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Dockets Management

Dockets Entered On March 19, 2007
Docket # Title
1976N-0052G OTC general comments & combinations
1995G-0321 25-hydroxyvitamin D3 be affirmed as GRAS
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1999P-4613 Revoke the Regulation That Approved Posilac
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0324 New Animal Drugs; Removal of Obsolete and Redundant Regulations
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
2003N-0573 Draft Animal Cloning Risk Assessment
2003P-0064 Withhold Approval of Generic Lovenox (enoxaparin sodium inje
2004N-0257 Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
2004P-0349 Action on Products containing added Mercury
2004P-0464 Vitamin D & Calcium & Reduced Risk of Osteoporosis
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
2005P-0237 Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
2006D-0480 Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
2006D-0526 International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics
2006N-0061 Charging for Investigational Drugs
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
2006N-0130 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
2006N-0472 Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
2006N-0525 Supplements and Other Changes to an Approved Application
2006P-0124 Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
2006P-0173 Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0423 Regulate Labeling and Packaging of Acetaminophen/APAP Containing Products
2006P-0535 Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
2007D-0040 Guidance for Industry on Developing Products for Weight Management
2007D-0080 Guidance for Industry on Indexing Structured Product Labeling
2007N-0073 Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
2007P-0100 Abbreviated New Drug Application (ANDA) filing of Ciprofloxacin Hydrochloride Capsules, 100mg, 250mg, and 750mg
1976N-0052G OTC general comments & combinations
NFR 5 FDA Vol #: 35
1995G-0321 25-hydroxyvitamin D3 be affirmed as GRAS
EMC 1 B. Sachau Vol #: 1
EMC 2 B. Achau Vol #: 1
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
EMC 4441 A. Travis Vol #: 320
1999P-4613 Revoke the Regulation That Approved Posilac
EMC 2434 A. Devik Vol #: 46
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1339 G. Cadrett Vol #: 6
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 776 Mission Possible International Vol #: 10
EMC 777 Mission Possible International Vol #: 10
EMC 778 Mission Possible International Vol #: 10
EMC 779 Mission Possible International Vol #: 10
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1455 C. Rowland Vol #: 12
EMC 1456 G. Thomas Vol #: 12
EMC 1457 A. Flynn Vol #: 12
EMC 1458 B. Chavis Vol #: 12
EMC 1459 M. Brewer Vol #: 12
EMC 1460 J. Goliboski Vol #: 12
EMC 1461 No Submitter Vol #: 12
EMC 1462 K. James Vol #: 12
2003N-0324 New Animal Drugs; Removal of Obsolete and Redundant Regulations
APE 1 PennField Oil Company/PennField Animal Health Vol #: 1
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
EREG 3 C. Van Schalkwyk Vol #: 15
2003N-0573 Draft Animal Cloning Risk Assessment
EC 3509 Ms. Sonia Ramirez Vol #: 21
EC 3510 Ms. Liliana Molina Vol #: 21
EC 3511 Mrs. Gail Hearth Vol #: 21
EC 3512 Ms. Christina Lin Vol #: 21
EC 3513 Ms. Lori Purifoy Vol #: 21
EC 3514 Ms. Lee Taylor Vol #: 21
EC 3515 n/a Vol #: 21
EMC 137 J. Waller Vol #: 5
EMC 138 J. Beck Vol #: 5
EMC 139 S. Rop Vol #: 5
EMC 140 J. Erickson Vol #: 5
EMC 141 S. Gottfried Vol #: 5
EMC 142 B. Vol #: 5
EMC 143 J. Holland Vol #: 5
EMC 144 N. Kastelz Vol #: 5
EMC 145 M. & W. Johnson Vol #: 5
EMC 146 B. Hughes Vol #: 5
EMC 147 K. Johnson Vol #: 5
EMC 148 D. Sasser Vol #: 5
2003P-0064 Withhold Approval of Generic Lovenox (enoxaparin sodium inje
RC 3 Sanofi Aventis Vol #: 6
2004N-0257 Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
EMC 22 B. Sachau Vol #: 3
2004P-0349 Action on Products containing added Mercury
LET 3 Coalition for Mercury Free Drugs Vol #: 4
2004P-0464 Vitamin D & Calcium & Reduced Risk of Osteoporosis
C 3 Juice Products Association (JPA) Vol #: 9
C 4 National Kidney Foundation Vol #: 9
EC 15 Consumer Healthcare Products Association Vol #: 9
EREG 2 G. Miller Vol #: 9
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
C 694 S Abbott Vol #: 32
C 695 G DiMaio Vol #: 32
C 696 M DiMaio Vol #: 32
EC 1820 Mrs. Anne Morais Vol #: 31
EC 1821 Mr. John Bowen Vol #: 31
EC 1822 Mrs. Jennifer Marrandette Vol #: 31
EREG 48 Celiac Sprue Association Vol #: 32
EREG 49 CSA Celiacs Vol #: 32
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
EMC 592 The National Medical Association Vol #: 12
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
EMC 2 S. Rainbolt-Kren Vol #: 8
EMC 3 R. Ihnen Vol #: 8
EMC 4 Biotechnology Industry Organization Vol #: 8
EREG 5 FedEx Express Vol #: 8
EREG 6 Pharmaceutical Research and Manufactuers of America Vol #: 8
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
C 98 National Welders Supply Company Vol #: 10
EMC 6 C. Robinson Vol #: 6
EMC 7 Consumer Healthcare Products Association Vol #: 6
EMC 8 National Marrow Donor Program Vol #: 6
EMC 9 Animal Health Insititute Vol #: 6
EMC 10 CVS Pharmacy Vol #: 6
EMC 11 Johnson & Johnson Pharmaceutical Group Vol #: 6
EMC 12 Wolters Kluwer Health Vol #: 6
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 2 FDA/CDER to Pharmaceutical Patent Attorneys Vol #: 1
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
C 14 XDx Inc Vol #: 1
2006D-0480 Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
C 1 Mayo Clinic Vol #: 1
2006D-0526 International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics
EMC 1 Abbott Laboratories Vol #: 1
2006N-0061 Charging for Investigational Drugs
C 8 Baxter Healthcare Corporation Vol #: 1
C 9 America's Health Insurance Plans (AHIP) Vol #: 1
C 10 Toucan Capital Corp Vol #: 1
C 11 TAP Pharmaceutical Products Inc Vol #: 1
C 12 R Reinhard Vol #: 1
C 13 Plasma Protein Therapeutics Association (PPTA) Vol #: 1
EC 12 Abigail Alliance Vol #: 1
EC 13 California Dept. of Health Services Vol #: 1
EC 14 California Dept. of Health Services Vol #: 1
EC 15 Pharm Res Vol #: 1
EC 16 FIU International Business Student Vol #: 1
EC 17 Johnson and Johnson Vol #: 1
EC 18 FIU Busines Student Vol #: 1
EC 19 GlaxoSmithKline Vol #: 1
EC 20 N/A Vol #: 1
EC 21 Sepracor Inc. Vol #: 1
EC 22 Blue Cross and Blue Shield Association Vol #: 1
EC 23 National Patient Advocate Foundation Vol #: 1
EC 24 Cancer Leadership Council Vol #: 1
EC 25 Cystic Fibrosis Foundation Vol #: 1
EC 26 American Society of Clinical Oncology (ASCO) Vol #: 1
EC 27 PPTA Vol #: 1
EC 28 Mr. James Ingram Vol #: 1
EC 29 Toucan Capital Vol #: 1
EMC 2 R. Reinhard Vol #: 1
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
C 14 R Chamblin Vol #: 1
C 15 Baxter Healthcare Corporation Vol #: 1
C 16 Hemophilia Federation of America Vol #: 1
C 17 America's Health Insurance Plans (AHIP) Vol #: 1
C 18 B Wilson Vol #: 1
C 19 R Wilson Vol #: 1
C 20 TAP Pharmaceutical Products Inc Vol #: 1
C 21 Toucan Capital Corp. Vol #: 1
C 22 Plasma Protein Therapeutics Association (PPTA) Vol #: 1
EC 60 Mr. Roger Luca Vol #: 1
EC 61 Mrs. Lynn Youngblom Vol #: 1
EC 62 Mr. Dane Youngblom Vol #: 1
EC 63 Dr. Mark Schilansky Vol #: 1
EC 64 Memorial Sloan-Kettering Cancer Center Vol #: 1
EC 65 Mr. DENNIS BROWN Vol #: 1
EC 66 Mr. Kurt Powers Vol #: 1
EC 67 Miss. Rosemarie Greg Vol #: 1
EC 68 Mr. Jon Powers Vol #: 1
EC 69 Daughter of cancer victim Vol #: 1
EC 70 Ms. Marilyn Brilliant Vol #: 2
EC 71 Mrs. Erin Lee Vol #: 1
EC 72 Miss. Sara Powers Vol #: 1
EC 73 Abigail Alliance Vol #: 1
EC 74 Mr. Don Peyton Vol #: 1
EC 75 Mrs. Susan Woomer Vol #: 1
EC 76 Mrs. Cynthia Yarosh Vol #: 1
EC 77 Mr. Brian Woomer Vol #: 1
EC 78 Ms. Gail Toftey Vol #: 1
EC 79 Mr. Jeffrey Smith Vol #: 1
EC 80 Mr. Brian Hamilton Vol #: 1
EC 81 Mrs. patricia powers Vol #: 1
EC 82 Mrs. patricia powers Vol #: 1
EC 83 Mrs. Priscilla Ryland Vol #: 1
EC 84 Mrs. Jessica Ottem Vol #: 1
EC 85 Pharm Res Vol #: 1
EC 86 Mrs. Deborah Youngblom Vol #: 1
EC 87 GlaxoSmithKline Vol #: 1
EC 88 Mrs. Angie Edwards Vol #: 1
EC 89 Blue Cross and Blue Shield Association Vol #: 1
EC 90 National Patient Advocate Foundation Vol #: 1
EC 91 American Society of Clinical Oncology (ASCO) Vol #: 1
EC 92 PPTA Vol #: 1
EC 93 National Breast Cancer Coalition Fund Vol #: 1
EC 94 American Society of Clinical Oncology Vol #: 1
EC 95 Dr. Stephen Arnon Vol #: 1
EC 96 California Dept. of Health Services Vol #: 1
EC 97 American Society of Clinical Oncology Vol #: 1
EC 98 Miss. Betsy Hieb Vol #: 1
EREG 2 S. Slotterbeck Vol #: 1
EREG 3 Greater New York Hospital Association Vol #: 1
2006N-0130 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
EMC 1 B. Sachau Vol #: 1
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
LET 11 FDA to Hon James P Moran, House of Representatives Vol #: 36
2006N-0472 Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
EMC 1 B. Sachau Vol #: 1
2006N-0525 Supplements and Other Changes to an Approved Application
EMC 2 Consumer Healthcare Products Association Vol #: 1
2006P-0124 Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
EMC 2 ViroPharma Incorporated Vol #: 1
2006P-0173 Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
SUP 3 Wyeth Pharmaceuticals Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 70 K Hoyt Vol #: 7
C 71 R Fuentes Vol #: 7
C 72 A Lopez Vol #: 7
C 73 S Schwartz Vol #: 7
2006P-0423 Regulate Labeling and Packaging of Acetaminophen/APAP Containing Products
SUP 1 Pharmacists Plannning Services, Inc Vol #: 1
2006P-0535 Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
LET 2 Coalition for Mercury Free Drugs Vol #: 1
2007D-0040 Guidance for Industry on Developing Products for Weight Management
C 1 University of Alabama At Birmingham, Duke University Medical Centre Vol #: 1
2007D-0080 Guidance for Industry on Indexing Structured Product Labeling
GDL 1 Draft Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007N-0073 Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
EMC 1 B. Sachau Vol #: 1
2007P-0100 Abbreviated New Drug Application (ANDA) filing of Ciprofloxacin Hydrochloride Capsules, 100mg, 250mg, and 750mg
ACK 1 FDA/DDM to JR Rapoza Associates, Inc. Vol #: 1
CP 1 JR Rapoza Associates, Inc. Vol #: 1

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