Dockets Entered on February 23, 2006

Dockets Management



Dockets Entered On February 23, 2006 Table of Contents



Docket #	Title

1980N-0476	Antifungal Drug Products for OTC Human Use

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

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

2000N-1269	Labeling for human prescription drug/Biologic Products

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

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

2003N-0312	Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds

2005N-0262	Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program

2005N-0488	Animal Drug User Fee Act; Public Meeting

2005P-0267	Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons

2005P-0319	Determination of PHENERGAN (Promethazine hydrochloride) 12.5mg and 50mg tablets

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

2005P-0459	To enforce ban on carbon monoxide gas in fresh meat packaging

2006D-0044	Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

2006P-0002	Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)

2006P-0007	Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.

2006P-0085	To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements

2006P-0086	To declare that the drug product, Butalbital, 50 mg and acetaminophen, 300 mg Tablets, is suitable for consideration in an abbreviated new drug application (ANDA).

1980N-0476	Antifungal Drug Products for OTC Human Use

ACK 2	HFA-305 to Mr. Jess F. Clarke, Jr.	Vol #:	20

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

C 2	Eligible	Vol #:	1

C 3	C. Green	Vol #:	1

C 4	M. Donahue	Vol #:	1

C 5	C. Blackwelder	Vol #:	1

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

C 18250	M. Crego	Vol #:	516

C 18251	J. Nicolow	Vol #:	516

C 18252	J. Caswell	Vol #:	516

2000N-1269	Labeling for human prescription drug/Biologic Products

C 60	Health Care Advocacy Alliance (HCAA)	Vol #:	5

C 61	California Academy of Physician Assistants (CAPA)	Vol #:	5



C 62	National Association of Hispanic Nurses (NAHN)	Vol #:	5

C 63	Colorado Council of Black Nurses, Inc.	Vol #:	5

C 64	The Literacy Council	Vol #:	5

C 65	Epilepsy Foundation	Vol #:	5

C 66	Civil Justice Association of California	Vol #:	5

C 67	Epilepsy Foundation Middle and West Tennessee	Vol #:	5

C 68	Osteopathic Physicians & Surgeons of California (OPSC)	Vol #:	5

LET 1	HF-40 to Health Care Advocacy Alliance (HCAA)	Vol #:	5

LET 2	HF-40 to California Academy of Physician Assistants (CAPA)	Vol #:	5

LET 3	HF-40 to National Association of Hispanic Nurses (NAHN)	Vol #:	5

LET 4	HF-40 to Colorado Council of Black Nurses, Inc.	Vol #:	5

LET 5	HF-40 to The Literacy Council	Vol #:	5

LET 6	HF-40 to Epilepsy Foundation	Vol #:	5

LET 7	HF-40 to Civil Justice Association of California	Vol #:	5

LET 8	HF-40 to Epilepsy Foundation Middle and West Tennessee	Vol #:	5

LET 9	HF-40 to Osteopathic Physicians & Surgeons of California (OPSC)	Vol #:	5

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

C 12844	M. Crego	Vol #:	806

C 12845	J. Nicolow	Vol #:	806

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

C 1367	J. Caswell	Vol #:	259

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

C 535	No signature	Vol #:	45

2003N-0312	Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds

C 12	American Feed Industry Association (AFIA)	Vol #:	6

2005N-0262	Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program

LET 7	AstraZeneca Pharmaceuticals, LP	Vol #:	2

LET 8	GlaxoSmithKline (GSK)	Vol #:	2

2005N-0488	Animal Drug User Fee Act; Public Meeting

N 1	FDA	Vol #:	1

2005P-0267	Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons

C 84	American Academy of Anesthesiologist Assistants (AAAA)	Vol #:	20



2005P-0319	Determination of PHENERGAN (Promethazine hydrochloride) 12.5mg and 50mg tablets

LET 2	Sheppard Mullin Richter & Hampton, LLP	Vol #:	1

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

C 824	R. Stewart	Vol #:	13

C 825	S. Stockler	Vol #:	13

C 826	E. Merckel	Vol #:	13

C 827	Eligible	Vol #:	13

C 828	J. Lindsey	Vol #:	13

C 829	D. Vukonich	Vol #:	13

C 830	J. Minzel	Vol #:	13

C 831	K. Wong	Vol #:	13

C 832	N. Albright	Vol #:	13

C 833	K. Koch	Vol #:	13

C 834	Eligible	Vol #:	13

C 835	C. Hawkins	Vol #:	13

C 836	M. Bond	Vol #:	13

C 837	S. Hermanson	Vol #:	13

C 838	Family Pharmacy Compounding Specialists	Vol #:	13

C 839	J. Barks	Vol #:	13

C 840	M. Reeves	Vol #:	13

C 841	L. Patterson	Vol #:	13

C 842	M. Lerch	Vol #:	13

C 843	F. Trubia	Vol #:	13

C 844	P. Mistretta	Vol #:	13

C 845	P. Gray	Vol #:	13

C 846	K. Prosser	Vol #:	13

C 847	C. Smith	Vol #:	13

C 848	J. Lee	Vol #:	13

C 849	R. Agee	Vol #:	13

C 850	M. Dayne	Vol #:	13

C 851	R. Lang, ND	Vol #:	21

C 852	D. Holloway	Vol #:	21

C 853	C. Hightower	Vol #:	21

C 854	G. Embry	Vol #:	21

C 855	L. Gorman	Vol #:	21

C 856	M. Lasseter	Vol #:	21



C 857	L. Stewart	Vol #:	21

C 858	J. Gibe	Vol #:	21

C 859	K. Driggs	Vol #:	21

C 860	J. DeSimone	Vol #:	21

C 861	L. Davis	Vol #:	21

C 862	G. Lee	Vol #:	21

C 863	M. Samford	Vol #:	21

C 864	S. Mazzotti	Vol #:	21

C 865	G. Jones	Vol #:	21

C 866	M. Nethery	Vol #:	21

C 867	K. Pasqualini	Vol #:	21

C 868	J. Bresson	Vol #:	21

C 869	M. Ramsey	Vol #:	21

C 870	M. Ramsey	Vol #:	21

C 871	K. Goerke	Vol #:	21

C 872	S. Putnam	Vol #:	21

C 873	D. Butler	Vol #:	21

C 874	B. Butler	Vol #:	21

C 875	C. Bogenen	Vol #:	21

C 876	G. Zucia	Vol #:	21

C 877	C. Ellis, MD	Vol #:	21

C 878	C. Keats	Vol #:	21

C 879	H. Zaloom	Vol #:	21

C 880	S. Horton	Vol #:	21

C 881	D. Gettel	Vol #:	21

C 882	N. Anderson	Vol #:	21

C 883	M. Knablein	Vol #:	21

C 884	L. Urbanski	Vol #:	21

C 885	R. Wolfe	Vol #:	21

C 886	S. Garcia	Vol #:	21

C 887	E. Morander	Vol #:	21

C 888	D. Schmitz	Vol #:	21

C 889	A. dormer	Vol #:	21

C 890	J. Franks, PhD	Vol #:	21

C 891	J. McCandless, M.D.	Vol #:	21

C 892	G. Brickert	Vol #:	21

C 893	S. Moore	Vol #:	21



C 894	J. Hawkins	Vol #:	21

C 895	B. Brumbach	Vol #:	21

C 896	J. Day	Vol #:	21

C 897	G. Litz	Vol #:	21

C 898	D. Ziebell	Vol #:	21

C 899	J. Koenigsmark	Vol #:	21

C 900	J. Evans	Vol #:	21

C 901	D. Atwood	Vol #:	21

C 902	D. Dorman	Vol #:	21

C 903	C. Turner	Vol #:	21

C 904	J. Dulinski	Vol #:	21

C 905	J. Stewart	Vol #:	21

C 906	H. Sheffield	Vol #:	21

C 907	E. Page	Vol #:	21

C 908	K. Mahoney	Vol #:	21

C 909	J. Tenney	Vol #:	21

C 910	D. Cipowski	Vol #:	21

C 911	K. Riccio	Vol #:	21

C 912	J. Wood	Vol #:	21

C 913	D. Mihalopoulos	Vol #:	21

C 914	J. Loncar	Vol #:	21

C 915	J. Loncar	Vol #:	21

C 916	E. Garwin	Vol #:	21

C 917	K. Cotto	Vol #:	21

C 918	L. Palm	Vol #:	21

C 919	G. Haskins	Vol #:	21

C 920	Dr. Monaco	Vol #:	21

C 921	E. Aroholk	Vol #:	21

C 922	J. Florshein	Vol #:	21

C 923	C. Crouse	Vol #:	21

C 924	T. Ambrosio	Vol #:	21

C 925	J. Altshuler	Vol #:	21

C 926	J. Pollock, MHC, NCC	Vol #:	21

C 927	L. Kalivas	Vol #:	21

C 928	J. Purcell	Vol #:	21

C 929	L. Amo	Vol #:	21

C 930	T. Colley	Vol #:	21



C 931	L. Lauzon	Vol #:	21

C 932	Dr. A. Bozarth	Vol #:	21

C 933	D. Kinderlehrer, MD	Vol #:	21

C 934	D. Pitlenger	Vol #:	21

C 935	M. Burger	Vol #:	21

C 936	C. Gregory	Vol #:	21

C 937	D. Lerew	Vol #:	21

C 938	L. Giovanna	Vol #:	21

C 939	J. Deloro	Vol #:	21

C 940	S. Dasaro	Vol #:	21

C 941	J. Boggess, MSC	Vol #:	21

C 942	J. Green	Vol #:	21

C 943	M. Hodgin	Vol #:	21

C 944	J. Glidewell	Vol #:	21

C 945	T. Nichols	Vol #:	21

C 946	G. Lemon	Vol #:	21

C 947	B. Singer	Vol #:	13

C 948	S. Banco	Vol #:	21

C 949	N. DeMeerleer	Vol #:	21

C 950	R. Kopecky	Vol #:	21

C 951	C. Gallogber, RN	Vol #:	21

C 952	K. Humes	Vol #:	21

C 953	D. Perry	Vol #:	21

C 954	L. Buff	Vol #:	21

C 955	D. Johnson	Vol #:	21

C 956	B. Uttley	Vol #:	21

C 957	L. Gotham	Vol #:	21

C 958	S. Raisen	Vol #:	21

C 959	S. Ashton	Vol #:	21

C 960	A. Newman	Vol #:	21

C 961	S. Henderson	Vol #:	21

C 962	K. Brady	Vol #:	21

C 963	S. Merryman	Vol #:	21

C 964	E. Mecnchini	Vol #:	21

C 965	Women in Balance Association	Vol #:	21

C 966	J. Genova	Vol #:	21

C 967	D. Petersen	Vol #:	21



C 968	A. Avers	Vol #:	21

C 969	S. Baker, MD	Vol #:	21

C 970	K. Hornak	Vol #:	21

C 971	T. Brown	Vol #:	21

C 972	K. Thielk	Vol #:	21

C 973	M. Vareas	Vol #:	21

C 974	L. Dye	Vol #:	21

C 975	J. Vaughn	Vol #:	21

C 976	B. Miller	Vol #:	21

C 977	H. Mattern	Vol #:	21

C 978	T. Ennis	Vol #:	21

C 979	B. Truelick	Vol #:	21

C 980	T. Lamarca	Vol #:	21

C 981	J. Himelstein	Vol #:	21

C 982	E. Skelton	Vol #:	21

C 983	A. Steucke	Vol #:	21

C 984	J. Miller	Vol #:	21

C 985	L. Klein	Vol #:	21

C 986	V. Toler	Vol #:	21

C 987	Eligible	Vol #:	21

C 988	C. Comstock	Vol #:	21

C 989	L. Wheeler, PhD	Vol #:	21

C 990	D. Ferguson	Vol #:	21

C 991	R. Ick	Vol #:	21

C 992	M. Glardon	Vol #:	21

C 993	G. Bogart	Vol #:	21

C 994	J. Castillo, MD	Vol #:	21

C 995	M. Kliesing	Vol #:	21

C 996	R. McWilliams	Vol #:	21

C 997	N. Bryant	Vol #:	21

C 998	M. Baird	Vol #:	21

C 999	B. Funn, MD	Vol #:	21

C 1000	G. Grant, MD	Vol #:	21

C 1001	C. Hawkins	Vol #:	21

C 1002	C. Stande	Vol #:	21

C 1003	N. Desiderio	Vol #:	21

C 1004	P. Stephens	Vol #:	21



C 1005	D. Porandwein	Vol #:	21

C 1006	P. Stone	Vol #:	21

C 1007	P. Stone	Vol #:	21

C 1008	M. Kooch	Vol #:	21

C 1009	H. Hopkins	Vol #:	21

C 1010	C. Chavez	Vol #:	21

C 1011	E. Dabelich	Vol #:	21

C 1012	P. Olson	Vol #:	21

C 1013	A. Lithman	Vol #:	21

C 1014	J. Norton	Vol #:	21

C 1015	H. Scheer	Vol #:	21

C 1016	P. Bradford	Vol #:	21

C 1017	C. Traxler	Vol #:	21

C 1018	A. Kuehule	Vol #:	21

C 1019	L. Sowel	Vol #:	21

C 1020	G. Schell	Vol #:	21

C 1021	S. Anderson	Vol #:	21

C 1022	C. Behn	Vol #:	21

C 1023	J. Lottinger	Vol #:	21

EC 4823	Ms. Vicki Greener	Vol #:	19

EC 4824	Ms. Kathleen Boyd	Vol #:	19

EC 4825	Ms. Patricia Walter	Vol #:	19

EC 4826	Ms. Nancy Zak	Vol #:	19

EC 4827	Ms. Christina Talanda	Vol #:	19

EC 4828	Ms. Kathleen Rush	Vol #:	19

EC 4829	Ms. Cheryl Cooney	Vol #:	19

EC 4830	Ms. Lynn Allard	Vol #:	19

EC 4831	Ms. Marylou Conley	Vol #:	19

EC 4832	Healing Touch	Vol #:	19

EC 4833	Ms. Linda Fels	Vol #:	19

EC 4834	Ms. Marti Elliott	Vol #:	19

EC 4835	Ms. Christine Rasmussen	Vol #:	19

EC 4836	Mr. Don Wetsel	Vol #:	19

EC 4837	Mrs. Maureen Gillette	Vol #:	19

EC 4838	Mrs. Deb Garber	Vol #:	19

EC 4839	Mrs. Lela Teague	Vol #:	19

EC 4840	Ms. Patricia Brown	Vol #:	19



EC 4841	InSpired Enterprises Intl Ltd	Vol #:	19

EC 4842	Mrs. Susan Larson	Vol #:	19

EC 4843	Mrs. Lee Aronson	Vol #:	19

EC 4844	Ms. Dana Gill	Vol #:	19

EC 4845	Association of Texas Midwives	Vol #:	19

EC 4846	Mrs. Cathey Levee	Vol #:	19

EC 4847	Dr. Rebecca Elia	Vol #:	19

EC 4848	Ms. Marilyn Gilmore	Vol #:	19

EC 4849	Mrs. Lynda Fanning	Vol #:	19

EC 4850	Mrs. Cassandra Rounsaville	Vol #:	19

EC 4851	Ms. Heather Philippe	Vol #:	19

EC 4852	Mrs. Mary Ellen Curley	Vol #:	19

EC 4853	Mrs. sheri purdy	Vol #:	19

EC 4854	Mrs. Nancy Kent	Vol #:	19

EC 4855	Ms. Lori Artinger	Vol #:	19

EC 4856	Ms. amy purdy	Vol #:	19

EC 4857	Mrs. Tammy Massengale	Vol #:	19

EC 4858	Ms. Janet White	Vol #:	19

EC 4859	Ms. Melissa Copeland	Vol #:	19

EC 4860	Mrs. Celinda Miller	Vol #:	19

EC 4861	Mrs. Pamela Sansbury	Vol #:	19

EC 4862	Ms. Laura Dobson	Vol #:	19

EC 4863	Ms. marianne chiappone	Vol #:	19

EC 4864	Mrs. Laura Casey	Vol #:	19

EC 4865	Mrs. Sara Mullins	Vol #:	19

EC 4866	Mr. Scott McFarlin	Vol #:	19

EC 4867	Mrs. Sasha Mitchell	Vol #:	19

EC 4868	Mrs. Suzanne Thomas	Vol #:	19

EC 4869	Ms. Dianne Houston	Vol #:	19

EC 4870	Mr. paul schaffer	Vol #:	19

EC 4871	Mrs. Helen Wright	Vol #:	19

EC 4872	Ms. Kathy Van Patten	Vol #:	19

EC 4873	Ms. Michelle Merrigan	Vol #:	19

EC 4874	Mrs. Vanessa Camuto	Vol #:	19

EC 4875	Mrs. Linda Huuskonen	Vol #:	19

EC 4876	Mrs. ANITA Hoffman	Vol #:	19

EC 4877	Ms. Dodi Lamm	Vol #:	19



EC 4878	Ms. Elizabeth Darche	Vol #:	19

EC 4879	Ms. myra cohen	Vol #:	19

EC 4880	Ms. Lois Kerr	Vol #:	19

EC 4881	Miss. Maureen Wildes	Vol #:	19

EC 4882	Ms. Tova E. Samuels	Vol #:	19

EC 4883	Ms. Wendy Strehlow	Vol #:	19

EC 4884	Mrs. Kara Bailiff	Vol #:	19

EC 4885	Ms. Katharine S Simmons	Vol #:	19

EC 4886	Ms. Diann Stevens	Vol #:	19

EC 4887	Dr. Claudia Cooke	Vol #:	19

EC 4888	Miss. DONNA TRIMBOLI	Vol #:	19

EC 4889	Ms. Debra Lumen	Vol #:	19

EC 4890	Mrs. Victoria Wilson	Vol #:	19

EC 4891	Ms. Vanessa L Lawson	Vol #:	19

EC 4892	Dr. Kristen Fox	Vol #:	19

EC 4893	Ms. Martha Rosas	Vol #:	19

EC 4894	Ms. Anne Markley	Vol #:	19

EC 4895	Ms. Victoria Lochowski	Vol #:	19

EC 4896	Mrs. Ann Roberson	Vol #:	19

EC 4897	Mrs. Carly Vernon	Vol #:	19

EC 4898	Ms. C. Feagles	Vol #:	19

EC 4899	Ms. Virginia Rogers	Vol #:	19

EC 4900	Mrs. Charlotte McLain	Vol #:	19

EC 4901	Ms. Brenna Yaekle	Vol #:	19

EC 4902	Woman to Woman Health, Inc	Vol #:	19

EC 4903	Individual Consumer	Vol #:	19

EC 4904	Mrs. Dru Kopcha	Vol #:	19

EC 4905	Ms. Virginia Adams	Vol #:	19

EC 4906	Mrs. Myrna Hughes	Vol #:	19

EC 4907	Ms. Keith Smiley	Vol #:	19

EC 4908	Ms. Sandra May	Vol #:	19

EC 4909	Ms. Diane Puderbaugh	Vol #:	19

EC 4910	Mrs. Gail Johnson	Vol #:	19

EC 4911	Mrs. Terry Lind	Vol #:	19

EC 4912	Ms. Marsha Woll	Vol #:	19

EC 4913	Mrs. Rita Reifman	Vol #:	19

EC 4914	Integrative Family Medicine Center	Vol #:	19



EC 4915	Ms. Jacqueline Williams	Vol #:	19

EC 4916	Ms. Mary Ciarcia	Vol #:	19

EC 4917	Ms. Joette Tripodi	Vol #:	19

EC 4918	Ms. Karen Murphy-Beers	Vol #:	19

EC 4919	Mrs. Linda Corrao-Ullrich	Vol #:	19

EC 4920	Ms. Judith Ciani Smith	Vol #:	19

EC 4921	Ms. Mercedes Moreno	Vol #:	19

EC 4922	Mrs. Janet Lantrip	Vol #:	19

EC 4923	Ms. Sandra Mitchell	Vol #:	19

EC 4924	Ms. Karen Hunter-Payne	Vol #:	19

EC 4925	Dr. Nancy Sordetto	Vol #:	19

EC 4926	Mrs. Kathleen Calcagno	Vol #:	19

EC 4927	Ms. Sal Medora	Vol #:	19

EC 4928	Ms. Laura Pendell	Vol #:	19

EC 4929	Choices for womean's health!!!	Vol #:	19

EC 4930	WVU University	Vol #:	19

EC 4931	Sutter Medical Center of Santa Rosa	Vol #:	19

EC 4932	Mrs. Wanda VanDeman	Vol #:	19

EC 4933	Mrs. Kathleen Owens	Vol #:	19

EC 4934	Ms. Mimi Ayele	Vol #:	19

EC 4935	Mrs. sharon churchill	Vol #:	20

EC 4936	Ms. Gillian Drummond	Vol #:	20

EC 4937	Ms. angie sanchez	Vol #:	20

EC 4938	Mrs. Sally Jones	Vol #:	20

EC 4939	Mrs. Wendy Stater	Vol #:	20

EC 4940	Mr. Daniel Petri	Vol #:	20

EC 4941	Mrs. D Kubiak	Vol #:	20

EC 4942	Ms. Donna M. Baker	Vol #:	20

EC 4943	Mrs. Henrietta Nebel	Vol #:	20

EC 4944	Ms. Betsy Myles	Vol #:	20

EC 4945	Ms. Judith Ray	Vol #:	20

EC 4946	Ms. Wendy Pritzker, RN	Vol #:	20

EC 4947	Mrs. Susan Schuster-Mainprize	Vol #:	20

EC 4948	Mrs. Laurie Thiboutot	Vol #:	20

EC 4949	Ms. Jill Foulston	Vol #:	20

EC 4950	Ms. Hilary Viets	Vol #:	20

EC 4951	TIKI TOUCH NATURAL HEALTH CLINIC	Vol #:	20



EC 4952	Ms. Anastasia Bain	Vol #:	20

EC 4953	Mrs. Cyntia Griffiths	Vol #:	20

EC 4954	Mrs. anne king-bolger	Vol #:	20

EC 4955	Mrs. Stephanie Lawthers	Vol #:	20

EC 4956	Ms. Gae Lindsay	Vol #:	20

EC 4957	Private consumer	Vol #:	20

EC 4958	Mrs. Cindy Kelly	Vol #:	20

EC 4959	Mr. Barbara Lanning	Vol #:	20

EC 4960	Ms. Elaine Jennings	Vol #:	20

EC 4961	Mrs. Kelly Sandefur	Vol #:	20

EC 4962	Mrs. Theresa Bond	Vol #:	20

EC 4963	Mrs. Suzanne Balcom	Vol #:	20

EC 4964	Ms. Elizabeth Hotchkiss	Vol #:	20

EC 4965	Ms. Janette Stearns	Vol #:	20

EC 4966	Miss. Michele Diamond	Vol #:	20

EC 4967	Mrs. jill bunting	Vol #:	20

EC 4968	Ms. Jacqueline Stein	Vol #:	20

EC 4969	Ms. Laurie Rae Tressler	Vol #:	20

EC 4970	Ms. Gwyneth Stine	Vol #:	20

EC 4971	Ms. Deborah Koons	Vol #:	20

EC 4972	Ms. Margaret Baylor	Vol #:	20

EC 4973	Mrs. Sharon Salemme	Vol #:	20

EC 4974	Ms. Patrice Wells	Vol #:	20

EC 4975	Ms. Jonel Brown	Vol #:	20

EC 4976	Mrs. Carolyn Tyler	Vol #:	20

EC 4977	Mrs. Joyce Jones	Vol #:	20

EC 4978	The Bank of The Pacific	Vol #:	20

EC 4979	Ms. Deborah Cooper	Vol #:	20

EC 4980	University of North Florida	Vol #:	20

EC 4981	Mrs. Joanne Dendinger	Vol #:	20

EC 4982	Ms. Deborah Warnick	Vol #:	20

EC 4983	Mrs. Heather Worden	Vol #:	20

EC 4984	Mrs. Jenny Noyes	Vol #:	20

EC 4985	Ms. mary ellen hammes	Vol #:	20

EC 4986	Ms. Joanne Blythe	Vol #:	20

EC 4987	Mrs. Carrie Thiel	Vol #:	20

EC 4988	Ms. Aeron Danann	Vol #:	20



EC 4989	Mrs. Sheryl Harper	Vol #:	20

EC 4990	Mrs. Debbie Burks	Vol #:	20

EC 4991	Ms. Anne Spalding	Vol #:	20

EC 4992	Mrs. Karen Vavan	Vol #:	20

EC 4993	Ms. tove tarpgaard	Vol #:	20

EC 4994	Mrs. Carol Sacks	Vol #:	20

EC 4995	Miss. MB Healy	Vol #:	20

EC 4996	women to women	Vol #:	20

EC 4997	Ms. Alison Zecha	Vol #:	20

EC 4998	Ms. A C FRIEDMAN	Vol #:	20

EC 4999	Ms. Regina Finnen	Vol #:	20

EC 5000	Mrs. Patricia White	Vol #:	20

EC 5001	Mrs. Penni Feldman	Vol #:	20

EC 5002	Ms. tonya jeffries	Vol #:	20

EC 5003	Miss. Lisa Iglehart	Vol #:	20

EC 5004	Mrs. Betsy Beacom	Vol #:	20

EC 5005	Mrs. Louise Green	Vol #:	20

EC 5006	Mrs. Cheryl Baxter	Vol #:	20

EC 5007	Mrs. Leah Smit	Vol #:	20

EC 5008	Ms. sue harrington	Vol #:	20

EC 5009	Ms. Vicki Urquhart	Vol #:	20

EC 5010	Health	Vol #:	20

EC 5011	Mrs. Susan McCarthy	Vol #:	20

EC 5012	Mr. Thomas Panto	Vol #:	20

EC 5013	Mrs. Marian Long	Vol #:	20

EC 5014	Ms. Lynn Vining	Vol #:	20

EC 5015	Mrs. zoe gladeau	Vol #:	20

EC 5016	Mrs. M. Campbell	Vol #:	20

EC 5017	Dr. Kathleen Stanton	Vol #:	20

EC 5018 Attachment	None	Vol #:	20

EC 5019	Mrs. suzanne eife	Vol #:	20

EC 5020	Mrs. Sally Martin	Vol #:	20

EC 5021	Mrs. NAN GRAY	Vol #:	20

EC 5022	Mrs. May Vandenberg	Vol #:	20

EC 5023	Ms. Anna Oakes	Vol #:	20

EC 5024	Ms. Cathy Silvasi	Vol #:	20

EC 5025	Dr. Bonnie Travis	Vol #:	20



EC 5026	Ms. Nancy Lane	Vol #:	20

EC 5027	Ms. Kathleen Lotten	Vol #:	20

EC 5028	Mrs. Frayda M Abramowitz	Vol #:	20

EC 5029	Ms. Janet Gorski	Vol #:	20

EC 5030	Mrs. Cynthia Wallbaum	Vol #:	20

EC 5031	Ms. Darice Clayton	Vol #:	20

EC 5032	Ms. Sandra Eaton	Vol #:	20

EC 5033	Dr. Pamela Evans	Vol #:	20

EC 5034	Ms. Vera Socha	Vol #:	20

EC 5035	Mrs. Patti Hoffman	Vol #:	20

EC 5036	Ms. Kathy Slattery	Vol #:	20

EC 5037	Ms. Linda Schrage	Vol #:	20

EC 5038	Mrs. Lissa Lefler	Vol #:	20

EC 5039	Ms. Sandy Koshari	Vol #:	20

EC 5040	Ms. Helen Stroud	Vol #:	20

EC 5041	Ms. diana kyricos	Vol #:	20

EC 5042	Mrs. Vrisayda Boggess	Vol #:	20

EC 5043	Ms. Jeanne Smith	Vol #:	20

EC 5044	Ms. Gena Kusiak	Vol #:	20

EC 5045	Mrs. Linda DeMent	Vol #:	20

EC 5046	Ms. K. Wilynn Zickler-Murphy	Vol #:	20

EC 5047	Ms. Gaye Sponamore	Vol #:	20

EC 5048	Mrs. brigitte rossetti	Vol #:	20

EC 5049	Mrs. Cynthia Lacunza	Vol #:	20

EC 5050	Mrs. Danielle Olson	Vol #:	20

EC 5051	Ms. Kathy Slattery	Vol #:	20

EC 5052	Mrs. Gloria Overstreet	Vol #:	20

EC 5053	Ms. Mollie Crowell	Vol #:	20

EC 5054	Medicap Pharmacy 8362	Vol #:	20

EC 5055	Ms. Anne Mininberg	Vol #:	20

EC 5056	Wholistic Kinesiology Center, Inc.	Vol #:	20

EC 5057	Mrs. Sharon Mylott	Vol #:	20

EC 5058	Ms. Dianne Beattie	Vol #:	20

EC 5059	Dr. Jo Robins	Vol #:	20

EC 5060	Mrs. Bernice Small-Chura	Vol #:	20

EC 5061	Mrs. Pamela Robinson	Vol #:	20

EC 5062	Ms. Jeanette Sanchez	Vol #:	20



EC 5063	Mrs. Debby Baker	Vol #:	20

EC 5064	Mrs. Barbara Rubis	Vol #:	20

EC 5065	Ms. Kate Cameron	Vol #:	20

EC 5066	Ms. Mary Wigginton	Vol #:	20

EC 5067	Mrs. Donna Schneider	Vol #:	20

EC 5068	Mrs. Claire C Murray	Vol #:	20

EC 5069	Ms. Charlene Tobey	Vol #:	20

EC 5070	Dr. Karen Pendleton	Vol #:	20

EC 5071	Ms. Dorothy Dotson	Vol #:	20

EC 5072	Contemporary Medicine	Vol #:	20

EC 5073	Dr. Suzanne Lewis	Vol #:	20

EC 5074	Ms. Jan Russell	Vol #:	20

EC 5075	Ms. Nan Masterson	Vol #:	20

EC 5076	Ms. misty canavarro	Vol #:	20

EC 5077	FFDinc	Vol #:	20

EC 5078	Mrs. Pamela Hanor	Vol #:	20

EC 5079	Dr. Tanya al-Khaliq	Vol #:	20

EC 5080	Ms. Linda King	Vol #:	20

EC 5081	Mrs. PATRICIA Dekal	Vol #:	20

EC 5082	Ms. Deanna Reiserer	Vol #:	20

EC 5083	Mrs. Evelyn Carrol	Vol #:	20

EC 5084	Mrs. Katherine Higgins	Vol #:	20

EC 5085	Ms. Doreen Palmiere	Vol #:	20

EC 5086	Ms. mary-frances hogan	Vol #:	20

EC 5087	Mrs. Paula McHenry-Hollub	Vol #:	20

EC 5088	Mr. Paul McHenry	Vol #:	20

EC 5089	Mrs. Linda Sommer	Vol #:	20

EC 5090	Ms. Gail Lynch	Vol #:	20

EC 5091	Mrs. esther kramer	Vol #:	20

EC 5092	Mrs. Doris CHRISTIAN	Vol #:	20

EC 5093	Ms. Karen Touzeau	Vol #:	20

EC 5094	Mrs. Mallory Perry	Vol #:	20

EC 5095	Ms. Lanette Dauster	Vol #:	20

EC 5096	Mrs. Diana Morris	Vol #:	20

EC 5097	Ms. Angela Silvio	Vol #:	20

EC 5098	Miss. Amy Thomas	Vol #:	20

EC 5099	Mrs. Susan Newcomer	Vol #:	20



EC 5100	Ms. Tricia Smith	Vol #:	20

EC 5101	Ms. susan mcconnell	Vol #:	20

EC 5102	Mrs. Teri Johnson	Vol #:	20

EC 5103	Ms. Kathleen Brown McNally	Vol #:	20

EC 5104	Dr. Lynn Friedman	Vol #:	20

EC 5105	Mrs. Eileen DeBrita	Vol #:	20

EC 5106	Ms. Sandra Wheeler	Vol #:	20

EC 5107	None	Vol #:	20

EC 5108	Mrs. Pamela Bearor-Amiralian	Vol #:	20

EC 5109	Mrs. Jean Elmore	Vol #:	20

EC 5110	Ms. Peggy Powell	Vol #:	20

EC 5111	Ms. Linda Lindsey	Vol #:	20

EC 5112	Mrs. susan cravey	Vol #:	20

EC 5113	Ms. cynthia richard	Vol #:	20

EC 5114	Mrs. sharon schreiber	Vol #:	20

EC 5115	Mr. John Loncar	Vol #:	20

EC 5116	Mrs. Angela Mousner	Vol #:	20

EC 5117	Mrs. Gina Odom	Vol #:	20

EC 5118	Ms. Jennifer Montgomery	Vol #:	20

EC 5119	Mrs. Barbara Platz	Vol #:	20

EC 5120	Mrs. Linda Mitchell	Vol #:	20

EC 5121	Ms. Vicki Mechner	Vol #:	20

EC 5122	Mrs. Denise White	Vol #:	20

EC 5123	Ms. Tamlyn Ellis	Vol #:	20

EC 5124	Ms. Marion Hochberg	Vol #:	20

EC 5125	Mrs. Mary Wade	Vol #:	20

EC 5126	Mrs. Lynn Resnick	Vol #:	20

EC 5127	Ms. Polly Peterson Stout	Vol #:	20

EC 5128	Mrs. Nancy Greene	Vol #:	20

EC 5129	Ms. Bonnie Sollinger	Vol #:	20

EC 5130	Ms. Emily Matthews,RN	Vol #:	20

EC 5131	Mrs. Heather Logan	Vol #:	20

EC 5132	Ms. Lee Kerkapoly	Vol #:	20

EC 5133	Mrs. Doris Saffran	Vol #:	20

EC 5134	Mrs. Rachel Barrow	Vol #:	20

EC 5135	Mrs. Toni Byrnes	Vol #:	20

EC 5136	Arbonne	Vol #:	20



EC 5137	Mrs. Judith Lipson	Vol #:	20

EC 5138	Ms. Patricia Greely	Vol #:	20

EC 5139	Ms. Diana Bowman	Vol #:	20

EC 5140	Ms. Susan McGarry	Vol #:	20

EC 5141	Mrs. Lisa Buie	Vol #:	20

EC 5142	Mrs. Angela Smith	Vol #:	20

EC 5143	Ms. julie larsonkeller larsonkeller	Vol #:	20

EC 5144	Mr. Brad Kennedy	Vol #:	20

EC 5145	Ms. Gail Egbert	Vol #:	20

EC 5146	Mrs. Rebecca Lam	Vol #:	20

EC 5147	Int'l Heaven Resorts Group	Vol #:	20

EC 5148	Mr. john seaton	Vol #:	20

EC 5149	Mrs. Suman Maan	Vol #:	20

EC 5150	Mrs. Lorrie Miller	Vol #:	20

EC 5151	Health By Hands	Vol #:	20

EC 5152	Mrs. Susan sadowski	Vol #:	20

EC 5153	Ms. jeanette scruton	Vol #:	20

EC 5154	Ms. Amy Koo	Vol #:	20

EC 5155	Ms. Sandra Rybarczyk	Vol #:	20

EC 5156	Ms. Debra Rudolph	Vol #:	20

EC 5157	Mrs. Dianna Glandon	Vol #:	20

EC 5158	Ms. Joyce Czarny	Vol #:	20

EC 5159	Steelsmith Natural Health Center	Vol #:	20

EC 5160	Mrs. Linda Rubenstein	Vol #:	20

EC 5161	Mrs. Margaret Pavlik	Vol #:	20

EC 5162	Ms. Barb LeClaire	Vol #:	20

EC 5163	Ms. Colett Welch	Vol #:	20

EC 5164	Mrs. Laura Gehlich	Vol #:	20

EC 5165	Mrs. klaudia toohey	Vol #:	20

EC 5166	Dr. L Kingsbury	Vol #:	20

EC 5167	Mrs. Sharon Messinger	Vol #:	20

EC 5168	Mrs. Elizabeth Mattiford	Vol #:	20

EC 5169	Mrs. Velma Hayden	Vol #:	20

EC 5170	Ms. Carolyn Dunlevy	Vol #:	20

EC 5171	Mrs. Sue Gilbreath	Vol #:	20

EC 5172	Ms. Julia Rinne	Vol #:	20

EC 5173	Ms. Debra Marrs	Vol #:	20



EC 5174	Ms. Mary Stancavage	Vol #:	20

EC 5175	Ms. Victoria Fatula	Vol #:	20

EC 5176	Ms. Teresa Carmichael	Vol #:	20

EC 5177	Ms. R. Prichason	Vol #:	20

EC 5178	Ms. Kathryn Fleisher	Vol #:	20

EC 5179	AMTA	Vol #:	20

EC 5180	Ms. sl dillard	Vol #:	20

EC 5181	Mr. Peter McArthur	Vol #:	20

EC 5182	Mrs. Marjorie Goodin	Vol #:	20

EC 5183	Mrs. Coraline Herrera	Vol #:	20

EC 5184	Ms. Monica Smith	Vol #:	20

EC 5185	Mrs. mary vane	Vol #:	20

EC 5186	Ms. Deborah Miller	Vol #:	20

EC 5187	Mrs. Patricia Schulz	Vol #:	20

EC 5188	Ms. Lynda Martin	Vol #:	20

EC 5189	none	Vol #:	20

EC 5190	Mrs. Sheila Hart	Vol #:	20

EC 5191	Ms. kate jelniker	Vol #:	20

EC 5192	City College of San Francisco	Vol #:	20

EC 5193	Bio-Identical Hormone Replacement Therapy	Vol #:	20

EC 5194	Ms. merritt swenson	Vol #:	20

EC 5195	Mrs. Kathleen Sorensen	Vol #:	20

EC 5196	Mrs. robin hertzberg	Vol #:	20

EC 5197	Ms. Nancy House	Vol #:	20

EC 5198	Ms. pamela taylor	Vol #:	20

EC 5199	Mrs. LUCYENE REES	Vol #:	20

EC 5200	Mrs. Marjorie Watkins	Vol #:	20

EC 5201	Mrs. Mary Ann Reynolds	Vol #:	20

EC 5202	Mrs. Laurie Schur	Vol #:	20

EC 5203	Mrs. Gisela Horejsi	Vol #:	20

EC 5204	Mr. William Vincenti	Vol #:	20

EC 5205	Mrs. J olson	Vol #:	20

EC 5206	Ms. Margaret Frese	Vol #:	20

EC 5207	Mrs. Kathryn Sandow	Vol #:	20

EC 5208	Harmony Women's Health	Vol #:	20

EC 5209	Mrs. Shari Miethe	Vol #:	20

EC 5210	Mrs. Gwen Reyher	Vol #:	20



EC 5211	Ms. Jo Ellen Davis	Vol #:	20

EC 5212	Miss. Sherene Kingma	Vol #:	20

2005P-0459	To enforce ban on carbon monoxide gas in fresh meat packaging

C 3	Food & Water Watch	Vol #:	2

2006D-0044	Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

C 1 Attachments	Institute of Health Economics	Vol #:	1

2006P-0002	Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)

C 1	D. Lowe	Vol #:	1

2006P-0007	Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.

C 1	D. Lowe	Vol #:	1

2006P-0085	To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements

ACK 1	Number not used	Vol #:	1

CP 1	Number not used	Vol #:	1

2006P-0086	To declare that the drug product, Butalbital, 50 mg and acetaminophen, 300 mg Tablets, is suitable for consideration in an abbreviated new drug application (ANDA).

ACK 1	HFA-305 to LachmanConsultant Services, Inc.	Vol #:	1

CP 1	LachmanConsultant Services, Inc.	Vol #:	1

Page created on March 14, 2006 dp

FDA/Dockets Management