Recently Issued US Federal Register
 

New! 
Your source for outsourcing.  Turn to Covidien Pharmaceuticals Outsourcing for high quality, service focused contract manufacturing.
 

1. Notice: Guidance for Industry on Labeling Over-the-Counter Human Drug Products--Questions and Answers; Availability
    
2. Notice: Training Program for Regulatory Project Managers; Information Available to Industry
    
3. Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Assay Migration Studies for In Vitro Diagnostic Devices; Availability
    
4. Notice: "Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act;" Availability
    
5. Notice: King Pharmaceuticals, Inc. and Alpharma Inc.; Agreement Containing Consent Order To Aid Public Comment
    

1. Notice: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA; Availability
    
2. Notice: Notice of Availability of Evaluations of the Highly Pathogenic Avian Influenza Subtype H5N1 Status of Germany and Poland
    

1. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Broadcast Advertisements
    
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
    
3. Notice: Government-Owned Inventions; Availability for Licensing
    

1. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
    
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
    
3. Notice: Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals, Inc; Analysis of Agreement Containing Consent Orders To Aid Public Comment
    
4. Notice: Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2009
    
5. Notice: Controlled Substances: Established Initial Aggregate Production Quotas for 2009
    
6. Notice: Scientific Workshop To Inform EPA's Response to National Academy of Science Comments on the Health Effects of Dioxin in EPA's 2003 Dioxin Reassessment
    

1. Notice: Regulatory Site Visit Training Program
    
2. Notice: Solicitation of Nominations for Membership on the National Vaccine Advisory Committee
    

1. Notice: SEQC--The Sequencing Quality Control Project
    
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; PDUFA Pilot Project Proprietary Name Review
    

1. Notice: Compliance Policy Guide; Radiofrequency IdentificationFeasibility Studies and Pilot Programs for Drugs; Notice to Extend Expiration Date
    
2. Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Expander; Availability
    
3. Proposed Rule: General and Plastic Surgery Devices: Proposed Classification for the Tissue Expander
    
4. Notice: Grant of Authority for Subzone Status, Amgen Manufacturing Limited (Biotechnology and Healthcare Products), Juncos, Puerto Rico
    

1. Notice: Guidance for Industry on Diabetes Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes; Availability
    
2. Notice: Determination That RUBRAMIN PC (Cyanocobalamin) Injection and Ten Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    
3. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
    
4. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly "Emergency Medical Device Shortages Program Survey")
    

1. Notice: Clinical Studies of Safety and Effectiveness of Orphan Products
    

1. Notice: Draft Guidance for Industry on Anesthetics for Companion Animals; Availability
    
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates
    
3. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
    

1. Notice: Guidance for Industry on Orally Disintegrating Tablets; Availability
    
2. Notice: Draft Guidance for Industry on Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches; Availability
    
3. Notice: Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Availability
    
4. Notice: Draft Guidance for Industry on Changes to Approved New Animal Drug Applications--New Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability
    
5. Notice: Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
    
6. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug Experience Reporting
    
7. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices
    
8. Notice: Advisory Committees; Filing of Closed Meeting Reports
    

1. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of the Impact of Coupons Embedded in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Perceptions of Product Risks and Benefits
    
2. Notice: Seeking To Evaluate Commercial Products, or Products in Development, for In Vitro Serological Diagnosis of Pertussis
    

1. Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Submission and Review of Sterility Information in Premarket Notification Submissions for Devices Labeled as Sterile; Availability
    
2. Notice: Withdrawal of Certain Proposed Rules and Other Proposed Actions
    
3. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007
    
4. Notice: Your Druggist Pharmacy; Revocation of Registration

1. Notice: Draft Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without anApproved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability
    
2. Notice: Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability
    
3. Notice: Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval--the Premarket Approval Supplement Decisionmaking Process; Availability
    

1. Notice: Quality Assurance Requirements for Respirators; Notice of Proposed Rulemaking
    
2. Notice: Government-Owned Inventions; Availability for Licensing
    
3. Final Rule: Rules of Practice Before the Board of Patent Appeals and Interferences in Ex Parte Appeals; Delay of Effective and Applicability Dates
    

1. Notice: Sentinel Initiative: Structure, Function, and Scope; Public Workshop; Request for Comments
    

1. Notice: Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability
    
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices
    

1. Notice: Draft Guidance for Industry on the Submission of Patent Information for Certain Old Antibiotics; Availability
    
2. Final Rule: Import and Production Quotas for Certain List I Chemicals
    

1. Notice: Proposed Substances To Be Evaluated for Set 23 Toxicological Profiles
    
2. Notice (A): Government-Owned Inventions; Availability for Licensing
    
3. Notice (B): Government-Owned Inventions; Availability for Licensing
    

1. Notice: Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials; Availability
    
2. Notice: Manufacturer of Controlled Substances; Notice of Registration