Dockets Entered on February 1, 2006

Dockets Management



Dockets Entered On February 17, 2006 Table of Contents



Docket #	Title

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

1981N-0022	OTC Weight Control Drug Products for Human Use

1998P-0151	Introduction Of Downed Cattle Into The Food Supply

1998P-0724	Prohibition of Cochineal Extract and Carmine Color Additives

1999N-4282	Biotechnology in the Year 2000 and Beyond; Public Meetings

2000P-1211	Establish Mandatory Pre-Market Safety Testing for GE Foods

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

2003D-0001	Nonclinical Safety Evaluation of Pediatric Drug Products

2003D-0420	Class II Special Controls Guidance Document: Pressure Regulators for Use with Medical Oxygen

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

2004D-0369	Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use

2004D-0555	Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex

2004N-0439	Current Good Manufacturing Practice for Positron Emission Tomography Drugs

2004N-0556	Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant

2004P-0223	Whole Grain Descriptive Claims

2005D-0434	Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens

2005D-0483	Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006

2005D-0505	Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System

2005N-0354	Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing

2005N-0467	Medical Devices; Radiology Devices; Reclassification of Bone Sonometers

2005N-0510	Anti-Counterfeit Drug Initiative Workshop and Vendor Display

2005P-0121	Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II

2005P-0332	amend the food definitions and standards of identity for bakery products (21 C.F.R. Part 136) and to repeal the Food definition and standard identitiy and quality for frozen cherry pie

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

2005P-0417	ANDA for Tretinoin Cream Drug Products in Strengths of 0.0375% and 0.075%

2006F-0058	Poly (iminoimidocarbonyliminoimidocarbonyliminohexamethylene) Hydrochloride (FAP 6B4764)

2006F-0059	Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)

2006M-0075	P020024 - AMPLATZER Duct Occluder and 180 Delivery System, Approved 5/14/03

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

LET 149	CDER/ONP to Novartis Consumer Health Inc	Vol #:	257

1981N-0022	OTC Weight Control Drug Products for Human Use

EC 2	Mr. Rainer Becker	Vol #:	98

1998P-0151	Introduction Of Downed Cattle Into The Food Supply

C 7520	N. Rich	Vol #:	319



C 7521	N. Rich	Vol #:	319

1998P-0724	Prohibition of Cochineal Extract and Carmine Color Additives

EC 12	Natural Health Ambassadors	Vol #:	1

EC 13	Ms. Doris Lin	Vol #:	1

EC 14	Dr. Arthur Church	Vol #:	1

1999N-4282	Biotechnology in the Year 2000 and Beyond; Public Meetings

C 18249	S. Orrock	Vol #:	516

2000P-1211	Establish Mandatory Pre-Market Safety Testing for GE Foods

C 12843	S. Orrock	Vol #:	806

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

C 533	Dr. J. Scott	Vol #:	45

C 534	Pharmaceutical Research and Manufacturers of America (PhRMA)	Vol #:	45

2003D-0001	Nonclinical Safety Evaluation of Pediatric Drug Products

GDL 2	Guidance	Vol #:	1

NAD 2	FDA	Vol #:	1

2003D-0420	Class II Special Controls Guidance Document: Pressure Regulators for Use with Medical Oxygen

GDL 1	Guidance	Vol #:	1

NAD 1	FDA	Vol #:	1

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

C 48	C. Gonzales	Vol #:	5

2004D-0369	Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use

C 99	American Farm Bureau Federation et al.	Vol #:	15

2004D-0555	Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex

C 13	Gay Men's Health Crisis (GMHC)	Vol #:	1

C 14	National Family Planning & Reproductive Health Association	Vol #:	1

C 15	J. Buehler, MD	Vol #:	1

EC 28	multiple health organizations	Vol #:	1

EC 29	Gay Men's Health Crisis	Vol #:	1

EC 30	San Francisco AIDS Foundation	Vol #:	1

EC 31 Attachment	Rollins School of Public Health, Emory University	Vol #:	1

EC 32	SIECUS	Vol #:	1



EC 33 Attachment	The AIDS Institute	Vol #:	1

EC 34 Attachment	The Center for HIV Law and Policy	Vol #:	1

EC 35	Illnois Caucus for Adolescent Health	Vol #:	1

EC 36	American Social Health Association	Vol #:	1

EC 37 Attachment	various organizations	Vol #:	1

EC 38	NFPRHA	Vol #:	1

EC 39	Planned Parenthood Federation of America, Inc.	Vol #:	1

EC 40	American Social Health Association	Vol #:	1

EC 41	National Coalition of STD Directors	Vol #:	1

2004N-0439	Current Good Manufacturing Practice for Positron Emission Tomography Drugs

C 8	Academy of Molecular Imaging (AMI)	Vol #:	1

2004N-0556	Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant

C 6	J. Buehler, MD	Vol #:	1

EC 26	Rollins School of Public Health, Emory University	Vol #:	1

EC 27	Mrs. Patricia Morris	Vol #:	1

EC 28	U.S. House of Representatives	Vol #:	1

EC 29	National Coaliton of STD Directors	Vol #:	1

EC 30	American Social Health Association	Vol #:	1

EC 31	National Coaltion of STD Directors	Vol #:	1

EC 32	Mayer Laboratories	Vol #:	1

EC 33	Oceans Seven, Int'l	Vol #:	1

EC 34	Condomania.com	Vol #:	1

2004P-0223	Whole Grain Descriptive Claims

LET 4	University of Minnesota	Vol #:	5

2005D-0434	Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens

C 1	Gen-Probe	Vol #:	1

2005D-0483	Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006

EC 5	Ms. Polly Peterson Stout	Vol #:	1

2005D-0505	Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System

GDL 1	Guideline	Vol #:	1

NAD 1	FDA	Vol #:	1

2005N-0354	Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing



C 6	American Osteopathic Association (AOA)	Vol #:	4

C 7	Y. Bokhour	Vol #:	4

EC 435	Mrs. Judy Wood	Vol #:	10

EC 436	Dalkon Shield Information Network	Vol #:	10

2005N-0467	Medical Devices; Radiology Devices; Reclassification of Bone Sonometers

BKG 1 References	References 1-3	Vol #:	1

NPR 1	FDA	Vol #:	1

2005N-0510	Anti-Counterfeit Drug Initiative Workshop and Vendor Display

EC 1	Covert Security Solutions, Inc.	Vol #:	1

EC 2	FFF Enterprises	Vol #:	1

EC 3 Attachment	H. D. Smith	Vol #:	1

2005P-0121	Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II

C 10	EBI., L.P.	Vol #:	3

2005P-0332	amend the food definitions and standards of identity for bakery products (21 C.F.R. Part 136) and to repeal the Food definition and standard identitiy and quality for frozen cherry pie



LET 1	HFS-800 to American Bakers Association	Vol #:	1

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

C 739	E. Stern	Vol #:	13

C 740	M. Johnson	Vol #:	13

C 741	L. Lenhart	Vol #:	13

C 742	C. Cellucei	Vol #:	13

C 743	W. Graham	Vol #:	13

C 744	N. Guerin	Vol #:	13

C 745	Eligible	Vol #:	13

C 746	L. Wofford	Vol #:	13

C 747	American Academy of Family Physicians (AAFP)	Vol #:	13

C 748	Eligible	Vol #:	13

C 749	L. Nishos	Vol #:	13

C 750	L. Nishos	Vol #:	13

C 751	L. Clemens	Vol #:	13

C 752	J. Jane	Vol #:	13

C 753	S. Dudavitz	Vol #:	13

C 754	C. Shenkin	Vol #:	13

C 755	R. Cary	Vol #:	13



C 756	K. Gliebe	Vol #:	13

C 757	J. Green	Vol #:	13

C 758	F. Masquat	Vol #:	13

C 759	L. Petcock	Vol #:	13

C 760	J. Martlock	Vol #:	13

C 761	H. Cerny	Vol #:	13

C 762	J. Sciabbarrasi, M.D.	Vol #:	13

C 763	P. Ducote	Vol #:	13

C 764	B. Simmons	Vol #:	13

C 765	R. Smith	Vol #:	13

C 766	J. Reed	Vol #:	13

C 767	D. Roll	Vol #:	13

C 768	M. Allgood	Vol #:	13

C 769	C. Tzauellas	Vol #:	13

C 770	J. Tew	Vol #:	13

C 771	B. Lake	Vol #:	13

C 772	G. Denyst	Vol #:	13

C 773	M. Maher	Vol #:	13

C 774	L. LeBlanc	Vol #:	13

C 775	K. Best	Vol #:	13

C 776	L. Millas	Vol #:	13

C 777	K. Miller	Vol #:	13

C 778	P. Hall, D.O.	Vol #:	13

C 779	J. Froklyn	Vol #:	13

C 780	T. Carlton	Vol #:	13

C 781	N. Greene	Vol #:	13

C 782	Eligible	Vol #:	13

C 783	K. Pearson	Vol #:	13

C 784	D. Crouch	Vol #:	13

C 785	S. Ingram	Vol #:	13

C 786	C. Johnson	Vol #:	13

C 787	H. Clark	Vol #:	13

C 788	J. Steimke	Vol #:	13

C 789	J. Cannedy	Vol #:	13

C 790	A. Bly	Vol #:	13

C 791	D. Maryan	Vol #:	13

C 792	B. Edwards, MD	Vol #:	13



C 793	G. Denyst	Vol #:	13

C 794	M. Jasken	Vol #:	13

C 795	S. Bygd	Vol #:	13

C 796	L. Bastian	Vol #:	13

C 797	L. LeNeau	Vol #:	13

C 798	E. Klarfeld	Vol #:	13

C 799	M. Stockwell	Vol #:	13

C 800	M. Reed	Vol #:	13

C 801	N. Barry	Vol #:	13

C 802	L. Bruhl	Vol #:	13

C 803	D. Hammond	Vol #:	13

C 804	E. Clair	Vol #:	13

C 805	P. Cordes	Vol #:	13

C 806	R. Richardson	Vol #:	13

C 807	S. Stern, MD, FACOG, FACS	Vol #:	13

C 808	M. Diciliano	Vol #:	13

C 809	L. Long	Vol #:	13

C 810	J. Durham	Vol #:	13

C 811	P. Ragsdale	Vol #:	13

C 812	M. Nicholson	Vol #:	13

C 813	M. Hensey	Vol #:	13

C 814	J. Landers	Vol #:	13

C 815	J. Linde	Vol #:	13

C 816	T. McCoke	Vol #:	13

C 817	J. George	Vol #:	13

C 818	B. Beatz	Vol #:	13

C 819	W. Thornton	Vol #:	13

C 820	L. Yakatan	Vol #:	13

C 821	D. Cory	Vol #:	13

C 822	B. Waddell	Vol #:	13

C 823	S. Q.	Vol #:	13

EC 2889	Dr. Stephanie Amspaugh	Vol #:	14

EC 2890	vitally interested consumer	Vol #:	14

EC 2891	Resource Management, Ft Knox	Vol #:	14

EC 2892	Miss. K C	Vol #:	14

EC 2893	Mrs. Angela Dann	Vol #:	14

EC 2894	Mrs. Lorraine Garpner	Vol #:	14



EC 2895	Mrs. Heather Falcon	Vol #:	14

EC 2896	Mrs. Anita W Duncan	Vol #:	14

EC 2897	Mrs. Linda Suermann	Vol #:	14

EC 2898	Ms. Rosel Pine	Vol #:	14

EC 2899	Mrs. Virginia Piccirilli	Vol #:	14

EC 2900	Mrs. Elizabeth Reynolds	Vol #:	14

EC 2901	Mrs. Karen Reno	Vol #:	14

EC 2902	TYLER OBSTETRICS	Vol #:	14

EC 2903	Dr. Susan DeNicola	Vol #:	14

EC 2904	Mrs. Geraldine Baker	Vol #:	14

EC 2905	Ms. Judie Harvey	Vol #:	14

EC 2906	Ms. Sarah Eck	Vol #:	14

EC 2907	Renfro Engineering	Vol #:	14

EC 2908	Mrs. Mary Brannam	Vol #:	14

EC 2909	Ms. Debra Patterson	Vol #:	14

EC 2910	Mrs. Michelle Sylivant	Vol #:	14

EC 2911	Mrs. Diane Porter	Vol #:	14

EC 2912	Mrs. Kimberle Ganzer-Wiley	Vol #:	14

EC 2913	Mrs. Janai Mes	Vol #:	14

EC 2914	Mrs. Lynn Cressy	Vol #:	14

EC 2915	Ms. Pamela Gibbens	Vol #:	14

EC 2916	Ms. Peggy Dean	Vol #:	14

EC 2917	Mrs. Carla Lyles	Vol #:	14

EC 2918	Mrs. Dawn Kenward	Vol #:	14

EC 2919	Mrs. Lynn Jackson	Vol #:	14

EC 2920	Ms. Stephanie Lou Haymond	Vol #:	14

EC 2921	Mrs. Susan Adams	Vol #:	14

EC 2922	Mrs. Amy Yates	Vol #:	14

EC 2923	Dr. peter bongiovanni	Vol #:	14

EC 2924	Ms. Jennifer Johnson	Vol #:	14

EC 2926	Mrs. Irlean Keyes	Vol #:	14

EC 2928	Mrs. Carol Church	Vol #:	14

EC 2931	Mrs. Rachel Harmel	Vol #:	14

EC 2932	Citizen of US	Vol #:	14

EC 2935	Mrs. Cindy Powell	Vol #:	14

EC 2937	Mrs. Sue Morgan	Vol #:	14

EC 2940	Ms. Jen Johnson	Vol #:	14



EC 2942	Mrs. Mary Jennifer Hempstead	Vol #:	14

EC 2944	none	Vol #:	14

EC 2945	none	Vol #:	14

EC 2946	Mrs. Margueritte Wilson	Vol #:	14

EC 2947	Mrs. Ann Fulkerson	Vol #:	14

EC 2949	Mrs. sandra lager	Vol #:	14

EC 2951	Ms. Julie Bakerville	Vol #:	14

EC 2952	Mrs. Laura Kubalskli	Vol #:	14

EC 2953	Mrs. Laura Kubalski	Vol #:	14

EC 2955	Mrs. Debra Stephens	Vol #:	14

EC 2956	Ms. Rebecca Harmon	Vol #:	14

EC 2957	Ms. Deborah LaBorde	Vol #:	14

EC 2958	Ms. Mary Johnson	Vol #:	14

EC 2959	Mrs. Terri Cox	Vol #:	14

EC 2960	Mrs. Jennifer Ford	Vol #:	14

EC 2961	Soteria Health	Vol #:	14

EC 2962	Mrs. Rhonda Sebastian	Vol #:	14

EC 2963	Ms. marisa walker	Vol #:	14

EC 2964	Ms. Mary Stanke	Vol #:	14

EC 2965	Ms. donna meade	Vol #:	14

EC 2966	Mr. Kevin Overton	Vol #:	14

EC 2967	Mr. Mike Moore	Vol #:	14

EC 2968	Mrs. Laura Elkins	Vol #:	14

EC 2969	Ms. Lanna Seuret	Vol #:	14

EC 2970	Ms. Patricia Peet	Vol #:	14

EC 2971	Ms. Gina Orlando	Vol #:	14

EC 2972	Mrs. Celeste Bishop	Vol #:	14

EC 2973	Mrs. Marla Trosper	Vol #:	14

EC 2974	Mrs. ER Moore	Vol #:	14

EC 2975	Ms. Dawn DelMonte	Vol #:	14

EC 2976	Nutritional Medicine Associates	Vol #:	14

EC 2977	Mrs. Linda Bufton	Vol #:	14

EC 2978	Mrs. Lori Meyer	Vol #:	14

EC 2979	Mrs. Silvy Fauconnier-Berman	Vol #:	14

EC 2980	Mr. Royston Cadenhead	Vol #:	14

EC 2981	Ms. Donna Davis	Vol #:	14

EC 2982	Ms. Carol Barreiro	Vol #:	14



EC 2983	Mrs. Cynthia Casper	Vol #:	14

EC 2984	Mrs. Cynthia Casper	Vol #:	14

EC 2985	Mrs. Cynthia Casper	Vol #:	14

EC 2986	Mrs. Elaina Richardson	Vol #:	14

EC 2987	Mrs. Dorothy Wilkes	Vol #:	14

EC 2988	Ms. Lynn Razaitis	Vol #:	14

EC 2989	Ms. Ruth Tschirhart	Vol #:	14

EC 2990	Ms. MARLENE EAKMAN	Vol #:	14

EC 2991	Mrs. Shelley Surber	Vol #:	14

EC 2992	Mrs. Debra Fox	Vol #:	14

EC 2993	Ms. Linda Buie	Vol #:	14

EC 2994	Ms. Connie Montgomery	Vol #:	14

EC 2995	Ms. Jill Nienhiser	Vol #:	14

EC 2996	Ms. Lynne Aldrich	Vol #:	14

EC 2997	Mrs. Debbie Moriarty	Vol #:	14

EC 2998	Ms. Helen Donna	Vol #:	14

EC 2999	Ms. Sue Chapin	Vol #:	4

EC 3000	Ms. Carol Williams	Vol #:	14

EC 3001	Ms. Roberta Walker	Vol #:	14

EC 3002	Ms. Mary Laufmann	Vol #:	14

EC 3003	Mrs. Dana Carlson	Vol #:	14

EC 3004	Ms. Tamara L Jones	Vol #:	14

EC 3005	Ms. Christal Oravets	Vol #:	14

EC 3006	Ms. Mary Hicklin	Vol #:	14

EC 3007	Mr. Robert Marchant	Vol #:	14

EC 3008	Klondis	Vol #:	14

EC 3009	Montefiore Medical Center	Vol #:	14

EC 3010	Bills Baths	Vol #:	14

EC 3011	Dr. Curtis Johnson	Vol #:	14

EC 3012	The Loft	Vol #:	14

EC 3013	Ms. Nancy C. Walker	Vol #:	14

EC 3014	Mrs. Karen L. Brown	Vol #:	14

EC 3015	Mrs. Nancy Brechnitz	Vol #:	14

EC 3016	Ms. Mary Erwin	Vol #:	14

EC 3017	Mrs. Kelly Sutton	Vol #:	14

EC 3018	Ms. Susan Williams	Vol #:	14

EC 3019	My self	Vol #:	14



EC 3020	Ms. Phyllis Myer	Vol #:	14

EC 3021	Ms. Susan Helms	Vol #:	14

EC 3022	Mrs. Maureen Masters	Vol #:	14

EC 3023	Mr. Randy Otts	Vol #:	14

EC 3024	Mrs. Ruthann Huber	Vol #:	14

EC 3025	Mrs. Carolyn Perkins	Vol #:	14

EC 3026	Mrs. Chris Geil	Vol #:	14

EC 3027	Ms. Ann Barrett-Gardenhire	Vol #:	14

EC 3028	Mrs. Linda Littlejohn	Vol #:	14

EC 3029	Ms. Judith Nerbetski	Vol #:	14

EC 3030	Mrs. Sheryl Budelier Perez	Vol #:	14

EC 3031	Mrs. rebecca radford-chan	Vol #:	14

EC 3032	MidMichigan Health Systems	Vol #:	14

EC 3033	Ms. Nancy Chen	Vol #:	14

EC 3034	Mrs. LB Ampleman	Vol #:	14

EC 3035	Mrs. Susan Cotton	Vol #:	14

EC 3036	Mr. james jhang	Vol #:	14

EC 3037	Mrs. Bonnie Wernick	Vol #:	14

EC 3038	Mrs. Violet O'Brien	Vol #:	14

EC 3039	Ms. Rebbeca Howard	Vol #:	14

EC 3040	Ms. Karen Schoen	Vol #:	14

EC 3041	Ms. Donna Mae Travis	Vol #:	14

EC 3042	Mrs. Cheryl Rathmann	Vol #:	14

EC 3043	Miss. Linda Foshee	Vol #:	14

EC 3044	Mrs. Cheryl DuFour	Vol #:	14

EC 3045	Mrs. Sirkku-Leena Wilson	Vol #:	14

EC 3046	Mrs. Krista Escobar	Vol #:	14

EC 3047	Ms. Shelly Schmaltz	Vol #:	14

EC 3048	Mrs. Margaret Bowden	Vol #:	14

EC 3049	Mrs. Dorothy Baumgardner	Vol #:	14

EC 3050	Mrs. Cheryl O'Leary	Vol #:	14

EC 3051	Dr. Melissa Smith	Vol #:	14

EC 3052	Ms. g powers	Vol #:	14

EC 3053	HealthPath,LLC	Vol #:	14

EC 3054	Mrs. Bonnie Sura	Vol #:	14

EC 3055	Ms. Marie Peters	Vol #:	14

EC 3056	Ms. Peggy Kelso	Vol #:	14



EC 3057	Ms. Therese Kelly	Vol #:	14

EC 3058	Mrs. kristin Stone	Vol #:	11

EC 3059	Ms. Sheila Konecke	Vol #:	11

EC 3060	Ms. Suzanne Bast	Vol #:	11

EC 3061	Ms. Debra Sotka	Vol #:	11

EC 3062	Ms. Maria Lesan	Vol #:	11

EC 3063	Ms. Ssylvia Ward	Vol #:	11

EC 3064	Miss. patricia grimes	Vol #:	11

EC 3065	Mrs. Karen Sochon	Vol #:	11

EC 3066	Ms. Roberta Oswald	Vol #:	11

EC 3067	Mrs. Gail Zeeb	Vol #:	11

EC 3068	common citizen	Vol #:	11

EC 3069	Mrs. Lynn Hall	Vol #:	11

EC 3070	Mr. Robert Rousseau	Vol #:	11

EC 3071	Mrs. Paula Kasper	Vol #:	14

EC 3072	Ms. Tammy Lomonaco	Vol #:	14

EC 3073	Ms. Kelly Kesner	Vol #:	14

EC 3074	Ms. Louise Finn	Vol #:	14

EC 3075	Mr. Sanford Guberman	Vol #:	14

EC 3076	Mrs. Sheryl Knight	Vol #:	14

EC 3077	Mrs. Corry Susong	Vol #:	14

EC 3078	Mrs. Margie Schlicter	Vol #:	14

EC 3079	Ms. Dawna Maloy	Vol #:	14

EC 3080	Dr. Douglas Roberts	Vol #:	14

EC 3081	Ms. debra roberts	Vol #:	14

EC 3082	Mrs. LYNN SCHODTLER	Vol #:	14

EC 3083	Mrs. PAMELA PASANT	Vol #:	14

EC 3084	n/a	Vol #:	14

EC 3086	Mrs. Laura Angotti	Vol #:	14

EC 3087	Ms. Betty Phillips	Vol #:	14

EC 3088	Ms. Mary Redmond	Vol #:	14

EC 3089	Mrs. Katelon T. Jeffereys	Vol #:	14

EC 3090	Ms. Cathleen Candey	Vol #:	14

EC 3091	Mrs. Kristine Lill	Vol #:	14

EC 3092	Mrs. Kathy Slick	Vol #:	14

EC 3093	Ms. Gabriele kohlieber	Vol #:	14

EC 3094	Ms. Janet Shaffer	Vol #:	14



EC 3095	Mrs. Cheryl Lukachek	Vol #:	14

EC 3096	Ms. Heidi Harrigan	Vol #:	14

EC 3097	Mrs. Mary Jo Drager	Vol #:	14

EC 3098	Ms. geraldine russell	Vol #:	14

EC 3099	NONE	Vol #:	14

EC 3100	Ms. Mary Jahn	Vol #:	14

EC 3101	Ms. Tami Morrison	Vol #:	14

EC 3102	US Army Tank Automotive Command	Vol #:	14

EC 3103	Ms. Susan Parker Leigh	Vol #:	14

EC 3104	Ms. Deborah Bolin	Vol #:	14

EC 3105	Mrs. Lynn Keener	Vol #:	14

EC 3106	Mrs. Melanie Trimmer	Vol #:	14

EC 3107	Ms. Barbara Duncan	Vol #:	14

EC 3108	Mrs. Brenda Eilenberger	Vol #:	14

EC 3109	Ms. Wendy Siceloff	Vol #:	14

EC 3110	WCCF	Vol #:	14

EC 3111	Mrs. Susan Fischer	Vol #:	14

EC 3112	Mrs. Shannon Kane	Vol #:	14

EC 3113	Ms. Sharrhan Williamson	Vol #:	14

EC 3114	Mrs. Valeria Foreman	Vol #:	14

EC 3115	Ms. V CHIARA	Vol #:	14

EC 3116	Mrs. Patti Herron	Vol #:	14

EC 3117	Mrs. m castell	Vol #:	14

EC 3118	Mr. Jon Edwards	Vol #:	14

EC 3119	Mrs. Connie Morris	Vol #:	14

EC 3120	Mrs. Joyce Wine	Vol #:	14

EC 3121	Mrs. Madhu Lulla	Vol #:	14

EC 3122	Ms. Lydia Thompson	Vol #:	14

EC 3123	Mrs. Theresa Allison	Vol #:	14

EC 3124	Mr. James Justus	Vol #:	14

EC 3125	Mrs. Helen Humphrey	Vol #:	14

EC 3126	Miss. Hilary Archuleta	Vol #:	14

EC 3127	Cleveland VA Medical Center	Vol #:	14

EC 3128	Mrs. Carrie Hahn	Vol #:	14

EC 3129	Mrs. Mary Henry	Vol #:	14

EC 3130	Ms. Tommi Holub	Vol #:	14

EC 3131	Mrs. Pat Hillard	Vol #:	14



EC 3132	Mrs. Dayna Tracy	Vol #:	14

EC 3133	Mrs. Lynn Hughes	Vol #:	14

EC 3134	Dr. Thomas Mathews	Vol #:	14

EC 3135	Mrs. Vicky Bettis	Vol #:	14

EC 3136	Mrs. Sherry Loeb	Vol #:	14

EC 3137	Dr. Susan Ketterer	Vol #:	14

EC 3138	Miss. Delores Owen	Vol #:	14

EC 3139	Mrs. Mary Bergstrom	Vol #:	14

EC 3140	Mrs. Rosemary Rahm	Vol #:	14

EC 3141	Ms. Holly Davis	Vol #:	14

EC 3142	Ms. Jane Scherrer	Vol #:	14

EC 3143	Ms. karen duffy	Vol #:	14

EC 3144	Ms. Joanne Bernardi	Vol #:	14

EC 3145	Ms. B. Haynes	Vol #:	14

EC 3146	Ms. Rose Burr	Vol #:	14

EC 3147	Ms. Debby Smetzer	Vol #:	14

EC 3148	Mr. Bruce Youngberg	Vol #:	14

EC 3149	Mrs. Sherry Maxwell	Vol #:	14

EC 3150	Ms. Helen Waters	Vol #:	14

EC 3151	Ms. tara scaife	Vol #:	14

EC 3152	Mrs. Jennifer Morrison	Vol #:	14

EC 3153	Mrs. MARLENE HERBST	Vol #:	14

EC 3154	Mrs. Donna Lawhon	Vol #:	14

EC 3155	Ms. Wendy Neuenhaus	Vol #:	14

EC 3156	Dr. Luke Bucci	Vol #:	14

EC 3157	Mrs. Nancy Hankin	Vol #:	14

EC 3158	Ms. Holly Zellweger	Vol #:	14

EC 3159	Mrs. Beverly Switter	Vol #:	14

EC 3160	Mrs. Nancy Plum	Vol #:	14

EC 3161	Mrs. Carol Straquadine	Vol #:	14

EC 3162	Mrs. Alice Crandall	Vol #:	14

EC 3163	Mr. IRVIN B. WILLARD	Vol #:	14

EC 3164	Dr. Kay King	Vol #:	14

EC 3165	Dr. Elaine Folayan	Vol #:	14

EC 3166	Ms. Sandra Harrison	Vol #:	14

EC 3167	Ms. Karen Hillebrand	Vol #:	14

EC 3168	Ms. Alexis King	Vol #:	14



EC 3169	Ms. Melanie Cambron	Vol #:	14

EC 3170	SELF	Vol #:	14

EC 3171	Ms. Gayle Paulson	Vol #:	14

EC 3172	Mrs. Kit Burchfield	Vol #:	14

EC 3173	none	Vol #:	14

EC 3174	Mrs. Dena Kline	Vol #:	14

EC 3175	Mrs. Lisa Roper	Vol #:	14

EC 3176	Ms. Patricia Bohn	Vol #:	14

EC 3177	Personal	Vol #:	14

EC 3178	Mrs. Beverly Emick	Vol #:	14

EC 3179	private citizen	Vol #:	14

EC 3180	Mr. David Benson	Vol #:	14

EC 3181	Mrs. Raj Inder Khalsa	Vol #:	14

EC 3182	Mr. Gordon Ashcom	Vol #:	14

EC 3183	Mrs. Kendra Verhagen	Vol #:	14

EC 3184	Ms. Margaret DiFrank	Vol #:	14

EC 3185	Mrs. Judy Martin	Vol #:	14

EC 3186	Ms. brenda shaw	Vol #:	14

EC 3187	Mrs. Patsy Austin	Vol #:	14

EC 3188	Mrs. Penny Georg	Vol #:	14

EC 3189	Mrs. Bobbi Klebba	Vol #:	14

EC 3190	Mr. Al Bettis	Vol #:	14

EC 3191	Mrs. Barbara Kimmel	Vol #:	14

EC 3192	Mrs. Bobbi Klebba	Vol #:	14

EC 3193	Mrs. Elizabeth Bald	Vol #:	14

EC 3194	Mrs. mary johnson	Vol #:	14

EC 3195	Ms. Rosemarie Waiand	Vol #:	14

EC 3196	Ms. Rachel Schneiderman	Vol #:	14

EC 3197	Arbonne International	Vol #:	14

EC 3198	Ms. Alixe Knight	Vol #:	14

EC 3199	Mrs. Christy Janes	Vol #:	14

EC 3200	Mrs. Elice Strickland	Vol #:	14

EC 3201	Mrs. Rhnee Samudio	Vol #:	14

EC 3202	Ms. Victoria Hamilton	Vol #:	14

EC 3203	Mrs. Kimberlee Hayward	Vol #:	14

EC 3204	Mrs. Sharlene Dybowski	Vol #:	14

EC 3205	Mrs. Lynda Bratcher	Vol #:	14



EC 3206	Mrs. Caroline Spencer	Vol #:	14

EC 3207	Mrs. Daryl Slye	Vol #:	14

EC 3208	Mr. Stephen Shafer	Vol #:	14

EC 3209	Mr. victor flaherty	Vol #:	14

EC 3210	Mrs. D P Di Raimondo	Vol #:	14

EC 3211	Ms. Nancy McDermott	Vol #:	14

EC 3212	Mrs. Gloria Swift	Vol #:	14

EC 3213	Ms. Debra Hofacre	Vol #:	14

EC 3214	Mr. Brent Mercer	Vol #:	14

EC 3215	Mrs. Jean Lollio	Vol #:	14

EC 3216	Mrs. karen lee	Vol #:	14

EC 3217	Ms. Kristine Mitchell	Vol #:	14

EC 3218	N/A	Vol #:	14

EC 3219	Mrs. Elaine Lack	Vol #:	14

EC 3220	Mrs. Joyce Lewis	Vol #:	14

EC 3221	Mrs. judy williams	Vol #:	14

2005P-0417	ANDA for Tretinoin Cream Drug Products in Strengths of 0.0375% and 0.075%

C 1	Johnson & Johnson Consumer & Personal Products Worldwide (J&JCPPW)	Vol #:	1

2006F-0058	Poly (iminoimidocarbonyliminoimidocarbonyliminohexamethylene) Hydrochloride (FAP 6B4764)

NFL 1	FDA	Vol #:	1

2006F-0059	Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)

EA 1	Environmental Assessment	Vol #:	1

NFL 1	FDA	Vol #:	1

2006M-0075	P020024 - AMPLATZER Duct Occluder and 180 Delivery System, Approved 5/14/03

AAV 1	AGA Medical Corporation	Vol #:	1

Page created on March 7, 2006 kk

FDA/Dockets Management