FDA - Food and Drug Administration |
DOCKETS ENTERED on APRIL 28, 1999
Updated as of 9:45 am, May 10, 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.
80N-0295 OTC drug review policy statement
MM 113 HFD-560 & Playtex Products, Inc. Vol#: 3
84G-0257 Affirmation of GRAS Status of Certain Enzymes
NFR 2 Vol#: 24
96N-0249 Exemp Requir governing the Sale and Distrib. of Cigarettes
AE 337 American Lung Assn Vol#: 21
97S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 3354 Herbalife International of America Inc Vol#: 20
LET 3355 Source Naturals Vol#: 20
LET 3356 Source Naturals Vol#: 20
LET 3357 E'OLA International Inc Vol#: 20
LET 3358 E'OLA International Inc Vol#: 20
LET 3359 E'OLA International Inc Vol#: 20
LET 3360 E'OLA International Inc Vol#: 20
LET 3361 E'OLA International Inc Vol#: 20
LET 3362 Amino Food Technologies Inc Vol#: 20
LET 3363 Reliance Vitamin Company Inc Vol#: 20
LET 3364 Kaire Nutraceuticals Inc Vol#: 20
LET 3365 Kaire Nutraceuticals Inc Vol#: 20
LET 3366 Kaire Nutraceuticals Inc Vol#: 20
LET 3367 Perrigo Co of South Carolina Vol#: 20
LET 3368 Perrigo Co of South Carolina Vol#: 20
LET 3369 Perrigo Co of South Carolina Vol#: 20
LET 3370 Perrigo Co of South Carolina Vol#: 20
LET 3371 Perrigo Co of South Carolina Vol#: 20
LET 3372 Perrigo Co of South Carolina Vol#: 20
LET 3373 Perrigo Co of South Carolina Vol#: 20
LET 3374 Perrigo Co of South Carolina Vol#: 20
LET 3375 Perrigo Co of South Carolina Vol#: 20
LET 3376 Perrigo Co of South Carolina Vol#: 20
LET 3377 Perrigo Co of South Carolina Vol#: 20
LET 3378 Perrigo Co of South Carolina Vol#: 20
LET 3379 Perrigo Co of South Carolina Vol#: 20
LET 3380 Perrigo Co of South Carolina Vol#: 20
LET 3381 Perrigo Co of South Carolina Vol#: 20
LET 3382 Perrigo Co of South Carolina Vol#: 20
LET 3383 Perrigo Co of South Carolina Vol#: 20
LET 3384 Perrigo Co of South Carolina Vol#: 20
LET 3385 Perrigo Co of South Carolina Vol#: 20
LET 3386 Perrigo Co of South Carolina Vol#: 20
LET 3387 Perrigo Co of South Carolina Vol#: 20
LET 3388 Perrigo Co of South Carolina Vol#: 20
LET 3389 Perrigo Co of South Carolina Vol#: 20
LET 3390 Perrigo Co of South Carolina Vol#: 20
LET 3391 Perrigo Co of South Carolina Vol#: 20
LET 3392 Perrigo Co of South Carolina Vol#: 20
LET 3393 Perrigo Co of South Carolina Vol#: 20
LET 3394 Perrigo Co of South Carolina Vol#: 20
LET 3395 Perrigo Co of South Carolina Vol#: 20
LET 3396 Perrigo Co of South Carolina Vol#: 20
LET 3397 Perrigo Co of South Carolina Vol#: 20
LET 3398 Perrigo Co of South Carolina Vol#: 20
LET 3399 Perrigo Co of South Carolina Vol#: 20
LET 3400 Perrigo Co of South Carolina Vol#: 20
LET 3401 Perrigo Co of South Carolina Vol#: 20
LET 3402 Perrigo Co of South Carolina Vol#: 20
LET 3403 Perrigo Co of South Carolina Vol#: 20
LET 3404 Perrigo Co of South Carolina Vol#: 20
LET 3405 Perrigo Co of South Carolina Vol#: 20
LET 3406 Weider Nutrition International Inc Vol#: 20
LET 3407 Weider Nutrition International Inc Vol#: 20
LET 3408 Weider Nutrition International Inc Vol#: 20
LET 3409 Weider Nutrition International Inc Vol#: 20
LET 3410 Weider Nutrition International Inc Vol#: 20
LET 3411 Weider Nutrition International Inc Vol#: 20
LET 3412 Weider Nutrition International Inc Vol#: 20
LET 3413 Weider Nutrition International Inc Vol#: 20
LET 3414 Weider Nutrition International Inc Vol#: 20
LET 3415 Weider Nutrition International Inc Vol#: 20
LET 3416 Weider Nutrition International Inc Vol#: 20
LET 3417 Fitness Labs Nutrition Corporation Vol#: 20
LET 3418 Fitness Labs Nutrition Corporation Vol#: 20
LET 3419 Fitness Labs Nutrition Corporation Vol#: 20
LET 3420 Fitness Labs Nutrition Corporation Vol#: 20
LET 3421 Fitness Labs Nutrition Corporation Vol#: 20
LET 3422 Fitness Labs Nutrition Corporation Vol#: 20
LET 3423 Rexall Sundown Inc Vol#: 20
LET 3424 Rainbow Light Nutritional Systems Inc Vol#: 20
LET 3425 Ayruvedic Concepts Ltd Vol#: 20
LET 3426 Labrada Bodybuilding Nutrition Inc Vol#: 21
LET 3427 Labrada Bodybuilding Nutrition Inc Vol#: 21
LET 3428 Kaire Nutraceuticals Inc Vol#: 21
LET 3429 Kaire Nutraceuticals Inc Vol#: 21
LET 3430 Kaire Nutraceuticals Inc Vol#: 21
LET 3431 Concepts in Confidence Vol#: 21
LET 3432 Labrada Bodybuilding Nutrition Inc Vol#: 21
LET 3433 Boston University School of Medicine Vol#: 21
LET 3437 Upsher-Smith Laboratories Inc Vol#: 21
LET 3438 Upsher-Smith Laboratories Inc Vol#: 21
LET 3439 Dynamic Essentials Incorporated Vol#: 21
LET 3440 Rexall Sundown Inc Vol#: 21
LET 3441 Rexall Sundown Inc Vol#: 21
LET 3442 Rexall Sundown Inc Vol#: 21
LET 3443 Rexall Sundown Inc Vol#: 21
LET 3444 Rexall Sundown Inc Vol#: 21
LET 3445 Rexall Sundown Inc Vol#: 21
LET 3446 Melaleuca Inc Vol#: 21
LET 3447 Mason Vitamins Inc Vol#: 21
LET 3448 Mason Vitamins Inc Vol#: 21
LET 3449 Mason Vitamins Inc Vol#: 21
LET 3450 Mason Vitamins Inc Vol#: 21
LET 3451 Mason Vitamins Inc Vol#: 21
LET 3452 Mason Vitamins Inc Vol#: 21
LET 3453 Mason Vitamins Inc Vol#: 21
LET 3454 Mason Vitamins Inc Vol#: 21
LET 3455 Mason Vitamins Inc Vol#: 21
LET 3456 Mason Vitamins Inc Vol#: 21
LET 3457 Melaleuca Inc Vol#: 21
LET 3458 Weider Nutrition International Inc Vol#: 21
LET 3459 Weider Nutrition International Inc Vol#: 21
LET 3460 Weider Nutrition International Inc Vol#: 21
LET 3461 Weider Nutrition International Inc Vol#: 21
LET 3462 Weider Nutrition International Inc Vol#: 21
LET 3463 Weider Nutrition International Inc Vol#: 21
LET 3464 Weider Nutrition International Inc Vol#: 21
LET 3465 Weider Nutrition International Inc Vol#: 21
LET 3466 Weider Nutrition International Inc Vol#: 21
LET 3467 Weider Nutrition International Inc Vol#: 21
LET 3468 Weider Nutrition International Inc Vol#: 21
LET 3469 Weider Nutrition International Inc Vol#: 21
LET 3470 Weider Nutrition International Inc Vol#: 21
LET 3471 Weider Nutrition International Inc Vol#: 21
LET 3472 Weider Nutrition International Inc Vol#: 21
LET 3473 Weider Nutrition International Inc Vol#: 21
LET 3474 Weider Nutrition International Inc Vol#: 21
LET 3475 Weider Nutrition International Inc Vol#: 21
LET 3476 Weider Nutrition International Inc Vol#: 21
LET 3477 Weider Nutrition International Inc Vol#: 21
LET 3478 Weider Nutrition International Inc Vol#: 21
LET 3480 Weider Nutrition International Inc Vol#: 21
LET 3481 Kaire Nutraceuticals Inc Vol#: 21
LET 3482 Kaire Nutraceuticals Inc Vol#: 21
LET 3483 Kaire Nutraceuticals Inc Vol#: 21
LET 3484 Pharmavite Corporation Vol#: 21
LET 3485 Pharmavite Corporation Vol#: 21
LET 3486 Mount Spring International Corp Vol#: 21
LET 3487 Mount Spring International Corp Vol#: 21
LET 3488 Mount Spring International Corp Vol#: 21
LET 3489 Mount Spring International Corp Vol#: 21
LET 3490 Mount Spring International Corp Vol#: 21
LET 3491 Mount Spring International Corp Vol#: 21
LET 3492 Samra Health & Beauty Inc Vol#: 21
LET 3494 Nutrition Professionals Inc Vol#: 21
LET 3495 Nutrition Professionals Inc Vol#: 21
LET 3496 Nutrition Professionals Inc Vol#: 21
LET 3497 Nutrition Professionals Inc Vol#: 21
LET 3498 Nutrition Professionals Inc Vol#: 21
LET 3499 Nutrition Professionals Inc Vol#: 21
LET 3500 Nutrition Professionals Inc Vol#: 21
LET 3501 Nutrition Professionals Inc Vol#: 21
LET 3502 Nutrition Professionals Inc Vol#: 21
LET 3503 Nutrition Professionals Inc Vol#: 21
LET 3504 Nutrition Professionals Inc Vol#: 21
LET 3505 Nutrition Professionals Inc Vol#: 21
LET 3506 Nutrition Professionals Inc Vol#: 21
LET 3507 Nutrition Professionals Inc Vol#: 21
LET 3508 NutraLife Corporation Vol#: 21
LET 3509 NutraLife Corporation Vol#: 21
98D-0693 Allergenic Extract or Allergen Patch Test
GDL 2 Vol#: 1
NAD 2 Vol#: 1
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
C 49 Beverly Huntsberger Vol#: 2
98D-1218 Pilot program for gamma irradiated blood & blood components
C 1 American Association of Blood Banks Vol#: 1
98F-0635 Safe use in contact with food/antioxidant&/or stabilizer
NWL 1 Vol#: 1
NWL 2 Vol#: 1
98H-0558 Civil Money Penalties;Bill Reed & Steve Reed,d/b/a Reed's
CS 1 HFA-305 Vol#: 1
OR 1 HF-3 Vol#: 1
98H-1261 Civil Money Penalties;Timothy Terrell,d/b/a Twin Roads Foodm
CS 1 HFA-305 Vol#: 1
EXB 1 GCF-1 Vol#: 1
OR 1 HF-3 Vol#: 1
98N-1038 Irradiation in the production, processing, &handling of food
C 796 James McNamer. Jr. Vol#: 18
C 798 Mary Jane & L.E. Daughenbaugh Vol#: 18
C 799 Christine Hoeflich Vol#: 18
C 800 Michael Maraney Vol#: 18
98N-1265 Distribution of Compounded Drug Products
C 1374 Julia W. Kramer Vol#: 72
C 1375 Markham J. Matson Vol#: 72
C 1376 Deborah L. Rotter Vol#: 72
C 1377 Denise T. Schoone Vol#: 72
C 1378 Karen A. Laskowski Vol#: 72
C 1379 Barbara J. Sullivan Vol#: 72
C 1380 Melinda Taylor Vol#: 72
C 1381 Heather S. Brady Vol#: 72
C 1383 Sandra L. Wagner Vol#: 72
C 1385 Suzanne Creswell Vol#: 72
C 1386 Christine E. Parker Vol#: 72
C 1387 Earline Sutton Vol#: 72
C 1388 Linda Rich Williams Vol#: 72
C 1389 Paula L. White Vol#: 72
C 1390 Danelle R. Jaime Vol#: 72
C 1394 Marylyn Burridge Vol#: 72
C 1396 Pricilla M. Welter Vol#: 72
C 1397 Marguerite Bookstein Vol#: 72
C 1399 Nutritional Concepts Vol#: 72
C 1400 Allen Hatch Jr Vol#: 72
C 1402 Mary Jo Underwood Vol#: 72
C 1403 Phyllis C. Doe Vol#: 72
C 1405 Philip M. Mattson Vol#: 72
C 1407 Patricia A. Matson Vol#: 72
C 1408 Russell R. Yost Vol#: 72
C 1409 Connie Cororan Vol#: 72
C 1410 Ervin J. Maveal Vol#: 72
C 1411 Dyan P. McCann Vol#: 72
C 1412 Patricia L. Nathan Vol#: 72
C 1416 Carolyn Elliott Vol#: 72
C 1420 Jo Sippie-Gora Vol#: 72
C 1422 Jane M. Benson Vol#: 72
C 1423 Philip Schmitz Vol#: 72
C 1424 Cynthia Lambros Vol#: 72
C 1426 Julia A. Schroeder Vol#: 72
C 1427 Margaret M. Lange Vol#: 72
C 1428 Michele Sackman Vol#: 72
C 1431 Diane D. Newman Vol#: 72
C 1432 Bobby S. Horne Vol#: 72
C 1433 Vera M. Borgmeyer Vol#: 72
C 1434 Dula V. P. Fuller Vol#: 72
C 1436 Angelika W. Christiansen Vol#: 72
C 1437 Marilyn Pepperdine Vol#: 72
C 1438 Jerry M. McGehee Vol#: 72
C 1439 Eileen Sturdevant Vol#: 72
C 1441 Dayton Ear, Nose & Throat Surgeons Inc Vol#: 72
C 1442 Carol M. Newman Vol#: 72
C 1445 Elaine M. Beulke Vol#: 72
C 1446 Mary B. Dawley Vol#: 72
C 1447 Dolleen R. Griffin Vol#: 72
C 1448 Judy Stephenson Vol#: 72
C 1452 Rosalina B. Smith Vol#: 72
C 1453 Bette Edgington Vol#: 72
C 1454 Doris A. Steppe Vol#: 72
C 1455 April McGuigan Vol#: 72
C 1456 Carolyn Bryggman Vol#: 72
C 1459 Valerie Corburn Vol#: 72
C 1460 Jennifer R. Heil Vol#: 72
C 1463 Isabel A. Montone Vol#: 72
C 1466 Robert H. Morrison Vol#: 72
C 1469 Katherine Banas Vol#: 72
C 1471 Carolyn S. Buchler Vol#: 72
C 1472 Patricia J. Bates Vol#: 72
C 1476 Wendy L. Gregory Vol#: 72
C 1477 Women's Contemporary Health-Care Vol#: 72
98P-0151 Introduction Of Downed Cattle Into The Food Supply
C 2108 Elizabeth Sourel Vol#: 52
C 2109 Elizabeth Weir Vol#: 52
C 2110 Robert S. Smith Vol#: 52
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
C 178 William G. Scaggs Vol#: 15
C 180 New Hampshire Lodging & Restaurant Assn. Vol#: 15
C 181 NFPA, National Food Processors Assn. Vol#: 15
C 182 Congress of the United States Vol#: 15
C 183 C & C Oyster Co., LTD Vol#: 15
C 184 State of Connecticut House of Representa Vol#: 15
C 185 Pristine Bay Oysters Vol#: 15
C 186 Heckes Oyster Co. Vol#: 15
C 187 Crab Broker, Inc. Vol#: 15
C 189 Pacific Coast Oyster Growers Assn. Vol#: 15
C 191 Florida Dept. of Environmental Protectio Vol#: 15
C 192 Taylor Shellfish Co. Vol#: 15
C 193 CFA, Consumer Federation of America Vol#: 15
C 194 Form Letters 10 Vol#: 16
C 195 Port Sulphur Fisheries, Inc. Vol#: 17
C 196 Coalition for Consumer Choice Vol#: 17
99D-0236 Skin Irriation/Sensitization testing of generic transdermal
C 5 Berlex Laboratories Vol#: 1
99D-0239 Resolving scientific disputes concerning regulation Medical
GDL 1 Vol#: 1
NAD 1 Vol#: 1
99D-0557 Use of Nonhuman Primate Xenografts in Humans
C 2 Stephanie Nickolan-Barron Vol#: 1
99D-0972 Policy on the disposition of publications that consitiute
GDL 1 Vol#: 1
NAD 1 Vol#: 1
99F-0994 Phosphorothioic acid, o,o,o-triphenyl ester, tert-butyl
NFL 1 Ciba Specialty Chemicals Corp. Vol#: 1
99H-0827 Civil Money Penalties;Angus I Hines Inc,d/b/a Sentry Food
ANS 1 Angus I Hines Inc,d/b/a Sentry food Mart Vol#: 1
99H-0858 Civil Monwy Penalties;Angus I Hines Inc.
ANS 1 Angus I Hines Inc,d/b/a Sentry food Mart Vol#: 1
99H-0878 Civil Money Penalties; Dell Oil Ltd,d/b/a Dell Oil
ANS 1 Dell Oil Ltd., d/b/a Dell Oil Vol#: 1
99H-0916 Civil Money Penalties; TVN, Inc. d/b/a Conoco Food Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1061 Civil Money Penalties;Casey's Marketing Co,d/b/a Casey's
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1062 Civil Money Penalties;Ali Fadhil,d/b/a M & M Mini Mart
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1063 Civil Money Penalties;Home Oil Stations Inc,d/b/a Home Oil
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1064 Civil Money Penalties;Stephen W Hunt,d/b/a Texaco Food Mart
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1065 Civil Money Penalties;Hy-Vee Inc,d/b/a Regal Liquors
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1066 Civil Money Penalties;Ijaz Mohammad,d/b/a Marlboro Shell
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1067 Civil Money Penalties;Okah Sunny Okoh,d/b/a JTS Food Mart
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1068 Civil Money Penalties;George S Smith & Dr Robert Smith,d/b/a
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1077 Civil Money Penalties;A T Williams Oil Co,d/b/a Wilco Servic
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1078 Civil Money Penalties;CVS Corp,d/b/a CVS Pharmacy #220
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1079 Civil Money Penalties;Kmart Corp,d/b/a Big K Store #3512
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1080 Civil Money Penalties;Kmart Corp,d/b/a Kmart Store #7642
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1081 Civil Money Penalties;Local Inc,d/b/a Local Food Stop
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1082 Civil Money Penalties;Stringers Inc,d/b/a Exxon at the Glen
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1083 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart Sto
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1084 Civil Money Penalties;Walgreen Eastern Co Inc,d/b/a Walgreen
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99N-0386 Talking with Stakeholders About FDA Modernization
EC 6 University of Indonesia Vol#: 1
EC 7 Bristol Myers Squibb Vol#: 1
99N-0803 Resrictions/Distribution of cigaretts/smokeless tobacco
N 1 Vol#: 1
99P-0301 Amend the Peanut Spread Regulations
C 2 Southern Peanut Farmers Federation Vol#: 1
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
C 92 George F. Bason, Jr. Vol#: 1
C 93 Diane C. Cheklich Vol#: 1
C 94 Elisabeth & Edgar Lehman Vol#: 1