DOCKETS ENTERED on 12/06/01

Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on December 6, 2001

TABLE OF CONTENTS

Hyper links are part of the Docket title - not all dockets/documents are linked

NOTE: Documents received by the Dockets Management Branch "MAY" be posted on the Internet.

PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE] [ ITEM CODES ]

90S-0308 Generic Drug Speeches & Policy and Procedure Guides *
94S-0120 510K Substantially Equivalent List *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
01N-0450 Prescription Drug User Fee Act (PDUFA) *
01P-0036 Carboplatin Injection 10 mg/mL in a ready-to-use solution *

77N-0085 Saccharin and Its Salts

CA 22688 Richard E. Luse Vol#: 453

CA 22847 OPINION BAllOT Vol#: 454

CA 22850 OPINION BAllOT Vol#: 454

CA 22867 OPINION BALLOT Vol#: 454

CA 22880 jOHN lEIKAM Vol#: 454

CA 23026 Mrs. Jean G. Cowan Vol#: 456

CA 23082 Robert Mininger Vol#: 456

CA 23179 Mrs. Rosemary Helon Vol#: 458

90S-0308 Generic Drug Speeches & Policy and Procedure Guides

M 720 HFD-600 Vol#: 51

M 721 HFD-600 Vol#: 51

M 722 HFD-600 Vol#: 51

M 723 HFD-600 Vol#: 51

M 724 HFD-600 Vol#: 51

M 725 HFD-600 Vol#: 51

94S-0120 510K Substantially Equivalent List

LST 108 List of November 2001 Vol#: 25

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

LET 8297 Herbalife International Of America Inc Vol#: 62

LET 8298 NBTY Inc Vol#: 62

LET 8299 CCA Industries Inc Vol#: 62

LET 8300 CCA Industries Inc Vol#: 62

LET 8301 Country Life Vol#: 62

LET 8302 Country Life Vol#: 62

LET 8303 Country Life Vol#: 62

LET 8304 Perrigo Company of South Carolina Vol#: 62

LET 8305 Source Naturals Vol#: 62

LET 8306 Source Naturals Vol#: 62

LET 8307 Source Naturals Vol#: 62

LET 8308 Source Naturals Vol#: 62

LET 8309 Source Naturals Vol#: 62

LET 8310 Source Naturals Vol#: 62

LET 8311 Natural Organics Inc Vol#: 62

LET 8312 Natural Organics Inc Vol#: 62

LET 8313 Natural Organics Inc Vol#: 62

LET 8314 Avon Products Inc Vol#: 62

LET 8315 Avon Products Inc Vol#: 62

LET 8316 Avon Products Inc Vol#: 62

LET 8317 Avon Products Inc Vol#: 62

LET 8318 Avon Products Inc Vol#: 62

LET 8319 Avon Products Inc Vol#: 62

LET 8320 Avon Products Inc Vol#: 62

LET 8321 Avon Products Inc Vol#: 62

LET 8322 Twin Laboratories Inc Vol#: 62

LET 8323 Twin Laboratories Inc Vol#: 62

LET 8324 Twin Laboratories Inc Vol#: 62

LET 8325 Twin Laboratories Inc Vol#: 62

LET 8326 Twin Laboratories Inc Vol#: 62

LET 8327 Twin Laboratories Inc Vol#: 62

LET 8328 J R Carlson Laboratories Inc Vol#: 62

LET 8329 J R Carlson Laboratories Inc Vol#: 62

LET 8330 J R Carlson Laboratories Inc Vol#: 62

LET 8331 J R Carlson Laboratories Inc Vol#: 62

LET 8332 J R Carlson Laboratories Inc Vol#: 62

LET 8333 J R Carlson Laboratories Inc Vol#: 62

LET 8334 J R Carlson Laboratories Inc Vol#: 62

LET 8335 J R Carlson Laboratories Inc Vol#: 62

LET 8336 J R Carlson Laboratories Inc Vol#: 62

LET 8337 J R Carlson Laboratories Inc Vol#: 62

LET 8338 J R Carlson Laboratories Inc Vol#: 62

LET 8339 J R Carlson Laboratories Inc Vol#: 62

LET 8340 Bayer Corporation Vol#: 62

LET 8341 Twin Laboratories Inc Vol#: 62

LET 8342 Solgar Vitamin and Herb Vol#: 62

LET 8343 Natural Organics Inc Vol#: 62

LET 8344 Solgar Vitamin and Herb Vol#: 62

LET 8345 Gifts of Nature Inc Vol#: 62

LET 8346 MMS Professional Products Inc Vol#: 62

LET 8347 Nature's Way Products Inc Vol#: 62

LET 8348 NOW Foods Vol#: 62

LET 8349 NBTY Inc Vol#: 62

LET 8350 NBTY Inc Vol#: 62

LET 8351 NBTY Inc Vol#: 62

LET 8352 NBTY Inc Vol#: 62

LET 8353 NBTY Inc Vol#: 62

LET 8354 NBTY Inc Vol#: 62

LET 8355 Twin Laboratories Inc Vol#: 62

LET 8356 Twin Laboratories Inc Vol#: 62

LET 8357 Twin Laboratories Inc Vol#: 62

LET 8358 NOW Foods Vol#: 62

LET 8359 Twin Laboratories Inc Vol#: 62

LET 8360 Shaklee Corporation Vol#: 62

LET 8361 Solstice Medicine Company Vol#: 62

LET 8362 Solstice Medicine Company Vol#: 62

LET 8363 Twin Laboratories Inc Vol#: 62

LET 8364 Twin Laboratories Inc Vol#: 62

LET 8365 Basic Organics Inc Vol#: 62

LET 8366 Basic Organics Inc Vol#: 62

LET 8367 Basic Organics Inc Vol#: 62

LET 8368 Basic Organics Inc Vol#: 62

LET 8369 Basic Organics Inc Vol#: 62

LET 8370 Basic Organics Inc Vol#: 62

LET 8371 Basic Organics Inc Vol#: 62

LET 8372 Basic Organics Inc Vol#: 62

LET 8373 Spirit Sciences USA Inc Vol#: 62

LET 8374 Aboca USA Vol#: 62

LET 8375 Goen Group Vol#: 62

LET 8376 Perrigo Company of South Carolina Vol#: 62

LET 8377 Perrigo Company of South Carolina Vol#: 62

LET 8378 Perrigo Company of South Carolina Vol#: 62

LET 8379 Perrigo Company of South Carolina Vol#: 62

LET 8380 Perrigo Company of South Carolina Vol#: 62

LET 8381 Perrigo Company of South Carolina Vol#: 62

LET 8382 Perrigo Company of South Carolina Vol#: 62

LET 8383 Weeks and Leo Co Inc Vol#: 62

LET 8384 Advitech Solutions Inc Vol#: 62

LET 8385 Tabak's Health Products Vol#: 62

LET 8386 Natural Organics Inc Vol#: 62

LET 8387 Natural Organics Inc Vol#: 62

LET 8388 Natural Organics Inc Vol#: 62

LET 8389 Country Life Vol#: 62

LET 8390 Nordic Naturals Inc Vol#: 62

LET 8391 FreeLife International Vol#: 62

LET 8392 FreeLife International Vol#: 62

LET 8393 Natural Bladder LLC Vol#: 62

LET 8394 Natural Bladder LLC Vol#: 62

LET 8395 Natural Bladder LLC Vol#: 62

LET 8396 Country Life Vol#: 62

LET 8397 Starlight International Vol#: 62

LET 8398 Medestea Internazionale SrLL Vol#: 62

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

C 5349 Edith Stearns Trask Vol#: 190

C 5350 Lila Lahalih Vol#: 190

C 5351 Barry Brown Vol#: 190

C 5352 Connie Holt Vol#: 190

C 5353 Mrs. Paul Clayton Husted Vol#: 190

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EC 204 Chronic Pain Patient Vol#: 4

EC 205 PA.Dept. of Health Health facility Quali Vol#: 4

01N-0450 Prescription Drug User Fee Act (PDUFA)

EAPE104 Consumer Healthcare Products Association Vol#: 1

EAPE105 American Dental Association Vol#: 1

EAPE106 Food and Drug Administration Vol#: 1

01P-0036 Carboplatin Injection 10 mg/mL in a ready-to-use solution

PAV 1 HFD-601 to Venable Vol#: 1