Dockets Entered on May 4, 2005

Dockets Management



Dockets Entered On May 4, 2005 Table of Contents



Docket #	Title

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

1998D-0514	Industry on ANDA's: Impurities in Drug Substances

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

2001N-0548	Guidelines for Voluntary Nutrition Labeling of Raw Fruits

2002V-0523	Laser Light Show

2004H-0322	Civil Money Penalty Re: Ecumed Health Group, Inc.

2004N-0456	Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes


2004N-0463	Food Labeling: Prominence of Calories

2004N-0527	Medical Devices; Medical Device Reporting

2004N-0539	Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability

2004Q-0151	Qualified Health Claim (QHC): soy protein and cancer

2005D-0068	Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System

2005D-0122	Guidance for Industry on Exploratory IND Studies

2005P-0167	Require Celgene Corporation to Revise the Labeling of Thalomid Capsules to Strengthen Warnings of the Potential for Serious Adverse Events

2005P-0168	Determine whether Aeroseb-Dex (Dexamethasone) Topical Aerosol, 0.01%, ( NDA 083-296 ) has been voluntarily withdrawn for safety or efficacy reasons

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

LET 16045	Garden of Life	Vol #:	142

LET 16046	Garden of Life	Vol #:	142

LET 16047	Garden of Life	Vol #:	142

LET 16048	Garden of Life	Vol #:	142

LET 16049	Garden of Life	Vol #:	142

LET 16050	Garden of Life	Vol #:	142

LET 16051	Garden of Life	Vol #:	142

LET 16052	Garden of Life	Vol #:	142

LET 16053	Garden of Life	Vol #:	142

LET 16054	Garden of Life	Vol #:	142

LET 16055	Garden of Life	Vol #:	142

LET 16056	NBTY Inc.	Vol #:	142

LET 16057	NBTY Inc.	Vol #:	142

LET 16058	NBTY Inc.	Vol #:	142

LET 16059	NBTY Inc.	Vol #:	142

LET 16060	NBTY Inc.	Vol #:	142

LET 16061	NBTY Inc.	Vol #:	142

LET 16062	NBTY Inc.	Vol #:	142

LET 16063	NBTY Inc.	Vol #:	142



LET 16064	NBTY Inc.	Vol #:	142

LET 16065	NBTY Inc.	Vol #:	142

LET 16066	Anabolic Laboratories, Inc.	Vol #:	142

LET 16067	Anabolic Laboratories, Inc.	Vol #:	142

LET 16068	Anabolic Laboratories, Inc.	Vol #:	142

LET 16069	Anabolic Laboratories, Inc.	Vol #:	142

LET 16070	Anabolic Laboratories, Inc.	Vol #:	142

LET 16071	Anabolic Laboratories, Inc.	Vol #:	142

LET 16072	Spirit Science USA, Inc.	Vol #:	142

LET 16073	Nature's Way Products, Inc.	Vol #:	142

LET 16074	Nature's Way Products, Inc.	Vol #:	142

LET 16075	Nature's Way Products, Inc.	Vol #:	142

LET 16076	Nature's Way Products, Inc.	Vol #:	142

LET 16077	Nature's Way Products, Inc.	Vol #:	142

LET 16078	Iovate Health Sciences U.S.A., Inc.	Vol #:	142

LET 16079	Iovate Health Sciences U.S.A., Inc.	Vol #:	142

LET 16080	Iovate Health Sciences U.S.A., Inc.	Vol #:	142

LET 16081	Iovate Health Sciences U.S.A., Inc.	Vol #:	142

LET 16082	Enzymatic Therapy	Vol #:	142

LET 16083	Enzymatic Therapy	Vol #:	142

LET 16084	Enzymatic Therapy	Vol #:	142

LET 16085	Enzymatic Therapy	Vol #:	142

LET 16086	Enzymatic Therapy	Vol #:	142

LET 16087	Hillestad Pharmaceuticals	Vol #:	142

1998D-0514	Industry on ANDA's: Impurities in Drug Substances

EC 2	Apotex Inc.	Vol #:	1

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

C 7479	L. Skardinski	Vol #:	319

C 7480	J. Bellett	Vol #:	319

2001N-0548	Guidelines for Voluntary Nutrition Labeling of Raw Fruits

EC 3	Southern Methodist University	Vol #:	1

EC 4	Miss. Crystal Smith	Vol #:	1

EC 5	Mrs. Jennifer Jackson	Vol #:	1

EREG 1	none	Vol #:	1

EREG 2	none	Vol #:	1



2002V-0523	Laser Light Show

EXP 1	Louisiana Arts and Science Museum	Vol #:	1

2004H-0322	Civil Money Penalty Re: Ecumed Health Group, Inc.

CS 6	HFA-305	Vol #:	1

OR 6	HF-3 to Ecumed Health Group, Amador Reyes, Juan C. Carrai, Richard W. Stone, M.D., and Erlind	Vol #:	1

2004N-0456	Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes



C 45	United States Potato Board	Vol #:	1

2004N-0463	Food Labeling: Prominence of Calories
C 25	Ms. M. M. Wood	Vol #:	1

C 26	F. G. Norris	Vol #:	1

C 27	L. K. Hunt	Vol #:	1

C 28	Mrs. G. P. Anderson	Vol #:	1

EC 1	Mr. Felix Bronstein	Vol #:	1

EC 2	Ms. Cathy Kristiansen	Vol #:	1

EC 3	Ms. Mary White	Vol #:	1

EC 4	Mrs. Tonya Miller	Vol #:	1

EC 5	Mr. Curtis Carll	Vol #:	1

EC 6	GMA	Vol #:	1

EC 7	Ms. Mandy Stahre	Vol #:	1

EC 8	Mr. Benjamin Larson	Vol #:	1

EC 9	University of Oregon	Vol #:	1

EC 10	Mrs. Jennifer Brown	Vol #:	1

EC 11	Mr. Matthew Bunch	Vol #:	1

EC 12	Mr. Mitchell Li	Vol #:	1

EC 13	Miss. Katharine Zandy	Vol #:	1

EMC 268	R. Ewing	Vol #:	3

EMC 269	B. N. Sale	Vol #:	3

EMC 270	M. Nestle	Vol #:	3

2004N-0527	Medical Devices; Medical Device Reporting

EC 3	Advanced Medical Technology Association	Vol #:	1

2004N-0539	Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability

EC 1	European Pharmacopoeia	Vol #:	1

2004Q-0151	Qualified Health Claim (QHC): soy protein and cancer



C 101	N. Rudy	Vol #:	9

EC 362	Mr. Larry Hill	Vol #:	8

EC 363	Mr. David Forde	Vol #:	8

EC 364	Mrs. BILL HOLLEY	Vol #:	8

EC 365	Mr. Dennis Hendren	Vol #:	8

EC 366	n/a	Vol #:	8

EC 367	Mr. Kevin Newman	Vol #:	8

EC 368	Ms. Paul Rinaldi	Vol #:	8

EC 369	Mr. terry hunt	Vol #:	8

EC 370	Ms. Patricia Buffum	Vol #:	8

EC 371	Mr. Thomas Sochor	Vol #:	8

EC 372	Ms. Susan Williams	Vol #:	8

EC 373	United States Naval Academy	Vol #:	8

EC 374	Mr. Larry Keopke	Vol #:	8

EC 375	Mrs. Gabriela Penciu	Vol #:	8

EC 376	Ms. Janet Bowers	Vol #:	8

EC 377	Mr. Orlin Buente	Vol #:	8

EC 378	Mr. Paul Morin	Vol #:	8

EC 379	Mr. Ronald Kramer	Vol #:	8

EC 380	Dr. A. C. Shen	Vol #:	8

EC 381	Mr. Ozzie Beck	Vol #:	8

EC 382	Mrs. Jeanne Schmelzer	Vol #:	8

EC 383	Mr. Stephen Farenell	Vol #:	8

EC 384	Mr. Lewis Beals	Vol #:	8

EC 385	Mr. Rick Williams	Vol #:	8

EC 386	Nutritional Alternatives	Vol #:	8

EC 387	Mr. John Toennies	Vol #:	8

EC 388	Mrs. Brenda Guzman	Vol #:	8

EC 389	Mr. Orest Burtniak	Vol #:	8

EC 390	Mr. Enrique Garcia	Vol #:	8

EC 391	Mr. Ken Laswhe	Vol #:	8

EC 392	Mr. James LeBleu	Vol #:	8

EC 393	Mr. Lester Hardeman	Vol #:	8

EC 394	Dr. Barbara Fouts	Vol #:	8

EC 395	Ms. Diana McClellan	Vol #:	8

EC 396	Mrs. Jo Ann Cauthen	Vol #:	8

EC 397	Mrs. Patricia Belson	Vol #:	8



EC 398	Mrs. Janet Faulkner	Vol #:	8

EC 399	Mr. Mark Wilcox	Vol #:	8

EC 400	Ms. lynn noe	Vol #:	8

EC 401	Miss. Sandra Miller	Vol #:	8

EC 402	Mrs. Patsy Yamashiro	Vol #:	8

EC 403	Mr. Lawrence Sawatsky	Vol #:	8

EC 404	n/a	Vol #:	8

EC 405	Mr. Bob Reece	Vol #:	8

EC 406	Ms. Alberta Phillips	Vol #:	8

EC 407	Mr. Dave Siplinger	Vol #:	8

EC 408	DBSA SW Iowa	Vol #:	8

EC 409	Ms. Terri Carlson	Vol #:	8

EC 410	Mrs. CLAUDIA LAHAIE	Vol #:	8

EC 411	Ms. Carolyn Bailey	Vol #:	8

EC 412	Mr. Larry Rayburn	Vol #:	8

EC 413	Dr. Michele Matsuo	Vol #:	8

EC 414	Mr. Ronald Skutt	Vol #:	8

EC 415	N/A	Vol #:	8

EC 416	Mr. Paul Gibson	Vol #:	8

EC 417	Ms. Marcy Lynn	Vol #:	8

EC 418	Dr. Peter Abeles	Vol #:	8

EC 419	Mr. Ronald Crane	Vol #:	8

2005D-0068	Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System

EC 1	retired dept ag grad sch student, red cross, nih,	Vol #:	1

2005D-0122	Guidance for Industry on Exploratory IND Studies

EC 1	Targa Therapeutics Corp.	Vol #:	1

2005P-0167	Require Celgene Corporation to Revise the Labeling of Thalomid Capsules to Strengthen Warnings of the Potential for Serious Adverse Events

ACK 1	HFA-305 to the State of Connecticut	Vol #:	1

CP 1	State of Connecticut	Vol #:	1

2005P-0168	Determine whether Aeroseb-Dex (Dexamethasone) Topical Aerosol, 0.01%, ( NDA 083-296 ) has been voluntarily withdrawn for safety or efficacy reasons

ACK 1	HFA-305 to ACADERM Inc.	Vol #:	1

CP 1	ACADERM Inc.	Vol #:	1

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FDA/Dockets Management