Table of Contents

92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 6417 Victoria Freeman Vol#: 164

C 6418 John S Larder Vol#: 164

C 6419 Josephine Sradomski Vol#: 164

C 6420 Lisa F Ryan Vol#: 164

C 6421 James Rupert Murphy Vol#: 164

C 6422 Susan Kaiser Johnson Vol#: 164

C 6423 Lee & Bob McLane Vol#: 164

C 6424 Martha D Sachs Vol#: 164

C 6425 Demetra C Wittmann Vol#: 164

C 6426 J M Vol#: 164

C 6427 Sr Linda Neil Vol#: 164

C 6428 Nikki Lynn Russell Vol#: 164

C 6429 Joe & Sue Overmyer Vol#: 164

C 6430 Mary Flahive Vol#: 164

C 6431 Suzanne Zemanl & 3 signatures Vol#: 164

C 6432 Judith Zarin Vol#: 164

C 6433 Don Schrader Vol#: 164

C 6434 Nancy Miles Vol#: 164

C 6435 Robert Cohen Vol#: 164

C 6436 Sarah Church Vol#: 164

C 6437 Astra Apsitis Vol#: 164

C 6438 The Larsens Vol#: 164

C 6439 Mary L Romain Vol#: 164

C 6440 H W Graves Vol#: 164

C 6441 John Kiesler Vol#: 164

C 6442 Sarah Ringler Vol#: 164

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

C 1038 Charles L Trusty Vol#: 25

96P-0243 Adopt Bioequivalency Requirements for Propafenone Tablets

SUP 2 Knoll Pharmaceutical Company Vol#: 3

97N-0276 Feed mill license in accord with Animal Drug Avalblty Act

REF 1 OMB Review Vol#: 1

97N-484S Human Cellular and Tissue-Based Products

C 228 Richard B. Ashman Vol#: 11

C 229 CNY Fertility Center Vol#: 11

C 230 CNY Fertility Center Vol#: 11

C 231 FAHCT, Foundation for the Accreditation Vol#: 11

C 232 The Midwest Ctr for Reproductive Hlth PA Vol#: 11

C 233 Fertility Center of New England, Inc. Vol#: 11

C 234 MEBTC, Midwest Eye-Banks & Transplantati Vol#: 11

C 235 JNC, Johnson Neurological Clinic, Inc. Vol#: 11

C 236 Dale K. Jones, M.D., P.A. Vol#: 11

C 237 University of Maryland School of Medicin Vol#: 11

C 238 Orthopaedic Specialties Vol#: 11

C 239 Neurological Surgeons, P.C. Vol#: 11

C 240 IHC Physician Group Vol#: 11

C 241 Johns Hopkins Medicine Vol#: 11

C 242 Wayne State University School of Medicin Vol#: 11

C 243 Western Spine Center, P.C. Vol#: 11

C 244 West Virginia University Dept. of Orthop Vol#: 11

C 245 The Neurosurgical Center of Southwest Va Vol#: 11

C 246 Orthopedic/Plastic Reconstructive Surgeo Vol#: 11

C 247 Midsouth Eyebank Vol#: 11

C 248 East Portland Orthopedic & Fracture Clin Vol#: 11

C 249 Nanu Clark Vol#: 11

C 250 Surgery Neurology Professional Assn. Vol#: 11

C 251 University of Florida College of Medicin Vol#: 12

C 252 Robert H. Horne, M.D. Vol#: 12

C 253 Tyler Neurosurgical Associates, P.A. Vol#: 12

C 254 Illinois SW Orthopedics, Ltd. Vol#: 12

C 255 Spine Care Medical Group Vol#: 12

C 256 xxxxxxxxxxxxxxxxxxxx Vol#: 12

C 257 Orthopedic Surgery Assocs of North Count Vol#: 12

C 258 BSI, Brain & Spine Institute, Inc. Vol#: 12

C 259 John W. Lamb, M.D., P.C. Vol#: 12

C 260 The Fertility Institutes Vol#: 12

C 261 NeuroMuscular Consultants a Medical Corp Vol#: 12

C 262 Atlantic Orthopaedic Specialists Vol#: 12

C 263 Midwest Orthopedic Specialists Vol#: 12

C 264 Resurgens Orthopaedics Vol#: 12

C 265 La Jolla Orthopaedic Surgery Vol#: 12

C 266 Midwest Neurosurgery Associates, P.C. Vol#: 12

C 267 Guillermo Pasarin, M.D., P.A. & Arnold L Vol#: 12

C 268 Orthopaedic & Rheumatology Associates, P Vol#: 12

C 269 South Texas Spinal Clinic, P.A. Vol#: 12

C 270 Piedmont Orthopaedic Complex Vol#: 12

C 271 St. Croix Orthopaedic, P.A. Vol#: 12

C 272 The Eye-Bank For Sight Restoration, Inc. Vol#: 12

C 273 Miami Neurosurgical Associates, P.A. Vol#: 12

C 274 Columbia Neurosurgical Associates, P.A. Vol#: 12

C 275 Eye Institute Austin Vol#: 12

C 276 Alta Bates Medical Center Vol#: 12

C 277 Assisted Reproductive Technology Vol#: 12

98H-1202 Civil Money Penalties; Lake Sammamish Mini Mart Inc & Bruce

BRF 1 Lake Sammamish Mini Mart Inc Vol#: 1

99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA

NAL 1 HFA-250 Vol#: 1

SS 1 Supporting Statement Vol#: 1

99D-1651 Chemistry,Mfging/Control Changes to an approved NADA/ANADA

C 2 U S Pharmacopeia Vol#: 1

C 3 Animal Health INstitute Vol#: 1

C 4 Pfizer Central Research Vol#: 1

99D-4488 Reducing microbial food safety hazards for sprouted seeds

THESE COMMENTS DUPLICATE THOSE FOR 99D-4489, ALSO BELOW

C 41 CSPI Vol#: 2

C 42 Kwong Tung Foods Inc Vol#: 2

C 43 Mary Wermann Vol#: 2

C 44 William Smith Vol#: 2

C 45 Illegible Vol#: 2

C 46 Alene Smith Vol#: 2

C 47 Peggy Swan Vol#: 2

C 48 Richard E Long MD & 28 signatures Vol#: 2

C 49 Brassica Protection Products Vol#: 2

C 50 Robert & Carol Wilson Vol#: 2

C 51 Willi Lehner Vol#: 2

C 52 Rose Kuras Vol#: 2

C 53 Energy Sprouts Inc Vol#: 2

C 54 Valerie Quinlan Vol#: 2

C 55 Iona Singleton Vol#: 2

C 56 Living Sprouts Co Vol#: 2

C 57 Linda Poehlman Vol#: 2

C 58 Mumm's Sprouting Seed Vol#: 2

99D-4489 Sampling & microbial testing of spent irrigation water

C 41 CSPI Vol#: 2

C 42 Kwong Tung Foods Inc Vol#: 2

C 43 Mary Wermann Vol#: 2

C 44 William Smith Vol#: 2

C 45 Illegible Vol#: 2

C 46 Alene Smith Vol#: 2

C 47 Peggy Swan Vol#: 2

C 48 Richard E Long MD & 28 signatures Vol#: 2

C 49 Brassica Protection Products Vol#: 2

C 50 Robert & Carol Wilson Vol#: 2

C 51 Willi Lehner Vol#: 2

C 52 Rose Kuras Vol#: 2

C 53 Energy Sprouts Inc Vol#: 2

C 54 Valerie Quinlan Vol#: 2

C 55 Iona Singleton Vol#: 2

C 56 Living Sprouts Co Vol#: 2

C 57 Linda Poehlman Vol#: 2

C 58 Mumm's Sprouting Seed Vol#: 2

99H-1249 Civil Money Penalty; Addie Bolden d/b/a Bolden's Grocery

LET 2 Office of Tobacco Programs Vol#: 1

99H-1352 Civil Money Penalty; Patrick L Malone d/b/a 7-Eleven #29627

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1449 Civil Money Penalties;Todd Angelstad,d/b/a Kenyon Motor Mart

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1480 Civil Money Penalties;Midjit Market Inc,d/b/a Green Valley

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1823 Civil Money Penalty;Frank Peters dba Gardner Park Variety

ANS 1 Frank Peters Vol#: 1

99H-1963 Civil Money Penalty;Naegler Brothers Inc,dba Fast-N-Friendly

ANS 1 Naegler Brothers Inc Vol#: 1

99H-1966 Civil Money Penalty;Fred's Stores of Tennessee Inc,dba Fred'

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2525 Civil Money Penalty;Jim Nassif Ent Inc,dba Tatnuck Square

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4976 Civil Money Penalty;Dixie Oil Company of Alabama, Inc;dba Di

LET 2 Office of Tobacco Programs Vol#: 1

99H-4991 Civil Money Penalty;David L. Palensky;dba 7-Eleven #11707

ANS 1 7 Eleven #11707 Vol#: 1

99H-5191 Civil Money Penalty;Wesley Vercelloti;dba Exxon Dallas Pike

LET 2 Office of Tobacco Programs Vol#: 1

99N-0240 Extralabel Drug Use in Animals;Agency Information Collection

NAL 2 HFA-250 Vol#: 1

SS 1 Supporting Statement Vol#: 1

99N-1415 Supplements and other changes to aproved NADA

C 4 Animal Health Institute Vol#: 1

REF 1 OMB Review Vol#: 1

99N-4068 Advisory Opinions; Extension,Collection of Information

N 2 HFA-250 Vol#: 1

99N-4069 Notice of Participation; Extension Collection Agency

N 2 HFA-250 Vol#: 1

99N-4491 Reuse of Single Use Devices proposal

C 5 Fairview Health Services Vol#: 1

C 6 Association of Disposable Device Mfg Vol#: 1

C 7 Cook Group Inc Vol#: 1

C 8 USC School of Medicine Vol#: 1

C 9 Moberly Medical Center Vol#: 1

C 10 Bruce F Mize, M.D. Vol#: 1

C 11 Jackie Fleckenstein, M.D. Vol#: 1

C 12 Michael Lee, M.D. Vol#: 1

C 13 Morris Pollock, M.D. Vol#: 1

C 14 St. Joseph's Hospital Vol#:

C 15 Prevea Clinic Vol#: 1

C 16 Carl T Hayden VA Medical Center Vol#: 1

C 17 MHG Endoscopy Clinic Vol#: 1

C 18 Carl T Hayden VA Medical Center Vol#: 1

C 19 Carl T Hayden VA Medical Center Vol#:

C 20 Carl T Hayden VA Medical Center Vol#: 1

99N-5325 Irradiation in Production,Processing & Handling of Food

N 1 HFA-250 Vol#: 1

99P-2146 Designate Fosamax (alendronate sodium) as an alternate refer

LET 1 HFD-1 to McKenna & Cuneo LLP Vol#: 1

99P-2148 Label or Labeling of food ingredients and regulation

LET 1 HFS-456 to Fran Stevens Vol#: 1

Page update October 6, 2003 jb