Dockets Entered onOctober 3, 2007

Dockets Management



Dockets Entered On October 3, 2007



Docket #	Title

2000P-0788	Totally Implanted Spinal Cord Stimulator

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

2006N-0475	Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation

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

2006P-0307	To amend 21CFR 201.17 regarding expiration dates

2007N-0018	Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form FDA 3356; El


2007N-0343	Electronic Nonclinical Study Data Submission; Notice of Pilot Project

2007N-0382	Ramipril Capsules and 180-day generic drug exclusivity

2000P-0788	Totally Implanted Spinal Cord Stimulator

LET 3	Anne E. Roan	Vol #:	9

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

EMC 3177	T. Aldridge	Vol #:	261

EMC 3178	P. Mahar	Vol #:	261

EMC 3179	J. Barnett	Vol #:	261

EMC 3180	M. Bedard	Vol #:	261

EMC 3181	B. Tache and J. Tache	Vol #:	261

EMC 3182	J. Landshof	Vol #:	261

EMC 3183	R. Jacques	Vol #:	261

EMC 3184	T. Truglas	Vol #:	261

EMC 3185	D. Shaw	Vol #:	261

EMC 3186	D. Martinez	Vol #:	261

EMC 3187	M. Caniglia	Vol #:	261

EMC 3188	J. Frontz	Vol #:	261

EMC 3189	S. Mathans	Vol #:	261

EMC 3190	E. Johnsen	Vol #:	261

EMC 3191	M. Gentry	Vol #:	261

EMC 3192	S. Sanati	Vol #:	261

EMC 3193	J. Hamer	Vol #:	261

EMC 3194	L. Ellsworth	Vol #:	261

EMC 3195	A. Moore	Vol #:	261

EMC 3196	M. Kowal	Vol #:	261

EMC 3197	P. Alvarez	Vol #:	261

EMC 3198	J. Lafolley	Vol #:	261



EMC 3199	D. Mikulka	Vol #:	261

EMC 3200	J. Wagner and V. Wagner	Vol #:	261

EMC 3201	V. Lopez	Vol #:	261

EMC 3202	M. Jones	Vol #:	261

EMC 3203	D. Bradford	Vol #:	261

EMC 3204	J. Seidel	Vol #:	261

EMC 3205	T. Austin	Vol #:	261

EMC 3206	T. Moore	Vol #:	261

EMC 3207	D. Barbee	Vol #:	261

EMC 3208	P. Yoquelet	Vol #:	261

EMC 3209	R. Wild	Vol #:	261

EMC 3210	M. Begley	Vol #:	261

EMC 3211	M. Thalman	Vol #:	261

EMC 3212	J. Weiss	Vol #:	261

EMC 3213	M. Reasor	Vol #:	261

EMC 3214	M. Satter	Vol #:	261

EMC 3215	M. Offenbach	Vol #:	261

EMC 3216	T. Premer	Vol #:	261

EMC 3217	N. Hasselbalch	Vol #:	261

EMC 3218	J. Correll	Vol #:	261

EMC 3219	A. Roselius	Vol #:	261

EMC 3220	A. Bruno	Vol #:	261

EMC 3221	C. Bivans	Vol #:	261

EMC 3222	G. Spencer	Vol #:	261

EMC 3223	F. Sawyer	Vol #:	261

EMC 3224	P. Berger	Vol #:	261

EMC 3225	D. Hoover	Vol #:	261

EMC 3226	K. Sturtz	Vol #:	261

EMC 3227	C. Herstine	Vol #:	261

EMC 3228	D. Shelton	Vol #:	261

EMC 3229	L. Lincoin	Vol #:	261

EMC 3230	M. Abbott	Vol #:	261

EMC 3231	J. France	Vol #:	261

EMC 3232	R. Imuta	Vol #:	261

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

C 3661	G Williams	Vol #:	33



C 3662	I Stewart	Vol #:	33

C 3663	D Gingery	Vol #:	33

C 3664	L Montague	Vol #:	33

C 3665	E Jurag	Vol #:	33

C 3666	M Marinac	Vol #:	33

C 3667	M Lagoon	Vol #:	33

C 3668	M Shaw	Vol #:	33

C 3669	A Chambers	Vol #:	33

C 3670	S Campbell	Vol #:	33

C 3671	D Sales	Vol #:	33

C 3672	R Jennings	Vol #:	33

C 3673	T Douglas	Vol #:	33

C 3674	E Knox	Vol #:	33

C 3675	C Rhame	Vol #:	33

C 3676	C Fields	Vol #:	33

C 3677	D Vaughan	Vol #:	33

C 3678	B Forney	Vol #:	33

C 3679	D Ziegler	Vol #:	33

C 3680	M Roddy	Vol #:	33

C 3681	J Hubbart	Vol #:	33

C 3682	M Gregory	Vol #:	33

C 3683	O Alvarado	Vol #:	33

C 3684	M Clark	Vol #:	33

C 3685	F Armitage	Vol #:	33

C 3686	F Block	Vol #:	33

C 3687	V Elliott	Vol #:	33

C 3688	M Gibbons	Vol #:	33

C 3689	M Landreth	Vol #:	33

C 3690	M Macky	Vol #:	33

C 3691	G Tschida	Vol #:	33

C 3692	L Robinson	Vol #:	33

C 3693	M Smith	Vol #:	33

C 3694	P Elliott	Vol #:	33

C 3695	G Ward	Vol #:	33

C 3696	S Long	Vol #:	33

C 3697	L Geitz	Vol #:	33

C 3698	M Wright	Vol #:	33



C 3699	G Grant	Vol #:	33

C 3700	D Ivey	Vol #:	33

C 3701	B Walz	Vol #:	33

C 3702	V Holman	Vol #:	33

C 3703	C Shaw	Vol #:	33

C 3704	A Czekanski	Vol #:	33

C 3705	M Biehn	Vol #:	33

C 3706	J Rauch	Vol #:	33

C 3707	I Hamilton	Vol #:	33

C 3708	C Poirier	Vol #:	33

C 3709	M Scott	Vol #:	33

C 3710	V Wrone	Vol #:	33

C 3711	J Till	Vol #:	33

C 3712	D Grob	Vol #:	33

C 3713	M Green	Vol #:	33

C 3714	M St.Sauveur	Vol #:	33

C 3715	T Rife	Vol #:	33

C 3716	H Alonso	Vol #:	33

C 3717	B DeCotiis	Vol #:	33

C 3718	K Mitzel	Vol #:	33

C 3719	T Tran	Vol #:	33

C 3720	G Guinasso	Vol #:	33

C 3721	L Fuller	Vol #:	33

C 3722	G DeGroot	Vol #:	33

C 3723	M Goodrich	Vol #:	33

C 3724	G Moreira	Vol #:	33

C 3725	B Mitchell	Vol #:	33

C 3726	A Delaney	Vol #:	33

C 3727	B Granville	Vol #:	33

C 3728	D Loftus	Vol #:	33

C 3729	F Tenigle	Vol #:	33

C 3730	P Mosley	Vol #:	33

C 3731	G Matzen	Vol #:	33

C 3732	F Herlovich	Vol #:	33

C 3733	D Schuurmans	Vol #:	33

C 3734	T Norton	Vol #:	33

C 3735	J O'Neill	Vol #:	33



C 3736	H Edwards	Vol #:	33

C 3737	D Friedline	Vol #:	33

C 3738	J Bell	Vol #:	33

C 3739	M Well	Vol #:	33

C 3740	V Harrod	Vol #:	33

C 3741	M Badger	Vol #:	33

C 3742	J Wagner	Vol #:	33

C 3743	P Holder	Vol #:	33

C 3744	C Kornbauer	Vol #:	33

C 3745	J Mott Jr	Vol #:	33

C 3746	E Scherf	Vol #:	33

C 3747	R Beadle Jr	Vol #:	33

C 3748	G Carver	Vol #:	33

C 3749	R Powell	Vol #:	33

C 3750	N Craven	Vol #:	33

C 3751	D Miller	Vol #:	33

C 3752	N Begley	Vol #:	33

C 3753	D Roger	Vol #:	33

C 3754	L Hunter	Vol #:	33

C 3755	L Schmeeckle	Vol #:	33

C 3756	A Richardson	Vol #:	33

C 3757	S Marshall	Vol #:	33

C 3758	A Hehrank	Vol #:	33

C 3759	B Brown	Vol #:	33

C 3760	M Meganck	Vol #:	33

C 3761	Coastal Health Practioners	Vol #:	33

C 3762	R Buzzell	Vol #:	33

C 3763	D Matlock	Vol #:	33

C 3764	H Chambers	Vol #:	33

C 3765	N Smith	Vol #:	33

C 3766	S Doerr	Vol #:	33

C 3767	J Sweeney	Vol #:	33

C 3768	B Longley	Vol #:	33

C 3769	D Smith	Vol #:	33

C 3770	V Keller	Vol #:	33

C 3771	P Poffhauser	Vol #:	33

C 3772	R Huettner	Vol #:	33



C 3773	D Winkler	Vol #:	33

C 3774	J Ramsey	Vol #:	33

C 3775	D Kinsey	Vol #:	33

C 3776	L Ritchie	Vol #:	33

C 3777	S Amer	Vol #:	33

C 3778	P Marmo	Vol #:	33

C 3779	R Donley	Vol #:	33

C 3780	R Cadoret	Vol #:	33

C 3781	J Smith	Vol #:	33

C 3782	G Neumann	Vol #:	33

C 3783	P Sussenbach	Vol #:	33

C 3784	R Wyatt	Vol #:	33

C 3785	R Burns	Vol #:	33

C 3786	M McGallion	Vol #:	33

C 3787	A Slimm	Vol #:	33

C 3788	I Tate	Vol #:	33

C 3789	L Blair	Vol #:	33

C 3790	M Riston	Vol #:	33

C 3791	I Waldrop	Vol #:	33

C 3792	N Brooke	Vol #:	33

C 3793	D Peichl	Vol #:	33

C 3794	R Meves	Vol #:	33

C 3795	J Coble	Vol #:	33

C 3796	V McCormick	Vol #:	33

C 3797	E Larkin	Vol #:	33

C 3798	P Knight	Vol #:	33

C 3799	M Kampsula	Vol #:	33

C 3800	J Malessa	Vol #:	33

C 3801	A Wraley	Vol #:	33

C 3802	D Shepherd	Vol #:	33

C 3803	E Graupman	Vol #:	33

C 3804	L Knight	Vol #:	33

C 3805	B Moore	Vol #:	33

C 3806	R Gehrke	Vol #:	33

C 3807	R Gentles	Vol #:	33

C 3808	B Kanefsky	Vol #:	33

C 3809	D Fending	Vol #:	33



C 3810	B Kijesky	Vol #:	33

C 3811	R Gould	Vol #:	33

C 3812	P Lukas	Vol #:	33

C 3813	K Johnson	Vol #:	33

C 3814	D Singleton	Vol #:	33

C 3815	D Worley	Vol #:	33

C 3816	T Smith	Vol #:	33

C 3817	A Gears	Vol #:	33

C 3818	B Morris	Vol #:	33

C 3819	K Preston	Vol #:	33

C 3820	R Fusilier	Vol #:	33

C 3821	I Siemssen	Vol #:	33

C 3822	T Knoles	Vol #:	33

C 3823	N Dean	Vol #:	33

C 3824	L Vontalge	Vol #:	33

C 3825	P Groves	Vol #:	33

C 3826	K Eakin	Vol #:	33

C 3827	R Smith	Vol #:	33

C 3828	I Smith	Vol #:	33

C 3829	M Ihde	Vol #:	33

C 3830	E Russell	Vol #:	33

C 3831	D Bui	Vol #:	33

C 3832	K McClean	Vol #:	33

C 3833	T Bloom	Vol #:	33

C 3834	J Vrana	Vol #:	33

C 3835	L Vangelas	Vol #:	33

C 3836	W Yaggi	Vol #:	33

C 3837	R Hick	Vol #:	33

C 3838	L Bossart	Vol #:	33

C 3839	N Thomas	Vol #:	33

C 3840	J Wassum	Vol #:	33

C 3841	C Provence	Vol #:	33

C 3842	E Rouse	Vol #:	33

C 3843	J Kornmiller	Vol #:	33

C 3844	I Berhowitz	Vol #:	33

C 3845	D Maddox	Vol #:	33

C 3846	M Stone	Vol #:	33



C 3847	H Watford	Vol #:	33

C 3848	F Howey	Vol #:	33

C 3849	L Allen	Vol #:	33

C 3850	J Burgess Sr	Vol #:	33

C 3851	M Litterell	Vol #:	33

C 3852	P Morin	Vol #:	33

C 3853	J Heefner	Vol #:	33

C 3854	D Paul	Vol #:	33

C 3855	F Osterlund	Vol #:	33

C 3856	M Looney	Vol #:	33

C 3857	M Jones	Vol #:	33

C 3858	B Brock	Vol #:	33

C 3859	B Blasias	Vol #:	33

C 3860	no signature	Vol #:	33

2006N-0475	Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation

NAL 1	FDA	Vol #:	1

SS 1	Supporting Statement	Vol #:	1

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

EMC 4	D. Robertson	Vol #:	1

2006P-0307	To amend 21CFR 201.17 regarding expiration dates

LET 6	Sapna Lohiya	Vol #:	1

2007N-0018	Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form FDA 3356; El



NAL 1	FDA	Vol #:	1

SS 1	Supporting Statement	Vol #:	1

2007N-0343	Electronic Nonclinical Study Data Submission; Notice of Pilot Project

N 1	FDA	Vol #:	1

2007N-0382	Ramipril Capsules and 180-day generic drug exclusivity

LET 1	Cobalt Pharmaceuticals, Inc.	Vol #:	1

LET 2	Lupin Pharmaceuticals, Inc.	Vol #:	1

LET 3	FDA/CDER/OGD	Vol #:	1

Page created on October 3, 2007 ue

FDA/Dockets Management