| | | | | | | | | | |
| |
|
|
| Dockets Entered
On May 18, 2007
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1999V-0190
|
| Variance Laser Light Show LSD110XL MRAK10 & MRAK250
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
| |
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
| |
|
|
| 2004E-0398
|
| Patent Extension for IRESSA (gefitinib), U.S. Patent No. 5,770,599
|
| |
|
|
| 2005D-0468
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
|
| |
|
|
| 2005E-0248
|
| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
|
| |
|
|
| 2006D-0079
|
| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
|
| |
|
|
| 2006D-0172
|
| Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54 : Additional Safeguards for Children in Clinical Investigations
|
|
|
|
|
|
| 2006D-0301
|
| Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waivers and Reductions
|
| |
|
|
| 2006D-0303
|
| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
|
| |
|
|
| 2006D-0451
|
| Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers
|
| |
|
|
| 2006D-0514
|
| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
|
| |
|
|
| 2006D-0515
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
|
| |
|
|
| 2006E-0259
|
| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
|
| |
|
|
| 2006E-0501
|
| Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
|
| |
|
|
| 2006E-0502
|
| Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
|
| |
|
|
| 2006N-0292
|
| Unique Device Identification
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| 2007D-0166
|
| Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products, VICH GL-43
|
| |
|
|
| 2007E-0046
|
| Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
|
| |
|
|
| 2007P-0203
|
| Abbreviated New Drug Application (ANDA) Suitability for Memantine Hydrochloride Orally Disintegrating Tablets 5 mg and 10 mg
|
|
| |
|
| 1999V-0190
|
| Variance Laser Light Show LSD110XL MRAK10 & MRAK250
|
| |
|
|
| VRA 4
|
| FDA/CDRH to Artistic Laser Productions
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| EREG 1
|
| L. Stone
|
| Vol #:
|
| 95
|
| |
|
|
| EREG 2
|
| E. Joiner
|
| Vol #:
|
| 95
|
| |
|
|
| EREG 3
|
| A. Lesch
|
| Vol #:
|
| 95
|
| |
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
| |
|
|
| EC 20
|
| Mr. s westbrooks
|
| Vol #:
|
| 2
|
| |
|
|
| EC 21
|
| none
|
| Vol #:
|
| 2
|
|
| |
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
| |
|
|
| EC 8
|
| BSN, RN (retired)
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2004E-0398
|
| Patent Extension for IRESSA (gefitinib), U.S. Patent No. 5,770,599
|
| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0468
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
|
| |
|
|
| EC 4
|
| Ms. charisse texeira
|
| Vol #:
|
| 1
|
|
| |
|
| 2005E-0248
|
| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
|
| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0079
|
| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
|
| |
|
|
| EC 6
|
| Ms. Elizabeth Greene
|
| Vol #:
|
| 1
|
| |
|
|
| EC 7
|
| Mr. Ken Youngblood
|
| Vol #:
|
| 1
|
| |
|
|
| EC 8
|
| Miss. L Franke
|
| Vol #:
|
| 1
|
| |
|
|
| EC 9
|
| none
|
| Vol #:
|
| 1
|
| |
|
|
| EC 10
|
| Ms. Kim Eyring
|
| Vol #:
|
| 1
|
| |
|
|
| EC 11
|
| Mr. Michael Damato
|
| Vol #:
|
| 1
|
| |
|
|
| EC 12
|
| Mr. Matt Ballotti
|
| Vol #:
|
| 1
|
| |
|
|
| EC 13
|
| Mr. GW Seals
|
| Vol #:
|
| 1
|
| |
|
|
| EC 14
|
| logical parent
|
| Vol #:
|
| 1
|
| |
|
|
| EC 15
|
| Mrs. Elizabeth Zirkle
|
| Vol #:
|
| 1
|
| |
|
|
| EC 16
|
| Mrs. SHELLIE BELL
|
| Vol #:
|
| 1
|
| |
|
|
| EC 17
|
| College Of The Siskiyous
|
| Vol #:
|
| 1
|
| |
|
|
| EC 18
|
| Mr. Michael Sertich
|
| Vol #:
|
| 1
|
| |
|
|
| EC 19
|
| Mr. JD Cogmon
|
| Vol #:
|
| 1
|
| |
|
|
| EC 20
|
| Mr. Escott Moss
|
| Vol #:
|
| 1
|
| |
|
|
| EC 21
|
| Mr. Andrew Houlihan
|
| Vol #:
|
| 1
|
| |
|
|
| EC 22
|
| Ms. Jennifer Bothell
|
| Vol #:
|
| 1
|
| |
|
|
| EC 23
|
| Mr. Joseph Dobrozsi
|
| Vol #:
|
| 1
|
| |
|
|
| EC 24
|
| Ms. Elizabeth Shaw
|
| Vol #:
|
| 1
|
| |
|
|
| EC 25
|
| Ms. Valerie Berg
|
| Vol #:
|
| 1
|
| |
|
|
| EC 26
|
| Mr. Gordon Kress
|
| Vol #:
|
| 1
|
| |
|
|
| EC 27
|
| Miss. Stephanie Jovani
|
| Vol #:
|
| 1
|
| |
|
|
| EC 28
|
| Miss. jane m
|
| Vol #:
|
| 1
|
| |
|
|
| EC 29
|
| Dr. Kirby Ram
|
| Vol #:
|
| 1
|
| |
|
|
| EC 30
|
| Mr. roy stubbs
|
| Vol #:
|
| 1
|
| |
|
|
| EC 31
|
| Mr. Charles Larkin
|
| Vol #:
|
| 1
|
| |
|
|
| EC 32
|
| Mr. Mike Jones
|
| Vol #:
|
| 1
|
| |
|
|
| EC 33
|
| Mr. phillip lee
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EC 34
|
| Mr. VICTOR RODRIGUEZ
|
| Vol #:
|
| 1
|
| |
|
|
| EC 35
|
| American
|
| Vol #:
|
| 1
|
| |
|
|
| EC 36
|
| Mr. Aaron Acker
|
| Vol #:
|
| 1
|
| |
|
|
| EC 37
|
| Mr. Arsalan Pourmand
|
| Vol #:
|
| 1
|
| |
|
|
| EC 38
|
| Mr. Jason Kaloudis
|
| Vol #:
|
| 1
|
| |
|
|
| EC 39
|
| Mr. Brad Putrycus
|
| Vol #:
|
| 1
|
| |
|
|
| EC 40
|
| Mr. Jesse Harding
|
| Vol #:
|
| 1
|
| |
|
|
| EC 41
|
| Ms. Elaine Kyle
|
| Vol #:
|
| 1
|
| |
|
|
| EC 42
|
| Mrs. amy murphy
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0172
|
| Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54 : Additional Safeguards for Children in Clinical Investigations
|
|
|
|
|
|
| | |
|
|
| EC 3
|
| Ms. charisse texeira
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0301
|
| Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waivers and Reductions
|
| |
|
|
| EC 1
|
| logical parent
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0303
|
| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
|
| |
|
|
| EC 16
|
| Ms. Marian Puglia
|
| Vol #:
|
| 1
|
| |
|
|
| EC 17
|
| a brand new kind of dinasaur
|
| Vol #:
|
| 1
|
| |
|
|
| EC 18
|
| Dyco Assoc., Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0451
|
| Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers
|
| |
|
|
| EC 2
|
| none
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| Ms. Janet Rininger
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| Dr. Mark Raintree
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| Ms. Carol Clayton
|
| Vol #:
|
| 1
|
| |
|
|
| EC 6
|
| Mr. Rene Baudisch
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0514
|
| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
|
|
|
|
|
|
| | |
|
|
| EC 3
|
| Biosafe SA
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| Biosafe SA
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| Cryobanks International, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 6
|
| Case Western Reserve University
|
| Vol #:
|
| 1
|
| |
|
|
| EC 7
|
| AABB
|
| Vol #:
|
| 1
|
| |
|
|
| EC 8
|
| AABB Interorganization Work Grop
|
| Vol #:
|
| 1
|
| |
|
|
| EC 9
|
| Community Blood Services
|
| Vol #:
|
| 1
|
| |
|
|
| EC 10
|
| Duke University Medical Center
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EC 11
|
| Duke University Medical Center
|
| Vol #:
|
| 1
|
| |
|
|
| EC 12
|
| Duke University Medical Center
|
| Vol #:
|
| 1
|
| |
|
|
| EC 13
|
| Michigan Community Blood Centers
|
| Vol #:
|
| 1
|
| |
|
|
| EC 14
|
| ViaCell
|
| Vol #:
|
| 1
|
| |
|
|
| EC 15
|
| American Society for Blood and Marrow Transplantat
|
| Vol #:
|
| 1
|
| |
|
|
| EC 16
|
| New York Blood Center
|
| Vol #:
|
| 1
|
| |
|
|
| EC 17
|
| StemCyte International Cord Blood Center
|
| Vol #:
|
| 1
|
| |
|
|
| EC 18
|
| StemCyte International Cord Blood Center
|
| Vol #:
|
| 3
|
| |
|
|
| EC 19
|
| StemCyte International Cord Blood Center
|
| Vol #:
|
| 3
|
| |
|
|
| 2006D-0515
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
|
| |
|
|
| EC 1
|
| Brand new kind of dinasaur
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Ms. charisse texeira
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0259
|
| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
|
| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0501
|
| Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
|
| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0502
|
| Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
|
| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0292
|
| Unique Device Identification
|
| |
|
|
| C 29
|
| Grandview Medical Center
|
| Vol #:
|
| 8
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| C 93
|
| B Keslinger
|
| Vol #:
|
| 7
|
| |
|
|
| 2007D-0166
|
| Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products, VICH GL-43
|
| |
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0046
|
| Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
|
| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0203
|
| Abbreviated New Drug Application (ANDA) Suitability for Memantine Hydrochloride Orally Disintegrating Tablets 5 mg and 10 mg
|
| |
|
|
| ACK 1
|
| FDA / DDM to Orgenus Pharma, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Orgenus Pharma, Inc.
|
| Vol #:
|
| 1
|
|
|
