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Dockets Management
Dockets Entered On January 11, 2006
Table of Contents
Docket # Title
1999D-2145 VICH GL11 on Impurities in New Veterinary Medicinal Products
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
2003E-0259 Patent Extension Extension for Geodon or Zeldox (ziprasidone HCl monohydrate), 4,831,031
2003N-0161 Medical Devices;Reprocessed Single-Use Devices;Termination
2004E-0021 Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
2004E-0304 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
2004E-0307 Patent Extension for Altima (pemetrexed), U.S. Patent No. 5,344,932
2004E-0389 Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
2004E-0394 Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
2004E-0445 Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
2005D-0069 Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems
2005D-0219 Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
2005D-0330 Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
2005D-0337 Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque
2005D-0483 Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
2005E-0233 Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
2005E-0247 Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
2005E-0249 Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
2005E-0254 Patent Extension Application for ERBITUX, U.S. Patent No. 6,217,866
2005E-0258 Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
2005N-0120 Agency Information Collection Activities: Proposed Collection; Comment Request;
2005N-0209 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substances Notification System
2005N-0343 Agency Emergency Processing Under OMB Review; Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
2005N-0413 Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
2005N-0416 Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
2005N-0510 Anti-Counterfeit Drug Initiative Workshop and Vendor Display
2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
2005P-0319 Determination of PHENERGAN (Promethazine hydrochloride) 12.5mg and 50mg tablets
2005P-0352 bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
1999D-2145 VICH GL11 on Impurities in New Veterinary Medicinal Products
GDL 3 GUIDANCE Vol #: 1
NAD 3 FDA Vol #: 1
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
C 523 Allen Co. Conservation District Vol #: 40
2003E-0259 Patent Extension Extension for Geodon or Zeldox (ziprasidone HCl monohydrate), 4,831,031
LET 3 HFD-5 to the U.S. Patent and Trademark Office Vol #: 1
2003N-0161 Medical Devices;Reprocessed Single-Use Devices;Termination
C 7 Association of Medical Device Reprocessors (AMDR) Vol #: 1
2004E-0021 Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
LET 3 HFD-5 to the U.S. Patent and Trademark Office Vol #: 1
2004E-0304 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
LET 4 HFD-5 to the U.S. Patent and Tradmark Office Vol #: 1
2004E-0307 Patent Extension for Altima (pemetrexed), U.S. Patent No. 5,344,932
LET 3 HFD-5 to the U.S. Patent and Trademark Office Vol #: 1
2004E-0389 Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
LET 3 HFD-5 to the U.S. Patent and Trademark Office Vol #: 1
2004E-0394 Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
LET 3 HFD-5 to the U.S. Patent and Trademark Office Vol #: 1
2004E-0445 Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
LET 3 HFD-5 to the U.S. Patent and Trademark Office Vol #: 1
2005D-0069 Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems
EC 1 Mr. Dave Lowe Vol #: 1
2005D-0219 Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
EC 6 Miss. Melody Ruano Vol #: 1
2005D-0330 Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
C 45 Virginia Blood Services Vol #: 4
2005D-0337 Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque
EC 3 U.S. Food Vol #: 1
2005D-0483 Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
GDL 2 GUIDANCE Vol #: 1
NAD 2 FDA Vol #: 1
2005E-0233 Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
LET 4 HFD-5 to the U.S. Patent and Trademark Office Vol #: 1
2005E-0247 Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
LET 4 HFD-5 to the U.S. Patent and Trademark Office Vol #: 1
2005E-0249 Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
LET 4 HFD-5 to the U.S. Patent and Trademark Office Vol #: 1
2005E-0254 Patent Extension Application for ERBITUX, U.S. Patent No. 6,217,866
LET 4 HFD-5 to The U.S. Patent and Trademark Office Vol #: 1
2005E-0258 Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
LET 2 HFD-5 to the U.S. Patent and Trademark Office Vol #: 1
2005N-0120 Agency Information Collection Activities: Proposed Collection; Comment Request;
NAL 1 FDA Vol #: 1
SS 1 SUPPORTING STATEMENT Vol #: 1
2005N-0209 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substances Notification System
NAL 1 FDA Vol #: 1
SS 1 SUPPORTING STATEMENT Vol #: 1
2005N-0343 Agency Emergency Processing Under OMB Review; Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
CR 1 FUJI Natural Food, Inc. (FUJI) Vol #: 1
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
EC 407 Mrs. Griselda Stein Vol #: 5
EC 408 Mr. John Herald Vol #: 5
EC 409 Academy of Managed Care Pharmacy Vol #: 5
EC 410 Mr. Ray Paradise Vol #: 5
EC 411 Mrs. Barbara Miller Vol #: 5
EC 412 Mrs. Elsa Saccoccio Vol #: 5
EC 413 Ms. Audrey Greve Vol #: 5
EC 414 Mr. Roberto Pietrosanti Vol #: 5
EC 415 Mrs. Karen DeLuca Vol #: 5
EC 416 Mrs. Barbara Olson Vol #: 5
EC 417 Mr. Nino Bilic Vol #: 5
EC 418 Miss. Janine Allington Vol #: 5
EC 419 Dr. Joshua Dyme Vol #: 5
EC 420 Mr. Dave Lowe Vol #: 5
EC 421 Mrs. Tracie Jerling Vol #: 5
EC 422 Ms. Liz Peters Vol #: 5
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
C 5 J. Locke Vol #: 2
2005N-0413 Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
C 6 National Nutritional Foods Association (NNFA) Vol #: 2
TR 1 November 17, 2005 Transcript Vol #: 3
2005N-0416 Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
CR 1 HFS-400 to Mead Johnson Nutritionals Vol #: 1
LET 1 HF-21 to Mead Johnson Nutritionals Vol #: 1
2005N-0510 Anti-Counterfeit Drug Initiative Workshop and Vendor Display
NM 1 FDA Vol #: 1
2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
EC 185 Fredericksburg Anesthesia Associates Vol #: 3
EC 186 Anesthesia Vol #: 3
2005P-0319 Determination of PHENERGAN (Promethazine hydrochloride) 12.5mg and 50mg tablets
EC 1
Attachment
Mr. Dave Lowe Vol #: 1
EC 2
Attachment
Mr. Dave Lowe Vol #: 1
2005P-0352 bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
EC 1
Attachment
Mr. Dave Lowe Vol #: 2
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 232 J. Spaugh Vol #: 3
C 233 K. Lindsey Vol #: 3
C 234 Z. Bengali Vol #: 3
C 235 J. Lamphere Vol #: 3
C 236 J. Freeman Vol #: 3
C 237 B. Cleland Vol #: 3
C 238 C. Wunstiqu Vol #: 3
C 239 B. Haines Vol #: 3
C 240 K. Miller Vol #: 3
C 241 S. Gedda Vol #: 3
C 242 M. Grover Vol #: 3
C 243 L. Vardaman Vol #: 3
C 244 B. Bunton Vol #: 3
C 245 D. Caudill Vol #: 3
C 246 Steven E. Pillow, M.D., P.A., FACOG & Associates Vol #: 3
C 247 V. Huttna Vol #: 3
C 248 S. Baker Vol #: 3
C 249 J. High Vol #: 3
C 250 L. William Vol #: 3
C 251 K. White Vol #: 3
C 252 B. Grgurich Vol #: 3
C 253 D. Harper Vol #: 3
C 254 D. Landers Vol #: 3
EC 29 Mr. Nathan Jefferson Vol #: 4
EC 30 Mrs. Jeanne Dimidio Vol #: 4
EC 31 Mrs. Sandra Villagrana Vol #: 4
EC 32 I'm also and RN Vol #: 4
EC 33 Ms. Melissa Curran Vol #: 4
EC 34 DNA Pharmacy Services Vol #: 4
EC 35 Mr. Michael Anneken Vol #: 4
EC 36 Mrs. Deborah Hawes Vol #: 4
EC 37 Ms. Evelyn Alexander Vol #: 4
EC 38 Rebecca J. Roberts, D.O. Vol #: 4
EC 39 Mrs. Susan Spille Vol #: 4
EC 40 Mrs. Lisa Sowry Vol #: 4
EC 41 Mrs. Rita Daughery Vol #: 4
EC 42 Ms. Claudia Rocklin Vol #: 4
EC 43 Mrs. Pamela Detrick Vol #: 4
EC 44 Mrs. Kathy Metz Vol #: 4
EC 45 Ms. Raylana Anderson Vol #: 4
EC 46 Mrs. Kim Collings Vol #: 4
EC 47 Campbell Family Medicine Vol #: 4
EC 48 Mrs. Jessica Wuebker Vol #: 4
EC 49 Mrs. GINA BENNIS Vol #: 4
EC 50 Mrs. Catherine Richardson Vol #: 4
EC 51 Mr. Guy Cass Vol #: 4
EC 52 Ms. Mary Snider Vol #: 4
EC 53 Dr. Craig Jace Vol #: 4
EC 54 Dr. Lynn Leibowitz Vol #: 4
EC 55 Deines Pharmacy, Inc Vol #: 4
EC 56 Ms. marta strock Vol #: 4
EC 57 Mrs. Karen Lefkowitz Vol #: 4
EC 58 Mrs. Melanie Jakab Vol #: 4
EC 59 Mrs. Vicki Wright Vol #: 4
EC 60 Medical Lake Vol #: 4
EC 61 Mrs. Sally Sullenberger Vol #: 4
EC 62 Miss. Peggy Helmer Vol #: 4
EC 63 Mrs. Sue Bensadon Vol #: 4
EC 64 Mrs. Linda Cherry Vol #: 4
EC 65 Mrs. Marjorie Krofchok Krofchok Vol #: 4
EC 66 Ms. Kathleen Boyle Vol #: 4
EC 67 Ms. Margaret Fischel Vol #: 4
EC 68 Mrs. Krista Stump Vol #: 4
EC 69 Mrs. Donna Graves Vol #: 4
EC 70 Ms. Carol Kroening Vol #: 4
EC 71 Mrs. Kathleen Easton Vol #: 4
EC 72 Mrs. Janet Porges Vol #: 4
EC 73 Mrs. Dawn Hathaway Vol #: 4
EC 74 SELF/CONSUMERS Vol #: 4
EC 75 Mrs. Karla Evans Vol #: 4
EC 76 US citizen Vol #: 4
EC 77 Mrs. Shirley Slaughter Vol #: 4
EC 78 Ms. Diana Jacobsen Vol #: 4
EC 79 Dr. Janice Pemberton Vol #: 4
EC 80 Ms. Carolyn Wiant Vol #: 4
EC 81 Ms. Carolyn Wiant Vol #: 4
EC 82 Mrs. candace hamood Vol #: 4
EC 83 Ontario Pharmacy Vol #: 4
EC 84 Mrs. Scotti Nieukirk Vol #: 4
EC 85 Ms. Suzanne Kostic Vol #: 4
EC 86 Ms. Andrea McCaffrey Vol #: 4
EC 87 Ms. Glenda Maier Vol #: 4
EC 88 Mrs. Paula Cook Vol #: 4
EC 89 Mrs. Barbara Klimek Vol #: 4
EC 90 Mrs. TAMMIE MOURADIAN Vol #: 4
EC 91 none Vol #: 4
EC 92 Miss. Lisa Denny Vol #: 4
EC 93 Mrs. Rayne Bordon Vol #: 4
EC 94 National Pharmacy Specialties Vol #: 4
EC 95 Ms. Diane DeVinney Vol #: 4
EC 96 Mrs. Janet Smith Vol #: 4
EC 97 Ms. a.m. angarola Vol #: 4
EC 98 Mrs. Shirley Harrison Vol #: 4
EC 99 Doane College Vol #: 4
EC 100 ElderWise Advocate Vol #: 4
EC 101 Mrs. Chris Lohry Vol #: 4
EC 102 Mrs. Joanne Allen Vol #: 4
EC 103 Mrs. Judy Schulz Vol #: 4
EC 104 Ms. Jennifer Huxoll Vol #: 4
EC 105 Mrs. Rosetta Mullen Vol #: 4
EC 106 Mrs. Rosetta Mullen Vol #: 4
EC 107 Mrs. Amy McCord Vol #: 4
EC 108 Ms. Helen Harrington Vol #: 4
EC 109 Ms. Susan Sorkenn Vol #: 4
EC 110 Mrs. Sara Hart Vol #: 4
EC 111 Mrs. Connie Watson Vol #: 4
EC 112 Ms. Melissa Folsom Vol #: 4
EC 113 Miss. Sheila Bachelor Vol #: 4
EC 114 Mrs. Lisa Thomas-Scheel Vol #: 4
EC 115 Mrs. Marcia Pomeroy Vol #: 4
EC 116 Mrs. Wanda McNally Vol #: 4
EC 117 Mrs. Rita Christopher Vol #: 4
EC 118 Ms. Amy Kelley Vol #: 4
EC 119 Mrs. Linda REason Vol #: 4
EC 120 None Vol #: 4
EC 121 Mrs. Joanne Prater Vol #: 4
EC 122 Mrs. Alice Dinicola Vol #: 4
EC 123 Mr. Scott Walsh Vol #: 4
EC 124 Mr. Scott Walsh Vol #: 4
EC 125 Ms. Nancy Sorensen-Kimmons Vol #: 4
EC 126 None Vol #: 4
EC 127 Mrs. Janet Divitto Vol #: 4
EC 128 Mrs. Earlene Steele-Pridemore Vol #: 4
EC 129 Mrs. Cyndi Lepine Vol #: 4
EC 130 Miss. Karen Fletcher Vol #: 4
EC 131 Ms. Merri McLaughlin Vol #: 4
EC 132 Mrs. sharon King Vol #: 4
EC 133 Mrs. Amy Blum Vol #: 4
EC 134 Ms. Jan Hemmerling Vol #: 4
EC 135 Ms. Wendy Hannigan Vol #: 4
EC 136 Mrs. Deborah Rumford Vol #: 4
EC 137 Ms. Roslyn Cohen Vol #: 4

Page created on January 26, 2006 RSC

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