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 13, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
84N-0102 Orphan Product Designations *
86V-0093 Magic eye theater/laser light show (EPCOT CTR) *
91V-0426 Request for variance for laser light show *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
94V-0074 Laser Light Show *
94V-0254 *
94V-0372 *
94V-0412 *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97P-0197 Require that warning labels about risks of salmonella *
98N-0313 Surgeons's and Patient Examination Gloves Reclassification *
98N-0607 General Requirements for Blood,Blood Components and Derivati *
98P-0683 Soy Protein Containing Products*
99D-2335 Guidance for Medical Gloves A workshop Manual *
99N-3089 Draft Affirmative Agenda for International Activities *
99N-4063 Positron emmission tomography drug products *
99P-1614 PRC for K892514 Epilator 629 by American Hair Removal
99P-1615 PRC for K905125 Guaranty Hair Removal System by Stephens 
99P-2630 Establish a Daily Value for "added sugars" *
99V-4395 Laser Light Show *

84N-0102 Orphan Product Designations

LST 89 September 1999 Vol#: 2

86V-0093 Magic eye theater/laser light show (EPCOT CTR)

EXP 2 Walt Disney World Co. Vol#: 1

91V-0426 Request for variance for laser light show

EXP 3 Walt Disney World Co. Vol#: 1

92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5988 Carolyn A Poinelic Vol#: 151

C 5989 Claire R Mullins Vol#: 151

C 5990 Sierra Club Vol#: 151

C 5991 Judith Ryskiewicz Vol#: 151

C 5992 Jack Herklotz Vol#: 151

C 5993 Geraldine Somers MD Vol#: 151

C 5994 Clark Hays Vol#: 151

C 5995 Michelle R Bernardo Vol#: 151

C 5996 Deborah S Walker Vol#: 151

C 5997 Francesca Finnegan Vol#: 151

C 5998 John Sakey Vol#: 151

C 5999 David Ahlers Vol#: 151

C 6000 James C Waites Vol#: 151

C 6001 Armanda Wilson Vol#: 151

C 6002 Jonathan Shane Newcombe Vol#: 151

C 6003 Rhonda Stewart Vol#: 151

C 6004 Denise Frizzell Vol#: 151

C 6005 Diane Priore Vol#: 151

C 6006 Carol P Johnson Vol#: 151

C 6007 Sarah Dorenkamp Vol#: 151

C 6008 Port Washington Twin Pines Consumers Asn Vol#: 151

C 6009 Jody Gordon Vol#: 151

C 6010 Karen Elcaness Vol#: 151

C 6011 Michele Leavitt Vol#: 151

C 6012 Terri Palmquist Vol#: 151

C 6013 Dan Golembeski Vol#: 151

C 6014 Elizabeth Raintree PhD Vol#: 151

C 6015 Megan Bailey Vol#: 151

C 6016 Steve Graham Vol#: 151

C 6017 Lorraine Rodgers Vol#: 151

C 6018 Glenda Shaffer Vol#: 151

EC 41 Myrna Kitchens Vol#: 151

94V-0074 Laser Light Show

EXP 1 Walt Disney World Co Vol#: 1

94V-0254

EXP 2 Walt Disney World Co. Vol#: 1

94V-0372

EXP 2 Walt Disney World Co. Vol#: 1

94V-0412

EXP 2 Walt Disney World Co. Vol#: 1

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

C 599 Esther Anne Rothman Vol#: 22

C 600 Anna Petrini Vol#: 22

C 601 FPI, Foodservice & Packaging Institute I Vol#: 22

C 602 W. L. Porada Vol#: 22

C 603 Bob Schramm Vol#: 22

C 604 Joseph Rizzo Vol#: 22

C 605 Omor Hassan Sayes Vol#: 22

C 606 David Wengerd Vol#: 22

C 607 David Levner Vol#: 22

C 608 UEP, United Egg Producers Vol#: 22

C 609 Jenney Gordon Vol#: 22

C 610 Marion Zinowski Vol#: 22

C 611 Stephanie Zinowski Vol#: 22

C 612 Michael & DeAnna Woolston Vol#: 22

C 613 Karen Wolf Vol#: 22

C 614 Kim C. Eaton Vol#: 22

C 615 Roni Lawrence Vol#: 23

C 616 Betty Jean Herner Vol#: 23

C 617 Carole Moomey Vol#: 23

C 618 Lois N. Cox Vol#: 23

C 619 House-Mouse Designs Vol#: 23

C 620 Betty Ford Vol#: 23

C 621 Susan Van Nuys Vol#: 23

C 622 Lee Spears et al Vol#: 23

C 623 Julie O'Donnell Vol#: 23

C 624 Charles Schwamb Vol#: 23

C 625 Michael Gurwitz Vol#: 23

C 626 Paul V. Sapia Vol#: 23

C 627 Jan D. Sinnott, Ph.D. Vol#: 23

C 628 Teresa A. Robinson Vol#: 23

C 629 Elizabeth M. Portelly Vol#: 23

C 630 Candy Colby Vol#: 23

C 631 L. Vurek Vol#: 23

C 632 Elaine F. Livesey-Fassel Vol#: 23

C 633 Bonnie & Robert West Vol#: 23

C 634 Susan Wiedman Vol#: 23

C 635 Patricia Daly Vol#: 23

C 636 Eileen Gottschalk Vol#: 23

C 637 94 signatures Vol#: 23

C 638 O. I. Nash Vol#: 23

C 639 AARP Vol#: 23

C 640 AQIS, Australian Quarantine & Inspection Vol#: 24

C 641 American Veterinary Medical Assn. Vol#: 24

C 642 Maryland Egg Council, Inc. Vol#: 24

C 643 Dolco Packaging Vol#: 24

C 644 The American Dietetic Assn. Vol#: 24

C 645 NERO, National Egg Regulatory Officials Vol#: 24

C 646 Geoffrey E. Doman Vol#: 24

C 647 M. N. O'Sullivan Vol#: 24

C 648 Jerome Mc Collom & Colleen Kronquist Vol#: 24

C 649 Eleanor Maragliana Vol#: 24

C 650 M. Custodio Vol#: 24

C 651 Teresa A. Maragliano Vol#: 24

C 652 Edward Alchastz Vol#: 24

C 653 Sandra L. Giardini Vol#: 24

C 654 Cindy K. Eckleberry Vol#: 24

C 655 Elaine Charkowski Vol#: 24

C 656 Gabrielle Koeferl Vol#: 24

C 657 Susan C. McBiede Vol#: 24

C 658 Patricia Panitz Vol#: 24

C 659 10 signatures Vol#: 24

C 660 Jann & Robert Moorehead Vol#: 24

C 661 Scott & Lori Walker Vol#: 24

C 662 Lois Blumenthal Vol#: 24

C 663 Kristen Krivoshia Vol#: 24

C 664 Sheila M. Richardson Vol#: 23

C 665 Austin Vol#: 24

C 666 Marianne R. Merritt, Esquire Vol#: 24

EC 5 Karen Davis, Ph.D. Vol#: 23

EC 6 Andy Wadsworth Vol#: 23

EC 7 Mary Finelli Vol#: 23

97P-0197 Require that warning labels about risks of salmonella

Following duplicates linked comments in 96P-0418 above

C 600 Esther Anne Rothman Vol#: 21

C 601 Anna Petrini Vol#: 21

C 602 FPI, Foodservice & Packaging Institute I Vol#: 21

C 603 W. L. Porada Vol#: 21

C 604 Bob Schramm Vol#: 21

C 605 Joseph Rizzo Vol#: 21

C 606 Omor Hassan Sayes Vol#: 21

C 607 David Wengerd Vol#: 21

C 608 David Levner Vol#: 21

C 609 UEP, United Egg Producers Vol#: 21

C 610 Jenney Gordon Vol#: 21

C 611 Marion Zinowski Vol#: 21

C 612 Stephanie Zinowski Vol#: 21

C 613 Michael & DeAnna Woolston Vol#: 21

C 614 Karen Wolf Vol#: 21

C 615 Kim C. Eaton Vol#: 21

C 616 Roni Lawrence Vol#: 22

C 617 Betty Jean Herner Vol#: 22

C 618 Carole Moomey Vol#: 22

C 619 Lois N. Cox Vol#: 22

C 620 House-Mouse Designs Vol#: 22

C 621 Betty Ford Vol#: 22

C 622 Susan Van Nuys Vol#: 22

C 623 Lee Spears et al Vol#: 22

C 624 Julie O'Donnell Vol#: 22

C 625 Charles Schwamb Vol#: 22

C 626 Michael Gurwitz Vol#: 22

C 627 Paul V. Sapia Vol#: 22

C 628 Jan D. Sinnott, Ph.D. Vol#: 22

C 629 Teresa A. Robinson Vol#: 22

C 630 Elizabeth M. Portelly Vol#: 22

C 631 Candy Colby Vol#: 22

C 632 L. Vurek Vol#: 22

C 633 Elaine F. Livesey-Fassel Vol#: 22

C 634 Bonnie & Robert West Vol#: 22

C 635 Susan Wiedman Vol#: 22

C 636 Patricia Daly Vol#: 22

C 637 Eileen Gottschalk Vol#: 22

C 638 94 signatures Vol#: 22

C 639 O. I. Nash Vol#: 22

C 640 AARP Vol#: 22

C 641 AQIS, Australian Quarantine & Inspection Vol#: 23

C 642 American Veterinary Medical Assn. Vol#: 23

C 643 Maryland Egg Council, Inc. Vol#: 23

C 644 Dolco Packaging Vol#: 23

C 645 The American Dietetic Assn. Vol#: 23

C 646 NERO, National Egg Regulatory Officials Vol#: 23

C 647 Geoffrey E. Doman Vol#: 23

C 648 M. N. O'Sullivan Vol#: 23

C 649 Jerome Mc Collom & Colleen Kronquist Vol#: 23

C 650 Eleanor Maragliana Vol#: 23

C 651 M. Custodio Vol#: 23

C 652 Teresa A. Maragliano Vol#: 23

C 653 Edward Alchastz Vol#: 23

C 654 Sandra L. Giardini Vol#: 23

C 655 Cindy K. Eckleberry Vol#: 23

C 656 Elaine Charkowski Vol#: 23

C 657 Gabrielle Koeferl Vol#: 23

C 658 Susan C. McBiede Vol#: 23

C 659 Patricia Panitz Vol#: 23

C 660 10 signatures Vol#: 23

C 661 Jann & Robert Moorehead Vol#: 23

C 662 Scott & Lori Walker Vol#: 23

C 663 Lois Blumenthal Vol#: 23

C 664 Kristen Krivoshia Vol#: 23

C 665 Sheila M. Richardson Vol#: 24

C 666 Austin Vol#: 23

C 667 Marianne R. Merritt, Esquire Vol#: 23

EC 5 Karen Davis, Ph.D. Vol#: 22

EC 6 Andy Wadsworth Vol#: 22

EC 7 Mary Finelli Vol#: 22

98D-0265 Section 111 - Pediatric Studies of Drugs, FDAMA

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

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

EC 15 Dan Nagle Vol#: 876

98N-0313 Surgeons's and Patient Examination Gloves Reclassification

C 6 Guthrie Foundation Vol#: 5

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

C 2 Sacramento Medical Foundation Vol#: 2

98P-0683 Soy Protein Containing Products

LET 3 Safetywize Consultants & Advocates Vol#: 21

99D-2335 Guidance for Medical Gloves A workshop Manual

AMD 1 Nelson Laboratories Vol#: 1

99D-3028 Diagnosis/Monitoring of HCV infection/Associated disease

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

99D-4130 Manufacturers to assemblers for Diagnostic X-Ray Systems

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

99H-0022 Civil Money Penalties;Mid-State Petroleum Inc,d/b/a Leland

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0024 Civil Money Penalties;Kmart Corp,d/b/a Kmart

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0026 Civil Money Penalties;The Whalen Corp,d/b/a A & C Exxon

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0056 Civil Money Penalties;Star Mart Inc,dba Star Mart

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-0072 Civil Money Penalties;Eckerd Corp,d/b/a Eckerd Drug Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0102 Civil Money Penalties;Jewell Ent Inc,d/b/a J J Mobil Mart

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0566 Civil Money Penalties;Ali M Ahmed,d/b/a Chevron Jubilee Food

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0613 Civil Money Penalties;George Pagounis,d/b/a Athens Texaco

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0712 Civil Money Penalties;Bobby Noah,d/b/a Tally's Tabacco Mart

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0735 Civil Money Penalties;Richard Thomas,d/b/a Hut Barbee-Que &

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0740 Civil Money Penalties;Patrick Flynn & Tracey Flynn,d/b/a 7-

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0755 Civil Money Penalty; ABS Associates Inc D/b/a/ Brown's Food

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0880 Civil Money Penalties;MFA Oil Co,d/b/a Break Time

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0959 Civil Money Penalties;McGovern Reality Trust,d/b/a Salem Sun

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0960 Civil Money Penalties;Charles Miller,d/b/a Miller Supply Co

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-3014 Civil Money Penalty;Roswil Inc,dba Ramey's Supermarket

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99N-0780 Acidified Foods in Hermetically Sealed Containers;Agency Inf

NAL 1 Vol#: 1

S 1 SUPPORTING STATEMENT Vol#: 1

99N-0926 Regulations under the Federal Import Milk Act;Agency Inform

NAL 1 Vol#: 1

S 1 SUPPORTING STATEMENT Vol#: 1

99N-1415 Supplements and other changes to aproved NADA

NPR 2 Vol#:

99N-3089 Draft Affirmative Agenda for International Activities

C 1 ICMAD, INC Vol#: 1

99N-4063 Positron emmission tomography drug products

C 1 Eastern Isotopes Vol#: 1

99P-1614 PRC for K892514 Epilator 629 by American Hair Removal System

LET 1 Andrea J. James Vol#: 1

99P-1615 PRC for K905125 Guaranty Hair Removal System by Stephens Mfg

LET 1 HFA-305 Vol#: 1

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

C 74 Ray Breitenbach, MD. MS Vol#: 1

99V-4395 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Lightwave Laser Productions Vol#: 1