Food and Drug Administration

DOCKETS ENTERED on June 23, 1999

Table of Contents

(Hyper links are at the end of the Docket  title - click on * )
78N-0038 Sunscreen Drug Products *
93N-0044 Intent to Amend Performance Standard; Laser Products *
98D-1218 Pilot program for gamma irradiated blood & blood components *
98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding; *
98N-1215 Foreign Establishment Registration and Listing *
98N-1265 Distribution of Compounded Drug Products *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-0968 Guidance regarding Surimi Ingredient Labeling *
99M-1980 P970061 - SCIMED RADIUS Coronary Stent with Delivery System *
99M-1981 P970024 - Angeion Sentinel Implantable Cardioverter Defibril *
99M-1982 P960006; SWEET TIP Rx Steroid-Eluting Positive-Fixation *
99M-2015 P980037 - AnjioJet Rheolytic Thrombectomy System *
99M-2016 P980003; Chilli Cooled Ablation System *
99N-0803 Resrictions/Distribution of cigaretts/smokeless tobacco *
99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-2076 Ban the Use of Trovan (trovafloxacin) *
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast *
99P-2078 ANDA Suitability for methotrexate for oral solution *
77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

ANS 3 HFD-560 to Aspirin Foundation of America Vol#: 233

ANS 4 HFD-560 to Brigham & Women's Hospital Vol#: 233

78N-0038 Sunscreen Drug Products

ACK 4 HFA-305 Vol#: 130

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

C 25 Consumer Electronics Manufactures Assn Vol#: 2

C 26 Spectra Precision Vol#: 2

C 27 Welch Allyn, Inc Vol#: 2

C 28 LaserCraft Vol#: 2

C 29 Laser Machining, Inc. Vol#: 2

96N-0417 CGMP in Packing or Holding Dietary Supplements

NM 1 Vol#: 3

97N-0074 President's National Food Safety Initiative

NM 3 Vol#: 10

98C-0158 D&C VIOLET NO.2 COLOR ABSORBABLE MENISCAL TASKS POLY(L-LACTC

NFR 1 Vol#: 1

98D-1218 Pilot program for gamma irradiated blood & blood components

C 3 University of Cambridge Nat Blood Servic Vol#: 1

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

C 132 Ginny Cuny Vol#: 19

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

C 2982 Form Letter count 22 Vol#: 82

C 2983 Form Letter count 6 Vol#: 83

98N-1215 Foreign Establishment Registration and Listing

C 3 Arnall Golden & Gregory, LLP Vol#: 1

C 4 Chemwerth, Inc Vol#: 1

98N-1265 Distribution of Compounded Drug Products

C 3291 K. L. Justice Vol#: 115

C 3292 Ann Kronberg Vol#: 115

C 3293 Jim Elswick Vol#: 115

C 3294 David B. Schwartz Vol#: 115

C 3295 Charles E. Daane Vol#: 115

C 3296 Frances Sullivan Vol#: 115

C 3297 Christine Ozahowski Vol#: 115

C 3298 John McConnell, Ph.D. Vol#: 115

C 3299 Rita Nazemi Vol#: 115

C 3300 Mary Jane Johnson Vol#: 115

C 3301 Ann Woodward Vol#: 115

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

C 2222 Connie B. Durkee Vol#: 64

98P-0968 Guidance regarding Surimi Ingredient Labeling

C 8 Louis Kemp Seafood Co. Vol#: 1

99M-1980 P970061 - SCIMED RADIUS Coronary Stent with Delivery System

AAV 1 Boston Scientific Corporation Vol#: 1

99M-1981 P970024 - Angeion Sentinel Implantable Cardioverter Defibril

AAV 1 Angeion Corp. Vol#: 1

99M-1982 P960006; SWEET TIP Rx Steroid-Eluting Positive-Fixation

AAV 1 Guidant Corp. Vol#: 1

99M-2015 P980037 - AnjioJet Rheolytic Thrombectomy System

AAV 1 Possis Medical, Inc. Vol#: 1

99M-2016 P980003; Chilli Cooled Ablation System

AAV 1 Cardiac Pathways Corporation Vol#: 1

99N-0791 Survey of Medical Device Mfg for Y2K Compliance of Mfg Syst

NAL 1 Vol#: 1

99N-0803 Resrictions/Distribution of cigaretts/smokeless tobacco

C 1 Brown & Williamson Tobacco Corporation Vol#: 1

99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health

TR 1 Transcript of May 26, 1999 meeting Vol#: 3

99N-1174 Development of Strategy for Dietary Supplements

NM 2 Vol#: 1

99N-1502 Quality Mammography Standards

BKG 1 HFZ-215 Vol#: 2

NFR 1 Vol#: 1

NPR 1 Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1084 Sylvia Echlov Vol#: 16

C 1085 C. Baynar Vol#: 16

C 1086 Henry Peck Vol#: 16

99P-2076 Ban the Use of Trovan (trovafloxacin)

ACK 1 HFA-305 Vol#: 1

CP 1 Public Citizen Health's Research Group Vol#: 1

99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast

ACK 1 HFA-305 Vol#: 1

CP 1 Health Care Without Harm Vol#: 1

99P-2078 ANDA Suitability for methotrexate for oral solution

ACK 1 HFA-305 Vol#: 1

CP 1 McKenna & Cuneo LLP Vol#: 1