Recently Issued US Federal Register
 

1. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements
    

1. Notice: Guidance for Industry and Food and Drug Administration Staff; Administrative Procedures for CLIA Categorization; Availability
    
2. Notice: Agency Emergency Processing Under Office of Management and Budget Review; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007
    

1. Notice: Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review
    
2. Notice: Prospective Grant of Exclusive License: Antibody Therapeutics for the Treatment of Cancer in Humans
    
3. Notice: Government-Owned Inventions; Availability for Licensing
    

1. Notice: Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment
    

1. Notice: Availability of an Environmental Assessment for Field Testing Mannheimia Haemolytica-Pasteurella Multocida Vaccine, Avirulent Live Culture
    
2. Notice: Determination of Regulatory Review Period for Purposes of Patent Extension; TEKTURNA
    
3. Notice: Manufacturer of Controlled Substances; Notice of Application
    

1. Notice: Determination of Regulatory Review Period for Purposes of Patent Extension; ARTEFILL
    
2. Notice: Determination of Regulatory Review Period for Purposes of Patent Extension; AZILECT
    
3. Notice: Government-Owned Inventions; Availability for Licensing
    

1. Notice: Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, Juvenile Diabetes Research Foundation Public Workshop
    
2. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)
    
3. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing
    
4. Notice: National Toxicology Program (NTP); Report on Carcinogens (RoC); Request for Public Comments on the RoC Expert Panel's Recommendations on Listing Status for Aristolochic Acids and Riddelliine in the 12th RoC and the Scientific Justifications for the Recommendations
    
5. Notice: Prospective Grant of an Exclusive License: Therapeutics for the Treatment of Spinal Cord Injury, Traumatic Brain Injury, and Leukemia
    

1. Notice: Prospective Grant of Exclusive License: Development of Cancer Therapeutics in Humans
    
2. Notice: Prospective Grant of Exclusive License: Method To Treat Psoriasis in Humans
    
3. Notice: Government-Owned Inventions; Availability for Licensing
    

1. Final Rule:  Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application (*Large Document, Linked Directly to Federal Register Website)
    
2. Notice: Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human  Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Availability
    
3. Notice: Determination That TAPAZOLE Tablets and 18 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    
4. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
    
5. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
    
6. Notice: Cooperative Agreement to Support the World Health Organization International Programme on Chemical Safety
    

1. Proposed Rule: Classification of Three Steroids as Schedule III Anabolic Steroids Under the Controlled Substances Act
    
2. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
    

1. Notice: Draft Guidance for Industry on Developing Coronary Drug Eluting Stents; Public Workshop
    
2. Notice: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability
    
3. Notice: Medtronic, Inc. Cardiovascular Division, Santa Rosa, CA; Notice of Revised Determination on Remand
    

1. Notice: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets; Public Workshop; Request for Comments
    
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
    

1. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking
    
2. Notice: Government-Owned Inventions; Availability for Licensing
    

1. Notice: Applications for Duty-Free Entry of Scientific Instruments
    

1. Notice: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/ Submissions: Compliance With Section 402(j) of the Public Health Service Act, Added by Title VIII of the Food and Drug Administration Amendments Act of 2007
    
2. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
    

1. Notice: Bio-Rad Laboratories, Waltham, MA; Notice of Termination of Investigation
    
2. Notice (A): Government-Owned Inventions; Availability for Licensing
    
3. Notice (B): Government-Owned Inventions; Availability for Licensing
    

1. Notice: Importer of Controlled Substances; Notice of Application
    
2. Notice (A): Manufacturer of Controlled Substances; Notice of Application
    
3. Notice (B): Manufacturer of Controlled Substances; Notice of Application
    

1. Notice: Antimicrobial Resistance; Public Hearing; Request for Comments
    
2. Notice: Foreign-Trade Zone 26 Atlanta, Georgia, Application for Subzone, Noramco, Inc. (Pharmaceutical Intermediate Manufacturing), Athens, Georgia
    

1. Notice: Manufacturer of Controlled Substances; Notice of Registration
    

1. Notice: Guidance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Availability
    
2. Notice: Guidance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Somatic Cell Therapy Investigational New Drug Applications; Availability
    
3. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, Form FDA 3602A
    
4. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reports of Corrections and Removals
    
5. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys