Dockets Entered on February 21, 2007

Dockets Management



Dockets Entered On February 21, 2007



Docket #	Title

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

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

2005N-0394	FDAs Communication of Drug Safety Information; Public Hearing

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

2007M-0058	P050007/S001 - StarClose Vascular Closure System, Model 1004, Version 2.10

2007N-0005	Prescription Drug User Fee Act (PDUFA): Public Meeting

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

LET 18731	Perrigo Company of South Carolina	Vol #:	169

LET 18732	Perrigo Company of South Carolina	Vol #:	169

LET 18733	Perrigo Company of South Carolina	Vol #:	169

LET 18734	Perrigo Company of South Carolina	Vol #:	169

LET 18735	Perrigo Company of South Carolina	Vol #:	169

LET 18736	NBTY Inc.	Vol #:	169

LET 18737	NBTY Inc.	Vol #:	169

LET 18738	NBTY Inc.	Vol #:	169

LET 18739	NBTY Inc.	Vol #:	169

LET 18740	NBTY Inc.	Vol #:	169

LET 18741	NBTY Inc.	Vol #:	169

LET 18742	NBTY Inc.	Vol #:	169

LET 18743	Perrigo Company of South Carolina	Vol #:	169

LET 18744	Perrigo Company of South Carolina	Vol #:	169

LET 18745	Arthur Andrew Medicals, Inc.	Vol #:	170

LET 18746	Traditional Medicinals, Inc.	Vol #:	170

LET 18747	Traditional Medicinals, Inc.	Vol #:	170

LET 18748	PuraPharm Corporation	Vol #:	170

LET 18749	PuraPharm Corporation	Vol #:	170

LET 18750	PuraPharm Corporation	Vol #:	170

LET 18751	PuraPharm Corporation	Vol #:	170

LET 18752	PuraPharm Corporation	Vol #:	170

LET 18753	PuraPharm Corporation	Vol #:	170

LET 18754	PuraPharm Corporation	Vol #:	170

LET 18755	PuraPharm Corporation	Vol #:	170

LET 18756	PuraPharm Corporation	Vol #:	170

LET 18757	PuraPharm Corporation	Vol #:	170

LET 18758	PuraPharm Corporation	Vol #:	170



LET 18759	PuraPharm Corporation	Vol #:	170

LET 18760	PuraPharm Corporation	Vol #:	170

LET 18761	PuraPharm Corporation	Vol #:	170

LET 18762	PuraPharm Corporation	Vol #:	170

LET 18763	PuraPharm Corporation	Vol #:	170

LET 18764	PuraPharm Corporation	Vol #:	170

LET 18765	PuraPharm Corporation	Vol #:	170

LET 18766	PuraPharm Corporation	Vol #:	170

LET 18767	PuraPharm Corporation	Vol #:	170

LET 18768	PuraPharm Corporation	Vol #:	170

LET 18769	PuraPharm Corporation	Vol #:	170

LET 18770	PuraPharm Corporation	Vol #:	170

LET 18771	PuraPharm Corporation	Vol #:	170

LET 18772	PuraPharm Corporation	Vol #:	170

LET 18773	PuraPharm Corporation	Vol #:	170

LET 18774	PuraPharm Corporation	Vol #:	170

LET 18775	PuraPharm Corporation	Vol #:	170

LET 18776	PuraPharm Corporation	Vol #:	170

LET 18777	PuraPharm Corporation	Vol #:	170

LET 18778	PuraPharm Corporation	Vol #:	170

LET 18779	PuraPharm Corporation	Vol #:	170

LET 18780	PuraPharm Corporation	Vol #:	170

LET 18781	PuraPharm Corporation	Vol #:	170

LET 18782	PuraPharm Corporation	Vol #:	170

LET 18783	PuraPharm Corporation	Vol #:	170

LET 18784	PuraPharm Corporation	Vol #:	170

LET 18785	PuraPharm Corporation	Vol #:	170

LET 18786	PuraPharm Corporation	Vol #:	170

LET 18787	PuraPharm Corporation	Vol #:	170

LET 18788	PuraPharm Corporation	Vol #:	170

LET 18789	PuraPharm Corporation	Vol #:	170

LET 18790	PuraPharm Corporation	Vol #:	170

LET 18791	PuraPharm Corporation	Vol #:	170

LET 18792	PuraPharm Corporation	Vol #:	170

LET 18793	PuraPharm Corporation	Vol #:	170

LET 18794	PuraPharm Corporation	Vol #:	170

LET 18795	PuraPharm Corporation	Vol #:	170



LET 18796	PuraPharm Corporation	Vol #:	170

LET 18797	PuraPharm Corporation	Vol #:	170

LET 18798	PuraPharm Corporation	Vol #:	170

LET 18799	PuraPharm Corporation	Vol #:	170

LET 18800	PuraPharm Corporation	Vol #:	170

LET 18801	PuraPharm Corporation	Vol #:	170

LET 18802	PuraPharm Corporation	Vol #:	170

LET 18803	PuraPharm Corporation	Vol #:	170

LET 18804	PuraPharm Corporation	Vol #:	170

LET 18805	PuraPharm Corporation	Vol #:	170

LET 18806	PuraPharm Corporation	Vol #:	170

LET 18807	PuraPharm Corporation	Vol #:	170

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

BKG 2	Background Information	Vol #:	15

NEC 1	FDA	Vol #:	15

2005N-0394	FDAs Communication of Drug Safety Information; Public Hearing

C 322	C. Grubb	Vol #:	8

C 323	K. Ailor	Vol #:	8

C 324	S. Sobel	Vol #:	8

C 325	L. Tosti	Vol #:	8

C 326	L. Knight	Vol #:	8

C 327	J. Appelbaum	Vol #:	8

C 328	C. Urban	Vol #:	8

C 329	M. Sullivan	Vol #:	8

C 330	S. Abernethy	Vol #:	8

C 331	R. Jacobson	Vol #:	8

C 332	J. Bennett	Vol #:	8

C 333	M. Finelli	Vol #:	8

C 334	D. Brown	Vol #:	8

C 335	J. Hancley	Vol #:	8

C 336	J. Janicke	Vol #:	8

C 337	M. Mock	Vol #:	8

C 338	H. Bruce	Vol #:	8

C 339	J. Back	Vol #:	8

C 340	J. Gilchrist	Vol #:	8



C 341	B. Gaab	Vol #:	8

C 342	A. Noland	Vol #:	8

C 343	J. King	Vol #:	8

C 344	N. Markham	Vol #:	8

C 345	A. Vicker	Vol #:	8

C 346	R. Lutz	Vol #:	8

C 347	A. Neville	Vol #:	8

C 348	B. Schueller	Vol #:	8

C 349	D. Keep	Vol #:	8

C 350	C. Boyer	Vol #:	8

C 351	A. Nicol	Vol #:	8

C 352	V. Schetler	Vol #:	8

C 353	M. Ashe	Vol #:	8

C 354	P. Greenwald	Vol #:	8

C 355	S. Bradfield	Vol #:	8

C 356	R. Powers	Vol #:	8

C 357	L. Thacker	Vol #:	8

C 358	M. Hedrick	Vol #:	8

C 359	G. & H Horejsi	Vol #:	8

C 360	A. & J. Brooks	Vol #:	8

C 361	G. Marsh	Vol #:	8

C 362	L. Hopkins	Vol #:	8

C 363	E. Herro	Vol #:	8

C 364	S. Bouvier	Vol #:	8

C 365	C. Perry	Vol #:	8

C 366	R. Nathan	Vol #:	8

C 367	C. Maloney	Vol #:	8

C 368	J. Hayes	Vol #:	8

C 369	S. Bouvier	Vol #:	8

C 370	J. Alexander	Vol #:	8

C 371	S. S. Cronan	Vol #:	8

C 372	V. James	Vol #:	8

C 373	N. Schoenfeld	Vol #:	8

C 374	L. Blakesley	Vol #:	8

C 375	J. Cahn	Vol #:	8

C 376	D. Selewach	Vol #:	8

C 377	K. Merola	Vol #:	8



C 378	S. Touillon	Vol #:	8

C 379	I. Welch	Vol #:	8

C 380	S. Henderson	Vol #:	8

C 381	S. Fioravante	Vol #:	8

C 382	B. Murr	Vol #:	8

C 383	L. Heloskie	Vol #:	8

C 384	A. Lange	Vol #:	8

C 385	M. Lewis	Vol #:	8

C 386	T. Jarvis	Vol #:	8

C 387	C. Welker	Vol #:	8

C 388	S. Conover	Vol #:	8

C 389	L. May	Vol #:	8

C 390	M. & G. Denton	Vol #:	8

C 391	A. LeBlanc	Vol #:	8

C 392	P. Filipski	Vol #:	8

C 393	A. Rinaldi	Vol #:	8

C 394	no signature	Vol #:	8

C 395	J. Grauer	Vol #:	8

C 396	J. Grauer	Vol #:	8

C 397	N. Dumas	Vol #:	8

C 398	C. Stras	Vol #:	8

C 399	D. Pixley	Vol #:	8

C 400	C. Cooper	Vol #:	8

C 401	M. Sovo	Vol #:	9

C 402	W. Packwood	Vol #:	9

C 403	D. Messinger	Vol #:	9

C 404	R. Amendola	Vol #:	9

C 405	T. Grassi	Vol #:	9

C 406	no signature	Vol #:	9

C 407	L. Ashlee	Vol #:	9

C 408	C. Suartpneldi	Vol #:	9

C 409	S. Montel	Vol #:	9

C 410	C. Logan	Vol #:	9

C 411	R. Iannacone	Vol #:	9

C 412	B. Nixon	Vol #:	9

C 413	E. Lombardo	Vol #:	9

C 414	R. Bateman	Vol #:	9



C 415	A. Kepich	Vol #:	9

C 416	K. Ballard	Vol #:	9

C 417	S. Cheney	Vol #:	9

C 418	J. Westervelt	Vol #:	9

C 419	J. Leclerc	Vol #:	9

C 420	no signature	Vol #:	9

C 421	F. Bahrami	Vol #:	9

C 422	J. Boldizar	Vol #:	9

C 423	S.Cava	Vol #:	9

C 424	L. Sharinay	Vol #:	9

C 425	J. Jackson	Vol #:	9

C 426	R. Schelling	Vol #:	9

C 427	C. Canella	Vol #:	9

C 428	D. Lisi	Vol #:	9

C 429	G. Naccarato	Vol #:	9

C 430	R. Mirvis	Vol #:	9

C 431	A. Chavez	Vol #:	9

C 432	D. Wurst	Vol #:	9

C 433	C. Holt	Vol #:	9

C 434	M. Stavish	Vol #:	9

C 435	J. Crouch	Vol #:	9

C 436	A. Nebel	Vol #:	9

C 437	L. Wallace	Vol #:	9

C 438	no signature	Vol #:	9

C 439	no signature	Vol #:	9

C 440	E. Mesick	Vol #:	9

C 441	J. Warriner	Vol #:	9

C 442	C. Haessiq	Vol #:	9

C 443	S. Hall	Vol #:	9

C 444	I. Putz	Vol #:	9

C 445	R. Odrobina	Vol #:	9

C 446	G. Priesler	Vol #:	9

C 447	R. Gilman	Vol #:	9

C 448	T. Seastrom	Vol #:	9

C 449	H. Fraser	Vol #:	9

C 450	J. Lacasse	Vol #:	9

C 451	J. MacMillan	Vol #:	9



C 452	S. Crocker	Vol #:	9

C 453	G. Scott	Vol #:	9

C 454	J. Menefee	Vol #:	9

C 455	D. Preller	Vol #:	9

C 456	J. Mardirosian	Vol #:	9

C 457	A. Barbier	Vol #:	9

C 458	L. Graham	Vol #:	9

C 459	B. Bledsoe	Vol #:	9

C 460	R. Carrothers	Vol #:	9

C 461	B. Oaubius	Vol #:	9

C 462	J. & P Schonig	Vol #:	9

C 463	J. Carver	Vol #:	9

C 464	L. White	Vol #:	9

C 465	P. Church	Vol #:	9

C 466	B. Raglan	Vol #:	9

C 467	J. Priest	Vol #:	9

C 468	E. Egbert	Vol #:	9

C 469	C. Stubbs	Vol #:	9

C 470	no signature	Vol #:	9

C 471	S. Lagow	Vol #:	9

C 472	L. Hoto	Vol #:	9

C 473	J. Ikola	Vol #:	9

C 474	V. Snyder	Vol #:	9

C 475	S. Burghause	Vol #:	9

C 476	M. Griffith	Vol #:	9

C 477	B. Bonsigmore	Vol #:	9

C 478	E. Anderson	Vol #:	9

C 479	E. Goehringer	Vol #:	9

C 480	P. Green	Vol #:	9

C 481	A. A. Friends	Vol #:	9

C 482	K. Baytos	Vol #:	9

C 483	N. Curias	Vol #:	9

C 484	M. Dinallo	Vol #:	9

C 485	M. Doty	Vol #:	9

C 486	J. Cunning	Vol #:	9

C 487	H. Campenella	Vol #:	9

C 488	B. Bouder	Vol #:	9



C 489	R. Blake	Vol #:	9

C 490	E. Mulbry	Vol #:	9

C 491	S. V	Vol #:	9

C 492	R. Hoover	Vol #:	9

C 493	K. Merloa	Vol #:	9

C 494	S. Cronan	Vol #:	9

C 495	J. Figurski	Vol #:	9

C 496	I. Rebelle	Vol #:	9

C 497	C. Lawless	Vol #:	9

C 498	L. Nicola	Vol #:	9

C 499	L. Greenleaf	Vol #:	9

C 500	P. Shaw	Vol #:	9

C 501	J. Colasuono	Vol #:	9

C 502	F. Evans	Vol #:	9

C 503	S. Snyder	Vol #:	9

C 504	S. Hall	Vol #:	9

C 505	A. Dotson	Vol #:	9

C 506	C. Sutton	Vol #:	9

C 507	T. Odum	Vol #:	9

C 508	C. Dziewior	Vol #:	9

C 509	D. Bump	Vol #:	9

C 510	D. Funk	Vol #:	9

C 511	L. McLaughlin	Vol #:	9

C 512	R. Stein	Vol #:	9

C 513	D. Brown	Vol #:	9

C 514	S. Astin	Vol #:	9

C 515	L. Setaro	Vol #:	9

C 516	E. Humenik	Vol #:	9

C 517	H. McVay	Vol #:	9

C 518	R. Sudol	Vol #:	9

C 519	C. Lindeke	Vol #:	9

C 520	M. Anderson	Vol #:	9

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

C 18258	K. Pautler	Vol #:	198

2007M-0058	P050007/S001 - StarClose Vascular Closure System, Model 1004, Version 2.10



AAV 1	Abbott Vascular Devices	Vol #:	1

2007N-0005	Prescription Drug User Fee Act (PDUFA): Public Meeting

TS 1	Prescription Drug User Fee Act (PDUFA IV)	Vol #:	1

TS 2	FDA - User-Fee Funding of Human Drug Review	Vol #:	1

TS 3	K Witczak	Vol #:	1

TS 4	Consumers Union	Vol #:	1

TS 5	Plasma Protein Therapeutics Association (PPTA)	Vol #:	1

TS 6	U S Chamber of Commerce	Vol #:	1

TS 7	Committee of Ten Thousand	Vol #:	1

TS 8	AHRP	Vol #:	1

TS 9	Coalition for Healthcare Communication	Vol #:	1

TS 10	Biotechnology Industry Organization	Vol #:	1

TS 11	Academy of Managed Care Pharmacy	Vol #:	1

TS 12	Drug Safety Institute	Vol #:	1

TS 13	Biotechnology Industry Organization	Vol #:	1

TS 14	National Research Center for Women & Families	Vol #:	1

TS 15	American Society of Health-Systems Pharmacists	Vol #:	1

TS 16	Mental Health America	Vol #:	1

TS 17	Council on Radionuclides and Radiopharmaceuticals (CORAR)	Vol #:	1

TS 18	W DeCamp	Vol #:	1

Page created on February 21, 2007 ue

FDA/Dockets Management