Dockets Entered on November 15, 2006

Dockets Management



Dockets Entered On November 15, 2006



Docket #	Title

1988N-0258	Prescription Drug Marketing Act of 1987; Guideline

1992N-0297	Prescription Drug Marketing Act of 1987, Drug Amds of 1992

2004P-0557	ANDA for a generic version of Efudex Cream(fluorouracil) cream

2004V-0277	Laser Light Show

2005P-0146	to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs

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

2005P-0402	Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."


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

2006D-0226	Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability

2006D-0303	Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements

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

2006D-0344	Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases

2006M-0460	P970053/S009 - Nidek EC-5000 Excimer Laser System

2006N-0328	Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions 21 CFR Part 571 ; Extension

2006N-0414	Suicidality Data from Adult Antidepressant Trials

2006N-0452	Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization

2006P-0085	To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements

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

2006P-0423	Regulate Labeling and Packaging of Acetaminophen/APAP Containing Products

2006P-0428	Combivent (ipratropium bromide and albuterol sulfate)

2006P-0444	Stay the potential grant effective approval of ANDA for 77-536 for moexipril hydrochloride tablets

2006P-0446	ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg

1988N-0258	Prescription Drug Marketing Act of 1987; Guideline

C 150	NuCare Pharmaceuticals, Inc.	Vol #:	8

N 1	FDA	Vol #:	8

1992N-0297	Prescription Drug Marketing Act of 1987, Drug Amds of 1992

C 144	NuCare Pharmaceuticals, Inc.	Vol #:	10

N 2	FDA	Vol #:	10

2004P-0557	ANDA for a generic version of Efudex Cream(fluorouracil) cream

C 4	D. Lowe	Vol #:	3

2004V-0277	Laser Light Show

VRA 2	FDA/CDRH to Linden Laser Systems	Vol #:	1



2005P-0146	to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs


SUP 2	Salix Pharmaceuticals, Inc.	Vol #:	1

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

SUP 19	Department of the Planet Earth	Vol #:	7

2005P-0402	Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."


LET 3	FDA to the Honorable Lane Evans	Vol #:	5

LET 4	FDA to the Honorable Raul M. Grijalva	Vol #:	5

LET 5	FDA to the Honorable Tammy Baldwin	Vol #:	5

LET 6	FDA to the Honorable Bart Gordon	Vol #:	5

LET 7	FDA to the Honorable Nita M. Lowery	Vol #:	5

LET 8	FDA to the Honorable John W. Olver	Vol #:	5

LET 9	FDA to the Honorable Steven R. Rothman	Vol #:	5

LET 10	FDA to the Honorable Alcee L. Hastings	Vol #:	5

LET 11	FDA to the Honorable Jerrold Nadler	Vol #:	5

LET 12	FDA to the Honorable Grace F. Napolitano	Vol #:	5

LET 13	FDA to the Honorable Lloyd Doggett	Vol #:	5

LET 14	FDA to the Honorable Barney Frank	Vol #:	5

LET 15	FDA to the Honorable Carolyn B. Maloney	Vol #:	5

LET 16	FDA to the Patrick J. Kennedy	Vol #:	5

LET 17	FDA to the Honorable Sue Wilkins Myrick	Vol #:	5

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

C 18210	National Black Women's Health Project, Inc.	Vol #:	198

2006D-0226	Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability

GDL 3	Guidance	Vol #:	1

NAD 2	FDA	Vol #:	1

2006D-0303	Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements

C 1	Bristol-Myers Squibb Company (BMS)	Vol #:	1

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

C 1	Coalition for 21st Century Medicine	Vol #:	1

2006D-0344	Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
C 5	Millennium Pharmaceuticals, Inc.	Vol #:	1



C 6	P&G Pharmaceuticals, Inc.	Vol #:	1

C 7	Sanofi-Synthelabo, Inc.	Vol #:	1

C 8	Genentech, Inc.	Vol #:	1

C 9	Wyeth Pharmaceuticals (wyeth)	Vol #:	1

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases



C 17	D. Freeney	Vol #:	7

C 18	D. Benedict	Vol #:	7

C 19	J and M Nugent	Vol #:	7

C 20	J. McDevitt	Vol #:	7

C 21	R. D'Aurora	Vol #:	7

C 22	J. Sheehan	Vol #:	7

C 23	B. Leehan	Vol #:	7

C 24	V. Negron	Vol #:	7

C 25	S. Ramon	Vol #:	7

C 26	L. Schexnayder	Vol #:	7

C 27	W. Burke, MD, PhD	Vol #:	7

C 28	C. Lowe	Vol #:	7

C 29	M. Jude	Vol #:	7

C 30	M. Miller	Vol #:	7

C 31	J. Lynch	Vol #:	7

C 32	B. Rose, RN, MSN, FCP	Vol #:	7

C 33	E. Woo	Vol #:	7

C 34	Dr. J. Hebert	Vol #:	7

C 35	R. Gallup	Vol #:	7

C 36	R and D Jacobson	Vol #:	7

C 37	K. Zinn	Vol #:	7

C 38	A. Fairchild	Vol #:	7

C 39	Dr. R. YOung	Vol #:	7

C 40	J. Huckestein	Vol #:	7

C 41	J. Smith	Vol #:	7

C 42	D. Jenkins	Vol #:	7

C 43	N. Sebik	Vol #:	7

C 44	R. Gunsett	Vol #:	7

C 45	D. Schaefer	Vol #:	7

C 46	M. Duggan	Vol #:	7



C 47	M. L'Heureux	Vol #:	7

C 48	M. Kolars	Vol #:	7

C 49	J. Wiley	Vol #:	7

2006M-0460	P970053/S009 - Nidek EC-5000 Excimer Laser System

AAV 1	Nidek Company LTD	Vol #:	1

2006N-0328	Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions 21 CFR Part 571 ; Extension

N 2	FDA	Vol #:	1

2006N-0414	Suicidality Data from Adult Antidepressant Trials

NM 1	FDA	Vol #:	1

2006N-0452	Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization

N 1	FDA	Vol #:	1

2006P-0085	To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements

C 2	MedicalCenter Brace& Limb, Inc.	Vol #:	1

C 3	Ballert Orthopedic	Vol #:	1

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

C 20	T. Phipps	Vol #:	6

2006P-0423	Regulate Labeling and Packaging of Acetaminophen/APAP Containing Products

C 1	D. Lowe	Vol #:	1

2006P-0428	Combivent (ipratropium bromide and albuterol sulfate)

C 1	D. Lowe	Vol #:	2

2006P-0444	Stay the potential grant effective approval of ANDA for 77-536 for moexipril hydrochloride tablets

C 1	D. Lowe	Vol #:	1

2006P-0446	ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg

C 1	D. Lowe	Vol #:	1

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FDA/Dockets Management