Federal Register Recent Federal Regulation Documents - Justia Regulation Tracker - Justia Regulations Tracker https://regulations.justia.com/regulations/fedreg/agencies/alcohol-tobacco-firearms-and-explosives-bureau?limit=200&mode=atom 2024-12-21T10:34:39-08:00 Justia Inc https://www.justia.com/ Justia Regulations Tracker https://regulations.justia.com/images/justiafedregulations.gif Copyright 2011 Justia Inc https://regulations.justia.com/regulations/fedreg/2016/02/08/2016-02444.html Notice - Office of Foods and Veterinary Medicine; Center for Food Safety and Applied Nutrition; Statement of Organization, Functions, and Delegations of Authority 2016-02-08T00:00:00-08:00 2016-02-08T00:00:00-08:00 2016-02444 Notice https://www.gpo.gov/fdsys/pkg/FR-2016-02-08/pdf/2016-02444.pdf https://regulations.justia.com/regulations/fedreg/2016/01/28/2016-01690.html Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommended Recordkeeping for Exempt Infant Formula Production 2016-01-28T00:00:00-08:00 2016-01-28T00:00:00-08:00 2016-01690 Notice https://www.gpo.gov/fdsys/pkg/FR-2016-01-28/pdf/2016-01690.pdf https://regulations.justia.com/regulations/fedreg/2016/01/28/2016-01686.html Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use 2016-01-28T00:00:00-08:00 2016-01-28T00:00:00-08:00 2016-01686 Notice https://www.gpo.gov/fdsys/pkg/FR-2016-01-28/pdf/2016-01686.pdf https://regulations.justia.com/regulations/fedreg/2016/01/28/2016-01685.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production; Recordkeeping and Registration Provisions 2016-01-28T00:00:00-08:00 2016-01-28T00:00:00-08:00 2016-01685 Notice https://www.gpo.gov/fdsys/pkg/FR-2016-01-28/pdf/2016-01685.pdf https://regulations.justia.com/regulations/fedreg/2016/01/28/2016-01684.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications 2016-01-28T00:00:00-08:00 2016-01-28T00:00:00-08:00 2016-01684 Notice https://www.gpo.gov/fdsys/pkg/FR-2016-01-28/pdf/2016-01684.pdf https://regulations.justia.com/regulations/fedreg/2016/01/28/2016-01683.html Notice - Bioequivalence Recommendations for Lamotrigine; Draft Guidance for Industry; Availability 2016-01-28T00:00:00-08:00 2016-01-28T00:00:00-08:00 2016-01683 Notice https://www.gpo.gov/fdsys/pkg/FR-2016-01-28/pdf/2016-01683.pdf https://regulations.justia.com/regulations/fedreg/2016/01/28/2016-01682.html Notice - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability 2016-01-28T00:00:00-08:00 2016-01-28T00:00:00-08:00 2016-01682 Notice https://www.gpo.gov/fdsys/pkg/FR-2016-01-28/pdf/2016-01682.pdf https://regulations.justia.com/regulations/fedreg/2016/01/28/2016-01681.html Notice - Food and Drug Administration/Xavier Medical Device Conference 2016-01-28T00:00:00-08:00 2016-01-28T00:00:00-08:00 2016-01681 Notice https://www.gpo.gov/fdsys/pkg/FR-2016-01-28/pdf/2016-01681.pdf https://regulations.justia.com/regulations/fedreg/2015/09/11/2015-22949.html Notice - Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications; Public Meeting 2015-09-11T00:00:00-07:00 2015-09-11T00:00:00-07:00 2015-22949 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-11/pdf/2015-22949.pdf https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22683.html Notice - Nonclinical Evaluation of Endocrine-Related Drug Toxicity; Guidance for Industry; Availability 2015-09-09T00:00:00-07:00 2015-09-09T00:00:00-07:00 2015-22683 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22683.pdf https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22682.html Proposed Rule - Homeopathic Product Regulation: Evaluating the Food and Drug Administration's Regulatory Framework After a Quarter-Century; Reopening of the Comment Period 2015-09-09T00:00:00-07:00 2015-09-09T00:00:00-07:00 2015-22682 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22682.pdf https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22680.html Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees 2015-09-09T00:00:00-07:00 2015-09-09T00:00:00-07:00 2015-22680 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22680.pdf https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22678.html Notice - Formal Dispute Resolution: Appeals Above the Division Level; Revised Draft Guidance for Industry and Review Staff; Availability 2015-09-09T00:00:00-07:00 2015-09-09T00:00:00-07:00 2015-22678 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22678.pdf https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22677.html Notice - Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum 2015-09-09T00:00:00-07:00 2015-09-09T00:00:00-07:00 2015-22677 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22677.pdf https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22676.html Notice - Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Request for Comments 2015-09-09T00:00:00-07:00 2015-09-09T00:00:00-07:00 2015-22676 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22676.pdf https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22675.html Notice - Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Request for Comments 2015-09-09T00:00:00-07:00 2015-09-09T00:00:00-07:00 2015-22675 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22675.pdf https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22674.html Notice - Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop; Public Workshop; Correction 2015-09-09T00:00:00-07:00 2015-09-09T00:00:00-07:00 2015-22674 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22674.pdf https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22673.html Notice - Determination That GLUCAGON (Glucagon Hydrochloride) for Injection, Equivalent to 1 Milligram Base/Vial and Equivalent to 10 Milligram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness 2015-09-09T00:00:00-07:00 2015-09-09T00:00:00-07:00 2015-22673 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22673.pdf https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22593.html Notice - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting 2015-09-09T00:00:00-07:00 2015-09-09T00:00:00-07:00 2015-22593 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22593.pdf https://regulations.justia.com/regulations/fedreg/2015/09/08/2015-22507.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations 2015-09-08T00:00:00-07:00 2015-09-08T00:00:00-07:00 2015-22507 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-22507.pdf https://regulations.justia.com/regulations/fedreg/2015/09/08/2015-22494.html Notice - Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Second Edition; Guidance for Industry; Availability 2015-09-08T00:00:00-07:00 2015-09-08T00:00:00-07:00 2015-22494 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-22494.pdf https://regulations.justia.com/regulations/fedreg/2015/09/04/2015-21905.html Rule - New Animal Drugs; Approval of New Animal Drug Applications 2015-09-04T00:00:00-07:00 2015-09-04T00:00:00-07:00 2015-21905 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-09-04/pdf/2015-21905.pdf https://regulations.justia.com/regulations/fedreg/2015/09/03/2015-21914.html Notice - Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal 2015-09-03T00:00:00-07:00 2015-09-03T00:00:00-07:00 2015-21914 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-03/pdf/2015-21914.pdf https://regulations.justia.com/regulations/fedreg/2015/09/03/2015-21874.html Notice - Compressed Medical Gases-Warning Letters for Specific Violations Covering Liquid and Gaseous Oxygen; Withdrawal of Compliance Policy Guide 2015-09-03T00:00:00-07:00 2015-09-03T00:00:00-07:00 2015-21874 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-03/pdf/2015-21874.pdf https://regulations.justia.com/regulations/fedreg/2015/09/02/2015-21645.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act 2015-09-02T00:00:00-07:00 2015-09-02T00:00:00-07:00 2015-21645 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-02/pdf/2015-21645.pdf https://regulations.justia.com/regulations/fedreg/2015/09/02/2015-21639.html Notice - Food and Drug Administration/Drug Information Association Oligonucleotide-Based Therapeutics Conference 2015 2015-09-02T00:00:00-07:00 2015-09-02T00:00:00-07:00 2015-21639 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-02/pdf/2015-21639.pdf https://regulations.justia.com/regulations/fedreg/2015/09/01/2015-21585.html Notice - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Middle East Respiratory Syndrome Coronavirus; Availability 2015-09-01T00:00:00-07:00 2015-09-01T00:00:00-07:00 2015-21585 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-01/pdf/2015-21585.pdf https://regulations.justia.com/regulations/fedreg/2015/09/01/2015-21583.html Notice - Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Guidance for Industry; Availability 2015-09-01T00:00:00-07:00 2015-09-01T00:00:00-07:00 2015-21583 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-01/pdf/2015-21583.pdf https://regulations.justia.com/regulations/fedreg/2015/09/01/2015-21582.html Notice - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Electronic Exchange of Documents: Electronic File Format; Guidance for Industry; Availability 2015-09-01T00:00:00-07:00 2015-09-01T00:00:00-07:00 2015-21582 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-01/pdf/2015-21582.pdf https://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21383.html Notice - Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability 2015-08-28T00:00:00-07:00 2015-08-28T00:00:00-07:00 2015-21383 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21383.pdf https://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21382.html Proposed Rule - Designation of Official Names and Proper Names for Certain Biological Products 2015-08-28T00:00:00-07:00 2015-08-28T00:00:00-07:00 2015-21382 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21382.pdf https://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21271.html Notice - Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Guidance for Tobacco Retailers; Availability 2015-08-28T00:00:00-07:00 2015-08-28T00:00:00-07:00 2015-21271 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21271.pdf https://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21237.html Rule - Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene Amplification Assay 2015-08-27T00:00:00-07:00 2015-08-27T00:00:00-07:00 2015-21237 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-27/pdf/2015-21237.pdf https://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21236.html Notice - Determination That BIAXIN XL Oral Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness 2015-08-27T00:00:00-07:00 2015-08-27T00:00:00-07:00 2015-21236 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-27/pdf/2015-21236.pdf https://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21235.html Notice - Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry; Availability 2015-08-27T00:00:00-07:00 2015-08-27T00:00:00-07:00 2015-21235 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-27/pdf/2015-21235.pdf https://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21149.html Notice - Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Extension of Comment Period 2015-08-26T00:00:00-07:00 2015-08-26T00:00:00-07:00 2015-21149 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-26/pdf/2015-21149.pdf https://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21095.html Notice - In Vitro Diagnostic Testing for Direct Oral Anticoagulants; Public Workshop; Request for Comments 2015-08-26T00:00:00-07:00 2015-08-26T00:00:00-07:00 2015-21095 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-26/pdf/2015-21095.pdf https://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21036.html Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting 2015-08-26T00:00:00-07:00 2015-08-26T00:00:00-07:00 2015-21036 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-26/pdf/2015-21036.pdf https://regulations.justia.com/regulations/fedreg/2015/08/25/2015-20948.html Notice - Medical Device Epidemiology Network Registry Task Force Report; Availability, Web Site Location and Request for Comments 2015-08-25T00:00:00-07:00 2015-08-25T00:00:00-07:00 2015-20948 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-25/pdf/2015-20948.pdf https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20833.html Notice - Use of Rare Pediatric Disease Priority Review Voucher; Approval of a Drug Product 2015-08-24T00:00:00-07:00 2015-08-24T00:00:00-07:00 2015-20833 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20833.pdf https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20832.html Notice - Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Notice of Public Workshop; Correction 2015-08-24T00:00:00-07:00 2015-08-24T00:00:00-07:00 2015-20832 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20832.pdf https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20820.html Notice - Science Board to the Food and Drug Administration; Notice of Meeting 2015-08-24T00:00:00-07:00 2015-08-24T00:00:00-07:00 2015-20820 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20820.pdf https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20780.html Notice - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant 2015-08-24T00:00:00-07:00 2015-08-24T00:00:00-07:00 2015-20780 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20780.pdf https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20760.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act 2015-08-24T00:00:00-07:00 2015-08-24T00:00:00-07:00 2015-20760 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20760.pdf https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20759.html Proposed Rule - Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Request for Comments; Extension of Comment Period 2015-08-24T00:00:00-07:00 2015-08-24T00:00:00-07:00 2015-20759 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20759.pdf https://regulations.justia.com/regulations/fedreg/2015/08/21/2015-20676.html Rule - Listing of Color Additives Exempt From Certification; Spirulina Extract 2015-08-21T00:00:00-07:00 2015-08-21T00:00:00-07:00 2015-20676 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-21/pdf/2015-20676.pdf https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20562.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Comment Request; Interstate Shellfish Dealers Certificate 2015-08-20T00:00:00-07:00 2015-08-20T00:00:00-07:00 2015-20562 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20562.pdf https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20561.html Notice - Lisa Marie Coroniti: Debarment Order 2015-08-20T00:00:00-07:00 2015-08-20T00:00:00-07:00 2015-20561 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20561.pdf https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20557.html Notice - Collecting On-Farm Antimicrobial Use and Resistance Data; Public Meeting; Request for Comments 2015-08-20T00:00:00-07:00 2015-08-20T00:00:00-07:00 2015-20557 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20557.pdf https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20556.html Notice - Technical Document for Using the Inactive Ingredient Database; Establishment of a Public Docket 2015-08-20T00:00:00-07:00 2015-08-20T00:00:00-07:00 2015-20556 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20556.pdf