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DOCKETS ENTERED on September 22, 2000

TABLE OF CONTENTS

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90S-0308 Generic Drug Speeches & Policy and Procedure Guides *
97N-0436 Methods informing consumers of contents of bottle water *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers *
00N-0086 Amendment of Regs - Certain Label Statements on Rx Drugs *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00P-0685 Revise of Yogurt Standards *
00P-1270 ANDA for combination oxycodone hydrochloride/acetaminophen *
00P-1271 Oxycodone hydrochloirde/acetaminophen tablet 2.5mg/400mg;5.0 *
00P-1289 Submission of supplement to abbreviated new drug application *
00P-1308 Methimazole tablets USP,15mg/20mg are suitable for ANDA *
00P-1533 PTCA Balloon Catheters (74LOX) *
00P-1535 Biopsy forceps covers/non-electric biopsy as Class I devices *

90S-0308 Generic Drug Speeches & Policy and Procedure Guides

RPT 1 HFD-7 Vol#: 48

97N-0436 Methods informing consumers of contents of bottle water

C 224 John Maggio Vol#: 7

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 783 T Sulanke Vol#: 28

C 784 No Signature Vol#: 28

C 785 J Tunick Vol#: 28

C 786 B Epstein Vol#: 28

C 787 Catholic Worker House of Hospitality Vol#: 28

EMC 30 K Stranc Vol#: 28

EMC 31 A Trattner Vol#: 28

EMC 32 M Patrick Vol#: 28

EMC 33 K Russel Vol#: 28

EMC 34 L Fassano Vol#: 28

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

C 14874 R. Daily Vol#: 450

C 14875 J. Jacobson Vol#: 450

C 14876 M Healey Vol#: 450

C 14877 L. East Vol#: 450

C 14878 L. Martin Vol#: 450

C 14879 J Klineman Vol#: 450

C 14880 M Berger Vol#: 450

C 14881 B Vrana Vol#: 450

C 14882 M McRae Vol#: 450

C 14883 G Rood Vol#: 450

C 14884 S Anton Vol#: 450

C 14885 E Wallace Vol#: 450

C 14886 J Witt Vol#: 450

C 14887 R Sage Vol#: 450

C 14888 A Kolesar Vol#: 450

C 14889 L Sandkamp Vol#: 450

C 14890 M Zezima Vol#: 450

C 14891 J Veltri, Jr. Vol#: 450

C 14892 L Campbell Vol#: 450

C 14893 E O'Loughlin Vol#: 450

C 14894 L DeRidder Vol#: 450

C 14895 W Schultz Vol#: 450

C 14896 B Sellers Vol#: 450

C 14897 M Kolvyn Vol#: 450

C 14898 J Wilz Vol#: 450

C 14899 L Cowan Vol#: 450

C 14900 M St. Louis Vol#: 450

C 14901 B Holloway Vol#: 450

C 14902 F Shaw Vol#: 450

C 14903 C Fielding Vol#: 450

C 14904 J Newhouse Vol#: 450

C 14905 W Obewneckling Vol#: 450

C 14906 J Allen Vol#: 450

C 14907 A Eason Vol#: 450

C 14908 S Hall Vol#: 450

C 14909 M Swindle Vol#: 450

C 14910 S Emhoff Vol#: 450

C 14911 G Amend Vol#: 450

C 14912 B Porter Vol#: 450

C 14913 C Parker Vol#: 450

C 14914 N Fitzgerald Vol#: 450

C 14915 P Poorman Vol#: 450

C 14916 M Pine Vol#: 450

C 14917 A Elmes Vol#: 450

C 14918 R Striebel Vol#: 450

C 14919 S Vogal Vol#: 40

C 14920 W Milam Vol#: 450

C 14921 C Weisnicht Vol#: 450

C 14922 G Keeran Vol#: 450

C 14923 B Habel Vol#: 450

C 14924 M Calvert Vol#: 450

C 14925 H Farnlund Vol#: 450

C 14926 M Durant Vol#: 450

C 14927 J Young Vol#: 450

C 14928 R Saxbury Vol#: 450

C 14929 A Cernos Vol#: 450

C 14930 S Ponchock Vol#: 450

C 14931 R Olsen Vol#: 451

C 14932 D Harris Vol#: 451

C 14933 L Brown Vol#: 451

C 14934 R Richardson Vol#: 451

C 14935 W Abraham Vol#: 451

C 14936 F Breeden Vol#: 451

C 14937 H Dresbach Vol#: 451

C 14938 D Ball Vol#: 451

C 14939 K Ambrose Vol#: 451

C 14940 E Drone Vol#: 451

C 14941 A Boyers Vol#: 451

C 14942 C Bishop Vol#: 451

C 14943 L Phillips Vol#: 451

C 14944 J McAuliff Vol#: 451

C 14945 D Pansius Vol#: 451

C 14946 M West Vol#: 451

C 14947 M Krumrey Vol#: 451

C 14948 D Henry Vol#: 451

C 14949 M Dealy Vol#: 451

C 14950 H Vesty Vol#: 451

C 14951 L Nall Vol#: 451

C 14952 B Norris Vol#: 451

C 14953 J Ripley Vol#: 451

C 14954 A Fedder Vol#: 451

C 14955 P Klahr Vol#: 451

C 14956 S Sherriff Vol#: 451

C 14957 S Scoggins Vol#: 451

C 14958 H Page Vol#: 451

C 14959 E Coxen Vol#: 451

C 14960 J Carpenter Vol#: 451

C 14961 L Cravens Vol#: 451

C 14962 S Espinosa Vol#: 451

C 14963 J Brimhall Vol#: 451

C 14964 H Lenz Vol#: 451

C 14965 L Peterson Vol#: 451

C 14966 R Cooper Vol#: 451

C 14967 J Keller Vol#: 451

C 14968 J Zuba Vol#: 451

C 14969 E Schulze Vol#: 451

C 14970 H Wendland Vol#: 451

C 14971 J Filey Vol#: 451

C 14972 R Clower Vol#: 451

C 14973 H Byrd Vol#: 451

C 14974 P McDermid Vol#: 451

C 14975 R Bentley Vol#: 451

C 14976 F Collagn-Oliver Vol#: 451

C 14977 J Gurian Vol#: 451

C 14978 K Buhn Vol#: 451

C 14979 R McGee Vol#: 451

C 14980 T Earls Vol#: 451

C 14981 C Robinson Vol#: 451

C 14982 L Romaine Vol#: 451

C 14983 S Prall Vol#: 451

C 14984 S Russell Vol#: 451

C 14985 R Rudzinski Vol#: 451

C 14986 A Weatherford Vol#: 451

C 14987 C Cooper Vol#: 451

C 14988 S Bunderson Vol#: 451

C 14989 T Callahan Vol#: 451

C 14990 J Mandrei Vol#: 451

C 14991 J Mueller Vol#: 451

C 14992 S Sheffield Vol#: 451

C 14993 C Pierce Vol#: 451

C 14994 J Marks Vol#: 451

C 14995 P Clegg Vol#: 451

C 14996 K Fluhart Vol#: 451

C 14997 S Weis Vol#: 451

C 14998 A Mance Vol#: 451

C 14999 J Buck Vol#: 451

C 15000 B Byers Vol#: 451

C 15001 K Rauh Vol#: 451

C 15002 W Bates Vol#: 451

C 15003 C Weidner Vol#: 451

C 15004 L Hayman Vol#: 451

C 15005 G Webb Vol#: 451

C 15006 F Crajha Vol#: 451

C 15007 S Scott Vol#: 451

C 15008 L Vasconceller Vol#: 451

C 15009 E Taylor Vol#: 451

C 15010 N Stoll Vol#: 451

C 15011 L Olson Vol#: 451

C 15012 S Coleman Vol#: 451

C 15013 K Whittier Vol#: 451

C 15014 S Loscalzo Vol#: 451

C 15015 A Myers Vol#: 451

C 15016 R Shippee Vol#: 451

C 15017 L Robertson Vol#: 451

C 15018 J Ross Vol#: 451

C 15019 R Freedman Vol#: 451

C 15020 D Black Vol#: 451

C 15021 T Owen Vol#: 451

C 15022 K Chapman Vol#: 451

C 15023 I Roberts Vol#: 451

C 15024 P Smith Vol#: 451

C 15025 N Dvorsky Vol#: 451

C 15026 P Knott Vol#: 451

C 15027 R Fullford Vol#: 451

C 15028 T Wertman Vol#: 451

C 15029 H Torrey Vol#: 451

C 15030 T Nagy Vol#: 451

C 15031 H Houghton Vol#: 451

C 15032 C Elliott Vol#: 451

C 15033 O Gertrude Vol#: 451

C 15034 D Oehler Vol#: 451

C 15035 M Juler Vol#: 451

C 15036 E Brandt Vol#: 451

EMC 3074 C Beck Vol#: 450

EMC 3075 D Miller Vol#: 450

EMC 3076 R Y Vol#: 450

EMC 3077 M Lynn Vol#: 450

EMC 3078 R Mancuso Vol#: 450

EMC 3079 M Grinstein-Camacho Vol#: 450

EMC 3080 K Swift Vol#: 450

EMC 3081 K McClintock Vol#: 450

EMC 3082 N Fini Vol#: 450

EMC 3083 J Sharp Vol#: 450

EMC 3084 H Harris Vol#: 450

EMC 3085 K Thrasher Vol#: 450

EMC 3086 R Phelps Vol#: 450

EMC 3087 S Wald Vol#: 450

EMC 3088 E Ball Vol#: 450

EMC 3089 N Wessex Vol#: 450

EMC 3090 C France Vol#: 450

EMC 3091 A Memmo Vol#: 450

EMC 3092 A Anderson Vol#: 450

EMC 3093 A Ravital Vol#: 450

EMC 3094 E Ryser Vol#: 450

EMC 3095 L Jacobs Vol#: 450

EMC 3096 D Cowman Vol#: 450

EMC 3097 L Jones Vol#: 450

EMC 3098 S Clary Vol#: 450

EMC 3099 R D'Errico Vol#: 450

EMC 3100 C Issacs Vol#: 450

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2622 M Ramphal Vol#: 188

00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers

C 8 M McCann PhD Vol#: 1

C 9 American Soc for Emergency Contraception Vol#: 1

00N-0086 Amendment of Regs - Certain Label Statements on Rx Drugs

C 5 E Hannigan Vol#: 1

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

EC 62 Work, Inc. Vol#: 11

EC 63 S Petrie Vol#: 11
 

00N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

EAPE95 Paul Magliocchetti Associates Vol#: 1

EAPE96 The Pink Sheet Vol#: 1

EAPE97 PhRMA Vol#: 1

EAPE98 Pharmacia Vol#: 1

EAPE99 Animal Health Institute Vol#: 1

EAPE100 Animal Health Institute Vol#: 1

EAPE101 Epilepsy Foundation Vol#: 1

EAPE102 Epilepsy Foundation Vol#: 1

EAPE103 U.S. FDA Vol#: 1

EAPE104 Bergner,Bockorny Vol#: 1

EAPE105 Bergner Bockorny Vol#: 1

EAPE106 Inside Washington Publishers Vol#: 1

00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop

C 20 Cholestech Corporation Vol#: 1

NEC 1 Vol#: 1

00P-0685 Revise of Yogurt Standards

CR 1 CFSAN/ONPLDS Vol#: 1

00P-1270 ANDA for combination oxycodone hydrochloride/acetaminophen

PAV 1 HFD-600 to King & Spalding Vol#: 1

00P-1271 Oxycodone hydrochloirde/acetaminophen tablet 2.5mg/400mg;5.0

PAV 1 HFD-600 to King & Spalding Vol#: 1
 
 

00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

BKG 1 Background Vol#: 5
 
 

00P-1276 Health Claim: Plant stanol esters and heart disease

BKG 1 Background Vol#: 5

00P-1289 Submission of supplement to abbreviated new drug application

PAV 1 HFD-600 to GensiaSicor Pharmaceuticals Vol#: 1

00P-1308 Methimazole tablets USP,15mg/20mg are suitable for ANDA

PAV 1 HFD-600 to Lachman Consultant Servic Inc Vol#: 1

00P-1533 PTCA Balloon Catheters (74LOX)

ACK 1 HFA-305 Vol#: 1

CCP 1 Cook MED Institute, Incorporated Vol#: 1

00P-1535 Biopsy forceps covers/non-electric biopsy as Class I devices

CP 1 Boston Scientific Corporation Vol#: 1