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