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| Dockets Entered
On November 17, 2005
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998D-0834
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| Non-Contraceptive Estrogen Class Labeling
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| 1999D-1540
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| Reviewers on Evaluation of Human Pregnancy Outcome Data
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0161
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| Medical Devices;Reprocessed Single-Use Devices;Termination
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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| 2004D-0378
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| International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| 2005D-0312
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| Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
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| 2005D-0334
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| Guidance for Industry on the Pediatric Research Equity Act
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| 2005D-0337
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque
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| 2005D-0348
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| Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order
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| 2005D-0385
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| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| 2005D-0412
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| Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicle
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0375
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| Stakeholder Meeting on the Implementation of a New Direction for Radiological Health Program; Public Meeting
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005N-0404
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| Solicitation of Public Review and Comment on Research Protocol:
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0433
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| Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
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| 2005P-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16898
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| Enzymatic Therapy
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| Vol #:
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| 152
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| LET
16899
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| Enzymatic Therapy
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| Vol #:
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| 152
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| LET
16900
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| Enzymatic Therapy
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| Vol #:
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| 152
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| LET
16901
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| Enzymatic Therapy
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| Vol #:
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| 152
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| LET
16902
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| Enzymatic Therapy
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| Vol #:
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| 152
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| LET
16903
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| Iovate Health Sciences U.S.A. Inc.
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| Vol #:
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| 152
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| LET
16904
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| Iovate Health Sciences U.S.A. Inc.
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| Vol #:
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| 152
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| LET
16905
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| Iovate Health Sciences U.S.A. Inc.
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| Vol #:
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| 152
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| LET
16906
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| DiaPro
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| Vol #:
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| 152
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| LET
16907
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| Pure Encapsulations
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| Vol #:
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| 152
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| 1998D-0834
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| Non-Contraceptive Estrogen Class Labeling
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| EMC 3
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| B. Sachau
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| Vol #:
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| 5
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| 1999D-1540
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| Reviewers on Evaluation of Human Pregnancy Outcome Data
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| EC
1
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| Mrs. kim salzwedel
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| Vol #:
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| 7
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| EC 1
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| Ms. Joan Fry
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| Vol #:
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| 1
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1159
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| D. Feinberg
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| Vol #:
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| 11
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| 2003N-0161
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| Medical Devices;Reprocessed Single-Use Devices;Termination
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| EC
4
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| Instituto de salud publica
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| Vol #:
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| 1
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| EMC 77
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| C. LaRue
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| Vol #:
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| 2
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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| EC
4
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| Mrs. k salz
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| Vol #:
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| 2
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| 2004D-0378
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| International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
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| EC
4
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| Mrs. kim salzwedel
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| Vol #:
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| 1
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| EC
1
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| Princeton University
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| Vol #:
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| 1
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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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| EC
2
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| Mrs. Patricia Taylor
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| Vol #:
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| 1
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| EC
3
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| Ms. Susan Keller
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| Vol #:
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| 1
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| EC
4
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| Miss. Dana Kilian
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| Vol #:
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| 1
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| EC
5
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| Mrs. Marni Bregman Reinhardt
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| Vol #:
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| 1
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| EC
6
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| Ms. Dona DeZube
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| Vol #:
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| 1
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| EC
7
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| Miss. Kristianna Acevedo
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| Vol #:
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| 1
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| LET
18
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| Fleminger Inc.
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| Vol #:
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| 8
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| 2005D-0312
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| Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
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| EC
1
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| Abbott
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| Vol #:
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| 1
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| 2005D-0334
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| Guidance for Industry on the Pediatric Research Equity Act
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| EC
2
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| Pharm Res & Mfrs of America
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| Vol #:
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| 1
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| EC
3
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| AstraZeneca
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| Vol #:
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| 1
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| EC
4
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| Division of AIDS, NIAID, NIH
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| Vol #:
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| 1
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| EC
5
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| Mrs. kim salzwedel
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| Vol #:
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| 1
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| 2005D-0337
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque
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| EC
2
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| Mr. Rob Gerlach
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| Vol #:
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| 1
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| 2005D-0348
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| Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order
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| EC
2
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| Advanced Medical Technology Association
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| Vol #:
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| 1
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| |
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| 2005D-0385
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| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
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| EC
3
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| Kezzler
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| Vol #:
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| 1
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| EC
1
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| Advanced Medical Technology Association
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| Vol #:
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| 1
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| 2005D-0412
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| Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicle
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| EC
2
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| Mrs. kim salzwedel
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| Vol #:
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| 1
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| EC
9
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| Mrs. kim salzwedel
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| Vol #:
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| 3
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| EMC 462
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| U.S. House of Representatives
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| Vol #:
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| 165
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| EREG
24
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| Food and Drug Administration
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| Vol #:
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| 97
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| EREG 25
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| citizen
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| Vol #:
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| 97
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| EC
7
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| Consumers Union
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| Vol #:
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| 4
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| EC
8
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| Consultor
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| Vol #:
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| 4
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| | | | | | | | |
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| EC
9
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| Prescription Access Litigation, Community Catalyst
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| Vol #:
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| 4
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| EMC 73
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| S. Hill
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| Vol #:
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| 4
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| 2005N-0375
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| Stakeholder Meeting on the Implementation of a New Direction for Radiological Health Program; Public Meeting
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| EC
1
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| none
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| Vol #:
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| 1
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|
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| APE 12
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| Planned Parenhood
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| Vol #:
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| 1
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| 2005N-0404
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| Solicitation of Public Review and Comment on Research Protocol:
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| EC
5
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| Dr. Susan Weiner
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| Vol #:
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| 1
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| EC
2
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| Ms. Marie Cowie
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| Vol #:
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| 1
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| EC
3
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| U.S. House of Representatives
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| Vol #:
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| 1
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| C
76
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| Montgomery Anesthesia Associates, P.C.
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| Vol #:
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| 20
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| C
77
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| Montgomery Anesthesia Associates, P.C.
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| Vol #:
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| 20
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| EC
154
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| University of Virginia
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| Vol #:
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| 3
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| EC
155
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| Dr. Silver Dwinell
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| Vol #:
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| 3
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| EC
156
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| University of Virginia Health System
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| Vol #:
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| 3
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| EC
157
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| University of Virginia
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| Vol #:
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| 3
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| EC
158
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| University of Virginia, Dept of Anesthesiology
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| Vol #:
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| 3
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| EC
159
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| Dr. Reuben Wechsler
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| Vol #:
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| 3
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| EC
160
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| Dr. Steven Feldstein
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| Vol #:
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| 3
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| EC
161
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| Dr. Steven Feldstein
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| Vol #:
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| 3
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| EC
162
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| New Milford Hospital
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| Vol #:
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| 3
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| EC
163
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| University of Virginia
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| Vol #:
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| 3
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| EC
164
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| Mrs. Terri Brothers
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| Vol #:
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| 3
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| EC
165
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| Dr. Ali Afrassiabi
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| Vol #:
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| 3
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| EC
166
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| University of Virginia
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| Vol #:
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| 3
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| EC
167
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| Dr. viola devany
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| Vol #:
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| 3
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| EC
168
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| Dr. Hasmukh Patel
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| Vol #:
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| 3
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| EC
169
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| Dr. Shital Patel
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| Vol #:
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| 3
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| EC
170
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| AMERICAN SOCIETY OF ANESTHESIOLOGISTS
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| Vol #:
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| 3
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| EC
171
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| Dr. Scott Schartel
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| Vol #:
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| 3
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| EC
172
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| Dr. Rodger Barnette
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| Vol #:
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| 3
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| EC
173
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| Mr. Jeff Fryer
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| Vol #:
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| 3
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