Food and Drug Administration

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 January 18, 2000

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

[FDA DOCKETS PAGE][FDA HOME PAGE] [ ITEM CODES ]

97N-484S Human Cellular and Tissue-Based Products*
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
98N-0607 General Requirements for Blood,Blood Components and Derivati *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-5013 Labeling of Over-the-Counter Human Drug Products/column form *
99P-4617 Extend the Implementation Dates of the OTC Drug Labeling Rul *
00V-0211 *

97N-0451 Microbial Safety of Produce; Public Meeting

C 95 Denise Denkinger Vol#: 15

97N-484S Human Cellular and Tissue-Based Products

C 355 Form letter count 16 Vol#: 20

C 356 Form letter count 6 Vol#: 21

C 357 Kevin Jon Lawson, M.D. Vol#: 19

C 358 Neurology & Neurosurgery Associates, P.A Vol#: 19

C 359 Reproductive Biology Laboratory Vol#: 19

C 360 Long Island Fertility & Endocrinology IV Vol#: 19

C 361 Conceptions Women's Hlth & Fertility Spe Vol#: 19

C 362 Donald E. Burtchin Vol#: 19

C 363 University of TX Southwestern Med. Ctr. Vol#: 19

C 364 Advanced Fertility Center of Chicago Vol#: 19

C 365 Dov B. Goldstein, M.D. Vol#: 19

C 366 OHSU, Oregon Health Sciences University Vol#: 19

C 367 Carolinas Medical Center Vol#: 19

C 368 Alfred J. Rodriguez, M.D., P.A. Vol#: 19

C 369 Dartmouth Hitchcock Medical Center Vol#: 19

C 370 Howard Shortley, M.D. Vol#: 19

C 371 San Francisco Ctr for Reproductive Medic Vol#: 19

C 372 AANS & CNS Vol#: 19

C 373 Northwest Lions Eye Bank Vol#: 19

C 374 Reproductive Science Institute Vol#: 19

C 375 Institute for Reproductive Medicine & Sc Vol#: 19

C 376 Susan P. Willman, M.D. Vol#: 22

C 377 Neurological Associates Vol#: 22

C 378 Ellen L. Bren Vol#: 22

C 379 Stewart Emore Vol#: 22

C 380 Iowa Neurological Surgery PC Vol#: 22

C 381 Mark W. Howard, M.D. Vol#: 22

C 382 Arkansas Spine Center Vol#: 22

C 383 LOC, Lakewood Orthopaedic Clinic, P.C. Vol#: 22

C 384 Henry Ford Health System Dept. of Neuros Vol#: 22

C 385 University of Rochester Medical Ctr Vol#: 22

C 386 Southeastern Fertility Institute Vol#: 22

C 387 Central Florida Lions Eye & Tissue Bank, Vol#: 22

C 388 Long Island Neurosurgical Associates, PC Vol#: 22

C 389 Appalachian Fertility & Endocrinology Ct Vol#: 22

C 390 Northwest Ctr for Infertility & Reproduc Vol#: 22

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 321 HFS-456 to VIVA Life Science Inc Vol#: 8

LET 322 HFS-456 to Traco Labs Inc Vol#: 8

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

CS 5 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

98N-0337 Over the counter human drugs labeling requirements

LET 3 HF-11 to CHPA Vol#: 4

98N-0607 General Requirements for Blood,Blood Components and Derivati

C 14 American Red Cross Vol#: 2

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 697 Debi Batini + 13 others Vol#: 23

C 698 Jane Sutcliffe Franzak Vol#: 23

C 699 Isabel N Ebrahimi Vol#: 23

C 700 Fairview Industries Inc Vol#: 23

C 701 Kristin M Ebbert Vol#: 23

C 702 Michael F Garger DC Vol#: 23

C 703 Marianna M Rivinus Vol#: 23

C 704 Lori Cangilose Vol#: 23

C 705 Lorna Masleniker Vol#: 23

C 706 Ward Stalnaker Vol#: 23

C 707 Meg Ryan Vol#: 23

C 708 Claudia Wilson Vol#: 23

C 709 William & Lois Bishop Vol#: 23

C 710 Michael P Anderson Vol#: 23

C 711 E Ann Hosmer MD Vol#: 23

C 712 Lora Byxbe Vol#: 23

C 713 Franciscan Sister of the Poor Vol#: 23

C 714 Katherine Conkling Thompson Vol#: 23

C 715 Debbie Saleh Vol#: 23

C 716 Deborah M Gillen Vol#: 23

C 717 Suzanne E Watson Vol#: 23

C 718 Susan & Hubert van Asch van Wyck Vol#: 23

C 719 Charlotte B Sornborger Vol#: 23

C 720 Fund for Animals Inc Vol#: 23

C 721 Jonathan Peter Vol#: 23

C 722 Alexandra Stockwell Vol#: 23

C 723 Robert Cohen Vol#: 23

C 724 G. B. Vol#: 23

C 725 Greg Edblom Vol#: 23

C 726 Becky Anderson Vol#: 23

C 727 Louise Cargiuolo Vol#: 23

C 728 Muriel A Horning Vol#: 23

C 729 Nicol Butters Vol#: 23

C 730 Mr & Mrs J L Denison Vol#: 23

C 731 Annette Evans Vol#: 24

C 732 William Johnson Vol#: 24

C 733 Bernice Futter Vol#: 24

C 734 Paul & Suzanne Macdonald Vol#: 24

C 735 Margaret C Howard Vol#: 24

C 736 Linda M Chivers Vol#: 24

C 737 Rebecca Biscaro RN Vol#: 24

C 738 Jane Dustin Vol#: 24

C 739 Tracie Wolfe Vol#: 24

C 740 Heidemarie Huber Vol#: 24

C 741 Sally Blaisdell Vol#: 24

C 742 Virginia Osborne Vol#: 24

C 743 Nora Olsen Vol#: 24

C 744 Maxine M Bellamy Vol#: 24

C 745 D H Wheat Vol#: 24

C 746 Joan E Shack Vol#: 24

C 747 Village Green Preservation Society Vol#: 24

C 748 Sheila Swift Vol#: 24

C 749 Kim Parker Vol#: 24

C 750 Lee Gooding + 11 signatures Vol#: 24

C 751 Charles Sone + 16 signatures Vol#: 24

C 752 Jeff Domaqalski + 20 signatures Vol#: 24

C 753 Rebecca Valentine + 3 signatures Vol#: 24

C 754 Barry & Mona Fansher Vol#: 24

C 755 Michelle Lieberman Vol#: 24

C 756 Erin Russell Vol#: 24

EMC 2 Judith Gorton Vol#: 23

EMC 3 G Hutchinson Vol#: 23

99D-5013 Labeling of Over-the-Counter Human Drug Products/column form

LET 1 HFD-560 to CHPA Vol#: 1

LET 2 HFD-560 to CTFA Vol#: 1

99H-5537 Civil Money Penalty;Qi Guang Huang;dba Chinese Kitchen

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5538 Civil Money Penalty;Spartan Stores,Inc;dba Ashcraft's

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5587 Civil Money Penalty;FFP Marketing Company,Inc;dba Robert

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99P-4617 Extend the Implementation Dates of the OTC Drug Labeling Rul

LET 1 HF-11 to CTFA Vol#: 1

00H-0103 Civil Money Penalty;Food Time,Inc;dba Food Time #92

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0105 Civil Money Penalty;Pritam,Inc;dba Mike Patel;dba One Stop

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0106 Civil Money Penalty;Premium Liquors,Inc;dba Premium Liquors

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0113 Civil Money Penalty;Bi-Lo,Inc;dba Bi-Lo Store #143

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0114 Civil Money Penalty;CVS Pharmacy,Inc;dba CVS Pharmacy #5586

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0115 Civil Money Penalty;Enmark Stations,Inc;dba Enmark Stations

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0116 Civil Money Penalty:Fakhoury Enterprises,Inc;dba Flash Food

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0125 Civil Money Penalty;Cherokee Food Services,LLC;dba Power

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0126 Civil Money Penalty;Doyle Ownby;D J's Market #1

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0127 Civil Money Penalty;J & B Market,Inc;dba J & B Market

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0128 Civil Money Penalty;Jim Tallman & Kay Tallman;dba Allen's

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0129 Civil Money Penalty;Julio Vasquez;dba Don Julio Grocery

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0130 Civil Money Penalty;Kreiser Fuel Service,Inc;dba North

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0131 Civil Money Penalty;Merrimack Fuel Mart,Inc;dba Merrimack

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0132 Civil Money Penalty;Onas Justus & Jenella Justus;dba J & J

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0133 Civil Money Penalty;Smith & Woods Management Corporation;BP

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0134 Civil Money Penalty;Walgreen Arizona Drug Co;dba Walgreens

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0142 Civil Money Penalty;Laxmi Enterprises Inc,dba E-Z Convenienc