Food and Drug Administration

DOCKETS ENTERED on June 16, 1999

Table of Contents

(Hyper links are at the end of the Docket  title - click on * )
77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *
93N-0044 Intent to Amend Performance Standard; Laser Products *
98N-0044 Effect of dietary supplement on structure/function of body *
98N-0583 Exports: Notification and Recordkeeping requirements *
98N-1215 Foreign Establishment Registration and Listing *
98N-1265 Distribution of Compounded Drug Products *
98P-0203 Eliminate Forced Molting of Laying Birds *
98P-0504 Raw Molluscan Shellfish of Undetectable Levels *
98P-0683 Soy Protein Containing Products *
98P-0869 Pediatric Studies of Drugs Provision of FDAMA - Section 505A *
98P-0968 Guidance regarding Surimi Ingredient Labeling *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-0186 Testing Orthopedic Implants with Metallic Plasma Sprayed *
99D-0302 Mammography Quality Standards Act Final Regs,Document #2 *
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99N-0391 International Guidelines on Vitamin and Mineral supplements *
99N-0438 Contamination ready-to-eat foods associated food prepartion *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99V-1935 Laser Light Show *
99V-1936 Laser Light Show *

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

C 235 Whitehall Robins Healthcare Vol#: 233

93N-0044 Intent to Amend Performance Standard; Laser Products

C 23 Weiner Associates Vol#: 2

97F-0421 Antioxidant and/or Stabilizer for Olefin Polymers in Contact

NFR 2 Vol#: 1

98D-0362 Stability Testing of Drug Substances and Drug Products

C 65 PhRMA Vol#: 5

C 66 Novartis Pharmaceuticals Corp Vol#: 5

C 67 National Pharmaceutical Alliance Vol#: 5

C 68 Merck & Company Inc Vol#: 5

98H-1014 Civil Money Penalties;Steve Smith, d/b/a/ Steves

ANS 1 Steve's Convenience Store Vol#: 1

98H-1163 Civil Money Penalties;Terry Wendt,d/b/a White hen Pantry

LET 3 HHS/FDA/CDER Vol#: 1

98H-1261 Civil Money Penalties;Timothy Terrell,d/b/a Twin Roads Foodm

MO 2 GCF-1 Vol#: 1

SUB 1 HF-3 Vol#: 1

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

C 22317 Lance Martin Vol#: 771

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 129 Sharron Cordaro Vol#: 19

C 130 Dorothy Anderson Vol#: 19

98N-0583 Exports: Notification and Recordkeeping requirements

C 4 Animal Health Institute (AHI) Vol#: 1

C 5 National Grain & Feed Association Vol#: 1

C 6 Merck & Company Inc Vol#: 1

C 7 Abbot Laboratories Vol#: 1

98N-1215 Foreign Establishment Registration and Listing

C 2 Purdue Pharma L.P. Vol#: 1

98N-1265 Distribution of Compounded Drug Products

C 3266 J. K. Banel Vol#: 115

C 3267 Linda Swister Vol#: 115

C 3268 Patricia Stephanski Vol#: 115

C 3269 Elvinn Miller Vol#: 115

C 3270 Betty A. Young Vol#: 115

C 3271 Rosamond March Vol#: 115

C 3272 Stacy Fatale Vol#: 115

98P-0203 Eliminate Forced Molting of Laying Birds

C 1595 Ms Kristy L Boettler Vol#: 41

C 1596 Donna Brigham Vol#: 41

C 1597 Helen Lipp Vol#: 41

C 1598 Marguerite Hafner Vol#: 41

C 1599 Kay Bushnell Vol#: 41

C 1600 Roann Schott Vol#: 41

C 1601 Abbie Lurie Vol#: 41

C 1602 Rosemary M Baskin Vol#: 41

C 1603 Joanne Chapman Vol#: 41

C 1604 Mrs Tony LaRussa Vol#: 41

C 1605 John W Arnold Vol#: 41

C 1606 T L Warm Vol#: 41

C 1607 Deborah Famiglietti Vol#: 41

C 1608 Judy Forrester Vol#: 41

C 1609 Kathleen P Marvel Vol#: 41

C 1610 Mrs L F Fiorentino Vol#: 41

C 1611 Charles Schwamb Vol#: 41

C 1612 Linda Wilson Vol#: 41

C 1613 Joanne Gulliksen Vol#: 41

C 1614 J B Lamont Vol#: 41

C 1615 Mrs Grace M Caloway Vol#: 41

C 1616 Ms Andrea Graffeuilh Vol#: 41

C 1617 Julie Van Horn Vol#: 41

C 1618 Ms Renay Koscielski Vol#: 41

C 1619 Ms Lucille Seaman Vol#: 41

C 1620 Miss Lee Mahavier Vol#: 41

C 1621 Debbie Lovensheimer Vol#: 41

C 1622 Miss N E Spring Vol#: 41

C 1623 Susan Cody Vol#: 41

C 1624 Mandy Gill Vol#: 41

C 1625 Fredrick Eliton Vol#: 41

C 1626 Michael W Paul Vol#: 41

C 1627 Barbara Gilpin Vol#: 41

C 1628 Darlene Cerullo Vol#: 41

C 1629 Rachel Samoels Vol#: 41

C 1630 R&R Suburan Steel Inc (6) Vol#: 41

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 258 Earl & Judy Robinson Vol#: 18

98P-0683 Soy Protein Containing Products

C 133 American Soybean Association Vol#: 19

98P-0869 Pediatric Studies of Drugs Provision of FDAMA - Section 505A

LET 1 HFD-1 to Pharmaceutical Formulation Inc Vol#: 1

98P-0968 Guidance regarding Surimi Ingredient Labeling

C 7 LM Foods L.L.C. Vol#: 1

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 148 June N. Robinson Vol#: 3

C 149 Rebecca Dale Vol#: 3

C 150 Donna Clark Vol#: 3

C 151 Henry Peck Vol#: 3

99D-0186 Testing Orthopedic Implants with Metallic Plasma Sprayed

C 2 Howmedica Inc Vol#: 1

99D-0302 Mammography Quality Standards Act Final Regs,Document #2

C 6 CRCPD'S Committee on Mammoraphy Vol#: 1

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 37 Helena Paul Vol#: 4

C 38 Fiona Miller Vol#: 4

C 39 Matt Kelly et al (14) Vol#: 4

C 40 Bernadette M Sonfeld Vol#: 4

C 41 Michelle Lieberman Vol#: 4

C 42 PETA Vol#: 4

C 43 Stacy Swartz Vol#: 4

C 44 Laura Barillaro Vol#: 4

C 45 Jane Hoffman Vol#: 4

99D-1273 Medical Devices: Draft Guidance for FDA Staff on Civil Money

GDL 1 Vol#: 1

NAD 1 Vol#: 1

99H-0359 Civil Money Penalty; Ramco Inc d/b/a Minit Mart #31

LET 2 Office of Tobacco Programs Vol#: 1

99H-0890 Civil Money Penalties;Marc K Quinn,d/b/a Marc's Variety

ANS 1 Marc's Variety Vol#: 1

99H-0958 Civil Money Penalties;Marstep Inc,d/b/a Frost Sunoco

LET 2 Office of Tobacco Programs (HF-11) Vol#: 1

99H-1000 Civil Money Penalties;Merl Phillip Kiper,d/b/a Village Markt

LET 2 Office of Tobacco Programs (HF-11) Vol#: 1

99H-1052 Civil Money Penalties;Sandy's Variety Store II,& Santo Baez

ANS 1 Sandy's Variety Store II Vol#: 1

99H-1144 Civil Money Penalties;Kiki Grillis,d/b/a Lamar Restaurant

ANS 1 Lamar Rest. Vol#: 1

99H-1204 Civil Money Penalties; Markram Hanna & Maureen Hanna,d/b/a

ANS 1 Ultramar Vol#: 1

99H-1258 Civil Money Penalties;Vista Food Market Inc,d/b/a Vista Food

ANS 1 Vista Food Market Vol#: 1

99H-1394 Civil Money Penalty; Bland Corner Market Inc d/b/a The Corne

ANS 1 Bland Corner Market Inc Vol#: 1

99H-1444 Civil Money Penalties;Edsel Lowery,d/b/a College Sundo

ANS 1 College Sun-Do Inc Vol#: 1

99H-1572 Civil Money Penalties;Kathy Phillips,d/b/a Haden's Time Save

ANS 1 Time Saver Stores Vol#: 1

99N-0391 International Guidelines on Vitamin and Mineral supplements

C 9 Metagenics Genetic Through Nutrition Vol#: 1

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

C 12 Kay Chemical Vol#: 5

C 13 Soap and Detergent Association Vol#: 5

99N-1309 Proposed Classification of Female Condoms

BKG 1 HFZ-471 Vol#: 1

NPR 1 Vol#: 1

99N-1392 Agency Information Collection: State Enforcement Notificatio

N 1 Vol#: 1

99N-1522 Agency Information Collection: Temporary Maketing Permit App

N 1 Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1082 Animal Health Institute Vol#: 16

99V-1935 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 HB Electronics, Inc. Vol#: 1

99V-1936 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Entertainment Plus, Inc. Vol#: 1