Dockets Entered on April 18, 2006

Dockets Management



	Dockets Entered On April 18, 2006 Table of Contents



	Docket #			Title

	1976N-0052N			OTC Nasal Decongestants

	1981N-0022			OTC Weight Control Drug Products for Human Use

	1992S-0251			Electronic Submissions; Establishment of Public Docket

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

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

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

	2001P-0230			Domestic Marketing & Importation of Transgenic Fish

	2003D-0206			Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products;

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

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

	2003P-0544			Modify existing food additive regulation with respect to the irradiation of ground beef byproducts

	2004P-0359			Suitability Petition for (New Strength) Methacholine Chloride 1280 mg/vial

	2004P-0464			Vitamin D and Calcium and Reduced Risk of Osteoporosis

	2005D-0286			Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability

	2005N-0437			Medical Gas Containers and Closures; Current Good Manufacturing

	2005N-0457			Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of a Claim for Generally Recognized as Safe Exemption Based on a Generally Recognized as Safe Determination


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

	2005P-0257			Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, is suitable for submission as an ANDA

	2005P-0377			Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives

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

	2005P-0421			To re-evaluate the prescribing information/package insert for new tramdol formulations in light of currently available safety information

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

	2006D-0066			Guidance for Industry and FDA Staff: Whole Grains Label Statements

	2006D-0083			Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines

	2006D-0088			Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines

	2006D-0138			Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims

	2006D-0139			International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Revised Guidance for Industry on Stability Testing of New Veterina


	2006E-0043			Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,529,990

	2006M-0161			Premarket Approval for Ceralas I Laser System and Ceralink Slit Lamp Adapter by QLT USA, Inc., P050021

	2006M-0162			Quantel Activis Laser and ZSL30 ACT, and HSBMBQ ACT Slit Lamp Adapters by - QLT USA, Inc.

	2006P-0077			Refrain from lifting the administrative stay for amlodipine maleate tablets (NDA 21-435) until after September 25, 2007.

	2006P-0092			Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded

	2006P-0098			Seeks a determination that Loperamide hydrochloride 2 mg orally dissolving film strip is suitable for an ANDA based on the reference listed drug loperamide hydrochloride 2 mg oral chewable tablet (Imo


	2006P-0165			Initiate administrative proceedings for the purpose of investigating and enjoining the unlawful sale and distribution by International Tan Makers, Inc., of ultraviolet suntanning lamps that are misbr

	2006V-0164			Laser Light Show



1976N-0052N	OTC Nasal Decongestants

C 249	Novartis Consumer Health, Inc. (Novartis)	Vol #:	94

1981N-0022	OTC Weight Control Drug Products for Human Use

C 127	Novartis Consumer Health, Inc. (Novartis)	Vol #:	106

1992S-0251	Electronic Submissions; Establishment of Public Docket

M 33	21CFR316 and 814, Orphan-Drug Designation Requests, Humanitarian Use Device Designation Requ	Vol #:	1

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

LET 17554	Perrigo Compay of South Carolina	Vol #:	161

LET 17555	Perrigo Company of South Carolina	Vol #:	161

LET 17556	Perrigo Company of South Carolina	Vol #:	161

LET 17557	Perrigo Company of South Carolina	Vol #:	161

LET 17558	Perrigo Company of South Carolina	Vol #:	162

LET 17559	Perrigo Company of South Carolina	Vol #:	162

LET 17560	Perrigo Company of South Carolina	Vol #:	162

LET 17561	Perrigo Company of South Carolina	Vol #:	162

LET 17562	Perrigo Company of South Carolina	Vol #:	162

LET 17563	Perrigo Company of South Carolina	Vol #:	162

LET 17564	Perrigo Company of South Carolina	Vol #:	162

LET 17565	Perrigo Company of South Carolina	Vol #:	162

LET 17566	Perrigo Company of South Carolina	Vol #:	162

LET 17567	Perrigo Company of South Carolina	Vol #:	162

LET 17568	Perrigo Company of South Carolina	Vol #:	162

LET 17569	Perrigo Company of South Carolina	Vol #:	162

LET 17570	Perrigo Company of South Carolina	Vol #:	162

LET 17571	Perrigo Company of South Carolina	Vol #:	162

LET 17572	Natural Source International, Ltd.	Vol #:	162

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

C 18263	D. Hammond	Vol #:	516

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

C 12856	D. Hammond	Vol #:	806

C 12857	L. Raschke	Vol #:	806

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

C 1377	D. Hammond	Vol #:	259



C 1378	K. Canan	Vol #:	259

2003D-0206	Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products;

GDL 2	GUIDANCE	Vol #:	1

NAD 2	FDA	Vol #:	1

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

EMC 1276	No signature	Vol #:	12

EMC 1277	W. Ford	Vol #:	12

EMC 1278	K. Nelson	Vol #:	12

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

C 10	D. Lowe	Vol #:	6

2003P-0544	Modify existing food additive regulation with respect to the irradiation of ground beef byproducts

C 55	L. Raschke	Vol #:	5

C 56	D. Hammond	Vol #:	5

2004P-0359	Suitability Petition for (New Strength) Methacholine Chloride 1280 mg/vial
OB 1	D. Lowe	Vol #:	1

2004P-0464	Vitamin D and Calcium and Reduced Risk of Osteoporosis

LET 5	Beverage Institute for Health and Wellness (BHWI)	Vol #:	9

2005D-0286	Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability

C 13	International Society for Pharmaceutical Engineering (ISPE)	Vol #:	1

2005N-0437	Medical Gas Containers and Closures; Current Good Manufacturing

EMC 1	T. Glenn	Vol #:	1

2005N-0457	Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of a Claim for Generally Recognized as Safe Exemption Based on a Generally Recognized as Safe Determination


N 2	FDA	Vol #:	1

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

TS 2	King & Spalding LLP	Vol #:	3

2005P-0257	Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, is suitable for submission as an ANDA

C 1	D. Lowe	Vol #:	1

2005P-0377	Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives

CR 1	New York State Institute for Basic Research in Developmental Disabilities	Vol #:	3



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

C 6272	E Stec	Vol #:	89

C 6273	R. Shemesh, MD	Vol #:	89

C 6274	M. Mittelstaedt	Vol #:	89

C 6275	K. Haines	Vol #:	89

C 6276	L. Griffin	Vol #:	89

C 6277	J. Hutton	Vol #:	89

C 6278	J. Lawson	Vol #:	89

C 6279	D. Sheeham	Vol #:	89

C 6280	J. M. Colvin	Vol #:	89

C 6281	P.S.McHenry	Vol #:	89

C 6282	F Chang	Vol #:	89

C 6283	M. L. Lenski	Vol #:	89

C 6284	K. Gallogly	Vol #:	89

C 6285	D. Fromberg	Vol #:	89

C 6286	P. Petus	Vol #:	89

C 6287	C. Goldsburg	Vol #:	89

C 6288	R. Molian	Vol #:	89

C 6289	M. Foster	Vol #:	89

C 6290	T.P. Carstensen	Vol #:	89

C 6291	B. Mills	Vol #:	89

C 6292	T Nason	Vol #:	89

C 6293	T. Urbanski	Vol #:	89

C 6294	J. Marie	Vol #:	89

C 6295	C. Unick	Vol #:	89

C 6296	Eligible	Vol #:	89

C 6297	D. Berger	Vol #:	89

C 6298	D. Baese	Vol #:	89

C 6299	J. Freeman	Vol #:	89

C 6300	D. Stellwag	Vol #:	89

C 6301	J. Panhais	Vol #:	89

C 6302	Janie Abell	Vol #:	89

C 6303	J. Reardon	Vol #:	89

C 6304	A.M. Smith	Vol #:	89

C 6305	V. Wall	Vol #:	89

C 6306	S. E.Coben	Vol #:	89



C 6307	L. Hickman	Vol #:	89

C 6308	J. Stefanick	Vol #:	89

C 6309	A Swink	Vol #:	89

C 6310	K. Greenwood	Vol #:	89

C 6311	M. Armstrong	Vol #:	89

C 6312	S. Schwegler	Vol #:	89

C 6313	L R. Waletzkyy, MD	Vol #:	89

C 6314	L. Tellington-Jones	Vol #:	89

C 6315	L. Tellington-Jones	Vol #:	89

C 6316	R. Harris	Vol #:	89

C 6317	J. Jenkins	Vol #:	89

C 6318	M, Dressel	Vol #:	89

C 6319	S.Hearst	Vol #:	89

C 6320	M. Carson	Vol #:	89

C 6321	T. Cook	Vol #:	89

C 6322	E.D. Larsen	Vol #:	89

C 6323	C. Constantine	Vol #:	89

C 6324	M. Schmid	Vol #:	89

C 6325	K. Schmid	Vol #:	89

C 6326	C. A. Durre	Vol #:	89

C 6327	G. Horgisi	Vol #:	89

C 6328	P. H. Williams	Vol #:	89

C 6329	J. Morrison	Vol #:	89

C 6330	L. Roberson	Vol #:	89

C 6331	K. Dudley	Vol #:	89

C 6332	M. Fraser	Vol #:	89

C 6333	K. Nokes	Vol #:	89

C 6334	D. Burdo	Vol #:	89

C 6335	J. Widmark	Vol #:	89

C 6336	C. Rementeria	Vol #:	89

C 6337	D. A. Jobin	Vol #:	89

C 6338	J. Moore	Vol #:	89

C 6339	J . Golden-Tevald, DO	Vol #:	89

C 6340	S. Kramer	Vol #:	89

C 6341	R. Greene	Vol #:	89

C 6342	S. Lee	Vol #:	89

C 6343	W. Hernacki	Vol #:	89



C 6344	M. Mickel	Vol #:	89

C 6345	S. Presley	Vol #:	89

C 6346	S. L. Konieczny	Vol #:	89

C 6347	C. Gower	Vol #:	89

C 6348	L. Keeley	Vol #:	89

C 6349	G. Waddell-Schultz	Vol #:	89

C 6350	B. ODell	Vol #:	89

C 6351	C. Duke-Bnonski	Vol #:	89

C 6352	E. Sczyrbowski	Vol #:	89

C 6353	H. Sczyrbowski	Vol #:	89

C 6354	M. L. Sczyrbowski	Vol #:	89

C 6355	D.N. Szabile	Vol #:	89

C 6356	J. R. Monsen	Vol #:	89

C 6357	E. Flamm	Vol #:	89

C 6358	D. Memory	Vol #:	89

C 6359	P. I Coulon	Vol #:	89

C 6360	B. Renschier	Vol #:	89

C 6361	B. Renschier	Vol #:	89

C 6362	J. A. Shadwell	Vol #:	89

C 6363	C. Holmer	Vol #:	89

C 6364	D. C. Smith	Vol #:	89

C 6365	L. Yarbrough	Vol #:	89

C 6366	P. Guger	Vol #:	89

C 6367	E. Powell	Vol #:	89

C 6368	D. Sanderson	Vol #:	89

C 6369	S Philipp	Vol #:	89

C 6370	R. Imperato	Vol #:	89

C 6371	R. Imperato	Vol #:	89

C 6372	R. Imperato	Vol #:	89

2005P-0421	To re-evaluate the prescribing information/package insert for new tramdol formulations in light of currently available safety information

LET 1	HFD-005 to Duane Morris, LLP	Vol #:	2

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

EMC 4	J. Dean	Vol #:	1

EMC 5	AmeriFlax	Vol #:	1

2006D-0066	Guidance for Industry and FDA Staff: Whole Grains Label Statements



C 10	University of Minnesota	Vol #:	1

C 11	USA Rice Federation	Vol #:	1

C 12	Archer Daniels Midland Company (ADM)	Vol #:	1

C 13	Campbell Soup Company (Campbell's)	Vol #:	1

C 14	Schwan Food Company (Schwan)	Vol #:	1

C 15	AACC International Task Force	Vol #:	1

2006D-0083	Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines

BKG 1	Background Material	Vol #:	2

2006D-0088	Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines

BKG 1	Background Material	Vol #:	2

2006D-0138	Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims

GDL 1	GUIDANCE	Vol #:	1

NAD 1	FDA	Vol #:	1

2006D-0139	International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Revised Guidance for Industry on Stability Testing of New Veterina



GDL 1	GUIDANCE	Vol #:	1

NAD 1	FDA	Vol #:	1

2006E-0043	Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,529,990

OB 1	D. Lowe	Vol #:	1

2006M-0161	Premarket Approval for Ceralas I Laser System and Ceralink Slit Lamp Adapter by QLT USA, Inc., P050021

AAV 1	QLT USA, Inc.	Vol #:	1

2006M-0162	Quantel Activis Laser and ZSL30 ACT, and HSBMBQ ACT Slit Lamp Adapters by - QLT USA, Inc.

AAV 1	QLT USA, Inc.	Vol #:	1

2006P-0077	Refrain from lifting the administrative stay for amlodipine maleate tablets (NDA 21-435) until after September 25, 2007.

OB 1	D. Lowe	Vol #:	1

2006P-0092	Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded

OB 1	D. Lowe	Vol #:	1

2006P-0098	Seeks a determination that Loperamide hydrochloride 2 mg orally dissolving film strip is suitable for an ANDA based on the reference listed drug loperamide hydrochloride 2 mg oral chewable tablet (Imo


OB 1	D. Lowe	Vol #:	1

OB 2	D. Lowe	Vol #:	1



2006P-0165	Initiate administrative proceedings for the purpose of investigating and enjoining the unlawful sale and distribution by International Tan Makers, Inc., of ultraviolet suntanning lamps that are misbr


ACK 1	HFA-305 to Banner & Witcoff, Ltd.	Vol #:	1

CP 1	Banner & Witcoff, Ltd.	Vol #:	1

2006V-0164	Laser Light Show

ACK 1	HFA-305 to MGM Productions, Inc.	Vol #:	1

VAR 1	MGM Productions, Inc.	Vol #:	1

Page created on June 26, 2006 kk

FDA/Dockets Management