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 July 10, 2002

TABLE OF CONTENTS

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90P-0201 Optimum size & Style of print to be used to label OTC Drugs *
94P-0390 Adopt Amendments Governing Health Claims & Nutrient Claims *
95N-0259 Over the Counter Drug Labeling; Public Hearing *
96N-0420 OTC Human Drugs; Proposed Labeling Requirements *
98N-0337 Over the counter human drugs labeling requirements *
00P-1468 ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m *
01N-0067 Reclassification of Dental Mercury *
01P-0209 Prescription Drug Products list amendment&approve new dosage *
01P-0283 ANDA for Pentoxifylline Extended-release Tablets, 500 mg. *
01P-0291 ANDA suitability for topical cream containing 5% lidocaine *
01P-0323 Not rely on non-public filings to approve an innovator NDA; *
01P-0521 ANDA for a tableted containing hydrocodone bitartrate & acet *
01P-0526 ANDA Suitability for 200 mg Carisoprodol Oral Tablets *
02D-0080 Streamlining Donor Interview Process: Recommendations for *
02N-0115 Risk Management of Prescription Drugs; Public Hearing *
02N-0152 Obtain Timely Pediatric Studies & Adequate Pediatric Labelin *
02N-0178 Canned Tomatoes Deviating from Identity Standard *
02N-0209 Governing First Amendment Case Law *
02P-0207 SRNT petition to regulate SF Garrett's Nicotine Water *

77N-0317 TETRACYCLINE, PROPOSAL TO REVISE REGULATIONS

C 390 Number Not Used Vol#: 6

C 507 Number Not Used Vol#: 7

90P-0201 Optimum size & Style of print to be used to label OTC Drugs

EMC 2 Consumer Healthcare Products Assn Vol#: 8

94P-0390 Adopt Amendments Governing Health Claims & Nutrient Claims

C 60 National Food Processors Assn Vol#: 5

95N-0259 Over the Counter Drug Labeling; Public Hearing

EMC 1 Consumer Healthcare Products Assn Vol#: 13

96N-0420 OTC Human Drugs; Proposed Labeling Requirements

EMC 1 Consumer Healthcare Products Assn Vol#: 24

98N-0337 Over the counter human drugs labeling requirements

EMC 1 Consumer Healthcare Products Assn Vol#: 9

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 284 Edward Borns Vol#: 5

EMC 285 G.B. Zerbe Vol#: 5

EMC 286 Mayra Nieves Vol#: 5

EMC 287 Robyne Hamme Vol#: 5

EMC 288 Veronica Jacobi Vol#: 5

EMC 289 Pete Viglia Vol#: 5

EMC 290 Guru Kamai Khalsa Vol#: 5

EMC 291 Abbe McGray Vol#: 5

EMC 292 Heather Yonosh Vol#: 5

EMC 293 David Gougler Vol#: 5

EMC 294 Karen Haralson Vol#: 5

EMC 295 Maeve Heald Vol#: 5

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 185 Raj Desai Vol#: 5

EMC 186 Richard Artley Vol#: 5

EMC 187 Edward Borns Vol#: 5

EMC 188 G.B. Zerbe Vol#: 5

EMC 189 Mayra Nieves Vol#: 5

EMC 190 Robyne Hamme Vol#: 5

EMC 191 Veronica Jacobi Vol#: 5

EMC 192 Pete Viglia Vol#: 5

EMC 193 Guru Kamai Khalsa Vol#: 5

EMC 194 Abbe McGray Vol#: 5

EMC 195 Heather Yonosh Vol#: 5

EMC 196 David Gougler Vol#: 5

EMC 197 Karen Haralson Vol#: 5

EMC 198 Maeve Heald Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 184 Raj Desai Vol#: 4

EMC 185 Richard Artley Vol#: 4

EMC 186 Edward Borns Vol#: 4

EMC 187 G.B. Zerbe Vol#: 4

EMC 188 Mayra Nieves Vol#: 4

EMC 189 Robyne Hamme Vol#: 4

EMC 190 Veronica Jacobi Vol#: 4

EMC 191 Pete Viglia Vol#: 4

EMC 192 Guru Kamai Khalsa Vol#: 4

EMC 193 Abbe McGray Vol#: 4

EMC 194 Heather Yonosh Vol#: 4

EMC 195 David Gougler Vol#: 4

EMC 196 Karen Haralson Vol#: 4

EMC 197 Maeve Heald Vol#: 4

EMC 198 Pete Viglia Vol#: 4

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 187 Raj Desai Vol#: 4

EMC 188 Richard Artley Vol#: 4

EMC 189 Edward Borns Vol#: 4

EMC 190 G.B. Zerbe Vol#: 4

EMC 191 Mayra Nieves Vol#: 4

EMC 192 Robyne Hamme Vol#: 4

EMC 193 Veronica Jacobi Vol#: 4

EMC 194 Pete Viglia Vol#: 4

EMC 195 Pete Viglia Vol#: 4

EMC 196 Guru Kamai Khalsa Vol#: 4

EMC 197 Heather Yonosh Vol#: 4

EMC 198 David Gougler Vol#: 4

EMC 199 Karen Haralson Vol#: 4

EMC 200 Maeve Heald Vol#: 4

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 3668 Richard Artley Vol#: 511

EMC 3669 Moji Ghodoussi Vol#: 511

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 877 Kathleen M. Streetman, R.N., C.P.A., M.A Vol#: 212

99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O

EMC 106 Steve Schenck Vol#: 1

00P-1468 ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m

PAV 1 HFD-600 to Lachman Consultant Services, Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 283 Raj Desai Vol#: 6

EMC 284 Richard Artley Vol#: 6

EMC 285 Edward Borns Vol#: 6

EMC 286 G. B. Zerbe Vol#: 6

EMC 287 Lezley McDouall Vol#: 6

EMC 288 Mayra Nieves Vol#: 6

EMC 289 Robyne Hamme Vol#: 6

EMC 290 Veronica Jacobi Vol#: 6

EMC 291 Pete Viglia Vol#: 6

EMC 292 Guru Kamal Khalsa Vol#: 6

EMC 293 Abbe McGray Vol#: 6

EMC 294 Heather Yonosh Vol#: 6

EMC 295 David Gougler Vol#: 6

EMC 296 Karen Haralson Vol#: 6

EMC 297 Maeve Heald Vol#: 6

01N-0067 Reclassification of Dental Mercury

EMC 218 John Parks Trowbridge, M.D. Vol#: 3

EMC 219 Jim Gruber Vol#: 3

EMC 220 Paula Munoz Vol#: 3

EMC 221 Carol Antill Vol#: 3

EMC 222 Mr. & Mrs. Cass Zabinski Vol#: 3

EMC 223 Jim Gruber Vol#: 3

EMC 224 Christie Cruzan Vol#: 3

EMC 225 Dr. Paul Gilbert Vol#: 3

EMC 226 Catherine Masden Vol#: 3

EMC 227 American Board of Family Practice Vol#: 3

EMC 228 Debbie Bevel Vol#: 3

EMC 229 Coalition For Informed Choice Vol#: 3

EMC 230 Janet Neath Vol#: 3

EMC 231 Mercury Awareness Team of Washington Vol#: 3

EMC 232 Dr. Daniel A. Boudreaux Vol#: 3

EMC 233 Melissa Neff RN Vol#: 3

EMC 234 Susan Jett Vol#: 3

EMC 235 Rosanne Cronin Vol#: 3

EMC 236 Janice Grissom Vol#: 3

EMC 237 Health Associates of Tulsa Vol#: 3

EMC 238 Consumers for Dental Choice, Inc. Vol#: 3

EMC 239 Shirley Castro Vol#: 3

EMC 240 Dr. Dawm Ewing RDH, Ph.D., ND, DIM Vol#: 3

EMC 241 Barbara Veres Vol#: 3

EMC 242 Dianne Caponi Vol#: 3

EMC 243 Valerie Goern Vol#: 3

EMC 244 A. Leslie Johnson, Jr. Vol#: 3

EMC 245 Robin Stone Vol#: 3

01N-0458 Fast Track Drug Development Programs Designation,Development

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

01N-0459 Food Labeling; Notification Procedures on Dietary Supplement

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

EMC 298 Catherine M. Armstrong Vol#: 10

01P-0169 Access & Safe Distribution of Alosetron

EMC 6 Debbie Spencer Vol#: 2

01P-0209 Prescription Drug Products list amendment&approve new dosage

PAV 1 HFD-600 to Duramed Pharmaceuticals Inc Vol#: 1

01P-0283 ANDA for Pentoxifylline Extended-release Tablets, 500 mg.

PDN 1 HFD-600 to The Weinberg Group Inc. Vol#: 1

01P-0291 ANDA suitability for topical cream containing 5% lidocaine

PDN 1 HFD-600 to Ferndale Laboratories, Inc. Vol#: 1

01P-0323 Not rely on non-public filings to approve an innovator NDA;

C 3 Abbott Laboratories Vol#: 1

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 1087 Susan Loeffler Vol#: 5

EMC 1088 Charlotte Whisenhunt Vol#: 5

EMC 1089 Charlotte Whisenhunt Vol#: 5

01P-0396 Request that FDA ban the production and sale of all ephedra

EMC 7 Anne Cecil Vol#: 1

01P-0521 ANDA for a tableted containing hydrocodone bitartrate & acet

PDN 1 HFD-600 to Atley Pharmaceuticals, Inc. Vol#: 1

01P-0526 ANDA Suitability for 200 mg Carisoprodol Oral Tablets

PDN 1 HFD-600 to Atley Pharmaceuticals, Inc. Vol#: 1

02D-0080 Streamlining Donor Interview Process: Recommendations for

C 3 San Diego Blood Bank (SDBB) Vol#: 1

EMC 1 American Assn of Blood Banks (AABB) Vol#: 1

EMC 2 Deborah Greene Vol#: 1

EMC 3 Puget Sound Blood Center Vol#: 1

EMC 4 America Blood Centers (ABC) Vol#: 1

EMC 5 Navy Blood Program Vol#: 1

EMC 6 Army Blood Program Vol#: 1

EMC 7 Air Force Blood Program Vol#: 1

EMC 8 Talisman Ltd. Vol#: 1

EMC 9 American Red Cross Vol#: 1

02D-0274 Denture Cleaners, Adhesives, Cushions & Repair Materials

NWL 1 Vol#: 1

02N-0063 Consumer Surveys on Food & Dietary Supplement Labeling

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

02N-0115 Risk Management of Prescription Drugs; Public Hearing

EMC 6 SAS Public Sector Group Vol#: 3

EMC 7 SAS Public Sector Group Vol#: 3

EMC 8 National Community Pharmacists Assn (NCP Vol#: 3

EMC 9 American Assn of Occupational Health Nur Vol#: 3

EMC 10 American Assn of Occupational Health Nur Vol#: 3

EMC 11 National Assn of Chain Drug Stores (NACD Vol#: 3

02N-0152 Obtain Timely Pediatric Studies & Adequate Pediatric Labelin

C 92 Jose L. Gonzalez, M.D. Vol#: 3

C 93 Timothy E. Corden, M.D. Vol#: 3

C 94 Aaron L. Friedman, M.D. Vol#: 3

C 95 The Everett Clinic Vol#: 3

C 96 Elizabeth Glaser Pediatric AIDS Foundati Vol#: 3

C 97 Robert H. Anderson, M.D. Vol#: 3

C 98 Glaser Pediatric Research Network Vol#: 3

C 99 George J. Cohen, M.D. Vol#: 3

C 100 Jeannine Hatt, M.D., FAAP Vol#: 3

C 101 Paul R. Haut, M.D., FAAP Vol#: 3

C 102 Bryan E. Hainline, M.D., PhD Vol#: 3

C 103 Michael Henrickson, M.D., FAAP, FACR Vol#: 3

C 104 Vipul N. Mankad, M.D. Vol#: 3

C 105 James B. Ruben, M.D. Vol#: 3

C 106 Paula Annunziato, M.D. Vol#: 3

C 107 John S. Fuqua, M.D. Vol#: 3

C 108 Edward E. Lawson, M.D. Vol#: 3

C 109 Thomas P. Graham, Jr., M.D. Vol#: 3

C 110 R. David Glasgow, M.D. Vol#: 3

C 111 Bernard Feldman, MD, MPH, FAAP Vol#: 3

C 112 R. Alan Grimes, MD Vol#: 3

C 113 Thomas P. Green, M.D. Vol#: 3

EMC 1 Kelly W. Peden Vol#: 3

EMC 2 Phyllis S. Kiehl, M.D. Vol#: 3

EMC 3 Henry Rodriguez, M.D. Vol#: 3

EMC 4 Sarah Stelzner, M.D. Vol#: 3

EMC 5 Erica A. Eugster, M.D. Vol#: 3

EMC 6 Dianne Elfenbein, M.D., FAAP Vol#: 3

EMC 7 Gloria C. Higgins, PhD, M.D. Vol#: 3

EMC 8 Pediatrix Medical Group, Inc. Vol#: 3

EMC 9 Dr. Marisa Flores, M.D. Vol#: 3

EMC 10 Richard F. Salmon, D.O. Vol#: 3

EMC 11 George Rylance Vol#: 3

EMC 12 Naomi Palmer, M.D. Vol#: 3

EMC 13 Joseph F. Fitzgerald, M.D. Vol#: 3

EMC 14 Susan Kneeland Vol#: 3

EMC 15 Wayne Sullender, M.D., FAAP Vol#: 3

EMC 16 Patricia C. Davis, M.D. Vol#: 3

EMC 17 H. Biemann Othersen, Jr., M.D. Vol#: 3

EMC 18 Alan Werzberger, M.D. Vol#: 3

EMC 19 Mae Sokol, M.D. Vol#: 3

EMC 20 Michael M. Frank, M.D. Vol#: 3

EMC 21 Michael M. Frank, M.D. Vol#: 3

EMC 22 Penelope H. Dennehy, M.D. Vol#: 3

EMC 23 Robert E. Piston, M.D. Vol#: 3

EMC 24 Number Not Used Vol#: 3

EMC 25 Jennifer Plumb, M.D. Vol#: 3

EMC 26 Allison B. Hall, M.D. Vol#: 3

EMC 27 Arthur Ablin, M.D. Vol#: 3

02N-0178 Canned Tomatoes Deviating from Identity Standard

LET 4 HFS-800 to Keller & Heckman Vol#: 1

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

EMC 2 L.R. Dillon, RPh, CQM Vol#: 1

02N-0209 Governing First Amendment Case Law

C 4 National Food Processors Assn Vol#: 2

02N-0268 Agency Information Collection Activities; Proposed Collectio

N 1 Vol#: 1

02N-0280 Agency Information Collection Activities; Comment Request

N 1 Vol#: 1

02P-0207 SRNT petition to regulate SF Garrett's Nicotine Water

EMC 4 Star Scientific, Inc. Vol#: 1