<![CDATA[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/2015/08?registers=between&min-day=1&max-day=31 Thu, 02 May 2024 23:14:12 -0700 Thu, 02 May 2024 23:14:12 -0700 Justia Regulations Tracker Copyright 2011 Justia Inc. https://regulations.justia.com/images/justiafedregulations.gif <![CDATA[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/2015/08?registers=between&min-day=1&max-day=31 Notice - Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21383.html https://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21383.html Fri, 28 Aug 2015 00:00:00 -0700 2015-21383 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21383.pdf Proposed Rule - Designation of Official Names and Proper Names for Certain Biological Products https://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21382.html https://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21382.html Fri, 28 Aug 2015 00:00:00 -0700 2015-21382 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21382.pdf Notice - Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Guidance for Tobacco Retailers; Availability https://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21271.html https://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21271.html Fri, 28 Aug 2015 00:00:00 -0700 2015-21271 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21271.pdf Rule - Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene Amplification Assay https://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21237.html https://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21237.html Thu, 27 Aug 2015 00:00:00 -0700 2015-21237 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-27/pdf/2015-21237.pdf Notice - Determination That BIAXIN XL Oral Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness https://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21236.html https://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21236.html Thu, 27 Aug 2015 00:00:00 -0700 2015-21236 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-27/pdf/2015-21236.pdf Notice - Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21235.html https://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21235.html Thu, 27 Aug 2015 00:00:00 -0700 2015-21235 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-27/pdf/2015-21235.pdf Notice - Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Extension of Comment Period https://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21149.html https://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21149.html Wed, 26 Aug 2015 00:00:00 -0700 2015-21149 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-26/pdf/2015-21149.pdf Notice - In Vitro Diagnostic Testing for Direct Oral Anticoagulants; Public Workshop; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21095.html https://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21095.html Wed, 26 Aug 2015 00:00:00 -0700 2015-21095 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-26/pdf/2015-21095.pdf 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 https://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21036.html https://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21036.html Wed, 26 Aug 2015 00:00:00 -0700 2015-21036 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-26/pdf/2015-21036.pdf Notice - Medical Device Epidemiology Network Registry Task Force Report; Availability, Web Site Location and Request for Comments https://regulations.justia.com/regulations/fedreg/2015/08/25/2015-20948.html https://regulations.justia.com/regulations/fedreg/2015/08/25/2015-20948.html Tue, 25 Aug 2015 00:00:00 -0700 2015-20948 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-25/pdf/2015-20948.pdf Notice - Use of Rare Pediatric Disease Priority Review Voucher; Approval of a Drug Product https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20833.html https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20833.html Mon, 24 Aug 2015 00:00:00 -0700 2015-20833 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20833.pdf Notice - Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Notice of Public Workshop; Correction https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20832.html https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20832.html Mon, 24 Aug 2015 00:00:00 -0700 2015-20832 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20832.pdf Notice - Science Board to the Food and Drug Administration; Notice of Meeting https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20820.html https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20820.html Mon, 24 Aug 2015 00:00:00 -0700 2015-20820 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20820.pdf Notice - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20780.html https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20780.html Mon, 24 Aug 2015 00:00:00 -0700 2015-20780 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20780.pdf 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 https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20760.html https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20760.html Mon, 24 Aug 2015 00:00:00 -0700 2015-20760 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20760.pdf 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 https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20759.html https://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20759.html Mon, 24 Aug 2015 00:00:00 -0700 2015-20759 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20759.pdf Rule - Listing of Color Additives Exempt From Certification; Spirulina Extract https://regulations.justia.com/regulations/fedreg/2015/08/21/2015-20676.html https://regulations.justia.com/regulations/fedreg/2015/08/21/2015-20676.html Fri, 21 Aug 2015 00:00:00 -0700 2015-20676 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-21/pdf/2015-20676.pdf Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Comment Request; Interstate Shellfish Dealers Certificate https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20562.html https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20562.html Thu, 20 Aug 2015 00:00:00 -0700 2015-20562 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20562.pdf Notice - Lisa Marie Coroniti: Debarment Order https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20561.html https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20561.html Thu, 20 Aug 2015 00:00:00 -0700 2015-20561 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20561.pdf Notice - Collecting On-Farm Antimicrobial Use and Resistance Data; Public Meeting; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20557.html https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20557.html Thu, 20 Aug 2015 00:00:00 -0700 2015-20557 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20557.pdf Notice - Technical Document for Using the Inactive Ingredient Database; Establishment of a Public Docket https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20556.html https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20556.html Thu, 20 Aug 2015 00:00:00 -0700 2015-20556 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20556.pdf Rule - Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20554.html https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20554.html Thu, 20 Aug 2015 00:00:00 -0700 2015-20554 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20554.pdf Notice - Pediatric Advisory Committee; Notice of Meeting; Correction https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20541.html https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20541.html Thu, 20 Aug 2015 00:00:00 -0700 2015-20541 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20541.pdf Notice - Bone, Reproductive, and Urologic Drugs Advisory Committee; Notice of Meeting https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20540.html https://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20540.html Thu, 20 Aug 2015 00:00:00 -0700 2015-20540 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20540.pdf Notice - Center for Devices and Radiological Health Participation in International Medical Device Regulators Forum, Regulated Product Submission, Table of Contents Pilot Program https://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20430.html https://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20430.html Wed, 19 Aug 2015 00:00:00 -0700 2015-20430 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-19/pdf/2015-20430.pdf Notice - Medical Devices; Export Certificates; Food and Drug Administration Export Reform and Enhancement Act of 1996; Certification Fees https://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20429.html https://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20429.html Wed, 19 Aug 2015 00:00:00 -0700 2015-20429 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-19/pdf/2015-20429.pdf Notice - Arthritis Advisory Committee; Notice of Meeting https://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20398.html https://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20398.html Wed, 19 Aug 2015 00:00:00 -0700 2015-20398 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-19/pdf/2015-20398.pdf Notice - Obstetrics and Gynecology Device Panel of the Medical Device Advisory Committee; Correction https://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20397.html https://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20397.html Wed, 19 Aug 2015 00:00:00 -0700 2015-20397 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-19/pdf/2015-20397.pdf Rule - Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20317.html https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20317.html Tue, 18 Aug 2015 00:00:00 -0700 2015-20317 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20317.pdf Notice - Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.2 https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20316.html https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20316.html Tue, 18 Aug 2015 00:00:00 -0700 2015-20316 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20316.pdf Notice - Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20312.html https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20312.html Tue, 18 Aug 2015 00:00:00 -0700 2015-20312 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20312.pdf Notice - Pilot Program for Medical Device Reporting on Malfunctions https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20309.html https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20309.html Tue, 18 Aug 2015 00:00:00 -0700 2015-20309 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20309.pdf Notice - Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Guidance for Industry and Food and Drug Administration Staff; Availability https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20308.html https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20308.html Tue, 18 Aug 2015 00:00:00 -0700 2015-20308 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20308.pdf Notice - Uncomplicated Gonorrhea: Developing Drugs for Treatment; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20306.html https://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20306.html Tue, 18 Aug 2015 00:00:00 -0700 2015-20306 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20306.pdf Notice - Rare Diseases: Common Issues in Drug Development; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20235.html https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20235.html Mon, 17 Aug 2015 00:00:00 -0700 2015-20235 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20235.pdf Notice - Botanical Drug Development; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20230.html https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20230.html Mon, 17 Aug 2015 00:00:00 -0700 2015-20230 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20230.pdf Notice - Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20229.html https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20229.html Mon, 17 Aug 2015 00:00:00 -0700 2015-20229 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20229.pdf Notice - Qualification of Biomarker-Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20228.html https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20228.html Mon, 17 Aug 2015 00:00:00 -0700 2015-20228 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20228.pdf Rule - Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20177.html https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20177.html Mon, 17 Aug 2015 00:00:00 -0700 2015-20177 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20177.pdf Notice - Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Extension of Comment Period https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20174.html https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20174.html Mon, 17 Aug 2015 00:00:00 -0700 2015-20174 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20174.pdf Notice - Disease Natural History Database Development-(U24) https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20130.html https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20130.html Mon, 17 Aug 2015 00:00:00 -0700 2015-20130 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20130.pdf Notice - Scientific Inquiry Into How Mobile Health and Social Data Sources May Inform Medical Product Safety and Efficacy; Public Workshop; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20129.html https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20129.html Mon, 17 Aug 2015 00:00:00 -0700 2015-20129 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20129.pdf Notice - Physiological Closed-Loop Controlled Devices; Public Workshop; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20127.html https://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20127.html Mon, 17 Aug 2015 00:00:00 -0700 2015-20127 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20127.pdf Notice - Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-20051.html https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-20051.html Fri, 14 Aug 2015 00:00:00 -0700 2015-20051 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-20051.pdf Notice - National Mammography Quality Assurance Advisory Committee, Renewal https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-20050.html https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-20050.html Fri, 14 Aug 2015 00:00:00 -0700 2015-20050 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-20050.pdf Notice - Intent To Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-20005.html https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-20005.html Fri, 14 Aug 2015 00:00:00 -0700 2015-20005 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-20005.pdf Notice - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040 https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-19991.html https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-19991.html Fri, 14 Aug 2015 00:00:00 -0700 2015-19991 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-19991.pdf Notice - Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-19990.html https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-19990.html Fri, 14 Aug 2015 00:00:00 -0700 2015-19990 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-19990.pdf Notice - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Draft Guidance for Industry and Food and Drug Administration Staff: Availability https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-19983.html https://regulations.justia.com/regulations/fedreg/2015/08/14/2015-19983.html Fri, 14 Aug 2015 00:00:00 -0700 2015-19983 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-19983.pdf Proposed Rule - Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use) https://regulations.justia.com/regulations/fedreg/2015/08/13/2015-19884.html https://regulations.justia.com/regulations/fedreg/2015/08/13/2015-19884.html Thu, 13 Aug 2015 00:00:00 -0700 2015-19884 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-13/pdf/2015-19884.pdf Notice - Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intent To Participate; Extension of Closing Date https://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19768.html https://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19768.html Wed, 12 Aug 2015 00:00:00 -0700 2015-19768 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-12/pdf/2015-19768.pdf Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration https://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19741.html https://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19741.html Wed, 12 Aug 2015 00:00:00 -0700 2015-19741 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-12/pdf/2015-19741.pdf Notice - Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19740.html https://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19740.html Wed, 12 Aug 2015 00:00:00 -0700 2015-19740 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-12/pdf/2015-19740.pdf Notice - Pediatric Advisory Committee; Notice of Meeting https://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19729.html https://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19729.html Wed, 12 Aug 2015 00:00:00 -0700 2015-19729 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-12/pdf/2015-19729.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Irradiation in the Production, Processing and Handling of Food https://regulations.justia.com/regulations/fedreg/2015/08/11/2015-19681.html https://regulations.justia.com/regulations/fedreg/2015/08/11/2015-19681.html Tue, 11 Aug 2015 00:00:00 -0700 2015-19681 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-11/pdf/2015-19681.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations Under the Federal Import Milk Act https://regulations.justia.com/regulations/fedreg/2015/08/11/2015-19669.html https://regulations.justia.com/regulations/fedreg/2015/08/11/2015-19669.html Tue, 11 Aug 2015 00:00:00 -0700 2015-19669 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-11/pdf/2015-19669.pdf Notice - Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting https://regulations.justia.com/regulations/fedreg/2015/08/10/2015-19548.html https://regulations.justia.com/regulations/fedreg/2015/08/10/2015-19548.html Mon, 10 Aug 2015 00:00:00 -0700 2015-19548 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-10/pdf/2015-19548.pdf Notice - Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting https://regulations.justia.com/regulations/fedreg/2015/08/10/2015-19547.html https://regulations.justia.com/regulations/fedreg/2015/08/10/2015-19547.html Mon, 10 Aug 2015 00:00:00 -0700 2015-19547 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-10/pdf/2015-19547.pdf Notice - Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Correction https://regulations.justia.com/regulations/fedreg/2015/08/07/2015-19487.html https://regulations.justia.com/regulations/fedreg/2015/08/07/2015-19487.html Fri, 07 Aug 2015 00:00:00 -0700 2015-19487 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-07/pdf/2015-19487.pdf Notice - Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Reopening of Comment Period; Correction https://regulations.justia.com/regulations/fedreg/2015/08/07/2015-19418.html https://regulations.justia.com/regulations/fedreg/2015/08/07/2015-19418.html Fri, 07 Aug 2015 00:00:00 -0700 2015-19418 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-07/pdf/2015-19418.pdf Notice - Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs; Revised Draft Guidance for Industry (Revision 2); Availability https://regulations.justia.com/regulations/fedreg/2015/08/06/2015-19244.html https://regulations.justia.com/regulations/fedreg/2015/08/06/2015-19244.html Thu, 06 Aug 2015 00:00:00 -0700 2015-19244 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-06/pdf/2015-19244.pdf Notice - Use of Nanomaterials in Food for Animals; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/05/2015-19179.html https://regulations.justia.com/regulations/fedreg/2015/08/05/2015-19179.html Wed, 05 Aug 2015 00:00:00 -0700 2015-19179 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-05/pdf/2015-19179.pdf Notice - Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/05/2015-19178.html https://regulations.justia.com/regulations/fedreg/2015/08/05/2015-19178.html Wed, 05 Aug 2015 00:00:00 -0700 2015-19178 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-05/pdf/2015-19178.pdf Rule - Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker https://regulations.justia.com/regulations/fedreg/2015/08/05/2015-19177.html https://regulations.justia.com/regulations/fedreg/2015/08/05/2015-19177.html Wed, 05 Aug 2015 00:00:00 -0700 2015-19177 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-05/pdf/2015-19177.pdf Rule - Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device https://regulations.justia.com/regulations/fedreg/2015/08/04/2015-19074.html https://regulations.justia.com/regulations/fedreg/2015/08/04/2015-19074.html Tue, 04 Aug 2015 00:00:00 -0700 2015-19074 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-04/pdf/2015-19074.pdf Rule - Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas Vaginalis https://regulations.justia.com/regulations/fedreg/2015/08/04/2015-19072.html https://regulations.justia.com/regulations/fedreg/2015/08/04/2015-19072.html Tue, 04 Aug 2015 00:00:00 -0700 2015-19072 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-04/pdf/2015-19072.pdf Notice - Evidentiary Considerations for Integration of Biomarkers in Drug Development; Notice of Public Meeting; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/08/04/2015-19037.html https://regulations.justia.com/regulations/fedreg/2015/08/04/2015-19037.html Tue, 04 Aug 2015 00:00:00 -0700 2015-19037 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-04/pdf/2015-19037.pdf Rule - Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments; Confirmation of Effective Date https://regulations.justia.com/regulations/fedreg/2015/08/04/2015-18996.html https://regulations.justia.com/regulations/fedreg/2015/08/04/2015-18996.html Tue, 04 Aug 2015 00:00:00 -0700 2015-18996 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-08-04/pdf/2015-18996.pdf Notice - Understanding Potential Intervention Measures To Reduce the Risk of Foodborne Illness From Consumption of Cheese Manufactured From Unpasteurized Milk https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18972.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18972.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18972 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18972.pdf Notice - Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop; Public Workshop https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18969.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18969.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18969 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18969.pdf Notice - Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18968.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18968.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18968 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18968.pdf Notice - Joint Food and Drug Administration/Health Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18960.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18960.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18960 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18960.pdf Notice - Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18957.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18957.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18957 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18957.pdf Notice - Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18956.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18956.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18956 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18956.pdf Notice - Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections; Public Meeting https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18919.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18919.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18919 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18919.pdf Notice - Outsourcing Facility Fee Rates for Fiscal Year 2016 https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18916.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18916.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18916 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18916.pdf Notice - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2016 https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18915.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18915.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18915 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18915.pdf Notice - Prescription Drug User Fee Rates for Fiscal Year 2016 https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18914.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18914.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18914 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18914.pdf Notice - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2016 https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18913.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18913.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18913 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18913.pdf Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18912.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18912.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18912 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18912.pdf Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18911.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18911.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18911 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18911.pdf Notice - Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18910.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18910.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18910 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18910.pdf Notice - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2016 https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18909.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18909.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18909 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18909.pdf Notice - Biosimilar User Fee Rates for Fiscal Year 2016 https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18908.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18908.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18908 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18908.pdf Notice - Medical Device User Fee Rates for Fiscal Year 2016 https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18907.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18907.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18907 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18907.pdf Notice - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2016 https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18906.html https://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18906.html Mon, 03 Aug 2015 00:00:00 -0700 2015-18906 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18906.pdf