Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860, Fax 301-827-6870

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 7, 2002

TABLE OF CONTENTS

Hyper links are part of the Docket title - not all dockets/documents are linked

NOTE: Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE] [ ITEM CODES ]

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
00D-1538 Electronic Records; Electronic Signatures, Validation *
01P-0572 Petition for Regulation of Ariva Tobacco Lozenges *
02N-0204 Bar Code Label Requirements for human drug products *
02P-0171 Misbranding of regulated drugs by third Parties *

77N-0318 Penicillin & Tetracycline and all Combinations

APE 139 Carlos M. Cooper Vol#: 28

APE 140 Donald Berend Vol#: 28

NFR 1 Robin F. Thomas Vol#: 32

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

LET 620 HFS-810 to Edge Labs Inc Vol#: 18

LET 621 HFS-810 to Indiana Botanical Gardens Inc Vol#: 18

LET 622 HFS-810 to Nature's Answer Vol#: 18

LET 623 HFS-810 to Enzymatic Therapy Inc Vol#: 18

LET 624 HFS-810 to Pharmavite Corporation Vol#: 18

LET 625 HFS-810 to Immunity Today LLC Vol#: 18

LET 626 HFS-810 to Melaleuca Inc Vol#: 18

LET 627 HFS-810 to Bayer Consumer Care Division Vol#: 18

LET 628 HFS-810 to 21st Century Laboratories Inc Vol#: 18

LET 629 HFS-810 to FreeLife International Vol#: 18

LET 630 HFS-810 to Country Life Vol#: 18

LET 631 HFS-810 to Nutra Therapeutics Internatio Vol#: 18

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 5850 Joseph O. Fisdren Vol#: 241

C 5851 Ms. Irene L. Parks Vol#: 241

C 5852 Jan Kemmerer Vol#: 241

C 5853 Nathalie Maillard Vol#: 241

C 5854 Melissa Fadden Vol#: 241

C 5855 Sue Rogan, RN Vol#: 241

C 5856 William A. Nixon, III Vol#: 241

C 5857 Christine Meisenheimer & William George Vol#: 241

C 5858 9 Signatures Vol#: 241

C 5859 Mr. & Mrs. Raymond Groh Vol#: 251

C 5860 Leon M. Despres Vol#: 251

C 5861 Gretchen Ney Laugier Vol#: 251

C 5862 James M. Walser Vol#: 251

C 5863 William H. Brown Vol#: 251

C 5864 Harley Morland Vol#: 251

C 5865 Richard K. Corbin Vol#: 251

C 5866 Robert Jamison Vol#: 251

C 5867 Mitchell Peritz Vol#: 251

C 5868 Steven Monteleone Vol#: 251

C 5869 Audrey A. O'Neill Vol#: 251

C 5870 Mrs. Mary Ellen Tang Vol#: 251

C 5871 Katya Lozier Vol#: 251

C 5872 Martha C. Christian Vol#: 251

C 5873 Shiela Cockshott Vol#: 251

C 5874 Kei Utsumi Vol#: 251

C 5875 Bob Sullivan Vol#: 251

C 5876 Mrs. Dolores A. Sauer Vol#: 251

C 5877 Mary J. McGloin Vol#: 251

C 5878 Bonnie Grey Vol#: 251

EMC 2788 newinters Vol#: 243

EMC 2789 Joanne Moore Vol#: 243

EMC 2790 germainme Vol#: 243

EMC 2791 Christine Meisenheimer & William George Vol#: 243

EMC 2792 Maria Carmela Vol#: 243

EMC 2793 Sandbar999 Vol#: 243

EMC 2794 number not used Vol#: 243

EMC 2795 Jean Litz Vol#: 243

EMC 2796 Connie Beck Crusha Vol#: 243

EMC 2797 Becky Whitley Vol#: 243

EMC 2798 Jennifer Canipe Vol#: 243

EMC 2799 Peggy Burris Vol#: 243

EMC 2800 John Riddell Vol#: 243

EMC 2801 Stephanie Emmert Vol#: 243

EMC 2802 Pat Harris Vol#: 243

EMC 2803 Alliance Medical Texas Vol#: 243

EMC 2804 Lisa Goudarzi Vol#: 243

EMC 2805 Barbara Widstrand Vol#: 243

EMC 2806 Steven Monteleone Vol#: 243

EMC 2807 Paul Sheridan Vol#: 243

EMC 2808 Jillian Forte Vol#: 243

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 3506 Ming Lowe Vol#: 212

C 3507 Beatrice Blythe Bertwell Vol#: 212

C 3508 Deanne L. Adams Vol#: 212

C 3509 Jessica Litchney Vol#: 212

C 3510 James Babb Vol#: 212

C 3511 Naomi Kiyabu Vol#: 212

C 3512 Michele Yeater Vol#: 212

C 3513 J. Rigney Vol#: 212

C 3514 Marlene & Armand Lerner Vol#: 212

C 3515 Daniel Schivone Vol#: 212

00D-1538 Electronic Records; Electronic Signatures, Validation

LST 10 Gen. References for Guidance 07/05/02 Vol#: 7

MM 25 HFC-240 & Vector Intelligence, Inc. Vol#: 7

MM 26 HFC-240 & InfinityQS International, Inc. Vol#: 7

MM 27 HFC-240 & Eurotherm Inc Vol#: 7

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

LST 10 Gen. References for Guidance 07/05/02 Vol#: 6

MM 25 HFC-240 & Vector Intelligence, Inc. Vol#: 6

MM 26 HFC-240 & InfinityQS International, Inc. Vol#: 6

MM 27 HFC-240 & Eurotherm Inc Vol#: 6

00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor

LST 10 Gen. References for Guidance 07/05/02 Vol#: 6

MM 25 HFC-240 & Vector Intelligence, Inc. Vol#: 6

MM 26 HFC-240 & InfinityQS International, Inc. Vol#: 6

MM 27 HFC-240 & Eurotherm Inc Vol#: 6

00D-1541 Electronic Signatures: Audit Trails

LST 10 Gen. References for Guidance 07/05/02 Vol#: 6

MM 26 HFC-240 & Vector Intelligence, Inc. Vol#: 6

MM 27 HFC-240 & InfinityQS International, Inc. Vol#: 6

MM 28 HFC-240 & Eurotherm Inc Vol#: 6

00D-1542 Electronic Signatures: Time Stamps

LST 10 Gen. References for Guidance 07/05/02 Vol#: 6

MM 25 HFC-240 & Vector Intelligence, Inc. Vol#: 6

MM 26 HFC-240 & InfinityQS International, Inc. Vol#: 6

MM 27 HFC-240 & Eurotherm Inc Vol#: 6

00D-1543 Electronic Signatures: Glossary of Terms

LST 10 Gen. References for Guidance 07/05/02 Vol#: 7

MM 25 HFC-240 & Vector Intelligence, Inc. Vol#: 7

MM 26 HFC-240 & InfinityQS International, Inc. Vol#: 7

MM 27 HFC-240 & Eurotherm Inc Vol#: 7

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9377 Unreadable Vol#: 408

C 9378 Veronica Garman Vol#: 408

C 9379 No Signature Vol#: 408

C 9380 No Signature Vol#: 408

C 9381 Miel Lim Vol#: 408

C 9382 Tiffany Rockhold Vol#: 408

C 9383 Holly Sanchez Vol#: 408

C 9384 Jordan Hara Vol#: 408

C 9385 Greg Moore Vol#: 408

C 9386 Andrea Ginn Vol#: 408

C 9387 Alex Cane Vol#: 408

C 9388 No Signature Vol#: 408

C 9389 Jeremy Schwartz Vol#: 408

01P-0572 Petition for Regulation of Ariva Tobacco Lozenges

LET 2 Star Scientific, Inc. Vol#: 2

02N-0204 Bar Code Label Requirements for human drug products

APE 1 Peter Mayberry Vol#: 2

APE 2 Medical Material Directorate Vol#: 2

APE 3 American College of Cardiology Vol#: 2

APE 4 Deus Technologies Vol#: 2

APE 5 VACO Vol#: 2

APE 6 HFZ-215 Vol#: 2

APE 7 TRICARE Management Activity Vol#: 2

APE 8 Ann Massey Vol#: 2

APE 9 HFZ-215 Vol#: 2

APE 10 Karen Peterson-Doyle Vol#: 2

APE 11 Amgen Inc. Vol#: 2

APE 12 HFZ-215 Vol#: 2

APE 13 Merck & Co., Inc. Vol#: 2

APE 14 Gen Probe, Inc. Vol#: 2

APE 15 Wyeth Pharmaceuticals Vol#: 2

APE 16 Jen Allison Vol#: 2

APE 17 Novartis Pharmaceuticals Vol#: 2

APE 18 Roche Laboratories, Inc. Vol#: 2

APE 19 Teva Pharmaceuticals Vol#: 2

APE 20 ESI Lederle Vol#: 2

APE 21 Stephen Barlas Vol#: 2

APE 22 HFD-560 Vol#: 2

APE 23 Merck & Co., Inc. Vol#: 2

APE 24 HFZ-300 Vol#: 2

APE 25 First DataBank, Inc. Vol#: 2

APE 26 DMLSS Program Office Vol#: 2

APE 27 HFD-400 Vol#: 2

APE 28 Elizabeth Callaghan Vol#: 2

APE 29 Dey, L.P. Vol#: 2

APE 30 Boyd Conley Vol#: 2

APE 31 Convatec Vol#: 2

APE 32 ESI Lederle Vol#: 2

APE 33 Roxane Laboratories, Inc. Vol#: 2

APE 34 HFZ-500 Vol#: 2

LST 1 Agenda of 7/26/02 meeting of Barcoding Vol#: 2

LST 2 Barcoding Attendees Vol#: 2

LST 3 Barcoding Attendees Vol#: 2

02N-0330 Int'l Conference on Harmonisation Workshop/Gene Therapy

NM 1 Vol#: 1

02P-0171 Misbranding of regulated drugs by third Parties

RC 1 The Institute for Human Rights Vol#: 1