Dockets Entered on January 4, 2006

Dockets Management



Dockets Entered On January 4, 2006 Table of Contents



Docket #	Title

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

1997S-0163	Dietary Supplements, Courtesy Letters (Letters of Objection)

1998D-0266	Section 121 Positron Emission Tomography (PET) FDAMA

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

2004N-0439	Current Good Manufacturing Practice for Positron Emission Tomography Drugs

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

2005D-0330	Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods

2005D-0340	Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment

2005D-0391	Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators

2005N-0394	FDAs Communication of Drug Safety Information; Public Hearing

2005P-0305	Remove Dietary Supplements that Contain the Drug Pyridoxamine

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

2005P-0420	Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP

2006P-0001	Date of Approval for Lunesta (Eszopiclone) Tablets

2006P-0002	Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)

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

LET 17054	Natural Organics Inc.	Vol #:	154

LET 17055	Standard Process Inc.	Vol #:	154

LET 17056	NOW Foods	Vol #:	154

LET 17057	NOW Foods	Vol #:	154

LET 17058	NOW Foods	Vol #:	154

LET 17059	Enzymatic Therapy	Vol #:	154

LET 17060	CocoaLife, LP	Vol #:	154

LET 17061	Enzymatic Therapy	Vol #:	154

LET 17062	Nature's Way Products, Inc.	Vol #:	154

LET 17063	Infinity2 Health Sciences, Inc.	Vol #:	154

LET 17064	IVAX Dermatologicals, Inc.	Vol #:	154

LET 17065	DW Performance Science	Vol #:	154

LET 17066	DW Performance Science	Vol #:	154

LET 17067	DW Performance Science	Vol #:	154

LET 17068	The Daily Wellness Company	Vol #:	154

LET 17069	DW Performance Science	Vol #:	154

LET 17070	DSM Nutritional Products, Inc.	Vol #:	154

LET 17071	Neways International, Inc.	Vol #:	154

1997S-0163	Dietary Supplements, Courtesy Letters (Letters of Objection)



LET 851	FDA/CFSAN to New Health Systems, LLC dba Chicken Soup for the Soul Supplements	Vol #:	26

LET 852	FDA/CFSAN to Miracle Breakthrough Labs Inc	Vol #:	26

LET 853	FDA/CFSAN to Gulf Biomedical Corporation	Vol #:	26

LET 854	FDA/CFSAN to New Chapter Inc	Vol #:	26

LET 855	FDA/CFSAN to NOW Foods	Vol #:	26

1998D-0266	Section 121 Positron Emission Tomography (PET) FDAMA

C 19	GE Healthcare	Vol #:	15

C 20	Bristol-Myers Squibb Medical Imaging	Vol #:	15

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

C 517	Congress of the United States	Vol #:	40

C 518	Congress of the United States	Vol #:	40

EC 222	Mr. Ricky Brunson	Vol #:	34

EC 223	Canadian Meat Council	Vol #:	34

EC 224	Cargill	Vol #:	34

EC 225	Mr. Lincoln Kelley	Vol #:	34

EC 226	National Milk Producers Federation	Vol #:	34

EC 227	Ms. Ken Yonce	Vol #:	34

EC 228	Georgia Department of Agriculture	Vol #:	34

EC 229 Attachment	CA Department of Food and Agriculture	Vol #:	34

EC 230	FOOD ANIMAL CONCERNS TRUST	Vol #:	34

EC 231	Kansas Livestock Association	Vol #:	34

EC 232	Waste Reduction by Waste Redusion, Inc.	Vol #:	34

EC 233	Mr. Burgess Guinn	Vol #:	34

EC 234	Mr. Marc Klocke	Vol #:	34

EC 235	Texas Department of Agriculture	Vol #:	34

EC 236	Georgia Department of Agriculture	Vol #:	34

EC 237	Consumers Union	Vol #:	34

EC 238	Nebraska By-Products, Inc.	Vol #:	34

EC 239	National Meat Association	Vol #:	34

EC 240	Embassy of Japan	Vol #:	34

EC 241	Dr. Anne Fetscher	Vol #:	34

EC 242	Minnesota Department of Agriculture	Vol #:	34

EC 243 Attachment	The Humane Society of the United States	Vol #:	34

EC 244	Scientists	Vol #:	34

EC 245	Simonsen Rendering	Vol #:	34



EC 246	R-CALF USA	Vol #:	34

EC 247	R-CALF USA	Vol #:	34

EC 248	Consumers Union	Vol #:	34

EC 249	Mr. Larry Riggs	Vol #:	34

EMC 128 Attachment	R-CALF USA	Vol #:	14

EMC 129 Attachment	R-CALF USA	Vol #:	14

EMC 130 Attachment	R-CALF USA	Vol #:	26

2004N-0439	Current Good Manufacturing Practice for Positron Emission Tomography Drugs

C 7	Bristol-Myers Squibb Medical Imaging	Vol #:	1

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

C 2	Rothwell Figg Ernst & Manbeck	Vol #:	3

2005D-0330	Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods

C 25	Department of Defense, Armed Services Blood Program Office	Vol #:	3

2005D-0340	Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment

C 5	Galderma Laboratories LP	Vol #:	1

2005D-0391	Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators

C 1	Cardiovascular Medicine & Cardiac Arrhythmias	Vol #:	1

2005N-0394	FDAs Communication of Drug Safety Information; Public Hearing

C 3	American Academy of Dermatology Association	Vol #:	2

2005P-0305	Remove Dietary Supplements that Contain the Drug Pyridoxamine

RC 2	BioStratum Inc	Vol #:	1

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

C 99	J Sisson	Vol #:	2

C 100	D A Jordan	Vol #:	2

C 101	D Carlton	Vol #:	2

C 102	S Heitke	Vol #:	2

C 103	K Murphy	Vol #:	2

C 104	C Dolphin	Vol #:	2

C 105	B Curtiss	Vol #:	2

C 106	B Walker	Vol #:	2

C 107	T Ozdemir	Vol #:	2

C 108	D Anders	Vol #:	2



C 109	G Prindle	Vol #:	2

C 110	R E MIller	Vol #:	2

C 111	C L Jones	Vol #:	2

C 112	N Knight	Vol #:	2

C 113	B Hemmer	Vol #:	2

C 114	D Stasheen	Vol #:	2

C 115	G M Louden	Vol #:	2

C 116	M DuBois	Vol #:	2

C 117	K Luras	Vol #:	2

C 118	P A Seaborne	Vol #:	2

C 119	T Detota	Vol #:	2

C 120	M J Balitz	Vol #:	2

C 121	B J Matlak	Vol #:	2

C 122	S Farlinger	Vol #:	2

C 123	E Burns	Vol #:	2

C 124	R Birckbichler	Vol #:	2

C 125	V K Weeden	Vol #:	2

C 126	number not used	Vol #:	2

C 127	S Mayle	Vol #:	2

C 128	D A Jordan	Vol #:	2

C 129	W L Russell	Vol #:	2

C 130	A D Sundeen	Vol #:	2

C 131	G Gregg	Vol #:	2

C 132	M Beverisck	Vol #:	2

C 133	C Turner	Vol #:	2

C 134	J A Waugh	Vol #:	2

C 135	Number not used	Vol #:	2

C 136	K A King	Vol #:	2

C 137	Number not used	Vol #:	2

C 138	J Cobb	Vol #:	2

C 139	P K Lachle	Vol #:	2

C 140	C Hall	Vol #:	2

C 141	J Corbett	Vol #:	2

C 142	S Foster	Vol #:	2

C 143	A Place for Women Menopause Center	Vol #:	2

C 144	C Glover-Johnson	Vol #:	2

C 145	J M Parker	Vol #:	2



C 146	T Brittain	Vol #:	2

C 147	C Wright	Vol #:	2

C 148	S Choi	Vol #:	2

C 149	D Clewell	Vol #:	2

C 150	M K Durett	Vol #:	2

C 151	D L Reed RN	Vol #:	2

C 152	J Solomon	Vol #:	2

C 153	R Harper	Vol #:	2

C 154	M K Venditti	Vol #:	2

C 155	L Jacobson	Vol #:	2

C 156	L Staples	Vol #:	2

C 157	K T McCabe	Vol #:	2

C 158	C Weatherholt	Vol #:	2

C 159	K Jeffries	Vol #:	2

2005P-0420	Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP

C 2	Impax Laboratories Inc	Vol #:	2

2006P-0001	Date of Approval for Lunesta (Eszopiclone) Tablets

ACK 1	HFA-305 to Venable LLP	Vol #:	1

CP 1	Sepracor Inc.	Vol #:	1

2006P-0002	Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)

CP 1	Lachman Consultant Services, Inc.	Vol #:	1

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FDA/Dockets Management