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 June 13, 2000

Table of Contents

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
83P-0187 REFRAIN FROM APPROVAL POLYURETHANE CONTRACEPTIVE SPONGE *
88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE *
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
95S-0158 Community Disclosure of Institutional Review Boards *
97N-0436 Methods informing consumers of contents of bottle water *
98D-0969 Effects of antimicrobial new animal drugs/use in food-produc *
98N-1215 Foreign Establishment Registration and Listing *
99N-4783 Administrative Practices & Procedures;Good Guidance Practice *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
99P-5198 Request amendment of the definition of milk *
00B-0108 Reclassify Antimicrobial Susceptibility Devices ClassIIItoII *
00D-0109 Assessment of Antimicrobial Susceptibility Devices *
00D-0892 Content/Format of NDA/ANDA for certain positron emission *
00D-1033 Clinical Trials for Serious/Life-Threatening Diseases *
00D-1223 Clinical Investigation of Medicinal Products in Pediatrics *
00N-0018 Reclassification of the knee joint Patellofemorotibal Metal *
00N-1060 Adoption of FDA Food Code *
00N-1220 Future of the IntNatl Conf.on Harminization of Thechnical Re *
00N-1246 Agency Information Collection Food Safety Survey *
00N-1256 Over-the-Counter Drug Products;Public Hearing *
00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz *
00P-1210 Restrict Sale of Coal Tar-Containing Products *
00P-1340 Withdrawn of ROWASA Suppositories *
00V-1339 Laser Display Device*
75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

C 55 CTFA The Soap & Detergent Assn Vol#: 68

83P-0187 REFRAIN FROM APPROVAL POLYURETHANE CONTRACEPTIVE SPONGE

EMC 62 Athena Ramos Vol#: 1

EMC 63 Jane Tarzand Vol#: 1

EMC 64 Pat Smith Vol#: 1

EMC 65 Sarah Harvey Vol#: 1

EMC 66 Julie Ptacek Vol#: 1

EMC 67 Rebecca Leontiev Vol#: 1

EMC 68 Yvonne Dillingham Vol#: 1

EMC 69 Valerie Swan Vol#: 1

EMC 70 C. E. Volonnino Vol#: 1

EMC 71 Janet M. Vilke Vol#: 1

EMC 72 Diana Ward Vol#: 1

EMC 73 Mary K. Mazzara Vol#: 1

EMC 74 Andree Malone Vol#: 1

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

C 88 AK Distributors Vol#: 2

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

C 75 AK Distributors Vol#: 3

95S-0158 Community Disclosure of Institutional Review Boards

C 2 CareStat Vol#: 5

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

EMC 9 Diane Gross Vol#: 2

EMC 10 Ann Devlin Vol#: 2

EMC 11 Denise Fuller Vol#: 2

EMC 12 David Rudko Vol#: 2

EMC 13 C. Kobernus Vol#: 2

EMC 14 Terry L. Chopin Vol#: 2

EMC 15 Beverly Archibald Vol#: 2

EMC 16 Renee Carter Vol#: 2

EMC 17 Dan Knott Vol#: 2

EMC 18 Dr. Charles G. Weiss Vol#: 2

EMC 19 Lisa Mike & Noelani Wright Vol#: 2

EMC 20 Andrea Wolper Vol#: 2

EMC 21 Mary Puckett Vol#: 2

EMC 22 P. T. Mackenzie Vol#: 2

EMC 23 JoAnne Winter Vol#: 2

EMC 24 Jerrie Wacholder Vol#: 2

EMC 25 Laurie Kuchera Vol#: 2

EMC 26 Lyn Goossens Vol#: 2

EMC 27 D. M. Norfleet Vol#: 2

EMC 28 Amy Lemmon Bowen Vol#: 2

EMC 29 Paul Senegal Vol#: 2

EMC 30 Edward Rybak Vol#: 2

EMC 31 Lois Barth Vol#: 2

EMC 32 Aviola Vol#: 2

EMC 33 Paula Glogovac Vol#: 2

EMC 34 Helen & Harold Tieger Vol#: 2

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

C 23 Aventis Pharmaceuticals Vol#: 4

98N-1215 Foreign Establishment Registration and Listing

MM 1 Colleen Swords Canadian Embassy Vol#: 1

99F-1581 Components of Paper & Paperboard in Contact with Dry Food

NFR 1 Vol#: 1

99H-0315 Civil Money Penalties;Worsley Operating Corp,d/b/a Scotchlma

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0316 Civil Money Penalties;Eckerd Corp,d/b/a Eckerd Drug Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0317 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0319 Civil Money Penalties;Trade Oil Co,d/b/a Trade Mart #21

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0320 Civil Money Penalties;Red Star Oil Co Inc,d/b/a Resco Mart

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0321 Civil Money Penalties;Food Lion Inc,d/b/a Food Lion #434

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0322 Civil Money Penalties;Food Lion Inc,d/b/a Food Lion #896

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0353 Civil Money Penalty; Kroger Limited Partnership I d/b/a Krog

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0354 Civil Money Penalty; James Lamere & Patricia Lamere d/b/a Wa

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0356 Civil Money Penalty; Plaza Service Corp d/b/a Gas Gauge Plus

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0430 Civil Money Penalties;John McPherson Jr,d/b/a K & S News

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0431 Civil Money Penalties;Allan Lee Nyseth,d/b/a Speedway Amoco

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0432 Civil Money Penalties;Service Distributing Co d/b/a Servco

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0434 Civil Money Penalties;Shothwest 9th TS Standard d/b/a South

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0435 Civil Money Penalties;Turner Oil Co of Wilson Inc,d/b/a

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0604 Civil Money Penalties;Happy Supermarket Inc,d/b/a Happy Supe

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0609 Civil Money Penalties;Joe Mola,d/b/a Mola's Shell

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0610 Civil Money Penalties;Mr Jiffy Inc, d/b/a Mr Jiffy #2

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0611 Civil Money Penalties;Noble Holdings Inc,d/b/a Roxbury

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0612 Civil Money Penalties;Southwest Conveneince Stores LLC,d/b/a

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0613 Civil Money Penalties;George Pagounis,d/b/a Athens Texaco

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0614 Civil Money Penalties;Ezekiel Perkins,d/b/a E-Z Variety

CR 1 GCF-1 Vol#: 1

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0615 Civil Money Penalties;Progressive Oil Co,d/b/a Dodges Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0616 Civil Money Penalties;Ramco Inc,d/b/a Minit Mart #25

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0617 Civil Money Penalty; Saver Systems Inc d/b/a Save-a-Lot

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0618 Civil Money Penalties;Ranjit Singh,d/b/a Kashmir Food & Spic

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0619 Civil Money Penalties;Sos Truck Stop Inc,d/b/a Metro 66

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0621 Civil Money Penalties;Southwest Convenience Stores LLC/d/b/a

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0622 Civil Money Penalties;Southwest Convenience Stores LLC,d/b/a

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0624 Civil Money Penalties;Ultramar Diamond Shamrock Corp,d/b/a

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0625 Civil Money Penalties;Whitaker Oil Inc,d/b/a Diagonal Sincla

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0626 Civil Money Penalties;DB Companies Inc,d/b/a Dairy Mart

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0628 Civil Money Penalties;Simpson-Perry Corp.,d/b/a Fastrip #12

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0629 Civil Money Penalties;The Pantry Inc,d/b/a The Pantry #906

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0630 Civil Money Penalties;Demoulas Super Markets Inc,d/b/a Marke

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0631

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0632 Civil Money Penalties;Avanti Petroleum Inc,d/b/a Vickers

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0633 Civil Money Penalties;Casey's Marketing Co,d/b/a Casey's

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0634 Civil Money Penalties;Secatide Inc,d/b/a Hi-way Grocery

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0713 Civil Money Penalties;Royce Pee,d/b/a Kwik Foods

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0714 Civil Money Penalties;Pump & Save Inc,d/b/a Pump & Save #751

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0715 Civil Money Penalties;J T Shaw,d/b/a Shaw's Express Mart

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0716 Civil Money Penalties;S K D Corp,d/b/a Dixie Grocery Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0717 Cicil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart 182

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0718 Civil Money Penalties;Wal-Mart Stores,d/b/a Wal-Mart #1088

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2234 Civil Money Penalty;Malecon Tobacco LLC,dba Matador Cigars

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2235 Civil Money Penalty;Racetrac Petroleumn Inc,dba Racetrac

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2236 Civil Money Penalty;Albert Rodgers,dba Rodgers Grocery & Har

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2237 Civil Money Penalty;Sayle Oil Co Inc,dba Holcomb Gas Mart

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2238 Civil Money Penalty;Vista Marketing Inc,dba Happy Stores

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2239 Civil Money Penalty;Waco Oil Co Inc,dba Shell

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2240 Civil Money Penalty;Jitney-Jungle Stores of America Inc,dba

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2241 Civil Money Penalty;Louis Cherry & Diane Cherry,dba Eastside

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2243 Civil Money Penalty;Timothy Mark Layne,dba Highway 28 Market

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2253 Civil Money Penalty;Aultman Ent Inc,dba Super Valu #71804

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2256 Civil Money Penalty;Eckerd Corp,dba Eckerd Drug #2718

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2258 Civil Money Penalty;Teckler Chikomo,dba John's Getty

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2260 Civil Money Penalty;Piggly Wiggly of Amory Inc,dba Maben Dis

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2261 Civil Money Penalty;Roy Gatlin,dba R & K Grocery & Grill

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2263 Civil Money Penalty;Barry Baggett,dba Baggett's Chevron

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4846 Civil Money Penalty;Daniel Weston & Linda Weston,dba Weston'

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4854 Civil Money Penalty;Sung Kim,dba Sunoco

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4895 Civil Money Penalty;Donald Meeks & Jean Meeks,dba Country

SET 1 GCF-1 Vol#: 1

99H-4909 Civil Money Penalty;Wal-Mart Stores Inc,dba,dba Wal-Mart

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4912 Civil Money Penalty;Gil Seon Her,dba Lee's Market

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4913 Civil Money Penalty;Houlka Supermarket Inc,dba Houlka Superm

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99M-4619 PMA Acticon Neosphincter, H990003

NAD 1 Vol#: 1

99M-4763 PMA, CardioSEAL Septal Occlusion System, H990005

NAD 1 Vol#: 1

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

C 13216 Lisa Baas Vol#: 404

C 13217 David Michael Eaker Vol#: 404

C 13218 Irene Grygorowicz Vol#: 404

C 13219 Sallie Mae Heise Vol#: 404

C 13220 Jocelyn Hollander Vol#: 404

C 13221 Myrna & Jim Gombrich Vol#: 404

C 13222 Barbara Rosales Vol#: 404

C 13223 Clarice K. Pollack Vol#: 404

C 13224 Ellen Buck Vol#: 404

C 13225 Eric V. Ohmart Vol#: 404

C 13226 Diane Wanda Crary Vol#: 404

C 13227 Barry Englestao Vol#: 404

C 13228 Joy Emerson Vol#: 404

C 13229 Kelly R. McKinnan Vol#: 404

C 13230 Carol J. Williams Vol#: 404

C 13231 Julianne Schneider Vol#: 404

C 13232 Elizabeth Beryer Vol#: 404

C 13233 Jason Landreth Vol#: 404

C 13234 Thomas D. Meek Vol#: 404

C 13235 Leslie Scaffoi Vol#: 404

C 13236 Shirley Hood Vol#: 404

C 13237 Suann Good Vol#: 404

C 13238 Rebecca Free Vol#: 404

C 13239 January Wyatt Vol#: 404

C 13240 Jeffrey R. Short, Jr. Vol#: 404

C 13241 Megan Costa Vol#: 404

C 13242 Carol Rosemond Vol#: 404

C 13243 Richard H. Adamson Vol#: 404

C 13244 Damian Parr Vol#: 404

C 13245 Lynn Lawson Vol#: 404

C 13246 Jessie Bush Vol#: 404

C 13247 Sandra Moilanen Vol#: 404

C 13248 Caroline Mitton Vol#: 404

C 13249 Lucinda Hobart Vol#: 404

C 13250 Jack Leishman Vol#: 404

C 13251 Eva A. Wolfgoeker Vol#: 404

C 13252 Johnathan Weber Vol#: 404

C 13253 Davis Landz Vol#: 404

C 13254 Mark L. Supan Vol#: 404

C 13255 Pamela Weber Vol#: 404

C 13256 Wat Stearns Vol#: 404

C 13257 Renee Ezell Vol#: 404

C 13258 Jacobson Vol#: 404

C 13259 Katherine Landers Vol#: 404

C 13260 Graham Harrman Vol#: 404

EMC 2817 William Hertling Vol#: 404

EMC 2818 Comet Vol#: 404

EMC 2819 Celeste D. Nicolls Vol#: 404

EMC 2820 John & Eleanor Rodgers Vol#: 404

EMC 2821 Teresa Parr Vol#: 404

EMC 2822 Jennifer Mollett Vol#: 404

EMC 2823 Kimberly Payne Vol#: 404

EMC 2824 Patt Mills Vol#: 404

EMC 2825 Collin Coyne Vol#: 404

EMC 2826 Arkelanor Vol#: 404

EMC 2827 Haylee Messing Vol#: 404

EMC 2828 Renne Leatto Vol#: 404

EMC 2829 Steve Kmetz Vol#: 404

EMC 2830 William Plummer Vol#: 404

EMC 2831 Lisa Reagan Vol#: 404

EMC 2832 John C. French Vol#: 404

EMC 2833 Roselene Haines Vol#: 404

99N-4783 Administrative Practices & Procedures;Good Guidance Practice

C 18 Assn of Medical Diagnostics Manufacturer Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 632 Illegible Vol#: 14

C 633 Adrienne Lauby Vol#: 14

C 634 Margaret Frank Vol#: 14

C 635 Amy Fisher Vol#: 14

99P-4613 Revoke the Regulation That Approved Posilac

C 196 Envoy Entertainment Management Productio Vol#: 28

C 197 Sylvia R. Steiner Vol#: 28

C 198 Richard, Georgiana Bishop & Janet Bishop Vol#: 28

EMC 2157 Charles Glueck Vol#: 28

EMC 2158 Dr. Michael Busch Vol#: 28

EMC 2159 Sally Treadwell Vol#: 28

EMC 2160 Barry & Donna Tobias Vol#: 28

EMC 2161 Allen deSomer Vol#: 28

EMC 2162 Eugene Ashworth Vol#: 28

EMC 2163 Shane Newman Vol#: 28

EMC 2164 Dennis & Robin Rowe Vol#: 28

EMC 2165 Philip F. Tomlinson, Jr., Ph.D. Vol#: 28

EMC 2166 Pam Whitworth Vol#: 28

EMC 2167 Connally B. Bennison Vol#: 28

EMC 2168 Louis Hammond Vol#: 28

EMC 2169 Anna A. Allen Vol#: 28

EMC 2170 Brian Stains Vol#: 28

EMC 2171 Kathleen Bailey Vol#: 28

EMC 2172 Dan & Annalisa Miller Vol#: 28

EMC 2173 Gary S. Rich Vol#: 28

EMC 2174 Paul Simdars Vol#: 28

EMC 2175 Daniel J. Miller Vol#: 28

EMC 2176 Cliff DeVries Vol#: 28

99P-5198 Request amendment of the definition of milk

LET 1 American Dairy Products Institute Vol#: 1

00B-0108 Reclassify Antimicrobial Susceptibility Devices ClassIIItoII

C 1 American Society for Microbiology Vol#: 3

00D-0109 Assessment of Antimicrobial Susceptibility Devices

C 1 MGH Massachusetts General Hospital Vol#: 1

C 2 The University Of Texas Vol#: 1

C 3 The University of Iowa Health Care Vol#: 1

C 4 Afd. Medische Microbiologie & Infectieze Vol#: 1

C 5 BD Biosciences Vol#: 1

C 6 American Society of Clinical Pathologist Vol#: 1

00D-0892 Content/Format of NDA/ANDA for certain positron emission

C 1 Michele Rakoff Vol#: 1

00D-1033 Clinical Trials for Serious/Life-Threatening Diseases

C 3 Bristol-Myers Pharm Res Institute Vol#: 1

C 4 Amgen Inc Vol#: 1

00D-1223 Clinical Investigation of Medicinal Products in Pediatrics

C 15 EMEA Vol#: 1

LET 2 DHHS Vol#: 1

00M-0424 PMA SVS Apex Plus Excimer Laser Workstation, Emphasis Discs

NAD 1 Vol#: 1

00M-0445 P980040; AMO SENSAR Soft Acrylic, UV Light-Absorbing, Poster

NAD 1 Vol#: 1

00M-0577 P990035; Omnisense Ultrasound Bone Sonometer

NAD 1 Vol#: 1

00M-0579 P990066; GE Medical Systems Senographe 2000D

NAD 1 Vol#: 1

00M-0580 P990016; McCue CUBA Clinical Ultrasonic Bone Sonometry Syste

NAD 1 Vol#: 1

00M-0599 H990011; CardioSEAL Septal Occlusion System

NAD 1 Vol#: 1

00M-0809 P990034; Cellugel Ophthalmic Viscosurgical Device

NAD 1 Vol#: 1

00M-0810 P900009/S6; Exogen 2000/Sonic Accelerated Fracture Healing

NAD 1 Vol#: 1

00M-0811 PMA Kremer Excimer Laser System (Serial # KEA940202)

NAD 1 Vol#: 1

00M-0901 PMA SpinalPak Bone Growth Stimulator P850022/S9

NAD 1 Vol#: 1

00M-0915 PMA Defender II Model 9201 Implantable Cardioverter Defibril

NAD 1 Vol#: 1

00M-1073 PMA SpinaLogic Bone Growth Stimulator, P910066/S11

NAD 1 Vol#: 1

00M-1212 Ray TFC & Ray TFC Unite Threaded Fusion Case w/Instrumentati

NAD 1 Vol#: 1

00M-1215 P970055; Biotrin Parvovirus B19 IgM Enzyme Immunoassay

NAD 1 Vol#: 1

00M-1216 P970054; Biotrin Parvovirus B19 IgG Enzyme Immunoassay

NAD 1 Vol#: 1

00N-0018 Reclassification of the knee joint Patellofemorotibal Metal

C 2 Stryker Howmedica Osteonics Vol#: 1

C 3 American Assn of Orthopaedic Surgeons Vol#: 1

00N-1060 Adoption of FDA Food Code

C 1 Thomas L. Schwarz Vol#: 1

00N-1220 Future of the IntNatl Conf.on Harminization of Thechnical Re

C 3 GlaxoWellcome Vol#: 1

00N-1246 Agency Information Collection Food Safety Survey

C 1 Joseph J. Byrne, Jr Vol#: 1

00N-1256 Over-the-Counter Drug Products;Public Hearing

APE 72 Roche Products Limited Vol#: 2

APE 73 AAAAI Vol#: 2

00N-1303 Agreement for Shipment of Devices for Sterilization

N 1 Vol#: 1

00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

ACK 2 HFA-305 Vol#: 1

CP 2 NCI, NAPA & GMOAI Vol#: 1

WDL 1 National Cheese Inst. et al Vol#: 1

00P-1210 Restrict Sale of Coal Tar-Containing Products

C 1 Occupational Knowledge International Vol#: 1

00P-1340 Withdrawn of ROWASA Suppositories

ACK 1 HFA-305 Vol#: 1

CP 1 Able Laboratories, Inc. Vol#: 1

00V-1339 Laser Display Device

ACK 1 HFA-305 Vol#: 1

VAR 1 Club Fusion Vol#: 1