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Dockets Management

Dockets Entered On November 8, 2007
Docket # Title
1978N-0038 Sunscreen Drug Products
2001D-0193 Premarket Notifications for Biological Indicators Intended
2005D-0490 Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
2005P-0450 Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
2006E-0532 Patent Extension Application for Anthelios SX Daily Moisturizing Cream With Sunscreen, U.S. Patent No. 4,585,597
2006N-0168 Food Labeling: Reference Daily Intakes & Daily Reference Values
2006N-0221 Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
2006P-0487 Health Claim Petition: Isomaltulose and Dental Caries
2007E-0442 Patent Term Extension Application for PROFENDER, U.S. Patent No. 5,514,773
2007E-0443 Patent Term Extension Application for AbioCor Implantable Replacement Heart, U.S. Patent No. 5,084,064
2007N-0262 Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
2007N-0427 Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
1978N-0038 Sunscreen Drug Products
EC 2638 Mrs. Anne Marie Treger Vol #: 163
EC 2639 Ms. Courtney Anderson Vol #: 163
EC 2640 Mr. hari matsuda Vol #: 163
EC 2641 Ciba Corporation Vol #: 163
2001D-0193 Premarket Notifications for Biological Indicators Intended
EC 4 ADVOCATES FOR TRUTH Vol #: 1
2005D-0490 Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
ANS 10 FDA/CFSAN to J. Korning/AAK Vol #: 1
ANS 11 FDA/CFSAN to S. Eslava from the National Raisin Company Vol #: 1
ELET 10 National Raisin Company Vol #: 1
2005P-0450 Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
EC 5 Mr. Leslie Johnson Vol #: 1
2006E-0532 Patent Extension Application for Anthelios SX Daily Moisturizing Cream With Sunscreen, U.S. Patent No. 4,585,597
AAV 1 U.S. Patent and Trademark Office to Buchanan Ingersoll, PC Vol #: 2
2006N-0168 Food Labeling: Reference Daily Intakes & Daily Reference Values
EC 1 Ms. Carla French Vol #: 1
EC 2 Mrs. Pam Buchholz Vol #: 1
EC 3 Renal Advantage Inc. Vol #: 1
EC 4 King Dialysis Vol #: 1
EC 5 Mrs. Joellen Ford Vol #: 1
EC 6 Triad Vol #: 1
EC 7 Mrs. Jane Wheeler Vol #: 1
EC 8 Arkansas Nephrology Services Vol #: 1
EC 9 Fresenius Medical Care Vol #: 1
EC 10 Ms. ANA REYES Vol #: 1
EC 11 Ms. Mary Kay Hensley Vol #: 1
EC 12 Midwest Dialysis Center Vol #: 1
EC 13 Ms. Jessica Sylvester Vol #: 1
EC 14 Satellite Healthcare Vol #: 1
EC 15 Ms. Andrea Clark Vol #: 1
EC 16 OSU Extension Vol #: 1
EC 17 RENAL NUTRITION Vol #: 1
EC 18 Mrs. Suzie Blasczyk Vol #: 1
EC 19 Danville Dialysis Services Vol #: 1
EC 20 Ms. Rita Megason Vol #: 1
EC 21 DaVita Dialysis Vol #: 1
EC 22 Ms. Diana Pisarcik Vol #: 1
EC 23 Lumberton Dialysis Vol #: 1
EC 24 Ms. Deanne Allegro Vol #: 1
EC 25 Dialysis Centers of Northwest Arkansas Vol #: 1
EC 26 DaVita, Inc. Vol #: 1
EC 27 Mrs. Cathleen Turner Vol #: 1
EC 28 Ms. LeeAnn Smith Vol #: 1
EC 29 Regional Dialysis Center Vol #: 1
EC 30 Ms. Donna Maynes Vol #: 1
EC 31 Altoona Regional Health System Vol #: 1
EC 32 Ms. Eva Petkac Donnelly Vol #: 1
EC 33 university hospitals case medical center Vol #: 1
EC 34 Mrs. Robin Montgomery Vol #: 1
EC 35 Mrs. Susan Coopersmith Vol #: 1
EC 36 Ms. Carrie Mukaida Vol #: 1
EC 37 Renal Advantage Vol #: 1
EC 38 LIBERTY DIALYSIS LLC Vol #: 1
EC 39 Mrs. Judith Tomko Vol #: 1
EC 40 Dialysis Clinic, Inc. Vol #: 1
EC 41 St. Joseph Hospital Vol #: 1
EC 42 Davita Vol #: 1
EC 43 Davita HealthCare Vol #: 1
EC 44 Ms. Cristy Halley Vol #: 1
EC 45 SW Kidney Institute Vol #: 1
EC 46 Ms. Patricia Williams Vol #: 1
EC 47 Mrs. Hannah Sobol Vol #: 1
EC 48 Southwest Kidney Institute Vol #: 1
EC 49 Southwest Kidney Institute Vol #: 1
EC 50 Mr. Dan Rosselli Vol #: 1
EC 51 Mrs. Briana Schmickle Vol #: 1
EC 52 Mrs. Amy Myrtue Nelson Vol #: 1
EC 53 DaVita Dialysis Vol #: 1
EC 54 Luther Midelfort Vol #: 1
EC 55 Ms. Jane Faith Vol #: 1
EC 56 Mrs. Meredith Ludwig Vol #: 1
EC 57 Mrs. Jill Haeft Vol #: 1
EC 58 Mrs. Susan Kendziorski Vol #: 1
EC 59 Ms. JoAnna Siciliano Vol #: 1
EC 60 Dialysis Care of Martin County Vol #: 1
EC 61 Mrs. Tiffanie Jacobson Vol #: 1
EC 62 Renal Falure Vol #: 1
2006N-0221 Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
NPR 1 FDA Vol #: 1
2006P-0487 Health Claim Petition: Isomaltulose and Dental Caries
EC 2 Ms. Suzanne Stapler Vol #: 1
2007E-0442 Patent Term Extension Application for PROFENDER, U.S. Patent No. 5,514,773
APP 1 Astellas Pharma, Inc. Vol #: 1
LET 1 U.S. Patent and Trademark Office to FDA/CDER Vol #: 1
2007E-0443 Patent Term Extension Application for AbioCor Implantable Replacement Heart, U.S. Patent No. 5,084,064
APP 1 Abiomed, Inc. Vol #: 1
LET 1 U.S. Patent and Trademark Office to FDA/CDER Vol #: 1
2007N-0262 Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
NEC 1 FDA Vol #: 1
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
EC 22 American Dietetic Association Vol #: 1
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
EC 34 Mrs. Tracey Richie Vol #: 1
EC 35 Mr. Jim Earley Vol #: 1
EC 36 Mrs. Valerie Bufford Vol #: 1
EC 37 Mrs. Katie Chase Vol #: 1
2007N-0427 Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications
NWL 1 FDA Vol #: 1
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
C 350 The Radakovich Family Vol #: 102
C 351 M. A. Moore Vol #: 102
C 352 R. Ayres Vol #: 102

Page created on November 8, 2007 ue

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