Dockets Entered on November 6, 2007

Dockets Management



Dockets Entered On November 6, 2007



Docket #	Title

1978N-0038	Sunscreen Drug Products

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

1998D-0307	Exports/Imports under FDA export reform/enhancement Act 1996

2001D-0193	Premarket Notifications for Biological Indicators Intended

2005V-0054	Laser LIGHT sHOW

2006N-0168	Food Labeling: Reference Daily Intakes & Daily Reference Values

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

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

2007N-0277	Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing

2007N-0308	Medical Devices; Cardiovascular Devices; Electrocardiograph Electrode; Designation of Special Controls

2007N-0347	Information Technology Strategic Planning; Public Meeting

2007N-0356	BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting

2007N-0357	Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2008 Proposed Guidance Development; Establishment of a Public Docket.

2007N-0417	Acarbose Tablets and 180-day exclusivity

2007P-0283	Take actions with respect to NDAs and ANDAs seeking approval of modified release oral dosage form drug products containing opioid active ingredients

2007P-0400	Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion

1978N-0038	Sunscreen Drug Products

EC 2632	Dr. Carol Sommerfield	Vol #:	162

EC 2633	Mr. Donald Davis	Vol #:	162

EC 2634	Ms. Margaret Gunsiorowski	Vol #:	162

EC 2635	Mrs. antonella pascolla-mills	Vol #:	162

EC 2636	Mrs. Mary Gunsiorowski	Vol #:	162

EC 2637	Miss. Stephanie Rodriguez	Vol #:	162

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

LET 21000	Enz Matic Therapy	Vol #:	182

LET 21001	Enz Matic Therapy	Vol #:	182

LET 21002	Enz Matic Therapy	Vol #:	182

LET 21003	Enz Matic Therapy	Vol #:	182

LET 21004	Enz Matic Therapy	Vol #:	182

LET 21005	Enz Matic Therapy	Vol #:	182

LET 21006	Enz Matic Therapy	Vol #:	182

LET 21007	Enz Matic Therapy	Vol #:	182

LET 21008	Enz Matic Therapy	Vol #:	182

LET 21009	Enz Matic Therapy	Vol #:	182

LET 21010	Enz Matic Therapy	Vol #:	182



LET 21011	Enz Matic Therapy	Vol #:	182

LET 21012	Enz Matic Therapy	Vol #:	182

LET 21013	Enz Matic Therapy	Vol #:	182

LET 21014	Tony Ferguson Licensing Trust	Vol #:	182

LET 21015	Procaps Laboratories	Vol #:	182

LET 21016	Integrity	Vol #:	182

LET 21017	Vita- Herbs, Inc.	Vol #:	182

LET 21018	Vita- Herbs, Inc.	Vol #:	182

LET 21019	Blosential, Inc	Vol #:	182

LET 21020	Pharmanex	Vol #:	182

LET 21021	Pharmanex	Vol #:	182

LET 21022	Perrigo Co.	Vol #:	182

LET 21023	Perrigo Co.	Vol #:	182

LET 21024	Perrigo Co.	Vol #:	182

LET 21025	Perrigo Co.	Vol #:	182

LET 21026	Perrigo Co.	Vol #:	182

LET 21027	Perrigo Co.	Vol #:	182

LET 21028	Perrigo Co.	Vol #:	182

LET 21029	Perrigo Co.	Vol #:	182

LET 21030	Perrigo Co.	Vol #:	182

LET 21031	NBTY	Vol #:	182

LET 21032	NBTY	Vol #:	182

LET 21033	NBTY	Vol #:	181

LET 21034	NBTY	Vol #:	182

LET 21035	NBTY	Vol #:	182

LET 21036	NBTY	Vol #:	182

LET 21037	Perrigo Co.	Vol #:	182

LET 21038	Perrigo Co.	Vol #:	182

LET 21039	Perrigo Co.	Vol #:	182

LET 21040	Perrigo Co.	Vol #:	182

LET 21041	Perrigo Co.	Vol #:	182

LET 21042	Perrigo Co.	Vol #:	182

LET 21043	Perrigo Co.	Vol #:	182

LET 21044	Perrigo Co.	Vol #:	182

LET 21045	Perrigo Co.	Vol #:	182

LET 21046	Perrigo Co.	Vol #:	182

LET 21047	Perrigo Co.	Vol #:	182



LET 21048	Perrigo Co.	Vol #:	182

LET 21049	Perrigo Co.	Vol #:	182

LET 21050	Perrigo Co.	Vol #:	182

LET 21051	Perrigo Co.	Vol #:	182

LET 21052	Perrigo Co.	Vol #:	180

LET 21053	Perrigo Co.	Vol #:	182

LET 21054	Perrigo Co.	Vol #:	182

LET 21055	Perrigo Co.	Vol #:	182

LET 21056	Perrigo Co.	Vol #:	182

LET 21057	Perrigo Co.	Vol #:	182

LET 21058	Perrigo Co.	Vol #:	182

LET 21059	Perrigo Co.	Vol #:	182

LET 21060	Perrigo Co.	Vol #:	182

LET 21061	Perrigo Co.	Vol #:	182

LET 21062	Perrigo Co.	Vol #:	182

LET 21063	Perrigo Co.	Vol #:	182

LET 21064	Vita Herbs, Inc.	Vol #:	182

LET 21065	Bayer Health Care	Vol #:	182

LET 21066	M-13 Ventures Ltd	Vol #:	182

LET 21067	Perrigo Co.	Vol #:	182

LET 21068	Perrigo Co.	Vol #:	182

LET 21069	Perrigo Co.	Vol #:	182

LET 21070	Perrigo Co.	Vol #:	182

LET 21071	PJW	Vol #:	182

LET 21072	Tsumura & Co.	Vol #:	182

LET 21073	Perrigo Co.	Vol #:	182

LET 21074	Perrigo Co.	Vol #:	182

LET 21075	Perrigo Co.	Vol #:	182

LET 21076	Perrigo Co.	Vol #:	182

LET 21077	Millennium Biotechnologies, Inc.	Vol #:	182

1998D-0307	Exports/Imports under FDA export reform/enhancement Act 1996

EC 64	Mr. Gregorio Altuna	Vol #:	1

2001D-0193	Premarket Notifications for Biological Indicators Intended

EC 3	IDEO CORP.	Vol #:	1

2005V-0054	Laser LIGHT sHOW



LET 2	Number not used	Vol #:	1

2006N-0168	Food Labeling: Reference Daily Intakes & Daily Reference Values

EREG 1	M. Avila	Vol #:	1

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

C 482	S. Keller	Vol #:	14

C 483	P. Griffiths	Vol #:	14

C 484	J. Sancis	Vol #:	14

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

EC 7	Mr. David Lott	Vol #:	1

2007N-0277	Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing

EC 21	GMA/FPA	Vol #:	1

2007N-0308	Medical Devices; Cardiovascular Devices; Electrocardiograph Electrode; Designation of Special Controls

C 1	Southwest Dermatopathology Consultants	Vol #:	1

2007N-0347	Information Technology Strategic Planning; Public Meeting

C 1	Wyth Pharmaceuticals	Vol #:	1

EC 16	BIO & PhRMA	Vol #:	1

2007N-0356	BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting

EAPE 234	National Alliance of State Pharmacy Associations	Vol #:	2

EAPE 235	IDRAC US; Thomson Scientific	Vol #:	2

EAPE 236	none	Vol #:	2

EAPE 237	General Motors	Vol #:	2

EAPE 238	Action CF	Vol #:	2

EAPE 239	America's Health Insurance Plans	Vol #:	2

EAPE 240	FDA/CDER/OAP	Vol #:	2

EAPE 241	NABP	Vol #:	2

EAPE 242	Ballay Pharmaceuticals, Inc.	Vol #:	2

EAPE 243	Ballay Pharmaceuticals, Inc.	Vol #:	2

EAPE 244	Leesburg Pharmacy	Vol #:	2

EAPE 245	American Pharmacists Association	Vol #:	2

EAPE 246	Novartis	Vol #:	2

EAPE 247	Howard Pharmacy School	Vol #:	2

EAPE 248	Atlantis Group	Vol #:	2



EAPE 249	Former Director, Bureau of Drugs, FDA	Vol #:	2

EAPE 250	Atlantis Group	Vol #:	2

EAPE 251	Atlantis Group	Vol #:	2

EAPE 252	Pinney Associates	Vol #:	2

EAPE 253	Family Research Council	Vol #:	2

EAPE 254	American Academy of Pediatrics	Vol #:	2

EAPE 255	FDA	Vol #:	2

EAPE 256	American Academy of Pediatrics	Vol #:	2

EAPE 257	Leesburg Pharmacy	Vol #:	2

EAPE 258	Ketchum	Vol #:	2

EAPE 259	Edelman	Vol #:	2

EAPE 260	ARHP	Vol #:	2

EAPE 261	ARHP	Vol #:	2

EAPE 262	National Consumers League	Vol #:	2

EAPE 263	Albany College of Pharmacy	Vol #:	2

EAPE 264	McNEIL	Vol #:	2

EAPE 265	McNeil Consumer Healthcare	Vol #:	2

EAPE 266	FDC Reports	Vol #:	2

EAPE 267	The Tan Sheet	Vol #:	2

EAPE 268	FDC Reports / The Tan Sheet	Vol #:	2

EAPE 269	National Lipid Association	Vol #:	2

EAPE 270	Harbor-UCLA Medical Center	Vol #:	2

EAPE 271	University of Pittsburgh	Vol #:	2

EAPE 272	Howard University	Vol #:	2

EAPE 273	American Pharmacists Association	Vol #:	2

EAPE 274	American College of Obstetricians & Gynecologists	Vol #:	2

EAPE 275	Johnson & Johnson	Vol #:	2

EAPE 276	Novartis Consumer Health, Inc.	Vol #:	2

EAPE 277	Novartis Consumer Health, Inc.	Vol #:	2

EAPE 278	Howard University School of Pharmacy	Vol #:	2

EC 33	Dr. Kenneth Ukauwa	Vol #:	1

2007N-0357	Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2008 Proposed Guidance Development; Establishment of a Public Docket.

C 1	Philips Medical Systems	Vol #:	1

2007N-0417	Acarbose Tablets and 180-day exclusivity

C 1	Roxane Laboratories	Vol #:	1



2007P-0283	Take actions with respect to NDAs and ANDAs seeking approval of modified release oral dosage form drug products containing opioid active ingredients

ACK 2	FDA/DDM to Endo Pharmaceuticals	Vol #:	1

CP 2	Endo Pharmaceuticals	Vol #:	1

2007P-0400	Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion

EC 2	Mrs. Diana Smith	Vol #:	1

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FDA/Dockets Management