Food and Drug Administration

DOCKETS ENTERED on June 8, 1999

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

92N-0139 Statement Policy: Foods Derived from New Plant Varieties
96P-0106 Prevent Outbreak of Bovine Spongiform Encephalopathy (BSE)
98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;
98N-1170 Sunlamp Products Performance Standard
98N-1265 Distribution of Compounded Drug Products
98P-0203 Eliminate Forced Molting of Laying Birds
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
99D-0557 Use of Nonhuman Primate Xenografts in Humans
99F-0719 Safe use Olestra in place of Fats and Oils in Prepackaged
99M-1696 NIR ON Ranger w/SOX & NIR ON Ranger Premounted Stent Sys
99N-0438 Contamination ready-to-eat foods associated food prepartion
99N-1076 Foodborne Listeria Monocytogenes comments/scientific data
99N-1174 Development of Strategy for Dietary Supplements
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99V-1795 Laser Light Show ML10-106,ML10-2.5 & Image-40

TOP

92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5383 Margery A Zwiebel Vol#: 99

C 5384 Cheryl Brown Vol#: 99

C 5385 Cheryl Naperala Vol#: 99

C 5386 Cynthia English Vol#: 99

C 5387 Fumi Schmidt Vol#: 99

C 5388 Catherine Russell Vol#: 99

C 5389 Richard Jehn Vol#: 99

C 5390 Mary Ann Boyce Vol#: 99

C 5391 Marsha Kully Vol#: 99

C 5392 Barbara Olm Vol#: 99

C 5393 Mary Ann R Unger Vol#: 99

C 5394 Richard T Murray Vol#: 99

C 5395 Judy Mahar Vol#: 99

C 5396 Pat Duncan Taylor Vol#: 99

C 5397 Virginia K Adams Vol#: 99

C 5398 Susan Vol#: 99

C 5399 Goldyn Summitt Vol#: 99

C 5400 Lorraine E Gersic Vol#: 99

C 5401 Patricia Bower Vol#: 99

C 5402 Robin Vol#: 99

C 5403 Ken Woody Vol#: 99

C 5404 Edward M Berridge Vol#: 99

C 5405 Robin R Nicely Vol#: 99

C 5406 Gayle Koehler Vol#: 99

C 5407 Sean Dockery Vol#: 99

C 5408 Judy Blake Vol#: 99

C 5409 Cheri Casciola Vol#: 99

C 5410 JT Adams Vol#: 99

C 5411 Wm Alobar Greywalker Vol#: 99

C 5412 Joseph Schneider Vol#: 99

C 5413 Toni Clark Vol#: 99

C 5414 Mary Dyer Vol#: 99

C 5415 Cleo Ware Vol#: 99

C 5416 Terry Neal Vol#: 99

C 5417 Joy Sparandera Vol#: 99

C 5418 Dr John Metzger Vol#: 99

C 5419 Rebecca Sidebotham Vol#: 99

C 5420 Karen S King Vol#: 99

C 5421 Penni Palthe Vol#: 99

C 5422 Peter Bowerman Vol#: 99

C 5423 Mary M Bonds Vol#: 99

C 5424 Carolyn Clark Vol#: 99

C 5425 Edward T Ramsey Vol#: 99

C 5426 Carole R Prism Vol#: 99

C 5427 Sandy Zeldes Vol#: 99

C 5428 Debora Thompson Vol#: 99

C 5429 Ed Buryn Vol#: 99

C 5430 Elly McCue Vol#: 99

C 5431 Clare Ritchie Vol#: 99

C 5432 Joan Helen Hubert Vol#: 99

C 5433 James K Freda Vol#: 99

C 5434 Dali Moyzes Vol#: 99

C 5435 Gwynne McLauglin Vol#: 99

C 5436 Bobbie Duffy Vol#: 99

C 5437 Andrea Press Vol#: 99

C 5438 Kelt Kinnick Vol#: 99

C 5439 Patrick Arakel Vol#: 99

C 5440 Patricia Coyne Vol#: 99

C 5441 Cindy Cole Vol#: 99

C 5442 Donna Watkins Vol#: 99

C 5443 Kimberle Ganzer Vol#: 99

C 5444 Cheri Bohman Vol#: 99

C 5445 Jordyn M Bonds Vol#: 99

C 5446 Laurel Hopwood Vol#: 99

C 5447 Richard & Joyce Kinmont Vol#: 99

C 5448 Unsigned Vol#: 99

C 5449 Jacqueline Wayman Vol#: 99

C 5450 Louis Blois Vol#: 99

C 5451 Jan Morgan Vol#: 99

C 5452 William J Boerst Vol#: 99

C 5453 Melba F Martinez Vol#: 99

C 5454 Jennifer H Dennis Vol#: 99

C 5455 Earl C Dennis Vol#: 99

C 5456 Wava J Gorton Vol#: 99

C 5457 Mona & Yardumian & Jack Manno Vol#: 99

C 5458 Elena Carignan Vol#: 99

C 5459 Linda Way Vol#: 99

C 5460 Scott & Kathy Luckey Vol#: 99

C 5461 Charlotte Mulder Vol#: 99

C 5462 Margaret Little Vol#: 99

C 5463 Concerned Human Vol#: 99

C 5464 Marc Spess Vol#: 99

C 5465 Carolyn Bamberger Vol#: 99

C 5466 Taran Singleton Vol#: 99

C 5467 Cynthia Mantel & Serge Bisson Vol#: 99

C 5468 Marcia E Herman-Giddens Vol#: 99

C 5469 Michael Stoick Vol#: 99

C 5470 James Wade Vol#: 99

C 5471 Delores Charboneau Vol#: 99

C 5472 Mike Williamson Vol#: 99

C 5473 Susan Carey Vol#: 99

C 5474 Max Goodspeed Vol#: 99

C 5475 Andrew & Susan Davenport Vol#: 99

C 5476 Janet Gerta Vol#: 99

C 5477 Constance Gravestock Vol#: 99

C 5478 Susan A Molenda Vol#: 99

C 5479 Beverly Jambois Vol#: 99

C 5480 Tracia Wilson Vol#: 99

C 5481 Denis Brown Vol#: 99

C 5482 Richard Cicchetti Vol#: 99

C 5483 Susan Freeman Vol#: 99

C 5484 Jill Davies Vol#: 99

C 5485 Sharron Cordaro Vol#: 99

C 5486 Sherry Halsey Vol#: 99

C 5487 Daniel M Karan Vol#: 99

C 5488 Mark Juhl Vol#: 99

C 5489 Richard Schwartz Vol#: 99

C 5490 Sonja Ralls Vol#: 99

C 5491 Marcus Farhood Vol#: 99

C 5492 Margo Johnson Vol#: 99

C 5493 Willaim Conboy Vol#: 99

C 5494 John Eaton & Sandi Hefner Vol#: 99

C 5495 Michael Polzin Vol#: 99

C 5496 Wendy Foster Vol#: 99

C 5497 James Paul Brown Vol#: 99

C 5498 Jenny L Brown Vol#: 99

C 5499 Miriam & James Watkins Vol#: 99

C 5500 Jim Walls Vol#: 99

C 5501 Jennifer Miller Vol#: 99

C 5502 Nelle Tobias Vol#: 99

C 5503 Marian & Jerry Gumbleton Vol#: 99

TOP

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

LST 44 List as of May 26, 1999 Vol#: 3

TOP

96P-0106 Prevent Outbreak of Bovine Spongiform Encephalopathy (BSE)

C 8 Maryanna Brown Vol#: 1

TOP

98H-1115 Civil Money Penalties;Milo Jackson,d/b/a MJ's Corner Store

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

98H-1261 Civil Money Penalties;Timothy Terrell,d/b/a Twin Roads Foodm

CS 2 HFA-305 Vol#: 1

OR 2 HF-3 Vol#: 1

TOP

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 128 Roxanne Scott Vol#: 19

TOP

98N-1170 Sunlamp Products Performance Standard

C 9 Wolff System Technology Corporation Vol#: 1

TOP

98N-1265 Distribution of Compounded Drug Products

C 3182 Peggy A. Marsell Vol#: 113

C 3183 Peter Johnson Vol#: 113

C 3184 Sandra K. Johnson Vol#: 113

C 3185 John A. Keenan Vol#: 113

C 3186 Deborah A. Peters Vol#: 113

C 3187 Barbara Anderson Vol#: 113

C 3188 Mary B. Knox Vol#: 113

C 3189 Lorraine Dale Marsh Vol#: 113

C 3190 Joyce Malerba-Goldstein Vol#: 113

C 3191 Guyla Kaye Barrett Vol#: 113

C 3192 Suzanne Schwimmer Vol#: 113

C 3193 Camilla T. Bishop Vol#: 113

TOP

98P-0203 Eliminate Forced Molting of Laying Birds

C 1538 Ziggie Swan Vol#: 35

C 1539 Irving Applebaum Vol#: 35

C 1540 Franque O'Hara Vol#: 35

C 1541 Mindy B Rogovin Vol#: 35

C 1542 Bonnie Hardy Vol#: 35

C 1543 Amy Cyr Vol#: 35

C 1544 Edward Butler Vol#: 35

C 1545 Cherie Bracewell Vol#: 35

C 1546 Jill M Biedka et al Vol#: 35

C 1547 Sister Madeline Clifton Vol#: 35

C 1548 Ms Regina Wright Vol#: 35

C 1549 Ms Joan M Weichmann Vol#: 35

C 1550 Glenda Spivey Vol#: 35

C 1551 Ms Linda Bastron Vol#: 35

C 1552 Sarah Bartley Vol#: 35

C 1553 Mrs Joan Verner Vol#: 35

C 1554 Ms Jean Lauren Vol#: 35

C 1555 Jennifer L Savage Vol#: 35

C 1556 Joyce Ritchie Vol#: 35

C 1557 Bryan & Carla Wilson Vol#: 35

TOP

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 141 Andrew Colucci Vol#: 3

C 142 P C Wuigryn Vol#: 3

C 143 Mrs Joan H Werner Vol#: 3

C 144 Jane Olsen Vol#: 3

C 145 C. W. Smith Vol#: 3

TOP

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 19 Ms Martine Sankari Vol#: 1

C 20 Jane Katz Vol#: 1

TOP

99F-0719 Safe use Olestra in place of Fats and Oils in Prepackaged

C 1 Evelyn Barnhill Vol#: 1

TOP

99H-1587 Civil Money Penalty;Wiste's Food Market Inc dba Wiste's Food

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1618 R L Jordan Oil Co of Georgia Inc dba Hot Spot

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1619 Civil Money Penalty; Del Goebel dba G & S Gas

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1620 Civil Money Penalty; Gewinner's Tom-Boy Supermarket Inc dba

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1621 Civil Money Penalty; Eckerd Corp dba Eckerd Drug #8236

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1622 Civil Money Penalty; Mary Corder dba 7-Eleven

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1623 Civil Money Penalty; Hackney Petroleum Inc dba Hackney Amoco

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1624 Civil Money Penalty; Willis Fjerstad dba Needles Country Sto

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1625 Civil Money Penalty; Rogers Petroleum Inc dba Solway Zoomerz

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1626 Civil Money Penalty; Circle K Stores Inc dba Circle K Food S

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1627 Civil Money Penalty; Dan Wilcox & Abby Renollet dba Viking B

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1628 Civil Money Penalty; FS Energy Fuel 24 LLC dba FS Fast Stop

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1629 Civil Money Penalty; Roger Todar & Diane Todar dba Christina

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

TOP

99M-1696 NIR ON Ranger w/SOX & NIR ON Ranger Premounted Stent Sys

AAV 1 Boston Scientific Corporation Vol#: 1

TOP

99N-0438 Contamination ready-to-eat foods associated food prepartion

C 10 Center for Science in the Public Interes Vol#: 1

TOP

99N-0554 Public meeting/health & nutrient content claims in food lab

C 14 American Medical Women's Association Vol#: 2

TOP

99N-1076 Foodborne Listeria Monocytogenes comments/scientific data

TS 1 NACMF Vol#: 2

TOP

99N-1174 Development of Strategy for Dietary Supplements

C 8 Association of Food & Drug Officials Vol#: 1

TOP

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 852 Joyce Frohn Vol#: 10

C 853 Evelyn V. Knayle Vol#: 10

C 854 Marilyn & William Harner Vol#: 10

C 855 Joan Bonagura Vol#: 10

C 856 Elsa M. Luker Vol#: 10

C 857 Gilbert K. Hardacre Vol#: 10

C 858 Kathryn S. Sawyer Vol#: 10

C 859 Robert Lockhart Vol#: 10

C 860 W. Gertrude Josendal Vol#: 10

TOP

99V-1795 Laser Light Show ML10-106,ML10-2.5 & Image-40

VAR 1 Dynamite Sound & Light Vol#: 1

TOP