Dockets Entered on September 18, 2006

Dockets Management



Dockets Entered On September 18, 2006



Docket #	Title

1995N-0309	CGMPs for the Production of Infant Formula

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

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

2004P-0520	180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution

2005D-0169	Guidance on Useful Written Consumer Medication Information (CMI)

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

2006D-0246	Manufactured Food Regulatory Program Standards

2006D-0331	Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research

2006E-0005	Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876

2006E-0006	Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819

2006E-0024	Patent Extension Application for VNS Therapy System, U.S. Patent No. 5,299,569

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

2006P-0125	Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from sale for safety or efficacy reasons

2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

2006P-0223	Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA

2006P-0306	Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone

2006P-0348	Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc

2006P-0370	Revoke FDA's prior approval of vagus nerve stimulation (VNS) for mangement of treatment-resistant depression (TRD)

2006P-0372	Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons

2006V-0388	Projector for a Laser Light Show

1995N-0309	CGMPs for the Production of Infant Formula

EC 8	PBM Nutritionals	Vol #:	13

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

C 1393	K. Bandstra	Vol #:	259

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

REF 2	OMB Review for Substances Prohibted From Use in Animal Food or Feed	Vol #:	46

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

C 65	K. Bandstra	Vol #:	5

2004P-0520	180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution

WDL 1	Teva Pharmaceuticals, USA (TEVA)	Vol #:	2

2005D-0169	Guidance on Useful Written Consumer Medication Information (CMI)



EC 21	Mrs. Susan Barton	Vol #:	2

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

C 18113	L. Eckhardt	Vol #:	196

C 18114	United States House of Represenatives	Vol #:	196

C 18115	C. Salon	Vol #:	196

C 18116	C. Turner	Vol #:	196

C 18117	B. Nielsen	Vol #:	196

C 18118	M. O'Connor	Vol #:	196

C 18119	D. Hall	Vol #:	196

C 18120	C. Brochu	Vol #:	196

C 18121	B. Peterson	Vol #:	196

C 18122	J. Hoeschler	Vol #:	196

C 18123	C. Donovan	Vol #:	196

C 18124	M. Gilliam	Vol #:	196

C 18125	C. Crumley	Vol #:	196

C 18126	D'Amico	Vol #:	196

C 18127	C. Pohle	Vol #:	196

C 18128	K. Lopez	Vol #:	196

C 18129	P. O'Brien	Vol #:	196

C 18130	M. Dudai	Vol #:	196

C 18131	T. Jones	Vol #:	196

C 18132	V. Burroughs	Vol #:	196

C 18133	L. Quigley	Vol #:	196

2006D-0246	Manufactured Food Regulatory Program Standards

C 1	Texas Department of State Health Services (DSHS)	Vol #:	1

C 2	Abbott Laboratories	Vol #:	1

2006D-0331	Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research

EC 16	Mr. Rick Heidel	Vol #:	1

EC 17	Mr. Peter Bodenbach	Vol #:	1

EC 18	Mr. Rick Heidel	Vol #:	1

EC 19	Mr. Luis Howard f Howard fami	Vol #:	1

EC 20	Mr. Dave Lowe	Vol #:	1

2006E-0005	Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876

LET 3	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1



2006E-0006	Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819

LET 3	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1

2006E-0024	Patent Extension Application for VNS Therapy System, U.S. Patent No. 5,299,569

LET 4	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1

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

C 2	Kerger & Associates	Vol #:	1

C 3	Dr. W. Duncan	Vol #:	1

C 4	R. Painter, M.D.	Vol #:	1

C 5	K. Knudson	Vol #:	1

C 6	R. West	Vol #:	1

C 7	C. Wilson, III	Vol #:	1

C 8	P. Monger	Vol #:	1

C 9	P. Simon	Vol #:	1

C 10	S. Cox	Vol #:	1

C 11	B. Nicholas	Vol #:	1

C 12	J. Trotter	Vol #:	1

C 13	C. Trotter	Vol #:	1

C 14	T. Elliott	Vol #:	1

C 15	M. Chapman	Vol #:	1

C 16	C. Drake, LPN	Vol #:	1

C 17	D. Vik	Vol #:	1

C 18	M. Zerbe	Vol #:	1

C 19	D. Zerbe	Vol #:	1

C 20	S. Mark	Vol #:	1

C 21	R. Thompson	Vol #:	1

C 22	B. Wandler	Vol #:	1

C 23	H. Pebbles	Vol #:	1

C 24	B. Allen	Vol #:	1

C 25	P. Christensen	Vol #:	1

C 26	D. Avery	Vol #:	1

C 27	G. Hockett	Vol #:	1

C 28	W. Buckman	Vol #:	1

C 29	D. Martinson	Vol #:	1

C 30	S. Johnson, MD	Vol #:	1

EC 62	Dr. Steve Markus	Vol #:	3



RPT 1	Trans-agency Working Group on the Health Effects of Dental Amalgam US Department of Heath and	Vol #:	7

RPT 2	International Academy of Oral Medicine and Toxicology	Vol #:	8

SUP 1	R. Edlich, M.D., PhD	Vol #:	1

SUP 2	A. Kerimian, PhD	Vol #:	9

TS 23	M. Flowers	Vol #:	1

TS 24	T. Klausen	Vol #:	1

2006P-0125	Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from sale for safety or efficacy reasons

LET 1	FDA/DDM to CDER	Vol #:	1

2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

EC 722	Ms. Sonia Dunkinson	Vol #:	3

2006P-0223	Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA


EC 700	Mrs. Bethany Perry	Vol #:	5

EC 701	self	Vol #:	5

EC 702	N/A	Vol #:	5

EC 703	Mrs. Thelma Kesl	Vol #:	5

2006P-0306	Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
EC 1	Consumers Union, publisher of Consumer Reports	Vol #:	1

2006P-0348	Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc



EC 3	Mr. Dave Lowe	Vol #:	3

2006P-0370	Revoke FDA's prior approval of vagus nerve stimulation (VNS) for mangement of treatment-resistant depression (TRD)

SUP 1	Public Citizen	Vol #:	1

2006P-0372	Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons

EC 1	Mr. Dave Lowe	Vol #:	2

2006V-0388	Projector for a Laser Light Show

ACK 1	FDA / DDM to Martin Professional Inc.	Vol #:	1

VAR 1	Martin Professional Inc.	Vol #:	1

Page created on October 4, 2006 kk

FDA/Dockets Management