| 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
Us]
DOCKETS ENTERED on January 24, 2002 TABLE OF CONTENTS Hyper links are part of the Docket title - not all dockets/documents are linked NOTE: Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence. |
|
01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm * 01N-0464 Vaccine Adverse Event Reporting System * 02P-0029 Mylan estradiol transdermal system as generic substitute * |
77N-0058 New Drug Applications; Withdrawal of Approval
CA 33385 W. J. Smith Vol#: 565
77N-0085 Saccharin and Its Salts
CA 33034 Anne S. Rose Vol#: 561
CA 33035 Mrs. H. W. Becker Vol#: 561
CA 33036 Mrs. Donald E. Reser Vol#: 561
CA 33037 Alice W. Salan Vol#: 561
CA 33038 Robert J. & Mildred C. Schroeder Vol#: 561
CA 33039 Doris E. Blair Vol#: 561
CA 33040 Jeanne A. Scott Vol#: 561
CA 33041 Mildred L. & John I. Campbell Vol#: 561
CA 33042 Randall Bovbjerg Vol#: 561
CA 33043 Sue C. Jefferson, R. D. & 122 other sig. Vol#: 561
CA 33044 Mrs. J. Bellgardt Vol#: 561
CA 33045 R. Schech Vol#: 561
CA 33046 Florence P. Maxwell Vol#: 561
CA 33047 Micheal D. Schrader Vol#: 561
CA 33048 Norman W. Paul Vol#: 561
CA 33049 The Rumbol Family Vol#: 561
CA 33050 H. G. & G. L. Rodefeld Vol#: 561
CA 33051 Stanley Grein Vol#: 561
CA 33052 Margo A. Brashears Vol#: 561
CA 33054 Ed Godlewski Vol#: 561
CA 33055 Larry Leikoff Vol#: 561
CA 33056 Chapman V. Hall Vol#: 561
CA 33057 Mason Caward Vol#: 561
CA 33058 Mr. & Mrs. Marvin McDaniel Vol#: 561
CA 33059 Jim Thomas Vol#: 561
CA 33060 Patricia Walker Vol#: 561
CA 33061 Mr. & Mrs. Carl W. Kuether Vol#: 561
CA 33062 Malone Aderholt Vol#: 561
CA 33063 Mrs. Jane Green Vol#: 561
CA 33064 Betsy Ann Stell Vol#: 561
CA 33065 Wendy Cutron Vol#: 561
CA 33066 Eleanor Cooper Vol#: 561
CA 33067 Suzanne Harris & 9 other signatures Vol#: 561
CA 33068 June Soisson Vol#: 561
CA 33070 Carole G. Taylor Vol#: 561
CA 33071 Gloria Cousins Vol#: 561
CA 33072 Spafford Frink Vol#: 561
CA 33073 Frances A. Keating Vol#: 561
CA 33074 Joan Backman Vol#: 561
CA 33075 Brandy Chamberlain Vol#: 561
CA 33076 Jan Barcus Vol#: 561
CA 33077 Tonya Zoldbrod Vol#: 561
CA 33078 Nicholas Scharff Vol#: 561
CA 33079 Jeanine Mecciola Vol#: 561
CA 33081 Cora Johnson & 18 other signatures Vol#: 561
CA 33082 Violet I. & Jack M. Minter Vol#: 561
CA 33083 John Davock Vol#: 561
CA 33084 John Powers Vol#: 561
CA 33085 Mr. & Mrs. Richard Adams & 4 other sig. Vol#: 561
CA 33087 Julie P. Seibert Vol#: 561
CA 33088 Eloise Zikes & 16 other signatures Vol#: 561
CA 33089 Heather Andersen Vol#: 561
CA 33090 Mrs. R. L. Burton Vol#: 561
CA 33091 Jameson W. Gilliam, C. P. A. Vol#: 561
CA 33092 R. E. Harter Vol#: 561
CA 33093 Helen Connolly Vol#: 561
CA 33094 Mrs. James Leier Vol#: 561
CA 33095 Arlene Cramer Vol#: 561
CA 33096 Mrs. John Weinert Vol#: 561
CA 33097 Mr. & Mrs. George Wray & Family Vol#: 561
CA 33098 Marsha O. Goodman Vol#: 561
CA 33099 Judi Powell Vol#: 562
CA 33100 Patricia Foxx Vol#: 562
CA 33101 John G. B. Howland Vol#: 562
CA 33102 Mrs. Jean Biller Vol#: 562
CA 33103 Mrs. C. Merkley Vol#: 562
CA 33104 Mrs. Jerry D. Channer Vol#: 562
CA 33105 L. M. Filley Vol#: 562
CA 33106 Mrs. Arthur L. Dunsmore Vol#: 562
CA 33107 Rita Smith Vol#: 562
CA 33108 Mr. & Mrs. Clifford C. Martin Vol#: 562
CA 33109 Kenneth Timms Vol#: 562
CA 33110 Margaret Nolan & 3 other signatures Vol#: 562
CA 33111 Barbara LeValley Vol#: 562
CA 33112 No Submitter Vol#: 562
CA 33113 Mary O. Everett & 18 other signatures Vol#: 562
CA 33114 Shirley Alverdes Vol#: 562
CA 33115 Thomas Lindsey Vol#: 562
CA 33116 Carl Meisenheimer Vol#: 562
CA 33117 Cheryl A. Evens Vol#: 562
CA 33118 Janice A. Conklin Vol#: 562
CA 33119 Rosalie Schocke Vol#: 562
CA 33120 Anthony G. Tappin Vol#: 562
CA 33121 Dot Fillmore & 37 other signatures Vol#: 562
CA 33122 Mr. & Mrs. Walter S. Scott Vol#: 562
CA 33123 Grace Paschka Vol#: 562
CA 33124 Dorothy R. Wolicki Vol#: 562
CA 33125 Hilana Soza Vol#: 562
CA 33126 Mr. & Mrs. T. Whorley Vol#: 562
CA 33127 Carol F. Witty Vol#: 562
CA 33128 Ugo F. Ippolito Vol#: 562
CA 33129 Janice Simpkin Vol#: 562
CA 33130 Deane W. Rockwell Vol#: 562
CA 33131 Joyce M. Connolly & 12 other signatures Vol#: 562
CA 33132 Buel & Sharon Trapnell Vol#: 562
CA 33133 The Blatt Family Vol#: 562
CA 33134 Mrs. Joseph V. Corker Vol#: 562
CA 33135 Jan Dean Bernard Vol#: 562
CA 33136 Mr. & Mrs. James Messmer Vol#: 562
CA 33137 Mrs. James Hall Vol#: 562
CA 33138 A. B. Clubs Vol#: 562
CA 33139 Mrs. N. R. Cote Vol#: 562
CA 33140 Mrs. Elsie R. Maresca Vol#: 562
CA 33141 Mrs. Naomi Herring Vol#: 562
CA 33142 Mrs. Dale C. Cooper Vol#: 562
CA 33143 (Mr. & Mrs.) Clarence Baker Vol#: 562
CA 33144 Mary Schleini Vol#: 562
CA 33145 Marian Rose Vol#: 562
CA 33146 Kathleen A. Barry Vol#: 562
CA 33147 Judi Leventhal Vol#: 562
CA 33148 J. C. Dickinson Vol#: 562
CA 33149 Florence McConnell & 42 other signatures Vol#: 562
CA 33150 Gerald Burlock Vol#: 562
CA 33151 Mrs. Angela Lehman Vol#: 562
CA 33152 Alan Moore Vol#: 562
CA 33153 Colleen Quinn Vol#: 562
CA 33154 Nancy C. & William Candershot Vol#: 562
CA 33155 Bob Kinrruel Vol#: 562
CA 33156 Ralph P. Pass Vol#: 562
CA 33157 Palma Gosciewski Vol#: 562
CA 33158 Sharon K. Gumz Vol#: 562
CA 33159 Leta E. Steele Vol#: 562
CA 33160 Stuart Tyrnauer Vol#: 562
CA 33161 Mrs. Mabel Ehirlein Vol#: 562
CA 33162 Fred Eis Vol#: 562
CA 33163 Mrs. Fred Siebrecht Vol#: 562
CA 33164 Mrs. Catherine L. Richmond Vol#: 562
CA 33165 Mrs. Grover Vol#: 562
CA 33166 Mr. & Mrs. Gerald Demberg Vol#: 562
CA 33167 Lisa Moore, R. N. Vol#: 562
CA 33168 Ann T. Gartner Vol#: 562
CA 33169 Mr. & Mrs. Gordon Lydia Vol#: 562
CA 33170 Rita M. Paisley Vol#: 562
CA 33171 William A. Peter Vol#: 562
CA 33172 Clareen J. Wielgus Vol#: 562
CA 33173 Zeld Baum Vol#: 562
CA 33174 Stephen A. Enkema Vol#: 562
CA 33175 Robert J. Cromwell Vol#: 562
CA 33176 Rosemary Bradley Vol#: 562
CA 33177 Stanley Factor Vol#: 562
CA 33178 Marion Guttentag Vol#: 562
CA 33179 Mrs. Mary Ann LeMaster Vol#: 562
CA 33180 Grace M. Launt Vol#: 562
CA 33181 Mrs. Margaret L. Johnson Vol#: 562
CA 33182 Albert J. Gori Vol#: 562
CA 33183 Mrs. Robert W. Mitchell Vol#: 562
CA 33184 Mrs. Lehman Petree Vol#: 562
CA 33185 Evelyn S. Herrman Vol#: 562
CA 33186 Beth Porter Vol#: 562
CA 33187 Peggy Meiners Vol#: 562
CA 33188 Robert Sparrel Vol#: 562
CA 33189 Sue B. Stewart Vol#: 562
CA 33190 Mrs. Ruth B. Ketterberg Vol#: 562
CA 33191 Quentin F. Scott Vol#: 562
CA 33192 Janna Mori Vol#: 562
CA 33193 Mrs. Bonnie Saunders Vol#: 562
CA 33194 Dona W. Anderson Vol#: 562
CA 33195 Mary Ann Walsh Vol#: 562
CA 33196 Mrs. E. Sheetz Vol#: 562
CA 33197 Ruth M. Hurley Vol#: 562
CA 33198 R. Kennedy Vol#: 562
CA 33199 Goldie Flock Vol#: 563
CA 33200 Mrs. James L. Tune Vol#: 563
CA 33201 Mary Arnold Vol#: 563
CA 33202 Mrs. Robert M. Utay Vol#: 563
CA 33203 Terry D. Tingen Vol#: 563
CA 33204 Mildred J. Kramer Vol#: 563
CA 33205 Phyllis Norris Vol#: 563
CA 33206 Helen Danik Vol#: 563
CA 33207 Mrs. M. Blonkenkein Vol#: 563
CA 33208 Mrs. Glen Odom Vol#: 563
CA 33209 Rodney N. Joiner Vol#: 563
CA 33210 R. E. Bryson Vol#: 563
CA 33211 Lola A. Flowers Vol#: 563
CA 33212 Doris M. O'Connell Vol#: 563
CA 33213 E. E. Klopral Vol#: 563
CA 33214 Phyllis C. Davis Vol#: 563
CA 33215 Mrs. H. Rene Woodward Raymond Vol#: 563
CA 33216 Eileen B. Cunningham Vol#: 563
CA 33217 Addie Dittmar Vol#: 563
CA 33218 Kenneth W. Short Vol#: 563
CA 33219 Mary E. Creighton Vol#: 563
CA 33220 Betty B. McDaniel & 45 other signatures Vol#: 563
CA 33221 Penny Fax Schwartz Vol#: 563
CA 33222 Donna Adams Vol#: 563
CA 33223 Margaret S. Coolidge Vol#: 563
CA 33224 Margie Beach Vol#: 563
CA 33225 Dorothy Jankowski Vol#: 563
CA 33226 Mrs. Mildred Griscom Vol#: 563
CA 33227 William O. Dooms Vol#: 563
CA 33228 Anita Phillips Vol#: 563
CA 33229 Sandee M. Morris Vol#: 563
CA 33230 Mrs. W. H. Walters Vol#: 563
CA 33231 Elizabeth E. & John T. Murphy Vol#: 563
CA 33232 Scott Roser Vol#: 563
CA 33233 William E. & Norma A. Richmond Vol#: 563
CA 33234 Mrs. Don Weems Vol#: 563
CA 33235 Ruth Meyer Vol#: 563
CA 33236 Donald R. Barker Vol#: 563
CA 33237 Elaine Caliguini Vol#: 563
CA 33238 Edwin G. Petri Vol#: 563
CA 33239 Cheryl Schmitt Vol#: 563
CA 33240 Ruth M. Determan Vol#: 563
CA 33241 Aline Brown Vol#: 563
CA 33242 Lawrence & Marie Brushaber Vol#: 563
CA 33243 Frances E. Ryan Vol#: 563
CA 33244 Ginger Tatom Vol#: 563
CA 33245 Frank Cavallaro Vol#: 563
CA 33246 Warren A. & Vivian E. Birge Vol#: 563
CA 33247 Mr. & Mrs. James L. Smith Vol#: 563
CA 33248 Ray & Margaret White Vol#: 563
CA 33249 Charles M. Harnish Vol#: 563
CA 33250 Thomas R. Snead Vol#: 563
CA 33251 Paul D. Leland Vol#: 563
CA 33252 Mr. & Mrs. James J. Walsh Vol#: 563
CA 33253 Marjorie Prochaska Vol#: 563
CA 33254 Annette L. Weaver Vol#: 563
CA 33255 Grace S. Desmond Vol#: 563
CA 33256 Mrs. Susan Moss Vol#: 563
CA 33257 Antonia Marotta & 1,065 other signatures Vol#: 563
CA 33258 Anthony G. Tappin Vol#: 563
CA 33259 Lisa A. Brighton & 145 other signatures Vol#: 563
CA 33260 Mina L. White Vol#: 563
CA 33261 Robert M. Wells, M. D. Vol#: 564
CA 33262 Katie Pretzinger Vol#: 564
CA 33263 Laurel Goodman Vol#: 563
CA 33264 Mrs. R. L. Burton Vol#: 564
CA 33265 Louise G. Collins Vol#: 564
CA 33266 William M. Greenslade Vol#: 564
CA 33267 Christine C. Orlando Vol#: 564
CA 33268 Steven D. Hughes Vol#: 564
CA 33269 Charlene Graeber Vol#: 564
CA 33270 Mrs. Mary Hemphill Vol#: 564
CA 33271 Sue C. Jefferson, R. D. & 95 other sig. Vol#: 564
CA 33272 C. A. Roggensack Vol#: 564
CA 33273 Mrs. H. W. Stark Vol#: 564
CA 33274 Terry Alan Zimmerman Vol#: 564
CA 33275 J. Scott Terrell Vol#: 564
CA 33276 Debbie Ritchie Vol#: 564
CA 33277 David R. Bush Vol#: 564
CA 33278 Jonathan T. Beall Vol#: 564
CA 33279 David C. Lord & 4 other signatures Vol#: 564
CA 33280 Micheal L. McPherson Vol#: 564
CA 33281 Marjorie Love Vol#: 564
CA 33282 Daniel A. Ellison Vol#: 564
CA 33283 Lori Prins Vol#: 564
CA 33284 Debra Knutson Vol#: 564
CA 33285 Donald Kopel Vol#: 564
CA 33286 David L. Swanson Vol#: 564
CA 33287 Jana Doughty Vol#: 564
CA 33288 Paul Wyckoff Vol#: 564
CA 33289 Eleanor Fong Vol#: 564
CA 33290 Mason Caward Vol#: 564
CA 33291 Orville C. Rogers Vol#: 564
CA 33292 John Cassanos Vol#: 564
CA 33293 Grace A. Rogers Vol#: 564
CA 33294 Carrie E. Platt Vol#: 564
CA 33295 D. V. Scanzaroli Vol#: 564
CA 33296 Donald L. Antle Vol#: 564
CA 33297 Mrs. Guy H. (Cindy) Kerr Vol#: 564
CA 33298 Peggy O'Neil Vol#: 564
CA 33299 Mrs. J. Stadelman Vol#: 564
CA 33300 William T. & Norma T. Armstrong Vol#: 564
CA 33301 The Bunten Family Vol#: 564
CA 33302 Alexander T. Hindmarsh, C. L. U. Vol#: 564
CA 33303 Ellen H. Van Osdol Vol#: 564
CA 33304 Kathy Blatter Vol#: 564
CA 33305 Micheal A. Colotti Vol#: 564
CA 33306 Merton J. Rhoda, Jr. Vol#: 564
CA 33307 Beverly B. Wayne & 53 other signatures Vol#: 564
CA 33349 Mrs. Stephen P. Espey Vol#: 565
CA 33350 A. Waggener Vol#: 565
CA 33351 Edna Roe Vol#: 565
CA 33352 Patricia Anne Baker Vol#: 565
CA 33353 Mrs. Shelden H. Reynolds Vol#: 565
CA 33354 Mrs. Kenneth D. Westlund Vol#: 565
CA 33355 Dennis Merlian Vol#: 565
CA 33356 Mrs. E. Hilgendorf & family Vol#: 565
CA 33357 Mr. Philip N. Hutmacher Vol#: 565
CA 33358 Mrs. Dixie Weems Vol#: 565
CA 33359 R. L. Lewis Vol#: 565
CA 33360 William & Ellen Reinke Vol#: 565
CA 33361 Joni Finnell Vol#: 565
CA 33362 Linda Werner Vol#: 565
CA 33363 Vincent V. Thursby Vol#: 565
CA 33364 Rita Eveland Vol#: 565
CA 33365 John R. DuBose Vol#: 565
CA 33366 A. H. Clarke, Jr. Vol#: 565
CA 33367 Laura Stanley Vol#: 565
CA 33368 Ellen Brownstein Vol#: 565
CA 33369 Nancy Manning Ph.D. Vol#: 565
CA 33370 Irvin M. Cederlind, MD Vol#: 565
CA 33371 Anthony F. Mugnolo Vol#: 565
CA 33372 Mr. Paul M. & Mrs. Jane M. Sivert Vol#: 565
CA 33373 Del L. Hyche Vol#: 565
CA 33374 Mrs. Terry L. Whitley Vol#: 565
CA 33375 Mrs. Jo Anne Longtin Vol#: 565
CA 33376 Mrs. Margaret Lundberg Vol#: 565
CA 33377 Robert P. Hermanns Vol#: 565
CA 33378 John A. Cummings Vol#: 565
CA 33379 Mrs. Bernadette Allen Vol#: 565
CA 33380 Barbara J. Garry Vol#: 565
CA 33381 Lee Anderson Vol#: 565
CA 33382 Gary K. Himes Vol#: 565
CA 33383 William H. Jarrett, II MD Vol#: 565
CA 33384 Tela S. Saffren Vol#: 565
CA 33386 Mrs. Anita Fahrenwald Vol#: 565
CA 33387 Harold Eidelamn Vol#: 565
CA 33388 Mr. Vance & Mrs. Georgia Kepley Vol#: 565
CA 33389 Mrs. W. E. Carriker Vol#: 565
CA 33390 Mrs. M. E. Foley Vol#: 565
CA 33391 Shirley J. Reichman Vol#: 565
CA 33392 Creel,Atwood,Spinuzzi & Chapman Vol#: 565
CA 33393 Lester E. Paul, Jr. Vol#: 565
CA 33394 Dawn Korducki Vol#: 565
00D-1538 Electronic Records; Electronic Signatures, Validation
LST 7 General References for Guidance Document Vol#: 6
LST 8 General References for Guidance Document Vol#: 6
MM 21 HFC-240 & Werum Software & System12/6/01 Vol#: 6
MM 22 HFC-240 & Daon Co 12/6/01 Vol#: 6
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec
LST 7 General References for Guidance Document Vol#: 5
LST 8 General References for Guidance Document Vol#: 5
MM 21 HFC-240 & Werum Software & System10/6/01 Vol#: 5
MM 22 HFC-240 & Daon Co 12/6/01 Vol#: 5
00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor
LST 7 General References for Guidance Document Vol#: 5
LST 8 General References for Guidance Document Vol#: 5
MM 21 HFC-240 & Werum Software & System10/6/01 Vol#: 5
MM 22 HFC-240 & Daon Co 12/6/01 Vol#: 5
00D-1541 Electronic Signatures: Audit Trails
LST 7 General References for Guidance Document Vol#: 5
LST 8 General References for Guidance Document Vol#: 5
MM 22 HFC-240 & Werum Software & System10/6/01 Vol#: 5
MM 23 HFC-240 & Daon Co 12/6/01 Vol#: 5
00D-1542 Electronic Signatures: Time Stamps
LST 7 General References for Guidance Document Vol#: 5
LST 8 General References for Guidance Document Vol#: 5
MM 21 HFC-240 & Werum Software & System10/6/01 Vol#: 5
MM 22 HFC-240 & Daon Co 12/6/01 Vol#: 5
00D-1543 Electronic Signatures: Glossary of Terms
LST 7 General References for Guidance Document Vol#: 7
LST 8 General References for Guidance Document Vol#: 7
MM 21 HFC-240 & Werum Software & System10/6/01 Vol#: 7
MM 22 HFC-240 & Daon Co 12/6/01 Vol#: 7
01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm
TR 1 11/27/01 meeting of DMCs Vol#: 2
01N-0464 Vaccine Adverse Event Reporting System
C 6 Department of the Army Vol#: 1
02M-0030 PMA, MammoReader, P010038
AAV 1 Intelligent Systems Software Inc Vol#: 1
02M-0034 PMA Dornier Epos Ultra, P000048
AAV 1 Dornier Medical Systems, Inc. Vol#: 1
02P-0029 Mylan estradiol transdermal system as generic substitute
02V-0040 Laser Light Show
ACK 1 HFA-305 Vol#: 1
VAR 1 Defiant & Film Effects, Inc. Vol#: 1
02V-0041
ACK 1 HFA-305 Vol#: 1
VAR 1 Laser Wizardy East Vol#: 1