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 May 28, 2002

TABLE OF CONTENTS

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80N-0295 OTC drug review policy statement *
97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container *
01N-0322 Institutional Review Boards *
01P-0353 ANDA for a generic albuterol inhalation aerosol *
01P-0518 Improve Rules for TV Sets *
02P-0243 Require Issuance of Medication Guide for All Statin Drugs *

80N-0295 OTC drug review policy statement

MM 127 FDA & CHPA Vol#: 3

95N-0253 Sale & Distribution Cigarettes protect children/adolescents

CA 2499 Ann M. Oria Vol#: 5012

CA 2500 Joel Knudson Vol#: 5012

CA 2501 Terri J. Brown Vol#: 5012

CA 2502 Curt G. Paradise Vol#: 5012

CA 2503 Cliff Gott Vol#: 5012

CA 2504 M. Celeste Leath Vol#: 5012

CA 2505 Dianne Talbot, R. N. Vol#: 5012

CA 2506 Micheal Wilson Vol#: 5012

CA 2507 Aaron Riggio Vol#: 5012

CA 2508 Colleen Durkin Vol#: 5012

CA 2509 Leslee Bailey Vol#: 5012

CA 2510 Janine Stephens Vol#: 5012

CA 2511 Suzanne Andrus Vol#: 5012

CA 2512 Sheila Pudists Vol#: 5012

CA 2513 Katherine Schriver Vol#: 5012

CA 2514 Susan Paredes Vol#: 5012

CA 2515 Karen Stein Vol#: 5012

CA 2516 Carol Golub Vol#: 5012

CA 2517 Karen Froelich Vol#: 5012

CA 2518 Herb Stumpre Vol#: 5012

CA 2519 Donna Ranken Vol#: 5012

CA 2520 Mary Alice Westrick, M. D. Vol#: 5012

CA 2521 Cindy Smith Vol#: 5012

CA 2522 Earl L. Geddes Vol#: 5012

CA 2523 Virginia Zipperer Vol#: 5012

CA 2524 Judy Day Vol#: 5012

CA 2525 M. Sharkey Vol#: 5012

CA 2526 Harry Griffith Vol#: 5012

CA 2527 W. S. Coghill Vol#: 5012

CA 2528 Betty Sugarman Vol#: 5012

CA 2529 Valerie Oxford Vol#: 5012

CA 2530 Mel W. Radison, M. D. Vol#: 5012

CA 2531 Katherine Gallagher Vol#: 5012

CA 2532 Michele M. Kasler Vol#: 5012

CA 2533 Col. R. A. McMahon, Jr. Vol#: 5012

CA 2534 Pearl Sonaplez Vol#: 5012

CA 2535 Jeanette T. Whittington Vol#: 5012

CA 2536 Janice R. Suess Vol#: 5012

CA 2537 Kay Metsher Vol#: 5012

CA 2538 Sarah Peyton Vol#: 5012

CA 2539 Judy Barnhart Vol#: 5012

CA 2540 Millie Neal Vol#: 5012

CA 2541 Bill Gilmore Vol#: 5012

CA 2542 Josephine E. Bennett Vol#: 5012

CA 2543 Joanne C. Peterson Vol#: 5012

CA 2544 Paul Hewitt Vol#: 5012

CA 2545 Cathy J. Howe Vol#: 5012

CA 2546 Patrick E. Gracnia Vol#: 5012

CA 2547 Ralph Uymund Vol#: 5012

CA 2548 Lisa Goss, R. N. Vol#: 5012

CA 2549 Jenny Aragon Vol#: 5012

CA 2550 Todd Garcia Vol#: 5012

CA 2551 Victor Roya Vol#: 5012

CA 2552 Martina Cheromiah Vol#: 5012

CA 2553 Jessica Waseta Vol#: 5012

CA 2554 James B. Sweet Vol#: 5012

CA 2555 Erin Van Dragt Vol#: 5012

CA 2556 Scott Chapman Vol#: 5012

CA 2557 Phil Miller Vol#: 5012

CA 2558 Alec Chapman Vol#: 5012

CA 2559 Lisa Fernando Vol#: 5012

CA 2560 Tara Kiro Vol#: 5012

CA 2561 Kristy Kercher Vol#: 5012

CA 2562 Jennifer Weeker Vol#: 5012

CA 2563 Leonard P. Vol#: 5012

CA 2564 Jennifer Payiarno Vol#: 5012

CA 2565 Joe T. Vol#: 5012

CA 2566 Jason Romero Vol#: 5012

CA 2567 Bernard Tarivio Vol#: 5012

CA 2568 Mary Chavez Vol#: 5012

CA 2569 Rochelle Fernando Vol#: 5012

CA 2570 Taylor Bowman Vol#: 5012

CA 2571 Bobbie Tsosie-Hohenstein Vol#: 5012

CA 2572 Justin Suazo Vol#: 5012

CA 2573 Ryan Sandoval Vol#: 5012

CA 2574 Valen Alonzo Vol#: 5012

CA 2575 Sarah Bautista Vol#: 5012

CA 2576 Gail Churonish Vol#: 5012

CA 2577 Melanie Bowman Vol#: 5012

CA 2578 Nathan Lucero, Jr. Vol#: 5012

CA 2579 James Bowman Vol#: 5012

CA 2580 Cara Francisco Vol#: 5012

CA 2581 Donald Day Vol#: 5012

CA 2582 Ben Romero Vol#: 5012

CA 2583 Tiffany Whitmore Vol#: 5012

CA 2584 Reina Hershey Vol#: 5012

CA 2585 Jennifer Antonio Vol#: 5012

CA 2586 Lorenzo Smith Vol#: 5012

CA 2587 Jarvis Aragon Vol#: 5012

CA 2588 Natasha Romero Vol#: 5012

CA 2589 Adrian Cheressosy Vol#: 5012

CA 2590 Janice Kowemy Vol#: 5012

CA 2591 Marylynn Penley Vol#: 5012

CA 2592 Ryan Jones Vol#: 5012

CA 2593 Crystal Yazzie Vol#: 5012

CA 2594 Nicole Thomas Vol#: 5012

CA 2595 Casey John Vol#: 5012

CA 2596 Sonia Viconti Vol#: 5012

CA 2597 Glenlee Jones Vol#: 5012

CA 2598 Franklin J. Vol#: 5012

CA 2599 Felicia Jojol Vol#: 5013

CA 2600 Joshua Mariana Vol#: 5013

CA 2601 Dean Smith Vol#: 5013

CA 2602 Ryan W. Vol#: 5013

CA 2603 Marlo Lucero Vol#: 5013

CA 2604 Preston Murmolejo Vol#: 5013

CA 2605 Tommy Pomero Vol#: 5013

CA 2606 Teresa Dose Vol#: 5013

CA 2607 Allen Elwood Vol#: 5013

CA 2608 Veronica Miller Vol#: 5013

CA 2609 Shawna Douma Vol#: 5013

CA 2610 Trina Riley Vol#: 5013

CA 2611 Ashley Sarracino Vol#: 5013

CA 2612 Aaron "Mousey" Johnson Vol#: 5013

CA 2613 Brandi Kie Vol#: 5013

CA 2614 Frank Ortiz Ceino Vol#: 5013

CA 2615 Keith Scott Vol#: 5013

CA 2616 Monica Waikaniwa Vol#: 5013

CA 2617 Mandy Francis Vol#: 5013

CA 2618 Joni Watuener Vol#: 5013

CA 2619 Jordan Reddell Vol#: 5013

CA 2620 Tunisha Vol#: 5013

CA 2621 Sahend Brown Vol#: 5013

CA 2622 Melody Curtis Vol#: 5013

CA 2623 Bea Chris Vol#: 5013

CA 2624 John Zamora Vol#: 5013

CA 2625 Linda Qumyzintauer Vol#: 5013

CA 2626 Jonathan Aurella Vol#: 5013

CA 2627 Robyn Leon Vol#: 5013

CA 2628 Aaron Alonzo Vol#: 5013

CA 2629 Mandi Chace Vol#: 5013

CA 2630 Brooke Hickee Vol#: 5013

CA 2631 Mary Cart Vol#: 5013

CA 2632 Keri Feyerherm Vol#: 5013

CA 2633 Kody Kowemecensa Vol#: 5013

CA 2634 Matt Sorracino Vol#: 5013

CA 2635 Evan Thomas Vol#: 5013

CA 2636 Walter Johnson Vol#: 5013

CA 2637 Sharone Dreromiah Vol#: 5013

CA 2638 Patricia Pine Vol#: 5013

CA 2639 Kristen Wolfe Vol#: 5013

CA 2640 Sara Rauch Vol#: 5013

CA 2641 Rachel Wolfe Vol#: 5013

CA 2642 Norma Ladner Vol#: 5013

CA 2643 Michele Hover Vol#: 5013

CA 2644 Shalon Gale Vol#: 5013

CA 2645 Lorraine Moyer Vol#: 5013

CA 2646 Randy Moyer Vol#: 5013

CA 2647 Ashley Guillot Vol#: 5013

CA 2648 Katherine Margret Vol#: 5013

CA 2649 Rob Johnston Vol#: 5013

CA 2650 Angelo Harston Vol#: 5013

CA 2651 Christine Smith Vol#: 5013

CA 2652 Carl Henderson Vol#: 5013

CA 2653 Steven Mathews Vol#: 5013

CA 2654 Martin Cordew Vol#: 5013

CA 2655 Denise Hicks Vol#: 5013

CA 2656 Carey Nillsen Vol#: 5013

CA 2657 Don Irvin Vol#: 5013

CA 2658 Jessica Warrick Vol#: 5013

CA 2659 Nicole Vol#: 5013

CA 2660 Aja Carin Vol#: 5013

CA 2661 Nicole Frostel Vol#: 5013

CA 2662 Juana Fernandez Vol#: 5013

CA 2663 Robert Armand Vol#: 5013

CA 2664 Krystle Jo Owens Vol#: 5013

CA 2665 Phillip Townsend Vol#: 5013

CA 2666 Anthony Tavard Vol#: 5013

CA 2667 Harrison McDaniel Vol#: 5013

CA 2668 Crystal Garea Vol#: 5013

CA 2669 Veronica Castillo Vol#: 5013

CA 2670 Billy Wanda Vol#: 5013

CA 2671 Aaron Wells Vol#: 5013

CA 2672 Sunny Gauger Vol#: 5013

CA 2673 Lonnie Thomas Vol#: 5013

CA 2674 Helen Nunez Vol#: 5013

CA 2675 Tiara Jefferson Vol#: 5013

CA 2676 Bobby Zakhor Vol#: 5013

CA 2677 William Robert Torkin, III Vol#: 5013

CA 2678 Meagan Brennan Vol#: 5013

CA 2679 Anna Feyerherm Vol#: 5013

CA 2680 Theresa Dohn Vol#: 5013

CA 2681 Joy Rathlef Vol#: 5013

CA 2682 Kovarn Sledge Vol#: 5013

CA 2683 Sean Covington Vol#: 5013

CA 2684 Mateena H. Vol#: 5013

CA 2685 Sarah Mutivawsky Vol#: 5013

CA 2686 Duane Perkins Vol#: 5013

CA 2687 Susan Kettering Vol#: 5013

CA 2688 Tiera Harris Vol#: 5013

CA 2689 Jim Eppenstein Vol#: 5013

CA 2690 Tatiana Carter Vol#: 5013

CA 2691 Sarah E. Epperson Vol#: 5013

CA 2692 Eduardo Pimentel Vol#: 5013

CA 2693 Jennifer M. Olivigni Vol#: 5013

CA 2694 Bethany Logsdon Vol#: 5013

CA 2695 Andrea Ring Vol#: 5013

CA 2696 Shelly Laulham Vol#: 5013

CA 2697 Adam Martin Vol#: 5013

CA 2698 Amy Williams Vol#: 5013

95P-0224 Cease Regs on Prescription Drug Advertisments to Consumers

C 1 Janet Lubeski Vol#: 1

C 2 Dottie Schaefer Vol#: 1

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9634 GlaxoSmithKline Vol#: 201

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

C 5809 Florence Delfino Vol#: 241

C 5810 Nancie L. Sailor Vol#: 241

99E-1086 Enbrel, Patent No. 5,712,155

N 1 Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9800 Meghan Curry Vol#: 570

01N-0322 Institutional Review Boards

C 11 American Society of Gene Therapy Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 894 Diane Suzuki Vol#: 190

01P-0353 ANDA for a generic albuterol inhalation aerosol

PAV 1 HFD-1 to Aspire Pharmaceuticals Inc Vol#: 1

01P-0518 Improve Rules for TV Sets

PDN 1 HFZ- 1 to Consumer Electronic Assn Vol#: 1

02P-0243 Require Issuance of Medication Guide for All Statin Drugs

ACK 1 HFA-305 Vol#: 1

CP 1 Julian M. Whitaker, M.D. Vol#: 1