Daily Dockets - 05/2/03

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DOCKETS ENTERED on May 2, 2003

Docket Number - Title

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

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

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

00P-1322 Food Labeling and Allergen Contamination Control

02N-0204 Bar Code Label Requirements for human drug products

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

02P-0435 Effective Approval of Alphanate Antihemophilic Factor

03D-0001 Nonclinical Safety Evaluation of Pediatric Drug Products

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

LET 38 HFD-1 to Soap & Detergent Assn. & CTFA Vol#: 149

LET 39 HFD-560 to Ben M. Durham, Jr. Vol#: 149

94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

C 8582 Annamarie Harrod et al Vol#: 116

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

C 2463 Elaine W. Vol#: 71

C 2464 Martha E. Viner Vol#: 71

C 2465 Brenda Millette Vol#: 71

C 2466 Claire L. Renn Vol#: 71

C 2467 Teri Tibbits Vol#: 71

C 2468 Priscilla Castellano Vol#: 71

C 2469 Linda Winter Vol#: 71

C 2470 Reda J. Short Vol#: 71

C 2471 Mrs. Frances Eglow Vol#: 71

C 2472 Fay C. Graning Vol#: 71

C 2473 Cherie Rickett Vol#: 71

C 2474 Cecile Nebel Vol#: 71

C 2475 Bernice Schneider Vol#: 71

C 2476 Dr. Mary R. Laner Vol#: 71

C 2477 Ms. Virginia R. Hay Vol#: 71

C 2478 Gractia P. Austin Vol#: 71

C 2479 Mrs. Eleanor McIntosh Vol#: 71

C 2480 Deborah Clawson Vol#: 71

C 2481 Phyllis & Edward Ball Vol#: 71

C 2482 Colleen Kirby Vol#: 71

C 2483 Martin Kaloostian Vol#: 71

C 2484 Shirley Newton Vol#: 71

C 2485 Mary L. Mayer Vol#: 71

C 2486 Dorothy D. Berg Vol#: 71

C 2487 Ms. Agnes Annunziata Vol#: 71

C 2488 Norma L. Kaecker Vol#: 71

C 2489 Mrs. Joy Grijalva Vol#: 71

C 2490 Russell Hammond Vol#: 71

C 2491 J. Blauster, RN, ANP Vol#: 71

C 2492 E. Dunn Vol#: 71

C 2493 J. Rigney Vol#: 71

C 2494 Josephine & Philip McKibben Vol#: 71

C 2495 Nancy & Leroy Sprey Vol#: 71

C 2496 P.L. Borman Vol#: 71

C 2497 Bette & Bob Rockow Vol#: 71

C 2498 Gene E. Carbone Vol#: 71

C 2499 Fran Hast Vol#: 71

C 2500 Steve Oppenheim Vol#: 71

C 2501 Abigail E. Worstell Vol#: 71

C 2502 Ms. Holly Rothkopf Vol#: 71

C 2503 E. Vol#: 71

C 2504 Johnson Quinn Vol#: 71

C 2505 Judy Wiss Vol#: 71

C 2506 J. Alice Felicia, M.A., L.P. Vol#: 71

C 2507 Inez Diamond Vol#: 71

C 2508 Amy L. Vandersall Vol#: 71

C 2509 Clifford Hames Vol#: 71

C 2510 Ag Radio Network, Inc. Vol#: 71

C 2511 Mrs. J. M. Gerstley Vol#: 71

C 2512 Susan V. Messina et al Vol#: 71

C 2513 Moise E. Berger Vol#: 71

C 2514 Harold O. Walker Vol#: 71

C 2515 Bill & Marilyn Voorhies Vol#: 71

C 2516 Betty Lou Wells Vol#: 71

C 2517 Ronald C. West Vol#: 71

C 2518 Loraine Campbell Vol#: 71

C 2519 John D. Mancuso Vol#: 71

C 2520 Judy Harvey Vol#: 71

C 2521 Carol A. Watson Vol#: 71

C 2522 Jeanne Jo L'Heureux Vol#: 71

C 2523 Janan C. Henry Vol#: 71

C 2524 Roselene Haines Vol#: 71

C 2525 Jack Altman Vol#: 71

C 2526 Linda Quimby Vol#: 71

C 2527 Michael Rossa Vol#: 71

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

LET 10193 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10194 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10195 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10196 Perrigo Company of South Carolina Vol#: 77

LET 10197 Perrigo Company of South Carolina Vol#: 77

LET 10198 Perrigo Company of south Carolina Vol#: 77

LET 10199 Perrigo Company of South Carolina Vol#: 77

LET 10200 Perrigo Company of South Carolina Vol#: 77

LET 10201 Perrigo Company of South Carolina Vol#: 77

LET 10202 Perrigo Company of South Carolina Vol#: 77

LET 10203 Perrigo Company of South Carolina Vol#: 77

LET 10204 Perrigo Company of South Carolina Vol#: 77

LET 10205 Bayer Corporation Vol#: 77

LET 10206 NBTY, Inc. Vol#: 77

LET 10207 NBTY, Inc. Vol#: 77

LET 10208 NBTY, Inc. Vol#: 77

LET 10209 NBTY, Inc. Vol#: 77

LET 10210 NBTY, Inc. Vol#: 77

LET 10211 NBTY, Inc. Vol#: 77

LET 10212 NBTY, Inc. Vol#: 77

LET 10213 NBTY, Inc. Vol#: 77

LET 10214 NBTY, Inc. Vol#: 77

LET 10215 NBTY, Inc. Vol#: 77

LET 10216 NBTY, Inc. Vol#: 77

LET 10217 NBTY, Inc. Vol#: 77

LET 10218 NBTY, Inc. Vol#: 77

LET 10219 NBTY, Inc. Vol#: 77

LET 10220 NBTY, Inc. Vol#: 77

LET 10221 NBTY, Inc. Vol#: 77

LET 10222 NBTY, Inc. Vol#: 77

LET 10223 NBTY, Inc. Vol#: 77

LET 10224 NBTY, Inc. Vol#: 77

LET 10225 NBTY, Inc. Vol#: 77

LET 10226 NBTY, Inc. Vol#: 77

LET 10227 NBTY, Inc. Vol#: 77

LET 10228 NBTY, Inc. Vol#: 77

LET 10229 NBTY Inc. Vol#: 77

LET 10230 NBTY, Inc. Vol#: 77

LET 10231 NBTY, Inc. Vol#: 77

LET 10232 NBTY, Inc. Vol#: 77

LET 10233 NBTY, Inc. Vol#: 77

LET 10234 NBTY, Inc. Vol#: 77

LET 10235 NBTY, Inc. Vol#: 77

LET 10236 NBTY, Inc. Vol#: 77

LET 10237 NBTY, Inc. Vol#: 77

LET 10238 NBTY, Inc. Vol#: 77

LET 10239 NBTY, Inc. Vol#: 77

LET 10240 Vol#: 77

LET 10241 NBTY, Inc. Vol#: 77

LET 10242 NBTY, Inc. Vol#: 77

LET 10243 BNBTY, Inc. Vol#: 77

LET 10244 NBTY, Inc. Vol#: 77

LET 10245 NBTY, Inc. Vol#: 77

LET 10246 NBTY, Inc. Vol#: 77

LET 10247 NBTY, Inc. Vol#: 77

LET 10248 NBTY, Inc. Vol#: 77

LET 10249 NBTY, Inc. Vol#: 77

LET 10250 NBTY, Inc. Vol#: 77

LET 10251 NBTY, Inc. Vol#: 77

LET 10252 NBTY, Inc. Vol#: 77

LET 10253 NBTY, Inc. Vol#: 77

LET 10254 NBTY, Inc. Vol#: 77

LET 10255 NBTY, Inc. Vol#: 77

LET 10256 NBTY, Inc. Vol#: 77

LET 10257 NBTY, Inc. Vol#: 77

LET 10258 NBTY, Inc. Vol#: 77

LET 10259 NBTY, Inc. Vol#: 77

LET 10260 NBTY, Inc. Vol#: 77

LET 10261 NBTY, Inc. Vol#: 77

LET 10262 NBTY, Inc. Vol#: 77

LET 10263 NBTY, Inc. Vol#: 77

LET 10264 NBTY, Inc. Vol#: 77

LET 10265 NBTY, Inc. Vol#: 77

LET 10266 NBTY, Inc. Vol#: 77

LET 10267 NBTY, Inc. Vol#: 77

LET 10268 NBTY, Inc. Vol#: 77

LET 10269 NBTY, Inc. Vol#: 77

LET 10270 NBTY, Inc. Vol#: 77

LET 10271 NBTY, Inc. Vol#: 77

LET 10272 NBTY, Inc. Vol#: 77

LET 10273 NBTY, Inc. Vol#: 77

LET 10274 NBTY, Inc. Vol#: 77

LET 10275 NBTY, Inc. Vol#: 77

LET 10276 PhytoPharmica Natural Medicines Vol#: 77

LET 10277 PhytoPharmica Natural Medicines Vol#: 77

LET 10278 PhytoPharmica Natural Medicines Vol#: 77

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 11562 Shannon Walker Vol#: 349

00P-1322 Food Labeling and Allergen Contamination Control

C 527 HFS-821 to Ms. Ruth Schneider Vol#: 30

EMC 498 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 499 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 500 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 501 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 502 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 503 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 504 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 505 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 506 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 507 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 508 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 509 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 510 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 511 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 512 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 513 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 514 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 515 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 516 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 517 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 518 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 519 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 520 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 521 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 522 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 523 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 524 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 525 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 526 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 527 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 528 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 529 The Food Allergy & anaphylaxis Network Vol#: 20

EMC 530 The Food Allergy & anaphylaxis Network Vol#: 20

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 2722 James Hosey Vol#: 228

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 1175 George Bakos Vol#: 5

02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate

EMC 109 Brent Kirkman, PhD Vol#: 3

EMC 110 Carol Greenwood Vol#: 3

02N-0204 Bar Code Label Requirements for human drug products

C 38 Precision Dynamics Corporation Vol#: 13

LET 3 HF-40 to Precision Dynamics Corporation Vol#: 13

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EMC 84 DGN-Ministry of Economy Mexico Vol#: 10

EMC 85 Min of Foreign Trade & Tourism of Peru Vol#: 10

EMC 86 European Communities Vol#: 10

EMC 87 National Standardization Agency of Indoe Vol#: 10

02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments

EMC 106 DGN-Ministry of Economy Mexico Vol#: 11

EMC 107 Min of Foreign Trade & Tourism of Peru Vol#: 11

EMC 108 National Standardization Agency of Indoe Vol#: 11

EMC 109 National Standardization Agency of Indoe Vol#: 11

EMC 110 National Standardization Agency of Indoe Vol#: 11

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

EMC 9 F. Hoffmann-La Roche, Ltd Vol#: 2

03M-0172 PMA Cypher Sirolimus-Eluting Coronary Stent on the Raptor

AAV 1 Cordis Corporation Vol#: 1