DOCKETS ENTERED on July 9, 2001

TABLE OF CONTENTS

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PDN 6 HFC-1 to Hyman, Phelps & McNamara, P.C. Vol#: 36

91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

REF 5 REFERENCES Vol#: 52

95P-0188 Exempt Medical Gases from the Requirements of 21 CFR 205

PDN 1 HFC-1 to Compressed Gas Association, Inc Vol#: 1

95P-0315 Reclassify Automated Differential Cell Counting Devices

C 1 America's Blood Centers Vol#: 1

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

C 5057 Janet L. Schminkey Vol#: 158

C 5058 Laurie Crawford Stone Vol#: 158

C 5059 Kathy Paolella Vol#: 158

C 5060 Helena Koelle Vol#: 158

C 5061 illegible Vol#: 158

C 5062 Terry Johnson Vol#: 158

C 5063 Raleigh Klein Vol#: 158

C 5064 Jeff Clouatre Vol#: 158

C 5065 Carol Norr Vol#: 158

C 5066 Janice Emich Vol#: 158

C 5067 Connie Wright Vol#: 158

C 5068 Susan Hammersley Vol#: 158

C 5069 Heather Bowler Vol#: 158

C 5070 Roy & Vicki Cosio Vol#: 158

99N-1852 Status reports/postmarketing studies-human drugs&biological

C 12 Celltech Pharmaceuticals, Inc. Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 4892 Eligible Vol#: 352

C 4893 Deborah Daniel Vol#: 352

C 4894 Zane Barber Vol#: 352

C 4895 Carrie Spring Vol#: 352

C 4896 Rose McCaslin Vol#: 352

C 4897 Sari Wilde Vol#: 352

C 4898 Josephi Panico Vol#: 352

C 4899 Lynda Evans Vol#: 352

C 4900 Sarah Coven Vol#: 352

C 4901 Renee Cote Vol#: 352

C 4902 Tierney Freeman Vol#: 352

C 4903 H. Tinn Vol#: 352

C 4904 D. Haylund Vol#: 352

C 4905 Dorothy J. LeGeyt Vol#: 352

C 4906 Jamie Nouri Vol#: 353

C 4907 Expanded Learning Vol#: 353

C 4908 Victoria Ponish Vol#: 353

C 4909 Kimberly A. Hambric Vol#: 353

C 4910 Michal Wyatt Vol#: 353

C 4911 J. Light et al. Vol#: 353

C 4912 Bill Knapp Vol#: 353

C 4913 James & Marian Bouck Vol#: 353

C 4914 Donny Smith Vol#: 353

C 4915 Deborah A. Goslin Vol#: 353

C 4916 B. Gamache Vol#: 353

C 4917 Kate Rau Vol#: 353

C 4918 R.M. Peach Vol#: 353

C 4919 W. James Rinehart Vol#: 353

C 4920 E. E. Pollyver Vol#: 353

C 4921 Heidi Schneider Vol#: 353

C 4922 David Blain Vol#: 353

C 4923 Mr & Mrs RL Brown Vol#: 353

C 4924 Donna LoPresti Vol#: 353

C 4925 Martin Sokolowski Vol#: 353

C 4926 Gloria Spudowski Vol#: 353

C 4927 Andrew Butz Vol#: 353

C 4928 Leslie Thatcher Vol#: 353

C 4929 Arwen O'Reilly Vol#: 353

C 4930 Sheryl Civjan Vol#: 353

C 4931 Jessica Renven Vol#: 353

C 4932 Lori Mucci Vol#: 353

C 4933 John F. Warwick Vol#: 353

C 4934 Eligible Vol#: 353

C 4935 Becky Jacobs Vol#: 353

C 4936 Sam & Ruth Neff Vol#: 353

C 4937 Laurie Bryant Vol#: 353

C 4938 Kevin Traynor Vol#: 353

C 4939 Ronald C. Lang Vol#: 353

C 4940 Susan Pavlakis Vol#: 353

C 4941 V.M. Heineman Vol#: 353

C 4942 Meg McLean Vol#: 353

C 4943 Vernette Hart Vol#: 353

C 4944 Jacob Sloane Vol#: 353

C 4945 David Adams Vol#: 353

C 4946 Mary Fiorillo Vol#: 353

C 4947 Saint Peter's University Hospital Vol#: 353

C 4948 Pennie L. Boots Vol#: 353

C 4949 John J. Brinkman Vol#: 353

C 4950 Stephen Seefeldt Vol#: 353

C 4951 Miriam Goodman Vol#: 353

C 4952 Mary Ann Newell Vol#: 353

C 4953 Anna P. Vinogradoff, PhD Vol#: 353

C 4954 William McAuliffe Vol#: 353

C 4955 Eligible Vol#: 353

C 4956 Jun Hodkins Vol#: 353

C 4957 Susan Merritt Vol#: 353

C 4958 Eligible Vol#: 353

C 4959 Eligible Vol#: 353

C 4960 Jane Leddy Vol#: 353

C 4961 Molly Vol#: 353

C 4962 Andrea Presson Vol#: 353

C 4963 Kitch C. Fairman Vol#: 353

C 4964 Jerry Wright Vol#: 353

C 4965 Carmen Mayer Vol#: 353

C 4966 Johnathan Ellis Vol#: 353

C 4967 Craig Hodkins Vol#: 353

C 4968 Joann Meyer Vol#: 353

C 4969 BJ Oliver Vol#: 353

C 4970 Eligible Vol#: 353

C 4971 V. Heineman Vol#: 353

C 4972 Gary Wilhelm Vol#: 353

C 4973 Karen Robinson Vol#: 353

C 4974 A. Antonion Vol#: 353

C 4975 Val Don Hickerson Vol#: 353

C 4976 Nancy Kippersmith Vol#: 353

C 4977 American Farm Bureau Federation Vol#: 353

C 4978 Gen E. Feldman Vol#: 353

C 4979 Kate Watters Vol#: 353

C 4980 Lorraine M. Swift Vol#: 353

C 4981 Joseph A. Swift Vol#: 353

C 4982 David Bolsover Vol#: 353

C 4983 David Podoll Vol#: 353

C 4984 Stephen S. Heath Vol#: 353

C 4985 Carol Chapman Vol#: 353

C 4986 E. Ilsen Vol#: 353

C 4987 Sky Malkas Doberty Vol#: 353

C 4988 Maguus Schevene Vol#: 353

C 4989 Zory Hamiel Vol#: 353

C 4990 Doreen Trees Vol#: 353

C 4991 Robyn Nick Vol#: 353

C 4992 D. Bernardoni Vol#: 353

C 4993 A. Huggins Vol#: 353

C 4994 D. McShan Vol#: 353

C 4995 Jacquline Forsythe Vol#: 353

C 4996 Genoa Hamiel Vol#: 353

C 4997 Sarah Strong Vol#: 353

C 4998 A. Graetz Vol#: 353

C 4999 Gina Trapella Vol#: 353

C 5000 Darla Petersen Vol#: 353

C 5001 Joseph Therianh Vol#: 353

C 5002 Judy Breese Vol#: 353

C 5003 California Fed for Animal Legislation Vol#: 353

C 5004 EJ Simpson Vol#: 353

C 5005 Kate Waffner Vol#: 353

C 5006 Scott Wolland Vol#: 353

EMC 7427 Nancy A. Mack Vol#: 354

EMC 7428 Nathaniel Cormier Vol#: 354

EMC 7429 Sharon Johnson Vol#: 354

EMC 7430 Andrew Pender Vol#: 354

EMC 7431 Sophie Summersett Vol#: 354

EMC 7432 Chris Ray Collins Vol#: 354

EMC 7433 Tina Pretsch Vol#: 354

EMC 7434 Troy Schulz Vol#: 354

EMC 7435 Cathy DuBois Vol#: 354

EMC 7436 Bill Turner Vol#: 354

EMC 7437 Nina Cestaro Vol#: 354

EMC 7438 Ryan Santens Vol#: 354

EMC 7439 Blair Brown Vol#: 354

EMC 7440 Lynne Shaw Vol#: 354

EMC 7441 Deana Voth Vol#: 354

EMC 7442 Daniel Novey Vol#: 354

EMC 7443 Mark Reback Vol#: 354

EMC 7444 Alan Page Vol#: 354

EMC 7445 Roberta Levitow Vol#: 354

EMC 7446 Amy Stinson Leavenworth Vol#: 354

EMC 7447 Sandra S. Haggard, Assoc. Prof. of Biolo Vol#: 354

EMC 7448 Jean Lauber Vol#: 354

EMC 7449 Jeanne Smith Vol#: 354

EMC 7450 Emily Spencer Vol#: 354

EMC 7451 Kathy Harrison Vol#: 354

EMC 7452 Linda Schrawyer Vol#: 354

EMC 7453 Terry Walters Vol#: 354

EMC 7454 Rae Ann Gustafson Vol#: 354

EMC 7455 Tony Elman Vol#: 354

EMC 7456 Cameron Dye Vol#: 354

EMC 7457 Kim Atkinson Vol#: 354

EMC 7458 Kathleen and Stanley Tenpas Vol#: 354

EMC 7459 Valerie Barzetti Vol#: 354

EMC 7460 Beate Storlie Vol#: 354

EMC 7461 unsigned Vol#: 354

EMC 7462 Kristi Ayala Vol#: 354

EMC 7463 Rob Leland Vol#: 354

EMC 7464 unsigned Vol#: 354

EMC 7465 Tina Cleveland Vol#: 354

EMC 7466 Sy Migdal Vol#: 354

EMC 7467 Jayne DeHaan Vol#: 354

EMC 7468 Sara Epstein Vol#: 354

EMC 7469 Steve Ginsberg Vol#: 354

EMC 7470 Chandra Metheny Vol#: 354

EMC 7471 Georgia Pinkel Vol#: 354

EMC 7472 Jean Baptiste and Hanne Qillevere Vol#: 354

EMC 7473 Ed Spaans Vol#: 354

EMC 7474 Vol#: 354

EMC 7475 Janis Goldstein Vol#: 354

EMC 7476 Arnie Anfinson Vol#: 354

EMC 7477 Shelby Michlin Vol#: 354

EMC 7478 Mike Wright Vol#: 354

EMC 7479 Geri McFadden Vol#: 354

EMC 7480 Laura Ridenour Vol#: 354

EMC 7481 Laura Ridenour Vol#: 354

EMC 7482 Gloria Muia Vol#: 354

EMC 7483 Joann S. Tsoutsouris, Ph.D. Vol#: 354

EMC 7484 Denise Brandt Vol#: 354

EMC 7485 Emily Bowe Vol#: 354

EMC 7486 Martha McKinney Vol#: 354

EMC 7487 Karen and William Aspin Vol#: 354

EMC 7488 Joan Schmidt Vol#: 354

EMC 7489 Jennifer Moran Vol#: 354

EMC 7490 Daniel A. Jud Vol#: 354

EMC 7491 Randall Braden Vol#: 354

EMC 7492 Chris Barnes Vol#: 354

EMC 7493 Michael Mead Vol#: 354

EMC 7494 Loretta Louviere Vol#: 354

EMC 7495 Kevin Koester Vol#: 354

EMC 7496 Steve Bridges Vol#: 354

EMC 7497 Scott and Rebecca Young Vol#: 354

EMC 7498 unsigned Vol#: 354

EMC 7499 Elaine Jacks Vol#: 354

EMC 7500 Christine Colasurdo Vol#: 354

EMC 7501 Carolyn Meyer, Meyer Consulting Co. Vol#: 354

EMC 7502 Mark Kincaid Vol#: 354

EMC 7503 Dr. Ann B. Markell Vol#: 354

EMC 7504 unsigned Vol#: 354

EMC 7505 Melanie Climis Vol#: 354

EMC 7506 Russ and Mary Raney Vol#: 354

EMC 7507 Judith K. Canepa Vol#: 354

EMC 7508 unsigned Vol#: 354

EMC 7509 Dr. John Hagelin Vol#: 354

EMC 7510 unsigned Vol#: 354

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 5168 Memary Peterson-Baur Vol#: 236

C 5169 Merriann Bell Vol#: 236

C 5170 Robert & Betty Smith Vol#: 236

C 5171 P. Desmond Keyes Vol#: 236

C 5172 Harlan Mittag Vol#: 236

C 5173 Elliott Libman Vol#: 236

C 5174 B. J. Felton Vol#: 236

C 5175 Elliott Libman Vol#: 236

C 5176 Rev. Paul J. Otting Vol#: 236

C 5177 Atlee F. Clapp Vol#: 236

C 5178 Christine Stevens Vol#: 236

C 5179 Kristin Benjamin Vol#: 236

C 5180 Michael W. Kozak Vol#: 236

C 5181 Noble K. Fuller Vol#: 236

C 5182 Pamela J. Wallace Vol#: 236

C 5183 unreadable Vol#: 236

C 5184 Pheelee Barn Vol#: 236

C 5185 Theresa Herinek Vol#: 236

C 5186 Julie Keeling Vol#: 236

C 5187 Angela Medbery Vol#: 236

C 5188 Sheila Heckman Vol#: 236

C 5189 Kevin J. Anderson Vol#: 236

C 5190 Mark DiMartino Vol#: 236

C 5191 Sharon Herron Vol#: 236

C 5192 Mae Johnson & Family Vol#: 236

C 5193 Barbara A. Huebner Vol#: 236

C 5194 Robert & Barbara Huebner Vol#: 236

C 5195 Jeanne L. Fabrikant Vol#: 236

C 5196 Rachel E. Peters Vol#: 236

C 5197 Ellen Halloran Vol#: 236

C 5198 Matthew Ennis Vol#: 236

C 5199 Susan Davidson Vol#: 236

C 5200 Christine Loyacano Vol#: 236

C 5201 Ryan Bates Vol#: 236

C 5202 Institute of Science,Technology & Public Vol#: 236

C 5203 unreadable Vol#: 236

C 5204 Susanne Romey Vol#: 236

C 5205 Judith Hoaglund Vol#: 236

C 5206 Lauren Darges Vol#: 236

C 5207 Vivien Straus Vol#: 236

C 5208 Donna Hudson Vol#: 236

C 5209 Sindriglis Family Vol#: 236

C 5210 Cathy Swedlund Vol#: 236

C 5211 Sandy L. Pittman Vol#: 236

C 5212 Rima Forrest Vol#: 236

C 5213 Michael A. Hant Vol#: 236

C 5214 Carol Boutard Vol#: 236

C 5215 Megan Montero Vol#: 236

C 5216 Autumn Shawn Vol#: 236

C 5217 Eric Carlberg Vol#: 236

C 5218 Nancy Strong Vol#: 236

C 5219 Anne & James Schifferle Vol#: 236

C 5220 Henry Peck Vol#: 236

C 5221 Tom B. Younker Vol#: 236

C 5222 Mary Granberg Vol#: 236

C 5223 Valerie L. Kurtz Vol#: 236

C 5224 John G. Koons Vol#: 236

C 5225 Anthony Boutard Vol#: 236

C 5226 Bonnie Grant Vol#: 236

C 5227 C. Bingham Vol#: 236

C 5228 unreadable Vol#: 236

C 5229 Richard & Marie E. Sayles Vol#: 236

C 5230 Ruby D. Lai Vol#: 236

C 5231 Kathleen Plunkett-Black Vol#: 236

C 5232 Elizabeth Henderson Vol#: 236

C 5233 C. Mager Vol#: 236

C 5234 Shantara & Michael Polizzi Vol#: 236

C 5235 Elizabeth A. Ryan Vol#: 236

C 5236 Amy Hutchinson Vol#: 236

01D-0185 Providing Regulatory Submissions in Electronic Format

C 6 PhRMA, Pharmaceutical Res. & Mfrs of Ame Vol#: 1

C 7 AstraZeneca Pharmaceuticals LP Vol#: 1

01H-0065 Civil Money Penalty for First Check Home Drug Test Decives

MO 6 GCF-1 Vol#: 1

01N-0051 Pilot program for Medical Devices and Blood Products

EC 1 BIOTRONIK, Inc. Vol#: 1

01N-0178 Premarket Notification 510(k) Submissions

EC 3 Miss Lori Vitale Vol#: 1

01N-0205 Applications for FDA Approval to Market a New Drug

EC 4 self Vol#: 1

01N-0238 Exemptions from Premarket Notification; Class II Devices

EC 1 Number Not Used Vol#: 1

01N-0249 Consumer and Producer Surveys on Economic Issues

EC 1 none Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

C 1 Vallemont Surgical Associates Vol#: 1

C 2 University of Massachusetts Medical Scho Vol#: 1

C 3 Robert R Schmidlin Vol#: 1

C 4 Ultimate Health Services Inc Vol#: 1

C 5 Hon Tom Barrett Vol#: 1

C 6 American Pain Foundation Inc Vol#: 1

C 7 Pain Control Consultants Inc Vol#: 1

C 8 Bon Secours - Holy Family Regional Healt Vol#: 1

C 9 Seacoast Hospice Vol#: 1

C 10 Joyce Alexander RN MSN AOCN Vol#: 1

C 11 Prutzman & Osgood Orthopedic Surgeons Lt Vol#: 1

EC 4 National Chronic Pain Foundation Vol#: 1

EC 5 Mr. Tim Crandall Vol#: 1

EC 6 Mrs. Lyn Harris Vol#: 1

EC 7 painmentalphysicalyahoogroups Vol#: 1

EC 8 Mr. Brandon Kerby Vol#: 1

EMC 1 Elsie Vol#: 2

EMC 2 Genevieve Monteforte Vol#: 2

EMC 3 Kent Vol#: 2

EMC 4 Karen R Carpenter Vol#: 2

EMC 5 RSDSA Vol#: 2

EMC 6 Abbey Strauss MD Vol#: 2

EMC 7 Alpine Anesthesia and Pain Management Vol#: 2

EMC 8 Carelina Medical Associates Vol#: 2

EMC 9 Stephen Segall MD Vol#: 2

EMC 10 New York Headache Center Vol#: 2

EMC 11 Joyce G Siegrist Vol#: 2

EMC 12 Commonwealth Pain Specialists Vol#: 2

EMC 13 Frisbie Memorial Hospital Vol#: 2

EMC 14 Paul L Weinstein MD Vol#: 2

EMC 15 Richard Lande Vol#: 2

EMC 16 Cindy Gail Vol#: 2

EMC 17 Isaac T Tam MD Vol#: 2

EMC 18 American Pain Foundation Vol#: 2

EMC 19 American Society of Addiction Medicine Vol#: 2

EMC 20 Anita Colletta-Trollinger Vol#: 2

EMC 21 Beth A Bunce Vol#: 2

EMC 22 Wilson H Hulley Vol#: 2

EMC 23 Stanley van den Noort MD Vol#: 2

EMC 24 Paul Schultz MD Vol#: 2

EMC 25 Judith Friedman RN CS OCN Vol#: 2

EMC 26 University of Pittsburgh Medical Center Vol#: 2

EMC 27 Cynthia S Guy MD Vol#: 2

EMC 28 Myron Yaster Vol#: 2

EMC 29 Un of Mississippi Medical Center Vol#: 2

EMC 30 Kim Rosenstein Vol#: 2

EMC 31 Seacoast Hospice Vol#: 2

EMC 32 Robert Scofield Vol#: 2

EMC 33 Dr Gary Silverman Vol#: 2

EMC 34 Rebecca McGehee Vol#: 2

EMC 35 Allen Togut MD Vol#: 2

EMC 36 blondepharm Vol#: 2

EMC 37 Dr Thomas Kanomata Vol#: 2

EMC 38 Saint Francis Hospital Home Health Agenc Vol#: 2

EMC 39 Neil Cohen MD Vol#: 2

EMC 40 Stephen L Winston MD Vol#: 2

EMC 41 Robert Peraino Vol#: 2

EMC 42 Kylea Taylor Vol#: 2

EMC 43 East Bay AIDS Center Vol#: 2

EMC 44 Tim Guith Vol#: 2

EMC 45 Michael A Kilgannon MD Vol#: 2

EMC 46 Cypress Pain Management & Palliative Car Vol#: 2

EMC 47 Sheron F Reed Vol#: 2

EMC 48 School of Medicine, University of Utah Vol#: 2

EMC 49 Sandra M Clarke Vol#: 2

EMC 50 Mary Kay Duffie Vol#: 2

EMC 51 Robert B Daggett MD Vol#: 2

EMC 52 Northwest Hospital Center Vol#: 2

EMC 53 Mark E Ohl MD Vol#: 2

EMC 54 Michael B Ross MD Vol#: 2

EMC 55 Marcia J LaVine Vol#: 2

EMC 56 Mercy Medicine Center - Des Moines Vol#: 2

EMC 57 Joyce Bergamo Vol#: 2

EMC 58 Charles D Cobau MD Vol#: 2

EMC 59 Faxton - St Luke's Healthcare Vol#: 2

EMC 60 Horst G Blume MD PhD Vol#: 2

EMC 61 St Mary's Hospital Vol#: 2

EMC 62 Grace Jones Vol#: 2

EMC 63 Kathleen S Lopez Vol#: 2

EMC 64 Richard Rockett Vol#: 2

EMC 65 Paula Morgan Vol#: 2

EMC 66 Elsie Jane Shank Vol#: 2

EMC 67 Hospice of Volusia/Flagler Vol#: 2

EMC 68 Larry Felker Vol#: 2

M 1 September 13-14, 2001 meeting informatio Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 67 Vivienne Verdon-Roe Vol#: 5

C 68 Virginia H. King Vol#: 5

C 69 Maxine Heiliger Vol#: 5

C 70 Nadya Tichman Vol#: 5

C 71 Michael Broffman Vol#: 5

C 72 Mr. & Mrs. Charles J. Ewing Vol#: 5

C 73 illegible Vol#: 5

C 74 Dallan Bjorkman Vol#: 5

C 75 illegible Vol#: 5

C 76 Andrew Flannery Vol#: 5

C 77 illegible Vol#: 5

C 78 illegible Vol#: 5

C 79 illegible Vol#: 5

C 80 Kenneth Henry Vol#: 5

C 81 illegible Vol#: 5

C 82 Jodi Thompson Vol#: 5

C 83 Lindsay Kay Vol#: 5

C 84 illegible Vol#: 5

C 85 Kelly Price Vol#: 5

C 86 Katie Hollenbaugh Vol#: 5

C 87 Azhar S. Hashem Vol#: 5

C 88 illegible Vol#: 5

C 89 illegible Vol#: 5

C 90 Fernando Villanueva Vol#: 5

C 91 illegible Vol#: 5

C 92 illegible Vol#: 5

C 93 Brandi Carlon Vol#: 5

C 94 Robert Beson IV Vol#: 5

C 95 illegible Vol#: 5

C 96 illegible Vol#: 5

C 97 Laurie Kuhl Vol#: 5

C 98 illegible Vol#: 5

C 99 illegible Vol#: 5

C 100 Maria G. Boehne Vol#: 5

C 101 illegible Vol#: 9

C 102 illegible Vol#: 9

C 103 illegible Vol#: 9

C 104 Ranjani Sanharan Vol#: 9

C 105 illegible Vol#: 9

C 106 Carol A. Lindsey Vol#: 9

C 107 Katelyn Grady Vol#: 9

C 108 illegible Vol#: 9

C 109 Shawna Dresser Vol#: 9

C 110 Margaret P. Morrison Vol#: 9

C 111 Danielle Rolli Vol#: 9

C 112 John McKeon Vol#: 9

C 113 Teresa Morrone & Brian L. Cooke Vol#: 9

C 114 Carol Jenkins Vol#: 9

C 115 Lucile Wheaton Vol#: 9

C 116 Darlene Darley Vol#: 9

C 117 Emily Kralik Vol#: 9

C 118 Carol Satya Winkelman Vol#: 9

C 119 Dennis R. Hicks & Stephanie Waxman Vol#: 9

C 120 Marshall D. Linton Vol#: 9

C 121 Abbot R. Foote Vol#: 9

C 122 Elaine E. Pratt Vol#: 9

C 123 Inge K. Szucs Vol#: 9

C 124 Jenifer Sally Daynes Vol#: 9

C 125 Joan L. Kiley Vol#: 9