Dockets Entered on February 6, 2004

Dockets Management



Dockets Entered On February 6, 2004



Docket #	Title

1977N-0094	OTC Internal Analgesic, Antipyretic & Antirheumatic Products

1995N-0304	Ephedrine Alkaloids: Reports of Adverse Events; Availability

2000N-1531	Proposal to Debar Bruce I Diamond PhD, Opportunity for Heari

2000P-1211	Establish Mandatory Pre-Market Safety Testing for GE Foods

2003D-0386	Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP

2003D-0497	Guidance for Industry on Pharmacogenomic Data Submissions

2003P-0366	Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)

2003P-0519	ANDA Suitability for Ondansetron Hydrochloride Injection and Ondansetron Hydrochloride Injection Premixed

2003P-0544	Modify existing food additive regulation with respect to the irradiation of ground beef byproducts

2004D-0042	Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products

2004N-0033	Factor VIII Inhibitors

2004P-0006	Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release

2004P-0055	Issue a written opinion stating that Bio-Rad's longstanding practice, previously accepted by the agency, of developing unified, truthful labeling for domestic and international sales of its control pr

2004P-0056	ANDA for Ondansetron Orally Disintegrating Tablets

1977N-0094	OTC Internal Analgesic, Antipyretic & Antirheumatic Products
LET 147	Bayer HealthCare (Bayer)	Vol #:	235

1995N-0304	Ephedrine Alkaloids: Reports of Adverse Events; Availability

BKG 4 Reference 1-161 2nd Reference List Reference 1-203	Backgroun Material for NFR 1	Vol #:	378

NFR 1	FDA	Vol #:	376

2000N-1449	Changes to an Approved NDA or ANDA; Agency Information Collection

EC 2	Davis, Kelly	Vol #:	1

2000N-1531	Proposal to Debar Bruce I Diamond PhD, Opportunity for Heari

EXT 2	Bruce Diamond, PhD	Vol #:	1

2000P-1211	Establish Mandatory Pre-Market Safety Testing for GE Foods

EMC 5762	Le-Ann Di Nardo	Vol #:	789

EMC 5763	John Mayo	Vol #:	789

EMC 5764	Elena Arvelo	Vol #:	789

EMC 5765	Scott Hopkins	Vol #:	789

EMC 5766	Kathy Henley	Vol #:	789

EMC 5767	John Mayo	Vol #:	789

EMC 5768	John Mayo	Vol #:	789

2001D-0224	Mass Spectrometry for Confirmation of Identity of Animal Drug Residues



EC 4	Milk, Caw	Vol #:	1

2002D-0124	Notifying FDA of Fatalities Related to Blood & Transfusion

EC 1	gunter, carmen	Vol #:	1

2002D-0371	Human Dura Mater; Class II Special Controls Guidance

EC 2	rogers, jerry	Vol #:	1

2003D-0092	Food and Cosmetic Security Guidances

EC 9	Mitchell, Marvin	Vol #:	1

EC 11	Clarfeld, Alex	Vol #:	1

EC 13	HUMAN, BERT	Vol #:	1

EC 14	scruggs, carol	Vol #:	1

2003D-0290	Compounding of Drugs for Use in Animals Compliance Policy Guide

EC 13	Bolton RPh., Christine	Vol #:	1

2003D-0386	Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP

C 3	Pharmaceutical Research and Manufacturers of America (PhRMA)	Vol #:	1

2003D-0465	Guidance for Industry on Providing Regulatory Submissions in Electronic Format b

EC 2	Foit, Darcy	Vol #:	1

2003D-0478	Guidance on Marketed Unapproved Drugs Compliance Policy Guide

EC 16	McCoy, Margaret	Vol #:	5

EC 17	Knapp, Kathleen	Vol #:	5

EC 18	Wisch, Ardythe	Vol #:	5

EC 19	Judge, Teri	Vol #:	5

EC 20	Burgan, Dale	Vol #:	5

EC 21	Maugh, Jo	Vol #:	5

EC 22	Donaldson, Karen	Vol #:	5

2003D-0497	Guidance for Industry on Pharmacogenomic Data Submissions

C 10	Bayer HealthCare (Bayer)	Vol #:	1

C 11	Aventis Pharmaceuticals, Inc. (Aventis)	Vol #:	1

C 12	Millennium Pharmaceuticals, Inc. (Millennium)	Vol #:	1

C 13	Quintiles Transnational Corp.	Vol #:	1

C 14	Pfizer, Inc.	Vol #:	1

C 15	Abbott Laboratories	Vol #:	1

C 16	Hoffmann-LaRoche, Inc.	Vol #:	1



C 17	Pharmaceutical research and Manufacturers of America (PhRMA)	Vol #:	1

C 18	Wyeth Pharmaceuticals (Wyeth)	Vol #:	1

C 19	GlaxoSmithKline (GSK)	Vol #:	1

C 20	Global Genomics AB	Vol #:	1

2003F-0535	Chlorine Dioxide (FAP 4A4751)

EC 1	Wencl, Ollie	Vol #:	1

2003N-0400	Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals

EC 145	Lantz, Kurt	Vol #:	10

EC 146	Belval, Nicole	Vol #:	10

EC 147	Hackemer, Mary Anne	Vol #:	10

EC 148	Lincoln, Terry	Vol #:	10

EC 149	Korsmo, Jill	Vol #:	10

EC 150	Carden, Danny	Vol #:	10

EC 151	cattellion, carine	Vol #:	10

EC 152	Weber, Dennis	Vol #:	10

EC 153	Jakopak, James	Vol #:	10

EC 154	Gompf, Sandra	Vol #:	10

EC 155	DeVillers, Roberta	Vol #:	10

EC 156	Fried, Danielle	Vol #:	10

EC 157	Glasser, william	Vol #:	10

EC 158	Matuszewski, Christy	Vol #:	10

EC 159	Strommen, Ed	Vol #:	10

EC 160	Shanahan, Kari	Vol #:	10

EC 161	Nishiyama, Marie	Vol #:	10

EC 162	Pastore, Marge	Vol #:	10

EC 163	Walker, Ken	Vol #:	10

EC 164	eastham, harry	Vol #:	10

EC 165	Watson, Ed	Vol #:	10

EC 166	Geislinger, Eric	Vol #:	10

EC 167	Holt, Errol	Vol #:	10

EC 168	burcaw, lindsay	Vol #:	10

EC 169	Flint, Eric	Vol #:	10

EC 170	Claypool, Tristan	Vol #:	10

EC 171	Doerfler, Debra	Vol #:	10

EC 172	Deremer, Nicole	Vol #:	10



EC 173	Rudd, Yvette	Vol #:	10

EC 174	Boivin, William	Vol #:	10

EC 175	Wardwell, Amber	Vol #:	10

EC 176	Salmonson, Jessica	Vol #:	10

EC 177	Desio, Kimberly	Vol #:	10

EC 178	JUng, Adam	Vol #:	10

EC 179	MILLET, Aude	Vol #:	10

EC 180	wood, alan	Vol #:	10

EC 181	Piersa, Kristen	Vol #:	10

EC 182	Davis, Chuck	Vol #:	10

EC 183	Taylor, Julianna	Vol #:	10

EC 184	Walker, Ken	Vol #:	10

EC 185	Merchant, Christine	Vol #:	10

EC 186	Davidson, Sandra	Vol #:	10

EC 187	Richards, Susan	Vol #:	10

EC 188	Stiebel, Danielle	Vol #:	10

EC 189	Strange, Marie	Vol #:	10

EC 190	Strange, Samantha	Vol #:	10

EC 191	Strange, Greg	Vol #:	10

EC 192	O`Neall, Gregory	Vol #:	10

EC 193	Steinman, Francis	Vol #:	10

EC 194	Conger, Jaimie	Vol #:	10

EC 195	cattellion, carine	Vol #:	10

EC 196	lewis, terri	Vol #:	10

EC 197	Maffucci, Allison	Vol #:	10

EC 198	Kohut, Matthew	Vol #:	10

EC 199	Baker, Shari	Vol #:	10

EC 200	Khalsa, Dharam Damama	Vol #:	10

EC 201	Berk, Marilyn	Vol #:	10

EC 202	Higgins, Jess	Vol #:	10

EC 203	Galle, Victoria	Vol #:	10

EC 204	Campbell, Leah	Vol #:	10

EC 205	Derwin, Danielle	Vol #:	10

EC 206	Killmer, Jennifer	Vol #:	10

EC 207	Paulson, Andrew	Vol #:	10

EC 208	Maynor, Teresa	Vol #:	10

EC 209	Harless, Travis	Vol #:	10



EC 210	Schaunaman, Lori	Vol #:	10

EC 211	TRIX, DIANE	Vol #:	10

EC 212	Johnson, Chris	Vol #:	10

EC 213	Douglas, Duff	Vol #:	10

EC 214	Cerqua, Natalie	Vol #:	10

EC 215	Winters, Bonnie	Vol #:	10

EC 216	Gorsuch, Tricia	Vol #:	10

EC 217	Houston, Ranae	Vol #:	10

EC 218	Newson, Roger	Vol #:	10

EC 219	Shenkle, karen	Vol #:	10

EC 220	Jackson, Linda	Vol #:	10

EC 221	Troxell, Tina	Vol #:	10

EC 222	Bard, Becky	Vol #:	10

EC 223	O'Neill, Tom	Vol #:	10

EC 224	Stoffel, Tim	Vol #:	10

EC 225	Haskett, Debbie	Vol #:	10

EC 226	Sellers, K	Vol #:	10

EC 227	Prezio, Laura	Vol #:	10

EC 228	Ivester, Suzanne	Vol #:	10

EC 229	Hintz, Ann	Vol #:	10

EC 230	McCarty, Greg	Vol #:	10

EC 231	cattellion, carine	Vol #:	10

EC 232	Brennan, Patricia	Vol #:	10

EC 233	Haddock, Joann	Vol #:	10

EC 234	Gaskins, D.	Vol #:	10

EC 235	McClanahan, Christina	Vol #:	10

EC 236	Peters, Candace	Vol #:	10

EC 237	White, Kim	Vol #:	10

EC 238	Peters, Stephen	Vol #:	10

EC 239	Brough, Clarice	Vol #:	10

EC 240	Seaberg, Gena	Vol #:	10

EC 241	Seaberg, Gena	Vol #:	10

EC 242	Seaberg, Gena	Vol #:	10

EC 243	Seaberg, Gena	Vol #:	10

EC 244	Shaw, Jasen	Vol #:	10

EC 245	Pariser, Aaron	Vol #:	10

EC 246	Watts, Andrew	Vol #:	10



EC 247	Romano, Anthony	Vol #:	10

EC 248	Verplank, Jenifer	Vol #:	10

EC 249	Pfab, Shelley	Vol #:	10

EC 250	Litt, Aaron	Vol #:	10

EC 251	Stanton, Sue	Vol #:	10

EC 252	Jung, Holly	Vol #:	10

EC 253	Jackson, James	Vol #:	10

EC 254	Gorman, Sarah	Vol #:	10

EC 255	Kulp-Shorten, Carol	Vol #:	10

EC 256	Zolitor, Lynn	Vol #:	10

EC 257	Golden, Nancy	Vol #:	10

EC 258	Bryant, Jessica	Vol #:	10

EC 259	Raim, Michael	Vol #:	10

EC 260	Hromanik, Dawn	Vol #:	10

EC 261	James, Jesse	Vol #:	10

EC 262	Boroff, Tina	Vol #:	10

EC 263	Maxwell, Herald	Vol #:	10

EC 264	Willems, Vicky	Vol #:	10

EC 265	Harless, Anita	Vol #:	10

EC 266	Hertz, Ira	Vol #:	10

EC 267	Abell, Charles	Vol #:	10

EC 268	MARTIN, Cheyenne	Vol #:	10

EC 269	Haskett, Debbie	Vol #:	10

EC 270	Gleisser, Linda	Vol #:	10

EC 271	Graves, Pat	Vol #:	10

EC 272	Jung, Adam	Vol #:	10

EC 273	Harrison, Dennis	Vol #:	10

EC 274	Maynard, Arlene	Vol #:	10

EC 275	Hawkins, Brenda	Vol #:	10

EC 276	davis, nancy	Vol #:	10

EC 277	Metzel, Ashley	Vol #:	10

EC 278	Wynn, Julianna	Vol #:	10

EC 279	Maffucci, Alllison	Vol #:	10

EC 280	McDonald, Maureen	Vol #:	10

EC 281	Maffucci, Jeannine	Vol #:	10

EC 282	Presser, Bonnie	Vol #:	10

EC 283	Haskett, Haven	Vol #:	10



EC 284	Walker, deborah	Vol #:	10

EC 285	DeMarco, Andrea	Vol #:	10

EC 286	Hulsey, Carrie	Vol #:	10

EC 287	Van Beemen, Annie	Vol #:	10

EC 288	Horne, Janel	Vol #:	10

EC 289	Schmitt, Janet	Vol #:	10

EC 290	Henderson, Patricia	Vol #:	10

EC 291	SHELTON, PENNIE	Vol #:	10

EC 292	Peterson, David	Vol #:	10

EC 293	Demel, Hanna	Vol #:	10

EC 294	Harrison, Lynn	Vol #:	10

EC 295	bently, becca	Vol #:	10

EC 296	Kosolosky, Nancy	Vol #:	10

EC 297	Blair, Rhonda	Vol #:	10

EC 298	STIDOM, SUZETTE	Vol #:	10

EC 299	Perkins, Cheryl	Vol #:	10

EC 300	Howell, Amanda	Vol #:	10

EC 301	Lind, Charlotte	Vol #:	10

EC 302	Letton, Lucy	Vol #:	10

EC 303	Forbes, Michaele	Vol #:	10

EC 304	Pelt, Woody	Vol #:	10

EC 305	Winfield, Crystalynn	Vol #:	10

EC 306	Knight, Ronnie	Vol #:	10

EC 307	Vasquez, Dnaleri	Vol #:	10

EC 308	Winfield-Vasquez, Khayman	Vol #:	10

EC 309	Lenz, Donna	Vol #:	10

EC 310	Anonymous, Anonymous	Vol #:	10

EC 311	Gotting, Rebecca	Vol #:	10

EC 312	Weisenberg, Tiffany	Vol #:	10

EC 313	Nelson, Teela	Vol #:	10

EC 314	Martin, Jeannette	Vol #:	10

EC 315	Gladden, Scott	Vol #:	10

EC 316	Gilligan, Gretchen	Vol #:	10

EC 317	Ohnmacht, Kristin	Vol #:	10

EC 318	rusick, amy	Vol #:	10

EC 319	Prichard, Pam	Vol #:	10

EC 320	Savage, Linda	Vol #:	10



EC 321	Johnson, Robert	Vol #:	10

EC 322	Finocchiaro, Mary Beth	Vol #:	10

EC 323	Hoffmann, Robert	Vol #:	10

EC 324	Butler, Cindy	Vol #:	10

EC 325	Cox, Deborah	Vol #:	10

EC 326	Knapp, Shelly	Vol #:	10

EC 327	Boudreaux, Yvonne	Vol #:	10

EC 328	Jung, Adam	Vol #:	10

EC 329	Taylor, David	Vol #:	10

EC 330	Derwin, Merriam	Vol #:	10

EC 331	Scardina , Jenniffer	Vol #:	10

EC 332	Rebrovich, Joann	Vol #:	10

EC 333	Stringfellow, Jennifer	Vol #:	10

EC 334	Lester, Kendra	Vol #:	10

EC 335	cattellion, carine	Vol #:	10

EC 336	Close, Char.	Vol #:	10

EC 337	Knapp, Scott	Vol #:	10

EC 338	Burgoyne, S	Vol #:	10

EC 339	Reid, Catherine	Vol #:	10

EC 340	STYGA, DAWN	Vol #:	10

EC 341	Watson, Billie	Vol #:	10

EC 342	Anderson, Ashley	Vol #:	10

EC 343	King, Julie	Vol #:	10

EC 344	Pot, Fien	Vol #:	10

EC 345	walton, kay	Vol #:	10

EC 346	Feyen, Kristien	Vol #:	10

EC 347	McKee Sr., Mark	Vol #:	10

EC 348	Smith, Jane	Vol #:	10

EC 349	Grace, John	Vol #:	10

EC 350	teabo, coleen	Vol #:	10

EC 351	Wills, Sandra	Vol #:	10

EC 352	Stringfellow, Michael	Vol #:	10

EC 353	Olufsen, Helene	Vol #:	10

EC 354	burke, john	Vol #:	10

EC 355	Milliken IV, Charles F	Vol #:	10

EC 356	Sanders, Lisa	Vol #:	10

EC 357	Minor, Richard	Vol #:	10



EC 358	cattellion, carine	Vol #:	10

EC 359	Liddick, Matthew	Vol #:	10

EC 360	Hanson, Tonya	Vol #:	10

EC 361	Hansen, Carl	Vol #:	10

EC 362	Goodenough, Shelly	Vol #:	10

EC 363	kbjghggg, Merenbhvcjhblknhckbh	Vol #:	10

EC 364	turnbull, tony	Vol #:	10

EC 365	Casner, Alex	Vol #:	10

EC 366	McCormick, Linda	Vol #:	10

EC 367	DuBuque, Anna	Vol #:	10

EC 368	Davidson, Ana	Vol #:	10

EC 369	Paulus, Kathy	Vol #:	10

EC 370	Baptista, Diane	Vol #:	10

EC 371	Parmely, Kevin	Vol #:	10

EC 372	Cattellion, Carine	Vol #:	10

EC 373	Guysi, George S.	Vol #:	10

EC 374	rusick, amy	Vol #:	10

EC 375	Westphal, Richard	Vol #:	10

EC 376	Poznich, Tom	Vol #:	10

EC 377	Lucchetti, Lynn	Vol #:	10

EC 378	MOORE, RAHONDA	Vol #:	10

EC 379	Turnbull, Carol	Vol #:	10

EC 380	Biggs, Cindy	Vol #:	10

EC 381	James, Dani Lee	Vol #:	10

EC 382	Watson, Lynda	Vol #:	10

EC 383	James, Dianne A.	Vol #:	10

EC 384	Deck, Becky	Vol #:	10

EC 385	peterpaul, maya	Vol #:	10

EC 386	Derwin, Danielle	Vol #:	10

EC 387	Lind, Charlotte	Vol #:	10

EC 388	cattellion, carine	Vol #:	10

EC 389	Jung, Adam	Vol #:	10

EC 390	rusick, amy	Vol #:	10

EC 391	Haskett, Deborah	Vol #:	10

EC 392	Lamb, Susan	Vol #:	10

EC 393	Haskett, Haven	Vol #:	10

EC 394	Sarver-Brown, Sally	Vol #:	10



EC 395	Kronk, Stacey	Vol #:	10

EC 396	cattellion, carine	Vol #:	10

EC 397	Brown, John	Vol #:	10

EC 398	Brown, Sally	Vol #:	10

EC 399	Boroff, Tina	Vol #:	10

EC 400	Maffucci, Allison	Vol #:	10

EC 401	Behnke, Steven	Vol #:	10

EC 402	Verplank, Jenifer	Vol #:	10

EC 403	Loetscher, Sara	Vol #:	10

EC 404	Unan, Mel	Vol #:	10

EC 405	Baney, MJ	Vol #:	10

EC 406	Lind, Charlotte	Vol #:	10

EC 407	Rebrovich, Daryl	Vol #:	10

EC 408	Bard, Becky	Vol #:	10

EC 409	Breakey, Mary Beth	Vol #:	10

EC 410	Enderle, Judith	Vol #:	10

EC 411	Arcilise, Nick	Vol #:	10

EC 412	Piatanesi, Lisa	Vol #:	10

EC 413	Schreurs, Jeroen	Vol #:	10

EC 414	Pixley, Amy	Vol #:	10

EC 415	Crimbring, Sara	Vol #:	10

EC 416	johnson, chris	Vol #:	10

EC 417	Flores, Cynthia	Vol #:	10

EC 418	Jacobs, Robert	Vol #:	10

EC 419	SCHERER, steven	Vol #:	10

EC 420	Moore, Kerri	Vol #:	10

EC 421	Conner, Sheila C.	Vol #:	10

EC 422	Campbell, Jennifer L.A	Vol #:	10

EC 423	Ellington, Penni G.	Vol #:	10

EC 424	Payton, Robert	Vol #:	10

EC 425	cattellion, carine	Vol #:	10

EC 426	Howard, Sheri	Vol #:	10

EC 427	Schnell, Tracy	Vol #:	10

EC 428	Campbell, Jay	Vol #:	10

EC 429	Steskal, Ricky	Vol #:	10

EC 430	Edlin, Linnea	Vol #:	10

EC 431	Guerrero, Lori	Vol #:	10



EC 432	Blanco, Katherine	Vol #:	10

EC 433	Schnell, Tracy	Vol #:	10

EC 434	Korsmo, Jill	Vol #:	10

EC 435	Olufsen, Helene	Vol #:	10

EC 437	Carpenter, Marre	Vol #:	10

EC 438	MILLER, Aude K.	Vol #:	10

EC 439	briggs'bradley, janet	Vol #:	10

EC 440	Schnell, Tracy	Vol #:	10

EC 441	Prichard, Pam	Vol #:	10

2003P-0366	Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)

SUP 3	Mylan Phamaceuticals, Inc. (Mylan)	Vol #:	1

2003P-0519	ANDA Suitability for Ondansetron Hydrochloride Injection and Ondansetron Hydrochloride Injection Premixed

AMD 1	Abbott Laboratories	Vol #:	1

C 1	Hyman, Phelps & McNamara, PC	Vol #:	1

2003P-0544	Modify existing food additive regulation with respect to the irradiation of ground beef byproducts

C 4	B. Kaufmann	Vol #:	1

C 5	M. Argast	Vol #:	1

C 6	J. Head	Vol #:	1

C 7	S. Berryman	Vol #:	1

C 8	A. Yuenger	Vol #:	1

C 9	D. Liewellyn	Vol #:	1

C 10	J. LaForge	Vol #:	1

C 11	M. Berrigan	Vol #:	1

C 12	G. Larkin	Vol #:	1

C 13	M. Bauman	Vol #:	1

C 14	Form Letters	Vol #:	2

C 15	Form Letters	Vol #:	3

2004D-0042	Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products

C 1	R. Beltramini	Vol #:	1

2004N-0033	Factor VIII Inhibitors

TR 1	Workshop on Factor VIII Inhibitors held on 11/21/2003	Vol #:	3

TS 1	HFM-300	Vol #:	1

TS 2	HFM-340	Vol #:	1

TS 3	J. Remy,MD,PhD	Vol #:	1



TS 4	S. Raut	Vol #:	1

TS 5	B. Verbruggen	Vol #:	1

TS 6	G. White, MD	Vol #:	1

TS 7	Assn of Hemophilia Clinic Directors of Canada (AHCDC)	Vol #:	1

TS 8	National Center on Birth Defects and Development Disabilities	Vol #:	1

TS 9	Paul Ehrlich Institute	Vol #:	1

TS 10	HFM-392	Vol #:	2

TS 11	HFM-217	Vol #:	2

TS 12	L. Aledort, MD	Vol #:	2

TS 13	B. Ewenstein,MD,PhD	Vol #:	2

TS 14	Bayer HealthCare	Vol #:	2

TS 15	Octagen Corporation	Vol #:	2

TS 16	Wyeth	Vol #:	2

TS 17	D. DiMichele, MD	Vol #:	2

2004P-0006	Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release

C 2	Teva Pharmaceuticals USA, Inc. (Teva)	Vol #:	2

2004P-0055	Issue a written opinion stating that Bio-Rad's longstanding practice, previously accepted by the agency, of developing unified, truthful labeling for domestic and international sales of its control pr


ACK 1	HFA-305 to Bio-Rad Laboratories	Vol #:	1

CP 1 Tab 1, 2, 3	Bio-Rad Laboratories	Vol #:	1

2004P-0056	ANDA for Ondansetron Orally Disintegrating Tablets

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

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

Page created on February 9, 2004 kk Page updated on February 26, 2004 jb

FDA/Dockets Management