Food and Drug Administration

DOCKETS ENTERED on July 8, 1999

Table of Contents

(Hyper links are at the end of the Docket  title - click on * )
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
98N-0583 Exports: Notification and Recordkeeping requirements *
98N-0970 Labeling for Menstrual Tampons *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1170 Sunlamp Products Performance Standard *
98N-1265 Distribution of Compounded Drug Products *
98P-0203 Eliminate Forced Molting of Laying Birds *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99D-0674 Investigational new drug applications for phase 2&3 of drugs *
99N-0188 Progestational Drug Products for Human Use *
99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-2209 Health Claim Notification Whole Grains & Heart Disease & Can *
99P-2247 Propoxyphene Napsylate/Acetaminophen 100mg/325mg *
99V-2246 Laser Light Show *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 3695 Tim Holden (CI) Vol#: 291

97D-0268 Container Closure Systems Used for Packaging of Human Drugs

GDL 2 HFD-210 Vol#: 4

NAD 2 Vol#: 4

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

EXB 3 Timothy Terrell,dba Twin Roads Foodmart Vol#: 1

LET 3 HF-3 Vol#: 1

MO 3 GCF-1 Vol#: 1

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

NM 1 Vol#: 771

98N-0583 Exports: Notification and Recordkeeping requirements

C 12 HIMA Vol#: 1

98N-0970 Labeling for Menstrual Tampons

C 7 Congress of the United States Vol#: 1

C 8 Yale University School of Medicine Vol#: 1

C 9 Playtex Products, Inc Vol#: 1

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

ANS 1 HFW-14 to Patsy T. Mink (CI) Vol#: 93

ANS 2 HFW-14 to Bob Graham (CI) Vol#: 93

ANS 3 HFW-14 to Richard Shelby (CI) Vol#: 93

ANS 4 HFW-14 to Ronald L. Girmus, Ph.D. Vol#: 93

ANS 5 HFW-14 to Mr. D. G. Chilson Vol#: 93

C 3167 Jan Barrett Vol#: 93

C 3168 Dennis Tete Vol#: 93

C 3169 Joyce E. Ford Vol#: 93

C 3170 Susan Noalani Terry Vol#: 93

C 3171 Pamela L. Larsen Vol#: 93

C 3172 E. B. Borunda Vol#: 93

C 3173 Dale Murphy Vol#: 93

C 3174 Brett Feldman Vol#: 93

C 3175 Kathy A. Ornstein Vol#: 93

C 3176 Sam Farr (CI) Vol#: 93

C 3177 Bob Graham (CI) Vol#: 93

C 3178 Peter T. King (CI) Vol#: 93

C 3179 Paul E. Kanjorski (CI) Vol#: 93

C 3180 Janice R. Olch Vol#: 93

C 3181 Barbara Werdelin Vol#: 93

C 3182 Joseph I. Leiberman (CI) Vol#: 93

C 3183 Julian C. Dixon (CI) Vol#: 93

C 3184 Steven R. Rothman (CI) Vol#: 93

C 3185 Barney Frank (CI) Vol#: 93

C 3186 Sam Farr (CI) Vol#: 93

C 3187 John W. Olver (CI) Vol#: 93

C 3188 Jennifer K. Muir Vol#: 93

C 3189 Max Cleland (CI) Vol#: 93

C 3190 Edward M. Kennedy (CI) Vol#: 93

C 3191 Ana Maria Castanheira Vol#: 93

C 3192 Andrew J. Kawczak Vol#: 93

C 3193 Bill Michel Vol#: 93

C 3194 Kelli Keith Vol#: 93

C 3195 Marjorie A. Gray Vol#: 93

C 3196 Dr Richard & Arlene Rose Vol#: 93

98N-1110 CGMP Regulations for Finished Pharmaceuticals

NAL 1 Vol#: 1

98N-1170 Sunlamp Products Performance Standard

C 14 Sun Industries, Inc. Vol#: 1

98N-1265 Distribution of Compounded Drug Products

C 3344 Wendy & Larry Drumm Vol#: 122

C 3345 Selitha Raja Vol#: 122

C 3346 Martha M Thompson Vol#: 122

C 3347 Claudia Ford Vol#: 122

C 3348 Joyce C Buckingham Vol#: 122

C 3349 Dr Lisa Cowley Vol#:

C 3350 Patricia Bagby Vol#: 122

C 3351 Charlotte C Shure Vol#: 122

C 3352 Eunice Fassio Vol#: 122

C 3353 Sharon Martorana Vol#: 122

C 3354 Leta Averett Vol#: 122

C 3355 Linda J Mason Vol#: 122

C 3356 Elizabeth D Keleshian Vol#: 122

C 3357 Evelyn C Spencer Vol#: 122

C 3358 Nancy Aldrich-Wolf Vol#: 122

C 3359 Janis Tettlebach Vol#: 122

C 3360 Illegible Vol#: 122

C 3361 Rosemary Mackie Vol#: 122

C 3362 Elizabeth S Murphy Vol#:

C 3363 Lillie Morell Vol#:

C 3364 Elizabeth de Vries Vol#: 122

C 3365 Janet Benway Vol#: 122

C 3366 Angeline Rinker Vol#: 122

C 3367 Kathleen E Podesto Jochum Vol#: 122

C 3368 Roxanne E Toth Vol#: 122

C 3369 Edith Mestel Vol#: 122

C 3370 Martha L Davidson Vol#: 122

C 3371 Patricia L Turci Vol#: 122

C 3372 Doris J Norrish Vol#: 122

C 3373 Barbara h Kraft Vol#: 122

C 3374 Sharon Levy Vol#: 122

C 3375 Ann B Cutshall Vol#: 122

C 3376 Jacquelyn Syija Vol#: 122

C 3377 Sandra Rae Hawkins Vol#: 122

C 3378 Joanna Berger Vol#: 122

C 3379 Diane Gaertner Vol#: 122

C 3380 Marsha Kulley Vol#: 122

C 3381 Gladys L Cosgrove Vol#: 122

C 3382 Shirley Hastings Vol#: 122

C 3383 Illegible Vol#: 122

C 3384 Mary K Traut Vol#: 122

C 3385 Dr Kay Willis Vol#: 122

C 3386 Vilma Estroff Vol#: 122

C 3387 Janice White Vol#: 122

C 3388 Marilyn L Scherer Vol#: 122

C 3389 Pamela Reetz Vol#: 122

C 3390 Cleo Castillo Vol#: 122

C 3391 Joan Schumpf Vol#: 122

C 3392 Melody Moody Vol#: 122

C 3393 Theodore & Ruth Ann Borduin Vol#: 122

C 3394 Bernita Kubal Vol#: 122

C 3395 Linda L Burns Vol#: 122

C 3396 Patricia L Taylor Vol#: 122

C 3397 Sara Hess Vol#: 122

C 3398 Pauline Robertson Vol#: 122

C 3399 Dora F Kennedy PhD Vol#: 122

98P-0203 Eliminate Forced Molting of Laying Birds

C 1699 Kathryn Ashford Vol#: 43

C 1700 Philip Ide Vol#: 43

C 1701 Mrs Jackie Duffin Vol#: 43

C 1702 Cynthia K Miller Vol#: 43

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 167 Form Letter count 164 Vol#: 6

C 168 Dr Richard & Arlene Rose Vol#: 9

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 166 M Burman Vol#: 7

C 167 Lynn Sunday Vol#: 7

C 168 Jill R Bail Vol#: 7

C 169 Ami Jo Gibson & (11) signatures Vol#: 7

C 170 Laura C Baldwin Pospisil Vol#: 7

C 171 Francis C Pospisil Vol#: 7

C 172 Mary Wargo Vol#: 7

C 173 Sharon D Krueger Vol#: 7

C 174 S M Bancroft Vol#: 7

99D-0674 Investigational new drug applications for phase 2&3 of drugs

C 1 Eli Lilly & Co. Vol#: 1

99D-1938 Development of Generic Drug Products

NAD 1 Vol#: 1

99H-0050 Civil Money Penalties; Suresh Chabria Inc,d/b/a Dairy Mar

CR 1 GCF-1 Vol#: 1

99H-0769 Civil Money Penalty; Wheel City Mobile Homes Inc d/b/a Wheel

LET 2 Office of Tobacco Programs Vol#: 1

99H-0976 Civil Money Penalties;Rajiv Karua,d/b/a Kaka Food Mart

LET 2 Office of Tobacco Programs Vol#: 1

99H-0982 Civil Money Penalties;Kazimir Ent Inc,d/b/a One Stop Liquor

LET 2 Office of Tobacco Programs Vol#: 1

99H-1097 Civil Money Penalties;Yoryi D Peguero,d/b/a Peguero Market

LET 2 Office of Tobacco Programs Vol#: 1

99H-1472 Civil Money Penalties;Shiloh Shopping Center Inc,d/b/a Shilo

ANS 1 Shiloh Shopping Center Vol#: 1

99H-1515 Civil Money Penalties;Phung Truong,d/b/a Bellrock Market

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-1700 Civil Money Penalties;Fast Fare Inc,d/b/a Fast Fare Convenie

ANS 1 Crown Central Petroleum Corp Vol#: 1

99H-1827 Civil Money Penalty;Ignacio Food Store Inc dba Ignacio Shur-

ANS 1 Ignacio Food Store Inc Vol#: 1

99H-2083 Civil Money Penalty;McLaren AFM Inc,dba Ameristop Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2084 Civil Money Penalty;Mobil Oil Corp,dba Amesbury Mobil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2085 Civil Money Penalty;Earl Lee Shawver,dba Bob's Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2086 Civil Money Penalty;Maxi Drug Inc,dba Brooks #881

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2087 Civil Money Penalty;R.J.K. & T.J.K. Inc,dba Four Seasons Win

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2088 Civil Money Penalty;Fred Kinerson,dba Jr's Walker River Mark

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2089 Civil Money Penalty;Robert Piccirillo,dba Mass Ave. Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2090 Civil Money Penalty;Route 114 Mobil Inc,dba Route 114 Mobil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2091 Civil Money Penalty;Kalvinder Singh,dba Stop N Shop #1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2092 Civil Money Penalty;Martin's Inc,dba Sunflower #9156

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2093 Civil Money Penalty;Mid-Ohio Petroleum Co,dba T & C Show

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2094 Civil Money Penalty;Matthew Warner,dba U-Pump-It

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2101 Civil Money Penalty;Paradise Petroleum Inc,dba Alli Petroleu

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2102 Civil Money Penalty;Conoco Inc,dba Conoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2103 Civil Money Penalty;Gresham Service Stations Inc,dba Double

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2104 Civil Money Penalty;Waring Oil Co,dba Interstate Station #20

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2105 Civil Money Penalty;Hill City Oil Co Inc,dba Jubilee Chevron

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2106 Civil Money Penalty;Brian Stewart & Wendy Stewart,dba Rose

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2107 Civil Money Penalty;Potter Foods Inc,dba Sunflower #9038

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

NPH 2 HHS/FDA/CDER Vol#: 1

99H-2108 Civil Money Penalty;Doris Brown,dba The Food Bank

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2109 Civil Money Penalty;Bi-Lo Inc,dba Bi-Lo #331

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2110 Civil Money Penalty;Bi-Lo Inc,dba Bi-Lo #358

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2111 Civil Money Penalty;Kim Campbell,dba The Depot Trading Post

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2112 Civil Money Penalty;Gary Collins,dba Collins Bait Shop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2113 Civil Money Penalty;Cox Triangle Inc,dba Cox Triangle

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2114 Civil Money Penalty;Sayle Oil Co Inc,dba Grenaea Gas Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2115 Civil Money Penalty;Surinder Singh Uppal,dba C Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2116 Civil Money Penalty;Michael Swearingen & Marilyn Swearingen

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2117 Civil Money Penalty;Robert M Wade Sr,dba Jiffy Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2118 Civil Money Penalty;Franklin Wright,dba Frank's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-0188 Progestational Drug Products for Human Use

C 2 Georgetown University Medical Center Vol#: 1

99N-0670 Labeling Requirements for Color Additives and Petitions

N 2 Vol#: 1

99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health

C 2 Molluscan Shellfish Institute et al Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1092 Dr Richard & Arlene Rose Vol#: 16

99P-1340 Declared Eternity eau de Parfum Misbranded

C 155 Martha McLaughlin Vol#: 4

C 156 Roy Smith Vol#: 4

99P-2209 Health Claim Notification Whole Grains & Heart Disease & Can

CP 1 General Mills Inc Vol#: 1

LET 1 HFS-451 to IOFM/NAS Vol#: 1

LET 2 Institute of Medicine (IOM/NAS) Vol#: 1

SUP 1 General Mills Inc Vol#: 1

99P-2247 Propoxyphene Napsylate/Acetaminophen 100mg/325mg

CP 1 Mikart, Inc. Pharmaceutical Manufacturer Vol#: 1

99V-2246 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Phantasm Laser Vol#: 1