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DOCKETS ENTERED on 4/09/03

Docket Number - Title

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
95S-0117 Human Drugs Patent Term Extension & New Patents *
98D-0834 Non-Contraceptive Estrogen Class Labeling *
01D-0583 Food Security Guidance *
01N-0275 Performance standard-Diagnostic X-Ray Systems & Major Co *
02A-0379 Device classification resulting manufacturer for image techn *
02N-0204 Bar Code Label Requirements for human drug products *
02N-0475 Draft "Financial Relationships & Interest in Research Involv *
02N-0534 Medical Device User Fee and Modernization Act of 2002 *
02P-0435 Effective Approval of Alphanate Antihemophilic Factor *
02P-0450 Withhold Approval of ANDA-Amino Acid Solution Drug Prod. *
02P-0472 Petition to Post Statement in Response to Warning Letter *
03D-0007 Estrogen Progestin Drug Prod.to Treat Vasomotor Symptoms & *
03N-0069 FDA Task Force on Consumer Health Info for Better Nutrition *
80N-0280 Vaginal Contraceptive Drug Products for OTC Use

EC 134 Ms. Dominique Houchens Vol#: 14

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

EMC 2 Brian DeLacey Vol#: 8

EMC 3 Healthcare Distribution Management Assn. Vol#: 8

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

EMC 354 Cynthia Bellini Olsen Vol#: 345

EMC 355 Donna McWhorter Vol#: 345

EMC 356 Debra Mercer Vol#: 345

EMC 357 Arron Cross Vol#: 345

EMC 358 American Association of Oriental Medicin Vol#: 345

EMC 359 Cara McCollum Vol#: 345

EMC 360 Brenda Marks L.Ac. Vol#: 345

EMC 361 Angela Lai Vol#: 345

EMC 362 The Daily Triplicate Vol#: 345

EMC 363 Pacific College of Oriental Medicine Vol#: 345

EMC 364 Allison Dimond Vol#: 345

EMC 365 Jylle Benson-Gauss Vol#: 345

EMC 366 Collum Vol#: 345

EMC 367 Marc O'Regan PA-c, MT., Cht Vol#: 345

EMC 368 Melanie Lewis Vol#: 345

EMC 369 Vitamin C Foundation Vol#: 345

EMC 370 National Consumers League Vol#: 345

EMC 371 Rebecca Komon Vol#: 345

EMC 372 MAK Wood, Inc. Vol#: 345

EMC 373 Gilda Jackson Vol#: 345

EMC 374 Marsha Bennett Vol#: 345

EMC 375 Shawnee Freese Vol#: 345

EMC 376 Eve Grossman, Lic.Ac. RN MSN MEd Vol#: 345

EMC 377 Judith Hewett Vol#: 345

EMC 378 Margaret Carl Vol#: 345

EMC 379 Mary Falzone Vol#: 345

EMC 380 Jenneffer Dozier Vol#: 345

EMC 381 American Academy of Family Physicians Vol#: 345

EMC 382 Michael Short, Lic.Ac. Vol#: 345

EMC 383 Number not used Vol#: 345

EMC 384 Kim Stone Vol#: 345

EMC 385 CA Department of Health Services Vol#: 345

EMC 386 Anton Wilhelm, Wendi Miyashiro Vol#: 345

EMC 387 Dorothy Phillips Vol#: 345

EMC 388 Mark Hensbergen, MSc Vol#: 345

EMC 389 Massachusetts Medical Society Vol#: 345

EMC 390 Jing River Acupuncture Vol#: 345

EMC 391 Roman Zacharko Vol#: 345

EMC 392 University of California at Davis Vol#: 345

EMC 393 American Pharmacists Association (APhA0 Vol#: 345

EMC 394 Julia Rose Vol#: 345

EMC 395 Carol Aalbers Vol#: 345

EMC 396 Kathleen Marsh Vol#: 345

EMC 397 University of Kansas School of Medicine Vol#: 345

EMC 398 Margaret Jessup Vol#: 345

EMC 399 Consumers Union of US Inc. Vol#: 345

EMC 400 J Jermain Vol#: 345

EMC 401 Scotty Salter Vol#: 345

EMC 402 Glenn Braswell Vol#: 345

EMC 403 June Robinson Vol#: 345

EMC 404 Daniel LaFlair Vol#: 345

EMC 405 Walter E Goldstein PhD Vol#: 345

EMC 406 Judy Fleming Vol#: 345

EMC 407 George Freidkin Vol#: 345

EMC 408 Michael Falcone Vol#: 345

EMC 409 Candace Lauer Vol#: 345

EMC 410 Number not used Vol#: 345

EMC 411 Annette R Schaefer Vol#: 345

EMC 412 Don Hunsaker Vol#: 345

EMC 413 Pam Green Vol#: 345

EMC 414 Sherilyn Fox Vol#: 345

EMC 415 Charlotte Dacumos Vol#: 345

EMC 416 Marcia L. Ramos Vol#: 345

EMC 417 Dr Jaya Kasturi MD Vol#: 345

EMC 418 Donna Richadson Vol#: 345

EMC 419 TJ Taylor Vol#: 345

EMC 420 Donna Jean Clark Vol#: 345

EMC 421 Melanie Clark Lic.Ac. M.Ac.Lic. Vol#: 345

EMC 422 Vandorn Hinnant Vol#: 345

EMC 423 Rhonda Walton Vol#: 345

EMC 424 Maggy Cairo Vol#: 345

EMC 425 Douglas H Posey Jr MD Vol#: 345

EMC 426 Christopher E. Grell Vol#: 345

EMC 427 flowerpeddle47 Vol#: 345

EMC 428 Teresa Evans Vol#: 345

EMC 429 Ashraf Mozayani PharmD, PhD, D-ABFT Vol#: 345

EMC 430 Jan Jenson Vol#: 345

EMC 431 Douglas H Posey Jr MD Vol#: 345

EMC 432 George A Bray MD Vol#: 345

EMC 433 Tsao-Lin E. Moy, L.Ac. MS Vol#: 345

EMC 434 Diana Clarisse, PhD Vol#: 345

EMC 435 Lindsey Seigle Vol#: 345

EMC 436 Zelene Quiles Vol#: 345

EMC 437 Number not used Vol#: 345

EMC 438 Anna Mazon Vol#: 345

EMC 439 Number not used Vol#: 345

EMC 440 Ann Myers Vol#: 345

EMC 441 Howard B Myers Vol#: 345

EMC 442 Kenneth Glowacki, L.Ac. (CA) Vol#: 345

EMC 443 Beata Woodard Vol#: 345

EMC 444 Number not used Vol#: 345

EMC 445 Timothy Cress Vol#: 345

EMC 446 John Cuomo Vol#: 345

EMC 447 Dave Newcomb Vol#: 345

EMC 448 Alan Feldstein Vol#: 345

EMC 449 Petra Hall Vol#: 345

EMC 450 Elizabeth Mummaw Vol#: 345

EMC 451 Helen Strecker Vol#: 345

EMC 452 Mozelle Vaughan Vol#: 345

EMC 453 Gretchen E Seitz L.Ac Vol#: 345

EMC 454 Cindy Banker MA Dipl. ABT (NCCAOM) Vol#: 345

EMC 455 Toni Bergeron Vol#: 345

EMC 456 Victoria Maghrak Vol#: 345

EMC 457 Lori Wilson Vol#: 345

EMC 458 David Breckler Vol#: 345

EMC 459 Laurel Holloway PhD Vol#: 345

EMC 460 S Claiborne Johnston, MD PhD Vol#: 345

EMC 461 University of California, San Francisco Vol#: 345

EMC 462 Small Business Administration, Advocacy Vol#: 345

EMC 463 Clark W Smaha Vol#: 345

EMC 464 Anne L. Tamburrino Vol#: 345

EMC 465 Angela Sahl Vol#: 345

EMC 466 Number not used Vol#: 345

EMC 467 University of Miami Vol#: 345

EMC 468 Julie B Mirr Vol#: 345

EMC 469 Angelo Carducci Vol#: 345

EMC 470 Alice C Gilbert Vol#: 345

EMC 471 City and County of San Francisco, CA Vol#: 345

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 81 List as of April 4, 2003 Vol#: 6

98D-0834 Non-Contraceptive Estrogen Class Labeling

EC 6 Endeavor Pharmaceuticals, Inc. Vol#: 1

99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols

GDL 2 Guideline Vol#: 2

NAD 2 Vol#: 2

99F-2999 Benzenepropanoic acid, 3-5-bis(1,1-dimethylethy)-4-hydroxy-

NWL 1 Vol#: 1

99N-2497 Actions That Can be Requested by Petition; Denials, Withdraw

NWL 1 Vol#: 2

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 3971 Doris Loud Vol#: 513

EMC 3972 Kris Walters Vol#: 513

00D-1662 Use of Xenotransplantation Products in Humans

GDL 2 GUIDANCE Vol#: 3

NAD 2 Vol#: 3

00P-1322 Food Labeling and Allergen Contamination Control

C 525 Lana J. Petersen Vol#: 29

EMC 497 Marcia Hurst Vol#: 20

01D-0435 ICH Technical Requirements: Registration of Pharmaceuticals

GDL 3 Guideline Vol#: 1

NAD 3 Vol#: 1

01D-0583 Food Security Guidance

EC 3 Advanced Farm Technology Company Vol#: 1

EC 4 Number Not Used Vol#: 1

01N-0275 Performance standard for Diagnostic X-Ray Systems & Major Co

EC 2 New Jersey Department of Environmental P Vol#: 1

EC 3 Philips Medical Systems SSR NA Vol#: 1

02A-0379 Device classification resulting manufacturer for image techn

APA 1 HFZ-1 to SG&A Consulting, Inc. Vol#: 1

02D-0324 Bioengineered Plants for Use in Humans and Animals

C 632 David Bellefeuille-Rice Vol#: 13

02E-0147 Patent Extension 5,258,494, OP-1 Implant

N 1 Vol#: 1

02E-0150 Gynecare Intergel, U.S. Patent Extension No. 5,532,221

N 1 Vol#: 1

02H-0443 Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care

CS 6 HFA-305 Vol#: 1

OR 5 HF-3 Vol#: 1

02N-0204 Bar Code Label Requirements for human drug products

EC 16 University of Michigan Vol#: 7

EC 17 Advocate Health Care Vol#: 7

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

C 109 Switzerland Vol#: 9

C 110 Distilled Spirits Council of the US, In. Vol#: 9

C 111 Prof Dr. Bungaran Saragih Vol#: 9

C 112 Scotch Whisky Assn Vol#: 9

C 113 American Chemistry Council Vol#: 9

C 114 Glutamate Assn (TGA) Vol#: 9

C 115 SEHSC Vol#: 9

C 116 National Grain and Feed Assn (NGFA) Vol#: 9

C 117 Formatta Corporation (Formatta) Vol#: 9

02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments

C 154 Scotch Whisky Assn Vol#: 10

C 155 Coalition for Safe Ceramicware, Inc. Vol#: 10

C 156 Dole Fresh Vegetables, Inc. Vol#: 10

C 157 American Assn of Exporters and Importers Vol#: 10

C 158 Formatta Corporation (Formatta) Vol#: 10

C 159 National Grain and Feed Assn (NGFA) Vol#: 10

C 160 Cargo Airline Assn (CAA) Vol#: 10

C 161 SEHSC Vol#: 10

C 162 Glutamate Assn (TGA) Vol#: 10

C 163 Aquanor Marketing, Inc. Vol#: 10

C 164 Taylor & Grant Specialies Limited Vol#: 10

C 165 Grocery Manufacturers of America (GMA) Vol#: 10

C 166 Kraft Foods Vol#: 10

C 167 National Standardization Agency of Idone Vol#: 10

C 168 Embassy of Malaysia Vol#: 10

C 169 BC Vegetable Marketing Commission Vol#: 10

C 170 Food Marketing Institute (FMI) Vol#: 10

C 171 International Dairy Foods Assn (IDFA) Vol#: 10

C 172 National Institute of Oilseed Products Vol#: 10

C 173 American Airlines Vol#: 10

C 174 NCBFAA Vol#: 12

C 175 Agriculture Dept of the Govt of Mexico Vol#: 12

C 176 Grunfeld, Desiderio, Lebowitz, Silverman Vol#: 12

C 177 National Tank Truck Carriers Vol#: 12

C 178 Embassy of Spain Vol#: 12

C 179 World Shipping Council Vol#: 12

C 180 Canadian Produce Marketing Assn (CPMA) Vol#: 12

C 181 Salmon Industry Assn Vol#: 12

C 182 American Assn of Port Authorities (AAPA) Vol#: 12

C 183 Animal Nutrition Assn of Canada Vol#: 12

C 184 Province of Nova Scotia Vol#: 12

C 185 American Wholesale Marketers Assn Vol#: 12

C 186 The Fertilizer Institute (TFI) Vol#: 12

C 187 Society of the Plastics Industry, Inc. Vol#: 12

C 188 Popowich Milling Corp. (PMC) Vol#: 12

C 189 Grain Millers, Inc. (GMI) Vol#: 12

C 190 Holland American International Specialie Vol#: 12

C 191 Council for Responsible Nutrition (CRN) Vol#: 12

C 192 Border Trade Alliance (BTA) Vol#: 12

C 193 J.R. Short Milling Company Vol#: 12

C 194 American Chemistry Council Vol#: 12

C 195 Chilean Exporters Assn (ASOEX) Vol#: 12

C 196 National Food Processors Assn (NFPA) Vol#: 12

C 197 American Frozen Food Institute (AFFI) Vol#: 12

C 198 Government of Australia Vol#: 12

C 199 The New Zealand Government Vol#: 12

C 200 International Mass Retail Assn (IMRA) Vol#: 12

C 201 Switzerland Vol#: 12

C 202 Distilled Spirits Council of the US, In. Vol#: 12

C 203 Texas Produce Export Assn Vol#: 12

C 204 Embassy of the Republic of Indonesia Vol#: 12

C 205 Form Letters 10 Vol#: 13

02N-0354 Long-term Antibiotic Drug Therapy Involving Anthrax;Emergenc

N 3 Vol#: 1

02N-0475 Draft "Financial Relationships & Interest in Research Involv

C 1 AHRP, The Alliance for Human Res. Protec Vol#: 1

02N-0534 Medical Device User Fee and Modernization Act of 2002

EC 6 National Electrical Manufacturers Associ Vol#: 1

02P-0057 Relisting of Ventolin Albuterol Sulfate Inhalation

N 1 Vol#: 1

02P-0435 Effective Approval of Alphanate Antihemophilic Factor

C 6 The University of Oklahoma Vol#: 1

C 7 Jimmy Everest Ctr. for Cancer & Blood Di Vol#: 1

C 8 Jimmy Everest Ctr. for Cancer & Blood Di Vol#: 1

C 9 Orthopaedic Hospital Vol#: 1

C 10 Phoenix Children's Hospital Vol#: 1

C 11 University of Colorado Hlth Sciences Ctr Vol#: 1

C 12 Hemophilia & Thrombosis Ctr. Angelo Biac Vol#: 1

02P-0450 Withhold Approval of ANDA for Amino Acid Solution Drug Prod.

C 2 B. Braun Medical, Inc Vol#: 2

02P-0472 Petition to Post Statement in Response to Warning Letter

LET 1 HFZ-1 to Zuckerman Spaeder LLP Vol#: 1

03D-0007 Estrogen Progestin Drug Prod.to Treat Vasomotor Symptoms &

EMC 3 number not used Vol#: 1

EMC 4 Eli Lilly & Co. Vol#: 1

03D-0057 How to use E-mail to submit a protocol

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

03D-0093 Small Entity Compliance Guide "Juice HACCP",

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

03D-0111 Potassium Iodide Tablets Shelf Life Extension

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

03D-0118 Decorative Contact Lens (Import alert #86-10)

BKG 1 BACKGROUND Vol#: 2

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach

EC 22 Pem Vol#: 1

03N-0068 Beverages: Bottled Water

EC 5 Mr. Duke Hashimoto Vol#: 1

EC 6 Dr. tbgads b asdfvg Vol#: 1

03N-0069 FDA Task Force on Consumer Health Info for Better Nutrition

EC 33 KOCT Vol#: 1

EC 34 ONC Vol#: 1

EC 35 Ms. Janet Rand Vol#: 1

EC 36 Number Not Used Vol#: 1

EC 37 Ms. Nancy Barnard Vol#: 1

EC 38 Number Not Used Vol#: 1

EC 39 Number Not Used Vol#: 1

EC 40 Number Not Used Vol#: 1

EC 41 Number Not Used Vol#: 1

03N-0084 Electronic Records;Electronic Signatures;Agency Information

EC 1 Number Not Used Vol#: 1

03N-0094 Annual Guidance Agenda

NAD 1 Vol#: 1

03N-0106 Using FDA forms 3503/3504 submissions Petitions,Food/color

N 1 Vol#: 1

03V-0124 Laser Light Show

ACK 1 HFA-305 Vol#: 1