Dockets Entered on July 20, 2006


Dockets Management
	Dockets Entered On July 20, 2006 Table of Contents



	Docket #	Title

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

	1998C-0431	Synthetic Iron Oxide

	1999F-4372	National Fisheries Institute and the Louisiana Dep of Agricu

	2001P-0345	Listing the color additive yellow #5 for use in food/Drug

	2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

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

	2005P-0456	Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons

	2006D-0108	Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs

	2006D-0246	Manufactured Food Regulatory Program Standards

	2006N-0107	FDA-Regulated Products Containing Nanotechnology Materials

	2006N-0247	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet

	2006P-0049	reduce the public health risks associated with the use of drugs manufactured or processed at foreign facilities

	2006P-0123	Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products

	2006P-0124	Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules

	2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

	2006P-0173	Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product

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

	LET 17981	Weleda Inc	Vol #:	165

	LET 17982	Swanson Health Products	Vol #:	165

	LET 17983	Source Naturals	Vol #:	165

	LET 17984	Perrigo Company of South Carolina	Vol #:	165

	LET 17985	Perrigo Company of South Carolina	Vol #:	165

	LET 17986	Perrigo Company of South Carolina	Vol #:	165

	LET 17987	Perrigo Company of South Carolina	Vol #:	165

	LET 17988	Natura Therapeutics Inc	Vol #:	165

	LET 17989	New Century Company	Vol #:	165

	LET 17990	Metagenics	Vol #:	165

	1998C-0431	Synthetic Iron Oxide

	NFR 2	FDA	Vol #:	1

	1999F-4372	National Fisheries Institute and the Louisiana Dep of Agricu

	EMC 476	Form Letter	Vol #:	14

	EMC 477	R. Grover	Vol #:	15

	EMC 478	M. Buckner	Vol #:	15

	EMC 479	Y. Waters	Vol #:	15



EMC 480	A. Hunter	Vol #:	15

EMC 481	M. Bushnell	Vol #:	15

EMC 482	E. Bryant	Vol #:	15

EMC 483	M. Kleeman	Vol #:	15

EMC 484	D. Raunio	Vol #:	15

EMC 485	S. Shamblin	Vol #:	15

EMC 486	S. Daniels	Vol #:	15

EMC 487	H. Kopp	Vol #:	15

EMC 488	M. Potts	Vol #:	15

EMC 489	B. Foose	Vol #:	15

EMC 490	L. Sparrowhawk	Vol #:	15

EMC 491	M. Buckner	Vol #:	15

EMC 492	A. Harlib	Vol #:	15

EMC 493	K. Greenawalt	Vol #:	15

2001P-0345	Listing the color additive yellow #5 for use in food/Drug

EC 1	Ms. Sara Chaudry	Vol #:	3

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

EMC 1324	J. Ricks	Vol #:	12

EMC 1325	C. Williamson	Vol #:	12

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

C 16036	P. Stober	Vol #:	177

C 16037	S. Zoemler	Vol #:	177

C 16038	M. Wallace	Vol #:	177

C 16039	R. Cromer	Vol #:	177

C 16040	M. Barlow	Vol #:	177

C 16041	E. Brennen	Vol #:	177

C 16042	D. Schultz	Vol #:	177

C 16043	R. Finnegan	Vol #:	177

C 16044	D. Burke	Vol #:	177

C 16045	S. Curry	Vol #:	177

C 16046	K. Wiktorski	Vol #:	177

C 16047	J. Lyon	Vol #:	177

C 16048	C. Slura	Vol #:	177

C 16049	T. Bunnell	Vol #:	177

C 16050	R. Sund	Vol #:	177



C 16051	St. John Hospital & Medical Center	Vol #:	177

C 16052	B. Biernat	Vol #:	177

C 16053	C. Pollack	Vol #:	177

C 16054	I. Caruso	Vol #:	177

C 16055	M. Cooper	Vol #:	177

C 16056	S. Sharpe	Vol #:	177

C 16057	P. Mittman	Vol #:	177

C 16058	L. Charles	Vol #:	177

C 16059	C. Christuccht	Vol #:	177

C 16060	P. Scott	Vol #:	177

C 16061	K. Dela	Vol #:	177

C 16062	C. Ahmed	Vol #:	177

C 16063	A. Ortiz	Vol #:	177

C 16064	E. Brown	Vol #:	177

C 16065	B. Samson	Vol #:	177

C 16066	M. Akins	Vol #:	177

C 16067	R. Gallagher	Vol #:	177

C 16068	M. Fiedler	Vol #:	177

C 16069	J. Griffiths	Vol #:	177

C 16070	J. Christiansen	Vol #:	177

C 16071	M. Lamb-Torres	Vol #:	177

C 16072	K. Herzog	Vol #:	177

C 16073	S. Talbott	Vol #:	177

C 16074	A. Scarpelit	Vol #:	177

C 16075	V. Scruggs	Vol #:	177

C 16076	M. Kiss	Vol #:	177

C 16077	L. Weber	Vol #:	177

C 16078	E. Lyons	Vol #:	177

C 16079	E. Bradley	Vol #:	177

C 16080	B. Camp	Vol #:	177

C 16081	P. Wilcox	Vol #:	177

C 16082	S. Fister	Vol #:	177

C 16083	R. Schroeder	Vol #:	177

C 16084	G. Brown	Vol #:	177

C 16085	C. Beattie	Vol #:	177

C 16086	J. Caryl	Vol #:	177

C 16087	L. Gannon	Vol #:	177



C 16088	S. Van Mierio	Vol #:	177

C 16089	D. Matheur	Vol #:	177

C 16090	B. Sykes	Vol #:	177

C 16091	J. Poor	Vol #:	177

C 16092	W. Priebe	Vol #:	177

C 16093	D. Menache	Vol #:	178

C 16094	D. Carrigan	Vol #:	178

C 16095	P. Lawson	Vol #:	178

C 16096	K. Vogel	Vol #:	178

C 16097	L. Boggs	Vol #:	178

C 16098	N. Melville	Vol #:	178

C 16099	J. Griffin	Vol #:	178

C 16100	G. Cannon	Vol #:	178

C 16101	G. Priebe	Vol #:	178

C 16102	C. Perfetti	Vol #:	178

C 16103	V. Senade	Vol #:	178

C 16104	L. Bronder	Vol #:	178

C 16105	V. Witt	Vol #:	178

C 16106	A. McDowell	Vol #:	178

C 16107	M. Bernett	Vol #:	178

C 16108	J. Jackson	Vol #:	178

C 16109	A. Caruso	Vol #:	178

C 16110	J. Alexander	Vol #:	178

C 16111	J. Cannon	Vol #:	178

C 16112	J. Ramsey	Vol #:	178

C 16113	S. Fenning	Vol #:	178

C 16114	L. Felske	Vol #:	178

C 16115	M. Rabin	Vol #:	178

C 16116	D. Hollensteiner	Vol #:	178

C 16117	T. Fey	Vol #:	178

C 16118	D. Fitzwilliam	Vol #:	178

C 16119	A. Scott	Vol #:	178

C 16120	S. Zanotti	Vol #:	178

C 16121	M. Roaque	Vol #:	178

C 16122	N. Hand	Vol #:	178

C 16123	M. Stegall	Vol #:	178

C 16124	N. Carducci	Vol #:	178



C 16125	R. Bailey	Vol #:	178

C 16126	S. Carrow	Vol #:	178

C 16127	D. Hawdusheit	Vol #:	178

C 16128	B. Seibels	Vol #:	178

C 16129	L. Charland	Vol #:	178

C 16130	J. Lynch	Vol #:	178

C 16131	M. Ellis	Vol #:	178

C 16132	N. Foley	Vol #:	178

C 16133	S. Matthews	Vol #:	178

C 16134	V. Jackson	Vol #:	178

C 16135	F. Marshall	Vol #:	178

C 16136	C. Stellas	Vol #:	178

C 16137	M. Nettle	Vol #:	178

C 16138	Somerset Gynecology & Obstetrics	Vol #:	178

C 16139	D. Ferrara	Vol #:	178

C 16140	L. Lowenstein	Vol #:	178

C 16141	M. Bilardi	Vol #:	178

C 16142	J. Tucker	Vol #:	178

C 16143	S. McCormick	Vol #:	178

C 16144	G. Bohn	Vol #:	178

C 16145	K. Vu	Vol #:	178

C 16146	R. Bulletset	Vol #:	178

C 16147	D. Fetrow	Vol #:	178

C 16148	J. Wall	Vol #:	178

C 16149	S. Garcia	Vol #:	178

C 16150	S. Kanter	Vol #:	178

C 16151	R. Murphy	Vol #:	178

C 16152	H. Westhook	Vol #:	179

C 16153	P. Wiegman	Vol #:	179

C 16154	A. Rock	Vol #:	178

C 16155	K. Kapitke	Vol #:	179

C 16156	J. Theoharris	Vol #:	179

C 16157	D. Theoharris	Vol #:	179

C 16158	R. Walkotten	Vol #:	179

C 16159	L. Harris	Vol #:	179

C 16160	C. Richards	Vol #:	179

C 16161	M. Henderson	Vol #:	179



C 16162	P. Caripides	Vol #:	179

C 16163	K. Colwell	Vol #:	179

C 16164	M. Sanburn	Vol #:	179

C 16165	M. Sutton	Vol #:	179

C 16166	R. Hamilton	Vol #:	179

C 16167	M. Pierro	Vol #:	179

C 16168	C. Layman	Vol #:	179

C 16169	N. Chess	Vol #:	179

C 16170	G. Schiff	Vol #:	179

C 16171	P. Dugan	Vol #:	179

C 16172	J. Peterson	Vol #:	179

C 16173	S. Eddy	Vol #:	179

C 16174	J. Davis	Vol #:	179

C 16175	K. Humphrey	Vol #:	179

C 16176	C. Holliday	Vol #:	179

C 16177	J. Guy	Vol #:	179

C 16178	B. & T. Bokmann	Vol #:	179

C 16179	M. Kanitsch	Vol #:	179

C 16180	M. Williams	Vol #:	179

C 16181	C. Mutter	Vol #:	179

C 16182	M. Kelly	Vol #:	179

C 16183	J. Redstone	Vol #:	179

C 16184	A. Muki	Vol #:	179

C 16185	P. Wallou	Vol #:	179

C 16186	S. Urban	Vol #:	179

C 16187	E. Shonkwiler	Vol #:	179

C 16188	M. Shonkwiler	Vol #:	179

C 16189	L. Collins	Vol #:	179

C 16190	C. Henry	Vol #:	179

C 16191	V. Elliott	Vol #:	179

C 16192	A. Wyman	Vol #:	179

C 16193	T. Richter	Vol #:	179

C 16194	L. Buffa	Vol #:	179

C 16195	L. Prusal	Vol #:	179

C 16196	J. Taylor	Vol #:	179

C 16197	R. Williams	Vol #:	179

C 16198	L. Dennison-Bules	Vol #:	179



C 16199	C. Smith	Vol #:	179

C 16200	T. Mendozo	Vol #:	179

C 16201	C. Arnold	Vol #:	179

C 16202	L. Smith	Vol #:	179

C 16203	D. Flores	Vol #:	179

C 16204	F. Flores	Vol #:	179

C 16205	M. Guerrero	Vol #:	179

C 16206	R. Juarez	Vol #:	179

C 16207	S. Juarez	Vol #:	179

C 16208	G. Zotara	Vol #:	179

C 16209	C. Seth	Vol #:	179

C 16210	D. Peterson	Vol #:	179

C 16211	W. Crow	Vol #:	179

C 16212	C. Crow	Vol #:	179

C 16213	V. Humphreys	Vol #:	179

C 16214	T. Mickiewicz	Vol #:	179

C 16215	J. Lindsey	Vol #:	179

C 16216	S. Coffman	Vol #:	179

C 16217	A. Stankiewicz	Vol #:	179

C 16218	F. Williams	Vol #:	179

C 16219	D. McCloskey	Vol #:	179

C 16220	S. Davis	Vol #:	180

C 16221	K. Crager	Vol #:	180

C 16222	V. Henry	Vol #:	180

C 16223	S. Littleton	Vol #:	180

C 16224	R. Lichter	Vol #:	180

C 16225	T. Ziegler	Vol #:	180

C 16226	J. Krilowicz	Vol #:	180

C 16227	J. Robertson	Vol #:	180

C 16228	S. Bumbalo	Vol #:	180

C 16229	K. Rayburn	Vol #:	180

C 16230	A. Veit	Vol #:	180

C 16231	L. Hartford	Vol #:	180

C 16232	J. Beirce	Vol #:	180

C 16233	F. Parma	Vol #:	180

C 16234	S. Zehnder	Vol #:	180

C 16235	T. Barker	Vol #:	180



C 16236	S. Bolton	Vol #:	180

C 16237	P. Anderson	Vol #:	180

C 16238	B. Peck	Vol #:	180

C 16239	T. Wiederkehr	Vol #:	180

C 16240	H. Scopelliti	Vol #:	180

C 16241	J. VanderHenst	Vol #:	180

C 16242	S. Dance	Vol #:	180

C 16243	P. Player	Vol #:	180

C 16244	P. Stotz	Vol #:	180

C 16245	F. Delaney	Vol #:	180

C 16246	E. Ingram	Vol #:	180

C 16247	J. Beavers	Vol #:	180

C 16248	A. Grimmer	Vol #:	180

C 16249	D. Hemmer	Vol #:	180

C 16250	R. Lively	Vol #:	180

C 16251	J. Lauer	Vol #:	180

C 16252	P. Marlow-Utley	Vol #:	180

C 16253	K. Stumpff	Vol #:	180

C 16254	E. Blinker	Vol #:	180

C 16255	D. Nelson	Vol #:	180

C 16256	D. Cullen	Vol #:	180

C 16257	J. Greene	Vol #:	180

C 16258	T. White	Vol #:	180

C 16259	L. Martin	Vol #:	180

C 16260	J. Schweers	Vol #:	180

C 16261	D. Fitch	Vol #:	180

C 16262	P. Dygert	Vol #:	180

C 16263	B. Peckham	Vol #:	180

C 16264	C. Wick	Vol #:	180

C 16265	L. Kavulich	Vol #:	180

C 16266	M. Swartzburg	Vol #:	180

C 16267	D. Beardsley	Vol #:	180

C 16268	D. White	Vol #:	180

C 16269	W. Sniffen	Vol #:	180

C 16270	L. Cali	Vol #:	180

C 16271	L. Hanson	Vol #:	180

C 16272	K. Faccinto	Vol #:	180



C 16273	K. Mohr	Vol #:	180

C 16274	C. Rey	Vol #:	180

C 16275	R. Rey	Vol #:	180

C 16276	L. Powell	Vol #:	180

C 16277	C. Allen	Vol #:	180

C 16278	A. Molina	Vol #:	180

C 16279	M. Blaschke	Vol #:	180

C 16280	S. Harbin	Vol #:	180

C 16281	S. Rholen	Vol #:	180

C 16282	M. Wagner	Vol #:	180

C 16283	C. Vera	Vol #:	180

C 16284	B. Snyder	Vol #:	180

C 16285	G. Casey	Vol #:	180

C 16286	S. Melendez	Vol #:	180

C 16287	T. Bolinger	Vol #:	180

C 16288	M. Smith	Vol #:	180

C 16289	J. Clubb	Vol #:	180

C 16290	F. Miller	Vol #:	180

C 16291	J. Miller	Vol #:	180

C 16292	A. Mitchell	Vol #:	180

C 16293	S. Brown	Vol #:	180

C 16294	P. Lublin	Vol #:	180

C 16295	S. Dugan	Vol #:	180

C 16296	E. Bostick	Vol #:	180

C 16297	K. Hurt	Vol #:	180

C 16298	L. Hanson	Vol #:	180

C 16299	J. Fischer	Vol #:	180

C 16300	B. Herrick-Brown	Vol #:	181

C 16301	M. Garrett	Vol #:	181

C 16302	T. Mayer	Vol #:	181

C 16303	M. Mortier	Vol #:	181

C 16304	D. Parrish	Vol #:	181

C 16305	J. Sherman	Vol #:	181

C 16306	P. Rixon	Vol #:	181

C 16307	C. Anglin	Vol #:	181

C 16308	P. Gates	Vol #:	181

C 16309	J. Richard	Vol #:	181



C 16310	J. Lodge	Vol #:	181

C 16311	S. Nevin	Vol #:	181

C 16312	M. Stucky	Vol #:	181

C 16313	S. Keehig	Vol #:	181

C 16314	J. Calhoun	Vol #:	181

C 16315	C. Wright	Vol #:	181

C 16316	K. Carter	Vol #:	181

C 16317	B. Bichsel	Vol #:	181

C 16318	M. Lubt	Vol #:	181

C 16319	L. D'Errico	Vol #:	181

C 16320	K. Wilson	Vol #:	181

C 16321	S. Byrne	Vol #:	181

C 16322	F. Reasoner	Vol #:	181

C 16323	J. Taber	Vol #:	181

C 16324	D. Trent	Vol #:	181

C 16325	G. Swanson	Vol #:	181

C 16326	C. Dunn	Vol #:	181

C 16327	P. Sorensen	Vol #:	181

C 16328	D. Dimont	Vol #:	181

C 16329	M. Espinoza	Vol #:	181

C 16330	S. Smith	Vol #:	181

C 16331	P. Jones	Vol #:	181

C 16332	B. Kettle	Vol #:	181

C 16333	D. Lewis	Vol #:	181

C 16334	D. Delgato	Vol #:	181

C 16335	D. Delgato	Vol #:	181

C 16336	L. Gogl	Vol #:	181

C 16337	D. Knoff	Vol #:	181

C 16338	B. Riemer	Vol #:	181

C 16339	V. Tracy	Vol #:	181

C 16340	S. Kouba	Vol #:	181

C 16341	L. Lovering	Vol #:	181

C 16342	L. Lovering	Vol #:	181

C 16343	C. Thiffant	Vol #:	181

C 16344	M. Dreyer	Vol #:	181

C 16345	A. Page	Vol #:	181

C 16346	E. Stapleton	Vol #:	181



C 16347	J. Sender	Vol #:	181

C 16348	S. Smith	Vol #:	181

C 16349	M. Wolfram	Vol #:	181

C 16350	M. Mobly	Vol #:	181

C 16351	P. Rushlow	Vol #:	181

C 16352	S. Brown	Vol #:	181

C 16353	C. Lippert	Vol #:	181

C 16354	E. Gross	Vol #:	181

C 16355	E. Gross	Vol #:	181

C 16356	S. Vought	Vol #:	181

C 16357	J. Rose	Vol #:	181

C 16358	H. Miskech	Vol #:	181

C 16359	J. Forzano	Vol #:	181

C 16360	A. Caldwell	Vol #:	181

C 16361	C. Skinner	Vol #:	181

C 16362	D. Coy	Vol #:	181

C 16363	K. Hasson	Vol #:	181

C 16364	H. Carter	Vol #:	181

C 16365	B. Watson	Vol #:	181

C 16366	A. Caldwell	Vol #:	181

C 16367	P. Miller	Vol #:	181

C 16368	M. Presteen	Vol #:	181

C 16369	A. Van Horn	Vol #:	181

C 16370	S. Schliesmann	Vol #:	181

C 16371	V. Appel	Vol #:	181

C 16372	P. Childers	Vol #:	181

C 16373	D. Childers	Vol #:	181

C 16374	L. Farrell	Vol #:	181

C 16375	S. Hamai	Vol #:	182

C 16376	E. Iwanaga	Vol #:	182

C 16377	P. Holm	Vol #:	182

C 16378	J. Murphy	Vol #:	182

C 16379	J. Greene	Vol #:	182

C 16380	P. Malott	Vol #:	182

C 16381	S. Wirtz	Vol #:	182

C 16382	E. Campbell	Vol #:	182

C 16383	C. Mitchell	Vol #:	182



C 16384	S. Guest	Vol #:	182

C 16385	C. Murray	Vol #:	182

C 16386	G. Kavanaugh	Vol #:	182

C 16387	B. Halminak	Vol #:	182

C 16388	G. Siber	Vol #:	182

C 16389	J. Nelson	Vol #:	182

C 16390	E. Stapleton	Vol #:	182

C 16391	M. Fisch	Vol #:	182

C 16392	C. Fonda	Vol #:	182

C 16393	M. Clark	Vol #:	182

C 16394	V. Janssen	Vol #:	182

C 16395	A. Avery	Vol #:	182

C 16396	C. Siracuse	Vol #:	182

C 16397	J. Klein	Vol #:	182

C 16398	B. Gaspar	Vol #:	182

C 16399	S. Whittle	Vol #:	182

C 16400	J. Urquiza	Vol #:	182

C 16401	V. Sheridan	Vol #:	182

C 16402	T. Marschall	Vol #:	182

C 16403	M. Nielsen	Vol #:	182

C 16404	K. Mixon	Vol #:	182

C 16405	M. Bluhm	Vol #:	182

C 16406	D. Green	Vol #:	182

C 16407	L. Smothermon	Vol #:	182

C 16408	S. Cahill	Vol #:	182

C 16409	F. Shirasago-Cahill	Vol #:	182

C 16410	E. Deruig	Vol #:	182

C 16411	N. Aultman	Vol #:	182

C 16412	C. Cantrell	Vol #:	182

C 16413	N. Morton	Vol #:	182

C 16414	L. Smith	Vol #:	182

C 16415	S. Shackelford	Vol #:	182

C 16416	W. Lunsford	Vol #:	182

C 16417	L. Irby	Vol #:	182

C 16418	D. Moseley	Vol #:	182

C 16419	R. Lucich	Vol #:	182

C 16420	Illegible	Vol #:	182



C 16421	A. Fishback	Vol #:	182

C 16422	D. Fischle	Vol #:	182

C 16423	P. Feldkamp	Vol #:	182

C 16424	S. Dewberry	Vol #:	182

C 16425	L. Jennings	Vol #:	182

C 16426	J. Collison	Vol #:	182

C 16427	S. Mings	Vol #:	182

C 16428	D. Pfleger	Vol #:	182

C 16429	B. Thomas	Vol #:	182

C 16430	R. Scantlebury	Vol #:	182

C 16431	V. Scantlebury	Vol #:	182

C 16432	C. Brokaw	Vol #:	182

C 16433	G. Sommerfeld	Vol #:	182

C 16434	M. Anderson	Vol #:	182

C 16435	B. Thornton	Vol #:	182

C 16436	S. Alcott	Vol #:	182

C 16437	C. Dixon	Vol #:	182

C 16438	D. Garrett	Vol #:	182

C 16439	L. Kuizatda	Vol #:	182

C 16440	L. Slater	Vol #:	182

C 16441	E. Dewdney	Vol #:	182

C 16442	T. Woods	Vol #:	182

C 16443	J. Gerbers	Vol #:	182

C 16444	R. Vacchio	Vol #:	182

C 16445	V. Matteson	Vol #:	182

C 16446	V. Matteson	Vol #:	182

C 16447	R. Vacchio	Vol #:	182

C 16448	C. Dumine	Vol #:	182

C 16449	A. Milan	Vol #:	182

C 16450	P. Miller	Vol #:	182

C 16451	S. Carroll	Vol #:	182

C 16452	K. Migliore	Vol #:	182

C 16453	M. Davis	Vol #:	182

C 16454	C. de Rodriguez	Vol #:	182

C 16455	G. Galloway	Vol #:	182

C 16456	K. Cinelli	Vol #:	182

C 16457	B. Powers	Vol #:	182



C 16458	J. S.	Vol #:	182

C 16459	C. Hasty	Vol #:	182

C 16460	M. Leavenworth	Vol #:	182

C 16461	K. Rolfe	Vol #:	182

C 16462	E. Fider	Vol #:	182

C 16463	J. Hurley	Vol #:	182

C 16464	M. Rose	Vol #:	182

EMC 3286	D. Hopkins	Vol #:	176

EMC 3287	C. Buziak	Vol #:	176

EMC 3288	S. Kruse	Vol #:	176

EMC 3289	D. Small	Vol #:	176

EMC 3290	B. Keate	Vol #:	176

EMC 3291	C. McCabe	Vol #:	176

EMC 3292	P. Stone	Vol #:	176

EMC 3293	E. Collins	Vol #:	176

EMC 3294	M. Gau	Vol #:	176

EMC 3295	P. Blake	Vol #:	176

EMC 3296	E. Stilwell	Vol #:	176

EMC 3297	Dr. R. Feintech	Vol #:	176

EMC 3298	T. Botwinik	Vol #:	176

EMC 3299	K. Howard	Vol #:	176

EMC 3300	K. Howard	Vol #:	176

EMC 3301	S. Kelly	Vol #:	176

EMC 3302	C. Ticknor	Vol #:	176

EMC 3303	S. Hackworth	Vol #:	176

EMC 3304	D. White, ARNP, CH, BS	Vol #:	176

EMC 3305	E. Cranos	Vol #:	176

EMC 3306	V. Stahler	Vol #:	176

EMC 3307	E. Cranos	Vol #:	176

EMC 3308	A. Smith	Vol #:	176

EMC 3309	A. Smith	Vol #:	176

EMC 3310	S. Jones	Vol #:	176

EMC 3311	F. McNeil	Vol #:	176

EMC 3312	C. Huston	Vol #:	176

EMC 3313	D. Tseng	Vol #:	176

EMC 3314	L. Cocanig	Vol #:	176

EMC 3315	M. Gerdes	Vol #:	176



EMC 3316	M. Malone	Vol #:	176

EMC 3317	C. Macdonald	Vol #:	176

EMC 3318	E. Treneer	Vol #:	176

EMC 3319	N. Slowinski	Vol #:	176

EMC 3320	J. Hutson	Vol #:	176

EMC 3321	R. Way	Vol #:	176

2005P-0456	Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons

C 7	Wyeth Pharmaceuticals	Vol #:	2

2006D-0108	Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs

EC 1	PPTA	Vol #:	1

EMC 1	Plasma Protein Therapeutics Association (PPTA)	Vol #:	1

2006D-0246	Manufactured Food Regulatory Program Standards

GDL 1	Guidance	Vol #:	1

NAD 1	FDA	Vol #:	1

2006N-0107	FDA-Regulated Products Containing Nanotechnology Materials

EC 7	Project on Emerging Nanotechnologies/Wilson Center	Vol #:	2

2006N-0247	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet

C 1	AMEDICA	Vol #:	1

2006P-0049	reduce the public health risks associated with the use of drugs manufactured or processed at foreign facilities

LET 1	FDA/CDER to Synthetic Organic Chemical Manufacturers Association's	Vol #:	1

2006P-0123	Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products

C 4	PriCara, Unit of Ortho-McNeil	Vol #:	1

2006P-0124	Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules

C 2	Memorial Hospital of Rhode Island	Vol #:	1

2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

EC 630	Ms. Nicole Chantee	Vol #:	3

EC 631	Ms. Electra Kaczorowski	Vol #:	3

EC 632	Women's Bioethics Project	Vol #:	3

2006P-0173	Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product


SUP 2	Wyeth Pharmaceuticals	Vol #:	1

Page created on October 6, 2006 kk

FDA/Dockets Management