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Dockets Management
Dockets Entered On July 28, 2004
Table of Contents
Docket # Title
1991N-0384 Nutrient Claims, Definitions of Terms, General Principles
1995D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr
1997N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998N-0359 Program priorities/Center for Food Safety & Applied Nutrition
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1999P-5106 Identify Sources of Natural Flavorings
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
2003P-0029 Remove metered-dose inhalers (MDI) containing moiety albuter
2004D-0188 Guidance for Industry on Development and Use of Risk Minimization Action Plans
2004N-0181 Critical Path Initiative
2004N-0184 Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
2004N-0234 Annual Guidance Agenda
2004N-0258 Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
2004P-0334 Submit Validation Data for Reprocessed Single-Use Electrosurgical Cutting and Coagulation Devices and Accessories
2004V-0335 projector for a Laser Light Show
2004V-0336 Laser Light Show
1991N-0384 Nutrient Claims, Definitions of Terms, General Principles
BKG 1 Background Material Vol #: 2
1995D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr
C 23 Nicomac, Inc. Vol #: 4
1997N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood
SUP 3 National Marrow Donor Program Vol #: 6
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 14111 The Hain Celestial Group Vol #: 122
LET 14112 Ferrosan A/S Vol #: 122
LET 14113 Source Naturals Vol #: 122
LET 14114 Source Naturals Vol #: 122
LET 14115 Planetary Formulas Vol #: 122
LET 14116 Source Naturals Vol #: 122
LET 14117 Source Naturals Vol #: 122
LET 14118 Herbsforever, Inc. Vol #: 122
LET 14119 Now Foods Vol #: 122
LET 14120 Now Foods Vol #: 122
1998N-0359 Program priorities/Center for Food Safety & Applied Nutrition
EC 15 Ms. Mary Lebert Vol #: 1
EC 16 Mr. Anthony Corbo Vol #: 8
EC 17 Ms. Paula Payton Vol #: 8
EC 18 Mr. Nathan Hetrick Vol #: 8
EC 19 The Michigan Group Vol #: 8
EC 20 Mr. Ralph Heymann Vol #: 8
EC 21 n/a Vol #: 8
EC 22 Mr. Greg Jackson Vol #: 8
EC 23 elinoff Vol #: 8
EC 24 Volusia Flagler Sierra club Vol #: 8
EC 25 Mental Health Association (MHA) Vol #: 8
EC 26 Ms. Reba Stone Vol #: 8
EC 27 Ms. Melissa Leonard Vol #: 8
EC 28 Dr. Sholey Argani Vol #: 8
EC 29 Mr. Kurt Kiebler Vol #: 8
EC 30 Ms. Sharon Callahan Vol #: 8
EC 31 Mr. Joseph Aiello Vol #: 8
EC 32 Ms. Ann Heneks Vol #: 8
EC 33 Ms. Deborah Dosker Vol #: 8
EC 34 Ms. Elizabeth M. Ferranti Vol #: 8
EC 35 Mr. Gregory Nerode Vol #: 8
EC 36 Ms. Barbara van Davis Vol #: 8
EC 37 Ms. Laren Leonard Vol #: 8
EC 38 Ms. DJ Davis Vol #: 8
EC 39 Albertson College Vol #: 8
EC 40 Mr. Robert Stone Vol #: 8
EC 41 Ms. Eve Hughes Vol #: 8
EC 42 Mr. Burt Culver Vol #: 8
EC 43 Ms. Ellen Black Vol #: 8
EC 44 Mr. Erik Lords Vol #: 8
EC 45 Mr. Curtis Tromm Vol #: 8
EC 46 Ms. Dru Carter Vol #: 8
EC 47 Mr. Dan Schuchat Vol #: 8
EC 48 Ms. Muriel Shickman Vol #: 8
EC 49 First Class Fitness Inc. Vol #: 8
EC 50 Mr. Alan Greene Vol #: 8
EC 51 Mr. Richard Berghofer Vol #: 8
EC 52 Ms. Sandra Batey Vol #: 8
EC 53 Ms. Patricia Gula Vol #: 8
EC 54 Mr. Jared Wetherington Vol #: 8
EC 55 Mr. Paul Durieux Vol #: 8
EC 56 Ms. renata dobryn Vol #: 8
EC 57 Ms. darla anelli Vol #: 8
EC 58 Ms. judy Muir Vol #: 8
EC 59 Mr. Jeffrey Smith Vol #: 8
EC 60 Dr. Paul Kirk Vol #: 8
EC 61 Mrs. Dorothy Leatherwood Vol #: 8
EC 62 Mr. Gilbert Eidam Vol #: 8
EC 63 Mr. Roger Fitch Vol #: 8
EC 64 Mr. Brian Lutenegger Vol #: 8
EC 65 Ms. A. T. Lang Vol #: 8
EC 66 Ms. yolanda krisch Vol #: 8
EC 67 National Education Association Vol #: 8
EC 68 L. A. Care Vol #: 8
EC 69 Mr. John Pritchard Vol #: 8
EC 70 Ms. Misha Fredericks Vol #: 8
EC 71 Ms. Vera Cousins Vol #: 8
EC 72 Mrs. Gelse Tkalec Vol #: 8
EC 73 Mr. Charles Alvarez Vol #: 8
EC 74 Ms. Jade Harper Vol #: 8
EC 75 Encouraging Signs Vol #: 8
EC 76 Mr. Jeremy Schneider Vol #: 8
EC 77 Ms. Nancy Martin Vol #: 8
EC 78 Ms. Al Bonvouloir Vol #: 8
EC 79 Ms. Y. Saavedra Vol #: 8
EC 80 Mr. Frederick Wen Vol #: 8
EC 81 Ms. HEATHER WILLIAMS Vol #: 8
EC 82 Mr. Paul Finnegan Vol #: 8
EC 83 Mr. Jacob Trachtman Vol #: 8
EC 84 Mr. Nathan Hetrick Vol #: 8
EC 85 Ms. Keval Kaur Khalsa Vol #: 8
EC 86 Mr. Richard Brown Vol #: 8
EC 87 Mr. Michael Toobert Vol #: 8
EC 88 Mrs. Charilyn Rudolph Vol #: 8
EC 89 Mr. Bob Sutter Vol #: 8
EC 90 Ms. Lorraine Kitman Vol #: 8
EC 91 Mr. James Heckman Vol #: 8
EC 92 Mr. craig clark Vol #: 8
EC 93 Mr. Colin Smith Vol #: 8
EC 94 Ms. marcia hoodwin Vol #: 8
EC 95 Ms. Lela Hall Vol #: 8
EC 96 Ms. Johanna Vine Vol #: 8
EC 97 Dr. Eileen Chieco Vol #: 8
EC 98 Mr. Paul Moss Vol #: 8
EC 99 Mrs. beverly perez Vol #: 8
EC 100 Miss. tina neumann Vol #: 8
EC 101 American Citizen/Food purchaser Vol #: 8
EC 102 Ms. Hazel Landa Vol #: 8
EC 103 Mr. Jon Koriagin Vol #: 8
EC 104 Mr. Mark Feldman Vol #: 8
EC 105 Ms. Jennifer M Weishaar Vol #: 8
EC 106 Mrs. Charlotte Thomas Vol #: 8
EC 107 Westminster College Vol #: 8
EC 108 Mr. Thomas V. Connor Vol #: 8
EC 109 Ms. Mary Halligan Vol #: 8
EC 110 Dr. Peter Cook Vol #: 8
EC 111 Mr. Walter McClatchey Vol #: 8
EC 112 Ms. Lisa Khalil Vol #: 8
EC 113 Miss. Stephanie Allen Vol #: 8
EC 114 GRACE Vol #: 8
EC 115 Mr. David Turnoy Vol #: 8
EC 116 Mr. John Wright Vol #: 8
EC 117 Individual Vol #: 8
EC 118 Weston A. Price Foundation Vol #: 8
EC 119 WAPF Vol #: 8
EC 120 Handcrafted Cuisine, LLC Vol #: 8
EC 121 Dr. Morton Saunders Vol #: 8
EC 122 Mrs. Erin Moore Vol #: 8
EC 123 The Health Connection Vol #: 8
EC 124 Dr. Harvey J. Gardner Vol #: 8
EC 125 Mrs. Patricia Schoofs Vol #: 8
EC 126 Mr. Robert Yang Vol #: 8
EC 127 Miss. Rosie Matchette Vol #: 8
EC 128 Ms. Patricia O'Leary Vol #: 8
EC 129 Mrs. Kelly Mohorc Vol #: 8
EC 130 Ms. Katherine McMillin Vol #: 8
EC 131 Ms. Eleanore Duyndam Vol #: 8
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7443 S. Azama Vol #: 307
1999P-5106 Identify Sources of Natural Flavorings
C 41 C. Stras Vol #: 2
C 42 K. Hanson Vol #: 2
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EMC 796 University of Geogia, College of Veterniary Medicine Vol #: 271
EXB 363 Center for Veterinary Medicine Vol #: 424
EXB 364 Center for Veterinary Medicine Vol #: 424
EXB 365 Center for Veterinary Medicine Vol #: 424
EXB 366 Center for Veterinary Medicine Vol #: 424
EXB 367 Center for Veterinary Medicine Vol #: 424
EXB 368 Center for Veterinary Medicine Vol #: 424
EXB 369 Center for Veterinary Medicine Vol #: 424
EXB 370 Center for Veterinary Medicine Vol #: 424
EXB 371 Center for Veterinary Medicine Vol #: 424
EXB 372 Center for Veterinary Medicine Vol #: 424
EXB 373 Center for Veterinary Medicine Vol #: 424
EXB 374 Center for Veterinary Medicine Vol #: 424
EXB 375 Center for Veterinary Medicine Vol #: 424
EXB 376 Center for Veterinary Medicine Vol #: 424
EXB 377 Center for Veterinary Medicine Vol #: 424
EXB 378 Center for Veterinary Medicine Vol #: 424
EXB 379 Center for Veterinary Medicine Vol #: 424
EXB 380 Center for Veterinary Medicine Vol #: 424
EXB 381 Center for Veterinary Medicine Vol #: 424
EXB 382 Center for Veterinary Medicine Vol #: 424
EXB 383 Center for Veterinary Medicine Vol #: 424
EXB 384 Center for Veterinary Medicine Vol #: 424
EXB 385 Center for Veterinary Medicine Vol #: 424
EXB 386 Center for Veterinary Medicine Vol #: 424
EXB 387 Center for Veterinary Medicine Vol #: 424
EXB 388 Center for Veterinary Medicine Vol #: 425
EXB 389 Center for Veterinary Medicine Vol #: 425
EXB 390 Center for Veterinary Medicine Vol #: 425
EXB 391 Center for Veterinary Medicine Vol #: 425
EXB 392 Center for Veterinary Medicine Vol #: 425
EXB 393 Center for Veterinary Medicine Vol #: 425
EXB 394 Center for Veterinary Medicine Vol #: 425
EXB 395 Center for Veterinary Medicine Vol #: 425
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
C 12737 Michael Lande Vol #: 789
C 12738 Murry Barr Vol #: 789
C 12739 Erika Smith Vol #: 789
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 1875 Institute for Human Rights, Inc. Vol #: 281
EMC 9066 C. Fitzpatrick Vol #: 284
EMC 9067 A. L. Hanson Vol #: 284
EMC 9068 K. Haphood Vol #: 284
EMC 9069 J. Jakstas Vol #: 284
EMC 9070 C. Carr Vol #: 284
EMC 9071 B. Halligan Vol #: 284
EMC 9072 L. J. Parrish Vol #: 284
EMC 9073 R. Cserr Vol #: 284
EMC 9074 E. P. Arnold Vol #: 284
EMC 9075 B. Seeliger Vol #: 284
EMC 9076 S. George Vol #: 284
EMC 9077 C. S. Mahan Vol #: 284
EMC 9078 Dr. S. S. Jacobs Vol #: 284
EMC 9079 P. Kalmus Vol #: 284
EMC 9080 V. Strickley Vol #: 284
EMC 9081 E. Babb Vol #: 284
EMC 9082 T. Smith Vol #: 284
EMC 9083 K. Kurczynski Vol #: 284
EMC 9084 J. K. Williams Vol #: 284
EMC 9085 J. Heimbach Vol #: 284
EMC 9086 B. Harmon Vol #: 284
EMC 9087 E. Ruby=Markie Vol #: 284
EMC 9088 M. Salas Vol #: 284
EMC 9089 R. D. Switzer Vol #: 284
EMC 9090 C. Carlson Vol #: 284
EMC 9091 S. Kranz Vol #: 284
EMC 9092 S. Hansen Vol #: 284
EMC 9093 D. Reiffel Vol #: 284
EMC 9094 E. Fraley-Russell Vol #: 284
EMC 9095 D. Schwartz Vol #: 284
EMC 9096 M. Kress Vol #: 284
EMC 9097 L. Price Vol #: 284
EMC 9098 A. Funderburk Vol #: 284
EMC 9099 R. Gordon Vol #: 284
EMC 9100 K. Brennan Vol #: 284
EMC 9101 K. Schantz Vol #: 284
EMC 9102 E. A. Meixell Vol #: 284
EMC 9103 L. Wenzel Vol #: 284
EMC 9104 J. Conlon Vol #: 284
EMC 9105 J. Williams Vol #: 284
EMC 9106 Y. Nusinovich Vol #: 284
EMC 9107 C. Cormier Vol #: 284
EMC 9108 B. Halverson Vol #: 284
EMC 9109 S. L. Frellsen Vol #: 284
EMC 9110 B. B. Wallace Vol #: 284
EMC 9111 S. Wolf Vol #: 284
EMC 9112 C. J. White Vol #: 284
EMC 9113 V. Moreno Vol #: 284
EMC 9114 Z. McCarthy Vol #: 284
EMC 9115 A. Tomblin Vol #: 284
EMC 9116 S. Hilton Vol #: 284
EMC 9117 R. O'Connor Vol #: 284
EMC 9118 M. Oliver Vol #: 284
EMC 9119 A. kresica Vol #: 284
EMC 9120 N. B. Field Vol #: 284
EMC 9121 D. Dreslough Vol #: 284
EMC 9122 M. L. Korch Vol #: 284
EMC 9123 C. Hanford Vol #: 284
EMC 9124 J. Saccoman Vol #: 284
EMC 9125 A. Buffardi Vol #: 284
EMC 9126 M. Lulofs Vol #: 284
EMC 9127 A. Yermish Vol #: 284
EMC 9128 A. Luke Vol #: 284
EMC 9129 J. Levine Vol #: 284
EMC 9130 N. L. Collins Vol #: 284
EMC 9131 K. Dumas Vol #: 284
EMC 9132 J. Green Vol #: 284
EMC 9133 J. Whetstone Vol #: 284
EMC 9134 K. Moseley Vol #: 284
EMC 9135 J. Montalvo Vol #: 284
EMC 9136 S. Albright Vol #: 284
EMC 9137 M. A. Austin Vol #: 284
EMC 9138 M. Wiley Vol #: 284
EMC 9139 A. Pogue Vol #: 284
EMC 9140 M. Hamilton Vol #: 284
EMC 9141 T. Derr Vol #: 284
EMC 9142 G. E. Longtin Vol #: 284
EMC 9143 S. Moreira Vol #: 284
EMC 9144 R. Arosteguy Vol #: 284
EMC 9145 R. Hamilton Vol #: 284
EMC 9146 K. D. Brown Vol #: 284
EMC 9147 A. Fleming Vol #: 284
EMC 9148 D. Gould Vol #: 284
EMC 9149 S. Libert Vol #: 284
EMC 9150 M. Jantho Vol #: 284
EMC 9151 D. Anderson Vol #: 284
EMC 9152 J. I. Craig Vol #: 284
EMC 9153 D. Josey Vol #: 284
EMC 9154 M. L. Weiss Vol #: 284
EMC 9155 A. R. Dunlap Vol #: 284
EMC 9156 K. Hodgson Vol #: 284
EMC 9157 S. G. Zitter Vol #: 284
EMC 9158 S. Krema Vol #: 284
EMC 9159 K. Hodges Vol #: 284
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
EC 496 Steptoe Vol #: 30
EC 497 Steptoe Vol #: 30
EC 498
Attachment 		Government of Japan Vol #: 30
EC 499
Attachment 		Confederation of European Spirits Producers Vol #: 30
EC 500
Attachment 		Government of Japan Vol #: 30
EC 501 European Commission Delegation Vol #: 30
EC 502 Ms. Marlene Chorniak Vol #: 30
EC 503
Attachment 		Customs and International Bar Association Vol #: 30
EC 504 Netherlands Ministry of Ag., Nature, Food Quality Vol #: 30
EC 505 Fresh Produce Association of the Americas Vol #: 30
2003P-0029 Remove metered-dose inhalers (MDI) containing moiety albuter
LET 2 HF-22 to American Lung Association Vol #: 2
2004D-0188 Guidance for Industry on Development and Use of Risk Minimization Action Plans
EC 3 National Association of Chain Drug Stores Vol #: 1
2004N-0181 Critical Path Initiative
C 5 VivoMetrics Vol #: 1
2004N-0184 Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
EXT 1 National Coalition of Food Importing Associations Vol #: 2
2004N-0234 Annual Guidance Agenda
EC 1 Mr. Donald Woods Vol #: 1
EC 2 HHNI Vol #: 1
2004N-0258 Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
C 9 International Sprout Growers Assn (ISGA) Vol #: 1
C 10 National Food Processors Assn (NFPA) Vol #: 1
EC 4
Attachment 		SECRETARIAT OF AGRICULTURE-SAGARPA-MEXICO Vol #: 1
EC 5
Attachment 		Western Growers Vol #: 1
EC 6
Attachment 		U.S. Apple Association Vol #: 1
EC 7 Fresh Produce Association of the Americas Vol #: 1
EC 8 Fresh Produce Association of the Americas Vol #: 1
EC 9
Attachment 		Fresh Produce Association of the Americas Vol #: 1
2004P-0334 Submit Validation Data for Reprocessed Single-Use Electrosurgical Cutting and Coagulation Devices and Accessories
ACK 1 HFA-305 to Hyman, Phelps & McNamara, P.C. Vol #: 1
CP 1 Hyman, Phelps & McNamara, PC (HP&M) Vol #: 1
2004V-0335 projector for a Laser Light Show
ACK 1 HFA-305 to Canisius High School Vol #: 1
VAR 1 Canisius High School Vol #: 1
2004V-0336 Laser Light Show
ACK 1 HFA-305 to CLLS Laser Show the Forum Vol #: 1
VAR 1 CLLS Laser Show the Forum Vol #: 1

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