345
EMC 302 Itay Neta Lic.Ac. Vol#: 345
EMC 303 New England School of Medicine Vol#: 345
EMC 304 Peter J. Meaden Vol#: 345
EMC 305 Mark Sklar Vol#: 345
EMC 306 Sandra Skover Vol#: 345
EMC 307 Lorraine Harris, L.Ac. Vol#: 345
EMC 308 Sheryl Stanley Vol#: 345
EMC 309 Chrisopher Mobley Vol#: 345
EMC 310 Peter Altman, L.Ac. Vol#: 345
EMC 311 Dorothy Pang Vol#: 345
EMC 312 Susan Ruschke Vol#: 345
EMC 313 Joseph Washburn Vol#: 345
EMC 314 Erin Raskin Vol#: 345
EMC 315 Rose Yen Vol#: 345
EMC 316 Alison Pigg Vol#: 345
EMC 317 Dianna Carrasco Vol#: 345
EMC 318 Eula Seyda Vol#: 345
EMC 319 Tom Hebert Vol#: 345
EMC 320 Marilyn Wray Vol#: 345
EMC 321 Jennifer Morgan Vol#: 345
EMC 322 Dwigfht L. Lorenz Vol#: 345
EMC 323 Rachel A Hartstein, Lic.Ac. Vol#: 345
EMC 324 Stephen Eggleston Vol#: 345
EMC 325 Robert Heinrich Vol#: 345
EMC 326 Toni Moore Vol#: 345
EMC 327 Alicia Gonzalez Vol#: 345
EMC 328 Lynette Raap Vol#: 345
EMC 329 Brian McNally Vol#: 345
EMC 330 Christa Cerra Vol#: 345
EMC 331 Yvonne Swett Vol#: 345
EMC 332 Tony Pace Vol#: 345
EMC 333 Karen Batten Vol#: 345
EMC 334 Deborah Hilfman Vol#: 345
EMC 335 Kristin Latzo Vol#: 345
EMC 336 Helen Belcher Vol#: 345
EMC 337 Kristen Desellems Vol#: 345
EMC 338 Ullman, Shapiro, & Ullman LLP Vol#: 345
EMC 339 Alan Call Vol#: 345
EMC 340 Julie Hutsell Vol#: 345
EMC 341 Betty Cooper Vol#: 345
EMC 342 Belia Pena Vol#: 345
EMC 343 Number not used Vol#: 345
EMC 344 Patricia Driscoll Vol#: 345
EMC 345 Sathuka A. Tien Vol#: 345
EMC 346 Guy Rordorf, MD Vol#: 345
EMC 347 Carolyn Williams Vol#: 345
EMC 348 Carolyn Rabiner, L.Ac. Vol#: 345
EMC 349 Metizu Chen Vol#: 345
EMC 350 Council for Responsible Nutrition Vol#: 345
EMC 351 Carla Vieira Vol#: 345
EMC 352 Jolene Ivie Vol#: 345
EMC 353 Lynda Schmidt Vol#: 345
96N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
C 102 Pharma Chemie, Inc. Vol#: 7
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
EMC 673 Barb Watts Vol#: 19
EMC 674 Victoria Loring Vol#: 19
EMC 675 Nkanyiso Mavuso Vol#: 19
00N-1200 Dietary Supplements Containing Ephedrine Alkaloids
EMC 42 Michael Short, Lic.Ac. Vol#: 78
00N-1484 Safety Reporting Requirements Human Drug/Biological Products
EMC 2 BioMarin Pharmaceuticals, Inc. Vol#: 3
EMC 3 Larry Vol#: 3
00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
02D-0103 Draft Revised Compliance Policy Guide; Male Condom Defects
EMC 1 Coyote Technologies, Inc. Vol#: 1
02D-0526 Guidance for drug Chemistry, Manufacturing, Control Info.
EMC 1 Paul G. King Consulting/FAME Systems Vol#: 1
02H-0443 Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
MO 4 GCF-1 Vol#: 1
02N-0204 Bar Code Label Requirements for human drug products
C 28 Fairview Pharmacy Services Vol#: 13
C 29 Valley General Hospital Vol#: 13
EMC 173 John Bossian, DO, FAAFP Vol#: 13
02N-0275 Bioterrorism Preparedness; Administrative Detention
EMC 12 European Confederation of Spirits Produ Vol#: 3
EMC 13 Rosa Maria Espinoza Vol#: 3
EMC 14 Belize Agricultural Health Authority Vol#: 3
EMC 15 Rosa Maria Espinoza Vol#: 3
EMC 16 Non Traditional Products Exporters Assn Vol#: 3
EMC 17 Belize Agricultural Health Authority Vol#: 3
N 1 Vol#: 2
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities
EMC 21 Canadian Courier & Messenger Assn (CCMA) Vol#: 10
EMC 22 National Tank Truck Carriers Vol#: 10
EMC 23 European Committee of Wine Companies Vol#: 10
EMC 24 BASF Corporation Vol#: 10
EMC 25 Canadian National Millers Assn Vol#: 10
EMC 26 National Standardization Agency of Idone Vol#: 10
EMC 27 Confederation of the EU Food & Drink Ind Vol#: 10
EMC 28 Confederation of European Spirits Produc Vol#: 10
EMC 29 Ricardo Harrison Vol#: 10
EMC 30 Scotch Whisky Assn Vol#: 10
EMC 31 Ministry of Agriculture of Ecuador Vol#: 10
EMC 32 Province of Newfoundland and Labrador Vol#: 10
EMC 33 Federation of German Food & Drink Indust Vol#: 10
EMC 34 Grupo Bimbo (GB) Vol#: 10
EMC 35 Belize Agricultural Health Authority Vol#: 10
EMC 36 Rodger May Vol#: 10
EMC 37 Flexible Packaging Assn (FPA) Vol#: 10
EMC 38 Refreshments Canada Vol#: 10
EMC 39 International Fresh-cut Produce Assn Vol#: 10
EMC 40 FEPACH A.G. Vol#: 10
EMC 41 Gobierno de Chile Vol#: 10
EMC 42 National Agricultural Council (NAC) Vol#: 10
EMC 43 Meat Industry Assn Vol#: 10
EMC 44 Fonterra Co-operative Group Ltd Vol#: 10
EMC 45 Deer Industry New Zealand Vol#: 10
EMC 46 European Starch Industry Vol#: 10
EMC 47 National Standardization Agency of Idone Vol#: 10
EMC 48 Swiss Government Vol#: 10
EMC 49 European Starch Industry Vol#: 10
EMC 50 National Standardization Agency of Idone Vol#: 10
EMC 51 Council for Reponsible Nutrition (CRN) Vol#: 10
EMC 52 Consumer Healthcare Products Assn (CHPA) Vol#: 10
EMC 53 Kraft Foods Vol#: 10
EMC 54 Pacific Coast Council of Customs Brokers Vol#: 10
EMC 55 Canadian Produce Marketing Assn (CPMA) Vol#: 10
EMC 56 British Embassy Washington Vol#: 10
EMC 57 American Assn of Exporters and Importers Vol#: 10
EMC 58 Assn of Food Industries Vol#: 10
EMC 59 Junta Agroempresarial Dominicana, Inc. Vol#: 10
EMC 60 Junta Agroempresarial Dominicana, Inc. Vol#: 10
EMC 61 Coalition for Safe Ceramicware, Inc. Vol#: 10
EMC 62 German Agricultural Marketing Board Vol#: 10
EMC 63 Ontario Agri Business Assn (OABA) Vol#: 10
EMC 64 Non Traditional Products Exporters Assn Vol#: 10
EMC 65 US Tuna Foundation (USTF) Vol#: 10
EMC 66 International Diary Food Assn (IDFA) Vol#: 10
EMC 67 Fertilizer Institute (TFI) Vol#: 10
EMC 68 United Fresh Fruit & Vegetable Assn Vol#: 10
EMC 69 NCBFAA Vol#: 10
EMC 70 The Glutamate Assn (TGA) Vol#: 10
EMC 71 The Laredo Licensed US Customs Broker As Vol#: 10
EMC 72 The Laredo Licensed US Customs Broker As Vol#: 10
EMC 73 SAGARPA Vol#: 10
EMC 74 California Tomato Commission Vol#: 10
EMC 75 Herb Pharm, Inc. Vol#: 10
EMC 76 Ivannia Chaves Jimenez Vol#: 10
EMC 77 BC Hot House Foods, Inc. Vol#: 10
EMC 78 Belize Agricultural Health Authority Vol#: 10
EMC 79 Canadian Horticultural Council Vol#: 10
EMC 80 Canadian Horticultural Council Vol#: 10
EMC 81 Rodolfo Delgado, CHB Vol#: 10
EMC 82 Emulsion Polymers Council (EPC) Vol#: 10
EMC 83 European Committee of Wine Companies Vol#: 10
02N-0277 Bioterrorism; Establishment & Maintenance of Records
EMC 12 European Confederation of Spirits Produ Vol#: 4
EMC 13 Belize Agricultural Health Authority Vol#: 4
EMC 14 Canadian Produce Marketing Assn Vol#: 4
EMC 15 Non Traditional Products Exporters Assn Vol#: 4
EMC 16 International Air Transport Assn Vol#: 4
EMC 17 Bernard Egan & Company Vol#: 4
EMC 18 Belize Agricultural Health Authority Vol#: 4
N 1 Vol#: 3
02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
C 153 Canadian National Millers Assn Vol#: 11
EMC 27 Canadian Courier & Messenger Assn (CCMA) Vol#: 11
EMC 28 Carriere Foods, Inc. Vol#: 11
EMC 29 European Committee of Wine Companies Vol#: 11
EMC 30 Royal Fumigation, Inc. Vol#: 11
EMC 31 Canadian National Millers Assn Vol#: 11
EMC 32 CAADES/CIDH Vol#: 11
EMC 33 Confederation of the EU Food & Drink Ind Vol#:
EMC 34 Confederation of European Spirits Produc Vol#: 11
EMC 35 Scotch Whisky Assn Vol#: 11
EMC 36 Ministry of Agriculture of Ecuador Vol#: 11
EMC 37 Province of Newfoundland and Labrador Vol#: 11
EMC 38 Federation of German Food & Drink Indust Vol#: 11
EMC 39 Grupo Bimbo (GB) Vol#: 11
EMC 40 Belize Agricultural Health Authority Vol#: 11
EMC 41 California Fisheries & Seafood Institute Vol#: 11
EMC 42 Rodger May Vol#: 11
EMC 43 Flexible Packaging Assn (FPA) Vol#: 11
EMC 44 Instituto Peruano del Esparrago Vol#: 11
EMC 45 Northern Border Customs Brokers Assn Vol#: 11
EMC 46 Linda Dominguez Vol#: 11
EMC 47 Refreshments Canada Vol#: 11
EMC 48 Embassy of Peru Vol#: 11
EMC 49 International Fresh-cut Produce Assn Vol#: 11
EMC 50 FEPACH AG Vol#: 11
EMC 51 FedEx Trade Networks Transport & Brokera Vol#: 11
EMC 52 Gobierno de Chile Vol#: 11
EMC 53 Embassy of Peru Vol#: 11
EMC 54 National Agricultural Council (NAC) Vol#: 11
EMC 55 Meat Industry Assn Vol#: 11
EMC 56 Fonterra Co-operative Group Ltd Vol#: 11
EMC 57 Deer Industry New Zealand Vol#: 11
EMC 58 European Starch Industry Vol#: 11
EMC 59 National Standardization Agency of Idone Vol#: 11
EMC 60 Swiss Government Vol#: 11
EMC 61 European Starch Industry Vol#: 11
EMC 62 Alfons Samosir Vol#: 11
EMC 63 Council for Reponsible Nutrition (CRN) Vol#: 11
EMC 64 Federacion Ecuatoriana de Exportadores Vol#: 11
EMC 65 Consumer Healthcare Products Assn (CHPA) Vol#: 11
EMC 66 National Agricultural Council (NAC) Vol#: 11
EMC 67 BASF Corporation Vol#: 11
EMC 68 Pacific Coast Council of Customs Brokers Vol#: 11
EMC 69 Kraft Foods Vol#: 11
EMC 70 Canadian Produce Marketing Assn (CPMA) Vol#: 11
EMC 71 British Embassy Washington Vol#: 11
EMC 72 American Assn of Exporters and Importers Vol#: 11
EMC 73 Western Grain Elevator Assn (WGEA) Vol#: 11
EMC 74 Junta Agroempresarial Dominicana, Inc. Vol#: 11
EMC 75 American Assn of Exporters and Importers Vol#: 11
EMC 76 Junta Agroempresarial Dominicana, Inc. Vol#: 11
EMC 77 Coalition for Safe Ceramicware, Inc. Vol#: 11
EMC 78 German Agricultural Marketing Board Vol#: 11
EMC 79 Ontario Agri Business Assn (OABA) Vol#: 11
EMC 80 Non Traditional Products Exporters Assn Vol#: 11
EMC 81 National Assn for the Specialty Food Tra Vol#: 11
EMC 82 Jamaica Exporters Assn Vol#: 11
EMC 83 US Tuna Foundation (USTF) Vol#: 11
EMC 84 United Fresh Fruit & Vegetable Assn Vol#: 11
EMC 85 Cargo Airline Assn (CAA) Vol#: 11
EMC 86 NCBFAA Vol#: 11
EMC 87 The Glutamate Assn (TGA) Vol#: 11
EMC 88 SAGARPA Vol#: 11
EMC 89 SAGARPA Vol#: 11
EMC 90 Herb Pharm, Inc. Vol#: 11
EMC 91 Bernard Egan & Company Vol#: 11
EMC 92 International Diary Food Assn (IDFA) Vol#: 11
EMC 93 Ivannia Chaves Jimenez Vol#: 11
EMC 94 Classic Seafood Vol#: 11
EMC 95 ANFPA Vol#: 11
EMC 96 Belize Agricultural Health Authority Vol#: 11
EMC 97 Canadian Horticultural Council Vol#: 11
EMC 98 Canadian Horticultural Council Vol#: 11
EMC 99 Rodolfo Delgado, CHB Vol#: 11
EMC 100 Canadian Dorper Sheep Assn Vol#: 11
EMC 101 Emulsion Polymers Council (EPC) Vol#: 11
02N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]
APE 9 ISPOR, Intl. Society for Pharmacoeconomi Vol#: 1
EMC 6 Judy Levine Vol#: 1
EMC 7 B. Sachau Vol#: 1
03P-0140 Refrain from Approving ANDAs for Topical Mupirocin Ointment
ACK 1 HFA-305 Vol#: 1