Dockets Entered on July 11, 2007

Dockets Management



Dockets Entered On July 11, 2007



Docket #	Title

2000D-1598	Voluntary Labeling for Bioengineered Foods

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

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

2004N-0226	Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010

2005D-0356	Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records

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

2005P-0464	Remove metered-dose inhalers (MDI) containing the single active moieties beclomethasone, fluticasone, and salmeterol, respectively, from the essential-use list of ozone-depleting substance

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

2006D-0480	Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food and Drug Administration

2006P-0218	To permit an abbrevation New Drug Application Triamcinolone Diacetate Suspension

2007D-0083	Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process

2007D-0118	Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products

2007D-0173	Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators

2007N-0121	Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing

2007P-0085	Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity

2000D-1598	Voluntary Labeling for Bioengineered Foods

LET 6	FDA	Vol #:	580

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

C 1423	A. Robinson	Vol #:	262

C 1424	N. de Peyster	Vol #:	262

C 1425	D. Mahoney	Vol #:	262

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

EC 525	Mrs. Eva Smith-Furgason	Vol #:	17

2004N-0226	Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010

EC 25	Mr. Duchowski Ryszard	Vol #:	2

EC 26	USANA Health Sciences-Ind. Dist.	Vol #:	2

2005D-0356	Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records

EC 6	Mrs. Jeannine Seymour	Vol #:	1

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

C 803	L. Pfeiffer	Vol #:	14

C 804	T. Wade	Vol #:	14

C 805	J. Davidson	Vol #:	14



C 806	M. Mcclain	Vol #:	14

C 807	L. Smith	Vol #:	14

C 808	A. Bean	Vol #:	14

C 809	P. H. Aldrich	Vol #:	14

C 810	A. Galynsky	Vol #:	14

C 811	J. Hyers	Vol #:	14

C 812	S. Blackman	Vol #:	14

C 813	W. Robins	Vol #:	14

C 814	H. Clarke	Vol #:	14

C 815	V. Freyholtz	Vol #:	14

C 816	R. Gustaveson	Vol #:	14

C 817	D. Hoover	Vol #:	14

C 818	L. Chaffee	Vol #:	14

C 819	D. R. Be Cotte	Vol #:	14

C 820	R. Kirby	Vol #:	14

C 821	C. Harden	Vol #:	14

C 822	G. Turner	Vol #:	14

C 823	C. Griffin	Vol #:	14

C 824	I. Mossman	Vol #:	14

C 825	M. Whitaker	Vol #:	14

C 826	B. Lenarcic	Vol #:	14

C 827	K. Merrimac	Vol #:	14

C 828	C. Skinder	Vol #:	14

C 829	J. Verry	Vol #:	14

C 830	P. Leach	Vol #:	14

C 831	T. Rice	Vol #:	14

C 832	M. Ashelman	Vol #:	14

C 833	S. Graves	Vol #:	14

C 834	C. Hull	Vol #:	14

C 835	M. Hostnik	Vol #:	14

C 836	A. Scibella	Vol #:	14

C 837	R. Royer	Vol #:	14

C 838	P. Gnehm	Vol #:	14

C 839	T.r. Mackin	Vol #:	14

C 840	E. Borunda	Vol #:	14

C 841	K. Hall	Vol #:	14

C 842	A. Mccaffray	Vol #:	14



C 843	W. Kelly	Vol #:	14

C 844	J. Krizanich	Vol #:	14

C 845	M. Gannon	Vol #:	14

C 846	J. Randle	Vol #:	14

C 847	K. Losonczy	Vol #:	14

C 848	L. Carren	Vol #:	14

C 849	C. Kenneth	Vol #:	14

C 850	J. Egan	Vol #:	14

C 851	F. Marceron	Vol #:	14

C 852	M. J. Potter	Vol #:	14

C 853	E. Kurie	Vol #:	14

C 854	J. O. Porter	Vol #:	14

C 855	J. Bernard	Vol #:	14

C 856	J. Rafferty	Vol #:	14

C 857	P. Murphy	Vol #:	14

C 858	J. Lutch	Vol #:	14

C 859	M. Lafrance	Vol #:	14

C 860	H. Ervin	Vol #:	14

C 861	V. Magilke	Vol #:	14

C 862	C. Eggert, Phd	Vol #:	14

C 863	J. And J. Fraser	Vol #:	14

C 864	J. Kopek	Vol #:	14

C 865	P. Gannon	Vol #:	14

C 866	H. Miele	Vol #:	14

C 867	A. Kuhn	Vol #:	14

C 868	J. Ortlieb	Vol #:	14

C 869	E. Hope	Vol #:	14

C 870	C. Fairbrother	Vol #:	14

C 871	A. Gibson	Vol #:	14

C 872	K. Hastings	Vol #:	14

C 873	K. Barnery	Vol #:	14

C 874	C. V. Kessler	Vol #:	14

C 875	P. Koedt	Vol #:	14

C 876	K. Merritt	Vol #:	14

C 877	J. Rico	Vol #:	14

C 878	T. Cheng Yang	Vol #:	14

C 879	M. Waterman	Vol #:	14



C 880	T. A. Zier	Vol #:	14

C 881	Pj Howell	Vol #:	14

C 882	Dr. E. PFeraco	Vol #:	14

C 883	M. Chernushin	Vol #:	14

C 884	T. Blaylock	Vol #:	14

C 885	Y. Yang	Vol #:	14

C 886	R. Johnson	Vol #:	14

C 887	A. Johnson	Vol #:	14

C 888	B. Robinson	Vol #:	14

C 889	L. S. Seymour	Vol #:	14

C 890	M. Pieper	Vol #:	14

C 891	M/m R. Anderlik	Vol #:	14

C 892	W. Drake	Vol #:	14

C 893	M. Mackenzie	Vol #:	14

C 894	J. Hedgecock	Vol #:	14

C 895	D. Compatabilities	Vol #:	14

C 896	J. Eron	Vol #:	14

C 897	J. Callahan	Vol #:	14

C 898	R. Averill	Vol #:	14

C 899	R. Succa-ruston	Vol #:	14

C 900	O. Jarsky	Vol #:	14

C 901	A. B. Bennett	Vol #:	14

C 902	J. Lewis	Vol #:	14

C 903	M. Dehart	Vol #:	14

C 904	J. Hensley	Vol #:	14

C 905	L. George	Vol #:	14

C 906	C. Olson	Vol #:	14

C 907	C. Thornburn	Vol #:	14

2005P-0464	Remove metered-dose inhalers (MDI) containing the single active moieties beclomethasone, fluticasone, and salmeterol, respectively, from the essential-use list of ozone-depleting substance



WDL 1	GlaxoSmithKline (GSK)	Vol #:	1

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

C 2	Wyeth Pharmaceuticals	Vol #:	1

2006D-0480	Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food and Drug Administration

EC 2131	Mr. Trey Looney	Vol #:	29



EC 2132	AMTA	Vol #:	29

EC 2133	Mrs. Barbara Greene-Hyduchak	Vol #:	29

EC 2134	Ms. Jordana Duncan	Vol #:	29

EC 2135	Mr. David Cook	Vol #:	29

EC 2136	Mrs. Diane Cooper	Vol #:	29

EC 2137	Mrs. Mary Hart	Vol #:	29

EC 2138	Mrs. Dionna Milem	Vol #:	29

EC 2139	Mr. RJ Barus	Vol #:	29

EC 2140	Redox Health	Vol #:	29

EC 2141	superior staffing registry for Nursing Assistants	Vol #:	29

EC 2142	Mr. John Higley	Vol #:	29

EC 2143	Ms. Catherine Adasiewicz	Vol #:	29

EC 2144	Miss. susan walton	Vol #:	29

EC 2145	Mr. Harold Turrentine	Vol #:	29

EC 2146	Ms. Emily Wagner	Vol #:	29

EC 2147	Mr. Kevin Allen	Vol #:	29

EC 2148	Mrs. Rhonda Williams	Vol #:	29

EC 2149	Ms. Karen Warnick	Vol #:	29

EC 2150	Mr. Joseph Warren	Vol #:	29

EC 2151	Miss. Jenn Man	Vol #:	29

EC 2152	Mrs. Julia Kunkowski	Vol #:	29

EC 2153	Mrs. ANNA JACOBI	Vol #:	29

EC 2154	Ms. Gale Strider	Vol #:	29

EC 2155	Ms. Darlene Holloway	Vol #:	29

EC 2156	NATIONALLY LICENSED MASSAGE THERAPIST	Vol #:	29

EC 2157	Mr. orland zales	Vol #:	29

EC 2158	Ms. Jane Williams	Vol #:	29

EC 2159	Ms. Barbra Cheadle	Vol #:	29

EC 2160	New Horizon Wellness Centers	Vol #:	29

EC 2161	Mr. Chuck Rosol	Vol #:	29

EC 2162	Mrs. Martina Dempsey	Vol #:	29

EC 2163	Mr. Norman Jones	Vol #:	29

EC 2164	Ms. April Wilson	Vol #:	29

EC 2165	Ms. Lita Radford	Vol #:	29

EC 2166	Ms. Elaine Correia	Vol #:	29

EC 2167	Mrs. Erica Carter	Vol #:	29

EC 2168	Mr. Trever Keele	Vol #:	29



EC 2169	American Massage Therapy Assoc.	Vol #:	29

EC 2170	Ms. Carol Freyder	Vol #:	29

EC 2171	Mr. Willard Horton	Vol #:	29

EC 2172	Ms. Darlene Holloway	Vol #:	29

EC 2173	Catering co. The Getaway	Vol #:	29

EC 2174	Mr. Derek Neibarger	Vol #:	29

EC 2175	Ms. Kellie Smith	Vol #:	29

EC 2176	Ms. Nancy Wilson	Vol #:	29

EC 2177	Mr. Jeffrey Mital	Vol #:	29

EC 2178	Mrs. Crystal Scordias	Vol #:	29

EC 2179	Mr. Scott Nicewonger	Vol #:	29

EC 2180	Ms. Lisa P. Leon Guerrero	Vol #:	29

EC 2181	Ms. Carlene Tapley	Vol #:	29

EC 2182	LIFE.	Vol #:	29

EC 2183	Ms. Bethanny Davis	Vol #:	29

EC 2184	Ms. Michelle E Bruce	Vol #:	29

EC 2185	Miss. Susan Heagney	Vol #:	29

EC 2186	Dr. Kim Smith	Vol #:	29

EC 2187	Ms. Yvonne Rodgers	Vol #:	29

EC 2188	Ms. Charlotte Manning	Vol #:	29

EC 2189	Ms. annette casar	Vol #:	29

EC 2190	Ms. Cynthia Goyette	Vol #:	29

EC 2191	Mr. Kevin Butcher	Vol #:	29

EC 2192	Mrs. Susan Alby	Vol #:	29

EC 2193	Mrs. Meaghan Maillet	Vol #:	29

EC 2194	Mrs. Linda Weitzel	Vol #:	29

EC 2195	Mr. charles Bull	Vol #:	29

EC 2196	Mr. Mark St. John	Vol #:	29

EC 2197	Radiance Network	Vol #:	29

EC 2198	Mrs. Susan Glave	Vol #:	29

EC 2199	Ms. Toni Ehrlich	Vol #:	29

EC 2200	Mr. Alex Pearson	Vol #:	29

EC 2201	Mr. Don Mechling	Vol #:	29

EC 2202	Ms. Margaret Folks	Vol #:	29

EC 2203	Mrs. Mary Lou Reed	Vol #:	29

EC 2204	Ms. Lor Matthews	Vol #:	29

EC 2205	Theta B Studio	Vol #:	29



EC 2206	Mr. Tim Pettry	Vol #:	29

EC 2207	Ms. Gail Selinger	Vol #:	29

EC 2208	Mr. Michael Amos	Vol #:	29

EC 2209	Mr. Michael Cepuch	Vol #:	29

EC 2210	Miss. Lori Green	Vol #:	29

EC 2211	Ms. stacey pederson	Vol #:	29

EC 2212	AMTA member	Vol #:	29

EC 2213	Miss. Meghan Goyette	Vol #:	29

EC 2214	Mr. Michael Purcell	Vol #:	29

EC 2215	Mrs. Robin Bukunus	Vol #:	29

EC 2216	Mrs. JOAN LAMPMAN	Vol #:	29

EC 2217	Mr. Van Ark	Vol #:	29

EC 2218	Ms. Steve Dodds	Vol #:	29

EC 2219	Miss. Jo Ciriani	Vol #:	29

EC 2220	Miss. vera radivojevich	Vol #:	29

EC 2221	NONE	Vol #:	29

EC 2222	FDA	Vol #:	29

EC 2223	Ms. ZSun-nee Matema	Vol #:	29

EC 2224	Ms. debbie hoerner	Vol #:	29

EC 2225	Miss. vic van	Vol #:	29

EC 2226	Mr. Ron Palmer	Vol #:	29

EC 2227	Mr. joe schafrath	Vol #:	29

EC 2228	Miss. Sue DeHart	Vol #:	29

EC 2229	Ms. Kim Wilson	Vol #:	29

EC 2230	Mr. Joseph Raffaele	Vol #:	29

EC 2231	Ms. sandra friedland	Vol #:	29

EC 2232	Mrs. janet rugg	Vol #:	29

EC 2233	Mr. Joe Gesualdi	Vol #:	29

EC 2234	Ms. Fe Tubio	Vol #:	29

EC 2235	Dr. Debbie Cowden	Vol #:	29

EC 2236	Ms. Susan McVicker	Vol #:	29

EC 2237	Mr. nancy Mohr	Vol #:	29

EC 2238	Mrs. Laura Neu	Vol #:	29

EC 2239	none	Vol #:	29

EC 2240	Ms. Kristy Wacek	Vol #:	29

EC 2241	Dr. Keith Frank	Vol #:	29

EC 2242	Healing Therapies	Vol #:	29



EC 2243	Ms. Carol Wyckoff	Vol #:	29

EC 2244	Mr. Paul Pollock	Vol #:	29

EC 2245	Ms. T Fuller	Vol #:	29

EC 2246	Miss. Andrea Eccard	Vol #:	29

EC 2247	Mr. Colin Rumbley	Vol #:	29

EC 2248	Mrs. Roberta Lewis	Vol #:	29

EC 2249	Miss. Jane Greene	Vol #:	29

EC 2250	Mr. Russ Spoto	Vol #:	29

2006P-0218	To permit an abbrevation New Drug Application Triamcinolone Diacetate Suspension

N 1	FDA	Vol #:	1

2007D-0083	Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process



C 4	Medtronic	Vol #:	1

2007D-0118	Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products

C 1	Wyeth Pharmaceuticals	Vol #:	1

2007D-0173	Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators

C 2	Consortium of Independent Reveiw Boards (CIRB)	Vol #:	1

C 3	R. Reinhard	Vol #:	1

C 4	Boehringer Ingelheim Pharmaceuticals, Inc.	Vol #:	1

2007N-0121	Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing

C 2	Lake Erie College of Osteopathic Medicine (LECOM)	Vol #:	7

C 3	Institute for Safe Medication Practices	Vol #:	7

M 1	Jeffrey Shuren, Assistant Commissioner for Policy	Vol #:	1

TS 1	Cynthia R. Pfeffer, M.D.	Vol #:	8

TS 2	Nancy M. Allen-LaPointe, Pharm.D.	Vol #:	8

TS 3	Ruth S. Day	Vol #:	8

TS 4	Michael S. Wolf, MA, MPH, PHD	Vol #:	8

TS 5	Dr. Vera Sharav, President	Vol #:	8

TS 6	John M. Coster, PhD, R.Ph	Vol #:	8

TS 7	Marissa Craddock	Vol #:	8

TS 8	Steven Heidenthal, R.Ph.	Vol #:	8

TS 9	Paul Johnson, R.Ph	Vol #:	8

TS 10	Kala L. Paul, M.D.	Vol #:	8

TS 11	Gerald K. McEvoy, Pharm.D.	Vol #:	8



TS 12	Bryan Ziegler, PharmD, MBA	Vol #:	8

TS 13	M. Alex Michaels, M.D.	Vol #:	8

2007P-0085	Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity

EC 1041	Ms. Jennifer Chapman	Vol #:	12

EC 1042	Mrs. Annika Klein	Vol #:	12

EC 1043	Mrs. Jessica Schultz-Reynolds	Vol #:	12

EC 1044	Ms. Judith Adamski	Vol #:	12

EC 1045	Ms. D Freeman	Vol #:	12

EC 1046	Ms. Julie Ward	Vol #:	12

EC 1047	Miss. Ida Taing	Vol #:	12

EC 1048	Don't Mess with Our Chocolate	Vol #:	12

EC 1049	Mrs. Monica DeLoach	Vol #:	12

EC 1050	Don't Mess With Our Chocolate	Vol #:	12

Page created on July 11, 2007 ue

FDA/Dockets Management