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 February 15, 2001

TABLE OF CONTENTS

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76N-052N OTC Nasal Decongestants *

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *

80N-0146 Nailbiting & Thumbsucking Deterrent Drug Product for OTC Use *

81N-0022 OTC Weight Control Drug Products for Human Use *

97N-0314 Prescription Drug Products; Levothyroxine Sodium *

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

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

98P-1121 Grated Parmesan Cheese Deviating from Identity standard *

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

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

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *

99P-5106 Identify Sources of Natural Flavorings *

00D-1587 Medical Devices Guidance for Prescription Drugs Abuse Assays *

00D-1679 Draft CPG for FDA Employees & Industry on Blood Donor Incent *

00N-0989 Human Gene Therapy *

00N-1396 Bioengineered Foods Consumed By Humans or Animals *

00N-1604 Test Sample Collection Systems for Drugs of Abuse Testing *

00P-1445 Paragraph IV ANDAs/180-Day Exclusivity Purporses *

00P-1466 Non-Approvable Letters for Neurontin *

00P-1499 Remove alosetron (Lotronex) from the market *

01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled *

01D-0037 Pre-Store leukocyle reduction/Blood components for transfusi *

76N-052N OTC Nasal Decongestants

EMC 100 Andrew Rose Vol#: 76

EMC 101 Andrew Barker Vol#: 76

EMC 102 Chuck Woolever Vol#: 76

EMC 103 Judith Kaplan Vol#: 76

EMC 104 D R Santillo Vol#: 76

EMC 105 Michael Arnold Vol#: 76

EMC 106 Jeff Lynch Vol#: 76

EMC 107 Kenny Croxdale Vol#: 76

EMC 108 Jim Morrison Vol#: 76

EMC 109 Ron Frank Vol#: 76

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

LET 139 Block Drug Company Inc Vol#: 235

80N-0146 Nailbiting & Thumbsucking Deterrent Drug Product for OTC Use

LET 9 Oakhurst Co. Vol#: 8

81N-0022 OTC Weight Control Drug Products for Human Use

EMC 57 Lisa Fulford Vol#: 95

97N-0314 Prescription Drug Products; Levothyroxine Sodium

PDN 1 HFC-1 to Jerome Stevens Pharmaceutical Vol#: 1

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

EXT 1 American Assn of Tissue Banks Vol#: 4

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

C 3853 Cheryl J. A. Vol#: 120

C 3854 Ginger Leilani Chapin Vol#: 120

C 3855 Yvonne K. Marley Vol#: 120

C 3856 Anna Coiro Vol#: 120

C 3857 Florence Fleming Vol#: 120

C 3858 Cheryl A. Maccaroni Vol#: 120

C 3859 Mike & Barb Wheeler Vol#: 120

C 3860 Judith A. Rittenhouse Vol#: 120

C 3861 Frances Washington Vol#: 120

C 3862 Stephanie Rowe Vol#: 120

C 3863 Ms. Denise M. Dimino Vol#: 120

C 3864 Lana Shelton et al Vol#: 120

C 3865 Roy C. & Judy A. Rineer Vol#: 120

C 3866 Dorothy C. Johnson Vol#: 120

C 3867 Jason Belkin Vol#: 121

98P-1121 Grated Parmesan Cheese Deviating from Identity standard

ANS 2 HFS-800 to The Antigo Cheese Co. Vol#: 1

ANS 3 HFS-800 to Kraft Foods, Inc. Vol#: 1

EXT 3 Kraft Foods, Inc. Vol#: 1

LET 4 The Antigo Cheese Co. Vol#: 1

LET 5 The Antigo Cheese Co. Vol#: 1

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

C 81 Daisey Machinery Co LTD Vol#: 8

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

C 82 Daisey Machinery Co LTD Vol#: 6

99N-1168 Public Health Impact of Foodborne Listeria Monocytogenes

EXT 2 NFPA, National Food Processors Assn. Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2868 Olivia Zivney Vol#: 200

C 2869 Katherine M Shea MD Vol#: 200

C 2870 Emiley Sprague Vol#: 200

C 2871 Marti Christoffer Vol#: 200

C 2872 Sandra Swafford Vol#: 200

C 2873 Emily Landis Vol#: 200

C 2874 David C Powell Vol#: 200

C 2875 Ginger Beugless Vol#: 200

C 2876 Estelle Spern-Etuers Vol#: 200

C 2877 Deanne Lembitz MD Vol#: 200

C 2878 John R Manning Vol#: 200

C 2879 Miriam H Lukens Vol#: 200

C 2880 Mary M Guy Vol#: 200

C 2881 Andrew Pavelchek Vol#: 200

C 2882 Lester Goldstein Vol#: 200

C 2883 Julius Gluck Vol#:

C 2884 Regina B Munroe Vol#: 200

C 2885 Danile Martens Vol#: 200

C 2886 Richard Beaulieu Vol#: 200

C 2887 Joyce Crews Vol#: 200

C 2888 Teresa M Byler Vol#: 200

C 2889 Norma B Hamilton MD Vol#: 200

C 2890 Irwin Yellowitz Vol#: 200

C 2891 Mary B Johnson Vol#: 200

99P-5106 Identify Sources of Natural Flavorings

EMC 71 Bill Hampton Vol#: 1

00D-1587 Medical Devices Guidance for Prescription Drugs Abuse Assays

C 2 Roche Diagnostic Corp Vol#: 1

00D-1679 Draft CPG for FDA Employees & Industry on Blood Donor Incent

C 2 S M F Blood Centers Vol#: 1

00N-0989 Human Gene Therapy

EMC 3 Steve Smith Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 93 K Jaffey Vol#: 15

EMC 94 Number Not Used Vol#:

EMC 95 L Darges Vol#: 15

EMC 96 L Klein Vol#: 15

EMC 97 M E Clare Vol#: 15

EMC 98 Number Not Used Vol#: 15

EMC 99 D Whitehouse Vol#: 15

EMC 100 P Moss Vol#: 15

EMC 101 E Stauffer Vol#: 16

EMC 102 G Abert Vol#: 16

EMC 103 Dr. N Zirpolo Vol#: 16

EMC 104 Number Not Used Vol#: 16

EMC 105 P Marucci Vol#: 16

EMC 106 D Fowle Vol#: 16

EMC 107 J Moix Vol#: 16

EMC 108 D Crossweller Vol#: 16

EMC 109 L Jones Vol#: 16

EMC 110 Number not used Vol#: 16

EMC 111 E Keller Vol#: 16

EMC 112 H Spencer Vol#: 16

EMC 113 C A Lozeau Vol#: 16

EMC 114 T Tanner Vol#: 16

EMC 115 J A Malkoff Vol#: 16

EMC 116 L Rose Vol#: 16

EMC 117 K C Shepard Vol#: 16

EMC 118 H Morgan Vol#: 16

EMC 119 J Mackie Vol#: 16

EMC 120 M Wildfire Vol#: 16

EMC 121 J Toth Vol#: 16

EMC 122 A Nordin Vol#: 16

EMC 123 J Heany Vol#: 16

EMC 124 J Webster Vol#: 16

EMC 125 K Kirkland Vol#: 16

EMC 126 Number Not Used Vol#: 16

EMC 127 P L Bela Vol#: 16

EMC 128 L Rimkus Vol#: 16

EMC 129 J Tober Vol#: 16

EMC 130 S Service Vol#: 16

EMC 131 R Bell DVM Vol#: 16

EMC 132 W McGee Vol#: 16

EMC 133 M Bernal Vol#: 16

EMC 134 H Gardner Vol#: 16

EMC 135 S Roberts Vol#: 16

EMC 136 H Doress Vol#: 16

EMC 137 S Green Vol#: 16

EMC 138 C O Costa Vol#: 16

EMC 139 Dr. T Walker Vol#: 16

EMC 140 R Maehr Vol#: 16

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

C 139 American Association of Bovine Practitio Vol#: 19

C 140 Jeffrey Werner Vol#: 19

00N-1604 Test Sample Collection Systems for Drugs of Abuse Testing

C 2 Roche Diagnostics Corp Vol#: 1


00P-1445 Paragraph IV ANDAs/180-Day Exclusivity Purporses

LET 1 HFD-1 to Zenith Goldline Pharmaceuticals Vol#: 1


00P-1466 Non-Approvable Letters for Neurontin

LET 1 HFD-1 to Pfizer, Inc. Vol#: 1

00P-1499 Remove alosetron (Lotronex) from the market

EMC 258 Stephanie Sarkis Vol#: 3

EMC 259 Janet Woodcock Vol#: 3

EMC 260 Melissa D Godwin Vol#: 3

EMC 261 Rita Weinberg Vol#: 3

EMC 262 Melva L Mack Vol#: 3

EMC 263 Valerie G Kennedy Vol#: 3

01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled

EMC 2 Philip H Coe Vol#: 1

EMC 3 Diana Di Paola Vol#: 1

EMC 4 Patrick Espinosa Vol#: 1

EMC 5 Noah & Natasha Brenner Vol#: 1

01D-0037 Pre-Store leukocyle reduction/Blood components for transfusi

C 1 Dartmouth-Hitchcock Medical Center Vol#: 1

EMC 1 Ellen Eagan MT (ASCP) SBB Vol#: 1