Dockets Entered on March 16, 2007

Dockets Management



Dockets Entered On March 16, 2007



Docket #	Title

1995G-0321	25-hydroxyvitamin D3 be affirmed as GRAS

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

1999P-0389	Abbreviated new drug application/topical dematological drug

1999P-1864	Reclassify Constrained Hip Prosthesis Metal/Polymer

2003N-0573	Draft Animal Cloning Risk Assessment

2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

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

2005N-0394	FDAs Communication of Drug Safety Information; Public Hearing

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

2006N-0464	Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing

2006P-0498	Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods

1995G-0321	25-hydroxyvitamin D3 be affirmed as GRAS

BKG 1	Background Material	Vol #:	2

NFR 1	FDA	Vol #:	1

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

LET 19499	NOW Foods	Vol #:	173

LET 19500	NOW Foods	Vol #:	173

LET 19501	NOW Foods	Vol #:	173

LET 19502	NOW Foods	Vol #:	173

LET 19503	NOW Foods	Vol #:	173

LET 19504	NOW Foods	Vol #:	173

LET 19505	NOW Foods	Vol #:	173

LET 19506	NOW Foods	Vol #:	173

LET 19507	NOW Foods	Vol #:	173

LET 19508	NOW Foods	Vol #:	173

LET 19509	NOW Foods	Vol #:	173

LET 19510	NOW Foods	Vol #:	173

LET 19511	NOW Foods	Vol #:	173

LET 19512	NOW Foods	Vol #:	173

LET 19513	NOW Foods	Vol #:	173

LET 19514	NOW Foods	Vol #:	173

LET 19515	NOW Foods	Vol #:	173

LET 19516	NOW Foods	Vol #:	173

LET 19517	NOW Foods	Vol #:	173

LET 19518	NOW Foods	Vol #:	173



LET 19519	NOW Foods	Vol #:	173

LET 19520	NOW Foods	Vol #:	173

1999P-0389	Abbreviated new drug application/topical dematological drug

RET 1	88-07-0027 Box 1	Vol #:	1

1999P-1864	Reclassify Constrained Hip Prosthesis Metal/Polymer

RET 1	88-07-0027 Box 1	Vol #:	3

2003N-0573	Draft Animal Cloning Risk Assessment

C 391	S. Dugan	Vol #:	32

EC 3486	Mrs. Sandra Berry	Vol #:	21

EC 3487	Ms. Alice A. Crawford	Vol #:	21

EC 3488	Dr. Ann Marini	Vol #:	21

EC 3489	Ms. maggie spiegel	Vol #:	21

EC 3490	Mr. Michael Gray	Vol #:	21

EC 3491	Mrs. Ellen Leventhal	Vol #:	21

EC 3492	Mrs. Elizabeth Ayala	Vol #:	21

EC 3493	Ms. JANICE BURGI	Vol #:	21

EC 3494	Ms. Alexandra Strain	Vol #:	21

EC 3495	Ms. Karen Stanley	Vol #:	21

EC 3496	Ms. Jacqueline Ward	Vol #:	21

EC 3497	Ms. Mariah Leal	Vol #:	21

EC 3498	Mrs. Kathy Rakestraw	Vol #:	21

EC 3499	Mrs. Tammy Grigsby	Vol #:	21

EC 3500	Mrs. Carrie Wolf	Vol #:	21

EC 3501	Ms. Karen Stanley	Vol #:	21

EC 3502	Ms. Kimberly Kalember	Vol #:	21

EC 3503	Mr. Krishna Venkatraman	Vol #:	21

EC 3504	Mrs. Colleen Klaum	Vol #:	21

EC 3505	Ms. Janet Waters	Vol #:	21

EC 3506	Ms. Debbie Williams	Vol #:	21

EC 3507	Mr. Wayne Flowers	Vol #:	21

EC 3508	Ms. Ruthann Roka	Vol #:	21

2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

CFF 1	FDA/CDRH	Vol #:	240

CFF 2	TMJ Implants, Inc.	Vol #:	240



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

EC 1810	Mrs. Donna Katz	Vol #:	31

EC 1811	Forest Hills Lutheran School	Vol #:	31

EC 1812	Ms. Kimberly Davis	Vol #:	31

EC 1813	Ms. Gloria Brown	Vol #:	31

EC 1814	northland celiac support group	Vol #:	31

EC 1815	Ms. Neda Baric	Vol #:	31

EC 1816	Mrs. Kathleen Apodaca	Vol #:	31

EC 1817	Ms. Alegria Katona	Vol #:	31

EC 1818	Mrs. Marisa OConnor	Vol #:	31

EC 1819	Mrs. Wendy Holcombe	Vol #:	31

2005N-0394	FDAs Communication of Drug Safety Information; Public Hearing

C 554	V. Medlyn	Vol #:	36

C 555	M. Howard	Vol #:	36

C 556	B. Tyler	Vol #:	36

C 557	T. Boriths	Vol #:	36

C 558	S. Moore	Vol #:	36

C 559	R. Fuentes	Vol #:	36

C 560	J. Crouch	Vol #:	36

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

C 18274	J. Wahlstrom	Vol #:	198

2006N-0464	Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing

TS 15	Northrup Grumman	Vol #:	4

2006P-0498	Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods

C 58	K. Seddon	Vol #:	1

C 59	E. deSosa	Vol #:	1

C 60	S.Anderson	Vol #:	1

C 61	B. Holzkemp	Vol #:	1

C 62	J. Van Sluyter	Vol #:	1

C 63	G. Maskell	Vol #:	1

C 64	W. Davis	Vol #:	1

C 65	K. Davis	Vol #:	1

C 66	P. Beasley	Vol #:	10

C 67	Watreeman	Vol #:	10



C 68	C. Rizzolo	Vol #:	1

C 69	J. Judd	Vol #:	10

C 70	R. Levinson	Vol #:	1

C 71	M. Henderson	Vol #:	1

C 72	D. Stout	Vol #:	1

C 73	K. Catalano	Vol #:	1

C 74	R. Harper	Vol #:	1

C 75	R. Freedman	Vol #:	1

C 76	J. Rigney	Vol #:	1

C 77	A. Camille	Vol #:	1

C 78	M. Lange	Vol #:	1

C 79	D. Tasso	Vol #:	1

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FDA/Dockets Management