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| Dockets Entered
On February 15, 2006
Table of Contents
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| Docket #
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| Title
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| 2000D-1400
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| Reproductive Toxicity Studies preventive vaccines Disease
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| 2003E-0407
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| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004E-0389
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| Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
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| 2005N-0296
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
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| 2005N-0425
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| Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
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| 2005P-0023
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| Determine if Tequin Injection 10mg/ml (200mg)- 20 mL was withdrawn for safety or effectiveness reasons
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| 2005P-0104
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| Determine whether Peptavlon (pentagastrin) was voluntarily withdrawn from sale for reasons other than safety or effectiveness
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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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| 2005P-0418
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| Dextroamphetamine sulfate tablets, 2.5 mg,7.5 mg,15 mg,20 mg, and 30 mg suitable for submission as an ANDA
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| 2006D-0017
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| Human Subject Protection--Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of FDA Guidance Documents
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| 2006D-0044
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| Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| 2006P-0069
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| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
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| 2006V-0076
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| Laser Light Show
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| 2000D-1400
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| Reproductive Toxicity Studies preventive vaccines Disease
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| BKG
1
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| Backgroung Material
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| Vol #:
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| 2
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2003E-0407
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| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
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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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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| N
1
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| FDA
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| Vol #:
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| 15
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| 2004E-0389
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| Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
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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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| 2005N-0296
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2005N-0425
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| Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
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| NSA
1
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| FDA
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| Vol #:
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| 1
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| 2005P-0023
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| Determine if Tequin Injection 10mg/ml (200mg)- 20 mL was withdrawn for safety or effectiveness reasons
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| EC
2519
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| Dr. michael eurs
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| Vol #:
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| 9
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| EC
2520
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| Ms. MaryAnn Gamel
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| Vol #:
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| 9
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| EC
2521
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| Ms. Glenda Hillyer
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| Vol #:
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| 9
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| EC
2522
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| Westlake Natural Health
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| Vol #:
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| 9
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| EC
2523
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| Mrs. Charlotte Nakosteen
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| Vol #:
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| 9
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| EC
2524
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| Ms. Candace Wingo
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| Vol #:
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| 9
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| EC
2525
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| Mrs. Sharon Scully
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| Vol #:
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| 9
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| EC
2526
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| Ms. Karen Hamburg
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| Vol #:
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| 9
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| EC
2527
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| Ms. Cindy Bader
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| Vol #:
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| 9
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| EC
2528
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| Ms. Lucia Hodges
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| Vol #:
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| 9
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| EC
2529
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| Dr. Javier Diaz-Blanco
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| Vol #:
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| 9
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| 2005P-0418
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| Dextroamphetamine sulfate tablets, 2.5 mg,7.5 mg,15 mg,20 mg, and 30 mg suitable for submission as an ANDA
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006D-0017
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| Human Subject Protection--Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of FDA Guidance Documents
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| GDL
1
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| Information Sheet Guidance For IRBs,Clinical Investigators, and Sponsors
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| Vol #:
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| 1
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| GDL
2
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| FDA Institutional Review Board Inspections
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| Vol #:
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| 1
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| GDL
3
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| Waiver of IRB Requirements for Drug and Biological Products Stuides
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| Vol #:
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| 1
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| GDL
4
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| Significant Risk and Nonsignificant Risk Medical Device Studies
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| Vol #:
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| 1
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| GDL
5
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| Frequently Asked Questions About Medical Devices
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| Vol #:
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| 1
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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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| 2006D-0044
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| Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
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| GDL
1
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| GUIDANCE
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| Vol #:
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| 1
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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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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| NM
1
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| FDA
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| Vol #:
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| 1
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| 2006P-0069
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| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
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| CP
1
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| The quaker Oats Company
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| Vol #:
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| 1
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| 2006V-0076
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| Laser Light Show
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| ACK
1
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| HFA-305 to Renishaw plc
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| Vol #:
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| 1
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| VAR
1
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| Renishaw
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| Vol #:
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| 1
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| VAR 2
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| Number not Used
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| Vol #:
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| 1
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