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]

DOCKETS ENTERED on December 17, 1999

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]
 
96M-0274 PMA Approval of SVS Apex (fomerly the Omnimed) Excimer Laser *
97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container *
97N-484S Human Cellular and Tissue-Based Products *
98D-0834 Non-Contraceptive Estrogen Class Labeling *
98P-0203 Eliminate Forced Molting of Laying Birds *
99D-2213 Invalidation of test results when using licensed & 510(k) *
99D-2873 Evidence models for the least burdensome means to market *
99D-4130 Manufacturers to assemblers for Diagnostic X-Ray Systems *
99P-4613 Revoke the Regulation That Approved Posilac *
96M-0274 PMA Approval of SVS Apex (fomerly the Omnimed) Excimer Laser

LET 4 HFZ-1 to Ellis Eye & Laser Centers Vol#: 1

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9609 PhRMA Vol#: 197

C 9610 Boehringer Ingelheim Pharmaceutical Inc Vol#: 197

C 9611 Allergy & Asthma Network-Mothers of Asth Vol#: 197

C 9612 Allergy & Asthma Network-Mothers of Asth Vol#: 197

C 9613 International Pharmaceutical Aerosol Con Vol#: 197

C 9614 Tommy Farese Vol#: 197

C 9615 Medeva Americas Inc Vol#: 197

C 9616 Cystic Fibrosis Foundation Vol#: 197

C 9617 Glaxo Wellcome Research & Development Vol#: 197

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

C 106 Advanced Orthopedic Care Assoc Vol#: 7

C 107 Indiana Back Center Vol#: 7

C 108 Goldsboro Orthopaedic Assoc Vol#: 8

C 109 Neuro-Group Vol#: 8

C 110 Neurosurgery Vol#: 8

C 111 Center fo Orthopaedics & Sport Medicine Vol#: 8

C 112 Neurosurgical Assoc of Lubbock Vol#: 8

C 113 Stantaniello Orthopaedic Med Corp Vol#: 8

C 114 DFW Neurosurgical Specialists Vol#:

C 115 Orthopedic Surgeon Vol#: 8

C 116 Spine Care Medical Group Vol#: 8

C 117 Orthopaedic Surgery Vol#: 8

C 118 Duke University Med Ctr Vol#: 8

C 119 Rowan Neurosurgical Assoc Vol#: 8

C 120 Orthopaedic Clinic of Daytona Beach Vol#: 8

C 121 Orthopedic Surgery Vol#: 8

C 122 Eye Ctrs of South Florida Vol#: 8

C 123 Dickson-Diveley Midwest Orthopaedic Clin Vol#: 8

C 124 Frederick W Tiley MD Vol#: 8

C 125 Adult & Pediatric Neurological Surgery Vol#: 8

C 126 Orthoclinic Vol#: 8

C 127 KSF Orthopeadic Center Vol#: 8

C 128 Peter M Klara MD PhD Vol#: 8

C 129 NY University School of Medicine Vol#: 8

C 130 Advanced Ferrility Services Vol#: 8

C 131 Frank P Cammisa Jr MD Vol#: 8

C 132 Tallahassee Neurological Clinic Vol#: 8

C 133 SLU Care Vol#: 8

C 134 Neurological Surgery Vol#: 8

C 135 Neurological Surgeons Vol#: 8

C 136 Neurological Surgeons Vol#: 8

C 137 Adirondack Neusurgical Specialists Vol#: 8

C 138 Hudson Valley Neurosurgical Assoc Vol#: 8

C 139 Bernauer Clinic Vol#: 8

C 140 Neurological Surgery SC Vol#: 8

C 141 Neurosurgical Assoc Vol#: 8

C 142 Orthopaedic Specialties Vol#: 8

C 143 Miami Children's Hospital Vol#: 8

C 144 James M Loddengaard MD Vol#: 8

C 145 Iowa Neurological Surgery Vol#: 8

EMC 9 Thomas E Grissinger Vol#: 7

EMC 10 Ann Williamson Vol#: 8

EMC 11 Amy Whitney Vol#: 8

98D-0834 Non-Contraceptive Estrogen Class Labeling

C 11 Wyeth-Ayerst Labs. Vol#: 3

98F-1200 Paper & Paperboard in Contact w/Aqueous & Fatty Foods

NWL 1 Vol#: 1

98N-0562 Civil Money Penalties; Rajaram K Matkari

AMD 1 GCF-1 Vol#: 2

98P-0203 Eliminate Forced Molting of Laying Birds

C 1913 Charles Insel Vol#: 46

C 1914 Helene Lieto Vol#: 46

C 1915 Shannon Wade Vol#: 46

C 1916 Mark Goldberg Vol#: 46

C 1917 Wright Vol#: 46

C 1918 Joan Wingard Vol#: 46

C 1919 Charlotte Harbeson Vol#: 46

C 1920 Jennifer A Nielsen Vol#: 46

C 1921 Janet Hansn Vol#: 46

C 1922 Kathleen Monahan Vol#: 46

C 1923 Patricia Smith Vol#: 46

C 1924 Joyce Janicki Vol#: 46

99D-2213 Invalidation of test results when using licensed & 510(k)

C 3 American Associaton of Blood Banks Vol#: 1

99D-2873 Evidence models for the least burdensome means to market

C 11 Medical Alley Vol#: 1

99D-4130 Manufacturers to assemblers for Diagnostic X-Ray Systems

C 2 Thomas J Quinn Vol#: 1

99D-5047 Industry on Pharmacokinetics in Patients with Impaired Hepat

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

99H-1619 Civil Money Penalty; Del Goebel dba G & S Gas

CS 2 HFA-305 Vol#: 1

OR 2 HF-3 Vol#: 1

99H-4719 Civil Money Penalty;Ibrahim A. Hamdallah,dba Eden Trading Co

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4722 Civil Money Penalty;Jose L. Perez and Amanda Cruz,dba Contin

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5031 Civil Money Penalty;Pow Chareonvaravut,dba 7-Eleven Store #2

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5032 Civil Money Penalty;BBC Inc,dba Briggs Chaney Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5038 Civil Money Penalty;Kenneth Brasell,dba Brasell Service Stat

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5039 Civil Money Penalty;H & F Services Inc,dba Texaco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5040 Civil Money Penalty;Holiday Stationstores Inc,dba Holiday St

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5041 Civil Money Penalty;Helen Mills,dba Mill's Tobacco Shack

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5042 Civil Money Penalty;Miner's Incorporated,dba U-Save-Always

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5043 Civil Money Penalty;Sayle Oil Company Inc,dba Texaco Gas Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5044 Civil Money Penalty;Shirley's Gas and Groceries Inc,dba Shir

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5045 Civil Money Penalty;Walgreen Co,dba Walgreen's Drug Store #2

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5049 Civil Money Penalty;Danny K. Moore,dba Sportsman's Crossing

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5050 Civil Money Penalty;John Lee,dba Perry County Mall

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5087 Civil Money Penalty;Arkco Petroleum Inc,dba Arkco #121

LET 1 Office of Tobacco Program Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5088 Civil Money Penalty;Bell's Cash Market Inc,dba Bell's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5089 Civil Money Penalty;BGMG Ltd,dba Lee's Tavern

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5090 Civil Money Penalty;Bramble Beverages Inc,dba Bargain Bevera

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5091 Civil Money Penalty;Casey's Marketing Company,dba Casey's #1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5092 Civil Money Penalty;John Chance and Marie Chance,dba Chance'

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5093 Civil Money Penalty;Cecil Channels and Helen Channels

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5094 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #8185

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5095 Civil Money Penalty;Fair Liquors inc,dba Fair Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5096 Civil Money Penalty;Sal's Party Store Inc,dba Sal's Party St

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5097 Civil Money Penalty;Schormann Enterprises Inc,dba Parkton Ex

LET 1 office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5098 Civil Money Penalty;Sohone Inc,dba New York Ave Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5099 Civil Money Penalty;Arthur Souza,dba A&R Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5100 Civil Money Penalty;South Arkansas Petroleum Company Inc,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5101 Civil Money Penalty;Speedway SuperAmerica LLC,dba Speedway P

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5102 Civil Money Penalty;Store 24 Inc,dba Store 24 #35

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5103 Civil Money Penalty;Supervalu Inc,dba Cub Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-4235 Practices in the dietary supplement industry survey

BKG 1 BACKGROUND Vol#: 1

N 2 Vol#: 1

S 1 SUPPORTING STATEMENT Vol#: 1

99P-4613 Revoke the Regulation That Approved Posilac

EMC 203 Anne Whitefield Vol#: 3

EMC 204 Rachel E. Debus Vol#: 3

EMC 205 Justin Sharber Vol#: 3

EMC 206 Joel Dee Vol#: 3

EMC 207 Sophie Hardy, RN Vol#: 3

EMC 208 Mark M. Giese Vol#: 3

EMC 209 Olsons Vol#: 3

EMC 210 Debbie MacKenzie Vol#: 3