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 October 6, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
77N-0240 Single-Entity Coronary Vasodilators *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97N-0511 Procedures the safe and sanitary processing/importing juice *
97P-0197 Require that warning labels about risks of salmonella *
98N-0313 Sugeons's and Patient Examination Gloves Reclassification *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
98P-0509 Refrain from Destroying Dietary Supp. Co Publications *
98P-0696 Require Food Labels to Disclose All Ingredients *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-2013 Cooperative Manufacturing Arrangements for Licensed *
99N-1591 Animal Drug Availabililty Act; Veterinary Feed Directive *
99N-2874 Stakeholders input under FDA Modernization Act of 1997 *
99N-3089 Draft Affirmative Agenda for International Activities *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-2630 Establish a Daily Value for "added sugars" *
99V-4322 Laser Light Show in Big Bang Theater, Am Museum of Nat Hist *
99V-4323 Laser Light Show in Space Theater, Am Museum of Nat Hist *
77N-0240 Single-Entity Coronary Vasodilators

SUP 32 Hercon Laboratories Corporation Vol#: 32

80N-0295 OTC drug review policy statement

MM 119 FDA/OTC & Warner-Lambert Company Vol#: 3

87F-0179 Sucrose polyester as replacement for fats & oil in food

RPT 3 Procter & Gamble Vol#: 39

96N-0417 CGMP in Packing or Holding Dietary Supplements

C 92 The Green Turtle Bay Vitamin Co., Inc Vol#: 3

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

C 444 Carol Lawrence Vol#: 17

C 445 VIVA, Vegetarians Intl. Voice for Animal Vol#: 17

C 446 Glenn McKinney Vol#: 17

C 447 Teresa G. Rojas Vol#: 17

C 448 William John Divney Vol#: 17

C 449 Steven D. Gruber Vol#: 17

C 450 Michele Malchisky Vol#: 17

C 451 Anthony Ficcio Vol#: 17

C 452 Katherine Najwer-Coyle Vol#: 17

C 453 Constance Dutton Vol#: 17

C 454 Jean Allison Thaler Vol#: 17

C 455 Gail Hale Vol#: 17

C 456 Carmen Arreola Vol#: 17

C 457 A. Tad Chamberlain Vol#: 17

C 458 Stephanie Schueler, P.E. Vol#: 17

C 459 Carolyn Long Vol#: 17

C 460 Marillyn George Vol#: 17

C 461 Myrna Lefferts & Mitchell Kalish Vol#: 17

C 462 Diana M. Burkley Vol#: 17

C 463 Linda Howe Vol#: 17

C 464 Denise Hall Vol#: 17

C 465 Sharon D. Krueger Vol#: 17

C 466 Michael S. Fenton Vol#: 17

C 467 Berniece Bear Vol#: 17

C 468 Voices for Animals Vol#: 17

C 469 Shawna Hurley Vol#: 17

C 470 Sarah Moran Vol#: 17

C 471 Country Roads Animal Sanctuary Vol#: 17

C 472 Elissa Ball Vol#: 17

C 473 Deva Joy Gouss, MSW, PC Vol#: 18

C 474 E. J. Sullivan Vol#: 18

C 475 Judy Libbey Vol#: 18

C 476 Jill Myers Vol#: 18

C 477 Kristina R. Cahill & Michael Wiesmeier Vol#: 18

C 478 Jan van Wyck Vol#: 18

C 479 Vicky Barbee Vol#: 18

C 480 Association of Food & Drug Officials Vol#: 16

C 481 Lu Haner Vol#: 18

C 482 Liz Knowles, Ed.D. Vol#: 18

C 483 Christine M. Brown Vol#: 18

C 484 Susan Kline Vol#: 18

C 485 Jackie Simonss Vol#: 18

C 486 Nancy Tucholski Vol#: 18

C 487 Stephan D. Hurlburt Vol#: 18

C 488 Jennifer Vaughan Paquette Vol#: 18

C 489 Melvin S. Vol#: 18

C 490 Jessica Grodio Vol#: 18

C 491 Lynn Strother Hinkle Vol#: 18

C 492 Concerned People For Animals, Inc. Vol#: 18

C 493 Joan Mahanke Vol#: 18

C 494 Patricia A. Lopez Vol#: 18

C 495 Joe Haptas Vol#: 18

C 496 Kelly Beard-Tittone Vol#: 18

C 497 Paula N. Tice Vol#: 18

C 498 Ms. Betty J. Herner Vol#: 18

C 499 Robin Jacobson Vol#: 18

C 500 Catalina Kidd Vol#: 18

C 501 Sira Melikian Vol#: 18

C 502 Beauty Without Cruelty U.S.A. Vol#: 18

C 503 Carol A. Lawson Vol#: 19

C 504 Carleen Peitzmeyer Vol#: 19

C 505 American Cannabis Society Vol#: 19

C 506 Bonnie Lynn Comstock Vol#: 19

C 507 Jane DiRico Vol#: 19

C 508 Marian A. Kelner Vol#: 19

LET 3 Commonwealth of Pennsylvania Vol#: 18

97N-0074 President's National Food Safety Initiative

C 112 ISDC Vol#: 10

C 113 Michelle Walleston Vol#: 10

C 114 Susan Brumbelow Vol#: 10

97N-0511 Procedures the safe and sanitary processing/importing juice

MM 2 FDA & Industry/Academia/Fresh Juice Ind Vol#: 13

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

Following duplicates linked comments in 96P-0418 above

C 445 Carol Lawrence Vol#: 16

C 446 VIVA, Vegetarians Intl. Voice for Animal Vol#: 16

C 447 Glenn McKinney Vol#: 16

C 448 Teresa G. Rojas Vol#: 16

C 449 William John Divney Vol#: 16

C 450 Steven D. Gruber Vol#: 16

C 451 Michele Malchisky Vol#: 16

C 452 Anthony Ficcio Vol#: 16

C 453 Katherine Najwer-Coyle Vol#: 16

C 454 Constance Dutton Vol#: 16

C 455 Jean Allison Thaler Vol#: 16

C 456 Gail Hale Vol#: 16

C 457 Carmen Arreola Vol#: 16

C 458 A. Tad Chamberlain Vol#: 16

C 459 Stephanie Schueler, P.E. Vol#: 16

C 460 Carolyn Long Vol#: 16

C 461 Marillyn George Vol#: 16

C 462 Myrna Lefferts & Mitchell Kalish Vol#: 16

C 463 Diana M. Burkley Vol#: 16

C 464 Linda Howe Vol#: 16

C 465 Denise Hall Vol#: 16

C 466 Sharon D. Krueger Vol#: 16

C 467 Michael S. Fenton Vol#: 16

C 468 Berniece Bear Vol#: 16

C 469 Voices for Animals Vol#: 16

C 470 Shawna Hurley Vol#: 16

C 471 Sarah Moran Vol#: 16

C 472 Country Roads Animal Sanctuary Vol#: 16

C 473 Elissa Ball Vol#: 16

C 474 Deva Joy Gouss, MSW, PC Vol#: 17

C 475 E. J. Sullivan Vol#: 17

C 476 Judy Libbey Vol#: 17

C 477 Jill Myers Vol#: 17

C 478 Kristina R. Cahill & Michael Wiesmeier Vol#: 17

C 479 Jan van Wyck Vol#: 17

C 480 Vicky Barbee Vol#: 17

C 481 Association of Food & Drug Officials Vol#: 17

C 482 Lu Haner Vol#: 17

C 483 Liz Knowles, Ed.D. Vol#: 17

C 484 Christine M. Brown Vol#: 17

C 485 Susan Kline Vol#: 17

C 486 Jackie Simonss Vol#: 17

C 487 Nancy Tucholski Vol#: 17

C 488 Stephan D. Hurlburt Vol#: 17

C 489 Jennifer Vaughan Paquette Vol#: 17

C 490 Melvin S. Vol#: 17

C 491 Jessica Grodio Vol#: 17

C 492 Lynn Strother Hinkle Vol#: 17

C 493 Concerned People For Animals, Inc. Vol#: 17

C 494 Joan Mahanke Vol#: 17

C 495 Patricia A. Lopez Vol#: 17

C 496 Joe Haptas Vol#: 17

C 497 Kelly Beard-Tittone Vol#: 17

C 498 Paula N. Tice Vol#: 17

C 499 Ms. Betty J. Herner Vol#: 17

C 500 Robin Jacobson Vol#: 17

C 501 Catalina Kidd Vol#: 17

C 502 Sira Melikian Vol#: 17

C 503 Beauty Without Cruelty U.S.A. Vol#: 17

C 504 Carol A. Lawson Vol#: 18

C 505 Carleen Peitzmeyer Vol#: 18

C 506 American Cannabis Society Vol#: 18

C 507 Bonnie Lynn Comstock Vol#: 18

C 508 Jane DiRico Vol#: 18

C 509 Marian A. Kelner Vol#: 18

LET 2 Commonwealth of Pennsylvania Vol#: 17

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

C 4 Medical College of Wisconsin Vol#: 5

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

C 24 The Society of the Plastics Industry Inc Vol#: 1

C 25 American Veterinary Medical Association Vol#: 1

C 26 Association of Food & Drug Officials Vol#: 1

C 27 International Jelly & Preserve Associati Vol#: 1

C 28 Association for Dressings & Sauces Vol#: 1

C 29 Food Marketing Institute Vol#: 1

C 30 United Egg Producers Vol#: 1

C 31 CTFA Vol#: 1

C 32 ConAgra Inc Vol#: 1

C 33 NFPA, National Food Processors Associati Vol#: 1

C 34 Enzyme Technical Association Vol#: 1

C 35 GMA Vol#: 1

C 36 Compliance Control Inc Vol#: 1

C 37 Consumer Healthcare Products Association Vol#: 1

C 38 Council for Responsible Nutrition Vol#: 1

EXT 2 American Herbal Products Association Vol#: 1

98P-0509 Refrain from Destroying Dietary Supp. Co Publications

EC 1 L. Robert Vol#: 5

98P-0696 Require Food Labels to Disclose All Ingredients

C 6 Susan Farinacci Vol#: 1

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

EC 1 Carole Williamson Vol#: 18

EC 2 Joan Meinecke Vol#: 18

EC 3 D. Medina Vol#: 18

EC 4 Paul Palmer, PhD Vol#: 18

99D-2013 Cooperative Manufacturing Arrangements for Licensed

C 3 San Diego Blood Bank Vol#: 1

99H-0365 Civil Money Penalty; WW & DR Inc d/b/a/ Hole in the Wall Gro

CS 2 HFA-305 Vol#: 1

99H-4016 Civil Money Penalty;Lane's Fast Lub Inc,dba Lane's Fast Lube

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4017 Civil Money Penalty;Kenneth D Leak,dba Leak's Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4018 Civil Money Penalty;S G R Inc, dba Gibbons Package Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4019 Civil Money Penalty;Short Stop Inc,dba, Highway 51 Chevron

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4020 Civil Money Penalty; TPI Petroleum Inc,dba Total Petroleum

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4021 Civil Money Penalty;Turnpike Market Inc,dba Turnpike Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4022 Civil Money Penalty;Ultramar Diamond Shamrock Corp,dba Diamo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4023 Civil Money Penalty;VAS Inc,dba Augusta Liquor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4024 Civil Money Penalty;VMM & Associates Inc,dba Stevenson Crown

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4025 Civil Money Penalty;Walgreen Drug Store #356

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4026 Civil Money Penalty;Walgreen Co,dba Walgreens Drug Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4055 Civil Money Penalty;Duggan Petroleum Co,dba Duggan Petroleum

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4056 Civil Money Penalty;Git-N-Go Convenience Stores Inc,dba Git-

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4057 Civil Money Penalty;Kenneth W Lazenby Trust,dba Bill & Tony

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4058 Civil Money Penalty;Little's Super Market Inc,dba Little's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

NPH 2 HHS/FDA/CDER Vol#: 1

99H-4059 Civil Money Penalty;Quiktrip Corporation,dba Quiktrip #535

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4060 Civil Money Penalty;Tom & Jerry's Quick Stop Inc,dba Tom &

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4061 Civil Money Penalty; U-City Quality Foods, Inc,dba U-City

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4062 Civil Money Penalty;Williams Express Inc,dba Williams Expres

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-1591 Animal Drug Availabililty Act; Veterinary Feed Directive

C 7 American Assn of Swine Practitioners Vol#: 1

99N-2874 Stakeholders input under FDA Modernization Act of 1997

C 1 Medical Device Manufacturers Assn Vol#: 1

99N-3089 Draft Affirmative Agenda for International Activities

C 1 Center for Science in the Pubic Interest Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1649 Tina Gilliam Vol#: 137

C 1650 Lavon Gentry Vol#: 137

C 1651 Davis & Barbara Bell Vol#: 137

C 1652 Gerald A Jayne Vol#: 137

C 1653 KAI Environmental Committee Vol#: 137

C 1654 Dennis Hicks & Stephanie Waxman Vol#: 137

C 1655 Alan Sahm Vol#: 137

C 1656 Steve Cabakoff Vol#: 137

C 1657 Louin Grenk Vol#: 137

C 1658 Keith MacDonald Vol#: 137

C 1659 Bonnie Edwards Vol#: 138

C 1660 Anne Hudes & Stephen Ajay Vol#: 137

C 1661 Nancy W Sommer Vol#: 137

C 1662 Patrice Mawhinney Vol#: 137

C 1663 Form Letter count 114 Vol#: 163

C 1664 Form letter count 29 Vol#: 164

C 1665 Mary A Rubach Vol#: 137

C 1666 Joan Linney Vol#: 137

C 1667 Joanne Rovno Vol#: 137

C 1668 Gregory & Edna Armstrong Vol#: 137

C 1669 Donita L Robinson Vol#: 137

C 1670 Margaret Coakley Vol#: 137

C 1671 Ward Stalnaker Vol#: 137

C 1672 A C Barbee Vol#: 137

C 1673 Aimee Marciniak Vol#: 137

C 1674 Daniel Krag MD Vol#: 137

C 1675 Cliff Gilbert Vol#: 137

C 1676 James Taylor Vol#: 137

C 1677 Heather L Best Vol#: 137

C 1678 Ted Brandon Vol#: 137

C 1679 P A Hollander Vol#: 137

C 1680 Constantina Economou Vol#: 137

C 1681 Jennifer Schnakenberg Vol#: 137

C 1682 Arlo L Peterson Vol#: 137

99P-1340 Declared Eternity eau de Parfum Misbranded

C 334 Ken Dunn Vol#: 6

C 335 F. Steven Chalmers Vol#: 6

C 336 League of Women Voters Vol#: 6

C 337 Gail Pierce Vol#: 6

C 338 Paula G. Davey Vol#: 6

C 339 Charles Kasler Vol#: 6

EC 45 Michael Cichorski Vol#: 6

EC 46 Neal Bolton Vol#: 6

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

EC 4 Gordon Indya Vol#: 1

EC 5 Richard Hoenig Vol#: 1

99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease

C 177 Form Letter count 39 Vol#: 7

99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia

C 176 Form Letter count 39 Vol#: 6

99V-4322 Laser Light Show in Big Bang Theater, Am Museum of Nat Hist

ACK 1 HFA-305 Vol#: 1

VAR 1 American Museum of Natural History Vol#: 1

99V-4323 Laser Light Show in Space Theater, Am Museum of Nat Hist

ACK 1 HFA-305 Vol#: 1

VAR 1 American Museum of Natural History Vol#: 1