Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on October 16, 2002

TABLE OF CONTENTS

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78N-0038 Sunscreen Drug Products *
96N-0277 Eligibility Criteria for Considering Additional Condition*
97N-484P Current Good Tissue Practice for Mfrs. of Human Cellular*
98P-0151 Introduction Of Downed Cattle Into The Food Supply*
99P-4613 Revoke the Regulation That Approved Posilac *
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec *
01N-0067 Reclassification of Dental Mercury *
01P-0120 Ban Unsafe IV Catheters and other Devices *
01P-0560 Refrain Approval of Any Buprenorphine Product *
02N-0204 Bar Code Label Requirements for human drug products*
02P-0139 Arava (leflunomide;Aventis) remove from the market*
02P-0163 Expedite Over-the-Counter Approval for Desloratidine*
02P-0170 ANDAs relaying Premax as reference listed drug not be appove*
02P-0246 Pharmacies of hospitals/other health care entities*
02P-0400 Determine Whether Niaspan Tablets, NDA 020381 Have Been *
02P-0448 ANDA Sutability for Albuterol Base Inhalation Solution *
02P-0450 Withhold Approval of ANDA for Amino Acid Solution Drug Prod. *

78N-0038 Sunscreen Drug Products

C 599 Johnson & Johnson Consumer Companies,Inc Vol#: 146

86P-0297 Standards of Identity to Amend Certain Chocolate Products

BKG 1 BACKGROUND Vol#: 4

93P-0091 Amend Standard Identity Cacao Products re: White Chocolate

BKG 1 BACKGROUND Vol#: 2

96N-0277 Eligibility Criteria for Considering Additional Condition

C 30 Johnson & Johnson Consumer Companies,Inc Vol#: 3

97N-484P Current Good Tissue Practice for Mfrs. of Human Cellular

SUP 1 Foundation for the Accreditation (FACT) Vol#: 5

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

C 5933 Shirley B. Rosen Vol#: 251

C 5934 Melanie Szekeres Vol#: 251

C 5935 Nancy J. Schindler Vol#: 251

C 5936 Lauranne B. Fisher Vol#: 251

EMC 2860 Rory Freedman Vol#: 243

EMC 2861 Steve Longo Vol#: 243

EMC 2862 Dr. Joyce L. Bloom Vol#: 243

EMC 2863 Tamara Brion Vol#: 243

EMC 2864 Jennie Meyer Vol#: 243

EMC 2865 Naomi Dyer Vol#: 243

EMC 2866 Systems Engineer & Energy Healer Vol#: 243

EMC 2867 Holly Beadle Vol#: 243

EMC 2868 Beth K. Graham Vol#: 243

EMC 2869 Mrs. Nancy Freyer Vol#: 243

EMC 2870 Susan Hughes Vol#: 243

EMC 2871 Cliff Weber Vol#: 243

EMC 2872 Lana Luhm Vol#: 243

EMC 2873 RP2C Vol#: 243

EMC 2874 Ronnie Perl Vol#: 243

EMC 2875 Doreen Rudnick Vol#: 243

EMC 2876 Shelley Anixter Vol#: 243

EMC 2877 Geoffrey Doman Vol#: 243

EMC 2878 Allen Wierman Vol#: 243

EMC 2879 Jerri Miller Vol#: 243

EMC 2880 Terre Roche Vol#: 243

EMC 2881 Rachel Yenkinson Vol#: 243

EMC 2882 Gail Philbin Vol#: 243

EMC 2883 Electrical Integration Boeing Airplane S Vol#: 243

EMC 2884 Glenn & Donna Sanders Vol#: 243

EMC 2885 Deborah Verga Vol#: 243

EMC 2886 Rachel Landau Vol#: 243

EMC 2887 Pam Lawless Vol#: 243

EMC 2888 Mrs. Julie M. Caracci Vol#: 243

EMC 2889 Joyce Janicki Vol#: 243

EMC 2890 Chris Mayer Vol#: 243

EMC 2891 Connie Marlowe Vol#: 243

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

EMC 384 Jennifer Dubow Vol#: 5

EMC 385 Susanne Walther Vol#: 5

EMC 386 Davis Terrell Vol#: 5

EMC 387 Ginia Wexler Vol#: 5

EMC 388 Amy Steele Vol#: 5

EMC 389 Sherri Vinton Vol#: 5

EMC 390 Laura Lindner Vol#: 5

EMC 391 Jed Griffin Vol#: 5

EMC 392 Maggie Anshutz Vol#: 5

EMC 393 Margaret Getz Vol#: 5

EMC 394 Evan Handley Vol#: 5

EMC 395 Diana Dexter Vol#: 5

EMC 396 Joan Gosling Vol#: 5

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

EMC 287 Jennifer Dubow Vol#: 5

EMC 288 Susanne Walther Vol#: 5

EMC 289 Davis Terrell Vol#: 5

EMC 290 Ginia Wexler Vol#: 5

EMC 291 Amy Steele Vol#: 5

EMC 292 Sherri Vinton Vol#: 5

EMC 293 Laura Lindner Vol#: 5

EMC 294 Jed Griffin Vol#: 5

EMC 295 Maggie Anshutz Vol#: 5

EMC 296 Margaret Getz Vol#: 5

EMC 297 Evan Handley Vol#: 5

EMC 298 Diana Dexter Vol#: 5

EMC 299 Joan Gosling Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 286 Jennifer Dubow Vol#: 4

EMC 287 Susanne Walther Vol#: 4

EMC 288 Davis Terrell Vol#: 4

EMC 289 Ginia Wexler Vol#: 4

EMC 290 Amy Steele Vol#: 4

EMC 291 Sherri Vinton Vol#: 4

EMC 292 Laura Lindner Vol#: 4

EMC 293 Jed Griffin Vol#: 4

EMC 294 Maggie Anshutz Vol#: 4

EMC 295 Margaret Getz Vol#: 4

EMC 296 Evan Handley Vol#: 4

EMC 297 Diana Dexter Vol#: 4

EMC 298 Joan Gosling Vol#: 4

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

EMC 281 Marilyn Richmond Vol#: 4

EMC 282 Marilyn Richmond Vol#: 4

EMC 283 Marilyn Richmond Vol#: 4

EMC 284 Marilyn Richmond Vol#: 4

EMC 285 Erica Gray Vol#: 4

EMC 286 Katrina Anderson Vol#: 4

EMC 287 Marlin Dixon Vol#: 4

EMC 288 Amy Witbeck Vol#: 4

EMC 289 Jennifer Dubow Vol#: 4

EMC 290 Susanne Walther Vol#: 4

EMC 291 Davis Terrell Vol#: 4

EMC 292 Ginia Wexler Vol#: 5

EMC 293 Amy Steele Vol#: 4

EMC 294 Sherri Vinton Vol#: 4

EMC 295 Laura Lindner Vol#: 4

EMC 296 Jed Griffin Vol#: 4

EMC 297 Maggie Anshutz Vol#: 4

EMC 298 Margaret Getz Vol#: 4

EMC 299 Evan Handley Vol#: 4

EMC 300 Diana Dexter Vol#: 4

EMC 301 Joan Gosling Vol#: 4

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

EMC 3750 Suzette Jacobs Vol#: 512

EMC 3751 David Kratz Mathies Vol#: 512

EMC 3752 Jennifer Dubow Vol#: 512

EMC 3753 Susanne Walther Vol#: 512

EMC 3754 Davis Terrell Vol#: 512

EMC 3755 Amy Steele Vol#: 512

EMC 3756 Sherri Vinton Vol#: 512

EMC 3757 Jeffri Frontz Vol#: 512

EMC 3758 Jeffri Frontz Vol#: 512

EMC 3759 Laura Lindner Vol#: 512

EMC 3760 Jed Griffin Vol#: 512

EMC 3761 Evan Handley Vol#: 512

EMC 3762 Diana Dexter Vol#: 512

EMC 3763 Joan Gosling Vol#: 512

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 888 Lindsey Green-Kent Vol#: 212

EMC 889 Laurel Hopewood Vol#: 212

99P-1340 Declared Eternity eau de Parfum Misbranded

C 747 Marjorie L. Marsh Vol#: 21

C 748 Denise J. Stone Vol#: 21

99P-4613 Revoke the Regulation That Approved Posilac

C 1431 Alliance Medical & Oxygen Vol#: 46

C 1432 Kathryn A. Watkins Vol#: 46

C 1433 Mrs. Phyllis B. Urguhart & Family Vol#: 46

C 1434 Bernice Van Steenbergen Vol#: 46

C 1435 Mrs. Jean Hendry Locke Vol#: 46

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

EMC 4 The Hollis Group, Inc. Vol#: 6

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

EMC 386 Jennifer Dubow Vol#: 6

EMC 387 Susanne Walther Vol#: 6

EMC 388 Davis Terrell Vol#: 6

EMC 389 Ginia Wexler Vol#: 6

EMC 390 Amy Steele Vol#: 6

EMC 391 Sherri Vinton Vol#: 6

EMC 392 Laura Lindner Vol#: 6

EMC 393 Jed Griffin Vol#: 6

EMC 394 Maggie Anshutz Vol#: 6

EMC 395 Margaret Getz Vol#: 6

EMC 396 Evan Handley Vol#: 6

EMC 397 Diana Dexter Vol#: 6

EMC 398 Joan Gosling Vol#: 6

01N-0067 Reclassification of Dental Mercury

C 111 DAMS, Inc. Vol#: 15

C 112 Kathryn Fairbanks Vol#: 15

EMC 625 Rosanne Cronin Vol#: 10

EMC 626 Guy M. Randal Vol#: 10

EMC 627 Laurette Janak Vol#: 10

EMC 628 Linda Shepard Vol#: 10

EMC 629 Sherri O'Shea, RD, CD, CLE Vol#: 10

EMC 630 no signature Vol#: 10

EMC 631 Rosanne Cronin Vol#: 10

EMC 632 Rosanne Cronin Vol#: 10

EMC 633 Mary Ann Newell Vol#: 10

EMC 634 Mary Ann Newell Vol#: 10

EMC 635 Jacques Imbeau D.M.D. FACNEM Vol#: 10

EMC 636 Mary Ann Newell Vol#: 10

SUP 2 Mary Ann Newell Vol#: 15

01P-0120 Ban Unsafe IV Catheters and other Devices

EMC 8 Public Citizen Health Research Group Vol#: 3

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 1233 M. C. Swearingen Vol#: 226

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

EMC 1129 Ryan Haight Vol#: 5

EMC 1130 B.D. MacPhee Vol#: 5

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

EMC 10 Heather Dennis Vol#: 1

01P-0560 Refrain Approval of Any Buprenorphine Product

PAV 1 HFD-1 to Hogan & Hartson, LLP Vol#: 1

01P-0574 Referencing discontinued labeling for Octreotide acetate inj

C 1 Mary Ann Hicks Vol#: 1

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

APE 117 Computype, Inc. Vol#: 7

APE 118 Computype, Inc. Vol#: 7

APE 119 Computype, Inc. Vol#: 7

APE 120 Portex,Inc. Vol#: 7

APE 121 Federation of American Hospitals Vol#: 7

APE 122 PhRMA Vol#: 7

APE 123 Barcode Technology, Inc. Vol#: 7

APE 124 Centers for Diesease Control & Preventio Vol#: 7

APE 125 Johns Hopkins Hospital Vol#: 7

APE 126 Computype, Inc. Vol#: 7

APE 127 Terry O'Brien Vol#: 7

APE 128 AIM Inc. Vol#: 7

APE 129 Assn of Hemophilia Clinic Directors of C Vol#: 7

APE 130 Consumer Healthcare Products Assn Vol#: 7

APE 131 Uniform Code Council, Inc. Vol#: 7

APE 132 Uniform Code Council, Inc. Vol#: 7

APE 133 ICCBBA, Inc. Vol#: 7

APE 134 Barcode Technology, Inc. Vol#: 7

APE 135 American Society of Health-System Pharm Vol#: 7

APE 136 American Medical Assn Vol#: 7

APE 137 Federation of American Hospitals Vol#: 7

APE 138 AmeriNet, Inc. Vol#: 7

APE 139 HIMSS Vol#: 7

APE 140 Meds-Alert USA, Inc. Vol#: 7

APE 141 John H. Riddick Vol#: 7

APE 142 findtheDOT, Inc. Vol#: 7

APE 143 National Patient Safety Foundation Vol#: 7

APE 144 Healthcare Compliance Packaging Council Vol#: 7

APE 145 Neuenschwander Company Vol#: 7

APE 146 Rack Design Group, Inc. Vol#: 7

APE 147 VISI Vol#: 7

APE 148 AdvaMed Vol#: 7

APE 149 ScriptPro USA, Inc. Vol#: 7

APE 150 HDMA Vol#: 7

APE 151 AIM, Inc. Vol#: 7

APE 152 findtheDOT, Inc. Vol#: 7

APE 153 Rack Design Group, Inc. Vol#: 7

APE 154 ADVIAS Vol#: 7

APE 155 Northwestern Memorial Hospital Vol#: 7

APE 156 Returns Online, Inc. Vol#: 7

APE 157 Consorta Catholic Resource Partners Vol#: 7

APE 158 Johns Hospkins Hospital Vol#: 7

APE 159 GenuOne, Inc. Vol#: 7

APE 160 GenuOne, Inc. Vol#: 7

APE 161 Assn of Hemophillia Clinic Directors of Vol#: 7

APE 162 Federation of American Hospitals Vol#: 7

APE 163 NACDS Vol#: 7

APE 164 Portex, Inc. Vol#: 7

APE 165 Karen Longe & Associates, Inc. Vol#: 7

APE 166 Institute for Safe Medication Practices Vol#: 7

APE 167 American Health Packaging Vol#: 7

APE 168 QuadraMed Enterprise Group Vol#: 7

APE 169 Genric Pharmaceutical Assn Vol#: 7

APE 170 ScriptPro Vol#: 7

EMC 161 ScriptPro USA, Inc. Vol#: 7

EMC 162 HDMA Vol#: 7

EMC 163 AIM, Inc. Vol#: 7

02P-0139 Arava (leflunomide;Aventis) remove from the market

LET 2 Public Citizen Vol#: 1

02P-0163 Expedite Over-the-Counter Approval for Desloratidine

LET 1 HFD-1 to WellPoint Health Networks Vol#: 1

02P-0166 Print clear, legible & intelligible product expiration date

LET 1 Honorable Barbara Lee (CI) Vol#: 1

02P-0170 ANDAs relaying Premax as reference listed drug not be appove

LET 1 HFD-1 to Amarin Pharmaceuticals, Inc. Vol#: 1

02P-0246 Pharmacies of hospitals/other health care entities

PAV 1 HFC-200 to University of Colorado Hospit Vol#: 1

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 36 Pauline Harding, M.D. Vol#: 1

EMC 37 Marianne E. Payton Vol#: 1

EMC 38 Allison Pennington Vol#: 1

02P-0400 Determine Whether Niaspan Tablets, NDA 020381 Have Been

WDL 1 HFD-7 to Barr Labs., Inc. Vol#: 1

02P-0448 ANDA Sutability for Albuterol Base Inhalation Solution

ACK 1 HFA-305 Vol#: 1

CP 1 SensorMedics Corporation Vol#: 1

02P-0450 Withhold Approval of ANDA for Amino Acid Solution Drug Prod.

ACK 1 HFA-305 Vol#: 1

CP 1 B. Braun Medical Inc. Vol#: 1