Dockets Home | Accessibility | Dockets Contacts and Location | Operating Status | Item Codes

DOCKETS ENTERED on 3/28/03

Docket Number - Title

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
01D-0583 Food Security Guidance *
02D-0018 Race and Ethnicity Data in Clinical Trials for FDA *
02N-0204 Bar Code Label Requirements for human drug products *
03N-0069 FDA Task Force on Consumer Health Info for Better Nutrition
03P-0126 Refrain from approving (ANDA)for Levothyroxine Sodium Tablet *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 3819 American Medical Assn Vol#: 310

C 3820 The Chemical Company, Inc. Vol#: 310

EC 481 Ms. Susan Crosier Vol#: 307

EC 482 Number Not Used Vol#: 307

EC 483 Mr. mike abreu Vol#: 307

EC 484 N/A Vol#: 307

EC 485 The Fitness Station Vol#: 307

EC 486 Wellness International Network Vol#: 307

EC 487 None Vol#: 307

EC 488 Ms. Hillery H. Maxymillian Vol#: 307

EC 489 911 Inc Designs Vol#: 307

EC 490 Mr. Herbert Cables Vol#: 307

EC 491 Mr. Bruce Counley Vol#: 307

EC 492 Mr. Bruce Counley Vol#: 307

EC 493 Mr. Raul Mendez Vol#: 307

EC 494 Mrs. annemiek van Kooten Vol#: 307

EC 495 Miss Gloria Thornburgh Vol#: 307

EC 496 The Health Shack Vol#: 307

EC 497 Moab Fitness Center Vol#: 307

EC 498 Miss Tracy Powell Vol#: 307

EC 499 Mr. Robert Billings Vol#: 307

EC 500 Mrs. P ROLLEY Vol#: 307

EC 501 Mr. Keith Ziomek Vol#: 307

EC 502 Number Not Used Vol#: 307

EC 503 Natural Solutions Herbs & Healthfoods Vol#: 307

EC 504 Jinke Group USA Vol#: 307

EC 505 Multi-Pak Corporation Vol#: 307

EC 506 Mr. Jonathan Davies Vol#: 307

EC 507 Ms. Bonnie Lee Hunt Vol#: 307

EC 508 good health inc. Vol#: 307

EC 509 Mr. Mark Damico Vol#: 307

EC 510 National Collegiate Athletic Association Vol#: 307

EC 511 Dr. Timothy Smuda Vol#: 307

EC 512 GreenAcres Natural Foods Vol#: 307

EC 513 Mrs. Tara Scaife Vol#: 307

EC 514 Mr. philip hudgins Vol#: 307

EC 515 Trash American Style Vol#: 307

EC 516 Mr. Eric Edson Vol#: 307

EC 517 Healthy Paths Vol#: 307

EC 518 Mrs. Sylvia Tries Vol#: 307

EC 519 New Dawn Natural Foods Vol#: 307

EC 520 Ms. Ann Lerner Vol#: 307

EC 521 Mr. Barry Lerner Vol#: 307

EC 522 Healthy Life General Store Vol#: 307

EC 523 Mr. D. Kyle Burns Vol#: 307

EC 524 market america Vol#: 307

EC 525 Ms. Joyce Schemonia Vol#: 307

EC 526 Mr. Christopher Williams Vol#: 307

EC 527 Mr. Timothy S Jr. Ward Vol#: 307

EC 528 PCE Vol#: 307

EC 529 Mr. Brad Boden Vol#: 307

EC 530 Razzberry's Vol#: 307

EC 531 Max Muscle Vol#: 307

EC 532 Miss Keshia Porter Vol#: 307

EC 533 Mr. Anthony Zerucha RN Vol#: 307

EC 534 Number Not Used Vol#: 307

EC 535 Mr. Brian Ramirez Vol#: 307

EC 536 Hudson Wellness Center Vol#: 307

EC 537 ME Vol#: 307

EC 538 Emerald City Smoothie Bonney Lake Vol#: 307

EC 539 Tampa Bay Devil Rays Vol#: 307

EC 540 Mr. Richard Cox Vol#: 307

EC 541 Dr. Michael Ziegler Vol#: 307

EC 542 Mr. MIguel Torres Vol#: 307

EC 543 public citz. Vol#: 307

EC 544 Mr. Keith Nuccio Vol#: 307

EC 545 NA Vol#: 307

EC 546 PURE, FRESH & ORGANIC Vol#: 307

EC 547 Mr. Chris Shumway Vol#: 307

EC 548 Mr. Scott Wakeman Vol#: 307

EC 549 Mr. Scott Ackland Vol#: 307

EC 550 Mr. Scott Weston Vol#: 307

EC 551 Mr. Shawn Carney Vol#: 307

EC 552 Mr. hans tuinenburg Vol#: 307

EC 553 none Vol#: 307

EC 554 Mr. James Brown Vol#: 307

EC 555 Overweight-Teen-Solutions.com Vol#: 307

EC 556 Mr. david hoffman Vol#: 307

EC 557 Mr. David Dean Vol#: 307

EC 558 Mr. Brian Adams Vol#: 307

EC 559 Mr. Jeff Berglund Vol#: 307

EC 560 Mrs. Corinne Meier Vol#: 307

EC 561 n/a Vol#: 307

EC 562 180th FW, Ohio ANG Vol#: 307

EC 563 Mr. Tony Bennett Vol#: 307

EC 564 Mr. Robert McCain Vol#: 307

EC 565 Whole Foods Market Vol#: 307

EC 566 Mr. Michael Gfesser Vol#: 307

EC 567 Wellness Business Group Vol#: 307

EC 568 none Vol#: 307

EC 569 Natural Balance Vol#: 307

EC 570 Mr. brian sanders Vol#: 307

EC 571 Private Vol#: 307

EC 572 Bellingham Bay Acupuncture Vol#: 307

EC 573 Miss shannon smith Vol#: 307

EC 574 Nature's Life Vol#: 307

EC 575 Mr. Paul Pierce Vol#: 307

EC 576 SELF Vol#: 307

EC 577 Private Citizen Vol#: 307

EC 578 None (Private Citizen) Vol#: 307

EC 579 Wellness International Network, Ltd. Vol#: 307

EC 580 Mr. Chico Diaz Vol#: 307

EC 581 Number Not Used Vol#: 307

EC 582 Natural Balance, Inc. Vol#: 307

EC 583 Mr. Richard Treglia Vol#: 307

EC 584 i.BioCeuticals LLC Vol#: 307

EC 585 Mr. Greg Harrley Vol#: 307

EC 586 Millennium2Health Vol#: 307

EC 587 NNFA Vol#: 307

EC 588 none Vol#: 307

EC 589 Mr. Justin Schwartz Vol#: 307

EC 590 Mr. mark langley Vol#: 307

EC 591 Mr. Sean Cooley Vol#: 307

EC 592 Williamsport Area High School Vol#: 307

EC 593 Dr. Margery Sarvey Vol#: 307

EC 594 Mrs. Lynda Cafardi Vol#: 307

EC 595 Eba Enterprises Vol#: 307

EC 596 soundkraft Vol#: 307

EC 597 Wellness International Network Vol#: 307

EC 598 none Vol#: 307

EC 599 Willy St. Co-op Vol#: 307

EC 600 Mr. Bill Earle Vol#: 307

EC 601 Wilfrid Laurier University Vol#: 307

EC 602 Harvest Food Co-op Vol#: 307

EC 603 Mr. eric capo Vol#: 307

EC 604 Mr. Brian Pienkos Vol#: 307

EC 605 Mrs. Jacqueline Siminou Vol#: 307

EC 606 Mr. Travis Davis Vol#: 307

EC 607 Nautilus Academy Vol#: 307

EC 608 Mr. Jamil Reis Vol#: 307

EC 609 Intensive Nutrition Inc. Vol#: 307

EC 610 montecito natural foods Vol#: 307

EC 611 Stay at home mom Vol#: 307

EC 612 Mrs. Dana neubert Vol#: 307

EC 613 UCDavis Vol#: 307

EC 614 N/A Vol#: 307

EC 615 Mrs. Joanne Elliott Vol#: 307

EC 616 Mrs. Angie Mays Vol#: 307

EC 617 Nourish Vol#: 307

EC 618 Columbus Health Foods Vol#: 307

EC 619 Mr. Huy Hoang Vol#: 307

EC 620 Ms. Mary Anderson Vol#: 307

EC 621 LTD Vol#: 307

EC 622 Mr. Chris Wagner Vol#: 307

EC 623 Mr. John Morman Vol#: 307

EC 624 Ms. Roberta Lorenz Vol#: 307

EC 625 Ms. Sunnie Wagner Vol#: 307

EC 626 Mr. Eli Walsh Vol#: 307

EC 627 Mr. Larry Brown Vol#: 307

EC 628 Delta Sigma Phi Vol#: 307

EC 629 Miss Roberta Hampton Vol#: 307

EC 630 Mr. Frederick Davis Vol#: 307

EC 631 Mr. Bret Bradshaw Vol#: 307

EC 632 Ms. Samantha Locklear Vol#: 307

EC 633 Mr. Rocky Bernstein Vol#: 307

EC 634 Mr. Bernard Courtney Vol#: 307

EMC 93 Form Letter count Vol#: 319

96N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements

EC 6 Number Not Used Vol#: 1

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

C 5722 Form letters count 292 Vol#: 202

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

C 6431 Mrs. Karen M. Smout Vol#: 274

C 6432 Lori C. Boynton Vol#: 274

C 6433 Cindi Tedesco Vol#: 274

C 6434 Virginia Volk-Anderson Vol#: 274

C 6435 Mrs. Shirley M. Chapman Vol#: 274

C 6436 Lucille K. Moran Vol#: 274

C 6437 Alma F. Blackwelder Vol#: 274

C 6438 Lauren Elizabeth Murphy Vol#: 274

C 6439 Mary Pearson Vol#: 274

C 6440 Mrs. Annie M. Lewallen Vol#: 274

C 6441 Lisa Schreiner Vol#: 274

00N-1484 Safety Reporting Requirements Human Drug/Biological Products

EC 8 Mr. William Shrader Vol#: 1

01D-0583 Food Security Guidance

EC 1 Number Not Used Vol#: 1

EC 2 America Tohkin Ent., Inc. Vol#: 1

02D-0018 Race and Ethnicity Data in Clinical Trials for FDA

C 11 AstraZeneca, LP Vol#: 1

02D-0258 Studies for Orally Administered Drug Products

EC 1 Number Not Used Vol#: 1

02D-0388 Establishing Pregnancy Exposure Registries

EC 2 Miss Colleen Kelley Vol#: 1

02F-0160 Safe use of Vitamin D3 in Calcium-Fortified Fruit Juices

EC 8 Ms. Rachel Stirewalt Vol#: 1

EC 9 Mrs. Debbie Seelig Vol#: 1

EC 10 US Citizen Vol#: 1

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

C 26 Novo Nordisk Pharmaceuticals, Inc. Vol#: 6

C 27 Uniform Code Council, Inc. Vol#: 6

EC 12 Single Dose, LLC Vol#: 6

MM 1 HF-11 & PhRMA Vol#: 6

MM 2 HF-22 & HDMA Vol#: 6

MM 3 HF-11 & HAHIT Vol#: 6

MM 4 HF-11 & HDMA Vol#: 6

02N-0253 Withdrawal of 53 Guidances on Individual Product Labeling

EC 19 Number Not Used Vol#: 1

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EC 73 Productos Agropecuarios Mamirmi, S.A. Vol#: 7

EC 74 Tahal Consulting Vol#: 7

EC 75 KOTRIC Vol#: 7

EC 76 Nova Scotia Fish Packers Association Vol#: 7

EC 77 Smokey Kettle Maple Co. Ltd Vol#: 7

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

C 62 Flegenheimer International, Inc. Vol#: 7

EC 74 Productos Agropecuarios Mamirmi, S.A. Vol#: 7

EC 75 E.K. Bare @ Sons Vol#: 7

EC 76 Corbett International Inc. Vol#: 7

EC 77 Metzler Systems, Inc. Vol#: 7

EC 78 Amex Distributing Co., Inc. Vol#: 7

EC 79 Ciruli Brothers Vol#: 7

EC 80 Brown Line Inc. Vol#: 7

EC 81 New Belgium Brewing Co. Vol#: 7

EC 82 Nova Scotia Fish Packers Association Vol#: 7

EC 83 THE PERISHABLE SPECIALIST, INC. Vol#: 7

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

EC 1 International Society for Pharmacoepidem Vol#: 1

EC 2 International Society for Pharmacoepidem Vol#: 1

EC 3 The Degge Group, Ltd. for ISPE Vol#: 1

EC 4 International Society for Pharmacoepidem Vol#: 1

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

EC 7 Dr. Paul G. King Vol#: 1

EC 8 Apotex Research Inc. Vol#: 1

03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach

EC 17 EFPIA Vol#: 1

EC 18 Number Not Used Vol#: 1

03N-0069 FDA Task Force on Consumer Health Info for Better Nutrition

EC 9 Wellness Int. Network Vol#: 1

EC 10 The Vita-Mine Inc. Vol#: 1

EC 11 None Vol#: 1

EC 12 Mr. Norman Nelson Vol#: 1

EC 13 Mrs. Pat BOLE Vol#: 1

EC 14 University of Houston Clear Lake Vol#: 1

EC 15 Mr. AL DECANIO Vol#: 1

EC 16 Mrs. Tammy Kindig Vol#: 1

EC 17 Select Speciality Hospital Vol#: 1

03N-0079 Consumer and Producer Surveys on Economic Issues

EC 1 Number Not Used Vol#: 1

EC 2 Number Not Used Vol#: 1

03P-0126 Refrain from approving (ANDA)for Levothyroxine Sodium Tablet

ACK 1 HFA-305 to Convington & Burling Vol#: 1

CP 1 Jones Pharma Inc.(Jones) King Pharma. Vol#: 1

03V-0125 Infrared Laser Aiming Device

ACK 1 HFA-305 Vol#: 1

VAR 1 Insight Technology Incorporated Vol#: 1