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Dockets Management
Dockets Entered On December 16, 2005
Table of Contents
Docket # Title
2000D-1598 Voluntary Labeling for Bioengineered Foods
2001D-0044 Clinical Laboratory Improvement Amendments of 1988
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003P-0132 Part 135 FDA regulations standard of identity frozen dessert
2004D-0555 Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
2004P-0107 Nutrient Content Claim: Carbohydrate Content of Foods
2004P-0298 Nutrient Content Claims for the Carbohydrate Content of Food
2004P-0299 Nutrient Content Claims for Carbohydrates
2005D-0340 Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
2005N-0329 Designation of New Animal Drugs for Minor Uses or Minor Species
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
2005N-0413 Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
2005P-0237 Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns
2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
2005P-0295 Standard Identity for Pure Birch Syrup and Birch Breakfast Style Syrup
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2005P-0433 Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
2000D-1598 Voluntary Labeling for Bioengineered Foods
C 10011 K. Blevins Vol #: 580
LET 4 K. Blevins Vol #: 580
2001D-0044 Clinical Laboratory Improvement Amendments of 1988
C 50
Attachment
Biosite Incorporated Vol #: 5
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1298 S. Hosking Vol #: 6
EMC 1299 S. Milles Vol #: 6
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
C 413 Farmers Union Industries, LLC Vol #: 36
C 414 Northwest Meat Processors Association Vol #: 36
C 415 American Association of Meat Processors (AAMP) Vol #: 36
C 416 Valley Proteins, Inc. Vol #: 36
C 417 R. Vogler Vol #: 36
C 418 H. Barlow, III Vol #: 36
C 419 D. Luckey Vol #: 36
C 420 D. Cowherd Vol #: 36
C 421 Baker Commodities, Inc. Vol #: 36
C 422 Land O'Lakes Purina Feed, LLC (LOLPF) Vol #: 36
C 423 M. Horn Vol #: 36
C 424 D. Taylor Vol #: 36
C 425 D. Godin Vol #: 36
C 426 Fayetteville animal Clinic, P.C. Vol #: 36
C 427 Form Letters Vol #: 38
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1175 No signature Vol #: 12
EMC 1176 No signature Vol #: 12
2003P-0132 Part 135 FDA regulations standard of identity frozen dessert
C 10 Family Dairies, USA Vol #: 1
C 11 E and D Roth Vol #: 1
C 12 D. Siegmann Vol #: 1
2004D-0555 Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
C 2 Public----Seattle & King County Vol #: 1
2004P-0107 Nutrient Content Claim: Carbohydrate Content of Foods
LET 3 ConAgra Foods Vol #: 1
2004P-0298 Nutrient Content Claims for the Carbohydrate Content of Food
LET 4 Unilever United States, Inc. Vol #: 2
2004P-0299 Nutrient Content Claims for Carbohydrates
LET 4 Frito-Lay, Inc. Vol #: 1
2005D-0340 Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
C 2 Pfizer, Inc. Vol #: 1
2005N-0329 Designation of New Animal Drugs for Minor Uses or Minor Species
EXT 3 AMerican Pet Products Manufacturers Association (APPMA) Vol #: 1
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
EMC 4 B. Raez Vol #: 1
EMC 5 C. Hodson Vol #: 1
EMC 6 Association for Molecular Pathology (AMP) Vol #: 1
LST 1 Agenda for December 7-8, 2005 Hearing Vol #: 2
TS 1 Director, Center for Drugs Evaluation and Research, FDA Vol #: 2
TS 2 WVU College of Law Vol #: 2
TS 3 Feinburg School of Medicine, Northwestern University Vol #: 2
TS 4 RTI Health Solutions Vol #: 2
TS 5 National Research Center for Women and Families Vol #: 2
TS 6 Plain Language Action and Information Network Vol #: 2
TS 7 E Liversidge Vol #: 2
TS 8 Time Inc Vol #: 2
TS 9 Cerner Corporation Vol #: 2
TS 10 APhaRC Vol #: 2
TS 11 Pharmaceutical Research & Manufacturers of America (PhRMA) Vol #: 2
TS 12 Stephen A Goldman Consulting Services LLC Vol #: 2
TS 13 ISMP Vol #: 2
TS 14 American Medical Association Vol #: 2
TS 15 American Pharmacists Association Vol #: 2
TS 16 Walgreen Co Vol #: 2
TS 17 Time Inc Vol #: 2
TS 18 Healthcare Communication Vol #: 2
TS 19 Healthcare CommunicatiCenter for Plain Language Vol #: 2
TS 20 Coalition for Healthcare Communication Vol #: 2
TS 21 List of Attendees for 12/7-8/2005 Public Meeting Vol #: 2
2005N-0413 Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
C 4 Fleminger, Inc. Vol #: 2
2005P-0237 Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns
LET 1 HFD-005 to Pharmaceutical Patent Attorneys, LLC Vol #: 1
2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
C 80 Anesthesiologists for the Safe Administration of Propofol Vol #: 20
C 81 H. Galoob, MD Vol #: 20
2005P-0295 Standard Identity for Pure Birch Syrup and Birch Breakfast Style Syrup
LET 1 HFS-800 to Alaska Birch Syrupmakers Association Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 9 International Academy of Compounding Pharmacists (IACP) Vol #: 1
C 10 B. Schraa, D.O. Vol #: 1
2005P-0433 Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
C 8 J. Raby Vol #: 1

Page created on December 28, 2005 RSC

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