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 October 11, 2001

TABLE OF CONTENTS

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94S-0120 510K Substantially Equivalent List *
95S-0117 Human Drugs Patent Term Extension & New Patents *
97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00P-1322 Food Labeling and Allergen Contamination Control *
01N-0284 Regulation for establishing import tolerances *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0470 Establish Appropriate Approval Standards for Generic Clonidi *

94S-0120 510K Substantially Equivalent List

LST 106 List of September 2001 Vol#: 25


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

LST 66 List as of October 2, 2001 Vol#: 4


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

C 24 American Association of Blood Banks Vol#: 1

C 25 American Association of Blood Banks Vol#: 1

C 26 American Association of Blood Banks Vol#: 1

97P-0441 Regulatory Status of Cholestin red yeast rice

ACK 1 HFA-305 Vol#: 16

PRC 1 Pharmanex, LLC Vol#: 16

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 544 HFS-810 to Biotech Corporation Vol#: 15

LET 545 HFS-810 to Pharmavite Corporation Vol#: 15

LET 546 HFS-810 to AZ Best Friend Inc Vol#: 15

LET 547 HFS-810 to Gifts of Nature Inc Vol#: 15


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

C 75 American Seed Trade Assn Inc. Vol#: 6


99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 3204 Laurra Maddock Vol#: 210

C 3205 Hy & Mary Lou Fenster Vol#: 210

C 3206 Mary Helen Gerwin Vol#: 210

C 3207 Tracey Fairchild Vol#: 210

C 3208 Barbara G. St. George, MS Vol#: 210

C 3209 Rae S. Sabella Vol#: 210

C 3210 Robin Costello Vol#: 210

C 3211 Kevin M. Crupi Vol#: 210

C 3212 Nicholas C. Reitter Vol#: 210

C 3213 Linda Lacova-Bhat Vol#: 210

C 3214 Christine Nassikas Vol#: 210

C 3215 Argiro P. Kaspis Vol#: 210

00D-1543 Electronic Signatures: Glossary of Terms

NCR 1 Vol#: 5

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9518 Carolyn Conrad Vol#: 476

C 9519 Steve Conrad Vol#: 476

C 9520 M. Cahill Vol#: 476

C 9521 Elmer H. Coffelt Vol#: 476

C 9522 David Yoder Vol#: 476

00P-1322 Food Labeling and Allergen Contamination Control

ACK 2 HFA-305 Vol#: 25

C 415 Laura Byers Vol#: 25

C 416 Gayle Rubin Vol#: 25

C 417 M. Hoth Vol#: 25

CP 2 Center for Science in the Public Interes Vol#: 25

01M-0210 P000035;TMJ Fossa-Eminence Prosthesis

CR 2 TMJ Implants, Inc. Vol#: 1

01M-0460 P000020; Stinger Ablation Catheter & Templink Extension Cabl

AAV 1 C. R. Bard, Inc. Vol#: 1

01M-0461 P830045/S076; Integrity Afx DR Model 5346 Dual Chamber Pulse

AAV 1 St. Jude Medical Vol#: 1

01M-0462 P880086/S083; Integrity Afx DR Model 5346 Dual Chamber Pulse

AAV 1 St. Judes Medical Vol#: 1

01N-0284 Regulation for establishing import tolerances

C 1 SD Animal Industry Board Vol#: 1


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

APE 2 American Feed Industry Association Vol#: 2

APE 3 Association of American Feed Control Vol#: 2

APE 4 Pennfield Animal Health Vol#: 2

01P-0169 Access & Safe Distribution of Alosetron

LET 2 The Lotronex Action Group Vol#: 3

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 302 Jim McIntyre Vol#: 18

EMC 303 Judy Schriebman Vol#: 18

EMC 304 number not used Vol#: 18

EMC 305 Phillip W. Kehn Vol#: 18

EMC 306 Richard & Gail Potts Vol#: 18

EMC 307 Vicki Nace Vol#: 18

EMC 308 Tammy Gersh Vol#: 18

EMC 309 Martha Booz Vol#: 18

EMC 310 Mary Keitelman Vol#: 18

EMC 311 Charles Hickling Vol#: 18

EMC 312 C.A. Damon Vol#: 18

EMC 313 Ruselle Rubine and David Rubine Vol#: 18

EMC 314 Carole Keene Vol#: 18

EMC 315 Susan Trivisonno Vol#: 18

EMC 316 Dmitry Kushnirsky Vol#: 18

EMC 317 Beverly Doran, RN Vol#: 18

EMC 318 Barbara Maximovich Vol#: 18

EMC 319 Irene & Zenon Waclawiw Vol#: 18

EMC 320 Carol Bennett Vol#: 18

EMC 321 Karen Spiegel Vol#: 18

EMC 322 Linda Neale Vol#: 18

EMC 323 Gina Fiorillo Vol#: 18

EMC 324 George Dedekian Vol#: 18

EMC 325 Dr. Lorraine Parker Vol#: 18

EMC 326 Jay Kammen Vol#: 18

EMC 327 L. Neil Frazer, PhD Vol#: 18

EMC 328 Andrew Kubersky Vol#: 18

EMC 329 Gail Whipple Vol#: 18

EMC 330 Theresa Williamson Vol#: 18

EMC 331 Douglas Stevenson Vol#: 18

EMC 332 John Strouss Vol#: 18

EMC 333 Susan Fay Vol#: 18

EMC 334 Sandra A. Herzog Vol#: 18

01P-0470 Establish Appropriate Approval Standards for Generic Clonidi

ACK 1 HFA-305 Vol#: 1

ACK 2 HFA-305 Vol#: 2

CP 1 Boehringer Ingelheim Pharm, Inc. Vol#: 1

PSA 1 Boehringer Ingelheim Pharm,Inc Vol#: 2

01V-0467 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Oasis State Werks Vol#: 1

01V-0468

ACK 1 HFA-305 Vol#: 1

VAR 1 Zippers Vol#: 1

01V-0469

ACK 1 HFA-305 Vol#: 1

VAR 1 Way-Out Entertainment & Events Vol#: 1