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 October 1, 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-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell *
99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease *
99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia *
99P-4235 ANDA for a topical dermatological drug product NADs and ANDA *

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

BKG 1 Background Vol#: 1

NPR 1 Vol#: 1

98N-0337 Over the counter human drugs labeling requirements

ACK 2 HFA-305 Vol#: 3

CP 2 The Consumer Healthcare Products Assn Vol#: 3
 

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 487 Stephan D. Hurlburt Vol#: 20

C 488 Jennifer Vaughan Paquette Vol#: 20

C 489 Melvin S. Vol#: 20

C 490 Jessica Grodio Vol#: 20

C 491 Lynn Strother Hinkle Vol#: 20

C 492 Concerned People For Animals, Inc. Vol#: 20

C 493 Joan Mahanke Vol#: 20

C 494 Patricia A. Lopez Vol#: 20

C 495 Joe Haptas Vol#: 20

C 496 Kelly Beard-Tittone Vol#: 20

C 497 Paula N. Tice Vol#: 20

C 498 Ms. Betty J. Herner Vol#: 20

C 499 Robin Jacobson Vol#: 20

C 500 Catalina Kidd Vol#: 20

C 501 Sira Melikian Vol#: 20

C 502 Beauty Without Cruelty U.S.A. Vol#: 20

C 503 Carol A. Lawson Vol#: 20

C 504 Carleen Peitzmeyer Vol#: 20

C 505 American Cannabis Society Vol#: 20

C 506 Bonnie Lynn Comstock Vol#: 20

C 507 Jane DiRico Vol#: 20

C 508 Marian A. Kelner Vol#: 20

C 509 UEP, United Egg Producers Vol#: 21

C 510 National Restaurant Assn. Vol#: 21

C 511 Michael Smith Vol#: 21

C 512 John W. Arnold Vol#: 21

C 513 Karen Allen Vol#: 21

C 514 Monte V. Gullo Vol#: 21

C 515 Susan Rothman Vol#: 21

C 516 Bernadine Sutliff Vol#: 21

C 517 Delia K. Uherec Vol#: 21

C 518 Susan Gensinger Vol#: 21

C 519 Tim Campbell Vol#: 21

C 520 T. J. Boriths Vol#: 21

C 521 Virginia Grossman Vol#: 21

C 522 Christina Costello Vol#: 21

C 523 Will Tuttle, Ph.D. Vol#: 21

C 524 Carol Muckleroy Vol#: 21

C 525 Doris Wurst Vol#: 21

C 526 H. Kett Vol#: 21

C 527 Thomas R. Durocher Vol#: 21

C 528 Bette Kent Vol#: 21

C 529 Vanessa Gaglione Vol#: 21

C 530 Princessland Academy of Music, Inc. Vol#: 21

C 531 NERO, National Egg Regulatory Officials Vol#: 21

C 532 FACT, Food Animal Concerns Trust Vol#: 21

C 533 J. D. Foster Vol#: 22

C 534 Beth Henke Vol#: 22

C 535 Emily Amarnick Vol#: 22

C 536 Lisa Schueck Vol#: 22

C 537 Emily E. Teodorski Vol#: 22

C 538 Kerry Veber Vol#: 22

C 539 Breen Casey Vol#: 22

C 540 Brian Gruetze Vol#: 22

C 541 Rob Cullen Vol#: 22

C 542 Kevin Robinson Vol#: 22

C 543 Sara Fusco Vol#: 22

C 544 Lindsey A. Davis Vol#: 22

C 545 Sean Hanery Vol#: 22

C 546 Lauren Burkurt Vol#: 22

C 547 Levanah Bartens Vol#: 22

C 548 Charles Rosenbloom, M.D. Vol#: 22

C 549 June Anna-Fey Vol#: 22

C 550 CSPI Vol#: 22

C 551 Nicole D. Grossman Vol#: 22

C 552 Brian Watson Vol#: 22

C 553 Flannery O'Bourke Vol#: 22

C 554 Jeany Oh Vol#: 22

C 555 Jennifer Keever & Lisa Williams Vol#: 22

C 556 Ronald Wingrove Vol#: 22

C 557 Emily J. Crement Vol#: 22

C 558 Kristin Zimmerman Vol#: 22

C 559 Derek Sorg Vol#: 22

C 560 Allison M. Babin Vol#: 22

C 561 Cliff Chion Vol#: 22

C 562 Barbara Kunze Vol#: 22

C 563 Matthew Fleming Vol#: 22

C 564 Barbara E. Bingnear Vol#: 22

C 565 Richard Brown Vol#: 23

C 566 Susan Lindsay Vol#: 23

C 567 Mrs. Douglas Long Vol#: 23

C 568 Debbie Casey Vol#: 23

C 569 Christine Weisheit Vol#: 23

C 570 Ilona Auth Vol#: 23

C 571 Joan & Baxter Dow & Family Vol#: 23

C 572 Kenneth G. DeNeal, Sr., R.Ph. Vol#: 23

C 573 Gwen Woodard Vol#: 23

C 574 Eva Sprouse Vol#: 23

C 575 Inherit the Earth Vol#: 23

C 576 21 signatures Vol#: 23

C 577 Howard & Arleen Wiley Vol#: 23

C 578 For the Sake of Animals Vol#: 23

C 579 Margaret H. Thompson Vol#: 23

C 580 Atake & Associates Vol#: 23

C 581 Lina M. Alta Vol#: 23

C 582 Heidi C. Lopez Vol#: 23

C 583 Linda M. Matthews Vol#: 23

C 584 Sharon Oscar Vol#: 23

C 585 Ms. Davy Davidson Vol#: 23

C 586 Luater Potate Vol#: 23

C 587 Pasteurized Eggs, L.P. Vol#: 23

C 588 United Poultry Concerns, Inc. Vol#: 23

C 589 Polly Strand Vol#: 24

C 590 HAVE, Inc. Vol#: 24

C 591 Annmarie L. Miller Vol#: 24

C 592 Mr. Caspar Sacco Vol#: 24

C 593 Caridad Polanco Vol#: 24

C 594 Claire Manber Vol#: 24

C 595 Paul J. Alix Vol#: 24

C 596 Lauren Devine Vol#: 24

C 597 Pamela Wasserman Vol#: 24

C 598 Daniel Polana Vol#: 24

C 599 Esther Anne Rothman Vol#: 24

C 600 Anna Petrini Vol#: 24

C 601 FPI, Foodservice & Packaging Institute I Vol#: 24

C 602 W. L. Porada Vol#: 24

C 603 Bob Schramm Vol#: 24

C 604 Joseph Rizzo Vol#: 24

C 605 Omor Hassan Sayes Vol#: 24

C 606 David Wengerd Vol#: 24

C 607 D. Levner Vol#: 24

C 608 UEP, United Egg Producers Vol#: 24

LET 2 Commonwealth of Pennsylvania Vol#: 20

99N-4006 Withdrawal of Forty-Four Abbreviated New Drug Applications

LET 1 HFA-305 Vol#: 1

NWL 1 Vol#: 1

99N-4027 Classification of the Electrogastrography System

BKG 1 Background Vol#: 1

NFR 1 Vol#: 1
 
 

99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease

Following duplicates linked comments in 99P-3030 below

C 91 Bill Stout Vol#: 5

C 92 Robert L Rickenbaugh Vol#: 5

C 93 John & Sarah Jarem Vol#: 5

C 94 Mr & Mrs Keith Fisher Vol#: 5

C 95 Pauline P Root Vol#: 5

C 96 Lowell Goemaat Vol#: 5

C 97 Audrey M Groleau Vol#: 5

C 98 Mrs H Nelson Vol#: 5

C 99 Gloria Tortarolo Vol#: 5

C 100 Susan Everett Vol#: 5

C 101 Audrey Grudzien Vol#: 5

C 102 Daniel C Carey Vol#: 5

C 103 Sylvia S Beste Vol#: 5

C 104 Mrs Linda Polier Vol#: 5

C 105 Ann F Schenck Vol#: 5

C 106 Louise L Hudspeth Vol#: 5

C 107 Mary Jo Smith Vol#: 5

C 108 Edith Hagerty Vol#: 5

C 109 Stephanie S Cramer Vol#: 5

C 110 Loretta Ziegler Vol#: 5

C 111 Greg Tripodes Vol#: 5

C 112 Barbara Gilpin Vol#: 5

C 113 M C Dilibert Vol#: 5

C 114 Alice Conway Vol#: 5

C 115 David P & Edna Wiener Vol#: 5

C 116 Velma League Vol#: 5

C 117 Hunter Clark Vol#: 5

C 118 John W Barrett Vol#: 5

C 119 Beverly Farr Vol#: 5

C 120 Dr Richard H Vail Vol#: 5

C 121 Richard L Rhodes Vol#: 5

C 122 Rose G Watson Vol#: 5

C 123 S C Chillemi Vol#: 5

C 124 B Gene Stair Vol#: 5

C 125 Faynene R Zink Vol#: 5

C 126 Susan W Harvey Vol#: 5

C 127 Allen E Herbeck Vol#: 5

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

C 91 Bill Stout Vol#: 4

C 92 Robert L Rickenbaugh Vol#: 4

C 93 John & Sarah Jarem Vol#: 4

C 94 Mr & Mrs Keith Fisher Vol#: 4

C 95 Pauline P Root Vol#: 4

C 96 Lowell Goemaat Vol#: 4

C 97 Audrey M Groleau Vol#: 4

C 98 Mrs H Nelson Vol#: 4

C 99 Gloria Tortarolo Vol#: 4

C 100 Susan Everett Vol#: 4

C 101 Audrey Grudzien Vol#: 4

C 102 Daniel C Carey Vol#: 4

C 103 Sylvia S Beste Vol#: 4

C 104 Mrs Linda Polier Vol#: 4

C 105 Ann F Schenck Vol#: 4

C 106 Louise L Hudspeth Vol#: 4

C 107 Mary Jo Smith Vol#: 4

C 108 Edith Hagerty Vol#: 4

C 109 Stephanie S Cramer Vol#: 4

C 110 Loretta Ziegler Vol#: 4

C 111 Greg Tripodes Vol#: 4

C 112 Barbara Gilpin Vol#: 4

C 113 M C Dilibert Vol#: 4

C 114 Alice Conway Vol#: 4

C 115 David P & Edna Wiener Vol#: 4

C 116 Velma League Vol#: 4

C 117 Hunter Clark Vol#: 4

C 118 John W Barrett Vol#: 4

C 119 Beverly Farr Vol#: 4

C 120 Dr Richard H Vail Vol#: 4

C 121 Richard L Rhodes Vol#: 4

C 122 Rose G Watson Vol#: 4

C 123 S C Chillemi Vol#: 4

C 124 B Gene Stair Vol#: 4

C 125 Faynene R Zink Vol#: 4

C 126 Susan W Harvey Vol#: 4

C 127 Allen E Herbeck Vol#: 4

99P-4235 ANDA for a topical dermatological drug product NADs and ANDA

ACK 1 HFA-305 Vol#: 1

CP 1 Pharmacia & Upjohn Inc. Vol#: 1