Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on November  1, 2002

TABLE OF CONTENTS

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81N-0033  Oral Health Care Drug Products for OTC Human Use                          1

95S-0117  Human Drugs Patent Term Extension & New Patents                           1

96N-0277  Eligibility Criteria for Considering Additional Condition                       1

00D-1392  Guidance for Industry on Botanical Drug Products                               2

01P-0120  Ban Unsafe IV Catheters and other Devices                                                2

02D-0337  Liposome Drug Products:Chemistry, Manufacturing, and Control        4

02D-0402  Field offices on "Regulatory procedures Manual, Chapter 9                  4

02N-0209  Governing First Amendment Case Law                                                 4

02N-0393  Draft Action Plan on Acrylamide                                                          4

02N-0403  Premarket Notification for Food Contact Substances;Public Me            4

02N-0445  FDA Regulation of Combination Products; Public Hearing                    4

02P-0139  Arava (leflunomide;Aventis) remove from the market                         5

81N-0033  Oral Health Care Drug Products for OTC Human Use

LET 55      HFD-560 to CHPA                           Vol#: 70

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

LST 77      List as of October 25, 2002               Vol#: 6

 

96N-0277  Eligibility Criteria for Considering Additional Condition

SUP 1       number not used                           Vol#: 3

 

98D-0481  180-day Generic Drug Exclusivity under Hatch-Waxman Amendmen

C   15      Alfred B. Engelberg                       Vol#: 1

 

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

C   6031    J. Capozzelli                             Vol#: 264

 

C   6032    Michelle Brenner                          Vol#: 264

 

C   6033    Carmita Frost                             Vol#: 264

 

C   6034    Darlene Wheeler                           Vol#: 264

 

C   6035    Jean Sutherland                           Vol#: 264

 

C   6036    Robert Ryan                               Vol#: 264

 

C   6037    Patricia Mathis                           Vol#: 264

 

C   6038    Leah Hackenson-Allers                     Vol#: 264

 

C   6039    Kathleen Shopa                            Vol#: 264

 

C   6040    Kerri & Susan McDonald                    Vol#: 264

 

C   6041    Patty Ferme                               Vol#: 264

 

C   6042    Terri Sider                               Vol#: 264

00D-1392  Guidance for Industry on Botanical Drug Products

C   29      CK Life Sciences International, Inc.      Vol#: 2

 

00D-1598  Voluntary Labeling for Bioengineered Foods

C   9836    Carol & Terry Brown                       Vol#: 572

 

C   9837    Marie Hammond                             Vol#: 572

 

C   9838    Roman Weber                               Vol#: 572

 

C   9839    Brenda McMillan                           Vol#: 572

 

C   9840    Dean Colway                               Vol#: 572

01P-0120  Ban Unsafe IV Catheters and other Devices

RPT 2       Ahrens Balwit & Associates,Inc.           Vol#: 1

 

01P-0230  Domestic Marketing & Importation of Transgenic Fish

C   1238    Mr. David Sanchez                         Vol#: 226

 

C   1239    Michael Tippett                           Vol#: 226

 

C   1240    Marie T. Peters                           Vol#: 226

 

C   1241    Peter Ruggles                             Vol#: 226

 

C   1242    Ms. Maria Elliott                         Vol#: 226

 

C   1243    Jim Williams                              Vol#: 226

 

EMC 2484    Ellen Anderson                            Vol#: 220

 

EMC 2485    Steven Jefferson (Australia)              Vol#: 220

 

EMC 2486    Eli Gilliat                               Vol#: 220

 

EMC 2487    Kristin Truse (United Kingdom)            Vol#: 220

 

EMC 2488    Joita Betty (Romania)                     Vol#: 220

 

EMC 2489    Natalie Winans                            Vol#: 220

 

EMC 2490    Maureen Groves                            Vol#: 220

 

EMC 2491    Gesinus-Visser (Switzerland)              Vol#: 220

 

EMC 2492    Diego Garcia (Brazil)                     Vol#: 220

 

EMC 2493    Andre Firmino (Portugal)                  Vol#: 220

 

EMC 2494    Clive Hoskin (Australia)                  Vol#: 220

 

EMC 2495    Anja Daniel                               Vol#: 220

 

EMC 2496    Carmen O'Shea (Australia)                 Vol#: 220

 

EMC 2497    Courtney                                  Vol#: 220

 

EMC 2498    John Piette                               Vol#: 220

 

EMC 2499    John Mooter                               Vol#: 220

 

EMC 2500    b                                         Vol#: 220

 

EMC 2501    Gabriel Sirois (Canada)                   Vol#: 220

 

EMC 2502    Camilla Gorham                            Vol#: 220

 

EMC 2503    GENEVIOS (France)                         Vol#: 220

 

EMC 2504    Hannah Bateson (United Kingdom)           Vol#: 220

 

EMC 2505    Earnest Boers (France)                    Vol#: 220

 

EMC 2506    Tegan Watson-Russell (Australia)          Vol#: 220

 

EMC 2507    Crystal Arri Taylor                       Vol#: 220

 

EMC 2508    Michael J. Mayo                           Vol#: 220

 

EMC 2509    Joanne Rule (United Kingdom)              Vol#: 220

 

EMC 2510    George Dumun III                          Vol#: 220

 

EMC 2511    Amanda Hayes                              Vol#: 220

 

EMC 2512    Christy George                            Vol#: 220

 

EMC 2513    Mary Nakasone                             Vol#: 220

 

EMC 2514    Nathan Schnell                            Vol#: 220

 

EMC 2515    William Sechrest                          Vol#: 220

 

EMC 2516    Holly Adams                               Vol#: 220

 

EMC 2517    Isabella Lacki                            Vol#: 220

 

EMC 2518    Maria Farina                              Vol#: 220

 

EMC 2519    Michael Kargol                            Vol#: 220

 

EMC 2520    Andrea Martin                             Vol#: 220

 

EMC 2521    Ronnie Wright                             Vol#: 220

 

EMC 2522    Sandra Schachat                           Vol#: 220

 

EMC 2523    Travis Ott                                Vol#: 220

 

EMC 2524    Lana G. Hoover                            Vol#: 220

 

02D-0324  Bioengineered Plants for Use in Humans and Animals

C   1       Agnes J. Janoscrat                        Vol#: 1

 

C   2       Richard E. Payne                          Vol#: 1

02D-0337  Liposome Drug Products:Chemistry, Manufacturing, and Control

C   2       Terumo Corporation                        Vol#: 1

02D-0402  Field offices on "Regulatory procedures Manual, Chapter 9

C   2       Caribmar Forwarding Co.                   Vol#: 1

 

02N-0208  State Enforcement Notifications,Agency Information Collectio

NAL 1                                                 Vol#: 1

02N-0209  Governing First Amendment Case Law

C   99      Congress of the United States             Vol#: 19

 

C   100     Resources for the Future                  Vol#: 19

 

C   101     Nancy Immel                               Vol#: 19

 

M   1       HF-26                                     Vol#: 19

02N-0393  Draft Action Plan on Acrylamide

C   3       Virginia Tech University                  Vol#: 1

02N-0403  Premarket Notification for Food Contact Substances;Public Me

TR  1       Food Contact Substances meeting 10/15/02  Vol#: 2

02N-0445  FDA Regulation of Combination Products; Public Hearing

APE 8       Aventis Behring                           Vol#: 2

 

APE 9       CBER/OCBQ/DCM                             Vol#: 2

 

APE 10      Brand Institute                           Vol#: 2

 

02N-0454  Notice of a Claim for GRAS Exemption Based on GRAS Determin

N   1                                                 Vol#: 1

 

02N-0466  Safety, Clinical and Immune Response of Dryvax

N   1                                                 Vol#: 1

02P-0139  Arava (leflunomide;Aventis) remove from the market

C   2       Public Citizen                            Vol#: 1