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] 

DOCKETS ENTERED on June 5, 2000

Table of Contents

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

(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 ]
 
93D-0139 Stability Testing of Biotechnological/Biological Products *
98P-0203 Eliminate Forced Molting of Laying Birds *
00D-0785 GUIDANCE ON MEDICAL DEVICE PATIENT LABELING *
00D-1223 Clinical Investigation of Medicinal Products in Pediatrics *
00N-1200 Dietary Supplements Containing Ephedrine Alkaloids *
00N-1256 Over-the-Counter Drug Products;Public Hearing *
00N-1266 Report to Congress on Pediatric Exclusivity *
00P-1276 Health Claim: Plant stanol esters and heart disease *
00P-1329 Permit dietary supplement manufacturer to include the phrase *
93D-0139 Stability Testing of Biotechnological/Biological Products

C 49 Merck & Co., Inc. Vol#: 2

C 50 Genentech, Inc. Vol#: 2

C 51 AstraZeneca Pharmaceuticals LP Vol#: 2

98P-0203 Eliminate Forced Molting of Laying Birds

C 1951 Barbara A. Frye Vol#: 46

99H-4574 Civil Money Penalty;Mustafa Uwainat,dba B-52 Market #2

LET 3 Office of Tobacco Programs Vol#: 1

M 1 GCF-1 Vol#: 1

99H-4970 Civil Money Penalty;Pat Weaver,dba Weaver's Country Store

LET 2 Office of Tobacco Programs Vol#: 1

M 1 GCF-1 Vol#: 1

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

C 13005 Beth Champayne Vol#: 401

C 13006 Elizabeth Good Vol#: 401

C 13007 Mollie M. Jacques Vol#: 401

C 13008 Susan S. DesGeorges Vol#: 401

C 13009 Dorothy A. Zizrkle Vol#: 401

C 13010 Christel Kedzie Vol#: 401

C 13011 G. A. Lorber Vol#: 401

C 13012 Barbara Vaile Vol#: 401

C 13013 Carol N. Telschow Vol#: 401

C 13014 Georgia Watkins Vol#: 401

C 13015 Carol Ellen Crenshaw Vol#: 401

C 13016 Linda Breuer Vol#: 401

C 13017 Holly Chabbott Vol#: 401

C 13018 Michael Nevesky Vol#: 401

C 13019 John Pruyn Vol#: 401

C 13020 Frank Getzewich Vol#: 401

C 13021 Roy Goodwin Vol#: 401

C 13022 Anita Zielasko Vol#: 401

C 13023 Richard M. Baumann. Sr. Vol#: 401

C 13024 Joanne Fredeicks Vol#: 401

C 13025 Joyce & John Weir Vol#: 401

C 13026 Ronald J. Steckman Vol#: 401

C 13027 Martha Dansdill Vol#: 401

C 13028 Jean Hughes-Taylor Vol#: 401

C 13029 Donna Lee D'Antuono Vol#: 401

C 13030 Richard Csontos Vol#: 401

C 13031 Mr & Mrs John Peters Vol#: 401

C 13032 Daniel J. Gaskell Vol#: 401

C 13033 Sandy Long Vol#: 401

C 13034 Geraldine K. Hahn Vol#: 401

C 13035 M. Anna Oshea Vol#: 401

C 13036 Patricia A. Hardie Vol#: 401

C 13037 Renee McGarvie Vol#: 401

C 13038 Nicholas Snyder Vol#: 401

C 13039 Guy Hudson Vol#: 401

C 13040 Mary Michele Massa Vol#: 401

C 13041 Jean Steiner Vol#: 401

C 13042 Stan Guzawer Vol#: 401

C 13043 Nancy & S. C. Sommer Vol#: 401

C 13044 Lorie G. Johns Vol#: 401

C 13045 Angela Greelee Vol#: 401

C 13046 Carl & Deborah Koellhoffer Vol#: 401

C 13047 John Shultz Vol#: 401

C 13048 Stephen & Kimberly Tichenor Vol#: 401

C 13049 Dr. Gut Markham Vol#: 401

C 13050 Harvey & Gloria Haase Vol#: 401

C 13051 Linda Hash Vol#: 401

C 13052 Kenneth T. Larson Vol#: 401

C 13053 Ann Lents Vol#: 401

C 13054 Ardith Truhan Vol#: 401

C 13055 Terry Brodnick Vol#: 401

C 13056 Ann E. Smith Vol#: 401

C 13057 Darlene Jakuss Vol#: 401

C 13058 E. Regina Stewart Vol#: 401

C 13059 Christina LaVaughn Vol#: 401

C 13060 Carolyn DiTomaso Vol#: 401

C 13061 Clark M. Tyler Vol#: 401

C 13062 Becky J. Rizun Vol#: 401

C 13063 Lori Jruin Vol#: 401

C 13064 Annelise Bucci Vol#: 401

C 13065 Christine Balint Vol#: 401

C 13066 Paula Bronson Vol#: 401

C 13067 Dr & Mrs J. Lauar Wozzel Vol#: 401

C 13068 Julie Ugolini Vol#: 401

C 13069 Kathleen Renanden Vol#: 401

C 13070 Elta Harper Vol#: 401

C 13071 Kathleen M. Lyndon Vol#: 401

C 13072 Jenny D. Green Vol#: 401

C 13073 Annie Zimmerman Vol#: 401

C 13074 Cindy Martin Vol#: 401

C 13075 Sarah Ann Renm Vol#: 401

C 13076 R. Schaffer, MD Vol#: 401

C 13077 Janet F. Foster Vol#: 401

C 13078 Maggie & Michael Bennett Vol#: 401

C 13079 Jaime & Arlene Cano Vol#: 401

C 13080 Sandra Kay Yandell Vol#: 401

C 13081 Walter L. Presley Vol#: 401

C 13082 Diane L. Zook Vol#: 401

C 13083 Timothy Judge Vol#: 401

C 13084 Robert Maxwell Vol#: 401

C 13085 Alice M. Webber Vol#: 401

C 13086 Shelly E. McKnight Vol#: 401

C 13087 Julie Terrell Vol#: 401

C 13088 Carol Wingeier Vol#: 401

C 13089 Kathleen A. Irish Vol#: 401

C 13090 Joan Trombini Vol#: 401

C 13091 Ann H. Savage Vol#: 401

C 13092 Robert Lenz Vol#: 401

C 13093 Daniel C. Shively Vol#: 401

C 13094 Krista M. Delaplane Vol#: 401

C 13095 Eve V. Eden Vol#: 401

C 13096 Fredrica Parlett Vol#: 401

C 13097 Cherie Pickett Vol#: 401

C 13098 Laura Schepps Vol#: 401

C 13099 Kim Crabill + 12 signatures Vol#: 401

C 13100 Yesha Naik Vol#: 401

C 13101 Julia Cheri Hoos Vol#: 401

C 13102 Carolyn Pankow Vol#: 401

C 13103 Johnathon Brammer Vol#: 401

C 13104 Frank J. Pfizenmayer Vol#: 401

C 13105 Janet Levine Vol#: 401

C 13106 Laura G. Katz Vol#: 401

C 13107 Dr. Doris A. Jaramillo Vol#: 401

C 13108 Linda Melvin Vol#: 401

C 13109 Brenda J. Curtin Vol#: 401

C 13110 Melissa A. Calabrese Vol#: 401

C 13111 Mary Ashwood Vol#: 401

EMC 2742 Suzanne Grasser Vol#: 402

EMC 2743 Jaime Van Zant Vol#: 402

EMC 2744 Melanie Ogilive Vol#: 402

EMC 2745 R. S. LaPlante Vol#: 402

EMC 2746 Sweetbay Vol#: 402

EMC 2747 Charlotte Sherman Vol#: 402

EMC 2748 Charlene Sherman-Ragatz Vol#: 402

EMC 2749 Andrew Ragatz Vol#: 402

EMC 2750 Carrie Jahde Vol#: 402

EMC 2751 Elaine Nowak Vol#: 402

EMC 2752 Maria H. Kamenos Vol#: 402

EMC 2753 Cynthia Coward Vol#: 402

EMC 2754 Diana Stover Vol#: 402

EMC 2755 Deborah Parmley-Weinstein Vol#: 402

EMC 2756 Wat Stearns Vol#: 402

EMC 2757 Madelyn Sundquist Vol#: 402

EMC 2758 Roy Jet Vol#: 402

EMC 2759 CrowNin Vol#: 1402

EMC 2760 M. McHale Vol#: 402

EMC 2761 Vicki King Vol#: 402

EMC 2762 John Johnson Vol#: 402

EMC 2763 Greedo45 Vol#: 402

EMC 2764 Alice Forner Vol#: 402

EMC 2765 John Miglietta Vol#: 402

EMC 2766 Joanne Camas Vol#: 402

EMC 2767 Thathurts Vol#: 402

EMC 2768 Beth J. Bush-Greenstein Vol#: 402

EMC 2769 J. Bailey Vol#: 402

EMC 2770 Caroline Kreide Vol#: 402

EMC 2771 Bonnie Leifer Vol#: 402

EMC 2772 Gerald Bishop Vol#: 402

EMC 2773 Roger Parent Vol#: 402

EMC 2774 Sandy Fuchs Vol#: 402

EMC 2775 Baha39 Vol#: 402

EMC 2776 Terri Holderith Vol#: 402

EMC 2777 Karen Traub Vol#: 402

EMC 2778 Jessica Tierney Vol#: 402

EMC 2779 Amy S. Ciccarelli Vol#: 402

EMC 2780 Cal & Lynn Lutz Vol#: 402

EMC 2781 LeDean Bruns Vol#: 402

99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia

BKG 1 Background to PDN2 Vol#: 9

00D-0785 GUIDANCE ON MEDICAL DEVICE PATIENT LABELING

C 1 Medtronic, Inc. Vol#: 1

C 2 HIMA Vol#: 1

00D-1223 Clinical Investigation of Medicinal Products in Pediatrics

C 14 Procter & Gamble Pharmaceuticals Vol#: 1

00H-1043 Civil Money Penalty:Casey's General Stores Inc dba #1366

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00N-0725 ''Inerstate Shellfish Dealers Certificate

N 2 Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

C 2 Congress of the United States Vol#: 1

C 3 Congress of the United States Vol#: 1

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

APE 48 NARAL Vol#: 2

APE 49 Linda M. Borschuk Vol#: 2

APE 50 Dr. Mario Guralnik Vol#: 2

APE 51 Kaiser Permanente Health Plan, Inc. Vol#: 2

APE 52 University of California, San Francisco Vol#: 2

APE 53 American Pharmaceutical Association Vol#: 2

APE 54 Cosmetic, Toiletry and Fragrance Assoc Vol#: 2

APE 55 Francesco International Vol#: 2

APE 56 Blue Cross and Blue Shield Association Vol#: 2

APE 57 Mothers of Asthmatics, Inc. Vol#: 2

APE 58 Berlex Laboratories Vol#: 2

CH 48 Charo Lopez Vol#: 1

CH 49 Janet M. Selby Vol#: 1

00N-1266 Report to Congress on Pediatric Exclusivity

C 1 Byron Chemical Company, Inc. Vol#: 1

C 2 NAPM, Nat Assn. of Pharm Mfr. Vol#: 1

C 3 Teva Pharmaceuticals USA Vol#: 1

C 4 Bristol-Myers Squibb Company Vol#: 1

00N-1283 Reporting & Recordkeeping Requirements/Electronic Products

N 1 Vol#: 1

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

MM 3 HFS-830 & McNeil Consumer Healthcare Vol#: 4

MM 4 HFS-830 & McNeil Consumer Healthcare Vol#: 4

MM 5 HFS-830 & McNeil Consumer Healthcare Vol#: 4

00P-1329 Permit dietary supplement manufacturer to include the phrase

ACK 1 HFA-305 Vol#: 1

CP 1 Arnall Golden & Gregory, LLP. Vol#: 1