Dockets Entered on January 19, 2006

Dockets Management



Dockets Entered On January 19, 2006 Tableof Contents



Docket #	Title

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

2000P-0586	Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

2003P-0132	Part 135 FDA regulations standard of identity frozen dessert

2004H-0322	Civil Money Penalty Re: Ecumed Health Group, Inc.

2005N-0262	Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program

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

2006N-0010	Able Laboratories, Inc.; Withdrawal of Approval of 43 Abbreviated New Drug Applications

2006P-0039	FDA issue new labeling requirements for caffeinated food products

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

LET 17139	Sedona Labs, Inc.	Vol #:	155

LET 17140	Enzymatic Therapy	Vol #:	155

LET 17141	Enzymatic Therapy	Vol #:	156

LET 17142	Enzymatic Therapy	Vol #:	156

LET 17143	Enzymatic Therapy	Vol #:	156

LET 17144	Enzymatic Therapy	Vol #:	156

LET 17145	Enzymatic Therapy	Vol #:	156

LET 17146	Enzymatic Therapy	Vol #:	156

LET 17147	Univera, Inc.d.b.a. Oasis LifeSciences	Vol #:	156

LET 17148	American Healing Technologies, Inc.	Vol #:	156

LET 17149	American Healing Technologies, Inc.	Vol #:	156

LET 17150	Futurebiotics LLC	Vol #:	156

LET 17151	Futurebiotics LLC	Vol #:	156

LET 17152	Enzymatic Therapy	Vol #:	156

LET 17153	Enzymatic Therapy	Vol #:	156

LET 17154	Natrol, Inc.	Vol #:	156

LET 17155	Enzymatic Therapy	Vol #:	156

LET 17156	Enzymatic Therapy	Vol #:	156

LET 17157	Enzymatic Therapy	Vol #:	156

LET 17158	Enzymatic Therapy	Vol #:	156

LET 17159	Enzymatic Therapy	Vol #:	156

LET 17160	Enzymatic Therapy	Vol #:	156

LET 17161	Enzymatic Therapy	Vol #:	156

LET 17162	Enzymatic Therapy	Vol #:	156

LET 17163	Enzymatic Therapy	Vol #:	156



LET 17164	Enzymatic Therapy	Vol #:	156

LET 17165	Enzymatic Therapy	Vol #:	156

2000P-0586	Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

C 86	National Family Farm Coalition (NFFC)	Vol #:	2

C 87	Daisy Brand, Inc. (Daisy Brand)	Vol #:	2

C 88	National Farmers Union (NFU)	Vol #:	2

C 89	Government of Mexico	Vol #:	2

C 90	Fonterra (USA), Inc.	Vol #:	27

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

C 526	Maury County Government	Vol #:	45

C 527	J. Todt et al.	Vol #:	45

C 528	D. Vauprau	Vol #:	45

LET 8	Honorable Nathaniel S. Berry	Vol #:	45

LET 9	Honorable Barbara A. Mikulski	Vol #:	45

2003P-0132	Part 135 FDA regulations standard of identity frozen dessert

C 46	P. Molnau	Vol #:	2

C 47	P. Nesbit	Vol #:	2

2004H-0322	Civil Money Penalty Re: Ecumed Health Group, Inc.

LET 9	Ecumed Health Group and Amador Reyes, Juan C. Carrai, Richard W. Stone,M.D. & Erlinda B. Enriq	Vol #:	10

2005N-0262	Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program

LET 5	GlaxoSmithKline (GSK)	Vol #:	4

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

C 290	J. Mosley	Vol #:	3

C 291	S. Brasch	Vol #:	3

C 292	L. Fagert, RN,BSN,MSN	Vol #:	3

C 293	D. Miller	Vol #:	3

C 294	S. Goin	Vol #:	3

C 295	E. McBroom	Vol #:	3

C 296	M. Frasure	Vol #:	3

C 297	N. Bargen	Vol #:	3

C 298	B. Berg	Vol #:	3

C 299	J. Engelbach	Vol #:	3

C 300	B. Fetner	Vol #:	3



C 301	N. DeLong	Vol #:	3

C 302	C. Falstrom	Vol #:	3

C 303	P. Shea	Vol #:	3

C 304	B. Gray	Vol #:	3

C 305	D. Bobbitt	Vol #:	3

C 306	E. Allshouse	Vol #:	3

C 307	J. Howse	Vol #:	3

C 308	B. Haskins	Vol #:	3

C 309	M. Olinde	Vol #:	3

C 310	R. Long	Vol #:	3

C 311	L. Karg	Vol #:	3

C 312	B. Glassill	Vol #:	3

C 313	D. Foord	Vol #:	3

C 314	P. Patterson	Vol #:	3

C 315	E. Allshouse	Vol #:	3

C 316	J. Howse	Vol #:	3

C 317	D. Mowitz	Vol #:	3

C 318	G. Clarke	Vol #:	3

C 319	D. Vadeboncouer	Vol #:	3

C 320	J. Heinrich	Vol #:	3

C 321	D. Parker	Vol #:	3

C 322	R. Minor, M.D.	Vol #:	3

C 323	D. Ferell	Vol #:	3

C 324	N. Peterson	Vol #:	3

C 325	A. Hollar	Vol #:	3

C 326	K. Balzario	Vol #:	3

C 327	S. Peterson	Vol #:	3

C 328	M. Rogers	Vol #:	3

C 329	A. Nizzardi	Vol #:	3

C 330	L. Sigmon	Vol #:	3

C 331	L. Bell	Vol #:	3

C 332	N. Codding	Vol #:	3

C 333	J. Conaway	Vol #:	3

C 334	N. Thomats	Vol #:	3

C 335	K. Simrin	Vol #:	3

C 336	J. Gallimore	Vol #:	3

C 337	G. Millins, MD	Vol #:	3



C 338	S. Smith	Vol #:	3

C 339	C.Lawrence	Vol #:	3

C 340	P. Kimbrel	Vol #:	3

C 341	S. Isbell	Vol #:	3

2006N-0010	Able Laboratories, Inc.; Withdrawal of Approval of 43 Abbreviated New Drug Applications

NWL 1	FDA	Vol #:	1

2006P-0039	FDA issue new labeling requirements for caffeinated food products

ACK 1	HFA-305 to Food and Drug Law Class	Vol #:	1

CP 1	Food and Drug Law Class	Vol #:	1

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FDA/Dockets Management