| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On May 8, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0301H
|
| External Analgesic Drug Products for OTC Human Use
|
|
|
|
|
| 1995P-0048
|
| Treatment & prevention of Nocturnal Leg Muscle Cramp for OTC
|
|
|
|
|
| 2001V-0157
|
| Slick Productions laser light show with Lasergraphix Lgx-1000 Ar Projector
|
|
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| 2004P-0448
|
| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
|
|
|
|
|
| 2006D-0169
|
| Guidance for Industry: Guidance on the labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Availability
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| 2006P-0484
|
| Change the indication for Stimulant Medications for the Treatment of Mental Diseases
|
|
|
|
|
| 2006P-0498
|
| Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
|
|
|
|
|
| 2006P-0535
|
| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
|
|
|
|
|
| 2007D-0027
|
| Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
|
|
|
|
|
| 2007N-0026
|
| Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
|
|
|
|
|
| 2007N-0051
|
| Safety of Fresh Produce; Public Hearings
|
|
|
|
|
| 2007N-0053
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations
|
|
|
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
|
|
|
|
| 2007N-0123
|
| Amlodipine Abbreviated New Drug Application Approvals
|
|
|
|
|
| 2007P-0004
|
| Take steps to insure the safety of Americans regarding the misuses of Lasik
|
|
|
|
|
| 2007P-0033
|
| Amend the Nutrition Facts label on food products as it relates to trans fats
|
|
|
|
|
| 2007P-0047
|
| Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
|
|
|
|
|
| 2007P-0059
|
| Withdrawal of New Animal Drug Application for Posilac - Rombinant Bovine Growth Hormone (rBGH)
|
|
|
|
|
| 2007P-0065
|
| To increase print size of direct-to-consumer advertisements
|
|
|
|
|
| 2007P-0074
|
| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
|
|
|
|
|
| 2007P-0079
|
| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
|
|
|
|
|
| 2007P-0094
|
| Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the- counter
|
|
|
|
|
|
|
|
|
| 2007P-0110
|
| To enforce pediatric exclusivity rights for amlodipine
|
|
|
|
|
| 2007P-0111
|
| Stay approval of any and all supplements to Lotrel concerning amlodipine and pediatric exclusivity
|
|
|
|
|
| 2007P-0149
|
| Canned Pacific Salmon Deviating From Identity Standard; Temporary Permit for Market Testing
|
|
|
|
|
| 2007P-0150
|
| Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing
|
|
| |
|
| 1978N-0301H
|
| External Analgesic Drug Products for OTC Human Use
|
|
|
|
|
| BKG 1
|
| Background Information
|
| Vol #:
|
| 2
|
|
| |
|
| 1995P-0048
|
| Treatment & prevention of Nocturnal Leg Muscle Cramp for OTC
|
|
|
|
|
| WDL 1
|
| Kirkpatrick & Lockhart Preston Gates Ellis
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001V-0157
|
| Slick Productions laser light show with Lasergraphix Lgx-1000 Ar Projector
|
|
|
|
|
| EXP 2
|
| Slick Porductions
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| C 935
|
| B. NARITA
|
| Vol #:
|
| 67
|
|
|
|
|
| 2004P-0448
|
| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
|
|
|
|
|
| AMD 2
|
| Hill Dermaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2006D-0169
|
| Guidance for Industry: Guidance on the labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Availability
|
|
|
|
|
| EC 3
|
| Mrs. C Remillard
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| Ms. charisse Texeira
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| TR 1
|
| Transcript of the 2/8/07 Public Meeting
|
| Vol #:
|
| 4
|
|
|
|
|
| 2006P-0484
|
| Change the indication for Stimulant Medications for the Treatment of Mental Diseases
|
|
|
|
|
| EC 6
|
| Mrs. Mary Pof McDole
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 7
|
| Mrs. Mary Poff McDole
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 8
|
| Ms. Eulena Cox
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 9
|
| Mrs. Mary Poff McDole
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0498
|
| Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
| |
|
|
|
| C 92
|
| A Hoffman
|
| Vol #:
|
| 1
|
|
|
|
|
| C 93
|
| A Wagner
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| Mr. John F Jones
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 5
|
| school nurse
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 6
|
| Mothers Against Slime
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 7
|
| Mr. GW Seals
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 8
|
| Mr. Chris Hughes
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 9
|
| Mr. daniel motta
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0535
|
| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
|
|
|
|
|
| EC 33
|
| Blue Valley School District
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 34
|
| Mrs. Alicia Higginbotham
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 35
|
| Mr. robert gaulding
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 36
|
| Mrs. Sabrina K. Hendrix
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 37
|
| Mr. Tmothy Geib
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 38
|
| Ms. alexandra biedermann
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 39
|
| Ms. Jennifer Pan
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 40
|
| SafeMinds
|
| Vol #:
|
| 3
|
|
| |
|
| 2007D-0027
|
| Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
|
|
| | | | | | | | |
|
| |
|
| EC 2
|
| National Grain and Feed Association
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| Mrs. Caroline Wayne
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0026
|
| Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
|
|
|
|
|
| EC 1
|
| Mr. Remek Kocz
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0051
|
| Safety of Fresh Produce; Public Hearings
|
|
|
|
|
| TR 1
|
| Transcript of 3/20/07 Public Hearing
|
| Vol #:
|
| 4
|
|
|
|
|
| 2007N-0053
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations
|
|
|
|
|
| EC 1
|
| Mrs. C Remillard
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
|
|
|
|
| EAPE 149
|
| Morgan, Laura
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 150
|
| Mazzoni, Jennifer
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 151
|
| Audet, Craig
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 152
|
| Hobbs, Nielsen
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 153
|
| Mehta, Mukesh
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 154
|
| LaMoy, Joe
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0123
|
| Amlodipine Abbreviated New Drug Application Approvals
|
|
|
|
|
| ANS 1
|
| FDA/CDER/OGD to Apotex Corp.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2007P-0004
|
| Take steps to insure the safety of Americans regarding the misuses of Lasik
|
|
|
|
|
| EC 2
|
| Ms. Caroline Miles
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0033
|
| Amend the Nutrition Facts label on food products as it relates to trans fats
|
|
|
|
|
| EC 4
|
| Mr. Robert McCune
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 5
|
| Mrs. Christine Heron
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 6
|
| na
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 7
|
| Mrs. Mary O'Brien
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 8
|
| Mrs. Angela Altimus
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 9
|
| Mr. Aaron Peterson
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 10
|
| Mr. Steven Opresnick
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 11
|
| Mr. John Riordan
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 12
|
| N/A
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 13
|
| Bose Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 14
|
| Ms. Barbara Brown
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0047
|
| Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
|
|
| | | | | | | | |
|
| |
|
| EC 1
|
| Mrs. Julie Casey
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0059
|
| Withdrawal of New Animal Drug Application for Posilac - Rombinant Bovine Growth Hormone (rBGH)
|
|
|
|
|
| EC 1
|
| Ms. Kyrie Collins
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Mrs. A Chait
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| Ms. Cheryl Jones
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| Ms. lavina Wetterberg
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 5
|
| n/a
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 6
|
| Mr. Mark Wachowiak
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 7
|
| Mrs. s Hellige
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 8
|
| Ms. Caroline Miles
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0065
|
| To increase print size of direct-to-consumer advertisements
|
|
|
|
|
| EC 1
|
| Bose Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Ms. charisse Texeira
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| Ms. Caroline Miles
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0074
|
| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
|
|
|
|
|
| EC 3
|
| Ms. Jane Bryant
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0079
|
| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
|
|
|
|
|
| EC 2
|
| Ms. Franni Ferrero
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| Mrs. April Keating
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0094
|
| Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the-counter
|
|
|
|
|
|
| |
|
|
|
| EC 1
|
| Mr. Jared Barrett
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Mrs. Woody Baker
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| Mr. Robert Cannon
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| Teacher
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 5
|
| Ms. Susan England
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 6
|
| Mrs. Lorrie Shorney
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 7
|
| Ms. Stephanie Olmstead-Dean
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 8
|
| Ms. M O'Leary
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 9
|
| Ms. Theresa Billotti
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 10
|
| Ms. Cybele May
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0110
|
| To enforce pediatric exclusivity rights for amlodipine
|
|
|
|
|
| EC 1
|
| Novartis Pharmaceuticals Corporation
|
| Vol #:
|
| 1
|
|
