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 Us]

DOCKETS ENTERED on December 7, 2000

TABLE OF CONTENTS

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78N-0038 Sunscreen Drug Products *
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
94F-0405 Safe use of aspartame as general purpose sweetener *
95P-0262 Revise "Approved Drug Products" (known as "Orange Book") *
96P-0317 Consider solid oral dosage form drug products as same dosage *
98D-0814 Good manufacturing practice for blood and blood components *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1400 Reproductive Toxicity Studies preventive vaccines Disease *
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d *
00P-1499 Remove alosetron (Lotronex) from the market *
00P-1655 ANADA Application; Proposed product differ from appoved list *
00P-1657 Request for exemption to allow phrase "may contain" on conta *
78N-0038 Sunscreen Drug Products

ANS 7 CRP2 to Martin A Weinstock MD PhD Vol#: 145

C 588 American Cancer Society Vol#: 145

C 589 American Academy of Dermatology Vol#: 145


92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

CH 10 Kansas Assoc for Medically Underserved Vol#: 6

CH 11 IACP Vol#: 6


94F-0405 Safe use of aspartame as general purpose sweetener

EMC 125 Mike Eastridge Vol#: 4

EMC 126 Donna Bowman Vol#: 4

EMC 127 Pamela S. Patterson Vol#: 4

EMC 128 Robin Vol#: 4

EMC 129 Betty Martini Vol#: 4

EMC 130 Antoinette (South Africa) Vol#: 4

EMC 131 Marlene G. Martin Vol#: 4

EMC 132 Bob Wylie Vol#: 4

EMC 133 Richard T. Murray Vol#: 4

EMC 134 Julie Vol#: 4

EMC 135 Phyllis Vol#: 4

EMC 136 Mary Ann Connolly Vol#: 4

EMC 137 Betty Martini Vol#: 4

EMC 138 Trina Vol#: 4

EMC 139 Bruce & Karyn Vol#: 4

EMC 140 Sherry Molteni Vol#: 4

EMC 141 Karen Vol#: 4

EMC 142 Karen Vol#: 4

EMC 143 Karen Vol#: 4

95P-0262 Revise "Approved Drug Products" (known as "Orange Book")

PDN 1 HFD-1 to Kleinfeld, Kaplan & Becker Vol#: 1


96P-0317 Consider solid oral dosage form drug products as same dosage

PDN 1 HFD-1 to Kleinfeld, Kaplan & Becker Vol#: 1


98D-0814 Good manufacturing practice for blood and blood components

EMC 1 Shaun A Gupta Vol#: 1

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 3173 Form letter count 3 Vol#: 97

C 3174 Form letter count 3 Vol#: 98

C 3175 Joy Ramer Vol#: 99

C 3176 Regina T. Webb Vol#: 99

C 3177 Susan Grace Blandin Vol#: 99

C 3178 L.B. Williams Vol#: 99

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 16713 Ms. Dorothy Krantz Vol#: 483

C 16714 Roger L. Secondine Vol#: 483

C 16715 Florence Bixby Vol#: 483

C 16716 Spirit Parrett Vol#: 483

C 16717 Susan Barrett Vol#: 483

C 16718 Lewis Austin Vol#: 483

C 16719 Carolyn Jesse Vol#: 483

C 16720 Charles Kevin Kinney Vol#: 483

C 16721 Darlene Brown Vol#: 483

C 16722 Maureen M. Christman Vol#: 483

C 16723 E. Affeldt Vol#: 483

C 16724 Grace Eileen Klotz Vol#: 483

C 16725 Catherine Schumacher Vol#: 483

C 16726 Mark Stutler Vol#: 483

C 16727 Leo R. LaBelle Vol#: 483

C 16728 Maria Krncevic Vol#: 483

C 16729 W. Donald Shirk Vol#: 483

C 16730 Sally Barrett Vol#: 483

C 16731 Kitty Li Vol#: 483

C 16732 Eileen Ambos Vol#: 483

C 16733 Stephen & Patti Graves Vol#: 483

C 16734 Sharon Dean Vol#: 483

C 16735 Amy E. Mitries Vol#: 483

C 16736 Ruth S. Allen Vol#: 483

C 16737 H. E. Frost Vol#: 483

C 16738 Marvin D. Arnold Vol#: 483

C 16739 Mr & Mrs Clarence Duesing Vol#: 483

C 16740 Melba Wolff Vol#: 483

C 16741 Lindsay MacDonald Vol#: 483

C 16742 Noel Taylor Vol#: 483

C 16743 Germane Drake Vol#: 483

C 16744 Hugh & Joan Sauer Vol#: 483

C 16745 Alfred Ritter Vol#: 483

C 16746 John C. Curley Vol#: 485

C 16747 Paul M. Lozano Vol#: 485

C 16748 Donna Gaines-Nulton Vol#: 485

C 16749 Barbara Knise Vol#: 485

C 16750 Brenda Mezick Vol#: 485

C 16751 Lee A. Althen Vol#: 485

C 16752 Mrs. Marjorie Beck Vol#: 485

C 16753 Andy & Ellinor Waldner Vol#: 485

C 16754 Irene Lattanzio Vol#: 485

C 16755 Jerrie Mershon Vol#: 485

C 16756 Anita Margolis Vol#: 485

C 16757 Jennifer Hollihan Vol#: 485

C 16758 Sandra Oslin & Michele Flynn Vol#: 485

C 16759 Meriom Kastner Vol#: 485

C 16760 S. Lasbe Vol#: 485

C 16761 Gary & Joyce Reid Vol#: 485

C 16762 Marie-Christine T. Babeluck Vol#: 485

C 16763 Charles J. Cada Vol#: 485

C 16764 Jill Potratz Vol#: 485

C 16765 Margaret Roeltgen Vol#: 485

C 16766 Edith Marie Pernice Vol#: 485

C 16767 Debra Hicks Vol#: 485

C 16768 Frank & Mary Kaderabek Vol#: 485

C 16769 Mr & Mrs Robert Burns Vol#: 485

C 16770 Richard A. Feldman Vol#: 485

C 16771 Claudia Case Vol#: 485

C 16772 Sheila Pardy Vol#: 485

C 16773 Crystal Moore Vol#: 485

C 16774 Diann Radmacher Vol#: 485

C 16775 Rob Hess Vol#: 485

C 16776 Nancy Brown Vol#: 485

C 16777 Woodrow Atchison Vol#: 485

C 16778 Susan J. Kramer Vol#: 485

C 16779 Rev. J. Colby Adams Vol#: 485

C 16780 James M. Sheats, Jr. Vol#: 485

C 16781 Cheryl Blake Vol#: 485

C 16782 Elizabeth B. Thompson Vol#: 485

C 16783 Julie Tortora Vol#: 485

C 16784 Sik-Chen Leung Vol#: 485

C 16785 Shannon Nelson Vol#: 485

C 16786 Ron Cox Vol#: 485

C 16787 Robert G. Jeman Vol#: 485

C 16788 Mary Kathryn Fuerch Vol#: 485

C 16789 James P. Murray Vol#: 485

C 16790 Holly Vanderbilt Vol#: 485

C 16791 Jesse & Clarissa James Vol#: 485

C 16792 Gary A. C. Young Vol#: 485

C 16793 J. P. Forkner Vol#: 485

C 16794 Jorqe Conoe Vol#: 485

C 16795 Joseph Downs Vol#: 485

C 16796 Robert & Dorothy Pogprelc Vol#: 485

C 16797 Mrs. E.W.M. Beiferman-Haines Vol#: 485

C 16798 Phyllis Koster Vol#: 485

C 16799 Regina B. Cross Vol#: 485

C 16800 Wanda Peck Vol#: 485

C 16801 Susan Berger Vol#: 485

EMC 3317 Kimberle Ganzer Vol#: 485

EMC 3318 Concerned Citizen Vol#: 485

EMC 3319 Suzanne Friesen Vol#: 485

EMC 3320 Josh Vol#: 485

00D-1400 Reproductive Toxicity Studies preventive vaccines Disease

C 1 Merck & Co., Inc. Vol#: 1

C 2 Bristol-Myers Squibb Pharm. Research Ins Vol#: 1

C 3 SmithKline Beecham Pharmaceuticals Vol#: 1

00M-1640 Nidek EC-5000 Excimer Laser System

AAV 1 Nidek Technologies, Inc. Vol#: 1

00M-1649 P000018 - Novoste Beta-Cath System

AAV 1 Noveste Corp. Vol#: 1

00M-1650 Cordis Checkmate System

AAV 1 Cordis Corporation Vol#: 1

00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

C 10 Traco Labs Inc Vol#: 12

C 11 McGill Vol#: 12

C 12 McNeil Consumer Healthcare Vol#: 12

EMC 3 CSPI Vol#: 12

00P-1276 Health Claim: Plant stanol esters and heart disease

C 12 Traco Labs Inc Vol#: 11

C 13 McGill Vol#: 11

C 14 McNeil Consumer Healthcare Vol#: 11

EMC 3 CSPI Vol#: 11

00P-1499 Remove alosetron (Lotronex) from the market

EMC 181 Kenneth Sullivan Vol#: 2

EMC 182 Kenneth Sullivan Vol#: 2


00P-1655 ANADA Application; Proposed product differ from appoved list

ACK 1 HFA-305 Vol#: 1

CP 1 HighlandVet-Pharma LLC Vol#: 1


00P-1657 Request for exemption to allow phrase "may contain" on conta

ACK 1 HFA-305 Vol#: 1

CP 1 Cintas Corp. Vol#: 1

00V-1656 Application for transfer of variance for laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Russell C Davis Planetarium Vol#: 1