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| Dockets Entered
On October 10, 2006
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1993N-0069
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| Debar Mr. Shulman; Notice of Opportunity for Hearing
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| 2004N-0234
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| Annual Guidance Agenda
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| 2006D-0296
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex on Residue on Ignition/Sulphated Ash General Chapter;
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| 2006D-0297
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0361
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| Deny Request to switch ketotifen fumarate ophthalmic solution, 0.025%
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| 2006P-0371
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| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
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| 2006P-0390
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| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
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| 2006P-0392
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| Refrain from approving any ANDA for a Diazepam Rectal Gel that Relies on Diastat
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0403
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| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC 6
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| Dr. Charles Fishman
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| Vol #:
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| 4
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| EC 7
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| Dr. William Liss
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| Vol #:
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| 4
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| EC 8
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| Dr. Jo Bohannon
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| Vol #:
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| 4
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| 1993N-0069
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| Debar Mr. Shulman; Notice of Opportunity for Hearing
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| LET 4
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| FDA/DDM to Robert Shulman
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| Vol #:
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| 1
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| 2004N-0234
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| Annual Guidance Agenda
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| EC 5
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| Rammell Consulting
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| Vol #:
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| 1
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| GDL 3
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| Guideline
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| 1
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| NAD 3
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| FDA
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| Vol #:
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| 1
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| 2006D-0296
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex on Residue on Ignition/Sulphated Ash General Chapter;
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| C 1
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| Wyeth Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| | | | | | | | |
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| 2006D-0297
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
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| C 2
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| Parenteral Drug Association (PDA)
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| Vol #:
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| 1
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| EC 3
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| Amgen
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| Vol #:
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| 1
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| EC 36
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| Mr. Warren Dowler
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| Vol #:
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| 2
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| EC 3
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| Genetic Alliance
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| Vol #:
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| 1
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| EC 4
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| Genetic Alliance
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| Vol #:
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| 1
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| EC 1
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| Mrs. Maria Rugg
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| Vol #:
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| 1
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| EC 16
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| Consumers Union
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| Vol #:
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| 12
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| EC 747
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| Mrs. Mary Lahan
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| Vol #:
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| 3
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| EC 748
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| National Organization for Women
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| Vol #:
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| 3
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| EC 749
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| n/a
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| Vol #:
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| 3
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| EC 750
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| African American Women in Touch
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| Vol #:
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| 3
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| EC 751
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| Breast Cancer Action
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| Vol #:
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| 3
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| EC 752
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| Mrs. Susan Boone
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| Vol #:
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| 3
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| EC 753
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| Ms. Gail Hamilton
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| Vol #:
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| 3
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| EC 754
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| Ms. Leslie Fladung
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| Vol #:
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| 3
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| EC 755
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| Humantics Foundation for Women
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| Vol #:
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| 3
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| EC 756
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| Mrs. Eileen Bento
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| Vol #:
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| 3
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| EC 757
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| Mrs. Cosima Meyer
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| Vol #:
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| 3
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| EC 758
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| Mrs. Susan Ayers
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| Vol #:
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| 3
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| EC 759
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| Miss. Jessica Maddox
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| Vol #:
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| 3
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| EC 760
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| Mrs. Rebecca Smith-Miles
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| Vol #:
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| 3
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| EC 761
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| Mrs. Cindy Fuchs-Morrissey
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| Vol #:
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| 3
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| EC 762
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| Command Trust
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| Vol #:
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| 3
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| EC 763
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| In the Know
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| Vol #:
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| 3
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| EC 764
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| Mrs. Rosalynn Maudlin
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| Vol #:
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| 3
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