Dockets Entered on October 1, 2007

Dockets Management



Dockets Entered On October 1, 2007



Docket #	Title

1978N-0038	Sunscreen Drug Products

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

1998P-1121	Grated Parmesan Cheese Deviating from Identity standard

1999P-1340	Declared Eternity eau de Parfum Misbranded

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

2007D-0168	Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations

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

2007N-0353	Drug Products Containing Hydrocodone; Enforcement Action Dates

2007P-0074	Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age

2007P-0127	Determine that any versions of tramadol for once-daily dosing will not be approved prior to expiration of three-year period of exclusivity for Ultram ER

2007P-0297	Request to reconsider the failure to approve Provenge

1978N-0038	Sunscreen Drug Products

EXT 10	Schering-Plough	Vol #:	134

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

LET 20911	CAMELYN USA	Vol #:	181

LET 20912	Vita-Herbs, Inc.	Vol #:	181

LET 20913	Hillestad	Vol #:	181

LET 20914	Univera, Inc.	Vol #:	181

LET 20915	Univera, Inc.	Vol #:	181

LET 20916	Univera, Inc.	Vol #:	181

LET 20917	Univera, Inc.	Vol #:	181

LET 20918	Univera, Inc.	Vol #:	181

LET 20919	Univera, Inc.	Vol #:	181

LET 20920	Univera, Inc.	Vol #:	181

LET 20921	Univera, Inc.	Vol #:	181

LET 20922	Univera, Inc.	Vol #:	181

LET 20923	Univera, Inc.	Vol #:	181

LET 20924	Univera, Inc.	Vol #:	181

LET 20925	Univera, Inc.	Vol #:	181

LET 20926	Univera, Inc.	Vol #:	181

LET 20927	Univera, Inc.	Vol #:	181

LET 20928	Univera, Inc.	Vol #:	181

LET 20929	Univera, Inc.	Vol #:	181

LET 20930	Univera, Inc.	Vol #:	181

LET 20931	Univera, Inc.	Vol #:	181



LET 20932	Dreamerz Foods, Inc.	Vol #:	181

LET 20933	PHARMAVITE	Vol #:	181

LET 20934	KONSYL PHARMACEUTICALS, INC.	Vol #:	181

LET 20935	IOVATE	Vol #:	181

LET 20936	Vita-Herbs, Inc.	Vol #:	181

LET 20937	Emord & Associates, P.C.	Vol #:	181

LET 20938	Wyeth Consumer Healthcare	Vol #:	181

LET 20939	FreeLife International, Inc.	Vol #:	181

LET 20940	PHARMAVITE	Vol #:	181

LET 20941	LOREAL	Vol #:	181

LET 20942	IOVATE	Vol #:	181

1998P-1121	Grated Parmesan Cheese Deviating from Identity standard

ANS 8	FDA to DairiConcepts, L.P.	Vol #:	2

LET 11	DairiConcepts	Vol #:	2

1999P-1340	Declared Eternity eau de Parfum Misbranded

C 764	Z. Denton	Vol #:	25

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

C 3300	P. Jackson	Vol #:	31

C 3301	C Blake	Vol #:	31

C 3302	B Mealor	Vol #:	31

C 3303	M Krieger	Vol #:	31

C 3304	J Daley	Vol #:	31

C 3305	E Cory	Vol #:	31

C 3306	J Olive	Vol #:	31

C 3307	C Bowman	Vol #:	31

C 3308	L Bona	Vol #:	31

C 3309	U Scarbrough	Vol #:	31

C 3310	B Bell	Vol #:	31

C 3311	G Stevenson	Vol #:	31

C 3312	L Vandagriff	Vol #:	31

C 3313	C Voight	Vol #:	31

C 3314	D Moudry	Vol #:	31

C 3315	B Cappiello	Vol #:	31

C 3316	A Gianakas	Vol #:	31

C 3317	J Turner	Vol #:	31



C 3318	D Trolley	Vol #:	31

C 3319	J Berter	Vol #:	31

C 3320	B Earle	Vol #:	31

C 3321	M Markham	Vol #:	31

C 3322	L Evans	Vol #:	31

C 3323	A Russell	Vol #:	31

C 3324	B Baker	Vol #:	31

C 3325	D Adams	Vol #:	31

C 3326	G Bredehorn	Vol #:	31

C 3327	W Ficken	Vol #:	31

C 3328	R Sutherland	Vol #:	31

C 3329	J Dunphy	Vol #:	31

C 3330	W Greiwe	Vol #:	31

C 3331	J Gilchrest	Vol #:	31

C 3332	G Hodges	Vol #:	31

C 3333	P Booth	Vol #:	31

C 3334	S Hammand	Vol #:	31

C 3335	B Franks	Vol #:	31

C 3336	D Key	Vol #:	31

C 3337	R Taormina	Vol #:	31

C 3338	N Douglas	Vol #:	31

C 3339	S Fries	Vol #:	31

C 3340	L Hopper	Vol #:	31

C 3341	L Krueger	Vol #:	31

C 3342	K Strattman	Vol #:	31

C 3343	C Holbrook	Vol #:	31

C 3344	E Needham	Vol #:	31

C 3345	C Waugh	Vol #:	31

C 3346	S Lindley	Vol #:	31

C 3347	R Davis	Vol #:	31

C 3348	L Goins	Vol #:	31

C 3349	D Galvin	Vol #:	31

C 3350	R Fawver	Vol #:	31

C 3351	J Hensil	Vol #:	31

C 3352	A Gladstone	Vol #:	31

C 3353	M Lamm Jr	Vol #:	31

C 3354	J Rockhold	Vol #:	31



C 3355	R Bolgerin	Vol #:	31

C 3356	B Stevens	Vol #:	31

C 3357	E Recker	Vol #:	31

C 3358	S Spiro	Vol #:	31

C 3359	No signature	Vol #:	31

C 3360	W Elsey	Vol #:	31

C 3361	M Bement	Vol #:	31

C 3362	N Zimmerman	Vol #:	31

C 3363	H Snedegar	Vol #:	31

C 3364	A Sherrod Sr	Vol #:	31

C 3365	M Wood	Vol #:	31

C 3366	S Whitaker	Vol #:	31

C 3367	H Coolidge	Vol #:	31

C 3368	R Noblitt	Vol #:	31

C 3369	V Huggins	Vol #:	31

C 3370	F Brussells	Vol #:	31

C 3371	M Sexson	Vol #:	31

C 3372	J Fischer	Vol #:	31

C 3373	M White	Vol #:	31

C 3374	G Dautrenil	Vol #:	31

C 3375	R Sears	Vol #:	31

C 3376	R Rainey	Vol #:	31

C 3377	V Gray	Vol #:	31

C 3378	C Glover	Vol #:	31

C 3379	V Gowda	Vol #:	31

C 3380	P Stokes	Vol #:	31

C 3381	L Brueske	Vol #:	31

C 3382	J Fancher	Vol #:	31

C 3383	P Evans	Vol #:	31

C 3384	K Harvard	Vol #:	31

C 3385	L Bodnen	Vol #:	31

C 3386	E Beaulieu	Vol #:	31

C 3387	E Holloway	Vol #:	31

C 3388	P Borelli	Vol #:	31

C 3389	B Voight	Vol #:	31

C 3390	P Clark	Vol #:	31

C 3391	L Doerr	Vol #:	31



C 3392	E Seickel	Vol #:	31

C 3393	C Jones	Vol #:	31

C 3394	T Rodehorst	Vol #:	31

C 3395	T Weiser	Vol #:	31

C 3396	W Dyott	Vol #:	31

C 3397	K Ristau	Vol #:	31

C 3398	J Bedore	Vol #:	31

C 3399	P Saul	Vol #:	31

C 3400	G Hiers	Vol #:	31

C 3401	S Maley	Vol #:	31

C 3402	K McGill	Vol #:	31

C 3403	B Upton	Vol #:	31

C 3404	B Beau	Vol #:	31

C 3405	T McLellan	Vol #:	31

C 3406	J Griggs	Vol #:	31

C 3407	K Goff	Vol #:	31

C 3408	V Roque	Vol #:	31

C 3409	S Downing	Vol #:	31

C 3410	J Smith	Vol #:	31

C 3411	W Harman	Vol #:	31

C 3412	K Briggs	Vol #:	31

C 3413	M Polk	Vol #:	31

C 3414	L Fuller	Vol #:	31

C 3415	P Koepp	Vol #:	31

C 3416	D Rafernker	Vol #:	31

C 3417	J Horton	Vol #:	31

C 3418	M Miller	Vol #:	31

C 3419	R Smith	Vol #:	31

C 3420	M Heverly	Vol #:	31

C 3421	G Kidman	Vol #:	31

C 3422	T Keene	Vol #:	31

C 3423	J Lanctot	Vol #:	31

C 3424	L Callahan	Vol #:	31

C 3425	B Lee	Vol #:	31

C 3426	J Dalafave	Vol #:	31

C 3427	D Crutchfield	Vol #:	31

C 3428	P Leef	Vol #:	31



C 3429	J Mims	Vol #:	31

C 3430	M Benjamin	Vol #:	31

C 3431	S Leonido	Vol #:	31

C 3432	D Rocher	Vol #:	31

C 3433	P Ringele	Vol #:	31

C 3434	J Watson	Vol #:	31

C 3435	S Wernli	Vol #:	31

C 3436	D Ramsey	Vol #:	31

C 3437	M Meck	Vol #:	31

C 3438	J Walker	Vol #:	31

C 3439	C Draper	Vol #:	31

C 3440	B Davis	Vol #:	31

C 3441	M Harrison	Vol #:	31

C 3442	M Kurocusk	Vol #:	31

C 3443	J Price	Vol #:	31

C 3444	H Dryer	Vol #:	31

C 3445	M Tins	Vol #:	31

C 3446	D Jensen	Vol #:	31

C 3447	P Snider	Vol #:	31

C 3448	M Chadwick	Vol #:	31

C 3449	N Jacobson	Vol #:	31

C 3450	M Visotski	Vol #:	31

C 3451	M Radda	Vol #:	31

C 3452	D Griffin	Vol #:	31

C 3453	P Work	Vol #:	31

C 3454	M Stanford	Vol #:	31

C 3455	L Godly	Vol #:	31

C 3456	B Sapp	Vol #:	31

C 3457	B Bunch	Vol #:	31

C 3458	C Little	Vol #:	31

C 3459	L Kuba	Vol #:	31

C 3460	W Watkins	Vol #:	31

C 3461	M Wissinger	Vol #:	32

C 3462	J Wicks	Vol #:	32

C 3463	L Harris	Vol #:	32

C 3464	V Young	Vol #:	32

C 3465	M Klug	Vol #:	32



C 3466	C McIntyre	Vol #:	32

C 3467	L Scheer	Vol #:	32

C 3468	M Newton	Vol #:	32

C 3469	G Massey	Vol #:	32

C 3470	B Thomson	Vol #:	32

C 3471	D Crawford	Vol #:	32

C 3472	B Dolan	Vol #:	32

C 3473	M Miller	Vol #:	32

C 3474	M Carlson	Vol #:	32

C 3475	M Sifford	Vol #:	32

C 3476	V Mills	Vol #:	32

C 3477	S Vitale III	Vol #:	32

C 3478	L Maldonado	Vol #:	32

C 3479	I Cook	Vol #:	32

C 3480	M Bee	Vol #:	32

C 3481	E Stein	Vol #:	32

C 3482	K Heinbre	Vol #:	32

C 3483	B Holmes	Vol #:	32

C 3484	J Kurosky	Vol #:	32

C 3485	E Reece	Vol #:	32

C 3486	N Nisar	Vol #:	32

C 3487	G Ferrant	Vol #:	32

C 3488	V Temple	Vol #:	32

C 3489	M Moore	Vol #:	32

C 3490	H Suppes	Vol #:	32

C 3491	J Simpson	Vol #:	32

C 3492	R Emanuelson	Vol #:	32

C 3493	D Kramer	Vol #:	32

C 3494	L Strobel	Vol #:	32

C 3495	J Kingsley	Vol #:	32

C 3496	W Holien	Vol #:	32

C 3497	W Lawhorn	Vol #:	32

C 3498	R Fitch	Vol #:	32

C 3499	I Stewart	Vol #:	32

C 3500	R Reddy	Vol #:	32

C 3501	T Thompson	Vol #:	32

C 3502	J Moore	Vol #:	32



C 3503	H Halbeck	Vol #:	32

C 3504	T Hiester	Vol #:	32

C 3505	C Swartz	Vol #:	32

C 3506	K Helms	Vol #:	32

C 3507	A Kohler	Vol #:	32

C 3508	C Giles	Vol #:	32

C 3509	C Verrell-Nielsen	Vol #:	32

C 3510	N Crockett	Vol #:	32

C 3511	B Reagan	Vol #:	32

C 3512	R Murray	Vol #:	32

C 3513	B Coulter	Vol #:	32

C 3514	R Pesthea	Vol #:	32

C 3515	W Moreland	Vol #:	32

C 3516	S Black	Vol #:	32

C 3517	S Anderson	Vol #:	32

C 3518	C McIntosh	Vol #:	32

C 3519	E Gear	Vol #:	32

C 3520	T Waosworth	Vol #:	32

C 3521	O Sexton	Vol #:	32

C 3522	V Grembia	Vol #:	32

C 3523	C Bienzen	Vol #:	32

C 3524	P Luibke	Vol #:	32

C 3525	G Friedman	Vol #:	32

C 3526	S Barger	Vol #:	32

C 3527	L Dower	Vol #:	32

C 3528	S Lustgarten	Vol #:	32

C 3529	M Paradise	Vol #:	32

C 3530	B Peterson	Vol #:	32

C 3531	M Hovey	Vol #:	32

C 3532	G Dobson	Vol #:	32

C 3533	V Autry	Vol #:	32

C 3534	M Pittman	Vol #:	32

C 3535	L Mikell	Vol #:	32

C 3536	A Heinter	Vol #:	32

C 3537	B Hemeter	Vol #:	32

C 3538	J Jordan	Vol #:	32

C 3539	E Caldwell	Vol #:	32



C 3540	I Brunet	Vol #:	32

C 3541	S Zakowski	Vol #:	32

C 3542	T Jackson	Vol #:	32

C 3543	R Shoemaker	Vol #:	32

C 3544	R Warman	Vol #:	32

C 3545	J Lee	Vol #:	32

C 3546	A Banks	Vol #:	32

C 3547	R Carroll	Vol #:	32

C 3548	W Ratsema	Vol #:	32

C 3549	P Falk	Vol #:	32

C 3550	L Zabonik	Vol #:	32

C 3551	M Weale	Vol #:	32

C 3552	M Loyd	Vol #:	32

C 3553	M Brininger	Vol #:	32

C 3554	C Metropulos	Vol #:	32

C 3555	C Mesnar	Vol #:	32

C 3556	J McCarthy	Vol #:	32

C 3557	M Adams	Vol #:	32

C 3558	I Zoltan	Vol #:	32

C 3559	R Phillips	Vol #:	32

C 3560	R Schmid	Vol #:	32

C 3561	R Hindman	Vol #:	32

2007D-0168	Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations

C 2	Endo Pharmaceuticals	Vol #:	1

C 3	Wyeth Pharmaceuticals	Vol #:	1

C 4	Astellas Pharma US, Inc. ("Astellas")	Vol #:	1

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

C 2	Federal Express Corporation	Vol #:	1

C 3	Food & Water Watch	Vol #:	1

EC 124	Ms. robin legan	Vol #:	1

EC 125	Zion Lutheran Church	Vol #:	1

EC 126	Marine Management Insurance Brokers, Inc	Vol #:	1

EC 127	Global Food Technologies, Inc.	Vol #:	1

EC 128	Mrs. Angela Wall	Vol #:	1

EC 129	Express Delivery	Vol #:	1



EC 130	Fedex Express	Vol #:	1

EC 131	Asociacin de Exportadores de Chile A.G. (ASOEX)	Vol #:	1

EC 132	Copper	Vol #:	1

EC 133	TUV RHEINLAND OF NORTH AMERICA	Vol #:	1

EC 134	Underwriters Laboratories Inc.	Vol #:	1

EC 135	Neogen Corporation	Vol #:	1

EC 136	Consumers Union	Vol #:	1

EC 137	AdvaMed	Vol #:	1

EC 138	N/A	Vol #:	1

EC 139	Mrs. Marcia Beasley	Vol #:	1

EC 140	Dr Mitchel W. Eisenstein, DC	Vol #:	1

EC 141	International Pharmaceutical Excipients Council	Vol #:	1

EC 142	Mr. Sherwood Anderson	Vol #:	1

EC 143	The Centanne Family	Vol #:	1

2007N-0353	Drug Products Containing Hydrocodone; Enforcement Action Dates

N 1	FDA	Vol #:	1

2007P-0074	Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age

N 1	FDA	Vol #:	1

2007P-0127	Determine that any versions of tramadol for once-daily dosing will not be approved prior to expiration of three-year period of exclusivity for Ultram ER

LET 1	J. Axelrad	Vol #:	1

2007P-0297	Request to reconsider the failure to approve Provenge

EC 107	Mr. Jack Henry	Vol #:	1

EC 108	Mr. Hendrik Klein	Vol #:	1

EC 109	Mr. Patrick Hape	Vol #:	1

EC 110	Mr. James Reilly	Vol #:	1

EC 111	Provenge Alliance	Vol #:	1

EC 112	Dr. Charles Bennett	Vol #:	1

EC 113	Dr. Charles Bennett	Vol #:	1

EC 114	self	Vol #:	1

EC 115	retired	Vol #:	1

EC 116	None	Vol #:	1

EC 117	Mr. Aga Chua	Vol #:	1

EC 118	Mr. sean morgan	Vol #:	1

EC 119	Ms. Sandra Iverson	Vol #:	1



EC 120	Mr. Craig Payne	Vol #:	1

EC 121	Mr. A; Monardo	Vol #:	1

EC 122	Mr. David Friedline	Vol #:	1

EC 123	Mr. patrick wear	Vol #:	1

EC 124	Dr. Giancarlo Nicoli	Vol #:	1

EC 125	Mr. Robert Paquin	Vol #:	1

Page created on October 1, 2007 ue

FDA/Dockets Management