Dockets Entered on August 24, 2005

Dockets Management



Dockets Entered On August 24, 2005 Table of Contents



Docket #	Title

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

2000N-0504	Egg Safety Action Plan

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

2005N-0190	Agency Information Collection Activities; Proposed Collection; Comment Request; Export of FDA Regulated Products Export Certificates

2005N-0279	Food Labeling; Gluten-Free Labeling of Foods; Public Meeting

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

2005P-0322	Immediately deny approval of the NDA for INCRELEX

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

LET 16515	Yu Sheng Tang Chinese Herbal Medicine, LLC	Vol #:	148

LET 16516	Traditiional Medicinals, Inc.	Vol #:	148

LET 16517	Parmavite LLC	Vol #:	148

LET 16518	Helping Hands Life Improvement Center,USA,Inc.	Vol #:	148

LET 16519	BioForce USA	Vol #:	148

LET 16520	Renaissance Herbs	Vol #:	148

LET 16521	Enzymatic Therapy	Vol #:	148

LET 16522	Enzymatic Therapy	Vol #:	148

LET 16523	Enzymatic Therapy	Vol #:	148

LET 16524	Enzymatic Therapy	Vol #:	148

2000N-0504	Egg Safety Action Plan

C 385	Form Letters (32 Signatures)	Vol #:	35

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


EMC 791	Juice Products Association	Vol #:	9

2005N-0190	Agency Information Collection Activities; Proposed Collection; Comment Request; Export of FDA Regulated Products Export Certificates

EC 3	Ms. Carlene Barous	Vol #:	1

2005N-0279	Food Labeling; Gluten-Free Labeling of Foods; Public Meeting

C 104	J. Freeberg	Vol #:	6

C 105	G. Rennick, Jr.	Vol #:	6

C 106	B. Sinclair	Vol #:	6

C 107	P. Arrants	Vol #:	6

C 108	J. Parent	Vol #:	6

C 109	No signature	Vol #:	6

C 110	F. Green	Vol #:	6



C 111	R. Daugherty	Vol #:	6

C 112	P. Courtney	Vol #:	6

C 113	Illegible	Vol #:	6

C 114	D. Mount	Vol #:	6

C 115	N. Obenour	Vol #:	6

C 116	L. Walker	Vol #:	6

C 117	T. Kownacki	Vol #:	6

C 118	R. Munger	Vol #:	6

C 119	G. Eberhardt	Vol #:	6

C 120	S. Brown	Vol #:	6

C 121	R. Robinson	Vol #:	6

C 122	No signature	Vol #:	6

C 123	J. Jacobowitz	Vol #:	6

C 124	J. Cinquepalmi	Vol #:	6

C 125	B. Acker	Vol #:	6

C 126	J. Sandsor	Vol #:	6

C 127	R. Lee	Vol #:	6

C 128	G. Wetherington	Vol #:	6

C 129	No signature	Vol #:	6

C 130	D. Wilson	Vol #:	6

C 131	D. Urhahn	Vol #:	7

C 132	S. Neubert	Vol #:	7

C 133	J. Rinehart	Vol #:	7

C 134	J. Morey	Vol #:	7

C 135	L. Alexander	Vol #:	7

C 136	No signature	Vol #:	7

C 137	E. Snow	Vol #:	7

C 138	E. Mefford	Vol #:	7

C 139	H. Cohen	Vol #:	7

C 140	H. Holmes	Vol #:	7

C 141	R. Brady	Vol #:	7

C 142	B. Raphael	Vol #:	7

C 143	No signature	Vol #:	7

C 144	V. Ziemer	Vol #:	7

C 145	B. Mellinger	Vol #:	7

C 146	No signature	Vol #:	7

C 147	K. Meiggs	Vol #:	7



C 148	B. Cutler	Vol #:	7

C 149	W. Jackson	Vol #:	7

C 150	B. Parker	Vol #:	7

C 151	V. Doran	Vol #:	7

C 152	D. Tonetti	Vol #:	7

C 153	C. Chopp	Vol #:	7

C 154	D. Kinney	Vol #:	7

C 155	B. Copus	Vol #:	7

C 156	C. Bonner	Vol #:	7

C 157	P. Berling	Vol #:	7

C 158	D. Michalek	Vol #:	7

C 159	no signature	Vol #:	8

C 160	no signature	Vol #:	8

C 161	B. Miller	Vol #:	8

C 162	G. Casner	Vol #:	8

C 163	J. Giorno	Vol #:	8

C 164	E. Schall	Vol #:	8

C 165	C. Hart	Vol #:	8

C 166	K. Wilhelm	Vol #:	8

C 167	T. Shott	Vol #:	8

C 168	R. Starcher	Vol #:	8

C 169	W. Lewis	Vol #:	8

C 170	C. Makuen	Vol #:	8

C 171	no signature	Vol #:	8

C 172	D. Bozzone	Vol #:	8

C 173	no signature	Vol #:	8

C 174	M. Wiggins	Vol #:	8

C 175	J. Adams	Vol #:	8

C 176	R. McCleod	Vol #:	8

C 177	M. Schlomann	Vol #:	8

C 178	B. Dienstbach	Vol #:	8

C 179	S. Thomas	Vol #:	8

C 180	B. Sanders	Vol #:	8

C 181	no signature	Vol #:	8

C 182	J. Becker	Vol #:	8

C 183	S. Petkus	Vol #:	8

C 184	S. Koch	Vol #:	8



C 185	D. Edwards	Vol #:	8

C 186	D. Stinson	Vol #:	8

C 187	P. Tighe	Vol #:	8

C 188	C. Grady	Vol #:	8

EC 147	Mrs. Jeanine Hopkins	Vol #:	4

EC 148	Celiac organization	Vol #:	4

EC 149	Mrs. Jennifer Lee	Vol #:	4

EC 150	Mrs. Amy Crawford	Vol #:	4

EC 151	Mrs. Kathleen Curtiss	Vol #:	4

EC 152	Mrs. Susan McWhite	Vol #:	4

EC 153	Mr. James Monroe	Vol #:	4

EC 154	Mrs. Darla McVay	Vol #:	4

EC 155	Mr. Michael Woody	Vol #:	4

EC 156	Mrs. Judith Monroe	Vol #:	4

EC 157	Miss. Holly Schneider	Vol #:	4

EC 158	Miss. Holly Schneider	Vol #:	4

EC 159	Mr. Joe Most	Vol #:	4

EC 160	Miss. Julianne Kohl	Vol #:	4

EC 161	Miss. Kristine Ganes	Vol #:	4

EC 162	Ms. Clay Hesser	Vol #:	4

EC 163	Mrs. Ann Hewitt	Vol #:	4

EC 164	Ms. Jodie Roeca	Vol #:	4

EC 165	Mr. Adam Schroeder	Vol #:	4

EC 166	Mrs. Barbara Klawiter	Vol #:	4

EC 167	Mrs. Michelle Reed	Vol #:	4

EC 168	Mrs. Melissa Drescher	Vol #:	4

EC 169	Mrs. Leigh Ann Adams	Vol #:	4

EC 170	Ms. Linda Huffstetler-Dearing	Vol #:	4

EC 171	Ms. Beverly Stone	Vol #:	4

EC 172	Medical Nutrition Therapy Northwest	Vol #:	4

EC 173	Ms. Sharon Forge	Vol #:	4

EC 174	Ms. Sharon Forge	Vol #:	4

EC 175	Mrs. Judith Bond	Vol #:	4

EC 176	Mrs. Phyllis Adams	Vol #:	4

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

EC 1	Dr. Mulki Giridhar Bhat	Vol #:	1



EC 2	Dr. Philip Boyle	Vol #:	1

2005P-0322	Immediately deny approval of the NDA for INCRELEX

C 1	Tercica, Inc.	Vol #:	2

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FDA/Dockets Management