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 November 5, 2001

TABLE OF CONTENTS

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95S-0117 Human Drugs Patent Term Extension & New Patents *
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
99P-1614 PRC for K892514 Epilator 629 by American Hair Removal System *
00N-1525 Debarment of Richard Elliott Humphreys;Notice of Opportunity *
00P-1276 Health Claim: Plant stanol esters and heart disease *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0368 Submitting Marketing Applications according to ICH/CTD Forma *
01N-0397 Transportation Safety & Potentially Sedating or Impairing *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01N-0458 Fast Track Drug Development Programs Designation,Development *
01N-0459 Food Labeling; Notification Procedures on Dietary Supplement *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0428 Generic Cefuroxime Axetil Products *
01P-0504 ANDA Suitability for Hydrocodone Bitartrate & Acetaminophen *
01P-0505 Administrative Reconsideration for K892514 Epilator 629 *

77N-0085 Saccharin and Its Salts

CA 13727 William Collins Vol#: 365

CA 13732 Karen DeBarry Vol#: 365

LETA8 Mrs. Bobbie Grissim Vol#: 365

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

LST 67 List as of October 23, 2001 Vol#: 4

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

RPT 98 Takara Shuzo Co., Ltd. Vol#: 77

RPT 99 Wealth Express Industrial Ltd Vol#: 77

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

C 33 Plasma Protein Therapeutics Assn Vol#: 1

99P-1614 PRC for K892514 Epilator 629 by American Hair Removal System

PDN 1 HFZ-1 to Andrea James Vol#: 1

99P-1615 PRC for K905125 Guaranty Hair Removal System by Stephens Mfg

PDN 1 HFZ-1 to Andrea James Vol#: 1

00D-1305 Patulin in Apple Juice,Apple Juice Concentrates,Juice Produc

GDL 2 Guideline Vol#: 1

NAD 2 Vol#: 1

00N-1525 Debarment of Richard Elliott Humphreys;Notice of Opportunity

HER 1 Richard E. Humphreys Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

ANS 8 GCF-1 to Animal Health Institute Vol#: 25

C 185 Animal Health Institute Vol#: 25

SF 1 GCF-1 Vol#: 25

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

C 14 Altus Food Company Vol#: 17

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

C 17 Altus Food Company Vol#: 17

00P-1322 Food Labeling and Allergen Contamination Control

EC 18 n/a Vol#: 17

EC 19 Mr. George Garbell Vol#: 17

EC 20 Mrs. Cheryl Klemond Vol#: 17

01D-0368 Submitting Marketing Applications according to ICH/CTD Forma

C 3 PhRMA Vol#: 1

C 4 Merck & Co., Inc. Vol#: 1

EC 1 Millennium Pharmaceuticals, Inc. Vol#: 1

01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm

NAD 1 Vol#: 1

01N-0222 Medical Devices: Third-Party review under FDAMA;Agency Infor

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

01N-0231 Veterinary adverse drug reaction, lack of effect, product

N 2 Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

C 321 Pain Consultants of Ohio Inc Vol#: 8

01N-0397 Transportation Safety & Potentially Sedating or Impairing

CV 13 Tri-Counties Regional Center Vol#: 2

TS 1 Georgetown University School of Medicine Vol#: 2

01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

CH 4 AAFCO Vol#: 1

CH 5 American Proteins, Inc. Vol#: 1

CH 6 Fats & Proteins Research Foundation, Inc Vol#: 1

CH 7 Iowa Farm Bureau Federation Vol#: 1

EC 2 Ronald Marshall Vol#: 4

TS 1 Land O'Lakes Farmland Feed Vol#: 1

TS 2 FACT Vol#: 1

TS 3 AG Innovations LLC Vol#: 1

TS 4 Pet Food Institute Vol#: 1

TS 5 National Grain & Feed Association Vol#: 1

TS 6 American Feed Industry Association Vol#: 1

TS 7 Valley Proteins Inc. Vol#: 1

TS 8 Kaluzny Bros, Inc. Vol#: 1

TS 9 Griffin Industries Inc. Vol#: 1

TS 10 Darling Internaltional Vol#: 1

TS 11 The Animal Protein Producers Industry Vol#: 1

TS 12 National Renderers Association, Inc. Vol#: 1

TS 13 American Meat Institute Vol#: 1

TS 14 VA Polytechnic Inst & State University Vol#: 1

TS 15 The Iowa Farm Bureau Federation Vol#: 1

01N-0458 Fast Track Drug Development Programs Designation,Development

EC 1 Mr. Andre Lawson Vol#: 1

01N-0459 Food Labeling; Notification Procedures on Dietary Supplement

EC 1 Consulting Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 348 Mark Lipsman Vol#: 51

C 349 Bob Gardner Vol#: 51

01P-0428 Generic Cefuroxime Axetil Products

C 1 Ranbaxy Laboratories, Ltd Vol#: 2

01P-0504 ANDA Suitability for Hydrocodone Bitartrate & Acetaminophen

ACK 1 HFA-305 Vol#: 1

CP 1 ANDAFAB ONE LP Vol#: 1

01P-0505 Administrative Reconsideration for K892514 Epilator 629

ACK 1 HFA-305 Vol#: 1

PRC 1 Andrea James Vol#: 1