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| Dockets Entered
On August 10, 2007
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| Docket #
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| Title
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| |
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| 2006N-0104
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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| |
|
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| 2006N-0105
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Environmental Impact Considerations Part 25 (21 CFR Part 25)
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| |
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| |
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| 2006P-0125
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| Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2006P-0160
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| Change Daranide Tablets, 50 mg to a generic version
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| 2006P-0253
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| ANDA Suitability for Loperamide Hydrochloride
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| 2006P-0399
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| To determine whether PhosLo (calcium acetate) Tablets, eq 169 mg calcium, and PhosLo (calcuim acetate) Capsules, eq 169 mg calcium, has been withdrawn for safety or efficacy reasons
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| 2006P-0446
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| ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg
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| 2006P-0462
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| Determine whether Prevacid NapraPAC, 15 mg/250 mg (lansoprazole delayed-release, 15 mg capsules and naproxen 250 mg tablets kit) (NDA No. 021507) by Tap Pharm, has been voluntarily withdrawn or withhe
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| 2007D-0185
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| Guidance for Industry and Review Staff on Labeling for Human Prescription Drugs Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information
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| 2007D-0213
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
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| 2007N-0179
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| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
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| 2007N-0186
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| Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
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| 2007N-0294
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| Medical Devices; Immunology and Microbiology Devices: Classification of In Vitro HIV Drug Resistance Genotype Assay
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| 2007P-0301
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| Alkaline and Earth Alkaline Citrates and Osteoporosis; Health Claim Peition
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| C 3643
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| We The People
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| Vol #:
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| 47
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| C 3644
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| C. Rosskam
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| Vol #:
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| 47
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| C 3645
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| C. Rosskam
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| Vol #:
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| 47
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| C 3646
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| C. Sceza
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| Vol #:
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| 47
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| C 3647
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| Dr. C. S. Cobb
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| Vol #:
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| 47
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| C 3648
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| J. Howe
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| Vol #:
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| 47
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| |
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| C 3649
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| G. Stevens
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| Vol #:
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| 47
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| |
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| C 3650
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| R. McDonald
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| Vol #:
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| 47
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| C 3651
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| A. K. Johnson
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| Vol #:
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| 47
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| C 3652
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| E. F. Smith
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| Vol #:
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| 47
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| C 3653
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| A. Urrea
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| Vol #:
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| 47
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| |
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| C 3654
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| D. Elliott
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| Vol #:
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| 47
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| |
|
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| C 3655
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| M. Hanson
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| Vol #:
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| 47
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| C 3656
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| C. & T. Gibson
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| Vol #:
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| 47
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| C 3657
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| E. A. Stranger
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| Vol #:
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| 47
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| C 3658
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| A. McGuire
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| Vol #:
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| 47
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| C 3659
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| R. And E.J. Williams
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| Vol #:
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| 47
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| C 3660
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| M. E. Callahan
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| Vol #:
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| 47
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| C 3661
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| Mrs. D. L. Murray
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| Vol #:
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| 47
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| C 3662
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| K. Eckstrand
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| Vol #:
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| 47
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| C 3663
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| C. Keaney
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| Vol #:
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| 47
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| C 3664
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| R. Sargent
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| Vol #:
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| 47
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| C 3665
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| B. Troutman
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| Vol #:
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| 47
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| |
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| C 3666
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| T. Hughes
|
| Vol #:
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| 47
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| |
|
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| C 3667
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| T. Ridenour
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| Vol #:
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| 47
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| C 3668
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| M. Schmid
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| Vol #:
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| 47
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| |
|
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| C 3669
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| J. Larrainzar
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| Vol #:
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| 47
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| |
|
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| C 3670
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| Ms. J. Williams Scarpa
|
| Vol #:
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| 47
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| |
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| C 3671
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| M. Jones
|
| Vol #:
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| 47
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| |
|
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| C 3672
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| M. Carlson
|
| Vol #:
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| 47
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| |
|
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| C 3673
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| S. Floyd
|
| Vol #:
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| 47
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| |
|
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| C 3674
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| H. & J. Olney
|
| Vol #:
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| 47
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| |
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| C 3675
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| K. MacNeil
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| Vol #:
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| 47
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| C 3676
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| K. Farago
|
| Vol #:
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| 47
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| C 3677
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| Dr. J. Erickson
|
| Vol #:
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| 47
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| |
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| C 3678
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| M. A. Golden
|
| Vol #:
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| 47
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| |
|
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| C 3679
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| Wegmans Food Markets, Inc.
|
| Vol #:
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| 47
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| |
|
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| C 3680
|
| Agricultural Trade Services
|
| Vol #:
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| 47
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| |
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| C 3681
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| C. Heeschen And P. Prodan
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| Vol #:
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| 47
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| |
|
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| C 3682
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| S. Berlin
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| Vol #:
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| 47
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| C 3683
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| Mrs. K. Loveless
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| Vol #:
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| 47
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| C 3684
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| Food & Water Watch
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| Vol #:
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| 47
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| |
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| C 3685
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| D. Baker
|
| Vol #:
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| 47
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| |
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| C 3686
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| P. Gettman
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| Vol #:
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| 47
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| C 3687
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| B. Valdez
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| Vol #:
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| 47
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| |
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| C 3688
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| P. Weber
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| Vol #:
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| 47
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| |
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| C 3689
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| K. Easton
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| Vol #:
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| 47
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| |
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| C 3690
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| S. Rivers
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| Vol #:
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| 47
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| |
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| C 3691
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| B. Martin
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| Vol #:
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| 47
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| |
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| C 3692
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| S. Douglas
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| Vol #:
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| 47
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| C 3693
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| G. Pilgreen
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| Vol #:
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| 47
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| C 3694
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| J. Marshall
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| Vol #:
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| 47
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| C 3695
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| K. Sprinkel
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| Vol #:
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| 47
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| |
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| C 3696
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| Unknown
|
| Vol #:
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| 47
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|
| | | | | | | |
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| |
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| C 3697
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| Unknown
|
| Vol #:
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| 55
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| |
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| C 3698
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| P. McCormick
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| Vol #:
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| 55
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| |
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| C 3699
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| G. Meadows
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| Vol #:
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| 55
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| |
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| C 3700
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| E. Parker
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| Vol #:
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| 55
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| |
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| C 3701
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| Food Irradiation Processing Alliance
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| Vol #:
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| 55
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| |
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| C 3702
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| E. Papier
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| Vol #:
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| 55
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| C 3703
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| S. Thankappan, Ph.D.
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| Vol #:
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| 55
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| C 3704
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| D. Mahoney
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| Vol #:
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| 55
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| |
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| C 3705
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| J. Householder
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| Vol #:
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| 55
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| C 3706
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| S. Hinckley
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| Vol #:
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| 55
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| |
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| C 3707
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| C. Roush
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| Vol #:
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| 55
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| |
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| C 3708
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| S. Rosenau
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| Vol #:
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| 55
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| |
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| C 3709
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| W. Henry
|
| Vol #:
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| 55
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| |
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| C 3710
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| E. Tobier
|
| Vol #:
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| 55
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| |
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| C 3711
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| M. Grimaud
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| Vol #:
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| 55
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| |
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| C 3712
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| S. Chague
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| Vol #:
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| 55
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| |
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| C 3713
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| M. Hansen, Ph.D.
|
| Vol #:
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| 55
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| |
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| C 3714
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| C. Hall
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| Vol #:
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| 55
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| |
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| C 3715
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| B. Hodge
|
| Vol #:
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| 55
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| |
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| C 3716
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| C. Hodge
|
| Vol #:
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| 55
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| |
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| C 3717
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| Ohio Farmers Union
|
| Vol #:
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| 55
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| |
|
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| C 3718
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| D. Sackett
|
| Vol #:
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| 55
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| |
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| C 3719
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| G. Tombleson
|
| Vol #:
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| 55
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| |
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| C 3720
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| T. Ley
|
| Vol #:
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| 55
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| |
|
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| C 3721
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| R. Lonow
|
| Vol #:
|
| 55
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| |
|
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| C 3722
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| A. Morley
|
| Vol #:
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| 55
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| |
|
|
| C 3723
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| L. A. Bassan
|
| Vol #:
|
| 55
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| |
|
|
| C 3724
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| Unknown
|
| Vol #:
|
| 55
|
| |
|
|
| C 3725
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| M. Vassallo, M.D./Ph.D.
|
| Vol #:
|
| 55
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| |
|
|
| C 3726
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| H. Fogarty
|
| Vol #:
|
| 55
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| |
|
|
| C 3727
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| L. Kline
|
| Vol #:
|
| 55
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| |
|
|
| C 3728
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| MDS Nordion
|
| Vol #:
|
| 55
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| |
|
|
| C 3729
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| Unknown
|
| Vol #:
|
| 55
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| |
|
|
| C 3730
|
| J. Staton
|
| Vol #:
|
| 55
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| |
|
|
| C 3731
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| S. Wuerthele, Ph.D.
|
| Vol #:
|
| 55
|
| |
|
|
| C 3732
|
| T. Weis
|
| Vol #:
|
| 55
|
| |
|
|
| C 3733
|
| Unknown
|
| Vol #:
|
| 55
|
|
| | | | | | | | |
|
| |
|
| C 3734
|
| J. Ridgeway
|
| Vol #:
|
| 55
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| |
|
|
| C 3735
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| C. Ridgeway
|
| Vol #:
|
| 55
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| |
|
|
| C 3736
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| Massachusetts General Hospital for Children
|
| Vol #:
|
| 55
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| |
|
|
| C 3737
|
| R. Sachs
|
| Vol #:
|
| 55
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| |
|
|
| C 3738
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| B. Hartley
|
| Vol #:
|
| 55
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| |
|
|
| C 3739
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| L. A. Masotta
|
| Vol #:
|
| 55
|
| |
|
|
| C 3740
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| L. Thorndike
|
| Vol #:
|
| 55
|
| |
|
|
| C 3741
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| J. Goetz
|
| Vol #:
|
| 55
|
| |
|
|
| 2006N-0104
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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|
|
|
|
|
| | |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS 1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0105
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Environmental Impact Considerations Part 25 (21 CFR Part 25)
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS 1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
| |
|
|
| C 573
|
| R. Newman
|
| Vol #:
|
| 4
|
| |
|
|
| C 574
|
| J. Frost
|
| Vol #:
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| 4
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| |
|
|
| C 575
|
| L. Schaard
|
| Vol #:
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| 4
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| |
|
|
| C 576
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| c. Tafter
|
| Vol #:
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| 4
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| |
|
|
| C 577
|
| S. Tuchman
|
| Vol #:
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| 4
|
| |
|
|
| C 578
|
| M. Ossman
|
| Vol #:
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| 4
|
| |
|
|
| C 579
|
| E. Helme
|
| Vol #:
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| 4
|
| |
|
|
| C 580
|
| C. Rone
|
| Vol #:
|
| 4
|
| |
|
|
| C 581
|
| A. Raymond
|
| Vol #:
|
| 4
|
| |
|
|
| C 582
|
| P. Green
|
| Vol #:
|
| 4
|
| |
|
|
| C 583
|
| G. Hause
|
| Vol #:
|
| 4
|
| |
|
|
| C 584
|
| K. Loomis
|
| Vol #:
|
| 4
|
| |
|
|
| C 585
|
| E. Hewer
|
| Vol #:
|
| 4
|
| |
|
|
| C 586
|
| K. Van Meter
|
| Vol #:
|
| 4
|
| |
|
|
| C 587
|
| G. Nations
|
| Vol #:
|
| 4
|
| |
|
|
| C 588
|
| F. Taylor
|
| Vol #:
|
| 4
|
| |
|
|
| C 589
|
| P. Doyle
|
| Vol #:
|
| 4
|
| |
|
|
| C 590
|
| M. Young
|
| Vol #:
|
| 4
|
| |
|
|
| C 591
|
| R. Anderson
|
| Vol #:
|
| 4
|
|
| | | | | | | |
|
| |
|
| C 592
|
| H. Watson
|
| Vol #:
|
| 4
|
| |
|
|
| C 593
|
| E. Vallier
|
| Vol #:
|
| 4
|
| |
|
|
| C 594
|
| H. Justine
|
| Vol #:
|
| 4
|
| |
|
|
| C 595
|
| C. Roberts
|
| Vol #:
|
| 4
|
| |
|
|
| C 596
|
| A. Sharp
|
| Vol #:
|
| 4
|
| |
|
|
| C 597
|
| G. Wright
|
| Vol #:
|
| 4
|
| |
|
|
| C 598
|
| C. Cook
|
| Vol #:
|
| 4
|
| |
|
|
| C 599
|
| C. Cook
|
| Vol #:
|
| 4
|
| |
|
|
| C 600
|
| no signature
|
| Vol #:
|
| 4
|
| |
|
|
| C 601
|
| C. Hamby
|
| Vol #:
|
| 4
|
| |
|
|
| C 602
|
| J. Roush
|
| Vol #:
|
| 4
|
| |
|
|
| C 603
|
| L .Kerns
|
| Vol #:
|
| 4
|
| |
|
|
| C 604
|
| V. Csurny
|
| Vol #:
|
| 4
|
| |
|
|
| C 605
|
| A. Garrett
|
| Vol #:
|
| 4
|
| |
|
|
| C 606
|
| M. Lawson
|
| Vol #:
|
| 4
|
| |
|
|
| C 607
|
| H. Parrott
|
| Vol #:
|
| 4
|
| |
|
|
| C 608
|
| C. Crowe
|
| Vol #:
|
| 4
|
| |
|
|
| C 609
|
| C. Beahn
|
| Vol #:
|
| 4
|
| |
|
|
| C 610
|
| R. Zechar
|
| Vol #:
|
| 4
|
| |
|
|
| C 611
|
| P. Bricker
|
| Vol #:
|
| 4
|
| |
|
|
| C 612
|
| L. Bretz
|
| Vol #:
|
| 4
|
| |
|
|
| C 613
|
| S. Trimball
|
| Vol #:
|
| 4
|
| |
|
|
| C 614
|
| S. Colvin
|
| Vol #:
|
| 4
|
| |
|
|
| C 615
|
| L. Martino
|
| Vol #:
|
| 4
|
| |
|
|
| C 616
|
| H. McQuinn
|
| Vol #:
|
| 4
|
| |
|
|
| C 617
|
| P. Geer
|
| Vol #:
|
| 4
|
| |
|
|
| C 618
|
| M. Yeager
|
| Vol #:
|
| 4
|
| |
|
|
| C 619
|
| E. Letteer
|
| Vol #:
|
| 4
|
| |
|
|
| C 620
|
| R. Koeller
|
| Vol #:
|
| 4
|
| |
|
|
| C 621
|
| E. Bax
|
| Vol #:
|
| 4
|
| |
|
|
| C 622
|
| W.Holland
|
| Vol #:
|
| 4
|
| |
|
|
| C 623
|
| G Lindow
|
| Vol #:
|
| 4
|
| |
|
|
| C 624
|
| V. Thomas
|
| Vol #:
|
| 4
|
| |
|
|
| C 625
|
| E. Elenbaas
|
| Vol #:
|
| 4
|
| |
|
|
| C 626
|
| N. Buchan
|
| Vol #:
|
| 4
|
| |
|
|
| C 627
|
| B. Harford
|
| Vol #:
|
| 4
|
| |
|
|
| C 628
|
| L. Breer
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
|
| |
|
| C 629
|
| F. Moore
|
| Vol #:
|
| 4
|
| |
|
|
| C 630
|
| K. Renard
|
| Vol #:
|
| 4
|
| |
|
|
| C 631
|
| J. Hamilton
|
| Vol #:
|
| 4
|
| |
|
|
| C 632
|
| G. Rogers
|
| Vol #:
|
| 4
|
| |
|
|
| C 633
|
| J Nahrgang
|
| Vol #:
|
| 4
|
| |
|
|
| C 634
|
| M. Boungankas
|
| Vol #:
|
| 4
|
| |
|
|
| C 635
|
| D. Weant
|
| Vol #:
|
| 4
|
| |
|
|
| C 636
|
| D. Husman
|
| Vol #:
|
| 4
|
| |
|
|
| C 637
|
| K. Johnson
|
| Vol #:
|
| 4
|
| |
|
|
| C 638
|
| H. Larsen
|
| Vol #:
|
| 4
|
| |
|
|
| C 639
|
| R. Schenk
|
| Vol #:
|
| 4
|
| |
|
|
| C 640
|
| R. Jones
|
| Vol #:
|
| 4
|
| |
|
|
| C 641
|
| J. Honeycutt Jr
|
| Vol #:
|
| 4
|
| |
|
|
| C 642
|
| R. Spelling
|
| Vol #:
|
| 4
|
| |
|
|
| C 643
|
| W. Notz
|
| Vol #:
|
| 4
|
| |
|
|
| C 644
|
| D. Herziq
|
| Vol #:
|
| 4
|
| |
|
|
| C 645
|
| J. Kent
|
| Vol #:
|
| 4
|
| |
|
|
| C 646
|
| G. Gartrell
|
| Vol #:
|
| 4
|
| |
|
|
| C 647
|
| J. Tinley
|
| Vol #:
|
| 4
|
| |
|
|
| C 648
|
| M. Carter
|
| Vol #:
|
| 4
|
| |
|
|
| C 649
|
| L. Strickland
|
| Vol #:
|
| 4
|
| |
|
|
| C 650
|
| P. Smith
|
| Vol #:
|
| 4
|
| |
|
|
| C 651
|
| A. House
|
| Vol #:
|
| 4
|
| |
|
|
| C 652
|
| A. Tenberge
|
| Vol #:
|
| 4
|
| |
|
|
| C 653
|
| J. Marcello
|
| Vol #:
|
| 4
|
| |
|
|
| C 654
|
| L. Biel
|
| Vol #:
|
| 4
|
| |
|
|
| C 655
|
| D. Amrich
|
| Vol #:
|
| 4
|
| |
|
|
| C 656
|
| R. Webster
|
| Vol #:
|
| 4
|
| |
|
|
| C 657
|
| L Smith
|
| Vol #:
|
| 4
|
| |
|
|
| C 658
|
| D. White
|
| Vol #:
|
| 4
|
| |
|
|
| C 659
|
| I Brendle
|
| Vol #:
|
| 4
|
| |
|
|
| C 660
|
| R. Gibson Sr
|
| Vol #:
|
| 4
|
| |
|
|
| C 661
|
| S. Smith
|
| Vol #:
|
| 4
|
| |
|
|
| C 662
|
| L. Boyce
|
| Vol #:
|
| 4
|
|
| |
|
| 2006P-0125
|
| Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from sale for safety or efficacy reasons
|
| |
|
|
| LET 2
|
| Nikki Mueller
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2006P-0160
|
| Change Daranide Tablets, 50 mg to a generic version
|
| |
|
|
| LET 2
|
| Mary Catchings
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0253
|
| ANDA Suitability for Loperamide Hydrochloride
|
| |
|
|
| LET 2
|
| Gary J. Buehler
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0399
|
| To determine whether PhosLo (calcium acetate) Tablets, eq 169 mg calcium, and PhosLo (calcuim acetate) Capsules, eq 169 mg calcium, has been withdrawn for safety or efficacy reasons
|
|
|
|
|
|
|
| |
|
|
| LET 1
|
| Nikki Mueller
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0446
|
| ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg
|
| |
|
|
| LET 2
|
| Mary Catchings
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0462
|
| Determine whether Prevacid NapraPAC, 15 mg/250 mg (lansoprazole delayed-release, 15 mg capsules and naproxen 250 mg tablets kit) (NDA No. 021507) by Tap Pharm, has been voluntarily withdrawn or withhe
|
|
|
|
|
|
|
| |
|
|
| LET 2
|
| Marguerita Brunso Sims
|
| Vol #:
|
| 1
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0185
|
| Guidance for Industry and Review Staff on Labeling for Human Prescription Drugs Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information
|
|
|
|
|
|
| | |
|
|
| C 1
|
| Sanofi Aventis
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0213
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
|
| |
|
|
| C 2
|
| Sanofi Aventis
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0179
|
| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
|
| |
|
|
| C 1
|
| American Pharmacists Association
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0186
|
| Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
|
|
|
|
|
|
|
| |
|
|
| EXT 1
|
| Consumer Healthcare Products Association (CHPA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0294
|
| Medical Devices; Immunology and Microbiology Devices: Classification of In Vitro HIV Drug Resistance Genotype Assay
|
| |
|
|
| BKG 1
|
| Background Material
|
| Vol #:
|
| 1
|
|
| |
|
| 2007P-0301
|
| Alkaline and Earth Alkaline Citrates and Osteoporosis; Health Claim Peition
|
| |
|
|
| LET 1
|
| Jillonne Kevala
|
| Vol #:
|
| 2
|
|
|
