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 August 25, 2000

TABLE OF CONTENTS

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85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984 *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
98F-0165 safe use of ionizing radition for reduction of salmonella *
98V-1233 Variance for protocols & software reporting requirements *
00D-0805 Requirements for Emergency Research *
00N-0504 Egg Safety Action Plan *
00P-1276 Health Claim: Plant stanol esters and heart disease *
00V-1476 Laser light show *
00V-1477 Laser Light Show *
00V-1478 Laser light show *

85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984

C 72 Andrx Pharmaceuticals Inc Vol#: 27
 
 

93F-0360 Safe use pentaerythritol mixed esters of C16-18 fatty acids

NWL 1 Vol#: 1

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

EMC 10 Juliana Nannarone Vol#: 4

EMC 11 Jessica Jerney Vol#: 4

EMC 12 Dawn Merydith Vol#: 4

EMC 13 Gail Zatz Vol#: 4

EMC 14 Joanne Landy Vol#: 4

98F-0165 safe use of ionizing radition for reduction of salmonella

HER 7 United Poultry Concerns, Inc Vol#: 1

HER 8 Hillarie Morris Vol#: 1
 
 

98F-1193 Safe Use of 3-iodo-2-propynyl butyl carbamate

NWL 1 Vol#: 1

98V-1233 Variance for protocols & software reporting requirements

VRA 1 HFZ-330 to William A Gibson Vol#: 1
 
 

99P-5317 Stay of Approval of ANDA for a Generic Version of Enalapril

WDL 1 TorPharm Vol#: 1
 
 

00C-1444 filing of Color Additive Petition in fingernail polish

NFL 1 FEM, Inc. Vol#: 1

00D-0805 Requirements for Emergency Research

C 8 University of MD/Medical Center Vol#: 1

00N-0504 Egg Safety Action Plan

C 27 PennAg Industries Assn, Poultry Council Vol#: 7

C 28 Hawaii Egg Producers Cooperative Vol#: 7

C 29 Ohio Poultry Assn. Vol#: 7

EMC 217 Justin Vazquez-Poritz Vol#: 7

EMC 218 Shirley Mohr Vol#: 7

EMC 219 Wei-Li Hu Vol#: 7

EMC 220 Ariella Hannah Mohr Vol#: 7

EMC 221 Lindsay Curry Vol#: 7

EMC 222 Yael Trock Vol#: 7

EMC 223 Delma S. Fleming, Ph.D. Vol#: 7

EMC 224 Noam Mohr Vol#: 7

EMC 225 Lillian Black Vol#: 7

EMC 226 Helen Navascues Vol#: 7

EMC 227 Rebecca Stang Vol#: 7

EMC 228 Stephanie Gipson Vol#: 7

EMC 229 Judd & Susan Hall Vol#: 7

EMC 230 Kathy Rossi Vol#: 7

EMC 231 Rob Vol#: 7

EMC 232 Susan Howard Vol#: 7

EMC 233 Dr. Kemmerer Vol#: 7

EMC 234 Thea Bergere Vol#: 7

EMC 235 Nancy A. Sheffield Vol#: 7

EMC 236 Susan Cronin Parano Vol#: 7

EMC 237 Edward Waller Vol#: 7

EMC 238 J. P. Vol#: 7

EMC 239 Cathy Kunkel Vol#: 7

EMC 240 Joanna Behrens Vol#: 7

EMC 241 Agneta Riberth Toll (France) Vol#: 7

EMC 242 Pacific Egg & Poutry Assn. Vol#: 7

EMC 243 State of Hawaii Dept of Agriculture Vol#: 7

EMC 244 West Coast United Egg Producers Vol#: 7

EMC 245 CSPI Vol#: 7

EMC 246 PETA, People for the Ethical Treatment o Vol#: 7

EMC 247 California Dept. of Food & Agriculture Vol#: 7

EMC 248 Mary Finelli Vol#: 7
 
 

00N-1246 Agency Information Collection Food Safety Survey

N 2 Vol#: 1
 
 

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

CH 470 Aaron Frodsham Vol#: 18

CH 471 Cole Harris Vol#: 18

CH 472 Melanie Weiss Vol#: 18

CH 473 Sandra E. Hausman Vol#: 18

CH 474 Kathy Anderson Vol#: 18

CH 475 Chiara Mattieson Vol#: 18

CH 476 James Notzen Vol#: 18

CH 477 Robert L. Whitman Vol#: 18

CH 478 Michael J. Shenk Vol#: 18

CH 479 Susan Gray Vol#: 18

CH 480 Jennifer Sykes Vol#: 18

CH 481 Paula E. Keats Vol#: 18

CH 482 Louis D. Evans Vol#: 18

CH 483 Emily A. Bieber Vol#: 18

CH 484 Pamela Upsher Vol#: 18

CH 485 Lydon Sacoff Vol#: 18

CH 486 Kimberly S. Jack Vol#: 18

CH 487 Claire Ross Vol#: 18

CH 488 Preeti Rout Vol#: 18

CH 489 Lisa Whitaker Vol#: 18

CH 490 Michele Bertram Vol#: 18

CH 491 Grace M. Abbott Vol#: 18

CH 492 Jill Vol#: 18

CH 493 Linda A. Hall Vol#: 18

CH 494 Jennifer Smith Vol#: 18

CH 495 Pam Shelden Mayes Vol#: 18

CH 496 Jennifer Abbott Vol#: 18

CH 497 Heidi Neri Vol#: 18

CH 498 Claire Ross Vol#: 18

CH 499 Rebecca Lotsoff Vol#: 18

CH 500 C Einecker Vol#: 18

CH 501 Betty Peary Vol#: 18

CH 502 Louise Vol#: 18

CH 503 Kathleen M. Smith Vol#: 18

CH 504 Cheryl Gaffney Vol#: 18

CH 505 Daniel Thompson Vol#: 18

CH 506 William C. Kraemer Vol#: 18

CH 507 Kay L. Hoff Vol#: 18

CH 508 Beth L. Slingluff, MS, ANP Vol#: 18

CH 509 Corinne Bradley Vol#: 18

CH 510 Amy S. Korte Vol#: 18

CH 511 Barbara Bowers Vol#: 18

CH 512 Beverly E. Messer Vol#: 18

CH 513 Lisa J. Smuckler Vol#: 18

CH 514 Lori Kozlik Vol#: 18

CH 515 Dan & Lori Thompson Vol#: 18

CH 516 Nancy Gronlund Vol#: 18

CH 517 Penny & Robert Morris Vol#: 18

CH 518 Callie Lipkin Vol#: 18

CH 519 Roy & Shirley Lundin Vol#: 18

CH 520 Elizabeth Gonzalez Vol#: 18

CH 521 Dawn Hall Vol#: 20

CH 522 Karen Fox Vol#: 20

CH 523 Virginia C. Lesli, MD Vol#: 20

CH 524 Lois J. Lipton Vol#: 20

CH 525 Marcia Liss Vol#: 20

CH 526 Michelle Kahlenberg Vol#: 20

CH 527 R. Peter Carey Vol#: 20

CH 528 James D. Sullivan Vol#: 20

SUP 3 One More Soul Vol#: 18
 
 

00N-1440 User Fee Cover Sheet; Form FDA 3397

N 1 Vol#: 1
 
 

00N-1441 Infant Formula Requirements

N 1 Vol#: 1

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

LET 3 McNeil Consumer Healthcare Vol#: 4

00V-1476 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 My Generation Vol#: 1

00V-1477 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Audio Line, Inc. Vol#: 1

00V-1478 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 DJ Brat Vol#: 1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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