<!doctype html public "-//w3c//dtd html 4.0 transitional//en">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 June 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.

 

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91N-384H  Nutrient Content Claims, Definition of Term:  Healthy                                                    1

99N-4063  Positron emmission tomography drug products                                                                 5

00N-1571  Enrofloxacin for Poultry: Opportunity for hearing                                                            5

01N-0322  Institutional Review Boards                                                                                                    6

01P-0495  Determine Ultram's safety or effectiveness reasons                                                          6

02D-0039  Medical Sterilization Packaging Systems                                                                           6

02N-0209  Governing First Amendment Case Law                                                                                6

91N-384H  Nutrient Content Claims, Definition of Term:  Healthy

C   124     State of Connecticut                      Vol#: 13

 

95N-0253  Sale & Distribution Cigarettes protect children/adolescents

CA  2799    Diana Sager                               Vol#: 5015

 

CA  2800    Dennis Bloom                              Vol#: 5015

 

CA  2801    Charles P. Heck, M. D.                    Vol#: 5015

 

CA  2802    Stephen Hildebrand                        Vol#: 5015

 

CA  2803    Lauren K. Coleman                         Vol#: 5015

 

CA  2804    DeAnne Baer                               Vol#: 5015

 

CA  2805    Dr. Jay & Lynn Zatzkin                    Vol#: 5015

 

CA  2806    Janet Rich                                Vol#: 5015

 

CA  2807    Lynn Zatzkin                              Vol#: 5015

 

CA  2808    Marjorie Griffin                          Vol#: 5015

 

CA  2809    Jeff Lane                                 Vol#: 5015

 

CA  2810    Thom Murray                               Vol#: 5015

 

CA  2811    Louis Nuernberger                         Vol#: 5015

 

CA  2812    Joan E. T. Cushnyr                        Vol#: 5015

 

CA  2813    Judy Schmidtke                            Vol#: 5015

 

CA  2814    Krystal Keller                            Vol#: 5015

 

CA  2815    Jake                                      Vol#: 5015

 

CA  2816    Sashi Milasch                             Vol#: 5015

 

CA  2817    Andrew Bortano                            Vol#: 5015

 

CA  2818    Kim Ozolin                                Vol#: 5015

 

CA  2819    Bill Hutchison                            Vol#: 5015

 

CA  2820    J. J. Rooks, M. D.                        Vol#: 5015

 

CA  2821    Judith A. Anderson                        Vol#: 5015

 

CA  2822    Ward White                                Vol#: 5015

 

CA  2823    Robert W. Bower, Jr.                      Vol#: 5015

 

CA  2824    Barry McCabe                              Vol#: 5015

 

CA  2825    Kyle Warnick                              Vol#: 5015

 

CA  2826    DeAnne Baer                               Vol#: 5015

 

CA  2827    Diane Holley                              Vol#: 5015

 

CA  2828    R. G. Cushnyr                             Vol#: 5015

 

CA  2829    Keith Foster                              Vol#: 5015

 

CA  2830    Robert Pagh                               Vol#: 5015

 

CA  2831    Katllen A. Mickolyzck                     Vol#: 5015

 

CA  2832    Constance & Scott Schalztein              Vol#: 5015

 

CA  2833    Illegible                                 Vol#: 5015

 

CA  2834    Donna Radtke                              Vol#: 5015

 

CA  2835    Darren Pirozzi                            Vol#: 5015

 

CA  2836    Dan Goodyear                              Vol#: 5015

 

CA  2837    Terrie Rand                               Vol#: 5015

 

CA  2838    Micheal C. Stolar                         Vol#: 5015

 

CA  2839    Kathy Lange                               Vol#: 5015

 

CA  2840    William Barton                            Vol#: 5015

 

CA  2841    Brad Lambert                              Vol#: 5015

 

CA  2842    Jamie Holmstrom                           Vol#: 5015

 

CA  2843    Denise Hogen                              Vol#: 5015

 

CA  2844    Rosie M. Uegpov                           Vol#: 5015

 

CA  2845    Carol Haas                                Vol#: 5015

 

CA  2846    Illegible                                 Vol#: 5015

 

CA  2847    William D. Beaird, Jr.                    Vol#: 5015

 

CA  2848    Jill Andersen                             Vol#: 5015

 

CA  2849    Don Rowen                                 Vol#: 5015

 

CA  2850    Tom Lane                                  Vol#: 5015

 

CA  2851    Bruce C. Genth                            Vol#: 5015

 

CA  2852    Gordon Malz                               Vol#: 5015

 

CA  2853    Shayne Powell                             Vol#: 5015

 

CA  2854    Bily P. & Christine R. Crisp              Vol#: 5015

 

CA  2855    Edward Daniel                             Vol#: 5015

 

CA  2856    P. Hadley                                 Vol#: 5015

 

CA  2857    Gary Starnes                              Vol#: 5015

 

CA  2858    Ernest G. Mitchell                        Vol#: 5015

 

CA  2859    Gerald E. Pings                           Vol#: 5015

 

CA  2860    Robert M. Bedette                         Vol#: 5015

 

CA  2861    Ben Brooks                                Vol#: 5015

 

CA  2862    Herbert Miles                             Vol#: 5015

 

CA  2863    Mike Wilson                               Vol#: 5015

 

CA  2864    Joseph D. Jones                           Vol#: 5015

 

CA  2865    Reid Maddox                               Vol#: 5015

 

CA  2866    Paul & Patrick Slack                      Vol#: 5015

 

CA  2867    Forrest G. Smith                          Vol#: 5015

 

CA  2868    Wade Cermak                               Vol#: 5015

 

CA  2869    Kevin L. Olson                            Vol#: 5015

 

CA  2870    Art Sallaz                                Vol#: 5015

 

CA  2871    James W. Nelsen                           Vol#: 5015

 

CA  2872    Edward R. Holden, Jr.                     Vol#: 5015

 

CA  2873    Len Brown                                 Vol#: 5015

 

CA  2874    Mike Nichols                              Vol#: 5015

 

CA  2875    Joe Blankenship                           Vol#: 5015

 

CA  2876    Thelma Getz                               Vol#: 5015

 

CA  2877    Elmo N. Wright, Jr.                       Vol#: 5015

 

CA  2878    David Banks                               Vol#: 5015

 

CA  2879    Janet Salger                              Vol#: 5015

 

CA  2880    Jim McGuire                               Vol#: 5015

 

CA  2881    Bobby W. Gooden, II                       Vol#: 5015

 

CA  2882    Marcelo Morales                           Vol#: 5015

 

CA  2883    H. L. Trembly                             Vol#: 5015

 

CA  2884    H. C. Duncan                              Vol#: 5015

 

CA  2885    Jerry O. Brianst                          Vol#: 5015

 

CA  2886    Ken Kenny                                 Vol#: 5015

 

CA  2887    E. Martin                                 Vol#: 5015

 

CA  2888    Helen Kretdermacher                       Vol#: 5015

 

CA  2889    Gerald F. Karlhelm                        Vol#: 5015

 

CA  2890    Pat Meo                                   Vol#: 5015

 

CA  2891    Alice Pettijohn                           Vol#: 5015

 

CA  2892    Noel Cullen                               Vol#: 5015

 

CA  2893    Janet Olson                               Vol#: 5015

 

CA  2894    Brenda Werner                             Vol#: 5015

 

CA  2895    Cynthia B. Jackson                        Vol#: 5015

 

CA  2896    Henie Simon                               Vol#: 5015

 

CA  2897    Lisa Dalfonso                             Vol#: 5015

 

CA  2898    Ethel S. Dergeon                          Vol#: 5015

 

96P-0500  Amend "Healthy" Definition re: Sodium Levels

C   34      State of Connecticut                      Vol#: 10

 

98D-0266  Section 121 Positron Emission Tomography (PET) FDAMA

C   13      Mayo Clinic                               Vol#: 11

 

C   14      Mayo Clinic                               Vol#: 11

 

C   15      Mayo Clinic                               Vol#: 11

 

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

C   5815    Kelly Brinkman                            Vol#: 241

 

EMC 2754    Corinne L. Thomas                         Vol#: 243

 

EMC 2755    Elvira M. Janz                            Vol#: 243

 

EMC 2756    Dianne Fradkin                            Vol#: 243

 

EMC 2757    Beatrice M. Brugge                        Vol#: 243

 

EMC 2758    Lana Luhm                                 Vol#: 243

 

EMC 2759    Lelia Cosimbescu, Ph.D.                   Vol#: 243

 

EMC 2760    Merilee J. Light                          Vol#: 243

 

99F-4372  National Fisheries Institute and the Louisiana Dep of Agricu

C   67      April Schoenherr                          Vol#: 4

 

99F-5321  Food Safety & Inspection service safe use of ionizing radiai

C   65      April Schoenherr                          Vol#: 4

 

99F-5322  Ionizing Radiation for the Treatment of Food

C   65      April Schoenherr                          Vol#: 3

 

99F-5522  Ionizing radiation /control of Food-borne pathogens safe use

C   66      April Schoenherr                          Vol#: 3

99N-2079  Assessment of Preclinical Reproductive Toxicity Data

C   13      PhRMA                                     Vol#: 3

 

99N-4063  Positron emmission tomography drug products

C   10      Mayo Clinic                               Vol#: 1

 

00N-1571  Enrofloxacin for Poultry: Opportunity for hearing

CS  7       HFA-305                                   Vol#: 259

 

EXT 2       Bayer Corporation                         Vol#: 259

 

OR  7       HF-3                                      Vol#: 259

 

RMO 7       Bayer Corporation                         Vol#: 259

 

01F-0047  Foodborne pathogens in raw-frozen-cooked-partially cooked

C   64      April Schoenherr                          Vol#: 6

01N-0322  Institutional Review Boards

C   21      Robert Reinhard                           Vol#: 1

 

C   22      Aventis Pasteur Inc.                      Vol#: 1

 

C   23      Northwest Biotherapeutics, Inc.           Vol#: 1

 

C   24      University of California                  Vol#: 1

 

EC  6       University of California Office of the P  Vol#: 1

 

EC  7       Council on Governmental Relations (COGR)  Vol#: 1

 

EC  8       Quintiles, Inc.                           Vol#: 1

 

EC  9       Quintiles, Inc.                           Vol#: 1

 

EC  10      University of North Carolina at Chapel H  Vol#: 1

 

EC  11      Biotechnology Industry Organization       Vol#: 1

 

EC  12      ARENA                                     Vol#: 1

 

EC  13      Vanderbilt University Medical Center      Vol#: 1

 

EC  14      GenVec Inc.                               Vol#: 1

 

EC  15      University of Colorado/AIDS Clinical Tri  Vol#: 1

01P-0495  Determine Ultram's safety or effectiveness reasons

C   8       Apotex Corp.                              Vol#: 2

 

02D-0039  Medical Sterilization Packaging Systems

C   12      Assn of Disposable Device Munufacturers   Vol#: 1

 

02N-0209  Governing First Amendment Case Law

C   2       K     B                                   Vol#: 2

 

EC  102     private citizen                           Vol#: 2

 

EC  103     Mr. LaWayne Tucker                        Vol#: 2

 

EC  104     Ms. Sharrhan Williamson                   Vol#: 2

 

EC  105     Mr. Kelly Peck                            Vol#: 2

 

EC  106     Dr. Robert Arbon                          Vol#: 2

 

EC  107     Mr. Robin Alexander                       Vol#: 2

 

EC  108     Mr. Bruce Huron                           Vol#: 2

 

EC  109     self                                      Vol#: 2

 

EC  110     Univ of Penn School of Medicine           Vol#: 2

 

EC  111     Mr. Richard Smith                         Vol#: 2

 

EC  112     Mr. Dean von Germeten                     Vol#: 2

 

EC  113     Individual                                Vol#: 2

 

EC  114     Trigon Blue Cross Blue Shield             Vol#: 2

 

EC  115     Mrs. Connie du Toit                       Vol#: 2

 

EC  116     None                                      Vol#: 2

 

EC  117     Trigon BCBS                               Vol#: 2

 

EC  118     Ms. Tamara Andreas                        Vol#: 2

 

EC  119     Mr. Ian Rossman                           Vol#: 2

 

02P-0191  Request for immediate final approval of tramadol Hydrochlori

C   4       Apotex (Apotex Corp. & Torpharm Inc.)     Vol#: 1

 

02V-0190  X-Ray Fluoroscopic Inspection Systems - SDS 400/S & P

CR  1       HFA-305                                   Vol#: 1

 

LET 1       Isorad                                    Vol#: 1

 

02V-0263  Laser Light Show

ACK 1       HFA-305                                   Vol#: 1

 

VAR 1       Disneyland Resort                         Vol#: 1

 

02V-0265

ACK 1       HFA-305                                   Vol#: 1

 

VAR 1       Canobie Lake Park                         Vol#: 1