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DOCKETS ENTERED on 1/6/03

Docket Number - Title

95N-0071 Proposal to Debar Amirul Islam; Notice of Opportunity for He

LET 3 Zuckerman Spaeder, LLP Vol#: 1

LET 4 London & Mead Vol#: 1

96D-0041 Clinical Safety Data Management: Safety Update Reports

GDL 1 GUIDANCE Vol#: 1

NAD 3 Vol#: 1

00D-1538 Electronic Records; Electronic Signatures, Validation

LST 12 Gen. References for Guidance 01/06/03 Vol#: 8

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

LST 12 Gen. References for Guidance 01/06/03 Vol#: 8

00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor

LST 12 Gen. References for Guidance 01/06/03 Vol#: 6

00D-1541 Electronic Signatures: Audit Trails

LST 12 Gen. References for Guidance 01/06/03 Vol#: 6

00D-1542 Electronic Signatures: Time Stamps

LST 12 Gen. References for Guidance 01/06/03 Vol#: 6

00D-1543 Electronic Signatures: Glossary of Terms

LST 12 Gen. References for Guidance 01/06/03 Vol#: 7

00N-1596 Uniform Compliance Date for Food Labeling Regulations

NFR 2 Vol#: 1

00P-1378 Cosmetic Products Containing Alpha Hydroxy Acids

C 1 Coloplast Corp. Vol#: 1

02D-0266 Guidance preventive measures to reduce risk of (CJD)

C 15 Heartland Lions Eye Banks (HLEB) Vol#: 1

C 16 University of Miami Vol#: 1

02D-0324 Bioengineered Plants for Use in Humans and Animals

C 201 Ray Wade Vol#: 6

C 202 Ken Maloney & Julie Ford-Maloney Vol#: 6

C 203 Sister Anne-Marie Baurqui, RSM Vol#: 6

C 204 Daniel C. Shively Vol#: 6

C 205 David Seaborg Vol#: 6

C 206 Michele Wuensch Vol#: 6

C 207 Jenny Jones Vol#: 6

C 208 Louise Hetzker Vol#: 6

C 209 Elizabeth & Sean Cortez-Mathis Vol#: 6

C 210 Richard Kark Vol#: 6

C 211 Marjory M. Donn Vol#: 6

C 212 Charles R. Zalac Vol#: 6

C 213 National Jewish Medical and Research Cen Vol#: 6

C 214 Effie E. Westervelt Vol#: 6

C 215 Betty Hutchinson Vol#: 6

C 216 Ty Conley Vol#: 6

C 217 John Bass Vol#: 6

C 218 Barbara Byrd Vol#: 6

C 219 Rita Bonasera Vol#: 6

C 220 Mort Cohen Vol#: 6

C 221 Adorers of the Blood of Christ Vol#: 6

C 222 Donald Danforth Plant Science Center Vol#: 6

C 223 Lucinda A. Caldwell Vol#: 6

C 224 Phyllis Pryzby Vol#: 6

C 225 Bob Giambalvo Vol#: 6

C 226 Patricia DeFerrari, PhD Vol#: 6

C 227 Rebecca Kimbell Vol#: 6

C 228 Margaret McBride Vol#: 6

C 229 Joyce Frohn Vol#: 6

C 230 L.D. Pratt Vol#: 6

C 231 Mary Ann S. Clymer Vol#: 6

C 232 Sandra R. Shmookler Vol#: 6

C 233 Charles & Lindsey Shere Vol#: 6

C 234 Lora Chamberlain Vol#: 6

C 235 Dave Rich Vol#: 6

C 236 Nancy W. Lienke Vol#: 6

C 237 Ben R. Gilbert Vol#: 6

C 238 Ann Amyes Vol#: 6

C 239 Gerald Geci Vol#: 6

C 240 Dini Schut Vol#: 6

C 241 Annapoorne Colangelo Vol#: 6

02D-0389 Nonclinical Studies for Development of Pharmaceutical Excipi

C 6 IPEC-Americas Vol#: 1

02N-0417 Applications for FDA Approval to Market a New Drug

C 30 National Assn of Chain Drug Stores Vol#: 4

C 31 State of New York Dept of Health Vol#: 4

C 32 Consumers Union (CU) Vol#: 4

02N-0518 International Conference on Harmonisation Meetings in Japan

NM 1 Meeting on 1/21/03 Vol#: 1

03P-0006 Determine if Levorphanol Tartrate withdrawn for safety reaso

ACK 1 HFA-305 to Lachman Consultant Services Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1

03V-0005 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Baton Rouge Communications Vol#: 1