Food and Drug Administration
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DOCKETS ENTERED on January 5, 2000

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]

Table of Contents 1

84N-0102 Orphan Product Designations 2

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims 2

95S-0117 Human Drugs Patent Term Extension & New Patents 2

97N-0511 Procedures the safe and sanitary processing/importing juice 2

97N-484S Human Cellular and Tissue-Based Products 2

98N-1109 Mercury Compounds in Drugs and Food 4

99M-5539 PMA TheraSphere, H980006 6

99N-4491 Reuse of Single Use Devices proposal 9

99P-1340 Declared Eternity eau de Parfum Misbranded 10

99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast 10

99P-4613 Revoke the Regulation That Approved Posilac 10

99P-5106 Identify Sources of Natural Flavorings 10

99P-5589 Reclassification of Absorbable Polydioxanone Surgical Suture 10

99V-5588 Laser Light Show 10

00P-0090 Determine Paxil Oral Capsules not withdrawn for safety reaso 10

00P-0091 ANDA Suitability for Pamidronate Disodium Injection 10

00P-0092 ANDA Suitability for Thiotepa for Injection 10

84N-0102 Orphan Product Designations

LST 92 December 1999 Vol#: 2

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

EMC 3 Debra E Fenech Vol#: 25

EMC 4 Carol Quimby Vol#: 25

EMC 5 Jan May Vol#: 25

EMC 6 J. D. Bilbro Vol#: 25

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 50 List as of December 23, 1999 Vol#: 3

97N-0511 Procedures the safe and sanitary processing/importing juice

EMC 19 Michael Vivona Vol#: 14

EMC 20 Hans G. Boehm Vol#: 14

EMC 21 Herbert E Steelman Vol#: 14

EMC 22 Walter Graff Vol#: 14

EMC 23 Donna McGahee Vol#: 14

EMC 24 Caroline Sabbagh Vol#: 14

EMC 25 Kathy DeLong Vol#: 14

EMC 26 J. David Schmidt Vol#: 14

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

C 278 University of Kentucky Vol#: 13

C 279 Viacord, Inc. Vol#: 13

C 280 CorCell, Inc. Vol#: 13

C 281 New England Eye & Tissue Transplant Bank Vol#: 13

C 282 Northwest Tissue Center Vol#: 13

C 283 Lions Eye Bank of District 2T-1 Vol#: 13

C 284 OGA, Obstetrical & Gynecological Associa Vol#: 13

C 285 New Mexico Lions Eye Bank Vol#: 13

C 286 UCLA, University of California, Los Ange Vol#: 13

C 287 El Paso Regional Transplant Bank Vol#: 13

C 288 Doheny Eye & Tissue Transplant Bank Vol#: 13

C 289 Lion's Eye & Bank of North Dakota, Inc. Vol#: 13

C 290 Cryogenic Labs., Inc. Vol#: 13

C 291 ReproTech, Ltd. Vol#: 13

C 292 Northern California Transplant Bank Vol#: 13

C 293 Fred Hutchinson Cancer Research Center Vol#: 13

C 294 University of Miami School of Medicine Vol#: 13

C 295 Lambda Legal Defense & Education Fund, I Vol#: 13

C 296 Medtronic Sofamor Danek Vol#: 13

C 297 t. Breeders, Inc. Vol#: 13

C 298 Johns Hopkins University Vol#: 13

C 299 American Society For Reproductive Medici Vol#: 13

EMC 12 Adrienne Lawyer Vol#: 12

EMC 13 Kaj Erik Johnsen Vol#: 12

EMC 14 Leland Traiman Vol#: 12

EMC 15 Bennett Fertility Institute Vol#: 12

EMC 16 Shawn Corne Vol#: 12

EMC 17 Anita Neuman Vol#: 12

EMC 18 Karen Damron Vol#: 12

EMC 19 Kate Kendell Vol#: 12

EMC 20 Michael Dively Vol#: 12

EMC 21 Leland Traiman, RN Vol#: 12

EMC 22 Marshawn Dyer & Michelle Blanson Vol#: 12

EMC 23 Gay & Lesbian Medical Assn. et al Vol#: 12

EMC 24 Doni Gewirtzman Vol#: 12

EMC 25 Dedra Chamberlin Vol#: 12

98D-0388 Dermatological Drug Product NDA's and ANDA's

WDL 1 Bristol-Myers Squibb Company Vol#: 1

98F-1199 Preservative for paper coating/safe use/with aqueous food

NWL 1 Vol#: 1

98N-1109 Mercury Compounds in Drugs and Food

M 2 HFD-560 Vol#: 2

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

NFL 1 HFS-024 Vol#: 1

99H-1463 Civil Money Penalties;Fred's of Marks & Lambert Inc,d/b/a

IDF 1 HF-3 Vol#: 1

99H-1479 Civil Money Penalty;Fred's Stores of Tennessee Inc,dba Fred'

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-4748 Civil Money Penalty;Linson 2 Inc,dba 7-Eleven Store #26753

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-5003 Civil Money Penalty;Suk In Chung & Haeng Ja Chung,dba Vermon

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-5408 Civil Money Penalty;Holyoke News Co., Inc;dba Amherst Newsro

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5458 Civil Money Penalty;ABCO Markets Inc;dba ABCO Desert Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5459 Civil Money Penalty;ABH Development, L.L.C.;dba Wright Broth

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5460 Civil Money Penalty;Beaver Park Investments, Inc;dba Kwik St

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5461 Civil Money Penalty;Canon Market, Inc;dba Canon Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5462 Civil Money Penalty;Don Carney;dba Carney 412 Auto & Truck S

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5463 Civil Money Penalty;Terry Cisco;dba Cisco Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5471 Civil Money Penalty;Goodman Oil Company;dba Goodman Oil Comp

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5472 Civil Money Penalty;Guttman Oil Company;dba Crossroad Food M

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5473 Civil Money Penalty;Hideaway Mini Mart, Inc;dba Hideaway Min

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5474 Civil Money Penalty;Sun S. Hong;dba A & A Foods #2

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5475 Civil Money Penalty;James M. Jacob and Gayle E. Jacob;dba G

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5476 Civil Money Penalty;Jindani Corporation;dba M & J Convenienc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99M-5539 PMA TheraSphere, H980006

AAV 1 DataMedix Corp for MDS Nordion Inc Vol#: 1

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

C 142 Jenny Clark Vol#: 16

C 143 Carol A Jason Vol#: 16

C 144 Richard B Katz Vol#: 16

C 145 Nancy Reynolds Vol#: 16

C 146 Mandy Conto Vol#: 16

C 147 Patricia A Raynor Vol#: 16

C 148 Caroline Mitton Vol#: 16

C 149 Frederick R Chaffee Vol#: 16

C 150 R Wilson Vol#: 16

C 151 M Ruth Niswander Vol#: 16

C 152 Valli Rebsamen Vol#: 16

C 153 Erin Riley Vol#: 16

C 154 Sara Staehle Vol#: 16

C 155 Bruce Berger Vol#: 16

C 156 Lou Battams Vol#: 16

C 157 Judi Shweky Vol#: 16

C 158 Ila Winslow Vol#: 16

C 159 Mary Hall Matson Vol#: 16

C 160 Ilene Norton Vol#: 16

C 161 Harold Edison & 14 signatures Vol#: 16

C 162 Charles & Helane Shields Vol#: 16

C 163 Charles S Myers Vol#: 16

C 164 Kami Pothukuchi Vol#: 16

C 165 Ann Ogle & Mark Ward Vol#: 16

C 166 John Silson Vol#: 16

C 167 Beverly Munchel-Kievit Vol#: 21

C 168 Marvin I Lewis Vol#: 21

C 169 Corinna Hawkes Vol#: 21

C 170 Michelle Mascarenhas Vol#: 21

C 171 Debra Susie PhD Vol#: 21

C 172 Marc Robert Vol#: 21

C 173 Myra W Bailes Vol#: 21

C 174 Alanna Hartzok Vol#: 21

C 175 Sue Seppi Vol#: 21

C 176 Linda A Johnson Vol#: 21

C 177 ICCR Members Vol#: 21

C 178 Food Dairy Companies & Restaurants Vol#: 21

C 179 David B Schmidt Vol#: 21

C 180 Consumer Policy Insitute Vol#: 21

C 181 Sandy C Smith Vol#: 21

C 182 Steve Baker & 7 signatures Vol#: 21

C 183 Monsanto Company Vol#: 21

C 184 Ms Rita Melnick Vol#: 21

C 185 Patricia O'Leary Vol#: 21

C 186 VA Assoc for Biological Farming Vol#: 21

C 187 PA Environmental Network Vol#: 21

C 188 Joan Candalino Vol#: 21

C 189 Michelle Mascarenhas Vol#: 21

C 190 Katie Wolff Vol#: 21

C 191 Karin Moro & 9 signatures Vol#: 21

C 192 Edward & Theresa Pimental Vol#: 21

C 193 Randall M Cullom Vol#: 21

C 194 Marv Lewis Vol#: 21

C 195 June Evans Vol#: 21

C 196 Kevin Wolfe Vol#: 21

C 197 Mrs Peer J Oppenheimer Vol#: 21

C 198 Virginia Robinson Vol#: 21

C 199 Dora Berginc Vol#: 21

C 200 Terri Vol#: 21

C 201 Matt Roberts Vol#: 21

C 202 Peter & Theresa Pasquoche + W L Lanham Vol#: 21

C 203 E Hosterman Vol#: 21

C 204 Connie Keeney Vol#: 21

C 205 Robert Evans Vol#: 21

C 206 S Melch Vol#: 21

C 207 Steve & Dolores Krick Vol#: 21

C 208 Renee Patton Vol#: 21

C 209 James Stedman Vol#: 21

C 210 Alberta Williams Vol#: 21

C 211 Philip & Jan Sorensen Vol#: 21

EMC 641 Shelli Marie O'Steen Vol#: 16

EMC 642 Rose Amelia Kircher Vol#: 16

EMC 643 Mary A Austin Vol#: 16

EMC 644 Korie Fox Vol#: 16

TR 2 Transcript Washington, DC Vol#: 20

TS 45 Environmental Defense Fund Vol#: 16

TS 46 Federal Focus Inc Vol#: 16

TS 47 Joseph A Levitt Vol#: 16

TS 48 James H Maryanski PhD Vol#: 16

TS 49 Bill Kovacs Vol#: 16

TS 50 Joseph Mendelson III Vol#: 16

TS 51 Federation of Animal Science Societies Vol#: 16

TS 52 NCAMP Vol#: 21

TS 53 John D Graham PhD Vol#: 21

TS 54 Calvert Inst for Policy Research Inc Vol#: 21

TS 55 Robert Hutchison Vol#: 21

TS 56 Philip Councell Jr Vol#: 21

TS 57 Fiel Detz Vol#: 21

TS 58 Jim Riddle Vol#: 21

TS 59 American Medical Assoc Vol#: 21

TS 60 American Society of Plant Physiologists Vol#: 21

TS 61 Organic Trade Assoc Vol#: 21

TS 62 E I Dupong De Nemours & Co Vol#: 21

TS 63 American Society for Microbiology Vol#: 21

TS 64 John Hagelin Vol#: 21

TS 65 Purina Mills Inc Vol#: 21

TS 66 Eric Johnson Vol#:

TS 67 Joseph Lemieux Vol#: 21

TS 68 American Corn Growers Assoc Vol#: 21

TS 69 National Cotton Council Vol#: 21

TS 70 American Crop Protection Assoc Vol#: 21

TS 71 National Corn Growers Assoc Vol#: 21

TS 72 Dr John A Thomas Vol#: 21

TS 73 Tony Anderson Vol#: 21

TS 74 Whole Foods Market Inc Vol#: 21

TS 75 Jeff Stein Vol#: 21

TS 76 Charles Santerre Vol#: 21

TS 77 Nat'l Food Processor Assoc Vol#: 21

99N-4491 Reuse of Single Use Devices proposal

C 21 USC School of Medicine Vol#: 1

C 22 MHG Endoscopy Clinic Vol#: 1

C 23 Ahmad I Dris, M.D. Vol#: 1

C 24 Maria Corazon Chang, M.D. Vol#: 1

C 25 Charles Manbren, M.D. Vol#: 1

C 26 Ron Ah Loy, M.D. Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 31 Elmo Johnson Vol#: 12

99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast

C 7 Natural Resources Defense Council Vol#: 3

99P-4613 Revoke the Regulation That Approved Posilac

C 18 John Power Vol#: 4

C 19 Duane Rice Vol#: 4

EMC 269 Rigo Marcus Vol#: 4

SUP 8 Robert Cohen Vol#: 4

99P-5106 Identify Sources of Natural Flavorings

EMC 1 William McMullin Vol#: 1

99P-5589 Reclassification of Absorbable Polydioxanone Surgical Suture

CCP 1 Ethicon, Inc. Vol#: 1

99V-5588 Laser Light Show

VAR 1 Gulf World, Inc. Vol#: 1

00P-0090 Determine Paxil Oral Capsules not withdrawn for safety reaso

ACK 1 HFA-305 Vol#: 1

CP 1 Pentech Pharmaceuticals Inc Vol#: 1

00P-0091 ANDA Suitability for Pamidronate Disodium Injection

ACK 1 HFA-305 Vol#: 1

CP 1 Mitchall G Clark Vol#: 1

00P-0092 ANDA Suitability for Thiotepa for Injection

ACK 1 HFA-305 Vol#: 1

CP 1 GensiaSicor Pharmaceuticals Vol#: 1