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 September 20, 2000

TABLE OF CONTENTS

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95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
96D-0009 Impurities in new drug products guideline *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
00D-1306 Content & Format of Prescription Drug Labeling *
00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment *
00P-1227 Amend Statements Made for Dietary Supplements *
00V-1490 Laser Light Show *
00V-1509 *

91G-0253 Affirmation of GRAS Status for Caprenin

NWL 1 Vol#: 1

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 75 NOW Vol#: 41

RPT 76 Iwade Research Institute of Mycology Co Vol#: 48

96D-0009 Impurities in new drug products guideline

C 5 Abbott Laboratories Vol#: 1

C 6 Boehringer Ingelheim Pharm Inc Vol#: 1

C 7 IAGIM Vol#: 1

C 8 Pharmacia Vol#: 1

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 5667 NBTY Inc. Vol#: 45

LET 5668 NBTY Inc. Vol#: 45

LET 5669 NBTY Inc. Vol#: 45

LET 5670 NBTY Inc. Vol#: 45

LET 5671 NBTY Inc. Vol#: 45

LET 5672 NBTY Inc. Vol#: 45

LET 5673 NBTY Inc. Vol#: 45

LET 5674 NBTY Inc. Vol#: 45

LET 5675 NBTY Inc. Vol#: 45

LET 5676 NBTY Inc. Vol#: 45

LET 5677 Biocodex, Inc. Vol#: 45

LET 5678 Solgar Vitamin & Herb Vol#: 45

LET 5679 Whitehall-Robins Healthcare Vol#: 45

LET 5680 Cyanotech Corporation Vol#: 45

LET 5681 Reliance Vitamin Company, Inc. Vol#: 45

LET 5682 Strictly Supplements, Inc. Vol#: 45

LET 5683 NOW Vol#: 45

LET 5684 Nature's Life Vol#: 45

LET 5685 Novogen Vol#: 45

LET 5686 Natures Answer Vol#: 45

LET 5687 Twin Laboratories, Inc. Vol#: 45

LET 5688 Twin Laboratories, Inc. Vol#: 45

LET 5689 Twin Laboratories, Inc. Vol#: 45

LET 5690 Twin Laboratories, Inc. Vol#: 45

LET 5691 Nutritional Specialties, Inc. Vol#: 45

LET 5692 Nutritional Specialties, Inc. Vol#: 45

LET 5693 Bioenergy Nutrients Vol#: 45

LET 5694 Bioenergy Nutrients Vol#: 45

LET 5695 Bioenergy Nutrients Vol#: 45

LET 5696 Bioenergy Nutrients Vol#: 45

LET 5697 Bioenergy Nutrients Vol#: 45

LET 5698 Bioenergy Nutrients Vol#: 45

LET 5699 Bioenergy Nutrients Vol#: 45

LET 5700 Bioenergy Nutrients Vol#: 45

LET 5701 Bioenergy Nutrients Vol#: 45

LET 5702 Bioenergy Nutrients Vol#: 45

LET 5703 Bioenergy Nutrients Vol#: 45

LET 5704 Bioenergy Nutrients Vol#: 45

LET 5705 XetaPharm, Inc. Vol#: 45

LET 5706 DMD Pharmaceuticals Vol#: 45

LET 5707 Bay To Bay Distribution, Inc. Vol#: 45

LET 5708 The Winning Combination Vol#: 45

LET 5709 EcoNutrients/Natural Prevention Vol#: 45

LET 5710 Wind River Herbs Vol#: 45

LET 5711 Wind River Herbs Vol#: 45

LET 5712 Wind River Herbs Vol#: 45

LET 5713 Wind River Herbs Vol#: 45

LET 5714 Wind River Herbs Vol#: 45

LET 5715 Wind River Herbs Vol#: 45

LET 5716 Wind River Herbs Vol#: 45

LET 5717 Wind River Herbs Vol#: 45

LET 5718 Wind River Herbs Vol#: 45

LET 5719 Wind River Herbs Vol#: 45

LET 5720 Wind River Herbs Vol#: 45

LET 5721 Wind River Herbs Vol#: 45

LET 5722 Wind River Herbs Vol#: 45

LET 5723 Wind River Herbs Vol#: 45

LET 5724 Wind River Herbs Vol#: 45

LET 5725 Wind River Herbs Vol#: 45

LET 5726 Wind River Herbs Vol#: 45

LET 5727 Wind River Herbs Vol#: 45

LET 5728 Wind River Herbs Vol#: 45

LET 5729 Wind River Herbs Vol#: 45

LET 5730 Wind River Herbs Vol#: 45

LET 5731 Wind River Herbs Vol#: 45

LET 5732 Wind River Herbs Vol#: 45

LET 5733 Wind River Herbs Vol#: 45

LET 5734 Wind River Herbs Vol#: 45

LET 5735 Wind River Herbs Vol#: 45

LET 5736 Wind River Herbs Vol#: 45

LET 5737 Wind River Herbs Vol#: 45

LET 5738 Wind River Herbs Vol#: 45

LET 5739 Wind River Herbs Vol#: 45

LET 5740 Wind River Herbs Vol#: 45

LET 5741 Wind River Herbs Vol#: 45

LET 5742 Wind River Herbs Vol#: 45

LET 5743 Wind River Herbs Vol#: 45

LET 5744 Wind River Herbs Vol#: 45

LET 5745 Wind River Herbs Vol#: 45

LET 5746 Wind River Herbs Vol#: 45

LET 5747 Wind River Herbs Vol#: 45

LET 5748 Wind River Herbs Vol#: 45

LET 5749 Wind River Herbs Vol#: 45

LET 5750 Wind River Herbs Vol#: 45

LET 5751 Wind River Herbs Vol#: 45

LET 5752 Wind River Herbs Vol#: 45

LET 5753 Country Life Vol#: 45

LET 5754 Country Life Vol#: 45

LET 5755 Country Life Vol#: 45

LET 5756 Rainbow Light Vol#: 45

LET 5757 Rainbow Light Vol#: 45

LET 5758 Rainbow Light Vol#: 45

LET 5759 Rainbow Light Vol#: 45

LET 5760 Rainbow Light Vol#: 45

LET 5761 Rexall Sundown Vol#: 45

LET 5762 NOW Vol#: 45

LET 5763 Now Vol#: 45

LET 5764 NF Formulas, Inc. Vol#: 45

LET 5765 The Winning Combination Vol#: 45

98N-0617 Treatment of Narcotic Dependence

C 120 Johns Hopkins Unversity School Of Med Vol#: 16

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

C 403 Gordon Fullerton Vol#: 18

C 404 Mrs Don B Landers Vol#: 18

C 405 George Helkey Vol#: 18

C 406 Sally M Ullman Vol#: 18

C 407 Lori Diversey Vol#: 18

C 408 Alicia A Van Slyke Vol#: 18

C 409 Miss Ceil F Brophy Vol#: 18

C 410 Anne S Bahl Vol#: 18

C 411 Susan Hurley Vol#: 18

C 412 Linden P Martineau Vol#: 18

C 413 Jennifer Carbry Vol#: 18

C 414 Joanne Delmoinco Vol#: 18

C 415 Julie Fleckenstein Vol#: 18

C 416 Brian D Vol#: 18

C 417 Analytical Chemical Services Vol#: 18

C 418 R Sietz Vol#: 18

C 419 Lori A Fullerton Vol#: 18

C 420 Kristy Ratcliff Vol#: 18

C 421 Sheila Burns Vol#: 18

C 422 Bob Willhite Vol#: 18

C 423 Barbara Fernandez Vol#: 18

C 424 Don Carter Vol#: 18

C 425 Grace Dellaquila Vol#: 18

C 426 Edwin I Ichiriu Vol#: 18

C 427 Kenneth & Rosemarie Smith Vol#: 18

EMC 304 Wayne Turner Vol#: 18

EMC 305 Mary Hartup Vol#: 18

EMC 306 Nanci Kuzins Vol#: 18

EMC 307 Heather Nelson & Family Vol#: 18

EMC 308 Wendy Gibson Vol#: 18

EMC 309 Charles Wood Vol#: 18

EMC 310 Sallie Vandervort Vol#: 18

EMC 311 Charles Wood Vol#: 18

EMC 312 Gay Stoufer Vol#: 18

EMC 313 Cynthia Poppe Vol#: 18

EMC 314 Katherine Maggi Vol#: 18

EMC 315 Lillian & Perry Brackett Vol#: 18

00D-1306 Content & Format of Prescription Drug Labeling

C 2 ALZA Corporation Vol#: 1

C 3 Chiron Corporation Vol#: 1

C 4 Knoll Pharmaceutical Company Vol#: 1

C 5 Thomson Healthcare Vol#: 1

C 6 Eli Lilly & Company Vol#: 1

C 7 PhRMA Vol#: 1

C 8 PhRMA Vol#: 1

C 9 Pharmacia & Upjohn Vol#: 1

00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment

C 15 Groton Laboratories Pfizer Inc Vol#: 2
 
 

00N-1246 Agency Information Collection Food Safety Survey

NCR 1 Vol#: 1
 
 

00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 657 D C Raskowski Vol#: 24
 
 

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

NEC 1 HFS-822 Vol#: 11
 
 

00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs

C 13 Department of Pharmacy Vol#: 1
 
 

00N-1489 Sterility Requirements for Aqueous-Based Drug Products

N 1 Vol#: 1

00P-1227 Amend Statements Made for Dietary Supplements

LET 1 HFD-007 to Ctr for Science in Public Int Vol#: 1

00V-1490 Laser Light Show

CR 1 The Mens Club of Dallas Vol#: 1

00V-1509

ACK 1 HFA-305 Vol#: 1