Dockets Entered on July 6, 2006


Dockets Management
	Dockets Entered On July 6, 2006 Table of Contents



	Docket #	Title

	2001P-0230	Domestic Marketing & Importation of Transgenic Fish

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

	2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

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

	2006N-0109	General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities

	2006P-0001	Date of Approval for Lunesta (Eszopiclone) Tablets

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

	2006P-0178	Immediately ban fluoroquinolone antibiotic gatifloxacin in humans


	2001P-0230	Domestic Marketing & Importation of Transgenic Fish

	C 1388	M. DiGiovanni	Vol #:	259

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

	C 61	M. DiGiovanni	Vol #:	5

	2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

	CS 13	FDA/DDM	Vol #:	6

	CS 14	FDA/DDM	Vol #:	6

	OR 13	Administrative Law Judge	Vol #:	6

	OR 14	Administrative Law Judge	Vol #:	6

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

	C 14051	M. Warner	Vol #:	160

	C 14052	J. Egasse	Vol #:	160

	C 14053	L. Nino	Vol #:	160

	C 14054	V. Schabloski	Vol #:	160

	C 14055	L. Slutter	Vol #:	160

	C 14056	M. McMinn	Vol #:	160

	C 14057	V. Cope	Vol #:	160

	C 14058	R. Agredano	Vol #:	160

	C 14059	J. Bigelow	Vol #:	160

	C 14060	C. Patterson	Vol #:	160

	C 14061	Dr. R. Tilden	Vol #:	160

	C 14062	S. Yancey	Vol #:	160



C 14063	L. Bevington	Vol #:	160

C 14064	M. Boulware	Vol #:	160

C 14065	S. Jensen	Vol #:	160

C 14066	N. Nutler	Vol #:	160

C 14067	J. McLane	Vol #:	160

C 14068	S. Craig	Vol #:	160

C 14069	J. McDonnell	Vol #:	160

C 14070	Illegible	Vol #:	160

C 14071	C. McDonough	Vol #:	160

C 14072	L. Fuller	Vol #:	160

C 14073	E. Reznak	Vol #:	160

C 14074	J. McLane	Vol #:	160

C 14075	S. McWilliams	Vol #:	160

C 14076	C. Simpson	Vol #:	160

C 14077	L. Ruggero	Vol #:	160

C 14078	D. Sexton	Vol #:	160

C 14079	S. Hillgardner	Vol #:	160

C 14080	F. Dia	Vol #:	160

C 14081	C. HArtzell	Vol #:	160

C 14082	N. Cole	Vol #:	160

C 14083	B. Howser	Vol #:	160

C 14084	D. Peralta	Vol #:	160

C 14085	D. Davis	Vol #:	160

C 14086	S. Paz	Vol #:	160

C 14087	C. Gulbranson	Vol #:	160

C 14088	T. FOx	Vol #:	160

C 14089	E. Craford	Vol #:	160

C 14090	N. Crawford	Vol #:	160

C 14091	O. Rosalez	Vol #:	160

C 14092	G. Elen	Vol #:	160

C 14093	J. Solomon, D.O.	Vol #:	160

C 14094	P. Johnson	Vol #:	160

C 14095	D. Cintron	Vol #:	160

C 14096	T. Funk, RN	Vol #:	160

C 14097	S. Moore	Vol #:	160

C 14098	N. Stott	Vol #:	160

C 14099	E. Strand	Vol #:	160



C 14100	E. Golden	Vol #:	160

C 14101	D. Bennett	Vol #:	160

C 14102	S. Kerp	Vol #:	160

C 14103	B. Mielke	Vol #:	160

C 14104	J. Hesson	Vol #:	160

C 14105	C. Alfaro	Vol #:	160

C 14106	E. Sharphorn	Vol #:	160

C 14107	M. Kennelly	Vol #:	160

C 14108	Illegible	Vol #:	160

C 14109	S. McCloud	Vol #:	160

C 14110	P. Ashburn	Vol #:	160

C 14111	L. Spurgeon	Vol #:	160

C 14112	R. Eiynck	Vol #:	160

C 14113	T. Bayer	Vol #:	160

C 14114	K. Kurtz	Vol #:	160

C 14115	D. Meyer	Vol #:	160

C 14116	C. Ferrigo	Vol #:	160

C 14117	P. Sol	Vol #:	160

C 14118	R. Bleak	Vol #:	160

C 14119	J. Bleak	Vol #:	160

C 14120	I. Scherer	Vol #:	160

C 14121	K. Kollar	Vol #:	160

C 14122	L. Lewis	Vol #:	160

C 14123	J. Nordernberg	Vol #:	160

C 14124	D. Richardson	Vol #:	160

C 14125	P. Richardson	Vol #:	160

C 14126	G. Ossama	Vol #:	160

C 14127	D. Nielson	Vol #:	160

C 14128	P. Stap	Vol #:	160

C 14129	W. Bernard, D.O.	Vol #:	160

C 14130	J. Nelson	Vol #:	160

C 14131	L. Ruggero	Vol #:	160

C 14132	Illegible	Vol #:	160

C 14133	B. Fleck	Vol #:	160

C 14134	M. Moss	Vol #:	160

C 14135	Illegible	Vol #:	160

C 14136	V. Jenseri	Vol #:	160



C 14137	G. Ossama	Vol #:	160

C 14138	D. Nielson	Vol #:	160

C 14139	K. Conrad	Vol #:	160

C 14140	C. Feldman	Vol #:	160

C 14141	Dr. M. Abell	Vol #:	160

C 14142	N. Griffin	Vol #:	160

C 14143	C. Lum	Vol #:	160

C 14144	C. Brusick	Vol #:	160

C 14145	A. Flores	Vol #:	160

C 14146	G. O'Connor	Vol #:	160

C 14147	C. Rackley	Vol #:	160

C 14148	C. Scully	Vol #:	160

C 14149	K. Lester	Vol #:	160

C 14150	M. Janney	Vol #:	160

C 14151	S. Norcini	Vol #:	160

C 14152	J. Heinlein	Vol #:	160

C 14153	M. Collins	Vol #:	160

C 14154	J. Sidoti	Vol #:	160

C 14155	J. Volz	Vol #:	160

C 14156	N. Navarra	Vol #:	160

C 14157	A. Sexton	Vol #:	160

C 14158	L. Reese	Vol #:	160

C 14159	L. Nevins	Vol #:	160

C 14160	J. Strother	Vol #:	160

C 14161	J. Ficker	Vol #:	160

C 14162	M. Cross	Vol #:	160

C 14163	J. Johnson	Vol #:	160

C 14164	V. Rickey	Vol #:	160

C 14165	M. Semper	Vol #:	160

C 14166	B. Pagelen	Vol #:	160

C 14167	S. Fredericks	Vol #:	160

C 14168	B. Boer	Vol #:	160

C 14169	B. Graff	Vol #:	160

C 14170	Z. Loneo	Vol #:	160

C 14171	D. Epsteri	Vol #:	160

C 14172	G. Bennett	Vol #:	160

C 14173	D. Grusaka	Vol #:	160



C 14174	K. Jackson	Vol #:	160

C 14175	M. Hoeschen	Vol #:	160

C 14176	Illegible	Vol #:	160

C 14177	K. Atwood	Vol #:	160

C 14178	V. Roszell	Vol #:	160

C 14179	M. Sengstacke	Vol #:	160

C 14180	Illegible	Vol #:	160

C 14181	Illegible	Vol #:	160

C 14182	E. Gosswiller	Vol #:	160

C 14183	T. Wobbe	Vol #:	160

C 14184	Illegible	Vol #:	160

C 14185	A. Baumer	Vol #:	160

C 14186	M. Fedorchuk	Vol #:	160

C 14187	L. Scheuter	Vol #:	160

C 14188	M. Storvell	Vol #:	160

C 14189	D. Ludewig	Vol #:	160

C 14190	B. Larson	Vol #:	160

C 14191	K. Grosse	Vol #:	160

C 14192	C. McShane	Vol #:	160

C 14193	Illegible	Vol #:	160

C 14194	D. Brewer	Vol #:	160

C 14195	D. Brewer	Vol #:	160

C 14196	T. Johnson	Vol #:	160

C 14197	A. Steele	Vol #:	160

C 14198	J. Zickel	Vol #:	160

C 14199	J. Todd	Vol #:	160

C 14200	B. Brandt	Vol #:	160

C 14201	J. Bovard	Vol #:	160

C 14202	B. Pilling	Vol #:	160

C 14203	P. Parenteau	Vol #:	160

C 14204	P. Parenteau	Vol #:	160

C 14205	J. Cruz	Vol #:	160

C 14206	S. Bitzan	Vol #:	160

C 14207	S. Bitzan	Vol #:	160

C 14208	S. Thurwanger	Vol #:	160

C 14209	D. Burns	Vol #:	160

C 14210	L. Guidry	Vol #:	160



C 14211	M. Terrebonne	Vol #:	160

C 14212	M. Cheriame	Vol #:	160

C 14213	M. Ougel	Vol #:	160

C 14214	C. Robiechaux	Vol #:	160

C 14215	M. Alario	Vol #:	160

C 14216	A. Allemand	Vol #:	160

C 14217	G. Adams	Vol #:	160

C 14218	K. Authement	Vol #:	160

C 14219	A. Danes	Vol #:	160

C 14220	A. Chiasson	Vol #:	160

C 14221	L. Pellegrin	Vol #:	160

C 14222	J. Duet	Vol #:	160

C 14223	D. Rodrigue	Vol #:	160

C 14224	L. Danoz	Vol #:	160

C 14225	D. Sanamo	Vol #:	160

C 14226	H. Bouzigard	Vol #:	160

C 14227	G. Orgeron	Vol #:	160

C 14228	C. Bruce	Vol #:	160

C 14229	P. Fremin	Vol #:	160

C 14230	M. Hymel	Vol #:	160

C 14231	P. Whitney	Vol #:	160

C 14232	S. Curole	Vol #:	160

C 14233	C. Robinson	Vol #:	160

C 14234	K. McNabb	Vol #:	160

C 14235	J. Munson	Vol #:	160

C 14236	M. Agneu	Vol #:	160

C 14237	K. Shira, RN	Vol #:	160

C 14238	E. Underwood	Vol #:	160

C 14239	K. Kazor	Vol #:	160

C 14240	J. Culbertson	Vol #:	160

C 14241	K. Dalechek	Vol #:	160

C 14242	J. Leckey	Vol #:	160

C 14243	P. Rodriguez	Vol #:	160

C 14244	M. Hunt	Vol #:	160

C 14245	K. Jaffey	Vol #:	160

C 14246	D. Bradley	Vol #:	160

C 14247	K. Golden	Vol #:	160



C 14248	B. Cornutt	Vol #:	160

C 14249	F. Jennings	Vol #:	160

C 14250	L. Murphy	Vol #:	160

C 14251	M. Hertzberg	Vol #:	161

C 14252	M. Craig	Vol #:	161

C 14253	D. Hudgins	Vol #:	161

C 14254	R. Rich	Vol #:	161

C 14255	C. Beguin	Vol #:	161

C 14256	L. Johnson	Vol #:	161

C 14257	M. Davis	Vol #:	161

C 14258	M. Dorsey	Vol #:	161

C 14259	D. Sabol	Vol #:	161

C 14260	D. Douglass	Vol #:	161

C 14261	R. Johnson	Vol #:	161

C 14262	M. Brady	Vol #:	161

C 14263	K. Ziegler	Vol #:	161

C 14264	J. Wolff	Vol #:	161

C 14265	M. Lehti	Vol #:	161

C 14266	K. Kistler	Vol #:	161

C 14267	S. Klemp	Vol #:	161

C 14268	M. Lindill	Vol #:	161

C 14269	J. Malmeritch	Vol #:	161

C 14270	K. Knight	Vol #:	161

C 14271	S. Hansen	Vol #:	161

C 14272	S. Klemp	Vol #:	161

C 14273	L. Garcia	Vol #:	161

C 14274	D. Adcock	Vol #:	161

C 14275	M. Murphy	Vol #:	161

C 14276	J. Lowry	Vol #:	161

C 14277	S. Hurtubise	Vol #:	161

C 14278	C. Jurzykowski	Vol #:	161

C 14279	S. St. George	Vol #:	161

C 14280	P. Dietderich	Vol #:	161

C 14281	R. Conrad	Vol #:	161

C 14282	O. Emmer	Vol #:	161

C 14283	J. Ginsburg	Vol #:	161

C 14284	C. Lord	Vol #:	161



C 14285	R. Berven	Vol #:	161

C 14286	S. Kisska	Vol #:	161

C 14287	S. Tate	Vol #:	161

C 14288	A. Oliver	Vol #:	161

C 14289	A. Lolley	Vol #:	161

C 14290	M. Samuels	Vol #:	161

C 14291	J. Sewell	Vol #:	161

C 14292	T. Hatcher	Vol #:	161

C 14293	K. McMurray	Vol #:	161

C 14294	K. Reilly	Vol #:	161

C 14295	G. Sas	Vol #:	161

C 14296	C. Duffey	Vol #:	161

C 14297	B. Gunther	Vol #:	161

C 14298	M. Klose	Vol #:	161

C 14299	A. Hart	Vol #:	161

C 14300	K. MacLaurin	Vol #:	161

C 14301	R. Jenkins	Vol #:	161

C 14302	G. Hardy	Vol #:	161

C 14303	S. Kumpf	Vol #:	161

C 14304	I. Smith	Vol #:	161

C 14305	C. Morole	Vol #:	161

C 14306	J. Nunes	Vol #:	161

C 14307	C. Goldsmith	Vol #:	161

C 14308	M. Miller	Vol #:	161

C 14309	L. Avery	Vol #:	161

C 14310	R. Lytell	Vol #:	161

C 14311	R. Neiman	Vol #:	161

C 14312	A. Stuka	Vol #:	161

C 14313	D. Barks	Vol #:	161

C 14314	J. Feldman	Vol #:	161

C 14315	M. Feldman	Vol #:	161

C 14316	C. Mandeville	Vol #:	161

C 14317	M. Bass	Vol #:	161

C 14318	D. Egan	Vol #:	161

C 14319	S. Naylor	Vol #:	161

C 14320	S. Richardson	Vol #:	161

C 14321	N. Neighbors	Vol #:	161



C 14322	A. Neighbors	Vol #:	161

C 14323	M. Sanberg	Vol #:	161

C 14324	J. Hirsh	Vol #:	161

C 14325	T. Clark	Vol #:	161

C 14326	S. Dreier	Vol #:	161

EC 33239	Ms. Charlene Kearney	Vol #:	142

EC 33240	Ms. jean moore	Vol #:	142

EC 33241	Mrs. Ethel Zimmerer	Vol #:	142

EC 33242	Mrs. Sabia Young	Vol #:	142

EC 33243	Ms. Mary Lifford	Vol #:	142

EC 33244	Mrs. Judy Schulz	Vol #:	142

EC 33245	Ms. Tanya Kazanjian	Vol #:	142

LET 2	FDA/CDER to Wiley Rein & Felding, LLP	Vol #:	160

2006N-0109	General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities

C 3	W. Cronkite	Vol #:	1

2006P-0001	Date of Approval for Lunesta (Eszopiclone) Tablets

LET 1	FDA/CDER to Venable LLP	Vol #:	1

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

EC 560	Miss. sam feuss	Vol #:	3

EC 561	Mrs. Heather Orn	Vol #:	3

EC 562	Mrs. Jane Robbins	Vol #:	3

EC 563	Mrs. Deborah Anderson	Vol #:	3

EC 564	Ms. Sarah Light	Vol #:	3

EC 565	underground creations inc	Vol #:	3

EC 566	Ms. Susan Whalen	Vol #:	3

EC 567	Mrs. Lou MacNaughton	Vol #:	3

EC 568	n/a	Vol #:	3

EC 569	Charlene Looney Implant Project	Vol #:	3

EC 570	Implant Veterans of Toxic Exposure	Vol #:	3

EC 571	Ms. Tammy Robinson	Vol #:	3

EC 572	Mrs. KATHERINE TAVARES	Vol #:	3

EC 573	Mrs. Lorraine Reeves	Vol #:	3

EC 574	Ms. Bindi Misuraca	Vol #:	3

EC 575	Mr. Joshua Holden	Vol #:	3

EC 576	Ms. Elizabeth De Witt	Vol #:	3



EC 577	Ms. Tabatha Myers	Vol #:	3

EC 578	Mr. Kirk Rhoads	Vol #:	3

EC 579	Mrs. Margaret Galloway	Vol #:	3

EC 580	Ms. Margery Coffey	Vol #:	3

EC 581	Miss. Danielle Dragona	Vol #:	3

EC 582	Ms. CYNTHIA FERNICOLA	Vol #:	3

EC 583	Ms. Katherine Allen	Vol #:	3

EC 584	None	Vol #:	3

2006P-0178	Immediately ban fluoroquinolone antibiotic gatifloxacin in humans

C 1	D. Lowe	Vol #:	1

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FDA/Dockets Management