DOCKETS ENTERED on 04/13/99

FDA - Food and Drug Administration

DOCKETS ENTERED on APRIL 13, 1999

Updated as of 11:30 am, April 15, 1999. The following documents were entered at the Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860 and are hyperlinked to the actual comments/letters/reports as indicated below.

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

78N-0038 Sunscreen Drug Products
81N-0022 OTC Weight Control Drug Products for Human Use
91N-384H Nutrient Content Claims, Definition of Term: Healthy
95S-0117 Human Drugs Patent Term Extension & New Patents
96P-0106 Prevent Outbreak of Bovine Spongiform Encephalopathy (BSE)
96P-0500 Amend "Healthy" Definition re: Sodium Levels
98D-0994 Draft Guidance for Industry on BACPAC I
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
98N-0826 Dietary Supplements of Health Claims
98N-1038 Irradiation in the production, processing, &handling of food
98N-1170 Sunlamp Products Performance Standard
98N-1265 Distribution of Compounded Drug Products
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0203 Eliminate Forced Molting of Laying Birds
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
98P-0680 Amend reg re: sale & distribution of turtles & viable eggs
98P-1194 Withdrawal NADA Approval for Posilac - rBGH

77N-0085 Saccharin and Its Salts

CA 27029 L Sorenson Vol#: 424

CA 27030 T Finley Vol#: 424

CA 27031 R B Hardeman Vol#: 424

CA 27032 A P Eishler Vol#: 424

CA 27033 P McGhee Vol#: 424

CA 27034 C J Hill Vol#: 424

CA 27035 R J Munna Vol#: 424

CA 27036 G C Sharp Vol#: 424

CA 27037 J Green Vol#: 424

CA 27039 B J Giant Vol#: 424

CA 27040 K B Coughlin Vol#: 424

CA 27041 M Redman Vol#: 424

CA 27042 C & M E King Vol#:

CA 27043 N Hughes Vol#: 424

CA 27045 J Strand Vol#: 424

CA 27046 F Hovendick Vol#: 424

CA 27047 H Krause Vol#: 424

CA 27048 J Willis Vol#: 424

CA 27049 B Felton Vol#: 424

CA 27050 S T Dempsey Vol#: 424

CA 27051 E H Wessell Vol#: 424

CA 27052 D M Kammeron Vol#: 424

CA 27053 M A Edwards Vol#: 424

77N-094W Analgestic/Antipyretic active ingredients for internal use

REF 1 Vol#: 12

78N-0038 Sunscreen Drug Products

LET 167 The Procter & Gamble Company Vol#: 111

81N-0022 OTC Weight Control Drug Products for Human Use

LET 112 HFD-560 to Consumer Healthcare Products Assn Vol#: 93

91N-384H Nutrient Content Claims, Definition of Term: Healthy

OB 16 Salt Institute Vol#: 13

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 41 List as of April 7, 1999 Vol#: 3

96P-0106 Prevent Outbreak of Bovine Spongiform Encephalopathy (BSE)

C 7 Cameron Lane Vol#: 1

96P-0500 Amend "Healthy" Definition re: Sodium Levels

C 33 Salt Institute Vol#: 10

98D-0994 Draft Guidance for Industry on BACPAC I

C 30 Janssen Pharmaceutica Vol#: 1

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 43 Alliance for Prudent Use of Antibiotics Vol#: 2

98N-0826 Dietary Supplements of Health Claims

C 17 Council for Responsible Nutrition Vol#: 1

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

C 565 Athena Peanut Vol#: 12

C 566 Franklin P. Shirley Vol#: 12

C 567 Patricia Meyer Vol#: 12

C 568 M. Hennessy Vol#: 12

C 569 S. Kent Vol#: 12

C 570 Katherine A. Dunsmore Vol#: 12

C 571 Lois Gruber Vol#: 12

C 572 Wendie Stauffer Vol#: 12

C 573 Don Skonieczka Vol#: 12

C 574 Suzan Rowe Vol#: 12

C 575 George Taevs Vol#: 12

C 576 Robin Koenig Vol#: 12

C 577 McMillan Vol#: 12

C 578 David MacClement Vol#: 12

C 579 University of Illinois Vol#: 12

C 580 Joseph R. Heckman Vol#: 12

C 581 Charles E. Olney Vol#: 12

C 582 Donald L. Newman Vol#: 12

C 583 Donald O. Nevinger Vol#: 12

C 584 Janette D. Sherman Vol#: 12

C 585 Packgoatz Vol#: 12

C 586 Robert W. Hutchison Vol#: 12

C 587 Michelle Billoir Vol#: 12

C 588 Mary Israel Vol#: 12

C 589 Thomas L. Goss Vol#: 12

C 590 Kait Marden Vol#: 12

C 591 Stefania Poli Vol#: 12

C 592 Ronnie Colby Vol#: 12

C 593 Dean Zeilon Vol#: 12

C 594 Harvest Co-op Markets Vol#: 12

C 595 Owen Haskell Vol#: 12

C 596 Arwen Wilder Vol#: 12

C 597 Mollie & Robert Nickelson Vol#: 12

C 598 Anthony Goodman Vol#: 12

C 599 John Burne Vol#: 12

98N-1170 Sunlamp Products Performance Standard

EXT 1 International Smart Tan Network Vol#: 1

98N-1265 Distribution of Compounded Drug Products

C 986 L. Gaspoon Vol#: 58

C 987 Mary McDaniel Vol#: 58

C 988 Barbara P. Murphy Vol#: 58

C 989 Willa Dawson Vol#: 58

C 990 Deanna Konrad Vol#: 58

C 991 Rachel Kohn Vol#: 58

C 992 Mary Grace Ehlert Vol#: 58

C 993 Madalyn Gerrard Vol#: 58

C 994 Aubie Chelot Vol#: 58

C 995 Tamara J. Potbury Vol#: 58

C 996 Laurie Sauber Vol#: 58

C 997 Theresa Liquori Vol#: 58

C 998 Gail M. Winters Vol#: 58

C 999 Mariana Garcia Vol#: 58

C 1000 Gail Belluardo Vol#: 58

C 1001 Sharon Fleory Vol#: 58

C 1002 Jayne London Vol#: 58

C 1003 Tamara McGeher Vol#: 58

C 1004 Arleen Krasnoff Vol#: 58

C 1005 Janet F. Davis Vol#: 58

C 1006 Ethel Manross Vol#: 58

C 1007 U. M. Miller Vol#: 58

C 1008 Barbara Deutscher Vol#: 58

C 1009 Sandra Regenscheid Vol#: 58

C 1010 Harold L. Sanders Vol#: 58

C 1011 Elaine J. Black Vol#: 58

C 1012 Jean Schoellerman Vol#: 58

C 1013 Denise Fohr Vol#: 58

C 1014 Carole N. Alder Vol#: 58

C 1015 Vicki Eider Vol#: 58

C 1016 W. D. Moore Vol#: 58

C 1017 Angela Brown Vol#: 58

C 1018 Jacqueline Herr Vol#: 58

C 1019 Sonic Cagney Vol#: 58

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 2078 Voices for Animals Vol#: 52

C 2079 David Stetler Vol#: 52

98P-0203 Eliminate Forced Molting of Laying Birds

C 867 Dr Denise J. Tartaglia Vol#: 22

C 868 Naomi Caplan Vol#: 22

C 869 John & Nancy Arnold Vol#: 22

C 870 Mary Ann Profilio Vol#: 22

C 871 Denise Hall Vol#: 22

C 872 Terry A. Kennedy Vol#: 22

C 873 Katherine A. Coleman Vol#: 22

C 874 Kelly L. Pfeffer Vol#: 22

C 875 Jane Wu Vol#: 22

C 876 Julia Henderson Vol#: 22

C 877 Kenneth G. DeNeal, Sr Vol#: 22

C 878 Michele Padgett Vol#: 22

C 879 Leroy Demonio Vol#: 22

C 880 Danielle Price Vol#: 22

C 881 Jennifer Danner Vol#: 22

C 882 Barbara Bruzzone Vol#: 22

C 883 Arthur E. Torrington Vol#: 22

C 884 Maryann Tartella Vol#: 22

C 885 Danielle Woodward Vol#: 22

C 886 Sherry Townsend Vol#: 22

C 887 Reta Vol#: 22

C 888 Susan Johnson Vol#: 22

C 889 Mr & Mrs Ken Livingston Vol#: 22

C 890 Judy A. Alessio Vol#: 22

C 891 Linda Johnsen Vol#: 22

C 892 R. T. C. Schrock Vol#: 22

C 893 Anne Pflug Vol#: 22

C 894 James L. Denison Vol#: 22

C 895 Laurie B. Corley Vol#: 22

C 896 Mark Glese Vol#: 22

C 897 Terry L. Murphy Vol#: 22

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 24 Dean Pellegini Vol#: 1

98P-0680 Amend reg re: sale & distribution of turtles & viable eggs

LET 1 Richard John Fife Vol#: 1

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 84 Deborah Brye Vol#: 3