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DOCKETS ENTERED on April 24, 2003

Docket Number - Title

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

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

98D-0834 Non-Contraceptive Estrogen Class Labeling

99D-1458 Enforcement Policy for FDA Personnel/Electronic Records& Sig

00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing

02N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]

03P-0171 Amend the standard of identity for canned tomatoes.

75N-0069 RADIOACTIVE DRUGS, INCLUDING BIOLOGICAL PRODUCTS

NI 1 Vol#: 1

75N-0125 CONDITIONS FOR USE OF METHADONE

NI 1 Vol#: 1

75N-0243 Pasteurized Milk Ordinance and Interstate Milk Shippers

NI 1 Vol#: 5

76N-0098 Physiologic Dependence, staffing & Urine Test Req-Methado

NI 1 Vol#: 1

77G-0379 Sorbic Acid & Its Salts

NI 2 Vol#: 1

77N-0003 Butylated Hydroxytoluene

NI 2 Vol#: 8

77N-0009 FD&C Yellow No. 5

NI 1 Vol#: 7

77N-0033 Brown & Yellow Mustard and Their Derivatives

NI 2 Vol#: 1

77N-0078 Acrylonitrile Copolymers; Contact with Food

NI 1 Vol#: 1

77N-0232 Gelatin; GRAS Status as Direct Human Food Ingredient

NI 2 Vol#: 2

77N-0318 Penicillin & Tetracycline and all Combinations

NI 1 Vol#: 40

77N-0424 Maximum Residue Limits for Ethylene Oxide et al

NI 2 Vol#: 11

77P-0146 Food; Designation of Ingred. Class Name for Cheese Cultur

NI 1 Vol#: 1

78N-0072 FOOD CHEMICALS CODEX MONOGRAPHS

NI 1 Vol#: 1

78N-0144 Cellulose Derivatives

NI 2 Vol#: 1

78N-0213 Tocopherols & Derivatives

NI 2 Vol#: 1

78N-0247 CHLORTETRACYCLINE-SULFAMETHAZINE TABLETS

NI 1 Vol#: 1

78N-0272 PHOSPHATES

NI 1 Vol#: 3

78N-0308 Biotin

NI 2 Vol#: 1

78N-0336 Lard and Lard Oil

NI 2 Vol#: 1

78N-0348 Glycerin; Affirmation of GRAS Status

NI 2 Vol#: 1

78N-1074 SPONGE FOR INTERNAL USE

NI 1 Vol#: 1

78N-2670 PORCINE BURN DRESSING

NI 1 Vol#: 1

78P-0052 FOOD LABELING, EMULSIFIERS & STABILIZERS (CAROB BEAN GUM)

NI 1 Vol#: 1

79P-0265 EXEMP HOMOEOPATHIC DRUG PROD FROM GMP REGULATIONS

NI 1 Vol#: 1

80N-0148 Hydrochloric Acid

NI 2 Vol#: 1

80N-0373 CHEESES AND RELATED CHEESE PROD

NI 1 Vol#: 1

80N-0418 Deletion of GRAS Status of Caffeine

NI 2 Vol#: 38

81N-0281 POLICY FOR REGULATING CARCINOGENIC CHEM IN FOOD & COLOR

NI 1 Vol#: 1

81N-0382 Sodium gluconate, zinc gluconate & gluconic acid

NI 1 Vol#: 1

82N-0006 Protein Hydrolysates (Milk Casein)

NI 2 Vol#: 1

82N-0167 Zinc Salts Proposed Affirmation of GRAS Status

NI 2 Vol#: 1

82N-0219 Regenerated Collagen Proposed GRAS Status

NI 2 Vol#: 1

82N-0246 Ascorbic Acid and Its Sodium & Calcium Salts

NI 2 Vol#: 1

82N-0318 CAFFEINE IN NONALCOHOLIC CARBONATED BEVERAGES

NI 1 Vol#: 1

82N-0389 COMMON OR USUAL NAMES FOR DILUTED FRUIT OR VEGETABLE JUIC

NI 1 Vol#: 4

82P-0316 Reclassify electroconvulsive therapy (ECT) SECTION 513(E)

NI 2 Vol#: 35

84N-0101 NEW DRUG & ANTIBIOTIC APPLICATION REVIEW; USER CHARGE

NI 1 Vol#: 4

84N-0334 VINYL CHLORIDE POLYMERS

NI 2 Vol#: 33

84N-0341 Unmodified Food Starches and Acid-Modified Starches etc

NI 2 Vol#: 1

92N-0406 Food labeling; Metric Labeling Requirements

NI 1 Vol#: 5

92P-0441 Exempt from Preempt for use of NIST Handbook 133

NI 1 Vol#: 10

93M-0150 Nonroller-Type Cardiopulmonary Bypass Blood Pump

NI 1 Vol#: 7

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

NI 2 Vol#: 2

93N-0200 Quality Stds For Foods w/o Identity Standards; Bottled Water

NI 1 Vol#: 3

93N-0226 Quantity of Contents Labeling Requirements for Drugs, Animal

NI 1 Vol#: 2

93N-0348 Lead in Food & Color Additives & GRAS Ingredients

NI 1 Vol#: 3

93N-0467 Substances Prohibited From Use in Animal Food or Feed

NI 1 Vol#: 1

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 2325 Joanne Hedges Vol#: 69

C 2326 Mrs. Betty Landers Vol#: 69

C 2327 Lisa Sammut Vol#: 69

C 2328 Barbara A. Lewis Vol#: 69

C 2329 Doris C. Hays Vol#: 69

C 2330 Sara Benzel Vol#: 69

C 2331 Dr. Robert & Vera Brandt Vol#: 69

C 2332 Major Linda Haeger Ret. Vol#: 69

C 2333 J. C. Lipein & Bill Baldewicz, Ph.D. Vol#: 69

C 2334 Laura H. Vol#: 69

C 2335 Victoria Gussman Vol#: 69

C 2336 Gerald Carter Vol#: 69

C 2337 Betty Leech Vol#: 69

C 2338 V. K. Cage Vol#: 69

C 2339 Sondra Resnikoff Vol#: 69

C 2340 Daphne T. Stevens Vol#: 69

C 2341 Barbara Bender Vol#: 69

C 2342 Lucy L. Hill Vol#: 69

C 2343 Evelyn A. Warner Vol#: 69

C 2344 Mr. & Mrs. D. K. Brown Vol#: 69

C 2345 Patricia M. Sells Vol#: 69

C 2346 Gertude Edzant Vol#: 69

C 2347 Pamela A. Sotir Vol#: 69

C 2348 Frances Barrish & Bernard Barrish Vol#: 69

C 2349 Maisic A. McDaniel Vol#: 69

C 2350 S. M. Keefer Vol#: 69

C 2351 Marilyn Buman Vol#: 69

C 2352 Nancy E. Ryther Vol#: 69

C 2353 Sylvia A. Krafft, RN Vol#: 69

C 2354 Julie Staub Vol#: 69

C 2355 Bea Slingsby Vol#: 69

C 2356 Lawrence Happerin Vol#: 69

C 2357 Ruth Snogren Vol#: 69

C 2358 Vincent Moyer & Ms. Rochelle Roth Vol#: 69

C 2359 Mrs. William Patterson Vol#: 69

C 2360 Carole Schindler Grover Vol#: 69

C 2361 Betty Rose Murphy Vol#: 69

C 2362 Mrs. Crystal Taylor Vol#: 69

C 2363 Jack H. & Joanne E. Townsend Vol#: 69

C 2364 Sandra Silva Vol#: 69

C 2365 Gary Arnold Vol#: 69

C 2366 Dana Wesolowski Vol#: 69

C 2367 Roald Cann Vol#: 69

C 2368 Jim & Virginia Wagner Vol#: 69

C 2369 Robert & Judith Steurich Vol#: 69

C 2370 Dorothy J. Coleman Vol#: 69

C 2371 Patty Sokolecki Vol#: 69

C 2372 Mrs. Agnes E. Summers Vol#: 69

C 2373 Olivia Sheckleton Vol#: 69

C 2374 Fay Plesent Vol#: 69

C 2375 Sylvia M. Danzenbaker Vol#: 69

C 2376 Janet Schneller, M.D. Vol#: 69

C 2377 Merrilie Egbers Vol#: 69

C 2378 Sue Hulett Vol#: 69

C 2379 Ruth E. Sievert Vol#: 69

C 2380 Don, Vicky & Amanda Walters Vol#: 69

C 2381 Lloyd L. Thomas, Jr. Vol#: 69

C 2382 Andrew A. Castagliola Vol#: 69

C 2383 Sandra Weissfisch Vol#: 69

C 2384 Jan Kaven Vol#: 69

C 2385 Ann Bowes Vol#: 69

C 2386 Thomas Reger Vol#: 69

C 2387 Natalie Waddell-Rutter Vol#: 69

C 2388 Claris Liningis Vol#: 69

C 2389 Emily Linford Vol#: 69

C 2390 Joanne Bretney Vol#: 69

C 2391 Leslie McCracken Vol#: 69

C 2392 Margy Schrubbe Vol#: 69

C 2393 Brian D. Akey Vol#: 69

C 2394 Ralph & Lorraine Vickers Vol#: 69

C 2395 Rebecca Shaffer Vol#: 69

C 2396 Harvard School of Public Health Vol#: 69

C 2397 Florence M. Mansur Vol#: 69

C 2398 Donald A. Brandon Vol#: 69

C 2399 Elizabeth Skelly Vol#: 69

C 2400 Diane Wicke Vol#: 69

C 2401 Mark E. Wojcik Vol#: 69

94P-0453 Amend Food Labeling Regs re: Quantity Of Fat Content Claims

NI 1 Vol#: 1

95N-0034 Effect Date PMA's OTC Denture Cushions, Pads, Repair Kits

NI 1 Vol#: 1

95N-0103 Labeling of foods with nutrient/health claims special requir

NI 1 Vol#: 1

95N-0189 Maltodextrin; Food Chemicals Codex Specifications

NI 1 Vol#: 1

95N-0203 Beverages: Bottled Water

NI 1 Vol#: 1

95N-0298 PMA Of Partially Fabricated Denture Kits

NI 1 Vol#: 1

95P-0250 Revoke Std of Identity - Various Lower-fat Milk & Cream Prod

NI 1 Vol#: 1

96N-0149 Reinvention of regulations needing revision; food standards

NI 1 Vol#: 5

96N-0177 Reinvention of certain food additive regulations

NI 1 Vol#: 1

96N-0244 Food Labeling; Declaration of Free Glutamate in Food

NI 1 Vol#: 17

96N-0421 Nutrient Claims pertaining available fat content of Food

NI 1 Vol#: 5

96P-0023 Amend 101.12(b) Table 2 on Hard Candies

NI 1 Vol#: 3

96P-0179 Establishes RACCs for various types of food products candies

NI 1 Vol#: 3

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

LET 9863 Enzymatic Therapy Natural Medicines Vol#: 75

LET 9864 Phyto Pharmica Natural Medicines Vol#: 75

LET 9865 Enzymatic Therapy Natural Medicines Vol#: 75

LET 9866 Enzymatic Therapy Natural Medicines Vol#: 75

LET 9867 Enzymatic Therapy Natural Medicines Vol#: 75

LET 9868 Nature's Sunshine Products, Inc. Vol#: 75

LET 9869 Solgar Vitamin and Herb Vol#: 75

LET 9870 Northwest Natural Products Vol#: 75

LET 9871 Nutrition Now, Inc. Vol#: 75

LET 9872 Solstice Medicine Company Vol#: 75

LET 9873 Solstice Medicine Company Vol#: 75

LET 9874 NBTY, Inc. Vol#: 75

LET 9875 NBTY, Inc. Vol#: 75

LET 9876 NBTY, Inc. Vol#: 75

LET 9877 NBTY, Inc. Vol#: 75

LET 9878 NBTY, Inc. Vol#: 75

LET 9879 NBTY, Inc. Vol#: 75

LET 9880 NBTY, Inc. Vol#: 75

LET 9881 NBTY, Inc. Vol#: 75

LET 9882 NBTY, Inc. Vol#: 75

LET 9883 NBTY, Inc. Vol#: 75

LET 9884 NBTY, Inc. Vol#: 75

LET 9885 NBTY, Inc. Vol#: 75

LET 9886 Cell Tech International Incorporated Vol#: 75

LET 9887 Enzymatic Therapy Natural Medicines Vol#: 75

LET 9888 PhytoPharmica Nautral Medicines Vol#: 75

LET 9889 Star Cor Pharmaceuticals Vol#: 75

LET 9890 PhytoPharmica Natural Medicines Vol#: 75

LET 9891 Flora, Inc. Vol#: 75

LET 9892 Flora, Inc. Vol#: 75

LET 9893 Gaia Herbs Vol#: 75

LET 9894 Solstice Medicine Company Vol#: 75

LET 9895 Solstice Medicine Company Vol#: 75

LET 9896 Gaia Herbs Vol#: 75

LET 9897 World Nutrition, Incorporated Vol#: 75

LET 9898 PhytoPharmica Nuatural Medicines Vol#: 75

LET 9899 PhytoPharmica Nautural Medicines Vol#: 75

LET 9900 Enzymatic Therapy Natural Medicines Vol#: 75

LET 9901 Enzymatic Therapy Natural Medicines Vol#: 75

LET 9902 PhytoPharmica Natural Medicines Vol#: 75

LET 9903 Nature's Sunshine Products, Inc. Vol#: 75

LET 9904 Enzymatic Therapy Natural Medicines Vol#: 753

LET 9905 Enzymatic Therapy Natural Medicines Vol#: 75

LET 9906 PhyutoPharmica Natural Medicines Vol#: 75

LET 9907 Enzymatic Therapy Natural Medicines Vol#: 75

LET 9908 Jagulana Herbal Products Vol#: 75

LET 9909 Jagulana Herbal Products Vol#: 75

LET 9910 Jagulana Herbal Products Vol#: 75

LET 9911 Jagulana Herbal Products Vol#: 75

LET 9912 Enzymatic Therapy Natural Medicines Vol#: 75

LET 9913 Natural Organics, Inc. Vol#: 75

LET 9914 Gaia Herbs Vol#: 75

LET 9915 NBTY, Inc. Vol#: 75

LET 9916 NBTY, Inc. Vol#: 75

LET 9917 NBTY, Inc. Vol#: 75

LET 9918 NBTY, Inc. Vol#: 75

LET 9919 NBTY, Inc. Vol#: 75

LET 9920 NBTY, Inc. Vol#: 75

LET 9921 Nupower Enterprise LLC Vol#: 75

LET 9922 Nupower Enterprise LLC Vol#: 75

LET 9923 Nupower Enterprise LLC Vol#: 75

LET 9924 Nupower Enterprise LLC Vol#: 75

LET 9925 Nupower Enterprise LLC Vol#: 75

LET 9926 Nupower Enterprise LLC Vol#: 75

LET 9927 NBTY, Inc. Vol#: 75

LET 9928 NBTY, Inc. Vol#: 74

LET 9929 NBTY, Inc. Vol#: 75

LET 9930 NBTY, Inc. Vol#: 75

98D-0834 Non-Contraceptive Estrogen Class Labeling

C 18 Novo Nordisk Pharmaceuticals, Inc. Vol#: 5

99D-1458 Enforcement Policy for FDA Personnel/Electronic Records& Sig

C 5 AdvaMed Vol#: 1

C 6 Scantox Vol#: 1

00D-1538 Electronic Records; Electronic Signatures, Validation

C 36 AdvaMed Vol#: 8

C 37 Scantox Vol#: 8

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

C 29 AdvaMed Vol#: 8

C 30 Scantox Vol#: 8

00D-1542 Electronic Signatures: Time Stamps

C 14 AdvaMed Vol#: 6

C 15 Scantox Vol#: 6

00D-1543 Electronic Signatures: Glossary of Terms

C 24 AdvaMed Vol#: 7

C 25 Scantox Vol#: 7

00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing

CS 38 HFA-305 Vol#: 362

LST 6 CVM & Bayer Corporation Vol#: 362

OR 40 HF-3 Vol#: 362

02N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]

TS 15 Risk Mgmt CDER/CBER Exe. Oversight Comm Vol#: 2

TS 16 CDER Vol#: 2

TS 17 International Society for Pharmacoepidem Vol#: 2

TS 18 American Society of Health-System Pharma Vol#: 2

TS 19 PhRMA Vol#: 2

TS 20 Watson Pharmaceuticals Vol#: 2

TS 21 CDER Vol#: 2

TS 22 PhRMA Vol#: 2

TS 23 Pharmacovigilance & Risk Management, In. Vol#: 2

TS 24 Pharmaceutical Safety Assessments Vol#: 2

TS 25 RCN Associates, Inc Vol#: 2

TS 26 International Society for Pharmacoeconom Vol#: 2

02N-0534 Medical Device User Fee and Modernization Act of 2002

C 27 AdvaMed Vol#: 2

03D-0060 Part11, Electronic records, electronic signatures scope

C 8 Scantox Vol#: 1

C 9 ABB Eutech Process Solutions, Ltd Vol#: 1

C 10 AdvaMed Vol#: 1

03M-0157 PMA, Medtronic Activa Dystonia Therapy, H020007

AAV 1 Medtronica Neurological Vol#: 1

03P-0171 Amend the standard of identity for canned tomatoes.

ACK 1 HFA-305 Vol#: 1

CP 1 Del Monte Corp. Vol#: 1

03V-0124 Laser Light Show

VRA 1 HFZ-300 to Universal Studios Florida Vol#: 1