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Dockets Management
Dockets Entered On September 29, 2004
Table of Contents
Docket # Title
1978N-0038 Sunscreen Drug Products
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2003H-0432 Civil Money Penalty, Korangy Radiology Associates, PA
2004N-0081 BSE Risk Materials in Foods and Cosmetics
2004N-0330 Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
2004N-0355 Scientific Considerations Related to Developing Follow-on Protein Products
2004P-0091 To premarket approval (PMA) for the gastric electrical stimulation ( GES), level III device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis
2004V-0447 Laser Light Show
1978N-0038 Sunscreen Drug Products
ANS 10 HFW-1 Vol #: 62
ANS 11 HFW-1 Vol #: 62
ANS 12 HFD-600 Vol #: 94
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 14533 Perrigo Company of South Carolina Vol #: 127
LET 14534 Perrigo Company of South Carolina Vol #: 127
LET 14535 Perrigo Company of South Carolina Vol #: 127
LET 14536 Perrigo Company of South Carolina Vol #: 127
LET 14537 Perrigo Company of South Carolina Vol #: 127
LET 14538 Perrigo Company of South Carolina Vol #: 127
LET 14539 Perrigo Company of South Carolina Vol #: 127
LET 14540 Perrigo Company of South Carolina Vol #: 127
LET 14541 NBTY Inc. Vol #: 127
LET 14542 NBTY, Inc. Vol #: 127
LET 14543 NBTY, Inc. Vol #: 127
LET 14544 NBTY, Inc. Vol #: 127
LET 14545 NBTY, Inc. Vol #: 127
LET 14546 NBTY, Inc. Vol #: 127
LET 14547 NBTY, Inc. Vol #: 127
LET 14548 NBTY, Inc. Vol #: 127
LET 14549 NBTY, Inc. Vol #: 127
LET 14550 NBTY, Inc. Vol #: 127
LET 14551 NBTY, Inc. Vol #: 127
2003H-0432 Civil Money Penalty, Korangy Radiology Associates, PA
TR 1 Admin. Complaint for Money Penalties Mtg. 9/20/04 Vol #: 5
2004N-0081 BSE Risk Materials in Foods and Cosmetics
EMC 280 D. Cunnius Vol #: 9
EMC 281 B. Apgar, MD Vol #: 9
EMC 282 L. Devine Vol #: 9
EMC 283 K. Wessel Vol #: 9
EMC 284 A. Yahre Vol #: 9
EMC 285 K. Harmel Vol #: 9
EMC 286 B. Schiano Vol #: 9
EMC 287 S. Kelly Vol #: 9
EMC 288 S. Dzienius Vol #: 9
EMC 289 Y. LeBris Vol #: 9
EMC 290 L. Slough and R. Beach Vol #: 9
EMC 291 B. Chin Vol #: 9
EMC 292 L. Martin Vol #: 9
EMC 293 D. Zelnio Vol #: 9
EMC 294 T. Triplett Vol #: 9
EMC 295 A. Cimino Vol #: 9
EMC 296 J. Ireland Vol #: 9
EMC 297 B. Coffey Vol #: 9
EMC 298 E. Happy Vol #: 9
EMC 299 P. Metralexis Vol #: 9
EMC 300 E. Driscoll Vol #: 9
EMC 301 T. Hutchinson Vol #: 9
EMC 302 M. Madden Vol #: 9
EMC 303 M. Brinker Vol #: 9
EMC 304 P. Metsinger Vol #: 9
EMC 305 No signature Vol #: 9
EMC 306 R. Landskroner Vol #: 9
EMC 307 M. Winther Vol #: 9
EMC 308 Dr. E. Boccagna Vol #: 9
EMC 309 S. Weiner Vol #: 9
EMC 310 W and M Forsythe Vol #: 9
EMC 311 J. Castner Vol #: 9
EMC 312 K. Hamilton Vol #: 9
EMC 313 S. Stark Vol #: 9
EMC 314 S. Moon Vol #: 9
EMC 315 A. Harris Vol #: 9
EMC 316 D. Lesh Vol #: 9
EMC 317 W. Ritter Vol #: 9
EMC 318 D. Shohan Vol #: 9
EMC 319 C. Merrow Vol #: 9
EMC 320 J. Oster Vol #: 9
EMC 321 A. Byrum Vol #: 9
EMC 322 L. Serfass Vol #: 9
EMC 323 M. Stein Vol #: 9
EMC 324 P. Brant Vol #: 9
EMC 325 L. Bergantino Vol #: 9
EMC 326 No signature Vol #: 9
EMC 327 A. Heenan, PhD Vol #: 9
EMC 328 P. Pan Vol #: 9
EMC 329 C. Mailander Vol #: 9
EMC 330 J. Pomies Vol #: 9
EMC 331 W. Creasy Vol #: 9
EMC 332 P. Salecki Vol #: 9
EMC 333 M. Dolan Vol #: 9
EMC 334 J. Moehlenkamp Vol #: 9
EMC 335 D. Brunetti Vol #: 9
EMC 336 J. Bozzy Vol #: 9
EMC 337 C. Adhikari Vol #: 9
EMC 338 D. Adms Vol #: 9
EMC 339 A. BArnhardt Vol #: 9
EMC 340 C. Frentzel Vol #: 9
EMC 341 S. Kurgis Vol #: 9
EMC 342 E. Haddad Vol #: 9
EMC 343 M. Erickson Vol #: 9
EMC 344 K. Peterson Vol #: 9
EMC 345 J. Carlson Vol #: 9
EMC 346 M. Wu Vol #: 9
EMC 347 R. Speed Vol #: 9
EMC 348 M. Campbell Vol #: 9
EMC 349 A. Brennan Vol #: 9
EMC 350 No signature Vol #: 9
EMC 351 J. Paley Vol #: 9
EMC 352 A. Ashton Vol #: 9
EMC 353 S. and L Eakins Vol #: 9
EMC 354 D. Fleming, PhD Vol #: 9
EMC 355 J. Eckert Vol #: 9
EMC 356 S. Lambert Vol #: 9
EMC 357 A. Gumula Vol #: 9
EMC 358 L. Hall Vol #: 9
EMC 359 N and G Shinn Vol #: 9
EMC 360 R. Wilgarde Vol #: 9
EMC 361 M. Maly Vol #: 9
EMC 362 S. Thompson Vol #: 9
EMC 363 B. Berkman Vol #: 9
EMC 364 S. Pelichoff Vol #: 9
EMC 365 B. Derr Vol #: 9
EMC 366 M. Rescineto Vol #: 9
EMC 367 G. Primack Vol #: 9
EMC 368 S. Drescher Vol #: 9
EMC 369 G. Schneider Vol #: 9
EMC 370 K. Newman Vol #: 9
EMC 371 K. Reilly Vol #: 9
EMC 372 R. Douglas Vol #: 9
EMC 373 R. Artley Vol #: 9
EMC 374 J. Taylor Vol #: 9
EMC 375 A. Gyger Vol #: 9
EMC 376 R. Gellman Vol #: 9
EMC 377 J. Busch Vol #: 9
EMC 378 M. Tsai Vol #: 9
EMC 379 L. Kendrick Vol #: 9
EMC 380 L. Hollings Vol #: 9
EMC 381 Patricia Vol #: 9
EMC 382 Patricia Vol #: 9
EMC 383 S. Stacey Vol #: 9
EMC 384 J. Benedetti Vol #: 9
EMC 385 M. Jerez Vol #: 9
EMC 386 S. Tov Vol #: 9
EMC 387 J. Dijkstra, MD Vol #: 9
EMC 388 K. Kingsley Vol #: 9
EMC 389 N. Lowell Vol #: 9
EMC 390 S. Foster Vol #: 9
EMC 391 A. Carithers Vol #: 9
EMC 392 D. Schmitt Vol #: 9
EMC 393 Mr and Mrs J. Denison Vol #: 9
EMC 394 D. Muraco Vol #: 9
EMC 395 M. Latta Vol #: 9
EMC 396 J. Graser Vol #: 9
EMC 397 S. Moran Vol #: 9
EMC 398 J. Graser Vol #: 9
EMC 399 D. Horn Vol #: 9
EMC 400 D. Dyer Vol #: 9
EMC 401 T. Torper Vol #: 10
EMC 402 D. Lozano Vol #: 10
EMC 403 S. Albert Vol #: 10
EMC 404 D. Carter Vol #: 9
EMC 405 K. Norris Vol #: 10
EMC 406 C. Stewart Vol #: 10
EMC 407 K. Intino Vol #: 10
EMC 408 J. Newton Vol #: 10
EMC 409 M. Layne Vol #: 10
EMC 410 M. Leduc Vol #: 10
EMC 411 No signature Vol #: 10
EMC 412 B. Orr Vol #: 10
EMC 413 Mr and Mrs Sanz Vol #: 10
EMC 414 No signature Vol #: 10
EMC 415 J. Fox Vol #: 10
EMC 416 K. Bellairs Vol #: 10
EMC 417 J. Rosa Vol #: 10
EMC 418 L. Melian Vol #: 10
EMC 419 C. Reavis Vol #: 10
EMC 420 K. Lok Vol #: 10
EMC 421 M. Vanasek Vol #: 10
EMC 422 R. Leibold Vol #: 10
EMC 423 S. Boltz Vol #: 10
EMC 424 M and K Kevany Vol #: 10
EMC 425 J. Ellis Vol #: 10
EMC 426 A. Detten Vol #: 10
EMC 427 B. Scott Vol #: 10
EMC 428 D. Laubenstein Vol #: 10
EMC 429 V. Howell Vol #: 10
EMC 430 D. Braun Vol #: 10
EMC 431 J. Jerkins Vol #: 10
EMC 432 S. Tye Vol #: 10
EMC 433 S. Lavine Vol #: 10
EMC 434 G. Goodman Vol #: 10
EMC 435 J. Alexander Vol #: 10
EMC 436 J. Miller Vol #: 10
EMC 437 I.N. Bayless Vol #: 10
EMC 438 Z. Jordan Vol #: 10
EMC 439 H. Gastfriend Vol #: 10
EMC 440 T. Williams Vol #: 10
EMC 441 No signature Vol #: 10
EMC 442 P. Moore Vol #: 10
EMC 443 C. Waite Vol #: 10
EMC 444 N. Beavers Vol #: 10
EMC 445 B. Wagner Vol #: 10
EMC 446 C. Bratton Vol #: 10
EMC 447 J. Simonelli Vol #: 10
EMC 448 R. Richardson Vol #: 10
EMC 449 Dr. A. Nichols, D.D. Vol #: 10
EMC 450 A. Roberts Vol #: 10
EMC 451 G. Darling Vol #: 10
EMC 452 A. Whitlock Vol #: 10
EMC 453 J. Rodriguez Vol #: 10
EMC 454 J. Schehr Vol #: 10
EMC 455 M. Waterbury Vol #: 10
EMC 456 No signature Vol #: 10
EMC 457 C.M. Fravel Vol #: 10
EMC 458 K. McGovern Vol #: 10
EMC 459 J. Pizarro Vol #: 10
EMC 460 T. Robson Vol #: 10
EMC 461 R and S Riley Vol #: 10
EMC 462 M. Neidell Vol #: 10
EMC 463 S. Pelch Vol #: 10
EMC 464 A and B Greenstein Vol #: 10
EMC 465 D. Burkhart Vol #: 10
EMC 466 C. Eichert Vol #: 10
EMC 467 T. Wheeler Vol #: 10
EMC 468 P. Thandi Vol #: 10
EMC 469 P. Thandi Vol #: 10
EMC 470 M. Grill Vol #: 10
EMC 471 No signature Vol #: 10
EMC 472 P. Patek Vol #: 10
EMC 473 T. LeFrois Vol #: 10
EMC 474 K. O'Donnell Vol #: 10
EMC 475 No signature Vol #: 10
EMC 476 P. Gavenonis Vol #: 10
EMC 477 Dr. S. Albano Vol #: 10
EMC 478 C. Gorham Vol #: 10
EMC 479 H. Frank Vol #: 10
EMC 480 D. Damme Vol #: 10
EMC 481 AJ Sennett Vol #: 10
EMC 482 D. Hall Vol #: 10
EMC 483 H. Monsimer Vol #: 10
EMC 484 S. Costello Vol #: 10
EMC 485 M. Kranz Vol #: 10
EMC 486 K. Shaffner Vol #: 10
EMC 487 F. Mariani Vol #: 10
EMC 488 J and M Thew Vol #: 10
EMC 489 S. Ramsey Vol #: 10
EMC 490 S. Ramsey Vol #: 10
EMC 491 F. Cone Vol #: 10
EMC 492 A. Robinson Vol #: 10
EMC 493 C. Hersh Vol #: 10
EMC 494 S. Farrin Vol #: 10
EMC 495 C. Bambara Vol #: 10
EMC 496 K. Sutterfield Vol #: 10
EMC 497 G. Benyk Vol #: 10
EMC 498 B. Claire Vol #: 10
EMC 499 M. Hass Vol #: 10
EMC 500 H. Thorpe Vol #: 10
EMC 501 H. Adams, RN Vol #: 10
EMC 502 G and C Cohen Vol #: 10
EMC 503 E. Ward Vol #: 10
EMC 504 A. Bakey Vol #: 10
EMC 505 D. Wood Vol #: 10
EMC 506 No signature Vol #: 10
EMC 507 K. Braun Vol #: 10
EMC 508 P. Morello Vol #: 10
EMC 509 M. Davis Vol #: 10
EMC 510 N. Dollard Vol #: 10
EMC 511 C. Harp Vol #: 10
EMC 512 S. Dragan Vol #: 10
EMC 513 J. Raubach Vol #: 10
EMC 514 Mr and Mrs U.E. Hopper Vol #: 10
EMC 515 Mr and Mrs U.E. Hopper Vol #: 10
EMC 516 J. Levesque Vol #: 10
EMC 517 G. Monroe Vol #: 10
EMC 518 J. Kring Vol #: 10
EMC 519 C. Hess Vol #: 10
EMC 520 P. Mihale Vol #: 10
EMC 521 S. Nagao Vol #: 10
EMC 522 L. LeBlang Vol #: 10
EMC 523 S. Kosek Vol #: 10
EMC 524 R. Mantia Vol #: 10
EMC 525 B. Flowers Vol #: 10
EMC 526 P. Ranney Vol #: 10
EMC 527 L. Barenholtz Vol #: 10
EMC 528 R. Johnson Vol #: 10
EMC 529 F. Lehman Vol #: 10
EMC 530 M. Sessions Vol #: 10
EMC 531 M. Fichter Vol #: 10
EMC 532 W.M. Holls, M..D. Vol #: 10
EMC 533 T. Becker Vol #: 10
EMC 534 C. Smith Vol #: 10
EMC 535 C. Malerich Vol #: 10
EMC 536 P. Welshofer Vol #: 10
EMC 537 P. Johnson Vol #: 10
EMC 538 K. Dixon Vol #: 10
EMC 539 G. Gardiner Vol #: 10
EMC 540 S. Schrader Vol #: 10
EMC 541 T. Mizhir Vol #: 10
EMC 542 A. Levy Vol #: 10
EMC 543 J. Wickline Vol #: 10
EMC 544 P. Nahay Vol #: 10
EMC 545 J. Distefano Vol #: 10
EMC 546 M. Larson Vol #: 10
EMC 547 M. Duffy Vol #: 10
EMC 548 R. Grant Vol #: 10
EMC 549 A. Gosack Vol #: 10
EMC 550 S. Haws Vol #: 10
EMC 551 C. Wear Vol #: 10
EMC 552 L. Marshall Vol #: 10
EMC 553 W. Stern Vol #: 10
EMC 554 H. Herrell Vol #: 10
EMC 555 S. Montague Vol #: 10
EMC 556 T. Ouellette, MD Vol #: 10
EMC 557 P. Perren Vol #: 10
EMC 558 C. Justice Vol #: 10
EMC 559 C. Curnow Vol #: 10
EMC 560 Mr and Mrs E. Sweitzer Vol #: 10
EMC 561 S. Corsi Vol #: 10
EMC 562 B. Storti Vol #: 10
EMC 563 M. Cover Vol #: 10
EMC 564 J. Weeks Vol #: 10
EMC 565 B. Dilworth Vol #: 10
EMC 566 B. Birdsey Vol #: 10
EMC 567 No signature Vol #: 10
EMC 568 A. Schoen Vol #: 10
EMC 569 R. Klingberg Vol #: 10
EMC 570 J. Grout Vol #: 10
EMC 571 C. Almond Vol #: 10
EMC 572 J. and F Chemes Vol #: 10
EMC 573 B. Orzechowski Vol #: 10
EMC 574 J. Mejuto Vol #: 10
EMC 575 Kris R. Vol #: 10
EMC 576 H.R. Harris Vol #: 10
EMC 577 P. Peters Vol #: 10
EMC 578 S. Walters Vol #: 10
EMC 579 S. Dell Vol #: 10
EMC 580 D. Spitler Vol #: 10
EMC 581 B. Domingo Vol #: 10
EMC 582 D. Morley Vol #: 10
EMC 583 D. Deslandes Vol #: 10
EMC 584 H. Chase Vol #: 10
EMC 585 G. Veiby Vol #: 10
EMC 586 L. Kligman Vol #: 10
EMC 587 J. Kovich Vol #: 10
EMC 588 M. MacDonald Vol #: 10
EMC 589 G. Janzen Vol #: 10
EMC 590 K. Lynn Vol #: 10
EMC 591 A. Dillon Vol #: 20
EMC 592 C. Mizerany Vol #: 10
EMC 593 C. Brown Vol #: 10
EMC 594 R. Pfaffe Vol #: 10
EMC 595 L. Campbell Vol #: 10
EMC 596 R. and M. Cohen Vol #: 10
EMC 597 K. McCarty Vol #: 10
EMC 598 S. Stephenson Vol #: 10
EMC 599 A. Tuggle Vol #: 10
EMC 600 J. Ingersoll Vol #: 10
EMC 601 D. Kolakowski Vol #: 10
EMC 602 R. Schmelz Vol #: 10
EMC 603 T. Edlund Vol #: 10
EMC 604 T. Edlund Vol #: 10
EMC 605 R. Teddlie Vol #: 10
EMC 606 R. Marquez Vol #: 10
EMC 607 M. Herman Vol #: 10
EMC 608 S. Figurski Vol #: 10
EMC 609 D. Lewis Vol #: 10
EMC 610 L. Bisson Vol #: 10
EMC 611 J. MacIntosh Vol #: 10
EMC 612 A. Kasper Vol #: 10
EMC 613 S. Pic Vol #: 10
EMC 614 F. Perlman Vol #: 10
EMC 615 R. Grover Vol #: 10
EMC 616 M. Woodfield Vol #: 10
EMC 617 L. Gray Vol #: 10
EMC 618 L. Ploeg Vol #: 10
EMC 619 No signature Vol #: 10
EMC 620 K. Avarese Vol #: 10
EMC 621 G. Berkowicz Vol #: 10
EMC 622 W. Schmidt Vol #: 10
EMC 623 J and R Ridolfi Vol #: 10
EMC 624 I. Muschel Vol #: 10
EMC 625 D. Turman Vol #: 10
EMC 626 B. Robinson Vol #: 10
EMC 627 No signature Vol #: 10
EMC 628 No signature Vol #: 10
EMC 629 S. Kay Vol #: 10
EMC 630 J. Bentzel Vol #: 10
EMC 631 M. Bahleda Vol #: 10
EMC 632 S. Bundy Vol #: 10
EMC 633 B. Wagner Vol #: 10
EMC 634 D. Weil Vol #: 10
EMC 635 T. Chilcote Vol #: 10
EMC 636 D. Weil Vol #: 10
EMC 637 D. Gray Vol #: 10
EMC 638 A. Stanberry Vol #: 10
EMC 639 G. Rocco Vol #: 10
EMC 640 M. Bonk Vol #: 10
EMC 641 J. Burke Vol #: 10
EMC 642 S. Eklund Vol #: 10
EMC 643 C. Delp Vol #: 10
EMC 644 H. Forkos Vol #: 10
EMC 645 M. Hefner Vol #: 10
EMC 646 B. Sliter Vol #: 10
EMC 647 Dr. C. Romesburg Vol #: 10
EMC 648 C. Adam Vol #: 10
EMC 649 B. Love Vol #: 10
EMC 650 C. McClintock Vol #: 10
EMC 651 T. Savage Vol #: 10
EMC 652 A. Marlin Vol #: 10
EMC 653 J. Bickford Vol #: 10
EMC 654 K. Bierbaum Vol #: 10
EMC 655 S. Rhodes Vol #: 10
EMC 656 P. Gold Vol #: 10
EMC 657 P. Tice Vol #: 10
EMC 658 R. Winrod Vol #: 10
EMC 659 K. Darling Vol #: 10
EMC 660 D. Livingston Vol #: 10
EMC 661 S. Wagner Vol #: 10
EMC 662 J. Kahl Vol #: 10
EMC 663 H. Twining Vol #: 10
EMC 664 R. Carr Vol #: 10
EMC 665 Cnance Vol #: 10
EMC 666 A. Singer Vol #: 10
EMC 667 J. Kaszas Vol #: 10
EMC 668 L. Vest Vol #: 10
EMC 669 K. Tassin Vol #: 10
EMC 670 D. Polo Vol #: 10
EMC 671 A. Sigurdson Vol #: 10
EMC 672 K. Kirsten Vol #: 10
EMC 673 L. Hardman Vol #: 10
EMC 674 No signature Vol #: 10
EMC 675 M. McDevitt Vol #: 10
EMC 676 B. Herner Vol #: 10
EMC 677 K. Roper Vol #: 10
EMC 678 C. Babst Vol #: 10
EMC 679 D. Taylor Vol #: 10
EMC 680 S. Bender Vol #: 10
EMC 681 L. Manis Vol #: 10
EMC 682 L. Reynolds Vol #: 10
EMC 683 E. Yocam Vol #: 10
EMC 684 S. Walker Vol #: 10
EMC 685 R. Roach Vol #: 10
EMC 686 Dr. L. Pizzini Vol #: 10
EMC 687 No signature Vol #: 10
EMC 688 G. Joubarne Vol #: 10
EMC 689 No signature Vol #: 10
EMC 690 A. Ang Vol #: 10
EMC 691 S. Florez Vol #: 10
EMC 692 K. Owen Vol #: 10
EMC 693 K. Owen Vol #: 10
EMC 694 T. Holmes Vol #: 10
EMC 695 A. Payne Vol #: 10
EMC 696 M. Hutton Vol #: 10
EMC 697 W. Fuchs Vol #: 10
2004N-0330 Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
EMC 5 J. Lowell, PhD Vol #: 2
2004N-0355 Scientific Considerations Related to Developing Follow-on Protein Products
EMC 1 Biotechnology Industry Organization (BIO) Vol #: 1
EMC 2 J. Leclair Vol #: 1
2004P-0091 To premarket approval (PMA) for the gastric electrical stimulation ( GES), level III device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis
EMC 6 T. Swick Vol #: 1
2004V-0447 Laser Light Show
ACK 1 HFA-305 to We WIll Rock You Las Vagas/ Rock You Vega, LLC Vol #: 1
VAR 1 We Will Rock You Las Vegas/Rock You Vegas L. L. C. Vol #: 1

Page created on September 30, 2004 kk

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