Dockets Entered on October 15, 2007

Dockets Management



Dockets Entered On October 15, 2007



Docket #	Title

1978N-0038	Sunscreen Drug Products

2001D-0193	Premarket Notifications for Biological Indicators Intended

2001V-0157	Slick Productions laser light show with Lasergraphix Lgx-1000 Ar Projector

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

2007D-0201	Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents

2007D-0367	Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval

2007D-0386	Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

2007D-0388	Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protec


2007N-0098	Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration

2007N-0262	Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)

2007N-0356	Behind The Counter Availability of Certain Drugs; Public Meeting

2007P-0074	Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age

1978N-0038	Sunscreen Drug Products

EC 2459	Mrs. Jessica Camelio	Vol #:	161

EREG 4	J. Kidd	Vol #:	162

2001D-0193	Premarket Notifications for Biological Indicators Intended

EC 1	Mr. Richard Lakin	Vol #:	1

2001V-0157	Slick Productions laser light show with Lasergraphix Lgx-1000 Ar Projector

VRA 1	FDA/CDRH to Slick Porductions	Vol #:	1

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

C 4123	Boehringer Ingelheim Pharmaceuticals, Inc.	Vol #:	35

C 4124	American Thoracic Society (ATS)	Vol #:	35

C 4125	B. Burns	Vol #:	35

C 4126	M. Dye	Vol #:	35

C 4127	D. Ricard	Vol #:	35

C 4128	D. Golladay	Vol #:	35

C 4129	H. Houser	Vol #:	35

C 4130	B. Beck	Vol #:	35

C 4131	A. Morgan	Vol #:	35

C 4132	B. Johnson	Vol #:	35

C 4133	S. Delaney	Vol #:	35

C 4134	M Graff	Vol #:	35

C 4135	J. Howard	Vol #:	35



C 4136	S. Leber	Vol #:	35

C 4137	S. Lask	Vol #:	35

C 4138	J. Yost	Vol #:	35

C 4139	W. Clark	Vol #:	35

C 4140	D. Nasby	Vol #:	35

C 4141	B. Leonard	Vol #:	35

C 4142	P Harrison	Vol #:	35

C 4143	M. Malavolti	Vol #:	35

C 4144	M. Fatula	Vol #:	35

C 4145	B. Colbert	Vol #:	35

C 4146	S. Hensley	Vol #:	35

C 4147	G. Stanley	Vol #:	35

C 4148	R. Volensky	Vol #:	35

C 4149	J. Hicks	Vol #:	35

C 4150	E. Bair	Vol #:	35

C 4151	M. Alley	Vol #:	35

C 4152	L. Clarke Dumbull	Vol #:	35

C 4153	S. Jones	Vol #:	35

C 4154	Y. Erickson	Vol #:	35

C 4155	R. Keeney	Vol #:	35

C 4156	M. Wells	Vol #:	35

C 4157	M. Schwartz	Vol #:	35

C 4158	G. Kahrs	Vol #:	35

C 4159	J. Scott	Vol #:	35

C 4160	P. Sjogren	Vol #:	35

C 4161	O. Payton	Vol #:	35

C 4162	P. Chedelawada	Vol #:	35

C 4163	B. Dunham	Vol #:	35

C 4164	N. Miner	Vol #:	35

C 4165	A. Hinson	Vol #:	35

C 4166	US STAKEHOLDERS GROUP ON MDI TRANSITION	Vol #:	35

C 4167	K. Ackerman	Vol #:	35

C 4168	D. Brunie	Vol #:	35

C 4169	D. Ruff	Vol #:	35

C 4170	J. Herman	Vol #:	35

C 4171	T. Parsons	Vol #:	35

C 4172	J. Freeman	Vol #:	35



C 4173	R. Horne	Vol #:	35

C 4174	. J Davis	Vol #:	35

C 4175	J. Botz	Vol #:	35

C 4176	A. Ausburn	Vol #:	35

C 4177	C. Slack	Vol #:	35

C 4178	T. Rogers	Vol #:	35

C 4179	W. DeVoe	Vol #:	35

C 4180	W. Snyder	Vol #:	35

C 4181	B. Washington	Vol #:	35

C 4182	M. Gephardt	Vol #:	35

C 4183	R. Brunofsky	Vol #:	35

C 4184	D. Dougherty	Vol #:	35

C 4185	W. Morrison Jr	Vol #:	35

C 4186	J. Flagg	Vol #:	35

C 4187	P. Cook	Vol #:	35

C 4188	J. Sonnenberg	Vol #:	35

C 4189	J. Ray	Vol #:	35

C 4190	M. Dorio	Vol #:	35

C 4191	M. Walker	Vol #:	35

C 4192	J. Washcovick	Vol #:	35

C 4193	B. Perreault	Vol #:	35

C 4194	J. Peralta	Vol #:	35

C 4195	P. DeLaet	Vol #:	35

C 4196	I. Fay	Vol #:	35

C 4197	no signature	Vol #:	35

C 4198	L. Boyce	Vol #:	35

C 4199	J. Garcia	Vol #:	35

C 4200	J. Garcia	Vol #:	35

2007D-0201	Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents

C 1	Enturia, Inc.	Vol #:	1

2007D-0367	Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval

GDL 1	Guidance	Vol #:	1

NAD 1	FDA	Vol #:	1

2007D-0386	Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

GDL 1	Guidance	Vol #:	1



NAD 1	FDA	Vol #:	1

2007D-0388	Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protec



GDL 1	Guidance	Vol #:	1

NAD 1	FDA	Vol #:	1

2007N-0098	Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration

N 2	FDA	Vol #:	1

2007N-0262	Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)

EC 4	Mrs. Angie Cornelius	Vol #:	1

2007N-0356	Behind The Counter Availability of Certain Drugs; Public Meeting

EAPE 101	Gallagher, Rita Munley	Vol #:	1

EAPE 102	Gallagher, Rita Munley	Vol #:	1

EAPE 103	Ezzo, Danielle	Vol #:	1

EAPE 104	Lenkel, Laurie	Vol #:	1

EAPE 105	Marzella Sulli, Maria	Vol #:	1

EC 7	Mr. Lucio Castillo	Vol #:	1

EC 8	Mr. Joshua Stanley	Vol #:	1

EC 9	Bartell Drugs (a regional chain)	Vol #:	1

EC 10	Walmart Pharmacy	Vol #:	1

EC 11	Mr. Arthur Klibbe	Vol #:	1

EC 12	self	Vol #:	1

EC 13	Ms. Judith Jordan	Vol #:	1

EC 14	consumer	Vol #:	1

2007P-0074	Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age

EC 7	Mrs. Mary Davis	Vol #:	1

Page created on October 15, 2007 ue

FDA/Dockets Management