DOCKETS ENTERED on June 3, 1999

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

76N-052N OTC Nasal Decongestants
84N-0102 Orphan Product Designations
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
97S-0162 30-Day Structure Function Claim Notification Letters Dietary
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
98N-1038 Irradiation in the production, processing, &handling of food
98N-1109 Mercury Compounds in Drugs and Food
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-0683 Soy Protein Containing Products
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
99N-0391 International Guidelines on Vitamin and Mineral supplements
99N-0438 Contamination ready-to-eat foods associated food prepartion
99N-1174 Development of Strategy for Dietary Supplements
99P-1720 Variance from the labeling regulation for natural rubber
99V-1717 Laser Light Show

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76N-052N OTC Nasal Decongestants

C 228 The Marshfield NeuroSciences Vol#: 73

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79N-0113 Parenteral Multivitamin Products

WDL 2 Schein Pharmaceutical, Inc Vol#: 1

TOP

84N-0102 Orphan Product Designations

LST 85 May 1999 Vol#: 2

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95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 3694 Phil Howry Vol#: 291

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97P-0354 Reclassify Shoulder Joint Prostheses

BKG 1 Vol#: 3

N 1 Vol#: 3

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97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 3602 Basic Research dba Silver Sage Vol#: 23

LET 3603 Basic Research dba Silver Sage Vol#: 23

LET 3604 Basic Research dba Wellness Dynamics Vol#: 23

LET 3605 Basic Research dba Wellness Dynamics Vol#: 23

LET 3606 Basic Research dba Wellness Dynamics Vol#: 23

LET 3607 Basic Research dba Wellness Dynamics Vol#: 23

LET 3608 Basic Research dba Silver Sage Vol#: 23

LET 3609 Basic Research dba Nutra Sport Vol#: 23

LET 3610 Indian Meadow Herbals Vol#: 23

LET 3611 Chick Cart Inc Vol#: 23

LET 3612 Cytos Pharmaceuticals LLC Vol#: 23

LET 3613 General Vitamin Corp Vol#: 23

LET 3614 Natural Bodylines Vol#: 23

LET 3615 Dietetics Pharma International Inc Vol#: 23

LET 3616 Infinity Inc Vol#: 23

LET 3617 Enforma Natural Products Inc Vol#: 23

LET 3618 Standard Process Inc Vol#: 23

LET 3619 Standard Process Inc Vol#: 23

LET 3620 Standard Process Inc Vol#: 23

LET 3621 Standard Process Inc Vol#: 23

LET 3622 Standard Process Inc Vol#: 23

LET 3623 Standard Process Inc Vol#: 23

LET 3624 Standard Process Inc Vol#: 23

LET 3625 Standard Process Inc Vol#: 23

LET 3626 Tyler Inc Vol#: 23

LET 3627 Tyler Inc Vol#: 23

LET 3628 Tyler Inc Vol#: 23

LET 3629 Tyler Inc Vol#: 23

LET 3630 Tyler Inc Vol#: 23

LET 3631 Tyler Inc Vol#: 23

LET 3632 Tyler Inc Vol#: 23

LET 3633 Tyler Inc Vol#: 23

LET 3634 Tyler Inc Vol#: 23

LET 3635 Tyler Inc Vol#: 23

LET 3636 Tyler Inc Vol#: 23

LET 3637 Tyler Inc Vol#: 23

LET 3638 Tyler Inc Vol#: 23

LET 3639 Weider Nutrition International Inc Vol#: 23

LET 3640 Weider Nutrition International Inc Vol#: 23

LET 3641 Weider Nutrition International Inc Vol#: 23

LET 3642 Weider Nutrition International Inc Vol#: 23

LET 3643 Nature's Herbs Vol#: 23

LET 3644 Nature's Herbs Vol#: 23

LET 3645 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3646 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3647 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3648 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3649 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3650 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3651 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3652 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3653 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3654 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3655 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3656 Vitamer Div. of Anabolic Inc Vol#: 23

LET 3657 Vitaceutical Labs Vol#: 23

LET 3658 Vitaceutical Labs Vol#: 23

LET 3659 Vitaceutical Labs Vol#: 23

LET 3660 Vitaceutical Labs Vol#: 23

LET 3661 Vitaceutical Labs Vol#: 23

LET 3662 Vitaceutical Labs Vol#: 23

LET 3663 Vitaceutical Labs Vol#: 23

LET 3664 Covex Sociedad Anonima Vol#: 23

LET 3665 Nature's Way Products Inc Vol#: 23

LET 3666 Naturalife Corporation Vol#: 23

LET 3667 Vital Dynamics Inc Vol#: 23

LET 3668 Oregon's Wild Harvest Vol#: 23

LET 3669 Prairie Sun Grains Ltd Vol#: 23

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

LET 272 HFS-456 to Pharmaton Natural Health Prod Vol#: 6

LET 273 HFS-456 to Oregon's Wild Harvest Vol#: 6

LET 274 HFS-456 to Standard Process Inc Vol#: 6

LET 275 HFS-456 to Weider Nutrition Internationa Vol#: 6

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98E-0485 Therma Choice Uterine Balloon Therapy System U.S.#5,105,808

NFL 1 Vol#: 1

98E-0850 Patent Extension 4,949,718 ThermaChoice Uterine Balloon Ther

NFL 1 Vol#: 1

98H-1115 Civil Money Penalties;Milo Jackson,d/b/a MJ's Corner Store

MO 1 GCF-1 Vol#: 1

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

C 2411 Majorie Rosenfeld Vol#: 57

C 2412 Douglass Adair Vol#: 57

C 2413 R. Price Vol#: 57

C 2414 Gregory V. Schmidt Vol#: 57

C 2415 Birute Tribys Vol#: 57

C 2416 Bill Palnusorns Vol#: 57

C 2417 Patricia J. Flanders Vol#: 57

C 2418 Carolyn Wooley Vol#: 57

C 2419 Carolyn Pressley Vol#: 57

C 2420 Mrs. L. Posner Vol#: 57

C 2421 Susan Vol#: 57

C 2422 I. Landau Vol#: 57

C 2423 Carl B. Arnold Vol#: 57

C 2424 S. Marc & Barbara Herskovitz Vol#: 57

C 2425 Richard & Lydia Ciacci Vol#: 57

C 2426 Ms. Joan Jacobsen Vol#: 57

C 2427 Victoria Gammello Vol#: 57

C 2428 Jamie, Grant & Leeia Jones Vol#: 57

C 2429 State of Michigan Dept. of Agriculture Vol#: 57

C 2430 Melba Dlugnoski Vol#: 57

C 2431 William Smirnow Vol#: 57

C 2432 Grace Chapman Vol#: 57

C 2433 Sylvia & George Gillberg Vol#: 57

C 2434 Stephen J. Snyder Vol#: 57

C 2435 Nancy Hiestand Vol#: 57

C 2436 Sandra Drentlaw Vol#: 57

C 2437 Kenneth S. & Helen Scott Warren Vol#: 57

C 2438 Nancy Taetzsch Vol#: 57

C 2439 Diana K. Weatherby Vol#: 57

C 2440 Barbara Keeler Vol#: 57

C 2441 Carol Elliker Vol#: 57

C 2442 Sue Roberts Health Concepts, Inc. Vol#: 57

C 2443 Lawrence Blacik Vol#: 57

C 2444 Valerie Kramer Vol#: 57

C 2445 Glenn Rubenstein Vol#: 57

C 2446 Bo Holland Vol#: 57

C 2447 Fresh Fields Whole Foods Market Vol#: 57

C 2448 FSI International Vol#: 57

C 2449 Oneota Community Food Cooperative Vol#: 57

C 2450 Violet Sparkles Vol#: 57

C 2451 Terri Middleton Vol#: 57

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98N-1109 Mercury Compounds in Drugs and Food

C 7 Angela Moskow Vol#: 2

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98N-1265 Distribution of Compounded Drug Products

C 3013 Form Letter Count 11 Vol#: 111

C 3014 Jacqueline Doyle Vol#: 110

C 3015 Kathleen & Stephen Unger Vol#: 110

C 3016 Robert Bowman Vol#: 110

C 3017 Denise Holena Vol#: 110

C 3018 Barbara Chadwick Vol#: 110

C 3019 Bay View OB/GYN Medical Group, Inc Vol#: 110

C 3020 Judith Pincus Vol#: 110

C 3021 Gretchen W. Mason Vol#: 112

C 3022 Virginia Hoag Vol#: 112

C 3023 Nina Ramos Vol#: 112

C 3024 Mrs. Farey Vol#: 112

C 3025 Carolyn J. Laukhuf Vol#: 112

C 3026 Iris Stripling Vol#: 112

C 3027 Pat Lindemaier Vol#: 112

C 3028 Linda Kolbe Vol#: 112

C 3029 Kathy Nonithnia Vol#: 112

C 3030 Gordon & Jennifer Fenner Vol#: 112

C 3031 Edonna Gamson Vol#: 112

C 3032 Joyce D. Wilson Vol#: 112

C 3033 Marlene A. Joyce Vol#: 112

C 3034 Judith Ewing Vol#: 112

C 3035 Kathryn Spitzley Vol#: 112

C 3036 Donna Mills Vol#: 112

C 3037 Virginia V. Jarrassat Vol#: 112

C 3038 Judy Cox Westra Vol#: 112

C 3039 Lisa A. Ittner Vol#: 112

C 3040 Pain & Policy Studies Group Vol#: 112

C 3041 Virginia Sage Vol#: 112

C 3042 Suzanne Kilkus Vol#: 112

C 3043 Barry & Daphine Cunningham Vol#: 112

C 3044 Daphnie J. Cunningham Vol#: 112

C 3045 Donna L. Pickett Vol#: 112

C 3046 Mark Handler Vol#: 112

C 3047 J. Labbate Vol#: 112

C 3048 Judith Jussim Vol#: 112

C 3049 Paula Vincent-Cowan Vol#: 112

C 3050 Joy L. Roberts Vol#: 112

C 3051 Sharon Chatterji Vol#: 112

C 3052 Donna L. Ihmn Vol#: 112

C 3053 Vicki Giella Vol#: 112

C 3054 Rosen Method Bodywork & Massage Therapy Vol#: 112

C 3055 Jean A. Schwichtenberg Vol#: 112

C 3056 Florence Bienefeld, Ph.D. Vol#: 112

C 3057 J. Nundahl Vol#: 112

C 3058 Nancy J. Hendrickson Vol#: 112

C 3059 Kathleen O'Daniel Vol#: 112

C 3060 Mary Jo Middleberg Vol#: 112

C 3061 Doris J. Norrish Vol#: 112

C 3062 Caryl Hatfield Vol#: 112

C 3063 Fleming Barnett Vol#: 112

C 3064 Eleanor M. Marx Vol#: 112

C 3065 Doris A. Spern Vol#: 112

C 3066 Marty Phelix Vol#: 112

C 3067 Diana Mether Vol#: 112

C 3068 Melinda Coleman Vol#: 112

C 3069 Deborah Brown Vol#: 112

C 3070 Theresa Wehlann Vol#: 112

C 3071 Anne MacNeil Vol#: 112

C 3072 Ruth B. Johns Vol#: 112

C 3073 Fleeta Baldwin Vol#: 112

C 3074 Margaret Matson Vol#: 112

C 3075 Congressman William E. Dannemeyer Vol#: 112

C 3076 Jan Holt Vol#: 112

C 3077 Sandra J. Otto Vol#: 112

C 3078 Sandra L. Newton Vol#: 112

C 3079 Patricia Thompson Vol#: 112

C 3080 Connie A. McKenzie Vol#: 112

C 3081 Donna A. S. Puckett Vol#: 112

C 3082 Elizabeth Luger Vol#: 112

C 3083 Karen C. Fuson Vol#: 112

C 3084 Bonnie J. Miller Vol#: 112

C 3085 Nancy Wykstra Vol#: 112

C 3086 Ramona Christensen Vol#: 112

C 3087 Cara Mayanna Vol#: 112

C 3088 Anne Rizk Vol#: 112

C 3089 Denise L. Dunlap Vol#: 112

C 3090 Viola A. Luttringer Vol#: 112

C 3091 Linda Anderson Vol#: 112

C 3092 Raymond Rafferzeder Vol#: 112

C 3093 Sue Lampson Vol#: 112

C 3094 Judy Phillips Vol#: 112

C 3095 Judith A. Thomas Vol#: 112

C 3096 Dorothy A. Campbell Vol#: 112

C 3097 West Virginia Pharmacists Association Vol#: 112

C 3098 Rosa M. Eseobedo Vol#: 112

C 3099 Lyn McKellips Vol#: 112

C 3100 Patricia Klug Vol#: 112

C 3101 Margaret E. Rhudy Vol#: 112

C 3102 Aliza Guggenheim Vol#: 112

C 3103 Irv Katz Vol#: 112

C 3104 Colleen Vicknair Vol#: 112

C 3105 Rosaleen M. Stone Vol#: 112

C 3106 The Associate Reformed Presbyterian Vol#: 112

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

C 2203 Elinore B. Gordon Vol#: 53

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98P-0203 Eliminate Forced Molting of Laying Birds

C 1512 Patricia Curnow Vol#: 35

C 1513 Mrs Helen J Farmer et al Vol#: 35

C 1514 Rachel Jacob Vol#: 35

C 1515 Aretta Baumgartner Vol#: 35

C 1516 Alison Keller Vol#: 35

C 1517 Kristyn Roan Vol#: 35

C 1518 Miss Brenda Johnson Vol#: 35

C 1519 Linda Ascatigno Vol#: 35

C 1520 Mark M Giese Vol#: 35

C 1521 Form letter count 9 Vol#: 36

C 1522 Form letter count 8 Vol#: 37

C 1523 Form letter count 8 Vol#: 38

C 1524 Samantha West Vol#: 35

C 1525 C L Butters Vol#: 35

C 1526 Sheila McLachlin Vol#: 35

C 1527 Carmelin Michell Vol#: 35

C 1528 Julie Smith Vol#: 35

C 1529 Carrie Packwood Vol#: 35

C 1530 Dawne Schulte et al Vol#: 35

C 1531 Miss Jennie Lanham Vol#: 35

C 1532 Mrs E Deards Vol#: 35

C 1533 Miss Carol A Diaz Vol#: 35

C 1534 Nazen Merjian Vol#: 35

C 1535 Deborah Uhlman Vol#: 35

C 1536 David Kaye Vol#: 35

C 1537 Darilyn Arancio Vol#: 35

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98P-0504 Raw Molluscan Shellfish of Undetectable Levels

ANS 23 HFW-14 Vol#: 18

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

C 20 Mary C. Hays Vol#: 1

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98P-0683 Soy Protein Containing Products

C 132 Richard F. James Vol#: 19

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98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 134 Theresa Brady Vol#: 3

C 135 Ola Humpries Vol#: 3

C 136 Dennis J Lenz Vol#: 3

C 137 Kathy Lusco Vol#: 3

C 138 Michael Phillips Vol#: 3

C 139 Carlo Maggiora Jr Vol#: 3

C 140 Terri Middleton Vol#: 3

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99D-1269 Draft Guidance on Quality Systems Inspections Technique

GDL 1 Vol#: 1

NAD 1 Vol#: 1

99H-0866 Civil Money Penalties;Asad Mohammadali & Farid Allana,d/b/a

ANS 1 Asad Mohammadali Vol#: 1

99H-1194 Civil Money Penalties;Larry Bunch,d/b/a Galena Country Corne

ANS 1 Country Corner Store Vol#: 1

99H-1243 Civil Money Penalties;Vista Stores LLC,d/b/a Vista Stores

ANS 1 Vista Stores LLC Vol#: 1

99H-1246 Civil Money Penalty; Ahmad Mekkaoui d/b/a Athol Getty

ANS 1 Athol Getty Vol#: 1

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99N-0391 International Guidelines on Vitamin and Mineral supplements

C 2 Nature's Life Vol#: 1

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99N-0438 Contamination ready-to-eat foods associated food prepartion

C 7 Research It Inc Vol#: 1

C 8 Georgia-Pacific Corporation Vol#: 1

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99N-1174 Development of Strategy for Dietary Supplements

C 6 National Organization for Rare Disorders Vol#: 1

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99P-1720 Variance from the labeling regulation for natural rubber

CP 1 Health Industry Manufacturers Ass. Vol#: 1

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99V-1717 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Laser Show Design Inc Vol#: 1

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