Recently Issued US Federal Register
 

1. Notice: Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability
    
2. Final Rule: Distribution of Certain Drug Products by Registered Blood Establishments and Comprehensive Hemophilia Diagnostic Treatment Centers That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures
    
3. Notice: Grant of Authority for Subzone Status; Noramco, Inc. (Pharmaceutical Intermediates), Athens, GA
    
4. Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
    
5. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recall Regulations
    

1. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
    

1. Notice: Withdrawal of Approval of 128 Suitability Petitions; Correction
    
2. Notice: Draft Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products; Availability
    

1. Notice: Determination and Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information
    
2. Notice: Notice of Intent To Establish the Global AIDS Coordinator's Expert Panel on Prevention of Mother-to-Child Transmission of HIV
    

1. Notice: Prospective Granting of a Co-Exclusive License
    
2. Notice (A): Government-Owned Inventions; Availability for Licensing
    
3. Notice (B): Government-Owned Inventions; Availability for Licensing
    

1. Notice: Determination That ATROVENT (Ipatropium Bromide) Inhalation Solution and 10 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007
    
3. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices
    

1. Notice: Prospective Grant of an Exclusive License: Therapeutics Based on Histone Deacetylase (HDAC) Inhibitors for the Prevention and Treatment of Central Nervous System (CNS) Metastases of Extra-CNS Origin Cancers
    
2. Notice: Government-Owned Inventions; Availability for Licensing
    
3. Notice: Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2009 Proposed Guidance Development
    

1. Direct Final Rule: Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
    
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
    
3. Final Rule: Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
    
4. Notice: Technical Amendment to Listing in Schedule III of Approved Drug Products Containing Tetrahydrocannabinols; Withdrawal of Proposed Rule
    

1. Notice: Draft Guidance for Industry on End-of-Phase 2A Meetings; Availability
    
2. Notice: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
    
3. Notice: Prospective Grant of Exclusive License: Use of Benztropinamine Analogs To Treat Psychiatric and Neurological Disorders
    
4. Notice (A): Government-Owned Inventions; Availability for Licensing
    
5. Notice (B): Government-Owned Inventions; Availability for Licensing
    

1. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
    

1. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
    
2. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program
    

1. Notice: Topical Drug Products Containing Papain; Enforcement Action Dates
    
2. Notice: Ophthalmic Balanced Salt Solutions for Ocular Surgical Procedures; Enforcement Action Dates
    
3. Notice: Review of NIOSH Draft Current Intelligence Bulletin, "A Strategy for Assigning the New NIOSH Skin Notations for Chemicals"
    

1. Notice: Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs; Availability
    
2. Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability
    
3. Notice: Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2009: Proposed
    
4. Notice: Draft Problem Formulation for Human Health Risk Assessments of Pathogens in Land-Applied Biosolids
    

1. Notice: Grant of Authority For Subzone Status, Banner Pharmacaps, Inc.
    
2. Notice: Availability of an Environmental Assessment for Field Testing Rabies Vaccine, Live Raccoon Poxvirus Vector
    
3. Proposed Rule: Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Meat, Meat Byproducts, and Meat Food Products Derived From Bovines 30 Months of Age or Older
    

1. Notice: Revised FSIS Testing Methodology for Escherichia coli (E. coli) (O157:H7)
    
2. Notice (A): Government-Owned Inventions; Availability for Licensing
    
3. Notice (B): Government-Owned Inventions; Availability for Licensing
    
4. Notice (C): Government-Owned Inventions; Availability for Licensing
    

1. Notice: Generic New Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009
    
2. Notice: Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009
    
3. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
    
4. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
    

1. Notice: Ecamsule Eligibility for Inclusion in Monograph; Over-the-Counter Sunscreen Drug Products for Human Use; Request for Safety and Effectiveness Data
    

1. Notice: Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on Public Advisory Panels or Committees and Request for Nonvoting Industry Representatives on Public Advisory Panels or Committees
    
2. Proposed Rule: General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period
    
3. Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Petitions for Exemption from Preemption
    
4. Interim Rule: Tuberculosis; Amend the Status of New Mexico From Accredited Free to Modified Accredited Advanced
    

1. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring