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 August 4, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
82N-0165 Orally administered menstrual drug prod for OTC *
96P-0480 Final Rule Re: Extralabel Drug Use in Animals *
97P-0498 Label foods & beverages containing greater than 5mg caffeine *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1265 Distribution of Compounded Drug Products *
98P-0008 Ban Cornstarch Powder on Latex Gloves *
98P-0869 Pediatric Studies of Drugs Provision of FDAMA - Section 505A *
99M-2605 PMA Novacor Left Ventricular Assist System *
99M-2606 PMA Guidant Pulsar & Pulsar Max Pulse Generators *
99N-1393 State Petitions for Exemption from Preemption *
99P-2630 Establish a Daily Value for "added sugars" *
82N-0165 Orally administered menstrual drug prod for OTC

PDN 3 HFD-560 to Direct Pharmaceuticals LTD Vol#: 10

96N-0417 CGMP in Packing or Holding Dietary Supplements

C 88 Herbal Alternatives USA Vol#: 3

EC 1 Edward M. Lieskovan, Pharm.D. Vol#: 3

96P-0480 Final Rule Re: Extralabel Drug Use in Animals

PDN 1 HFC-1 to Int'l Ctr for Tech Assessment Vol#: 1

97P-0498 Label foods & beverages containing greater than 5mg caffeine

LET 4 University of Vermont Vol#: 1

98H-1025 Civil Money Penalties;G E T Inc.,d/b/a 1st Stop Food Store 2

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

98N-0044 Effect of dietary supplement on structure/function of body

C 22354 Form Letters Count 14 Vol#: 872

C 22355 Lauren Oujiri Vol#: 871

98N-0617 Treatment of Narcotic Dependence

C 1 Harborview Medical Center Vol#: 1

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

C 4547 Nicole Morris Vol#: 113

C 4548 illegible Vol#: 113

C 4549 L. C. Gardner Vol#: 113

C 4550 Sarah E. Steinberg Vol#: 113

C 4551 Margeny Walker Vol#: 113

C 4552 Paul A. McCutchen Vol#: 113

C 4553 Amy Countryman Vol#: 113

C 4554 Dianna J. Dennell RN/ND Vol#: 113

C 4555 John L. Close Vol#: 113

C 4556 Alahna Weller Vol#: 113

C 4557 David Anton Vol#: 113

C 4558 W. H. Vol#: 113

C 4559 Alice S. Fenn Vol#: 113

C 4560 Elisa Maria Butterfield Vol#: 113

C 4561 no signature Vol#: 113

C 4562 Maida Hendelsin Vol#: 113

C 4563 Jeff Aycrigg Vol#: 113

C 4564 Virginia Gould RN Vol#: 113

C 4565 Rebecca Groff Vol#: 113

C 4566 Edmund F. Kuell Vol#: 113

C 4567 Doreen Stabinsky, Ph.D. Vol#: 113

C 4568 Dr. David Feldman Vol#: 113

C 4569 Alana D. Olson Vol#: 113

C 4570 Ben L. Cox Vol#: 113

C 4571 Mark Skrabacz Vol#: 113

C 4572 Susan Higgins Vol#: 113

C 4573 no signature Vol#: 113

C 4574 Myla Reson Vol#: 113

C 4575 Mark R. Lee Vol#: 113

C 4576 Frederick E. Sawyer Vol#: 113

C 4577 Ethan Bloch Vol#: 113

C 4578 Nancy J. Messer Vol#: 113

C 4579 Custina Goff Vol#: 113

C 4580 Cathy Robbins Vol#: 113

C 4581 E. Treffs Vol#: 113

C 4582 David Zeitlin Vol#: 113

C 4583 Judy Scotnicki Vol#: 113

C 4584 B. Geary Vol#: 113

C 4585 Margaret Vol#: 114

C 4586 Corrie Conklin Vol#: 114

C 4587 Elina Wadds Vol#: 114

C 4588 6 signatures Vol#: 114

C 4589 Susan Quinn Vol#: 114

C 4590 Elaine Schenk Vol#: 114

C 4591 Kim Kirley Vol#: 114

C 4592 Charlene Kirley Vol#: 114

C 4593 Cherrie Jacobsen Vol#: 114

C 4594 Gail Imamura Vol#: 114

C 4595 Luke Kirley Vol#: 114

C4596 Maribeth Hulsey Vol#: 114

98N-1265 Distribution of Compounded Drug Products

C 4699 Pamela Rogers Mann Vol#: 150

C 4700 Susan Marshall Vol#: 150

C 4701 Debora Chelson Vol#: 150

C 4702 N. Marley Robertson N.M.D. Vol#: 150

C 4703 Judith R. Stine Vol#: 150

C 4704 Kathryn A. Barnidge Vol#: 150

C 4705 Helen Ross Vol#: 150

C 4706 Mary Kahler Hench Vol#: 150

C 4707 Laura Granson Vol#: 150

C 4708 T. Wolf Vol#: 150

C 4709 Stephanie Ellenhogen Vol#: 150

C 4710 Harrietta Murphy Vol#: 150

C 4711 Donna Marans Vol#: 150

C 4712 Terry Martin Vol#: 150

C 4713 Diane C. Nixon Vol#: 150

C 4714 Lenora Hurst Vol#: 150

C 4715 Debra Jackson Vol#: 150

C 4716 Elizabeth Ahn Vol#: 150

C 4717 Judith Rymer Vol#: 150

C 4718 H. Rosenberg Vol#: 150

C 4719 Esther Wallach Vol#: 150

C 4720 Elizabeth Roussel Vol#: 150

C 4721 Susan Spitz Vol#: 150

C 4722 Audrey M. Rauch Vol#: 150

C 4723 Beth Pouncey Vol#: 150

C 4724 Betsy Feinberg Vol#: 150

C 4725 Lee Pratt Vol#: 150

C 4726 Tommie L. Smoot Vol#: 150

C 4727 Kathleen Allohette Vol#: 150

C 4728 Angela Ober Vol#: 150

C 4729 A. Kessel Vol#: 150

C 4730 Alice Megonigal Vol#: 150

C 4731 Kathleen Partins Vol#: 150

C 4732 Ann Townsend Vol#: 150

C 4733 Joan Lorenzana Vol#: 150

C 4734 Elizabeth Crowell Vol#: 150

C 4735 M. Corey Vol#: 150

C 4736 Janice Williams Vol#: 150

C 4737 Marilyn Cargeman Vol#: 150

C 4738 Ruth L. Bell Vol#: 150

C 4739 Rhonda Weaver Vol#: 150

C 4740 Mikell Murphy Vol#: 150

C 4741 Mimi Lippincott Vol#: 150

C 4742 D. Mackovitch Vol#: 150

C 4743 Mary M. Greene Vol#: 150

C 4744 Elaine J. Laird Vol#: 150

C 4745 Karen Watson Vol#: 150

C 4746 Marion A. Tott Vol#: 150

C 4747 Lois Rickmann Vol#: 150

C 4748 Ruth Green Vol#: 150

C 4749 George Reading Vol#: 150

C 4750 Patricia Cook Vol#: 150

C 4751 Jeanette D. Gregg Vol#: 150

C 4752 Janet Bochoff Vol#: 150

C 4753 Arlene J. Mahler Vol#: 150

C 4754 Cecilia Rodriguez Vol#: 150

C 4755 Linda M. Cate Vol#: 150

C 4756 Susan P. Schaller Vol#: 150

C 4757 James Croonquist Vol#: 150

C 4758 Amy M. Manges Vol#: 150

C 4759 Ann Gilbert Vol#: 150

C 4760 Garth Penoff Vol#: 150

C 4761 Charlotte Popper Vol#: 150

C 4762 Sue Johnson Vol#: 150

C 4763 Jeanne Gross Vol#: 150

C 4764 Debra L. Raab Vol#: 150

C 4765 Annamarie Strote Vol#: 150

C 4766 Yvonne Van Asten Vol#: 150

C 4767 Elyse Rosenblum Vol#: 150

C 4768 Sylvia Melvin Vol#: 150

C 4769 Sandra Pfeffer Vol#: 150

C 4770 Linda Netzloff Vol#: 150

C 4771 Cynthia Akin Vol#: 150

C 4772 E. E. Gillespie Vol#: 150

C 4773 Regina Camelonge-Mahoney Vol#: 150

C 4774 Nancy W. Colley Vol#: 150

C 4775 Nancy Woodroff Vol#: 150

C 4776 Diane Medici Vol#: 150

C 4777 Carla Fischer Vol#: 150

C 4778 Joie & Lew Goodkin Vol#: 150

C 4779 Lydia D. Morris Vol#: 150

C 4780 Robert Gienta Vol#: 150

C 4781 Julie Hattory Vol#: 150

C 4782 Lynette Putterman Vol#: 150

C 4783 Adriane Stewart Vol#: 150

C 4784 Janet Moran-Kagel Vol#: 150

C 4785 Dortha Mattox Vol#: 150

C 4786 Marjorie Willis Vol#: 150

C 4787 Jeanne P. Price Vol#: 150

C 4788 Juliet Hall Vol#: 150

C 4789 Anne L. DeLorenzo Vol#: 150

C 4790 Sydney L. Parker Vol#: 150

C 4791 Gail Mason Vol#: 150

C 4792 Nada S. Bevic Vol#: 150

C 4793 Denise Sullivan Vol#: 150

C 4794 MaryAnn Colonna Vol#: 150

C 4795 Josephine O'Sullivan Vol#: 150

C 4796 Ellen Bowen Vol#: 150

C 4797 Risa Beth Sydelle Vol#: 150

C 4798 Marie Stengone Vol#: 150

C 4799 Melanie Haley Vol#: 150

C 4800 Catherine Bodenhorn Vol#: 150

C 4801 Erika P. Hawkins Vol#: 151

C 4802 Shirley Howden Vol#: 151

C 4803 Illegible Vol#: 151

C 4804 Mable Harvey Vol#: 151

C 4805 Patricia Williams Vol#: 151

C 4806 Steven Santos Vol#: 151

C 4807 Barry C. Danforth Vol#: 151

C 4808 Elizabeth Bellamy Vol#: 151

C 4809 Marcia Goldstein Vol#: 151

C 4810 Melissa Zwanger Vol#: 151

C 4811 E. Heel Cohen Vol#: 151

C 4812 Jill Cashman Vol#: 151

C 4813 Dorothy Holt Vol#: 151

C 4814 Nancy Engel Vol#: 151

C 4815 Judith S. Blalock Vol#: 151

C 4816 Joyce Spitzer Vol#: 151

C 4817 Rita D. Gnap Vol#: 151

C 4818 Anastasia Maggi Vol#: 151

C 4819 Suzanne M. Knighton Vol#: 151

C 4820 Susan E. Gaulke Vol#: 151

C 4821 Susan Ealing Vol#: 151

C 4822 JoAnna Graves Vol#: 151

C 4823 Susan Dietz Vol#: 151

C 4824 Amy Banker Vol#: 151

C 4825 Patricia J. Downs Vol#: 151

C 4826 Albert M. Lazzo Vol#: 151

C 4827 Sharon Porter Vol#: 151

C 4828 Howard & Linda Meyer Vol#: 151

C 4829 Nancy Carroll Jones Vol#: 151

C 4830 Alan Brauer Vol#: 151

C 4831 G. Silma Vol#: 151

C 4832 Linda Dungan Vol#: 151

C 4833 Diane Papasavas Vol#: 151

C 4834 Rita L. Merk Vol#: 151

C 4835 Carolyn R. Butler Vol#: 151

C 4836 Judith K. Steel Vol#: 151

C 4837 Bernice Kreger Vol#: 151

C 4838 Darlene Leli Vol#: 151

C 4839 Laurie J. Diesher Vol#: 151

C 4840 L. Drake Vol#: 151

C 4841 Helen J. Congo Vol#: 151

C 4842 Janice E. Davis Vol#: 151

C 4843 B. Shere Vol#: 151

C 4844 Carol Codner Vol#: 151

C 4845 Joyce Jacques Vol#: 151

C 4846 Ramona W. James Vol#: 151

C 4847 Pharmacists Society of the State of NY Vol#: 151

C 4848 Marilyn J. Martinez Vol#: 151

C 4849 Kelly Lynch Vol#: 151

C 4850 Joan Engel Vol#: 151

C 4851 Bess Tawtman Vol#: 151

C 4852 Elaine Tawtman Vol#: 151

C 4853 Susan Haleper Vol#: 151

C 4854 Eleftheria Haritos Vol#: 151

C 4855 Donna Brauer Vol#: 151

C 4856 Fred Astaire Dance Studios Vol#: 151

C 4857 Karin Lyngstad, DC Vol#: 151

C 4858 Ann Martindale Vol#: 151

C 4859 Jacobi Group Vol#: 151

C 4860 V. M. Johnson Vol#: 151

C 4861 Karen Johnson Vol#: 151

C 4862 Elizabeth Ortman Vol#: 151

C 4863 David Lebe Vol#: 151

C 4864 Jack H. Potter Vol#: 151

C 4865 Jill Doughty Vol#: 151

C 4866 Valerie Sottysiak Vol#: 151

C 4867 Kathleen Thomas Vol#: 151

C 4868 Monna Sweatt Vol#: 151

98P-0008 Ban Cornstarch Powder on Latex Gloves

PDN 1 HFZ-1 to Health Research Group Vol#: 7

98P-0869 Pediatric Studies of Drugs Provision of FDAMA - Section 505A

PDN 1 HFD-1 to Pharmaceutical Formulation Inc Vol#: 1

99H-0578 Civil Money Penalties;Sinclair Oil Corp,d/b/a Sinclair

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-0641 Civil Money Penalties;Jim Levingston,d/b/a Total Comet Stop

WDL 1 GCF-1 Vol#: 1

99H-1205 Civil Money Penalty;Rowe-Mentone Inc d/b/a Five Star Conveni

ANS 2 Rowe Mentone Inc Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2019 Civil Money Penalty;D K J Corp,dba Lancer Mart

LET 2 Office of Tobacco Programs Vol#: 1

99H-2388 Civil Money Penalty;Ratso Rizzo Inc,dba, Trail Head Tavern

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2487 Civil Money Penalty;Henry Arnzen,dba,Henry's Bar & Grill

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2488 Civil Money Penalty;Best-Wade Petroleum Inc,dba,Short Stop F

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2489 Civil Money Penalty;Equilon Enterprises LLC,dba Texaco Star

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2490 Civil Money Penalty;Greer Autry & Sons Inc,dba Greer's Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2491 Civil Money Penalty;Hari Inc,dba Blue's #3

LET 1 Offie of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2492 Civil Money Penalty,Lawrence Harvey,dba Larry's Lunch

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2493 Civil Money Penalty;Host Enterprises Inc,dba Winks

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2494 Civil Money Penalty;IMS Group Inc,dba Quik Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2495 Civil Money Penalty;Logan Superfoods Inc,dba Harvey's Fine

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2496 Civil Money Penalty;Piggly Wiggly of Union,dba Piggly Wiggly

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2522 Civil Money Penalty;Big Store Inc,dba Big Store IGA

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2523 Civil Money Penalty;D&S Grocers Inc,dba Corner Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2524 Civil Money Penalty;L.R.'S Discount Gas & Foods Inc,dba L.R.

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2525 Civil Money Penalty;Jim Nassis,dba Tatnuck Square Getty Inc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2526 Civil Money Penalty;Schrader Oil Co,dba Schrader's Country

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2527 Civil Money Penalty;Brenda J. Taylor,dba Taylor's Express Ma

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2528 Civil Money Penalty;Rev Enterprises Inc,dba Sandy's #1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2529 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #1273

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99M-2605 PMA Novacor Left Ventricular Assist System

AAV 1 Baxter Healthcare Corp. Vol#: 1

99M-2606 PMA Guidant Pulsar & Pulsar Max Pulse Generators

AAV 1 Guidant Corp. Vol#: 1

99N-1174 Development of Strategy for Dietary Supplements

C 35 Jim Thomas Vol#: 1

99N-1393 State Petitions for Exemption from Preemption

C 1 The Association for Dressings & Sauces Vol#: 1

C 2 International Jelly & Preserve Assn. Vol#: 1

99P-2630 Establish a Daily Value for "added sugars"

ACK 1 HFA-305 Vol#: 1

CP 1 CSPI Vol#: 1