Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail]  

DOCKETS ENTERED on November 12, 1999

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
78N-036L OTC Laxative *
80N-0295 OTC drug review policy statement*
85V-0189 Laser Light Show *
92V-0278*
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
94P-0043 Establish common or usual name for blue crab *
95V-0312 Laser Light Show *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97D-0433 In Vivo Bioequivalence Studies Based on Population *
97P-0197 Require that warning labels about risks of salmonella enteri *
97V-0114 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000 *
98N-0313 Surgeons's and Patient Examination Gloves Reclassification *
98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell *
98V-1135 Laser Light Show *
99D-1878 Good Manufacturing Practice for Blood and Blood Components: *
99D-4070 "Stability Testing: Photostability testing of New Veterinary *
99N-2210 Reclassification of Cardiopulmonary Bypass Accessory Equipme *
99N-4235 Practices in the dietary supplement industry survey *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast *
99P-2630 Establish a Daily Value for "added sugars" *
99P-4932 ANDA Suitability Petitions for Parenteral Drugs *
99V-1630 Laser Light Show *
99V-2628 *
99V-2906 Mobolaser ML10-200, ML10-300, ML10-300W *
99V-2974 Projector for Laser Light Show*
99V-3018 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-2.5 *
99V-3020 Laser Light Show *
99V-3080 Mobolazer ML10-200, ML10-300, ML10-300W, L10-1.0 *
99V-4002 Laser Light Show *
99V-4931 Laser Scenic Element *
78N-036L OTC Laxative

MM 18 HFD-24 & ORM Pharmacology/Toxicology Sen Vol#: 107

80N-0295 OTC drug review policy statement

MM 122 HFD-560 & CTFA & CHCPA Vol#: 3

85V-0189 Laser Light Show

VRA 9 HFZ-300 to dba Beamin Lasers Vol#: 1

92V-0278

VRA 3 HFZ-300 to Jeff Cone Studios Vol#:
 

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 996 Harvard School of Public Health et al Vol#: 25

94P-0043 Establish common or usual name for blue crab

C 12 Phillips Foods Inc & Seafood Restaurants Vol#: 1

C 13 National Fisheries Institute Vol#: 1

95V-0312 Laser Light Show

VRA 3 HFZ-300 to Laseronics Northwest Vol#: 1

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

THESE LINKED COMMENTS DUPLICATE THOSE IN 97P-0197 AND 98N-1230, ALSO BELOW

C 785 Michelle Browning Vol#: 31

C 786 Melissa Waz Vol#: 31

97D-0433 In Vivo Bioequivalence Studies Based on Population

C 26 International Generic Pharmaceutical All Vol#: 2

C 27 Procter & Gamble Vol#: 2

C 28 Internat'l Society for Clinical Biostati Vol#: 2

C 29 PhRMA Vol#: 2

C 30 Bristol-Myers Squibb Pharmaceutical Rese Vol#: 2

C 31 Whitehall-Robins Healthcare Vol#: 2

C 32 AstraZeneca LP Vol#: 2

97P-0028 Questran Tablets (Oral Cholestyramine Tablets)

WDL 1 Hyman, Phelps & McNamara, P.C. Vol#: 1

97P-0197 Require that warning labels about risks of salmonella enteri

C 786 Michelle Browning Vol#: 30

C 787 Melissa Waz Vol#: 30

97V-0114 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000

VRA 1 HFZ-300 to Campion Sales Company, Inc. Vol#: 1

98N-0313 Surgeons's and Patient Examination Gloves Reclassification

SUP 1 CDC Vol#: 8

98N-0617 Treatment of Narcotic Dependence

C 23 Montefiore Medical Center Vol#: 8

C 24 The Lindesmith Center Vol#: 8

C 25 Oregon Dept of Human Resources Vol#: 8

C 26 Randy & Sherry Bomar Vol#: 8

C 27 Thomas B Reid III MD Vol#: 8

C 28 Form Letter count 3 Vol#: 9

EMC 5 Scott G Koerner Vol#: 8

EMC 6 Annette Rodriguez Vol#: 8

EMC 7 RLO Vol#: 8

EMC 8 Sue Vol#: 8

TS 6 Medical College of Virginia Vol#: 8

TS 7 LAARC, Matrix Institute on Addictions Vol#: 8

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 785 Michelle Browning Vol#: 32

C 786 Melissa Waz Vol#: 32

98P-0863 Permit export of propofol injection 1% to Mexico

WDL 1 Gensia Sicor Pharmaceuticals, Inc. Vol#: 1

98V-1135 Laser Light Show

VRA 1 HFZ-300 to Luners Pro Sound & Lighting Vol#: 1

99D-1878 Good Manufacturing Practice for Blood and Blood Components:

C 30 Tania L Motschman, MS, MT(ASCP)SBB) Vol#: 1

99D-4070 "Stability Testing: Photostability testing of New Veterinary

THIS LINKED COMMENT DUPLICATES 99D-4071, ALSO BELOW

C 1 Animal Health Institute Vol#: 1

99D-4071 'Impurities: Residual Solvents.;

C 1 Animal Health Institute Vol#: 1

99D-4114 Testing for Replication Competent Retrovirus in Retroviral

BKG 1 Background material Vol#: 1

99H-1381 Civil Money Penalties;Glenn Warner Jr,d/b/a Belle Haven Texa

ANS 1 Belle Haven Texaco Vol#: 1

99H-4229 Civil Money Penalty;Sub-Q Inc,dba Weston Richardson Drug

ANS 1 Richardson Drug Vol#: 1

99H-4365 Civil Money Penalty;June Ent Inc,dba Carrollton Exxon

ANS 1 June Enterprises Inc Vol#: 1

99N-2210 Reclassification of Cardiopulmonary Bypass Accessory Equipme

C 1 Paladin Medical Inc Vol#: 1

99N-4235 Practices in the dietary supplement industry survey

C 1 Consumer Healthcare Products Association Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 426 Bertha L Bassett Vol#: 9

C 427 Len & Annette Kocurek Vol#: 9

C 428 Margaret Marechofer Vol#: 9

C 429 Bill Adams Vol#: 9

C 430 Dr Cecile-Marie Sastre Vol#: 9

C 431 Susan Lapp Vol#: 9

C 432 Willard & Carolyn Todd Vol#: 9

C 433 Paula M Lazzaro Vol#: 9

C 434 Susan Pitman Vol#: 9

C 435 Beverly A Boylan Vol#: 9

C 436 V T Stamoules Vol#: 9

C 437 Mary C Tarr Vol#: 9

C 438 Ruth M Sackstedre Vol#: 9

C 439 Martha Zuckerman Vol#: 9

C 440 Joanna Dewey PhD Vol#: 9

C 441 Janet Bonner Vol#: 9

C 442 Linda Anderson Vol#: 9

C 443 Herb Lifchetz Vol#: 9

C 444 Darren Fuemmeler Vol#: 9

C 445 Eleanore Osmond Vol#: 9

C 446 Marie Elaine Tomko Vol#: 9

C 447 Lori B Caress Vol#: 9

C 448 Elaine Penny Baer Vol#: 9

C 449 Melanie Lynn Burham Cave Vol#: 9

C 450 Jean Bailey Vol#: 9

C 451 P Doherty Vol#: 9

C 452 Rachel Baliensat Vol#: 9

C 453 David Maciewski Vol#: 9

C 454 Brian MacNaughton Vol#: 9

C 455 Susan D Schwen Vol#: 9

C 456 Mary Gavalis Vol#: 9

C 457 Lee Rodin Vol#: 9

C 458 Liberty Goodwin Vol#: 9

C 459 Michael H Roegner Vol#: 9

C 460 Emily Houston Vol#: 9

C 461 Beulah Clark Vol#: 9

C 462 Claudia Marshall Vol#: 9

C 463 Richard H Conrad PhD Vol#: 9

C 464 Beatrice Roth Vol#: 9

C 465 B Gayle Thompson Vol#: 9

C 466 Jean A Temreine Vol#: 9

C 467 Paul Hover Vol#: 9

C 468 Sallie Bones Vol#: 9

C 469 Carolyn R Whiting Vol#: 9

C 470 Kathleen M Flaherty Vol#: 9

C 471 Joseph W Lyons Vol#: 9

C 472 Carol J L Wilder Vol#: 9

C 473 Donna L Bullock Vol#: 9

C 474 Miriam Stein Vol#: 9

C 475 Jennifer Mulcahy Vol#: 9

C 476 Marce LaCouture Vol#: 9

EC 66 Gloria Jean Pierce Vol#: 9

EC 67 E-The People Vol#: 9

EC 68 Environmental Health Network of Calif Vol#: 9

EC 69 Deborah Swanner Vol#: 9

EC 70 Allen Pretlow Vol#: 9

EC 71 Katherine A Los Vol#: 9

EC 72 Susan Beck Vol#: 9

EC 73 Cree Wisner Vol#: 9

EC 74 Melissa Kaplan Vol#: 9

EC 75 Robert Service Vol#: 9

EC 76 Sandra K DenBraber Vol#: 9

EC 77 Janis Blackburn Vol#: 9

EC 78 Barb Trotter Vol#: 9

EC 79 Mary S Kloss Vol#: 9

EC 80 Beverly A Peterson Vol#: 9

EC 81 Larry Vinson Vol#: 9

EC 82 Jeannette Cabanis-Brewin Vol#: 9

EC 83 Annie Couture Vol#: 9

EC 84 Stuart Kaufman Vol#: 9

EC 85 Nancy Morris Vol#: 9

EC 86 Susan Colletta Vol#: 9

EC 87 Form letter count 12 Vol#: 8

EC 88 Mary Grace Vol#: 9

EC 89 Maggie MacRaven Vol#: 9

EC 90 Jerry Dunlap Vol#: 9

EC 91 Nell Hammond Vol#: 9

EC 92 Sharon Vol#: 9

EC 93 Vee Christodoulou Vol#: 9

EC 94 Ester Ford Vol#: 9

EC 95 Jan Pierce Vol#: 9

EC 96 Donna Marshall Vol#: 9

EC 97 Stedman Vol#: 9

EC 98 Darren Vigil Vol#: 9

EC 99 Beth M Stedman Vol#: 9

EC 100 Craig H Stone Vol#: 9

EC 101 Cynthia Rosenwald Vol#: 9

EC 102 Phoebe Herrin Vol#: 9

EC 103 Mrs B L Wade Vol#: 9

EC 104 Kristin Vinson Vol#: 9

EC 105 Evelyn W Stone Vol#: 9

EC 106 Nancy Manning Vol#: 9

EC 107 Stephanie Vinson Vol#: 9

EC 108 James H Knapp Vol#: 9

EC 109 Donna Rice Vol#: 9

EC 110 Roy & Sylvia Draper Vol#:

EC 111 Royce Berkowitz Vol#: 9

EC 112 Ankara St George Vol#: 9

EC 113 Joycelyn Sanford Vol#: 9

EC 114 Marce LaCouture Vol#: 9

99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast

EMC 1 Form Letter count 6 Vol#: 4

EMC 2 Bill Ravanesi Vol#: 3

99P-2630 Establish a Daily Value for "added sugars"

SUP 2 CSPI Vol#: 6

99P-4932 ANDA Suitability Petitions for Parenteral Drugs

ACK 1 HFA-305 Vol#: 1

CP 1 Hyman, Phelps & McNamara, P.C. Vol#: 1

99V-1630 Laser Light Show

VRA 1 HFZ-300 to Laser Laser Services Vol#: 1

99V-2628

VRA 1 HFZ-300 to Eaton Sales & Marketing Vol#: 1

99V-2906 Mobolaser ML10-200, ML10-300, ML10-300W, ML10-1000, ML10-1.0

VRA 1 HFZ-300 to Core Systems, Inc. Vol#: 1

99V-2974 Projector for Laser Light Show

VRA 1 HFZ-300 to L & L Productions Vol#: 1

99V-3018 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, ML10-2.5

VRA 1 HFZ-300 to Waveland Bowl Vol#: 1

99V-3020 Laser Light Show

VRA 1 HFZ-300 to Patrick AFB Bowling Center Vol#: 1

99V-3080 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, ML10-1.0

VRA 1 HFZ-300 to Doug Vierling Vol#: 1

99V-4002 Laser Light Show

VRA 1 HFZ-300 to P.F. Entertainment, L.L.C. Vol#: 1

99V-4931 Laser Scenic Element

ACK 1 HFA-305 Vol#: 1

VAR 1 Walt Disney Theatrical Productions Vol#: 1