Dockets Entered on August 2, 2007

Dockets Management



Dockets Entered On August 2, 2007



Docket #	Title

1975N-0183H	Health-Care Antiseptic Drug Products for OTC Human Use

1977N-0094	OTC Internal Analgesic, Antipyretic & Antirheumatic Products

1978N-0038	Sunscreen Drug Products

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

1998D-1232	Points to consider guidance documents on assayed&unassayed

1998F-0196	Safe use of Selenium Yeast in Animal Feeds

2002D-0005	Pharmacovigilance of Veterinary Medicinal Products

2005N-0272	Irradiation in the Production, Processing & Handling of Food

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

2006D-0347	Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

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

2007D-0125	Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

2007D-0213	Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date

2007D-0249	Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage

2007N-0215	Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

2007N-0217	Licensure of Apheresis Blood Products; Public Workshop

2007N-0277	Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing

2007P-0147	Use of the Term Natural Consistent with USDA's Food Safety and Inspection Service

1975N-0183H	Health-Care Antiseptic Drug Products for OTC Human Use

EC 4	Advanced Enzyme Technologies Ltd.	Vol #:	200

1977N-0094	OTC Internal Analgesic, Antipyretic & Antirheumatic Products

EC 1	Advanced Enzyme Technologies Ltd.	Vol #:	203

EC 2	Advanced Enzyme Technologies Ltd.	Vol #:	203

1978N-0038	Sunscreen Drug Products

EC 3	Ms. Rose Walters	Vol #:	147

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

LET 20412	INTE\|MEDICA	Vol #:	179

LET 20413	Michael's Naturopathic Programs	Vol #:	179

LET 20414	Enzmatic Therapy	Vol #:	179

LET 20415	Enzmatic Therapy	Vol #:	179

LET 20416	Enzmatic Therapy	Vol #:	179

LET 20417	Source Naturals	Vol #:	179

LET 20418	IQ Organics LLC	Vol #:	179



LET 20419	Enzmatic	Vol #:	179

LET 20420	Enzmatic	Vol #:	179

LET 20421	Enzmatic	Vol #:	179

LET 20422	Enzmatic	Vol #:	179

LET 20423	Enzmatic	Vol #:	179

LET 20424	Enzmatic	Vol #:	179

LET 20425	Nature's Way	Vol #:	179

LET 20426	American Institute of Eastern Medicine	Vol #:	179

LET 20427	World Nutrition, Inc.	Vol #:	179

LET 20428	American Institute of Medicine	Vol #:	179

LET 20429	LA Weight Loss Centers, Inc.	Vol #:	179

LET 20430	PatentHEALTH, LLC.	Vol #:	179

LET 20431	M. Santana, LLC.	Vol #:	179

LET 20432	SUNFOOD NUTRITION	Vol #:	179

LET 20433	Carlson	Vol #:	179

LET 20434	Carlson	Vol #:	179

LET 20435	Carlson	Vol #:	179

LET 20436	Carlson	Vol #:	179

LET 20437	Carlson	Vol #:	179

LET 20438	Carlson	Vol #:	179

LET 20439	Immunotec Research Inc.	Vol #:	179

LET 20440	Immunotec Research Inc.	Vol #:	179

LET 20441	Gronek & Associates	Vol #:	179

LET 20442	Natural Health International	Vol #:	179

LET 20443	Natural Health International	Vol #:	179

LET 20444	Natural Health International	Vol #:	179

LET 20445	Natural Health International	Vol #:	179

LET 20446	Natural Health International	Vol #:	179

LET 20447	Natural Health International	Vol #:	179

LET 20448	Enzmatic	Vol #:	179

LET 20449	Enzmatic	Vol #:	179

LET 20450	Enzmatic	Vol #:	179

LET 20451	Enzmatic	Vol #:	179

LET 20452	Enzmatic	Vol #:	179

LET 20453	Enzmatic	Vol #:	179

LET 20454	NBTY	Vol #:	179

LET 20455	NBTY	Vol #:	179



LET 20456	NBTY	Vol #:	179

LET 20457	NBTY	Vol #:	179

LET 20458	NBTY	Vol #:	179

LET 20459	NBTY	Vol #:	179

LET 20460	NBTY	Vol #:	179

LET 20461	NBTY	Vol #:	179

LET 20462	ParimePharm Health Co., Ltd.	Vol #:	179

LET 20463	NEUROSCIENCE	Vol #:	179

LET 20464	Herguan, Inc.	Vol #:	179

1998D-1232	Points to consider guidance documents on assayed&unassayed

EC 3	Ms. Kimberly Adkins	Vol #:	1

EC 4	Mrs. Marcy Thompson	Vol #:	1

EC 5	Mr. Ron Jacobson	Vol #:	1

EC 6	Ms. Maria Hitt	Vol #:	1

1998F-0196	Safe use of Selenium Yeast in Animal Feeds

NFR 4	FDA	Vol #:	1

2002D-0005	Pharmacovigilance of Veterinary Medicinal Products

EC 2	Veterinary Medical Informatics Laboratories	Vol #:	1

EC 3	Animal Health Institute	Vol #:	1

2005N-0272	Irradiation in the Production, Processing & Handling of Food

C 2948	T. Dixon	Vol #:	37

C 2949	L. Strauss	Vol #:	37

C 2950	D. S. Mclellan, Jr.	Vol #:	37

C 2951	T. Slind	Vol #:	37

C 2952	J. Groth	Vol #:	37

C 2953	J. Calderone	Vol #:	37

C 2954	R. Whitelock	Vol #:	37

C 2955	A. Delamater	Vol #:	37

C 2956	G. Mills	Vol #:	37

C 2957	J. Owens	Vol #:	37

C 2958	A. Haqqi	Vol #:	37

C 2959	L. Hilgers	Vol #:	37

C 2960	D. Gaal	Vol #:	37

C 2961	M. Wright	Vol #:	37



C 2962	E. Aiken	Vol #:	37

C 2963	M. Jones	Vol #:	37

C 2964	C. Palmer	Vol #:	37

C 2965	D. Grabow	Vol #:	37

C 2966	F. Craig	Vol #:	37

C 2967	B. Appleton	Vol #:	37

C 2968	J. Crabb	Vol #:	37

C 2969	K. Jackson	Vol #:	37

C 2970	B. Van Wicklen	Vol #:	37

C 2971	L. Adira	Vol #:	37

C 2972	L. Duke	Vol #:	37

C 2973	P. Montgomery	Vol #:	37

C 2974	R. Von Tobel	Vol #:	37

C 2975	D. Sandoval	Vol #:	37

C 2976	J. La Barre	Vol #:	37

C 2977	G. Khoury	Vol #:	37

C 2978	K. Eastin	Vol #:	37

C 2979	S. Askew	Vol #:	37

C 2980	H. Anacker	Vol #:	37

C 2981	R. Ebron	Vol #:	37

C 2982	L. Smith	Vol #:	37

C 2983	N. Cook	Vol #:	37

C 2984	O. Kim	Vol #:	37

C 2985	W. Mourant	Vol #:	37

C 2986	M. Woods	Vol #:	37

C 2987	M. Pabon	Vol #:	37

C 2988	M. Morris	Vol #:	37

C 2989	R. Robintree	Vol #:	37

C 2990	J. Treecrone	Vol #:	37

C 2991	B. Gloriod	Vol #:	37

C 2992	R. Hoppin	Vol #:	37

C 2993	S. Hand	Vol #:	37

C 2994	J. Milkent	Vol #:	37

C 2995	M. Sneddon	Vol #:	37

C 2996	M. Galleher	Vol #:	37

C 2997	G. Chernetz	Vol #:	37

C 2998	A. D. Kardoff	Vol #:	37



C 2999	S. Tyoni	Vol #:	37

C 3000	D. Morgan	Vol #:	37

C 3001	B. G. Coulter	Vol #:	37

C 3002	B. Tolles	Vol #:	37

C 3003	R. Cornish	Vol #:	37

C 3004	E. Becker	Vol #:	37

C 3005	M. Barton	Vol #:	37

C 3006	V. Lazar	Vol #:	37

C 3007	J. Benitez	Vol #:	37

C 3008	V. Pellizzer	Vol #:	37

C 3009	M. Smith	Vol #:	37

C 3010	S. Brandt	Vol #:	37

C 3011	A. Keys	Vol #:	37

C 3012	E. Grant	Vol #:	37

C 3013	M. B. Karasik	Vol #:	37

C 3014	R. King	Vol #:	37

C 3015	E. B. Pedraza	Vol #:	37

C 3016	C. Brady	Vol #:	37

C 3017	M. L. Feelings	Vol #:	37

C 3018	J. Powers	Vol #:	37

C 3019	C. Zieg	Vol #:	37

C 3020	M. Chaiken	Vol #:	37

C 3021	T. Niesytto	Vol #:	37

C 3022	J. Cody	Vol #:	37

C 3023	J. Domingue	Vol #:	37

C 3024	A. Smith	Vol #:	37

C 3025	P. Hopkins	Vol #:	37

C 3026	J. Benner	Vol #:	37

C 3027	J. Du Bois	Vol #:	37

C 3028	L. Kiser	Vol #:	37

C 3029	M. J. Lawler	Vol #:	37

C 3030	S. Howard	Vol #:	37

C 3031	L. Hames	Vol #:	37

C 3032	L. Coleman	Vol #:	37

C 3033	K. Goldstein	Vol #:	37

C 3034	A. Rickard	Vol #:	37

C 3035	A. Jones	Vol #:	37



C 3036	P. Steele	Vol #:	37

C 3037	M. Walzer	Vol #:	37

C 3038	M. Rowen	Vol #:	37

C 3039	S. Benyamin	Vol #:	37

C 3040	A. Adams	Vol #:	37

C 3041	A. M. Bucher	Vol #:	37

C 3042	T. Kulas	Vol #:	37

C 3043	S. Gano	Vol #:	37

C 3044	R. Bestwick	Vol #:	37

C 3045	C. Erb	Vol #:	37

C 3046	L. And M. Seaver	Vol #:	37

C 3047	I. Richardson	Vol #:	37

C 3048	C. Kistner	Vol #:	37

C 3049	J. Reseigh	Vol #:	37

C 3050	C. Fettis	Vol #:	37

C 3051	P. Ratcliff	Vol #:	37

C 3052	E. Johnson	Vol #:	37

C 3053	R. Burkowski	Vol #:	37

C 3054	A. Garcia	Vol #:	37

C 3055	S. Dietrich	Vol #:	37

C 3056	B. A. Stone	Vol #:	37

C 3057	C. De Leon	Vol #:	37

C 3058	G. Rudetsky	Vol #:	37

C 3059	L. Powers	Vol #:	37

C 3060	D. Korson	Vol #:	37

C 3061	S. Moseley	Vol #:	37

C 3062	G. Greiner	Vol #:	37

C 3063	J. Byram	Vol #:	37

C 3064	S. Stapler	Vol #:	37

C 3065	M. Kraus	Vol #:	37

C 3066	J. Hamilton-schultze	Vol #:	37

C 3067	C. Clapham	Vol #:	37

C 3068	R. J. Van Der Voort	Vol #:	37

C 3069	A. Konars	Vol #:	37

C 3070	D. Liolis	Vol #:	37

C 3071	C. Dolan	Vol #:	37

C 3072	N. Roberts	Vol #:	37



C 3073	T. Gordon	Vol #:	37

C 3074	R. Goodman	Vol #:	37

C 3075	L. Adams	Vol #:	37

C 3076	V. Hartman	Vol #:	37

C 3077	T. Robinson	Vol #:	37

C 3078	S. Huckins	Vol #:	37

C 3079	T. Aiello	Vol #:	37

C 3080	C. Reiher	Vol #:	37

C 3081	M. Hochman	Vol #:	37

C 3082	C. Olah	Vol #:	37

C 3083	K. Williams	Vol #:	37

C 3084	J. L.	Vol #:	37

C 3085	R. Backman	Vol #:	38

C 3086	M. Roddis	Vol #:	38

C 3087	S. Tocco	Vol #:	38

C 3088	S. Kiley	Vol #:	38

C 3089	G. Atchley	Vol #:	38

C 3090	R. Slojkowski	Vol #:	38

C 3091	C. Fertal	Vol #:	38

C 3092	C. Althage	Vol #:	38

C 3093	C. Navaroli	Vol #:	38

C 3094	E. Schwanitz	Vol #:	38

C 3095	B. Newman	Vol #:	38

C 3096	D. Williams	Vol #:	38

C 3097	B. A. Harris	Vol #:	38

C 3098	A. Jurgelski	Vol #:	38

C 3099	L. Legere	Vol #:	38

C 3100	C. Graff	Vol #:	38

C 3101	A. Emis	Vol #:	38

C 3102	A. Neal	Vol #:	38

C 3103	M. Moonjey	Vol #:	38

C 3104	C. Marshall	Vol #:	38

C 3105	M. Lefever	Vol #:	38

C 3106	T. Aprill	Vol #:	38

C 3107	P. Wentz	Vol #:	38

C 3108	M. B. Rosenbaum	Vol #:	38

C 3109	G. Giamboi	Vol #:	38



C 3110	R. Everhart	Vol #:	38

C 3111	R. Olson	Vol #:	38

C 3112	E. Emerson	Vol #:	38

C 3113	T. Baert	Vol #:	38

C 3114	G. Miller	Vol #:	38

C 3115	W. Rodrigues	Vol #:	38

C 3116	C. Slay	Vol #:	38

C 3117	C. Ishkanian	Vol #:	38

C 3118	E. Luther	Vol #:	38

C 3119	D. Barham	Vol #:	38

C 3120	D. Shurtleff	Vol #:	38

C 3121	C. Rutherford	Vol #:	38

C 3122	L. Hegenbarth	Vol #:	38

C 3123	J. Mcbride	Vol #:	38

C 3124	J. Keller	Vol #:	38

C 3125	C. Bailey	Vol #:	38

C 3126	G. Diaz	Vol #:	38

C 3127	D. Lohr	Vol #:	38

C 3128	I. Garcia	Vol #:	38

C 3129	G. Diaz	Vol #:	38

C 3130	M. Beam	Vol #:	38

C 3131	I. Adams	Vol #:	38

C 3132	C. Hanger	Vol #:	38

C 3133	A. Hammer	Vol #:	38

C 3134	G. Moore	Vol #:	38

C 3135	A. Ferre	Vol #:	38

C 3136	A. Ringler	Vol #:	38

C 3137	A. Tam	Vol #:	38

C 3138	M. Pucillo-dunphy	Vol #:	38

C 3139	K. Trepes	Vol #:	38

C 3140	A. Peradotta	Vol #:	38

C 3141	J. Operschall	Vol #:	38

C 3142	S. Hill	Vol #:	38

C 3143	J. Pszanka	Vol #:	38

C 3144	L. Sherry	Vol #:	38

C 3145	D. J. Lafond	Vol #:	38

C 3146	H. Banks	Vol #:	38



C 3147	M. Hodges	Vol #:	38

C 3148	G. Huig	Vol #:	38

C 3149	D. Sonier	Vol #:	38

C 3150	V. Bustamante	Vol #:	38

C 3151	M. Sawada	Vol #:	38

C 3152	S. Darby	Vol #:	38

C 3153	L. O'shaughnessy	Vol #:	38

C 3154	C. Tyler	Vol #:	38

C 3155	D. Hooper	Vol #:	38

C 3156	J. Jeffrey	Vol #:	38

C 3157	J. Boltz	Vol #:	38

C 3158	J. Vanderbilt	Vol #:	38

C 3159	S. Sanders	Vol #:	38

C 3160	V. Hall	Vol #:	38

C 3161	V. Goolsby	Vol #:	38

C 3162	B. Kennedy	Vol #:	38

C 3163	C. Bowen	Vol #:	38

C 3164	P. Harcarik	Vol #:	38

C 3165	S. Kent	Vol #:	38

C 3166	C. Rumps	Vol #:	38

C 3167	K. Kelly-hoffman	Vol #:	38

C 3168	C. Suggs Iv	Vol #:	38

C 3169	C. Bruncati	Vol #:	38

C 3170	E. Nshelley	Vol #:	38

C 3171	R. Carfora	Vol #:	38

C 3172	H. Hines	Vol #:	38

C 3173	P. Constantino	Vol #:	38

C 3174	J. Trader	Vol #:	38

C 3175	G. S. Khan	Vol #:	38

C 3176	R. Hodge	Vol #:	38

C 3177	C. Adkins	Vol #:	38

C 3178	R. Severin	Vol #:	38

C 3179	C. Zoll	Vol #:	38

C 3180	M. A. Soufis	Vol #:	38

C 3181	D. Green	Vol #:	38

C 3182	J. Topp	Vol #:	38

C 3183	T. Garcia Pugh	Vol #:	38



C 3184	L. Kerr	Vol #:	38

C 3185	M. Mcbride	Vol #:	38

C 3186	J. Brown	Vol #:	38

C 3187	L. Mcbride	Vol #:	38

C 3188	K. Shoop	Vol #:	38

C 3189	E. Talmadge	Vol #:	38

C 3190	N. Hediger	Vol #:	38

C 3191	P. Eaton	Vol #:	38

C 3192	N. Boyd	Vol #:	38

C 3193	L. Ertz	Vol #:	38

C 3194	S. English	Vol #:	38

C 3195	D. Ort	Vol #:	38

C 3196	D. Sanders	Vol #:	38

C 3197	R. Wickless	Vol #:	38

C 3198	B. Napier	Vol #:	38

C 3199	H. De Jesus	Vol #:	38

C 3200	C. Touby	Vol #:	38

C 3201	S. Johnston	Vol #:	38

C 3202	D. Southhard	Vol #:	38

C 3203	K. Bilodeau	Vol #:	38

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

EC 2	Mr. ian gottesman	Vol #:	1

EC 3	Miss. Wendy Endres	Vol #:	1

EC 4	PPTA	Vol #:	1

2006D-0347	Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

EXT 3	NANOGEN, Inc	Vol #:	3

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

EC 1	Mr. Brent Cowgill	Vol #:	1

EC 2	Mr. Dwayne Hann	Vol #:	1

EC 3	Mr. Philippe Burnham	Vol #:	1

EC 4	American Academy of Allergy, Asthma and Immunology	Vol #:	1

EC 5	Capital Allergy and Respiratory Disease Center	Vol #:	1

EC 6	Graceway Pharmaceuticals, LLC	Vol #:	1

EC 7	Graceway Pharmaceuticals, LLC	Vol #:	1

EC 8	Ms. Judith Clemenko	Vol #:	1



EC 9	Ms. Carol Farmer	Vol #:	1

EC 10	Mr. roger moore	Vol #:	1

EC 11	Mrs. Sara Morris	Vol #:	1

EC 12	Ms. Arlene Leonard	Vol #:	1

EC 13	Ms. Jan Faleski	Vol #:	1

EC 14	Dr. Nicholas Gross	Vol #:	1

EC 15	Mrs. Laura Podlich	Vol #:	1

EC 16	International Pharmaceutical Aerosol Consortium	Vol #:	1

EC 17	Richard J. Greene, M.D.	Vol #:	1

EC 18	University of Pennsylvania	Vol #:	1

EC 19	Dr. Natalie Pope	Vol #:	1

2007D-0125	Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

EC 1	Salt Institute	Vol #:	1

EC 2	Mr. Seth Kowitz	Vol #:	1

EC 3	Ms. Vicki Huss	Vol #:	1

2007D-0213	Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date

EC 1	Mr. Joe Public	Vol #:	1

EC 2	GlaxoSmithKline	Vol #:	1

2007D-0249	Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage

EC 1	Columbia University	Vol #:	2

2007N-0215	Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

EC 6	University of Pennsylvania Health System	Vol #:	1

EC 7	Mr. Charles Keyserling	Vol #:	1

EC 8	Mr. Charles Keyserling	Vol #:	1

EC 9	Vanderbilt University	Vol #:	1

EC 10	Dr. Vivian Fonseca	Vol #:	1

EC 11	CANYONS MEDICAL CENTER	Vol #:	1

EC 12	Camino Medical Group	Vol #:	1

EC 13	Dr. Robert Frederich	Vol #:	1

EC 14	MidState Endocrine Associates	Vol #:	1

EC 15	Dr. Alan Garber	Vol #:	1

EC 16	Arbor Research Collaborative for Health	Vol #:	1

EC 17	Dr. Pradip Jamnadas	Vol #:	1

EC 18	Dr. Peter McCullough	Vol #:	1



EC 19	Mount Sinai School of Medicine	Vol #:	1

2007N-0217	Licensure of Apheresis Blood Products; Public Workshop

EC 7	Indiana Blood Center	Vol #:	1

EC 8	Mrs. Susan Neff	Vol #:	1

2007N-0277	Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing

EC 2	NONE	Vol #:	1

EC 3	Mr. Galilee Robison	Vol #:	1

2007P-0147	Use of the Term Natural Consistent with USDA's Food Safety and Inspection Service

EC 14	Ms. BooNooNooNooS french	Vol #:	2

Page created on August 3, 2007 ue

FDA/Dockets Management