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| Dockets Entered
On February 6, 2006
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003M-0332
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| P010001, Ceramic TRANSCEND Hip Articulation System, Approved 2/3/03
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| 2004N-0366
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| Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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| 2005N-0317
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006N-0029
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Coupons on Consumer Perceptions of Products in Prescription Drugs in Direct-to-Consumer Prescription Drug Prin
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| 2006N-0032
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| Referral of ZINECARD (dexrazoxane) and RELPAX (eletriptan) Written Requests for the Conduct of Pediatric Studies
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| 2006N-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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| 2006N-0037
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Trans Fat Claims on Foods
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| 2006N-0038
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food
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| 2006N-0064
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| Independent Evaluation of the Food and Drug Administration's First Cycle Review Performance Retrospective Analysis Final Report; Availability
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| 1976N-0052N
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| OTC Nasal Decongestants
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| EMC 138
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| L. Skimming
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| Vol #:
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| 77
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| EMC 59
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| L. Skimming
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| Vol #:
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| 98
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7514
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| R. Wilce
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| Vol #:
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| 319
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| EMC 1
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| L. Karn
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| Vol #:
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| 3
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| EMC 2
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| B. O'Brien
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| Vol #:
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| 1
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| EMC 3
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| B. Sachau
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| Vol #:
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| 3
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| EMC 4
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| B. Sachau
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| Vol #:
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| 3
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| EMC 5
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| B. Sachau
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| Vol #:
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| 3
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| EMC 6
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| P. Kothari
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| Vol #:
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| 3
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| EMC 7
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| D. Halpern
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| Vol #:
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| 3
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| EMC 8
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| T. Swirsky
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| Vol #:
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| 3
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 625
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| K. Knudsen
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| Vol #:
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| 24
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| EMC 626
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| K. Flaherty
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| Vol #:
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| 24
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| EMC 805
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| M. Marini
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| Vol #:
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| 33
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| NAL
1
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| FDA
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| Vol #:
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| 5
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| SS
1
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| Supporting Statement
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| Vol #:
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| 5
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1305
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| J. Abrams
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| Vol #:
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| 6
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 596
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 597
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| Mission Possible International
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| Vol #:
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| 9
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| EMC
598
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| Calorie Control Council
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| Vol #:
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| 9
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| EMC 599
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 600
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 601
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 602
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 603
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 604
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| Mission Possible International
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| Vol #:
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| 9
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| 2003M-0332
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| P010001, Ceramic TRANSCEND Hip Articulation System, Approved 2/3/03
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| C 1
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| P. Kynard
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| Vol #:
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| 1
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1209
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| T. Byrum
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| Vol #:
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| 12
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| EMC 1210
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| G. Pryor
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| Vol #:
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| 12
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| EMC 1211
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| R. Meyers
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| Vol #:
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| 12
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| EMC 1212
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| J. Tallon
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| Vol #:
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| 12
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| EMC 1213
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| J. Worton
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| Vol #:
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| 12
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| EMC 1214
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| No signature
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| Vol #:
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| 12
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| EMC 1215
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| N. Ramos
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| Vol #:
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| 12
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| EMC
3
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| American Society for Reproductive Medicine (ASRM)
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| Vol #:
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| 1
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| 2004N-0366
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| Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies
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| EMC
1
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| EMC 792
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| T. Weaver
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| Vol #:
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| 9
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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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| EMC
2
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| American Society for Reproductive Medicine (ASRM)
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| Vol #:
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| 1
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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| EMC 3
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| A. Ragosta
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| Vol #:
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| 1
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| 2005N-0317
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| EMC 1
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| K. Hall
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| Vol #:
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| 1
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| EMC 2
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| S. Tumbarello
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| Vol #:
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| 1
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| EMC 3
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| M. Dallaire, R.N.
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| Vol #:
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| 1
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| EMC 4
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| M. Kraeszig, DVM
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| Vol #:
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| 1
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| EMC 5
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| No signature
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| Vol #:
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| 1
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| EMC 6
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| E. Piehl
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| EMC 11
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| D. May
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| Vol #:
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| 6
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| EMC 12
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| J. Ragsdale
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| Vol #:
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| 6
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| EMC 13
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| S. Crane
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| Vol #:
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| 6
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| EMC 14
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| S. Crane
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| Vol #:
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| 6
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| EMC 15
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| K. Boham
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| Vol #:
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| 6
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| EMC 16
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| B. Crane
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| Vol #:
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| 6
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| EMC 17
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| M. Choate
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| Vol #:
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| 6
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| 2006N-0029
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Coupons on Consumer Perceptions of Products in Prescription Drugs in Direct-to- Consumer Prescription Drug Prin
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| N
1
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| FDA
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| Vol #:
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| 1
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|
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| 2006N-0032
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| Referral of ZINECARD (dexrazoxane) and RELPAX (eletriptan) Written Requests for the Conduct of Pediatric Studies
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2006N-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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| N
1
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| FDA
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| Vol #:
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| 1
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| |
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| 2006N-0037
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Trans Fat Claims on Foods
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2006N-0038
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2006N-0064
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| Independent Evaluation of the Food and Drug Administration's First Cycle Review Performance Retrospective Analysis Final Report; Availability
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| RPT
1
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| Report
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| Vol #:
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| 1
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