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 July 21, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

98N-0337 Over the counter human drugs labeling requirements *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1265 Distribution of Compounded Drug Products *
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99P-1340 Declared Eternity eau de Parfum Misbranded *
98H-1114 Civil Money Penalites;Interstate Foods Inc,d/b/a the Curb

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1152 Civil Money Penalties;Gant Oil Co.,d/b/a Gant Oil Station 30

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1155 Civil Money Penalties;1 Stop Mini Mart Inc

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1157 Civil Money Penalties;Mundelein Amoco Inc,d/b/a Mundelein Am

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1175 Civil Money Penalties;Eads News Inc,d/b/a Eads News & Smoke

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1177 Civil Money Penalties; Food Maxx Inc

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1179 Civil Money Penalties; Ruth Gillis,d/b/a Gillis General Merc

LET 2 Office of Tobacco Programs Vol#: 1

98H-1202 Civil Money Penalties; Lake Sammamish Mini Mart Inc & Bruce

EXB 1 GCF-1 Vol#: 1

98N-0337 Over the counter human drugs labeling requirements

OB 1 CHPA, Consumer Healthcare Products Assn. Vol#: 1

98N-1038 Irradiation in the production, processing, &handling of food

C 3617 Elaine Davis Vol#: 98

C 3618 Rev. Dick & Mary Weston-Jones Vol#: 98

C 3619 Naomi Mallinson Vol#: 98

C 3620 Mr. & Mrs. Bill Moehring Vol#: 98

C 3621 Bill & Sharon Schnoebelen Vol#: 98

C 3622 Bill Yeary Vol#: 98

C 3623 Wendell Whitman Vol#: 98

C 3624 Nancy Coulter Vol#: 98

C 3625 Mr. Christian R. Brown Vol#: 98

C 3626 Debbie Huber Vol#: 99

C 3627 Kelle Vol#: 99

C 3628 Brian Koehler Vol#: 99

C 3629 David Bye Vol#: 99

C 3630 Ran Vol#: 99

C 3631 Ezequiel & Irma Barragan Vol#: 99

C 3632 Concerned citizen Vol#: 99

C 3633 Russ Michael Vol#: 99

C 3634 Vernette Vol#: 99

C 3635 Carolyn A. Stone Vol#: 99

C 3636 Dave Adams Vol#: 99

C 3637 Ahuva Ragdoll Vol#: 99

C 3638 Marian S. Tucker Vol#: 99

C 3639 Andrew Epstein Vol#: 99

C 3640 Anson Chong Vol#: 99

C 3641 Judi L. Kelley Vol#: 99

C 3642 Anita Shattuck Vol#: 99

C 3643 Beverly Morris Vol#: 99

C 3644 Dr. Barry Green Vol#: 99

C 3645 Peggy L. Prucha Vol#: 99

C 3646 Karen Bufka Vol#: 99

C 3647 Claudia Vol#: 99

C 3648 American Assn. of Nutritional Consultant Vol#: 99

C 3649 Dr. Hiroshi Satomi (Tokyo) Vol#: 99

C 3650 RoseMarie Georgatos Vol#: 99

C 3651 Doug Vol#: 99

C 3652 Jeanne McWilliams Vol#: 99

C 3653 John M. Camfield, Ph.D. Vol#: 99

C 3654 John Marchese Vol#: 99

C 3655 John Pelrine Vol#: 99

C 3656 Concerned in Indiana Vol#: 99

C 3657 Judy Bentley Vol#: 99

C 3658 Karen Johnson Vol#: 99

C 3659 Kathy Summerhays Vol#: 99

C 3660 Katherine Prown, Ph.D. Vol#: 99

C 3661 Kim Odell Vol#: 99

C 3662 Kim K. Sperry Vol#: 99

C 3663 Kathryn & Ron Khosla Vol#: 99

C 3664 Carol Lankfer Vol#: 99

C 3665 Laura Heidinger Vol#: 99

C 3666 Laura Schlivek Vol#: 99

C 3667 Linda L. Gates Vol#: 99

C 3668 Heather A. Myers Vol#: 99

C 3669 Juliette Haynes Vol#: 99

C 3670 Eileen Coleman Vol#: 99

C 3671 Elizabeth A. Florwick, RN, CNHP Vol#: 99

C 3672 Geneva Durkee Vol#: 99

C 3673 Jennifer A. Fox Vol#: 99

C 3674 Gift Vol#: 99

C 3675 Joyce Epstein Vol#: 99

C 3676 American Assn of Nutritional Consultants Vol#: 99

C 3677 Dee Holl-Matthews Vol#: 99

C 3678 Marilyn J. Wulff Vol#: 99

C 3679 Anthony White Vol#: 99

C 3680 Lori Alogna Vol#: 99

C 3681 Food Irradiation Network Japan Vol#: 99

C 3682 Holte Vol#: 99

C 3683 MCN Vol#: 99

C 3684 Dannette Riddle Vol#: 99

C 3685 Jan Vol#: 99

C 3686 Jeanie Levitan Vol#: 99

C 3687 Matthew B. Miller Vol#: 99

C 3688 Mary Kasse Vol#: 99

C 3689 Lynn Schuetze Vol#: 99

C 3690 Ames Research Center Vol#: 99

C 3691 Wade Mock Vol#: 99

C 3692 Margaret Weston Vol#: 99

C 3693 Monica Klug Vol#: 99

C 3694 Eric Johnson Vol#: 99

C 3695 Meg Walters Vol#: 99

C 3696 William D. & Nancy A. Steinbach Vol#: 99

C 3697 Poo-Kay Vol#: 99

C 3698 Frank Rankin Vol#: 99

C 3699 Richard Cicchetti Vol#: 99

C 3700 Robert P. Schultz Vol#: 99

C 3701 Sharon L. Fox Vol#: 99

C 3702 Lynn Holter Vol#: 99

C 3703 S.K. Holleman Vol#: 99

C 3704 Marcie McGrath-Wall Vol#: 99

C 3705 Maxtec Peripherals Vol#: 99

C 3706 Stephen W. Hager Vol#: 99

C 3707 Stirling Cousins Vol#: 99

C 3708 Leonard Seastone Vol#: 99

C 3709 Sundara Tours Vol#: 99

C 3710 Susan Evans Vol#: 99

C 3711 Sarah Tamblyn Vol#: 99

C 3712 Nan Trump Vol#: 99

C 3713 Willow Vol#: 99

C 3714 Claire Morris Vol#: 100

C 3715 Lee Lewis Vol#: 100

C 3716 Charles K. Alexander III Vol#: 100

C 3717 Cynthia Christensen Vol#: 100

C 3718 Susan Longtin Vol#: 100

C 3719 Teresa Whitaker Vol#: 100

C 3720 Rebecca C. Glasscock Vol#: 100

C 3721 Dr. Darrel Crain Vol#: 100

C 3722 Katie Finkelstein Vol#: 100

C 3723 Dennis Clement Vol#: 100

C 3724 Stacey DeGroff Vol#: 100

C 3725 Susan & Ernest Zagaria Vol#: 100

C 3726 Anna Bell Clements Vol#: 100

C 3727 Arlen Grossman Vol#: 100

C 3728 Ann E. Bailey Vol#: 100

C 3729 Elizabeth G. Astridge Vol#: 100

C 3730 Gary J. Astridge Vol#: 100

C 3731 John P. Marrin Vol#: 100

C 3732 Trudy Dunham Vol#: 100

C 3733 Susan Harriet Hozer Vol#: 100

C 3734 Andrew E. Nixon Vol#: 100

C 3735 Azoath Veldo-Bartsha Vol#: 100

C 3736 Susan C. Agee Vol#: 100

C 3737 Carole Lees & Associates Vol#: 100

C 3738 Matthew Frost Vol#: 100

C 3739 Margaret R. Jaros Vol#: 100

C 3740 John Adam Vol#: 100

C 3741 Margaret Pich Vol#: 100

C 3742 Joanna Conrardy Vol#: 100

C 3743 Katia Iannacome Vol#: 100

C 3744 Maxine Lathrop Vol#: 100

C 3745 Gary & Joanne Ashley Vol#: 100

C 3746 Kevin M. McCarron Vol#: 100

C 3747 Mary Dosch Vol#: 100

C 3748 Elizabeth Outka & Oliver Pollard Vol#: 100

C 3749 Mary Elizabeth Fullon Vol#: 100

C 3750 Bonnie Mino & David Valverde Vol#: 100

C 3751 Nancy H. Maxwell Vol#: 100

C 3752 Pat & Tex LaMountain Vol#: 100

C 3753 Michael Collier Vol#: 100

C 3754 Randy & Ruth Davis Vol#: 100

C 3755 Rev. Lea D. Brown Vol#: 100

C 3756 PSRNYC, Physicians For Social Responsibi Vol#: 100

C 3757 Ross Heinrichs Vol#: 100

C 3758 Melissa Saft Vol#: 100

C 3759 Lorraine Wulfe Vol#: 100

C 3760 Robert F. Moriarty Vol#: 100

C 3761 Richard J. Sarro Vol#: 100

C 3762 John Butler Vol#: 100

C 3763 Daileen Vol#: 100

C 3764 Linda Zeigler Vol#: 100

C 3765 Keshini Ladduwahetty Vol#: 100

C 3766 Karin Taylor Vol#: 100

C 3767 Four Winds Nutrition Club Vol#: 100

C 3768 Betty Mc Vicker Vol#: 100

C 3769 Bob Gooch Vol#: 100

C 3770 Robert W. Hull Vol#: 100

C 3771 Joan Kasich Vol#: 100

98N-1265 Distribution of Compounded Drug Products

C 3783 Unites States Senate Vol#: 136

C 3784 Helen J Burke Vol#: 136

C 3785 Nancy Treinen Vol#: 136

C 3786 Betty Decker Vol#: 136

C 3787 Shirley Sinko Vol#: 138

C 3788 Grace A Day Vol#: 138

C 3789 Charlie Scott Vol#: 138

C 3790 Eileen T Fahy Vol#: 138

C 3791 Doris M Wedwaldt Vol#: 138

C 3792 Janet Gleeson Vol#: 138

C 3793 Margaret J Waggoner Vol#: 138

C 3794 Susie Zeiger Vol#: 138

C 3795 Maria Julia Garcia Vol#: 138

C 3796 Patricia Hammell Vol#: 138

C 3797 Laura Soltanoff Vol#: 138

C 3798 Barbara A Young Vol#: 138

C 3799 Elaine Reed Vol#: 138

C 3800 Sandra LaLetta Vol#: 138

C 3801 Cynthia Stephens Vol#: 138

C 3802 Kelly Gold Vol#: 138

C 3803 Kathleen Gold Vol#: 138

C 3804 Janet Rudrick Vol#: 138

C 3805 Nancy F Puls Vol#: 138

C 3806 Carol Rubinstein Vol#: 138

C 3807 R J Krauss Vol#: 138

C 3808 Lovina Werner Vol#: 138

C 3809 Mary F Cheers Vol#: 138

C 3810 Dorothy J Pultz Vol#: 138

C 3811 Mary Thorngate Vol#: 138

C 3812 Ruth M Fisher Vol#: 138

C 3813 Beverly S Sterling Vol#: 138

C 3814 Linda A Barthels Vol#: 138

C 3815 Robert & Bertha Adkins Vol#: 138

C 3816 Sandra M Tully Vol#: 138

C 3817 Susan A Falkman Vol#: 138

C 3818 Terri G Horswell Vol#: 138

C 3819 Shirley A Snyder Vol#: 138

C 3820 Elaine Wells & Demetre Lagios Vol#: 138

C 3821 Janet L Atkins Vol#: 138

C 3822 Irene Mumm Vol#: 138

C 3823 Ms Inge Flugrath Vol#: 138

C 3824 Ms Doris V McEvoy Vol#: 138

C 3825 Judith A Leahy Vol#: 138

C 3826 Faith Podolslf Vol#: 138

C 3827 Iris Cutler Vol#: 138

C 3828 Patricia L Harris Vol#: 138

C 3829 Betty M Clark Vol#: 138

C 3830 Mary E Ketterer Vol#: 138

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 193 Jean Fitzell Vol#: 12

C 194 Madonna Niles Vol#: 12

C 195 Mary Lou Ingrams Vol#: 12

C 196 Dennis & Chloe Nicholson Vol#: 12

C 197 Charlie Betcher Vol#: 12

C 198 Ms Anderson Vol#: 12

C 199 Gene Groom Vol#: 12

C 200 Theresa M Gregg Vol#: 12

C 201 Ms Suzanne Pease Vol#: 12

C 202 Mr Luiz M Seabra Vol#: 12

C 203 Jim Reynolds Vol#: 12

C 204 Shawna Owen Vol#: 12

C 205 Dori Dority Vol#: 12

C 206 June Yawrich Vol#: 12

C 207 Kenneth G DeNeal Vol#: 12

C 208 Ms Jan Kramer Vol#: 12

C 209 Avery Brown Vol#: 12

C 210 Maria A Long Vol#: 12

C 211 Katherine Peaslee Vol#: 12

C 212 Ernest & Nina Scher Vol#: 12

C 213 Dr Lyla Stone Vol#: 12

C 214 Melody Boime Vol#: 12

C 215 Jane Saks Vol#: 12

C 216 Jackie Pomies Vol#: 12

C 217 Denise Abbott Vol#: 12

C 218 Richard L Carrothers Vol#: 12

C 219 Donald R Garlit Vol#: 12

C 220 Susian Iaco Bucci Vol#: 12

C 221 Evelyn & Kathy Green Vol#: 12

C 222 Number not used Vol#: 12

C 223 Yvonne Butrick Vol#: 12

C 224 Florence R Rossi Vol#: 12

C 225 Caroline Novobilski Vol#: 12

C 226 Teri-Jo Valliere Vol#: 12

C 227 Lyndia Giglio Vol#: 12

C 228 Alma Blackwelder Vol#: 12

C 229 J Capozzelli Vol#: 12

C 230 Mrs Joseph Saeva Vol#: 12

C 231 Ms Connie Esposito Vol#: 12

C 232 Rob Branch-Dasch Vol#: 12

C 233 Kitty Brige Vol#: 12

C 234 B Santhoff Vol#: 12

C 235 Bill & Carleen Boehl Vol#: 12

C 236 Ms Celia Newman Vol#: 12

99H-0623 Civil Money Penalties;Michael Spears,d/b/a The Patriot II

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-0974 Civil Money Penalties;George Knight & Jackie Knight,d/b/a

LET 2 Office of Tobacco Programs Vol#: 1

99H-1305 Civil Money Penalties;William Bainbridge Sr & Lois Bainbridg

ANS 1 Wigg's Country Store Vol#: 1

99H-1467 Civil Money Penalties;Cathy Lee McKee,d/b/a C & E's Truck

LET 2 Office of Tobacco Programs Vol#: 1

99H-1523 Civil Money Penalties;Energy Mart Stores Inc,dba Energy Mart

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-1644 Civil Money Penalty; Rebecca Rhoades dba Silverton Liquors

LET 2 Office of Tobacco Programs Vol#: 1

99H-1668 Civil Money Penalty;Vernon Klein,dba Buckaroo Jackpot

ANS 1 Vernon Klein,dba Buckaroo Jackpot Vol#: 1

99H-1681 Civil Money Penalty;Coastal Investments Inc dba One Stop Foo

ANS 1 Coastal Investments Vol#: 1

99H-1721 Civil Money Penalty;N Gale Bennett,dba Steve's Cash Grocery

ANS 1 N Gail Bennett,dba Steve's Cash Grocery Vol#: 1

99H-1763 Civil Money Penalty;South-Western Foods Inc dba Grocery Stor

LET 2 Office of Tobacco Programs Vol#: 1

99H-1805 Civil Money Penalty;Kyung Lim Hong,dba Bell Street Deli & Gr

ANS 1 Kyung Lim Hong,dba Bell St Deli & Grocer Vol#: 1

99H-1854 Civil Money Penalty;Samuel Shoup & Nina Shoup dba Ashland Ch

ANS 1 Ashland Chevron Service Station Vol#: 1

99H-1934 Civil Money Penalty;Waring Oil Co,dba Interstate Station

ANS 1 Waring Oil Co Vol#: 1

99H-1953 Civil Money Penalty;Service Gas Co Inc,dba Sentry Food Mart

ANS 1 Service Gas Co Inc, Vol#: 1

99H-1977 Civil Money Penalty;Don Colcord,dba The Apothecary Shoppe

ANS 1 Don Colcord,dba The Apothecary Shoppe Vol#: 1

99H-2023 Civil Money Penalty;Town Zippy Mart Inc,dba Town Zippy Mart

ANS 1 Town Zippy Mart Inc Vol#: 1

99H-2090 Civil Money Penalty;Route 114 Mobil Inc,dba Route 114 Mobil

ANS 1 Route 114 Mobil Inc Vol#: 1

99H-2104 Civil Money Penalty;Waring Oil Co,dba Interstate Station #20

ANS 1 Waring Oil Co Vol#: 1

99H-2217 Civil Money Penalty;All American Quality Foods Inc,dba Quali

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2218 Civil Money Penalty;Amoco Oil Co,dba Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2219 Civil Money Penalty;Ange's Service Inc,dba Ange's Service

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2220 Civil Money Penalty;Jack Audy,dba Ames Street Mobil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2221 Civil Money Penalty;Raymond Bates,dba Deberry's Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2222 Civil Money Penalty;Lenwood Blackmon,dba B & B Kwik Serve

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2223 Civil Money Penalty;Roger Coyle,dba Anderson's Ashland Servi

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2224 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #4567

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2225 Civil Money Penalty;Felicia A Doler,dba Mr C Mini Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2226 Civil Money Penalty;Energy Retailers Inc,dba Energy Retailer

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2227 Civil Money Penalty;Eranosian Ent Inc,dba Grantville Package

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2228 Civil Money Penalty;E-Z Serve Convenience Stores Inc,dba Maj

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2229 Civil Money Penalty;Jesse Landon Hampton,dba Skullbone Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2230 Civil Money Penalty;Michael R Hanson & Elaine Hanson,dba Han

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2231 Civil Money Penalty;J & L Oil Inc,dba J & L Oil Co

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2232 Civil Money Penalty;JFM Inc,dba Jr Food Mart #10

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2233 Civil Money Penalty;Paul Lowery,dba Short Stop Travel Ctr II

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2234 Civil Money Penalty;Malecon Tobacco LLC,dba Matador Cigars

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2235 Civil Money Penalty;Racetrac Petroleumn Inc,dba Racetrac

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2236 Civil Money Penalty;Albert Rodgers,dba Rodgers Grocery & Har

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2237 Civil Money Penalty;Sayle Oil Co Inc,dba Holcomb Gas Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2238 Civil Money Penalty;Vista Marketing Inc,dba Happy Stores

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2239 Civil Money Penalty;Waco Oil Co Inc,dba Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 181 Karen Ann Watson-Gegeo Vol#: 4

C 182 Phyllis J Treglown Vol#: 4