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DOCKETS ENTERED on 4/21/03
Docket Number - Title
99D-1458 Enforcement Policy for FDA
Personnel/Electronic Records& Sig
99F-4372 National Fisheries Institute and the
Louisiana Dep of Agricu
99F-5321 Food Safety & Inspection service
safe use of ionizing radiai
99F-5322
Ionizing Radiation for the Treatment of Food
99F-5522 Ionizing
radiation /control of Food-borne pathogens safe use
00N-1396 Bioengineered Foods Consumed By Humans
or Animals
00N-1484 Safety Reporting Requirements Human
Drug/Biological Products
00N-1571 Enrofloxacin for Poultry: Opportunity
for Hearing
01P-0470 Establish Appropriate Approval
Standards for Generic Clonidi
02N-0204 Bar Code Label Requirements for human
drug products
02N-0534 Medical Device User Fee and
Modernization Act of 2002
02P-0377 Petition Requesting Stay of Approval of
Mifeprex
02P-0399 Determine Whether Estrostep 21 Tablets,
NDA 020130 Have Been
02P-0447 Immediately revoke its acceptance for
NDA 21-435 for amlodin
02P-0470 Change Dosgae Form of Eqvalan Paste
1.87% From Paste to Gran
96N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
NM 4 Vol#: 7
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
EMC 677 Bonnie Benton Vol#: 19
99D-1458
Enforcement Policy for FDA Personnel/Electronic Records& Sig
C 3 Merck & Co., Inc. Vol#: 1
99F-4372
National Fisheries Institute and the Louisiana Dep of Agricu
EMC 430 Center for Food Safety Vol#: 7
EMC 431 Agricultural Organization/Food & Agri-Bu Vol#: 7
99F-5321
Food Safety & Inspection service safe use of ionizing radiai
EMC 333 Center for Food Safety Vol#: 7
EMC 334 Agricultural Organization/Food & Agri-Bu Vol#: 7
99F-5322
Ionizing Radiation for the Treatment of Food
EMC 332 Center for Food Safety Vol#: 5
EMC 333 Agricultural Organization/Food & Agri-Bu Vol#: 5
99F-5522 Ionizing
radiation /control of Food-borne pathogens safe use
EMC 335 Center for Food Safety Vol#: 5
EMC 336 Agricultural Organization/Food & Agri-Bu Vol#: 5
99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
EMC 3973 Beth Treweek Vol#: 514
EMC 3974 Tala Deaton Vol#: 514
EMC 3975 Stephanie Ellington Vol#: 514
99P-1340 Declared Eternity eau de Parfum Misbranded
EMC 441 Greg Williams Vol#: 21
EMC 442 No signature Vol#: 21
99P-2630 Establish a Daily Value for "added sugars"
EMC 478 Emily Willenbrand Vol#: 32
00D-1538 Electronic Records; Electronic Signatures, Validation
C 34 Merck & Co., Inc. Vol#: 8
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec
C 27 Merck & Co., Inc. Vol#: 8
00D-1542 Electronic Signatures: Time Stamps
C 12 Merck & Co., Inc. Vol#: 6
00D-1543 Electronic Signatures: Glossary of Terms
C 23 Merck & Co., Inc. Vol#: 7
00D-1598 Voluntary Labeling for Bioengineered Foods
EMC 12008 Cheri Riley Vol#: 574
00N-1396
Bioengineered Foods Consumed By Humans or Animals
C 9452 Form Letter Count (3) Vol#: 412
C 9453 Form Letter Count (11) Vol#: 413
C 9454 Form Letter Count (16) Vol#: 414
C 9455 Cliff & Janet Owen Vol#: 408
C 9456 Christi Oates Vol#: 408
C 9457 Bob Segal Vol#: 408
C 9458 Anthony DelGreco Vol#: 408
C 9459 Joy York Vol#: 408
C 9460 David & Barbara Starre Vol#: 408
C 9461 Elizabeth Hefner Vol#: 408
C 9462 Colleen Ostlund, C.H. Vol#: 408
C 9463 Rose Marie Williams, MA Vol#: 408
C 9464 Robert H. Fraser Vol#: 408
C 9465 Laura L. Smoak Vol#: 408
C 9466 Kelly Stoflet Vol#: 408
C 9467 Deborah Williams Vol#: 408
C 9468 Patrick Newell Vol#: 408
C 9469 Vanessa London Vol#: 408
C 9470 Sierra Club Genetic Engineering Committe Vol#: 408
C 9471 Unreadable Vol#: 408
C 9472 Cynthia Torges Vol#: 408
C 9473 Katey Kukla Vol#: 408
C 9474 Michelle Hackett Vol#: 408
C 9475 Shawn Carney Vol#: 408
C 9476 T. Jeffrey & Beatrice Mangin Vol#: 408
C 9477 Charles Ginsberg Vol#: 408
C 9478 Alisha Ritt Vol#: 408
C 9479 Bryan Bonfiglio Vol#: 408
C 9480 Jeanelle Thomas Vol#: 408
C 9481 Joy H. Wolff Vol#: 408
C 9482 Desiree Ferrell Vol#: 408
C 9483 Hans Kueck Vol#: 408
C 9484 Mr. & Mrs. Mohandas T. R. Ah Vol#: 408
C 9485 Kyle Brewer Vol#: 408
C 9486 Zack Wood Vol#: 408
C 9487 Isabel A. Leonard Vol#: 408
C 9488 Barbara Joan Birnbaum Vol#: 408
C 9489 Mr. & Mrs. G. R. Denison Vol#: 408
C 9490 Walt Blackford Vol#: 408
C 9491 Karl J. Volk Vol#: 408
C 9492 Kirk Workman Vol#: 408
C 9493 Gary S. Cunningham Vol#: 408
C 9494 Tamara Tuthill Vol#: 408
C 9495 Jerilyn Keyak Vol#: 408
C 9496 Leta S. Armstrong Vol#: 408
C 9497 Shirley Bowman Vol#: 408
C 9498 Melinda S. Morton Vol#: 408
C 9499 Frank Miller Vol#: 408
C 9500 Margie M. Epp Vol#: 408
C 9501 Marian Vimont Vol#: 408
C 9502 Earl C. Brydon Vol#: 408
C 9503 Ronald Harris Vol#: 408
C 9504 Delilah Smith Vol#: 408
C 9505 Mamie Mary Hunt Vol#: 408
C 9506 Nancy Morris Vol#: 408
C 9507 Jessica Williams Vol#: 408
C 9508 Jerry R. Williams Vol#: 408
C 9509 Vicki Leeds Vol#: 408
C 9510 Nancy Draper Vol#: 408
C 9511 Phillip Robert Miner Vol#: 408
C 9512 Melinda S. Morton Vol#: 408
C 9513 Lora Nell Davidson Vol#: 408
C 9514 Noel C. Nelson Vol#: 408
C 9515 Joanne Steele Vol#: 408
C 9516 Sylvia Forbes Vol#: 408
C 9517 Paul Frehe Vol#: 408
C 9518 Ben Moseley Vol#: 408
C 9519 Lisa & Michael Dorou Vol#: 408
C 9520 Lisa & Michael Dorou Vol#: 408
C 9521 Rose Marie Williams Vol#: 408
C 9522 Justina Williams Vol#: 408
C 9523 Veronique Foster Vol#: 408
C 9524 Phyllis I. Pereira Vol#: 408
C 9525 Judy Thomsen Vol#: 408
C 9526 Elias W. Keim Vol#: 408
C 9527 Rebecca Oliver Vol#: 408
C 9528 Emily I. Delcamp Vol#: 408
C 9529 Kenneth D. Johnson Vol#: 408
C 9530 Daniel M. Hiel Vol#: 408
C 9531 Jen Punzel Vol#: 408
C 9532 Karen Kerney Vol#: 408
C 9533 John Harman Vol#: 408
C 9534 Gerald Theisen, Ph.D. Vol#: 408
C 9535 Ronald V. Ginther Vol#: 408
C 9536 R. Lucille Balukjian Vol#: 408
C 9537 J. Ponte-Rogers Vol#: 408
00N-1484 Safety
Reporting Requirements Human Drug/Biological Products
C 1 SNOMED International Vol#: 3
00N-1571
Enrofloxacin for Poultry: Opportunity for Hearing
RMO 20 Bayer Corporation Vol#: 362
01E-0031 Patent Extension for EXELON, No. 4,948,807
N 1 Vol#: 1
01P-0470
Establish Appropriate Approval Standards for Generic Clonidi
SUP 2 Mylan Technologies Inc Vol#: 2
02E-0343 Patent Term Application for Zevalin No. 5,776,456
N 1 Vol#: 1
02N-0204 Bar Code
Label Requirements for human drug products
02N-0282 Agency Info. Collection Activities;Notices of Participation
NAL 1 Vol#: 1
02N-0405 Med. Device Reporting: Mfg., Importer, User Facility & Distr
NAL 1 Vol#: 1
02N-0534 Medical
Device User Fee and Modernization Act of 2002
C 24 Aircast Inc. (Aircast) Vol#: 2
02P-0377
Petition Requesting Stay of Approval of Mifeprex
LET 2 HFD-1 to American Assn of Pro Life Obste Vol#: 1
02P-0399
Determine Whether Estrostep 21 Tablets, NDA 020130 Have Been
LET 1 HFD-1 to Barr Laboratories, Inc. Vol#: 1
02P-0447
Immediately revoke its acceptance for NDA 21-435 for amlodin
LET 1 HFD-1 to Pfizer Inc. Vol#: 1
02P-0470
Change Dosgae Form of Eqvalan Paste 1.87% From Paste to Gran
PAV 1 HFV-100 to Karen A. Sisson Vol#: 1
03D-0044 Reporting Results for Studies Evaluating Diagnostic Tests
C 1 Albert Rabinovitch,MD,PhD Vol#: 1
03D-0060 Part11, Electronic records, electronic signatures scope
C 3 Merck & Co., Inc. Vol#: 1
03D-0120 Multiplex Tests for Heritable DNA Markers, Mutations & Expre
GDL 1 Draft Guidance for Industry & FDA Review Vol#: 1
NAD 1 Vol#: 1
03E-0032 Patent Term Extension Application for IMAGENT, No. 5,639,443
N 1 Vol#: 1
03N-0068 Beverages: Bottled Water
C 1 Jessica Pulz Vol#: 1
03N-0142 Submitting & Reviewing Complete Responses for Clinical Holds
N 1 Vol#: 1