Dockets Entered on October 9, 2007

Dockets Management



Dockets Entered On October 9, 2007



Docket #	Title

1981N-0033	Oral Health Care Drug Products for OTC Human Use

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

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

2006P-0394	Revise the labeling requirements for eggs sold in the United States

2007D-0309	Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes

2007N-0311	Midodrine Exclusivity Issues

2007N-0330	Presidential Interagency Working Group on Import Safety; Public Meeting

2007P-0094	Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the- counter


2007P-0235	Change the labeling requirements for eggs sold in the United States

1981N-0033	Oral Health Care Drug Products for OTC Human Use

ACK 8	FDA/DDM to Beutlich Pharmaceuticals LP	Vol #:	77

CP 7	Beutlich Pharmaceuticals LP	Vol #:	77

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

EMC 3358	N. Patel	Vol #:	261

EMC 3359	S. Joyner	Vol #:	261

EMC 3360	T. LaClair	Vol #:	261

EMC 3361	R. McNamara	Vol #:	261

EMC 3362	O. Suter	Vol #:	261

EMC 3363	E. Theimer	Vol #:	261

EMC 3364	A. Shankar	Vol #:	261

EMC 3365	J. Lente	Vol #:	261

EMC 3366	J. Allen	Vol #:	261

EMC 3367	U. Sarmiento	Vol #:	261

EMC 3368	S. Kell	Vol #:	261

EMC 3369	A. Reynolds	Vol #:	261

EMC 3370	D. Baskin	Vol #:	261

EMC 3371	J. Welch	Vol #:	261

EMC 3372	D. Kelly	Vol #:	261

EMC 3373	P.K. Sarkar	Vol #:	261

EMC 3374	L. Fantasia	Vol #:	261

EMC 3375	L. Rivera	Vol #:	261

EMC 3376	S. Tamez	Vol #:	261

EMC 3377	P. Olch	Vol #:	261

EMC 3378	R.Barclay	Vol #:	261



EMC 3379	S. Rosenberg	Vol #:	261

EMC 3380	D. Carl	Vol #:	261

EMC 3381	D. Gardner	Vol #:	261

EMC 3382	Grissle I	Vol #:	261

EMC 3383	V M	Vol #:	261

EMC 3384	Rose T	Vol #:	261

EMC 3385	L. Govette	Vol #:	261

EMC 3386	A. Kingbsury	Vol #:	261

EMC 3387	Z. Shaila	Vol #:	261

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

C 3942	J Lounsbury	Vol #:	34

C 3943	M Magliocca	Vol #:	34

C 3944	K Hopson	Vol #:	34

C 3945	N Lewis	Vol #:	34

C 3946	S Suresu	Vol #:	34

C 3947	D Nelson	Vol #:	34

C 3948	T Reidy	Vol #:	34

C 3949	B Griffith	Vol #:	34

C 3950	J Ranger	Vol #:	34

C 3951	C Harris	Vol #:	34

C 3952	W Beckert	Vol #:	34

C 3953	J Armstrong	Vol #:	34

C 3954	A Timmel	Vol #:	34

C 3955	T Boileau	Vol #:	34

C 3956	N Mathes	Vol #:	34

C 3957	D Chandler	Vol #:	34

C 3958	A Shuman	Vol #:	34

C 3959	M Molloy	Vol #:	34

C 3960	C Lilte	Vol #:	34

C 3961	S Driver	Vol #:	34

C 3962	P Panebianco	Vol #:	34

C 3963	D Winter	Vol #:	34

C 3964	V Gilbert	Vol #:	34

C 3965	C Broun	Vol #:	34

C 3966	R Werner	Vol #:	34

C 3967	C Secor	Vol #:	34



C 3968	B Pogue	Vol #:	34

C 3969	H Diamer	Vol #:	34

C 3970	B Mauro	Vol #:	34

C 3971	J Schwartz	Vol #:	34

C 3972	D Adkins	Vol #:	34

C 3973	D Morris	Vol #:	34

C 3974	M Allen	Vol #:	34

C 3975	C Dunman	Vol #:	34

C 3976	A Frank	Vol #:	34

C 3977	S Crawford	Vol #:	34

C 3978	M Hylton	Vol #:	34

C 3979	B Hogan	Vol #:	34

C 3980	S Crane	Vol #:	34

C 3981	G Ramsey	Vol #:	34

C 3982	E Wright Jr	Vol #:	34

C 3983	D Schwoeppe	Vol #:	34

C 3984	M Branstetter	Vol #:	34

C 3985	J Pierce	Vol #:	34

C 3986	M Kooi	Vol #:	34

C 3987	B Harris	Vol #:	34

C 3988	D James	Vol #:	34

C 3989	J Linthicum	Vol #:	34

C 3990	M Watkins	Vol #:	34

C 3991	F Bold	Vol #:	34

C 3992	V Feaman	Vol #:	34

C 3993	P Ellis	Vol #:	34

C 3994	M Quarton	Vol #:	34

C 3995	D Duda	Vol #:	34

C 3996	B Haak	Vol #:	34

C 3997	A Dufford	Vol #:	34

C 3998	R Feldman	Vol #:	34

C 3999	G Latimer Jr	Vol #:	34

C 4000	Donald G Day	Vol #:	34

C 4001	P Hupfer	Vol #:	34

C 4002	A Wanat	Vol #:	34

C 4003	A Boman	Vol #:	34

C 4004	G Frankezfield	Vol #:	34



C 4005	D Miller	Vol #:	34

C 4006	B Giglio	Vol #:	34

C 4007	E Bush	Vol #:	34

C 4008	P Jones	Vol #:	34

C 4009	S Costanza	Vol #:	34

C 4010	T Swier	Vol #:	34

C 4011	V VanArtsdalen	Vol #:	34

C 4012	M Crabtree	Vol #:	34

C 4013	M Edwards	Vol #:	34

C 4014	G Daulerio	Vol #:	34

C 4015	V Paul	Vol #:	34

C 4016	H Conn	Vol #:	34

C 4017	M Powell	Vol #:	34

C 4018	R Moser	Vol #:	34

C 4019	B Massinting	Vol #:	34

C 4020	V Willis	Vol #:	34

C 4021	P Carlston	Vol #:	34

C 4022	O Cole	Vol #:	34

C 4023	American Association for Respiratory Care (AARC)	Vol #:	34

C 4024	N Johnson	Vol #:	34

C 4025	R Gerling	Vol #:	34

C 4026	J Dorwart	Vol #:	34

C 4027	P Post	Vol #:	34

C 4028	T Cassis	Vol #:	34

C 4029	D Escalante	Vol #:	34

C 4030	E Dukes	Vol #:	34

C 4031	H Doering	Vol #:	34

C 4032	M Rafael	Vol #:	34

C 4033	J Bailey	Vol #:	34

C 4034	D Rathjen	Vol #:	34

C 4035	D Gillespie	Vol #:	34

C 4036	M Brandt	Vol #:	34

C 4037	D Nails	Vol #:	34

C 4038	G Norcross Sr	Vol #:	34

C 4039	K Boman	Vol #:	34

C 4040	no signature	Vol #:	34

C 4041	M Thompson	Vol #:	34



C 4042	N Valleau	Vol #:	34

C 4043	R Weiner	Vol #:	34

C 4044	A Stoddard	Vol #:	34

C 4045	D Hamilton	Vol #:	34

C 4046	L Hilton	Vol #:	34

C 4047	J Chenger	Vol #:	34

C 4048	L Grodensky	Vol #:	34

C 4049	F Panas	Vol #:	34

C 4050	P Wheatbrook	Vol #:	34

C 4051	H Buddy	Vol #:	34

C 4052	L Robertson	Vol #:	34

C 4053	J Sanders	Vol #:	34

C 4054	N Burnam	Vol #:	34

C 4055	J Black	Vol #:	34

C 4056	K Hunt	Vol #:	34

C 4057	D Grady	Vol #:	34

C 4058	S Vogt	Vol #:	34

C 4059	J McKay	Vol #:	34

C 4060	L Justiniano	Vol #:	34

C 4061	K Koenig	Vol #:	35

C 4062	S Gamble	Vol #:	35

C 4063	D Beto	Vol #:	35

2006P-0394	Revise the labeling requirements for eggs sold in the United States

C 153	J. D. Alden	Vol #:	7

C 154	Q. Cann	Vol #:	7

C 155	V. Becker	Vol #:	7

C 156	M. Seidner	Vol #:	7

C 157	C. Luce	Vol #:	7

C 158	M. Murphy	Vol #:	7

C 159	J. Jackson	Vol #:	7

C 160	C. Varley	Vol #:	7

C 161	K. Rosenberg	Vol #:	7

C 162	L. Johnson	Vol #:	7

C 163	D. Labega	Vol #:	7

C 164	Unknown	Vol #:	7

C 165	D. Dinges	Vol #:	7



2007D-0309	Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes

GDL 1	Guidance	Vol #:	1

NAD 1	FDA	Vol #:	1

2007N-0311	Midodrine Exclusivity Issues

C 2	MYLAN PHARMACEUTICALS, INC	Vol #:	1

C 3	SANDOZ	Vol #:	1

C 4	IMPAX	Vol #:	1

2007N-0330	Presidential Interagency Working Group on Import Safety; Public Meeting

C 10	Lois Case	Vol #:	1

C 11	David A. Eisenberg	Vol #:	1

C 12	Hank Giclas	Vol #:	1

C 13	Number not Used	Vol #:	1

C 14	National Association of Dental Laboratories	Vol #:	1

C 15	Institute of Food Technologists	Vol #:	1

C 16	COTECNA	Vol #:	1

C 17	Path Tracer	Vol #:	1

C 18	Number not Used	Vol #:	1

C 19	Philadelphia University	Vol #:	1

C 20	Salcsecure, LLC	Vol #:	1

C 21	Gary Hubbard	Vol #:	1

C 22	AdvaMed	Vol #:	1

TS 5	NSF International	Vol #:	2

TS 6	National Association of Dental Laboratories	Vol #:	2

TS 7	Consumer Federation of America	Vol #:	2

TS 8	American Association of Exports and Importers	Vol #:	2

TS 9	Presidential Interagency Working Group on Import	Vol #:	2

TS 10	Interagency Working Group on Import Safety	Vol #:	2

TS 11	Edward Sherwin Consultants LLC	Vol #:	2

TS 12	STTAS	Vol #:	2

TS 13	Consumers Union	Vol #:	2

TS 14	Catfish Farmers of America	Vol #:	2

TS 15	Underwriters Laboratories, Inc.	Vol #:	2

TS 16	Western Pistachio Association	Vol #:	2

TS 17	Grocery Manufacturers Association	Vol #:	2

2007P-0094	Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the-counter



C 2	Engel & Novitt, LLP	Vol #:	1

2007P-0235	Change the labeling requirements for eggs sold in the United States

C 15	P. Goddard	Vol #:	2

C 16	G. Crawford	Vol #:	2

C 17	M. Cohen	Vol #:	2

C 18	R. Bodin	Vol #:	2

C 19	J. Nudelman	Vol #:	2

C 20	Unknown	Vol #:	2

C 21	G. Roja	Vol #:	2

C 22	M. Chesnut	Vol #:	2

C 23	R. Dong	Vol #:	2

C 24	S. Rabb	Vol #:	2

C 25	J. Klipsch	Vol #:	2

C 26	K. Berger	Vol #:	2

C 27	R. Glidden	Vol #:	2

C 28	J. Rowe	Vol #:	2

C 29	G. Kuhmester	Vol #:	2

C 30	C. Firehak	Vol #:	2

C 31	A. K. El Mekki	Vol #:	2

C 32	D. T. Comer	Vol #:	2

C 33	P. Gosmann	Vol #:	2

C 34	P. Magar	Vol #:	2

C 35	L. Wyman	Vol #:	2

Page created on October 9, 2007 ue

FDA/Dockets Management