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 16, 2000

TABLE OF CONTENTS

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92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1568 ANDA Suitability Petition for Ursodiol Oral Suspension *
77N-0085 Saccharin and Its Salts

M 1 Loren Y. Johnson Vol#: 16

91F-0170 Resinous and Polymeric Coatings

NWL 1 Vol#: 1

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

APE 2 Piper Marbury Rudnick & Wolfe, LLP Vol#: 5

APE 3 America's Blood Centers Vol#: 5

APE 4 Purity Wholesale Grocers, Inc. Vol#: 5

APE 5 American Veterinary Distributors Assoc. Vol#: 5

APE 6 Food Marketing Institute Vol#: 6

APE 7 American Red Cross Vol#: 6

APE 8 American Pharmaceutical Assoc. Vol#: 6

APE 9 PhRMA Vol#: 6

APE 10 Kent & O'Connor Vol#: 6

94G-0267 Triglyceride Containing Behenic & Oleic Acids

NWL 1 Vol#: 1

97C-0415 Amend Regulations to Provide the Safe Use of Zinc Sulfide

NCD 1 Vol#: 1

97C-0466 Amend regulation to provide safe use of astaxanthin

NCD 1 Vol#: 1

97N-0165 Pediatric Patients certain new drugs/biological Products

NCR 1 Vol#: 6

99F-3087 Sodium Stearoyl Lactylate

NFR 1 Vol#: 1

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

C 15488 Ronald A. Rose Vol#: 461

C 15489 Russ & Lora Wilson Vol#: 461

C 15490 Cathy Alcorn Vol#: 461

C 15491 Denise Edwina Creishton Vol#: 461

C 15492 Deb Primos Vol#: 461

C 15493 Shawn A. May Vol#: 461

C 15494 Alice P. Mulvaney Vol#: 461

C 15495 Nola W. Lopez Vol#: 461

C 15496 Edward Aylesbury Vol#: 461

C 15497 Brenda Lowe Vol#: 461

C 15498 Louise Marie Payne Vol#: 461

C 15499 John P. & Elizabeth E. Klamo Vol#: 461

C 15500 William L. Riggins Vol#: 461

C 15501 Frank B. Thompson Vol#: 461

C 15502 Rena M. Dodd Vol#: 461

C 15503 Ruby J. Tedder Vol#: 461

C 15504 Walker Talley Vol#: 461

C 15505 Josie Bridges Vol#: 461

C 15506 Richard A. Roberts Vol#: 461

C 15507 Michael H & Regina R. Bennett Vol#: 461

C 15508 Larry Clouse Vol#: 461

C 15509 Steve Gertsch Vol#: 461

C 15510 Constance Swensen Vol#: 461

C 15511 Ruth LaBan Vol#: 461

C 15512 Donna Jones Vol#: 461

C 15513 Billie Williams Vol#: 461

C 15514 Jim & Joey Nelson Vol#: 461

C 15515 Priscilla J. Speer Vol#: 461

C 15516 Dr. & Mrs. Ray Rudolph Vol#: 461

C 15517 Louis W. Franklin Vol#: 461

C 15518 Joseph A. Ivey Vol#: 461

C 15519 Harriet Arner Vol#: 461

C 15520 Stephanie Altom Vol#: 461

C 15521 Caleta L. Duncan Vol#: 461

C 15522 Mary Adams Vol#: 461

C 15523 Jean M. Fagan Vol#: 461

C 15524 Monica Johnson Vol#: 461

C 15525 Rosalie B. Brandt Vol#: 461

C 15526 Curbelo Vol#: 461

C 15527 H. F. Nelk Vol#: 461

C 15528 Margaret Penn Rodriguez Vol#: 461

C 15529 Pamela Havlen Vol#: 461

C 15530 Mr & Mrs C. R. Bralley Vol#: 461

C 15531 Blanche Schuyle Bower Vol#: 461

C 15532 Lydia C. Kirby Vol#: 461

C 15533 Raymond W. Albright Vol#: 461

C 15534 Patricia Barton Vol#: 461

C 15535 Debra Oran Vol#: 461

C 15536 Claire E. Bottoms Vol#: 461

C 15537 Nancy Lee Dennis Vol#: 461

C 15538 Frances M. Jones-Little Vol#: 461

C 15539 J. Laflam Vol#: 461

C 15540 Robert T. Means Vol#: 461

C 15541 Rollin O. Lehman Vol#: 461

C 15542 Jane E. Jones Vol#: 461

C 15543 Mae Hanna Vol#: 461

C 15544 Sallye Dickey Vol#: 461

C 15545 Mrs. Mary Sinka Vol#: 461

C 15546 Betty J. Rice Vol#: 461

C 15547 Ann L. Rice Vol#: 461

C 15548 Susan Lewis Vol#: 461

C 15549 Nancy C. Gilbertson Vol#: 461

C 15550 Mary Kathleen Clark Vol#: 461

C 15551 Brenda T. Beach Vol#: 461

00D-1309 Channels trade policy commodities with methyl parathion

N 1 Vol#: 1

00H-1242 Civil Money Penalty;Laser Vision Centers Inc. et al

LST 1 GCF-1 Vol#: 1

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

CH 665 Jillian A. England Vol#: 24

CH 666 Nancy Muni Vol#: 24

CH 667 Barbara A. Engler Vol#: 24

00N-1534 National Surveys Prescriptions Drug Info provide to patients

N 1 Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 6538 Varrow Murphy Vol#:

C 6539 June Iantel Vol#: 295

C 6540 Wandy Resfuss Vol#: 295

C 6541 R C Petrarca Vol#: 295

C 6542 Thomas Zimmerman Vol#: 295

C 6543 Donald Thompson Jr Vol#: 295

C 6544 M B Curtis Vol#: 295

C 6545 Jacquelyn MacArthur Vol#: 295

C 6546 Darcue Nelson Vol#: 295

C 6547 Harriet L Bohn Vol#: 295

C 6548 Kyle Blernstein Vol#: 295

C 6549 Cynthia Roche-Cotter Vol#: 295

C 6550 Ann Vanderpool Vol#: 295

C 6551 Deborah Naterci Vol#: 295

C 6552 Zac Zachary Vol#: 295

C 6553 Lynne Jackman Vol#: 295

C 6554 Carla Kallan Vol#: 295

C 6555 Tracee Lyles Vol#: 295

C 6556 Paula S Heinold Vol#: 295

C 6557 Carol Deshaies Vol#: 295

C 6558 Lenora Mayer Vol#: 295

C 6559 Namiah Freedom Vol#: 295

C 6560 E Anne Sunrise Vol#: 295

C 6561 Suska Davis Vol#: 295

C 6562 Wendy Peyton Vol#: 295

C 6563 Jack B Demonnin Vol#: 295

C 6564 Marlo Jones Vol#: 295

C 6565 Suzan Greenfield Vol#: 295

C 6566 Linda Forest Vol#: 295

C 6567 Marjorie Graeber Vol#: 295

C 6568 Vicki Clancy Vol#: 295

C 6569 Pat Sloane Vol#: 295

C 6570 Joan Schmidt Vol#: 295

C 6571 Catherine Wiik Vol#: 295

C 6572 Donald Burger Vol#: 295

C 6573 Cynthia Malleck Vol#: 295

C 6574 Wilfred J McNer III Vol#: 295

EMC 3334 Grace Braley Vol#: 295

EMC 3335 Betty Barfield Vol#: 295

EMC 3336 Peg Hitman Vol#: 295

EMC 3337 Alan Wynzel Vol#: 295

EMC 3338 Eleanor Mccormick Vol#: 295

EMC 3339 Kerry O'Regan Vol#: 295

EMC 3340 Laraine Saylor Vol#: 295

EMC 3341 Jerry Wernicke Vol#: 295

EMC 3342 Don Miller Vol#: 295

EMC 3343 Janelle Dote Vol#: 295

EMC 3344 Jenny Lackey Vol#: 295

EMC 3345 Bob Ricchetti Vol#: 295

EMC 3346 Jonathan A Janssen Vol#: 295

EMC 3347 Richard K Kavanaugh Vol#: 295

EMC 3348 Ester M Winsjansen Vol#: 295

EMC 3349 Erin Stoesz Vol#: 295

EMC 3350 Jemifer Stoesz Vol#: 295

EMC 3351 Andrew Zwerin Vol#: 295

EMC 3352 Anette Gurdjian Vol#: 295

EMC 3353 Kim A Rowe Vol#: 295

EMC 3354 Don Levin Vol#: 295

EMC 3355 Christine Loeffler Vol#: 295

EMC 3356 Tracy Kerievsky Vol#: 295

EMC 3357 Nathan Payne Vol#: 295

EMC 3358 Eileen McDonough Foster Vol#: 295

EMC 3359 lizetteca@aol.com Vol#: 295

EMC 3360 Luci Saha MD MPH Vol#: 295

EMC 3361 Ann Phillips Vol#: 295

EMC 3362 Paul Stitt Vol#: 295

EMC 3363 Janet Gardner Vol#: 295

EMC 3364 Greg Schwartz Vol#: 295

EMC 3365 Laura C Schuck Vol#: 295

EMC 3366 Cassie Blake Vol#: 295

EMC 3367 Jonathan Oliver Vol#: 295

EMC 3368 Seth Wilson Vol#: 295

EMC 3369 Amanda Gibson Vol#: 295

EMC 3370 Molly Collins Vol#: 295

EMC 3371 James Lazo Vol#: 295

EMC 3372 Connie Van Den Berg Vol#: 295

EMC 3373 Bemjamin vam Leeuwen Vol#: 295

EMC 3374 Linda Cooney Vol#: 295

EMC 3375 Matthew Kimmel Vol#: 295

EMC 3376 BMC Network Vol#: 295

EMC 3377 John Carter Vol#: 295

EMC 3378 Rhonda Richlen Vol#: 295

EMC 3379 William Beuscher Vol#: 295

EMC 3380 Kathleem Deacon Vol#: 295

EMC 3381 Evan Schulte Vol#: 295

EMC 3382 Abbey Wickert Vol#: 295

EMC 3383 Kaukima Everhart Vol#: 295

EMC 3384 Rex Manz Vol#: 295

EMC 3385 Sankaran Sriram Vol#: 295

EMC 3386 David Bennett Vol#: 295

EMC 3387 Martee Crosson Vol#: 295

EMC 3388 Sally Eckhoff Vol#: 295

EMC 3389 Dart Boy Vol#: 295

EMC 3390 Felicia Petty Vol#: 295

EMC 3391 Varrow Murphy Vol#: 295

EMC 3392 Wandy Resfuss Vol#: 295

00P-1568 ANDA Suitability Petition for Ursodiol Oral Suspension

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services Inc Vol#: 1