| | | | | | | | | | |
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| Dockets Entered
On March 7, 2007
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| |
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| |
|
|
| 1995N-0294
|
| Quality/fill container; common or unusual name regulations
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 1997S-0163
|
| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
| |
|
|
| 2003P-0064
|
| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
|
| |
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
| |
|
|
| 2005D-0062
|
| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
|
| |
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
| |
|
|
| 2006E-0234
|
| Patent Extension Application for GEM 21S Growth-factor Enhanced Matrix, U.S. Patent No. 5,124,316
|
| |
|
|
| 2006E-0260
|
| Patent Extension Application for ORENCIA (abatacept), U.S. Patent No. 5,851,795
|
| |
|
|
| 2006N-0036
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
|
|
|
|
|
|
|
|
|
| 2006N-0357
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
|
| |
|
|
| 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
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| |
|
|
| 2006P-0271
|
| Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.
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| |
|
|
| 2007E-0011
|
| Patent Extension Application for Lantus (insulin glargine rDNA origin), U.S. Patent No. 5,101,013
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|
| |
|
| 1978N-0038
|
| Sunscreen Drug Products
|
| |
|
|
| C 605
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| Florida House of Representatives
|
| Vol #:
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| 150
|
| |
|
|
| C 606
|
| Lotus Communications Corp
|
| Vol #:
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| 150
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| |
|
|
| C 607
|
| A Castro MD
|
| Vol #:
|
| 150
|
| |
|
|
| C 608
|
| G Mejia MD
|
| Vol #:
|
| 150
|
| |
|
|
| C 609
|
| J Casellas MD
|
| Vol #:
|
| 150
|
| |
|
|
| C 610
|
| L Grauer MD
|
| Vol #:
|
| 150
|
| |
|
|
| C 611
|
| J Cura MD
|
| Vol #:
|
| 150
|
| |
|
|
| C 612
|
| Cardiac Care Clinic of Tampa Bay
|
| Vol #:
|
| 150
|
| |
|
|
| 1995N-0294
|
| Quality/fill container; common or unusual name regulations
|
| |
|
|
| MT 1
|
| Telephone Conversation between FDA and GMA/FPA
|
| Vol #:
|
| 5
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET 19248
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19249
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19250
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19251
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19252
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
|
| | | | | | | |
|
| |
|
| LET 19253
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19254
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19255
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19256
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19257
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19258
|
| Cambridge Institute for Better Vision, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19259
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19260
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19261
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19262
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19263
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19264
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19265
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19266
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19267
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19268
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19269
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19270
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19271
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19272
|
| Doctor's Best, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19273
|
| EarthLab, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19274
|
| EarthLab, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19275
|
| EarthLab, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19276
|
| EarthLab, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19277
|
| EarthLab, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19278
|
| EarthLab, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19279
|
| Medexus
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19280
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19281
|
| Cenestra Health
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19282
|
| Renaissance Herbs
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19283
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19284
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19285
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19286
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19287
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19288
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19289
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
|
| | | | | | | | |
|
| |
|
| LET 19290
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19291
|
| Herbalife International of America, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19292
|
| Herbalife International of America, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19293
|
| Neways International, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19294
|
| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19295
|
| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19296
|
| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19297
|
| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| 1997S-0163
|
| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
| |
|
|
| LET 919
|
| FDA/CFSAN to Alltech Biotechnology Center
|
| Vol #:
|
| 27
|
| |
|
|
| LET 920
|
| FDA/CFSAN to New Chapter Inc
|
| Vol #:
|
| 27
|
| |
|
|
| LET 921
|
| FDA/CFSAN to Global Pharmatech Inc
|
| Vol #:
|
| 27
|
| |
|
|
| LET 922
|
| FDA/CFSAN to Hillestad Pharmaceuticals USA Inc
|
| Vol #:
|
| 27
|
| |
|
|
| LET 923
|
| FDA/CFSAN to Nor-Cal Beverage Co., Inc
|
| Vol #:
|
| 27
|
| |
|
|
| LET 924
|
| FDA/CFSAN to Sara's Tea Inc
|
| Vol #:
|
| 27
|
| |
|
|
| LET 925
|
| FDA/CFSAN to Botanical Laboratories
|
| Vol #:
|
| 27
|
| |
|
|
| 2003P-0064
|
| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
|
| |
|
|
| C 12
|
| Massachussetts Institute of Technology
|
| Vol #:
|
| 6
|
| |
|
|
| C 13
|
| Massachussetts Institute of Technology-Center for Biomedical Engineering
|
| Vol #:
|
| 6
|
| |
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
| |
|
|
| REF 1
|
| Reference to GDL2 (Guidance for Industry-Compliance w/ 21 CFR Part 1271.150(c)(1)-Manufacturin
|
| Vol #:
|
| 1
|
|
| |
|
| 2005D-0062
|
| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
|
| |
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 2
|
| |
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 2
|
| |
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
| |
|
|
| ACK 1
|
| FDA/DDM to TMJ Implants, Inc., Robert W. Christensen, and Maureen Mooney
|
| Vol #:
|
| 242
|
| |
|
|
| PSA 1
|
| TMJ Implants, Inc., Robert W. Christensen, and Maureen Mooney
|
| Vol #:
|
| 242
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| EC 1661
|
| Miss. wendy hyatt
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1662
|
| Mane Event hs
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1663
|
| CSA SUPPORT GROUP CHAIRWOMAN
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1664
|
| Mrs. Sandra Tate
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1665
|
| Ms. Vivian Young
|
| Vol #:
|
| 31
|
|
| | | | | | | | |
|
| |
|
| EC 1666
|
| none
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1667
|
| Ms. Debra Jensen
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1668
|
| Mrs. Theresa Cannon
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1669
|
| Mrs. Sandra Brooks
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1670
|
| Clemson University
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1671
|
| Mrs. Monique Wihlen
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1672
|
| Special Settings Pediatric Therapy, Inc.
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1673
|
| Ms. Kathleen Morris
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1674
|
| Ms. Emily Cook
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1675
|
| Mrs. Bethanie Morgan
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1676
|
| Mrs. Christine Roehler
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1677
|
| Mrs. Linda Wayman
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1678
|
| Mrs. Susan Roenke
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1679
|
| Ms. Jennifer Pan
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1680
|
| Mrs. Annette Marvin
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1681
|
| Mr. Earl Messick
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1682
|
| Mrs. Lynn Dillow
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1683
|
| Winston Salem GIG
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1684
|
| Mrs. Pamela Osti
|
| Vol #:
|
| 31
|
|
| |
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
| |
|
|
| C 9
|
| American Clinical Laboratory Association et al
|
| Vol #:
|
| 1
|
| |
|
|
| C 10
|
| Coalition for 21st Century Medicine
|
| Vol #:
|
| 1
|
| |
|
|
| EC 34
|
| Association for Molecular Pathology
|
| Vol #:
|
| 2
|
| |
|
|
| EC 35
|
| Dr. Ken Bloom
|
| Vol #:
|
| 2
|
| |
|
|
| EC 36
|
| Johns Hopkins Genetics and Public Policy Center
|
| Vol #:
|
| 2
|
| |
|
|
| EC 37
|
| Mayo Clinic Rochester
|
| Vol #:
|
| 2
|
| |
|
|
| EC 38
|
| Coalition for 21st Century Medicine
|
| Vol #:
|
| 2
|
| |
|
|
| EC 39
|
| Ventana Medical Systems, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 40
|
| Ventana Medical Systems, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 41
|
| Claire Altman Heine Foundation, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 42
|
| 20/20 GeneSystems, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 43
|
| Ventana Medical Systems, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 44
|
| Personalized molecular medicine organizations
|
| Vol #:
|
| 2
|
| |
|
|
| EC 45
|
| Ovarian Cancer National Allliance
|
| Vol #:
|
| 2
|
| |
|
|
| EC 46
|
| Genomic Health, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 47
|
| CardioDx
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| EC 48
|
| KS
|
| Vol #:
|
| 2
|
| |
|
|
| EC 49
|
| Life Sciences Management Group, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 50
|
| Association of American Medical Colleges
|
| Vol #:
|
| 2
|
| |
|
|
| EC 51
|
| American Society for Microbiology
|
| Vol #:
|
| 2
|
| |
|
|
| EC 52
|
| Parent Project Muscular Dystrophy
|
| Vol #:
|
| 2
|
| |
|
|
| EC 53
|
| Incontinentia Pigmenti International Foundation
|
| Vol #:
|
| 2
|
| |
|
|
| EC 54
|
| Parent Project Muscular Dystrophy (PPMD)
|
| Vol #:
|
| 2
|
| |
|
|
| EC 55
|
| Trimethylaminuria Foundation
|
| Vol #:
|
| 2
|
| |
|
|
| EC 56
|
| Johnson
|
| Vol #:
|
| 2
|
| |
|
|
| EC 57
|
| XDx
|
| Vol #:
|
| 2
|
| |
|
|
| EC 58
|
| University of Cambridge
|
| Vol #:
|
| 2
|
| |
|
|
| EC 59
|
| National Tay-Sachs
|
| Vol #:
|
| 2
|
| |
|
|
| EC 60
|
| Target Discovery, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 61
|
| National Tay-Sachs
|
| Vol #:
|
| 2
|
| |
|
|
| EC 62
|
| National Breast Cancer Coalition Fund
|
| Vol #:
|
| 2
|
| |
|
|
| EC 63
|
| Genzyme Corp.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 64
|
| Advanced Medical Technology Association
|
| Vol #:
|
| 2
|
| |
|
|
| EC 65
|
| Genetic Alliance
|
| Vol #:
|
| 2
|
| |
|
|
| EC 66
|
| Ciphergen Biosystems, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 67
|
| Ciphergen Biosystems, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 68
|
| Target Discovery, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 69
|
| Washington Legal Foundation
|
| Vol #:
|
| 2
|
| |
|
|
| 2006E-0234
|
| Patent Extension Application for GEM 21S Growth-factor Enhanced Matrix, U.S. Patent No. 5,124,316
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0260
|
| Patent Extension Application for ORENCIA (abatacept), U.S. Patent No. 5,851,795
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0036
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
|
|
|
|
|
|
|
| |
|
|
| N 3
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0357
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
|
| |
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0472
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
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| |
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| EC 1
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| nothing
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| Vol #:
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| 1
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| | | | | | | | |
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| |
|
| 2006P-0271
|
| Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.
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| |
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|
| PAV 1
|
| FDA to Clinical and Laboratory Standards Institute (CLSI)
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| Vol #:
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| 1
|
| |
|
|
| 2007E-0011
|
| Patent Extension Application for Lantus (insulin glargine rDNA origin), U.S. Patent No. 5,101,013
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| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
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|
