| | | | | | | | | | |
|
|
| Dockets
Entered On February 19, 2004
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1993D-0398
|
| Microbiological Testing Antimicrobial Drug Residues in Foods
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| 2003N-0136
|
| Adoption of FDA Food Code by Local,State,and Tribal Governme
|
|
|
| 2003N-0164
|
| Mid-Year Stakeholder Meeting on the Implementation of MDUFMA Provisions
|
|
|
| 2003N-0360
|
| Agency Info Collection: Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
|
|
|
| 2003N-0456
|
| Agency Information Collection:Prevention of Medical Gas Mix-ups at Health Care Facilities
|
|
|
| 2003N-0483
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Food Labeling Regulations
|
|
|
| 2003Q-0559
|
| Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
|
|
|
| 2004D-0001
|
| Global Harmonization Task Force, Study Group 1, 2, 3 and 4; New Proposed and Final Documents; Availability
|
|
|
| 2004D-0035
|
| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
|
|
|
| 2004F-0066
|
| Filing of Food Additive Petition (FAP 4A4754) permit the manufacture of mannitol by fermentation of sugars such as fructose, glucose, or maltose by the action of the microorganism Lactobacillus interm
|
|
|
|
| 2004N-0034
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Current Good Manufacturing Practice Quality System Regulation
|
|
|
| 2004N-0045
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Health and Diet Survey b
|
|
|
| 2004N-0047
|
| Determination That Chlorthalidone Tablets and Seven Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectivenes
|
|
|
| 2004N-0049
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
| 2004N-0050
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
|
|
|
| 2004P-0006
|
| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
|
|
|
| 1993D-0398
|
| Microbiological Testing Antimicrobial Drug Residues in Foods
|
|
|
| GDL
2
|
| Guideline
|
| Vol #:
|
| 1
|
|
|
| NAD
4
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET
12723
|
| BioCell Technology, LLC
|
| Vol #:
|
| 103
|
|
|
| LET
12724
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 103
|
|
|
| LET
12725
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 103
|
|
|
| LET
12726
|
| Enzymatic Theapy Natural Medicines
|
| Vol #:
|
| 103
|
|
|
| LET
12727
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 103
|
|
|
| LET
12728
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 103
|
|
|
| LET
12729
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 103
|
|
|
| LET
12730
|
| Muscle Tech Research and Development, Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12731
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 103
|
|
|
| LET
12732
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 103
|
|
|
| LET
12733
|
| Perrifo Company of South Carolina
|
| Vol #:
|
| 103
|
|
|
| LET
12734
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 103
|
|
|
| LET
12735
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 103
|
|
| | | | | | | | |
|
|
| LET
12736
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 103
|
|
|
| LET
12737
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 103
|
|
|
| LET
12738
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 103
|
|
|
| LET
12739
|
| Avon Products, Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12740
|
| Avon Products, Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12741
|
| Herb Pharm
|
| Vol #:
|
| 103
|
|
|
| LET
12742
|
| Herb Pharm
|
| Vol #:
|
| 103
|
|
|
| LET
12743
|
| Herb Pharm
|
| Vol #:
|
| 103
|
|
|
| LET
12744
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 103
|
|
|
| LET
12745
|
| Adeeva Nutritionals Canada Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12746
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 103
|
|
|
| LET
12747
|
| Smooth Sailing Company
|
| Vol #:
|
| 103
|
|
|
| LET
12748
|
| Lignan Research
|
| Vol #:
|
| 103
|
|
|
| LET
12749
|
| Muscle Tech Research and Development, Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12750
|
| Semd LLC
|
| Vol #:
|
| 103
|
|
|
| 2003N-0136
|
| Adoption of FDA Food Code by Local,State,and Tribal Governme
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003N-0164
|
| Mid-Year Stakeholder Meeting on the Implementation of MDUFMA Provisions
|
|
|
| NM 1
|
| Number not used
|
| Vol #:
|
| 1
|
|
|
| 2003N-0360
|
| Agency Info Collection: Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003N-0456
|
| Agency Information Collection:Prevention of Medical Gas Mix-ups at Health Care Facilities
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003N-0483
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Food Labeling Regulations
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003Q-0559
|
| Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
|
|
|
| C
1
|
| The Soyfoods Council
|
| Vol #:
|
| 5
|
|
|
| EMC
1
|
| ACH Food Companies Inc
|
| Vol #:
|
| 5
|
|
|
| EMC
2
|
| Institute of Shortening and Edible Oils Inc
|
| Vol #:
|
| 5
|
|
|
| 2004D-0001
|
| Global Harmonization Task Force, Study Group 1, 2, 3 and 4; New Proposed and Final Documents; Availability
|
|
|
| BKG 1
|
| Background Material for
Study Groups 1 - 4
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2004D-0035
|
| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
|
|
|
| GDL
1
|
| Guideline
|
| Vol #:
|
| 1
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004F-0066
|
| Filing of Food Additive Petition (FAP 4A4754) permit the manufacture of mannitol by fermentation of sugars such as fructose, glucose, or maltose by the action of the microorganism Lactobacillus interm
|
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0034
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Current Good Manufacturing Practice Quality System Regulation
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0045
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Health and Diet Survey b
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0047
|
| Determination That Chlorthalidone Tablets and Seven Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectivenes
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0049
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0050
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
|
|
|
| BKG 1
|
| Clariant GmbH
|
| Vol #:
|
| 1
|
|
|
| LET 1
|
| HFD-560 to Keller & Heckman
|
| Vol #:
|
| 1
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004P-0006
|
| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
|
|
|
| RC
2
|
| Purdue Pharma LP
|
| Vol #:
|
| 2
|
|