Recently Issued US Federal Register
 

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1. Notice: Identification of Human Cell Lines Project
    

1. Notice: Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to the Agency's Compliance and Enforcement Data; Availability
    
2. Notice: Withdrawal of Approval of New Animal Drug Applications
    

1. Notice: Annual Computational Science Symposium; Public Conference
    

1. Proposed Rule: Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner; Notice of Availability of Study Data
    
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Consumer Response to Health Claims and Disclaimers About the Relationship Between Selenium and Risk of Various Cancers
    

1. Notice: Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
    
2. Notice: Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling; Availability
    
3. Notice: Pediatric Medical Devices; Public Workshop; Reopening of Comment Period
    
4. Proposed Rule: Import Tolerances for Residues of Unapproved New Animal Drugs in Food
    

1. Notice: Prospective Grant of Exclusive License: Development of T Cell Receptors and Chimeric Antigen Receptors Into Therapeutics for Adoptive Transfer in Humans To Treat Cancer
    

1. Notice (A): Government-Owned Inventions; Availability for Licensing
    
2. Notice (B): Government-Owned Inventions; Availability for Licensing
    

1. Notice: Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Intended To Repair or Replace Knee Cartilage; Availability
    
2. Notice: Determination That PREZISTA (darunavir) Tablets, 300 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    
3. Notice: Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public Workshop
    
4. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
    
5. Notice: United States Pharmacopeial Convention; Filing of Food Additive Petition; Amendment
    

1. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Healthcare Professional Survey of Prescription Drug Promotion
    
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008
    

1. Notice: Availability of the Report on the International Workshop on Alternative Methods To Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions
    
2. 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
    
3. Notice: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
    

1. Notice: Determination That AVALIDE (Hydrochlorothiazide and Irbesartan), Oral Tablets, 25 Milligrams/300 Milligrams and 12.5 Milligrams/75 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    

1. Notice: Privacy Act of 1974; Report of an Altered System of Records, Including Addition of Routine Uses to an Existing System of Records; Bioresearch Monitoring Information System
    

1. Notice: National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy
    

1. Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability
    
2. Proposed Rule: Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets
    
3. Final Rule: Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma
    

1. Notice: Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability
    
2. Notice: Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability
    
3. Notice: Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability
    
4. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma
    
5. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices
    
6. Notice: Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency; Availability
    
7. Final Rule: Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions
    
8. Notice: Determination That HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Tablets, 5 Milligrams/1.5 Milligrams, and HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Oral Solution, 5 Milligrams/5 Milliliters and 1.5 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    

1. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Consumer Responses to Nutrition Facts Labels With Various Footnote Formats and Declaration of Amount of Added Sugars
    

1. Notice: Availability of an Environmental Assessment for Field Testing Swine Influenza Vaccine, RNA
    
2. Notice: Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed; Request for Information and Comments
    
3. Notice: Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]; Availability
    
4. Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes; Availability
    

1. Notice: Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption (IDE) Clinical Investigations; Extension of Comment Period
    
2. Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Extension of Comment Period
    
3. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
    
4. Notice: Prospective Grant of Exclusive License: Use of Methanocarba Analogues of Purine and Pyrimidine Nucleosides and Nucleotides to Treat or Prevent Cardiac Diseases in Humans
    

1. Notice: Foreign-Trade Zone 7--Mayaguez, PR, Expansion of Manufacturing Authority; Amgen Manufacturing Limited (Biotechnology and Healthcare Products), Juncos, PR
    

1. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
    
2. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"
    
3. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Food and Drug Administration Form 2830
    

1. Notice: Gluten in Drug Products; Request for Information and Comments
    
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements
    
3. Notice: Animal Drug User Fee Act; Reopening of the Comment Period
    
4. Notice: Animal Generic Drug User Fee Act; Reopening of the Comment Period
    
5. Notice: Prospective Grant of Exclusive License: Avian Influenza Vaccines for Domesticated Poultry/Wild Birds To Be Provided to the National Veterinary Stockpile Program and Avian Influenza Vaccines To Be Sold as Veterinary Biological Products
    
6. Notice: Prospective Grant of Exclusive License: Veterinary Biological Products for Swine Influenza Vaccines
    

1. Notice: Establishing Timeframes for Implementation of Product Safety Labeling Changes; Request for Comments
    
2. Notice: Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability
    
3. Notice: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop
    

1. Interim Final Rule: Applications for Food and Drug Administration Approval To Market a New Drug; Revision of Postmarketing Reporting Requirements -- Discontinuance
    
2. Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability
    
3. Notice: Determination that Bretylium Tosylate Injection, 50 Milligrams/ Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    
4. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
    
5. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Examination of Online Direct-to-Consumer Prescription Drug Promotion
    
6. Notice: Webinar Overview of the National Vaccine Advisory Committee Healthcare Personnel Influenza Vaccination Subgroup's Draft Report and Draft Recommendations for Achieving the Healthy People 2020 Annual Coverage Goals for Influenza Vaccination in Healthcare Personnel
    

1. Notice: Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review; Proposed Rule
    

1. Notice: Scientific Information Request on CYP2C19 Variants and Platelet Reactivity Tests
    
2. Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body