Dockets Entered on March 9, 2007

Dockets Management



Dockets Entered On March 9, 2007



Docket #	Title

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

2002P-0122	Request Rulemaking on Functional Foods & Establish Adv. Com.

2002P-0154	The Labeling of Serono's REBIF is Misleading

2002P-0317	Recall Aspartame as a Neurotoxic Drug

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

2003N-0573	Draft Animal Cloning Risk Assessment

2003P-0064	Withhold Approval of Generic Lovenox (enoxaparin sodium inje

2004N-0081	BSE Risk Materials in Foods and Cosmetics

2004N-0230	Food; Current Good Manufacturing Practice Regulations; Public Meetings

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

2005N-0373	Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants

2005P-0121	Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II

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

2006D-0301	Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waivers and Reductions

2006D-0336	Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions

2006D-0347	Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

2006N-0061	Charging for Investigational Drugs

2006N-0062	Expanded Access to Investigational Drugs for Treatment Use

2006N-0352	Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam

2006N-0525	Supplements and Other Changes to an Approved Application

2006P-0307	To amend 21CFR 201.17 regarding expiration dates

2006P-0351	Restriction or withdrawal of the use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapy in the following conditions

2006P-0394	Revise the labeling requirements for eggs sold in the United States

2006P-0487	Health Claim Petition: Isomaltulose and Dental Caries

2007V-0081	Laser Light Show

2007V-0082	Laser Light Show

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

LET 19347	Perrigo Company of South Carolina	Vol #:	172

LET 19348	Perrigo Company of South Carolina	Vol #:	172

LET 19349	Perrigo Company of South Carolina	Vol #:	172

LET 19350	Perrigo Company of South Carolina	Vol #:	172

LET 19351	Perrigo Company of South Carolina	Vol #:	172

LET 19352	Perrigo Company of South Carolina	Vol #:	172

LET 19353	Perrigo Company of South Carolina	Vol #:	172

LET 19354	Perrigo Company of South Carolina	Vol #:	172



LET 19355	Perrigo Company of South Carolina	Vol #:	172

LET 19356	Global Healing Center, Inc.	Vol #:	172

LET 19357	Global Healing Center, Inc.	Vol #:	172

LET 19358	Global Healing Center, Inc.	Vol #:	172

LET 19359	Global Healing Center, Inc.	Vol #:	172

LET 19360	Global Healing Center, Inc.	Vol #:	172

LET 19361	Global Healing Center, Inc.	Vol #:	172

LET 19362	Global Healing Center, Inc.	Vol #:	172

LET 19363	Global Healing Center, Inc.	Vol #:	172

LET 19364	ITV Global, Inc.	Vol #:	172

LET 19365	Enzymatic Therapy, Inc.	Vol #:	172

LET 19366	New Century Company	Vol #:	172

LET 19367	Enzymatic Therapy, Inc.	Vol #:	172

LET 19368	Enzymatic Therapy, Inc.	Vol #:	172

LET 19369	Source Naturals	Vol #:	172

LET 19370	Planetary Herbals	Vol #:	172

LET 19371	Enzymatic Therapy, Inc.	Vol #:	172

LET 19372	Enzymatic Therapy, Inc.	Vol #:	172

LET 19373	Enzymatic Therapy, Inc.	Vol #:	172

LET 19374	Enzymatic Therapy, Inc.	Vol #:	172

LET 19375	Enzymatic Therapy, Inc.	Vol #:	172

LET 19376	Enzymatic Therapy, Inc.	Vol #:	172

LET 19377	Enzymatic Therapy, Inc.	Vol #:	172

LET 19378	Enzymatic Therapy, Inc.	Vol #:	172

LET 19379	Enzymatic Therapy, Inc.	Vol #:	172

LET 19380	Planetary Herbals	Vol #:	172

LET 19381	Source Naturals	Vol #:	172

LET 19382	Tronex Company	Vol #:	172

LET 19383	Enzymatic Therapy, Inc.	Vol #:	172

LET 19384	Doctor's Best, Inc.	Vol #:	172

2002P-0122	Request Rulemaking on Functional Foods & Establish Adv. Com.

C 6	Grocery Manufacturers/Food Products Association (GMA/FPA)	Vol #:	2

2002P-0154	The Labeling of Serono's REBIF is Misleading

WDL 1	Biogen Idec	Vol #:	1

2002P-0317	Recall Aspartame as a Neurotoxic Drug



EMC 774	Mission Possible International	Vol #:	10

EMC 775	Mission Possible International	Vol #:	10

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

EMC 1454	J. Palmer	Vol #:	12

2003N-0573	Draft Animal Cloning Risk Assessment

C 316	C. Miller	Vol #:	32

C 317	A. Rowe	Vol #:	32

C 318	C. Brehob	Vol #:	32

C 319	C. Laura	Vol #:	32

C 320	M. Bushell	Vol #:	32

C 321	M. Brenneman	Vol #:	32

C 322	R. Ripple	Vol #:	32

C 323	A. Korrick	Vol #:	36

C 324	F. Hamilton	Vol #:	32

C 325	J. Cavanaugh	Vol #:	32

C 326	L. Durant	Vol #:	32

C 327	E. Auistin	Vol #:	32

C 328	M. Everson	Vol #:	32

C 329	Dr. J. Eisenstein	Vol #:	32

C 330	G. Carlson	Vol #:	32

C 331	S. Lien	Vol #:	32

C 332	E. Samuels	Vol #:	32

C 333	P. Nobuto	Vol #:	32

C 334	G. Smith	Vol #:	32

C 335	T.C. Florczak	Vol #:	32

C 336	J. Beckham	Vol #:	32

C 337	A. Korrick	Vol #:	32

C 338	E. Stiltner	Vol #:	32

C 339	D. Carey	Vol #:	32

C 340	A. Enerman	Vol #:	32

C 341	M. Weintraub	Vol #:	32

C 342	M. Geise	Vol #:	32

C 343	B. Okorie	Vol #:	32

C 344	L. Sevant	Vol #:	32

C 345	D. Duveruus	Vol #:	32



C 346	R. Gautsol	Vol #:	32

C 347	C. Ritlaw	Vol #:	32

C 348	N. Butka	Vol #:	32

C 349	B. Wilder	Vol #:	32

C 350	W. Perry	Vol #:	32

C 351	B. Keith	Vol #:	32

C 352	O. Winners	Vol #:	32

C 353	Dms	Vol #:	32

C 354	K. Freel	Vol #:	32

C 355	Form Letter Count 12	Vol #:	33

C 356	S.Emerma	Vol #:	32

C 357	M. Curry	Vol #:	32

C 358	K. Clayton	Vol #:	32

C 359	J. Johnson	Vol #:	32

C 360	M. Peterson	Vol #:	32

C 361	Friends of Animals	Vol #:	32

EMC 136	T. Nuggett	Vol #:	5

2003P-0064	Withhold Approval of Generic Lovenox (enoxaparin sodium inje

SUP 4	Sanofi-aventis U.S. LLC	Vol #:	6

2004N-0081	BSE Risk Materials in Foods and Cosmetics

C 153	Gelatin Manufacturers of Europe (GME)	Vol #:	13

2004N-0230	Food; Current Good Manufacturing Practice Regulations; Public Meetings

C 646	American Bakers Association	Vol #:	11

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

C 687	K McCracken	Vol #:	32

C 688	J DiMaio	Vol #:	32

C 689	K McCracken	Vol #:	32

C 690	J Di Maio	Vol #:	32

C 691	S Francis	Vol #:	32

EREG 47	M. Pacheco	Vol #:	32

2005N-0373	Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants

C 5	Gelatin Maufacturers of Europe (GME)	Vol #:	8

EREG 4	Hematech, Inc.	Vol #:	8



2005P-0121	Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II

C 13	Pennsylvania Spine Institute	Vol #:	7

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

C 14	Hogan & Hartson	Vol #:	7

2006D-0301	Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waivers and Reductions

GDL 2	Guidance	Vol #:	1

NAD 2	FDA	Vol #:	1

2006D-0336	Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions

C 11	Abbott Molecular Inc	Vol #:	1

2006D-0347	Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

C 11	Save Babies Through Screening	Vol #:	1

C 12	KS&A	Vol #:	1

C 13	Pfizer Inc	Vol #:	1

2006N-0061	Charging for Investigational Drugs

C 6	A Garcia	Vol #:	1

EXT 1	Public Citizen	Vol #:	1

2006N-0062	Expanded Access to Investigational Drugs for Treatment Use

C 7	D Swanson RPh	Vol #:	1

C 8	Breast Cancer Action	Vol #:	1

EXT 1	Public Citizen	Vol #:	2

2006N-0352	Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam

EMC 1159	C. Brown	Vol #:	31

EMC 1160	M. Newell	Vol #:	31

EMC 1161	C. Biagioli	Vol #:	31

2006N-0525	Supplements and Other Changes to an Approved Application

C 2	Wyeth Pharmaceuticals Inc	Vol #:	1

2006P-0307	To amend 21CFR 201.17 regarding expiration dates

LET 3	S Lohiya	Vol #:	1

2006P-0351	Restriction or withdrawal of the use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapy in the following conditions

LET 2	FDA/CDER to A Mandal MD	Vol #:	1



2006P-0394	Revise the labeling requirements for eggs sold in the United States

C 63	M Giese	Vol #:	6

C 64	C Holt	Vol #:	6

C 65	B Knapp	Vol #:	6

C 66	Voices for Animals	Vol #:	6

C 67	S Cohen	Vol #:	6

C 68	D Finder	Vol #:	6

C 69	B Osborn	Vol #:	6

2006P-0487	Health Claim Petition: Isomaltulose and Dental Caries

LET 3	Cargill Inc	Vol #:	1

2007V-0081	Laser Light Show

ACK 1	FDA / DDM to Fusion Laser Light Show	Vol #:	1

VAR 1	Fusion Laser Light Show	Vol #:	1

2007V-0082	Laser Light Show

ACK 1	FDA / DDM to Information Database Solutions	Vol #:	1

VAR 1	Information Database Solutions	Vol #:	1

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FDA/Dockets Management