Dockets

2004N-0337

Subpart D IRB Referral, Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder; a Functional Magnetic Resonance Study (Updated 9/15/04)

Scientific Considerations Related to Developing Follow-on Protein Products (New 10/05/04)

Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients (Updated 9/15/04)

Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles (New 10/05/04)

Amend Food Additive Regulations in 172.380 Vitamin D3 to Permit the Use of Vitamin D3 in Cheese and Cheese Products at a Level Above That Permitted Under 184.1950 Vitamin D (New 10/05/04)

Notice Announcing Publication of the Report to Congress Entitled "Plan for the Transfer of Responsibility for Medicare Appeals" and Soliciting Comments (New 8/09/04)

Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed with, or Otherwise Containing Material from Cattle (New 10/04/04)

Stimulating Innovation in Medical Technologies(Updated 9/15/04)

Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(F) B (Updated 9/15/04)

Public Information Regulations (New 10/25/04)

Pandemic Influenza Preparedness and Response Plan (New 9/21/04)

Guidance: Clinical Trial Design for Hip Replacement Systems (New 5/10/04)

Qualified Health Claim (QHC); Lycopene, Tomatoes and Cancer (Updated 7/01/04)

Nutrient Content Claim: Expand the Definition of Lean (New 4/27/04)

Critical Path Initiative (New 9/8/04)

Qualified Health Claim (QHC): Chromium Picolinate and Diabetes (Updated 10/19/04)

Part II, Electronic Record; Electronic Signatures; Public Meeting (Updated 9/13/04)

Prescription Drug Importation; Public Meeting (Updated 7/13/04)

Nutrient Content Claim: Carbohydrate Content in Food (Grocery Manufactures of America) (New 3/12/04)

Nutrient Content Claim: Carbohydrate Content in Food (ConAgra Foods) (New 3/1/04)

Nutrient Content Claim: Carbohydrate Content in Food (Kraft Foods North America Inc) (New 3/12/04)

Qualified Health Claim (QHC): Calcium and Kidney/Urinary Stones (Updated 10/19/04)

Qualified Health Claim (QHC): Calcium and Bone Fractures (Updated 10/25/04)

Qualified Health Claim (QHC): Calcium and Menstrual Disorders (Updated 10/25/04)

Qualified Health Claim (QHC): Calcium and Hypertension (New 10/25/04)

Qualified Health Claim (QHC): Calcium and Various Cancers (Updated 10/21/04)

Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cancer (Updated 4/12/04)

Qualified Health Claim (QHC) for Eggs with Enhanced Omega-3 Fatty Acid Content and a Balanced 1:1 Ratio of Omega-3/Omega-6 Fatty Acids and reduced risk of heart disease and sudden fatal heart attack (Updated 5/25/04)

Health Claim Petition: Glucosamine Sulfate and Osteoarthritis

Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis (New 10/25/04)