Dockets Entered on December 3, 2007

Dockets Management



Dockets Entered On December 3, 2007



Docket #	Title

1978N-0038	Sunscreen Drug Products

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

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

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

2007D-0290	Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)

2007D-0310	Companion to Guidance for Industry on Pharmacogenomic Data

2007H-0433	Civil Money Penalty; Advanced Bionics Corporation

2007N-0279	Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping

2007N-0306	Current Good Manufacturing Practice Regulations for Type A Medicated Articles; Agency Information Collection Activities

2007N-0417	Acarbose Tablets and 180-day exclusivity

2007P-0085	Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity

1978N-0038	Sunscreen Drug Products

C 695	House of Representatives Alabama State House	Vol #:	176

C 696	House of Representatives Alabama State House	Vol #:	176

C 697	House of Representatives Alabama State House	Vol #:	176

C 698	Toren Anderson M. D.	Vol #:	176

C 699	House of Representatives Alabama State House	Vol #:	176

C 700	Wyeth Comsumer healthcare	Vol #:	176

C 701	State Representative District 48	Vol #:	176

C 702	Board of Chosen Freeholders County of Cape May	Vol #:	176

C 703	Senate of Virginia	Vol #:	176

C 704	New Jersey Senate	Vol #:	176

C 705	R. L. Visser	Vol #:	176

C 706	Borough of Avalon	Vol #:	176

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

LET 21184	Perrigo Company of South Carolina	Vol #:	182

LET 21185	Perrigo Company of South Carolina	Vol #:	182

LET 21186	Perrigo Company of South Carolina	Vol #:	182

LET 21187	Perrigo Company of South Carolina	Vol #:	182

LET 21188	Perrigo Company of South Carolina	Vol #:	182

LET 21189	Perrigo Company of South Carolina	Vol #:	182

LET 21190	Perrigo Company of South Carolina	Vol #:	182

LET 21191	Perrigo Company of South Carolina	Vol #:	182

LET 21192	Perrigo Company of South Carolina	Vol #:	182

LET 21193	Perrigo Company of South Carolina	Vol #:	182



LET 21194	Perrigo Company of South Carolina	Vol #:	182

LET 21195	Perrigo Company of South Carolina	Vol #:	182

LET 21196	Perrigo Company of South Carolina	Vol #:	182

LET 21197	Perrigo Company of South Carolina	Vol #:	182

LET 21198	Perrigo Company of South Carolina	Vol #:	182

LET 21199	Perrigo Company of South Carolina	Vol #:	182

LET 21200	Perrigo Company of South Carolina	Vol #:	182

LET 21201	Perrigo Company of South Carolina	Vol #:	182

LET 21202	Perrigo Company of South Carolina	Vol #:	182

LET 21203	Perrigo Company of South Carolina	Vol #:	182

LET 21204	Waiora	Vol #:	182

LET 21205	Waiora	Vol #:	182

LET 21206	Waiora	Vol #:	182

LET 21207	Waiora	Vol #:	182

LET 21208	Waiora	Vol #:	182

LET 21209	Perrigo Company and South Carolina	Vol #:	182

LET 21210	Perrigo Company and South Carolina	Vol #:	182

LET 21211	Perrigo Company and South Carolina	Vol #:	182

LET 21212	Perrigo Company and South Carolina	Vol #:	182

LET 21213	Perrigo Company and South Carolina	Vol #:	182

LET 21214	Perrigo Company and South Carolina	Vol #:	182

LET 21215	Perrigo Company and South Carolina	Vol #:	182

LET 21216	Perrigo Company and South Carolina	Vol #:	182

LET 21217	Perrigo Company and South Carolina	Vol #:	182

LET 21218	Perrigo Company and South Carolina	Vol #:	182

LET 21219	Perrigo Company and South Carolina	Vol #:	182

LET 21220	Perrigo Company and South Carolina	Vol #:	182

LET 21221	Perrigo Company and South Carolina	Vol #:	182

LET 21222	Perrigo Company and South Carolina	Vol #:	182

LET 21223	Perrigo Company and South Carolina	Vol #:	182

LET 21224	Perrigo Company and South Carolina	Vol #:	182

LET 21225	Perrigo Company and South Carolina	Vol #:	182

LET 21226	Perrigo Company and South Carolina	Vol #:	182

LET 21227	Perrigo Company and South Carolina	Vol #:	182

LET 21228	Perrigo Company and South Carolina	Vol #:	182

LET 21229	Perrigo Company and South Carolina	Vol #:	182

LET 21230	Perrigo Company and South Carolina	Vol #:	182



LET 21231	Perrigo Company and South Carolina	Vol #:	182

LET 21232	Perrigo Company and South Carolina	Vol #:	182

LET 21233	Perrigo Company and South Carolina	Vol #:	182

LET 21234	Perrigo Company and South Carolina	Vol #:	182

LET 21235	Perrigo Company and South Carolina	Vol #:	182

LET 21236	Perrigo Company and South Carolina	Vol #:	182

LET 21237	Perrigo Company and South Carolina	Vol #:	182

LET 21238	Perrigo Company and South Carolina	Vol #:	182

LET 21239	Perrigo Company and South Carolina	Vol #:	182

LET 21240	Perrigo Company and South Carolina	Vol #:	182

LET 21241	Perrigo Company and South Carolina	Vol #:	182

LET 21242	Perrigo Company and South Carolina	Vol #:	182

LET 21243	Perrigo Company and South Carolina	Vol #:	182

LET 21244	Perrigo Company and South Carolina	Vol #:	182

LET 21245	Perrigo Company and South Carolina	Vol #:	182

LET 21246	Perrigo Company and South Carolina	Vol #:	182

LET 21247	Perrigo Company and South Carolina	Vol #:	182

LET 21248	HIGHLAND LABORATORIES	Vol #:	182

LET 21249	HIGHLAND LABORATORIES	Vol #:	182

LET 21250	HIGHLAND LABORATORIES	Vol #:	182

LET 21251	HIGHLAND LABORATORIES	Vol #:	182

LET 21252	HIGHLAND LABORATORIES	Vol #:	182

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

C 24	Coalition for 21st Century Medicine	Vol #:	3

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

C 4257	E. R. Yatch	Vol #:	40

C 4258	S. Robinson	Vol #:	40

C 4259	S. L. Detamore	Vol #:	40

C 4260	R. A. Bailey	Vol #:	40

2007D-0290	Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)

C 2	P. Alain	Vol #:	1

2007D-0310	Companion to Guidance for Industry on Pharmacogenomic Data

C 6	AstraZeneca	Vol #:	1

2007H-0433	Civil Money Penalty; Advanced Bionics Corporation



CS 1	FDA/DDM	Vol #:	1

OR 1	FDA/Administrative Law Judge	Vol #:	1

2007N-0279	Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping

N 2	FDA	Vol #:	1

NFL 1	FDA	Vol #:	1

2007N-0306	Current Good Manufacturing Practice Regulations for Type A Medicated Articles; Agency Information Collection Activities

N 2	FDA	Vol #:	1

2007N-0417	Acarbose Tablets and 180-day exclusivity

C 3	Impax Laboratories, Inc.	Vol #:	1

2007P-0085	Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity

C 358	J. Gregg	Vol #:	102

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FDA/Dockets Management