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Dockets Management

Dockets Entered On October 2, 2007
Docket # Title
1978N-0038 Sunscreen Drug Products
1992N-0391 Analysis of Adverse Reactions to Monosodium Glutamate (MSG)
1994P-0036 Req labeling of trans fatty acid & prohibit deceptive claims
1997S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
1998D-0077 Treatment of osteoarthritis/drugs, devices and biological pt
1998D-0307 Exports/Imports under FDA export reform/enhancement Act 1996
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2006D-0138 Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2007D-0168 Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
2007D-0266 International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System
2007D-0268 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
2007N-0014 Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and GRAS Affirmation; Electronic Submission
2007N-0330 Presidential Interagency Working Group on Import Safety; Public Meeting
2007N-0347 Information Technology Strategic Planning; Public Meeting
2007N-0359 Agency Emergency Processing Under OMB Review; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification Form
2007P-0097 Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
2007P-0250 Enact stricter guidelines in prescribing methadone for any reason
2007P-0282 Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
2007P-0369 Stay the effective date of any refusal of Entry AQZ-0251860-6 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extensio
2007P-0370 Stay the effective date of any refusal of Entry AQZ-0251196-5 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the
2007P-0371 Stay the effective date of any refusal of Entry AQZ-0251197-3 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
2007P-0372 Stay the effective date of any refusal of Entry AQZ-0251198-1 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
2007P-0373 Stay the effective date of any refusal of Entry AQZ-0251199-9 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
2007P-0374 Stay the effective date of any refusal of Entry AQZ-0251206-2 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
2007P-0375 Stay the effective date of any refusal of Entry AQZ-0251212-0 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
2007P-0376 Stay the effective date of any refusal of Entry AQZ-0251619-6 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
2007P-0377 Stay the effective date of any refusal of Entry AQZ-0251620-4 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
2007P-0378 Stay the effective date of any refusal of Entry AQZ-0251861-4 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
2007P-0379 Stay the effective date of any refusal of Entry AQZ-0252410-9 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 30-day extension of time to supply the r
1978N-0038 Sunscreen Drug Products
EC 2450 Mrs. Patricia Blais Vol #: 161
EC 2451 Ms. Jain Irvine Vol #: 161
1992N-0391 Analysis of Adverse Reactions to Monosodium Glutamate (MSG)
C 248 Carolyn Harris Vol #: 18
1994P-0036 Req labeling of trans fatty acid & prohibit deceptive claims
C 2759 Bruce Jacks Vol #: 90
C 2760 Jeanne Q. Lillis Vol #: 90
C 2761 Mary R. Mossman Vol #: 90
1997S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
LET 953 FDA/CFSAN to Konsyl Pharmaceuticals, Inc. Vol #: 28
LET 954 FDA/CFSAN to Camelyn U. S. A., Inc. Vol #: 28
LET 955 FDA/CFSAN to Market America, Inc. Vol #: 28
LET 956 FDA/CFSAN to Source of Health, Inc. Vol #: 28
LET 957 FDA/CFSAN to Camelyn U. S. A., Inc. Vol #: 28
LET 958 FDA/CFSAN to Pharmavite, L. L. C. Vol #: 28
LET 959 FDA/CFSAN to Integrity Vol #: 28
LET 960 FDA/CFSAN to Medicine Chest, Inc. Vol #: 28
LET 961 FDA/CFSAN to Market America, Inc. Vol #: 28
1998D-0077 Treatment of osteoarthritis/drugs, devices and biological pt
EC 2 UNTHSC, FORT WORTH, TX Vol #: 1
1998D-0307 Exports/Imports under FDA export reform/enhancement Act 1996
EC 62 Ms. Tawana Morgan Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
C 743 C.J. Gifford Vol #: 35
2006D-0138 Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
GDL 2 Guidance Vol #: 1
NAD 2 FDA Vol #: 1
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
C 3562 M Kail Vol #: 32
C 3563 R Stirar Vol #: 32
C 3564 H Dannible Vol #: 32
C 3565 S Beck Vol #: 32
C 3566 C Burrell Vol #: 32
C 3567 J Perry Vol #: 32
C 3568 P Jones Vol #: 32
C 3569 S Thomas Vol #: 32
C 3570 C Peterson Vol #: 32
C 3571 W Nivh Vol #: 32
C 3572 R Juntilla Vol #: 32
C 3573 L Sorgman Vol #: 32
C 3574 M Fedor Vol #: 32
C 3575 K Hoover Vol #: 32
C 3576 D Ciotola Vol #: 32
C 3577 D McIntosh Vol #: 32
C 3578 P Stillwagon Vol #: 32
C 3579 C Townsend Vol #: 32
C 3580 G Fare Vol #: 32
C 3581 F Hugell Vol #: 32
C 3582 P Owerns Vol #: 32
C 3583 D Mitchell Vol #: 32
C 3584 M Nasternak Vol #: 32
C 3585 B Reynolds Vol #: 32
C 3586 New York University School of Medicine Vol #: 32
C 3587 J Maltais Vol #: 32
C 3588 C Kucera Vol #: 32
C 3589 K Thomson Vol #: 32
C 3590 B Nowlin Vol #: 32
C 3591 M Brown Vol #: 32
C 3592 M Pace Vol #: 32
C 3593 J Gluck Vol #: 32
C 3594 M Fleming Vol #: 32
C 3595 C Speakman Vol #: 32
C 3596 B Wilkins Vol #: 32
C 3597 B Ethridge Vol #: 32
C 3598 V LaVan Vol #: 32
C 3599 D Graves Vol #: 32
C 3600 S Kauffman Vol #: 32
C 3601 J Bender Vol #: 32
C 3602 D Simmerman Vol #: 32
C 3603 J Nyhoff Vol #: 32
C 3604 H Johnson Vol #: 32
C 3605 G Batley Vol #: 32
C 3606 S Zimmerman Vol #: 32
C 3607 E Hagar Vol #: 32
C 3608 B Smith Vol #: 32
C 3609 V Marsh Vol #: 32
C 3610 S Utterback Vol #: 32
C 3611 G Watson Vol #: 32
C 3612 M Heiso Vol #: 32
C 3613 J Harbick Vol #: 32
C 3614 A Galey Vol #: 32
C 3615 F Wiese Vol #: 32
C 3616 V Rice Vol #: 32
C 3617 J Atkins Vol #: 32
C 3618 M Hollry Vol #: 32
C 3619 J Moore Vol #: 32
C 3620 F Cox Vol #: 32
C 3621 S Elam Vol #: 32
C 3622 M Gorson Vol #: 32
C 3623 J Winder Vol #: 32
C 3624 K Craig Vol #: 32
C 3625 J Bowling Vol #: 32
C 3626 J Silvrants Vol #: 32
C 3627 P Nachman Vol #: 32
C 3628 S Leeapman Vol #: 32
C 3629 N Lynch Vol #: 32
C 3630 V Clawson Vol #: 32
C 3631 T Hardin Vol #: 32
C 3632 P Halfon Vol #: 32
C 3633 L Taylor Vol #: 32
C 3634 University of Pennsylvania Medical Center Vol #: 32
C 3635 A Davis Vol #: 32
C 3636 K Peterson Vol #: 32
C 3637 Y Kaweblum Vol #: 32
C 3638 B O'Leary Vol #: 32
C 3639 V Bailey Vol #: 32
C 3640 N Wilcox Sr Vol #: 32
C 3641 L Molnar Vol #: 32
C 3642 C Haller Vol #: 32
C 3643 K Boone Vol #: 32
C 3644 N Birschbach Vol #: 32
C 3645 P Ingalls Vol #: 32
C 3646 P Boswell Vol #: 32
C 3647 M Small Vol #: 32
C 3648 R Hartbauer Vol #: 32
C 3649 J Klein Vol #: 32
C 3650 P Deane Vol #: 32
C 3651 D Whitehead Vol #: 32
C 3652 S Arison Vol #: 32
C 3653 J Santiago Vol #: 32
C 3654 A Jones Vol #: 32
C 3655 D Reed Vol #: 32
C 3656 B Kleber Vol #: 32
C 3657 P Wolfe Vol #: 32
C 3658 N Gordon Vol #: 32
C 3659 W Gallagher Vol #: 32
C 3660 S Wohlner Vol #: 32
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 149 Nicole Perrot Vol #: 7
2007D-0168 Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
EC 5 Axcan Scandipharm Inc. Vol #: 1
2007D-0266 International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System
EC 1 AstraZeneca LP Vol #: 1
2007D-0268 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
EC 8 Mr. Robert Chamberlin Vol #: 1
2007N-0014 Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and GRAS Affirmation; Electronic Submission
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2007N-0330 Presidential Interagency Working Group on Import Safety; Public Meeting
EC 144 American Dehydrated Onion and Garlic Association Vol #: 1
EC 145 National Cattlemen's Beef Association Vol #: 1
EC 146 National Association of Manufacturers Vol #: 1
EC 147 Federal Express Corporation Vol #: 1
EC 148 Southern Shrimp Alliance Vol #: 1
EC 149 Meat Importers Council of America, Inc. Vol #: 1
EC 150 American Council of Independent Laboratories Vol #: 1
EC 151 American Feed Industry Association Vol #: 1
EC 152 American Apparel Vol #: 1
EC 153 Western Growers Vol #: 1
EC 154 Motor and Equipment Manufacturers Association (MEM Vol #: 1
EC 155 SOCMA's Bulk Pharmaceuticals Task Force Vol #: 1
EC 156 Motor and Equipment Manufacturers Association (MEM Vol #: 1
EC 157 National Milk Producers Federation Vol #: 1
EC 158 Motor and Equipment Manufacturers Association (MEM Vol #: 1
EC 159 Retail Industry Leaders Association Vol #: 1
EC 160 U.S. Association of Importers of Textiles and Appa Vol #: 1
EC 161 Toy Industry Association Vol #: 1
EC 162 United Fresh Produce Association Vol #: 1
EC 163 National Fisheries Institute Vol #: 1
EC 164 International Pharmaceutical Excipients Council Vol #: 1
2007N-0347 Information Technology Strategic Planning; Public Meeting
EC 1 Octagon Research Solutions Vol #: 1
EC 2 PhRMA & BIO trade association Vol #: 1
EC 3 Ms. Sharen Griffin Vol #: 1
EC 4 Thomson Scientific Vol #: 1
2007N-0359 Agency Emergency Processing Under OMB Review; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification Form
N 1 FDA Vol #: 1
2007P-0097 Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
C 11 POINT REYES WINERY/VINEYARDS Vol #: 1
2007P-0250 Enact stricter guidelines in prescribing methadone for any reason
EC 2 Mr. stephen rebro Vol #: 1
2007P-0282 Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
EC 64 Mr. Grant Henderson Vol #: 1
2007P-0369 Stay the effective date of any refusal of Entry AQZ-0251860-6 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
LET 1 Thunder Bay Seafood Co., Inc. Vol #: 1
PSA 1 Thunder Bay Seafood Co., Inc. Vol #: 1
2007P-0370 Stay the effective date of any refusal of Entry AQZ-0251196-5 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
LET 1 Fuerst, Humphrey, Ittleman, PL Vol #: 1
PSA 1 Thunder Bay Seafood Co., Inc Vol #: 1
2007P-0371 Stay the effective date of any refusal of Entry AQZ-0251197-3 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
LET 1 Thunder Bay Seafood Co., Inc. Vol #: 1
PSA 1 Thunder Bay Seafood Co., Inc. Vol #: 1
2007P-0372 Stay the effective date of any refusal of Entry AQZ-0251198-1 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
LET 1 Thunder Bay Seafood Co., Inc. Vol #: 1
PSA 1 Thunder Bay Seafood Co., Inc. Vol #: 1
2007P-0373 Stay the effective date of any refusal of Entry AQZ-0251199-9 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
LET 1 Thunder Bay Seafood Co., Inc. Vol #: 1
PSA 1 Thunder Bay Seafood Co., Inc. Vol #: 1
2007P-0374 Stay the effective date of any refusal of Entry AQZ-0251206-2 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
LET 1 Thunder Bay Seafood Co., Inc. Vol #: 1
PSA 1 Thunder Bay Seafood Co., Inc. Vol #: 1
2007P-0375 Stay the effective date of any refusal of Entry AQZ-0251212-0 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
LET 1 Thunder Bay Seafood Co., Inc. Vol #: 1
PSA 1 Thunder Bay Seafood Co., Inc. Vol #: 1
2007P-0376 Stay the effective date of any refusal of Entry AQZ-0251619-6 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
LET 1 Thunder Bay Seafood Co., Inc. Vol #: 1
PSA 1 Thunder Bay Seafood Co., Inc. Vol #: 1
2007P-0377 Stay the effective date of any refusal of Entry AQZ-0251620-4 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
LET 1 Thunder Bay Seafood Co., Inc. Vol #: 1
PSA 1 Thunder Bay Seafood Co., Inc. Vol #: 1
2007P-0378 Stay the effective date of any refusal of Entry AQZ-0251861-4 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 7 day extension of time to supply the re
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
LET 1 Thunder Bay Seafood Co., Inc. Vol #: 1
PSA 1 Thunder Bay Seafood Co., Inc. Vol #: 1
2007P-0379 Stay the effective date of any refusal of Entry AQZ-0252410-9 as a consequence of the denial by Los Angeles District to provide Thunder Bay Seafood Co., Inc. a 30-day extension of time to supply the r
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
LET 1 Thunder Bay Seafood Co., Inc. Vol #: 1
PSA 1 Thunder Bay Seafood Co., Inc. Vol #: 1

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