<![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?registers=between&min-day=1&min-month=1&max-day=31&max-month=12 Sat, 27 Apr 2024 06:13:24 -0700 Sat, 27 Apr 2024 06:13:24 -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?registers=between&min-day=1&min-month=1&max-day=31&max-month=12 Notice - Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications; Public Meeting https://regulations.justia.com/regulations/fedreg/2015/09/11/2015-22949.html https://regulations.justia.com/regulations/fedreg/2015/09/11/2015-22949.html Fri, 11 Sep 2015 00:00:00 -0700 2015-22949 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-11/pdf/2015-22949.pdf Notice - Nonclinical Evaluation of Endocrine-Related Drug Toxicity; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22683.html https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22683.html Wed, 09 Sep 2015 00:00:00 -0700 2015-22683 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22683.pdf Proposed Rule - Homeopathic Product Regulation: Evaluating the Food and Drug Administration's Regulatory Framework After a Quarter-Century; Reopening of the Comment Period https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22682.html https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22682.html Wed, 09 Sep 2015 00:00:00 -0700 2015-22682 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22682.pdf 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 https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22680.html https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22680.html Wed, 09 Sep 2015 00:00:00 -0700 2015-22680 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22680.pdf Notice - Formal Dispute Resolution: Appeals Above the Division Level; Revised Draft Guidance for Industry and Review Staff; Availability https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22678.html https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22678.html Wed, 09 Sep 2015 00:00:00 -0700 2015-22678 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22678.pdf Notice - Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22677.html https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22677.html Wed, 09 Sep 2015 00:00:00 -0700 2015-22677 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22677.pdf Notice - Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22676.html https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22676.html Wed, 09 Sep 2015 00:00:00 -0700 2015-22676 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22676.pdf Notice - Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22675.html https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22675.html Wed, 09 Sep 2015 00:00:00 -0700 2015-22675 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22675.pdf Notice - Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop; Public Workshop; Correction https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22674.html https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22674.html Wed, 09 Sep 2015 00:00:00 -0700 2015-22674 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22674.pdf 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 https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22673.html https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22673.html Wed, 09 Sep 2015 00:00:00 -0700 2015-22673 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22673.pdf Notice - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22593.html https://regulations.justia.com/regulations/fedreg/2015/09/09/2015-22593.html Wed, 09 Sep 2015 00:00:00 -0700 2015-22593 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-09/pdf/2015-22593.pdf Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations https://regulations.justia.com/regulations/fedreg/2015/09/08/2015-22507.html https://regulations.justia.com/regulations/fedreg/2015/09/08/2015-22507.html Tue, 08 Sep 2015 00:00:00 -0700 2015-22507 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-22507.pdf Notice - Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Second Edition; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/09/08/2015-22494.html https://regulations.justia.com/regulations/fedreg/2015/09/08/2015-22494.html Tue, 08 Sep 2015 00:00:00 -0700 2015-22494 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-22494.pdf Rule - New Animal Drugs; Approval of New Animal Drug Applications https://regulations.justia.com/regulations/fedreg/2015/09/04/2015-21905.html https://regulations.justia.com/regulations/fedreg/2015/09/04/2015-21905.html Fri, 04 Sep 2015 00:00:00 -0700 2015-21905 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-09-04/pdf/2015-21905.pdf Notice - Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal https://regulations.justia.com/regulations/fedreg/2015/09/03/2015-21914.html https://regulations.justia.com/regulations/fedreg/2015/09/03/2015-21914.html Thu, 03 Sep 2015 00:00:00 -0700 2015-21914 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-03/pdf/2015-21914.pdf Notice - Compressed Medical Gases-Warning Letters for Specific Violations Covering Liquid and Gaseous Oxygen; Withdrawal of Compliance Policy Guide https://regulations.justia.com/regulations/fedreg/2015/09/03/2015-21874.html https://regulations.justia.com/regulations/fedreg/2015/09/03/2015-21874.html Thu, 03 Sep 2015 00:00:00 -0700 2015-21874 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-03/pdf/2015-21874.pdf 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 https://regulations.justia.com/regulations/fedreg/2015/09/02/2015-21645.html https://regulations.justia.com/regulations/fedreg/2015/09/02/2015-21645.html Wed, 02 Sep 2015 00:00:00 -0700 2015-21645 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-02/pdf/2015-21645.pdf Notice - Food and Drug Administration/Drug Information Association Oligonucleotide-Based Therapeutics Conference 2015 https://regulations.justia.com/regulations/fedreg/2015/09/02/2015-21639.html https://regulations.justia.com/regulations/fedreg/2015/09/02/2015-21639.html Wed, 02 Sep 2015 00:00:00 -0700 2015-21639 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-02/pdf/2015-21639.pdf Notice - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Middle East Respiratory Syndrome Coronavirus; Availability https://regulations.justia.com/regulations/fedreg/2015/09/01/2015-21585.html https://regulations.justia.com/regulations/fedreg/2015/09/01/2015-21585.html Tue, 01 Sep 2015 00:00:00 -0700 2015-21585 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-01/pdf/2015-21585.pdf Notice - Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/09/01/2015-21583.html https://regulations.justia.com/regulations/fedreg/2015/09/01/2015-21583.html Tue, 01 Sep 2015 00:00:00 -0700 2015-21583 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-01/pdf/2015-21583.pdf 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 https://regulations.justia.com/regulations/fedreg/2015/09/01/2015-21582.html https://regulations.justia.com/regulations/fedreg/2015/09/01/2015-21582.html Tue, 01 Sep 2015 00:00:00 -0700 2015-21582 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-09-01/pdf/2015-21582.pdf 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 Notice - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/07/31/2015-18796.html https://regulations.justia.com/regulations/fedreg/2015/07/31/2015-18796.html Fri, 31 Jul 2015 00:00:00 -0700 2015-18796 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-31/pdf/2015-18796.pdf Notice - Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Reopening of Comment Period https://regulations.justia.com/regulations/fedreg/2015/07/31/2015-18782.html https://regulations.justia.com/regulations/fedreg/2015/07/31/2015-18782.html Fri, 31 Jul 2015 00:00:00 -0700 2015-18782 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-31/pdf/2015-18782.pdf Notice - Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products; Extension of Comment Period https://regulations.justia.com/regulations/fedreg/2015/07/30/2015-18668.html https://regulations.justia.com/regulations/fedreg/2015/07/30/2015-18668.html Thu, 30 Jul 2015 00:00:00 -0700 2015-18668 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-30/pdf/2015-18668.pdf Proposed Rule - The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/07/30/2015-18655.html https://regulations.justia.com/regulations/fedreg/2015/07/30/2015-18655.html Thu, 30 Jul 2015 00:00:00 -0700 2015-18655 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-07-30/pdf/2015-18655.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Veterinary Feed Directive https://regulations.justia.com/regulations/fedreg/2015/07/30/2015-18650.html https://regulations.justia.com/regulations/fedreg/2015/07/30/2015-18650.html Thu, 30 Jul 2015 00:00:00 -0700 2015-18650 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-30/pdf/2015-18650.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Enforcement Notifications https://regulations.justia.com/regulations/fedreg/2015/07/30/2015-18649.html https://regulations.justia.com/regulations/fedreg/2015/07/30/2015-18649.html Thu, 30 Jul 2015 00:00:00 -0700 2015-18649 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-30/pdf/2015-18649.pdf Notice - Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/07/28/2015-18448.html https://regulations.justia.com/regulations/fedreg/2015/07/28/2015-18448.html Tue, 28 Jul 2015 00:00:00 -0700 2015-18448 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-28/pdf/2015-18448.pdf Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products https://regulations.justia.com/regulations/fedreg/2015/07/28/2015-18410.html https://regulations.justia.com/regulations/fedreg/2015/07/28/2015-18410.html Tue, 28 Jul 2015 00:00:00 -0700 2015-18410 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-28/pdf/2015-18410.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications https://regulations.justia.com/regulations/fedreg/2015/07/27/2015-18295.html https://regulations.justia.com/regulations/fedreg/2015/07/27/2015-18295.html Mon, 27 Jul 2015 00:00:00 -0700 2015-18295 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-27/pdf/2015-18295.pdf Notice - Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/07/27/2015-18270.html https://regulations.justia.com/regulations/fedreg/2015/07/27/2015-18270.html Mon, 27 Jul 2015 00:00:00 -0700 2015-18270 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-27/pdf/2015-18270.pdf Proposed Rule - Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Reopening of the Comment Period as to Specific Documents https://regulations.justia.com/regulations/fedreg/2015/07/27/2015-17929.html https://regulations.justia.com/regulations/fedreg/2015/07/27/2015-17929.html Mon, 27 Jul 2015 00:00:00 -0700 2015-17929 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-07-27/pdf/2015-17929.pdf Proposed Rule - Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Supplemental Proposed Rule To Solicit Comment on Limited Additional Provisions https://regulations.justia.com/regulations/fedreg/2015/07/27/2015-17928.html https://regulations.justia.com/regulations/fedreg/2015/07/27/2015-17928.html Mon, 27 Jul 2015 00:00:00 -0700 2015-17928 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-07-27/pdf/2015-17928.pdf Notice - Risk Evaluation and Mitigation Strategies: Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access; Public Meeting, Request for Comments https://regulations.justia.com/regulations/fedreg/2015/07/24/2015-18149.html https://regulations.justia.com/regulations/fedreg/2015/07/24/2015-18149.html Fri, 24 Jul 2015 00:00:00 -0700 2015-18149 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-24/pdf/2015-18149.pdf Notice - Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability https://regulations.justia.com/regulations/fedreg/2015/07/24/2015-18142.html https://regulations.justia.com/regulations/fedreg/2015/07/24/2015-18142.html Fri, 24 Jul 2015 00:00:00 -0700 2015-18142 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-24/pdf/2015-18142.pdf Proposed Rule - User Fee Program To Provide for Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications https://regulations.justia.com/regulations/fedreg/2015/07/24/2015-18141.html https://regulations.justia.com/regulations/fedreg/2015/07/24/2015-18141.html Fri, 24 Jul 2015 00:00:00 -0700 2015-18141 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-07-24/pdf/2015-18141.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Petition To Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements https://regulations.justia.com/regulations/fedreg/2015/07/24/2015-18140.html https://regulations.justia.com/regulations/fedreg/2015/07/24/2015-18140.html Fri, 24 Jul 2015 00:00:00 -0700 2015-18140 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-24/pdf/2015-18140.pdf Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices; Correction https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18043.html https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18043.html Thu, 23 Jul 2015 00:00:00 -0700 2015-18043 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-23/pdf/2015-18043.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18042.html https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18042.html Thu, 23 Jul 2015 00:00:00 -0700 2015-18042 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-23/pdf/2015-18042.pdf Notice - Intent To Review a Study Data Reviewer's Guide Template https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18027.html https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18027.html Thu, 23 Jul 2015 00:00:00 -0700 2015-18027 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-23/pdf/2015-18027.pdf Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18026.html https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18026.html Thu, 23 Jul 2015 00:00:00 -0700 2015-18026 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-23/pdf/2015-18026.pdf Notice - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability; Correction https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18024.html https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18024.html Thu, 23 Jul 2015 00:00:00 -0700 2015-18024 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-23/pdf/2015-18024.pdf Notice - Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18023.html https://regulations.justia.com/regulations/fedreg/2015/07/23/2015-18023.html Thu, 23 Jul 2015 00:00:00 -0700 2015-18023 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-23/pdf/2015-18023.pdf Notice - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting https://regulations.justia.com/regulations/fedreg/2015/07/22/2015-17985.html https://regulations.justia.com/regulations/fedreg/2015/07/22/2015-17985.html Wed, 22 Jul 2015 00:00:00 -0700 2015-17985 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-22/pdf/2015-17985.pdf Rule - Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Correction; Confirmation of Effective Date https://regulations.justia.com/regulations/fedreg/2015/07/22/2015-17930.html https://regulations.justia.com/regulations/fedreg/2015/07/22/2015-17930.html Wed, 22 Jul 2015 00:00:00 -0700 2015-17930 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-07-22/pdf/2015-17930.pdf Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant Facility Types https://regulations.justia.com/regulations/fedreg/2015/07/21/2015-17809.html https://regulations.justia.com/regulations/fedreg/2015/07/21/2015-17809.html Tue, 21 Jul 2015 00:00:00 -0700 2015-17809 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-21/pdf/2015-17809.pdf Notice - Medical Device Patient Labeling; Request for Comments; Public Workshop https://regulations.justia.com/regulations/fedreg/2015/07/21/2015-17800.html https://regulations.justia.com/regulations/fedreg/2015/07/21/2015-17800.html Tue, 21 Jul 2015 00:00:00 -0700 2015-17800 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-21/pdf/2015-17800.pdf Notice - Cooperative Agreement for Research, Education, and Outreach in Support of the Food and Drug Administration Food Safety Modernization Act https://regulations.justia.com/regulations/fedreg/2015/07/21/2015-17795.html https://regulations.justia.com/regulations/fedreg/2015/07/21/2015-17795.html Tue, 21 Jul 2015 00:00:00 -0700 2015-17795 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-21/pdf/2015-17795.pdf Notice - Determination That TESSALON (Benzonatate) Capsules and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17730.html https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17730.html Mon, 20 Jul 2015 00:00:00 -0700 2015-17730 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-20/pdf/2015-17730.pdf Notice - List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Extension of Nomination Period https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17729.html https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17729.html Mon, 20 Jul 2015 00:00:00 -0700 2015-17729 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-20/pdf/2015-17729.pdf Notice - Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17726.html https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17726.html Mon, 20 Jul 2015 00:00:00 -0700 2015-17726 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-20/pdf/2015-17726.pdf Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Market Claims in Direct-to-Consumer Prescription Drug Print Ads https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17725.html https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17725.html Mon, 20 Jul 2015 00:00:00 -0700 2015-17725 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-20/pdf/2015-17725.pdf Rule - Regulatory Hearing Before the Food and Drug Administration; Technical Amendment https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17714.html https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17714.html Mon, 20 Jul 2015 00:00:00 -0700 2015-17714 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-07-20/pdf/2015-17714.pdf Notice - David J. Brancato: Grant of Special Termination; Final Order Terminating Debarment https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17712.html https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17712.html Mon, 20 Jul 2015 00:00:00 -0700 2015-17712 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-20/pdf/2015-17712.pdf Notice - Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17684.html https://regulations.justia.com/regulations/fedreg/2015/07/20/2015-17684.html Mon, 20 Jul 2015 00:00:00 -0700 2015-17684 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-20/pdf/2015-17684.pdf Notice - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting https://regulations.justia.com/regulations/fedreg/2015/07/17/2015-17559.html https://regulations.justia.com/regulations/fedreg/2015/07/17/2015-17559.html Fri, 17 Jul 2015 00:00:00 -0700 2015-17559 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-17/pdf/2015-17559.pdf Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act https://regulations.justia.com/regulations/fedreg/2015/07/17/2015-17558.html https://regulations.justia.com/regulations/fedreg/2015/07/17/2015-17558.html Fri, 17 Jul 2015 00:00:00 -0700 2015-17558 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-17/pdf/2015-17558.pdf Notice - Testicular Toxicity: Evaluation During Drug Development; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/07/17/2015-17557.html https://regulations.justia.com/regulations/fedreg/2015/07/17/2015-17557.html Fri, 17 Jul 2015 00:00:00 -0700 2015-17557 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-17/pdf/2015-17557.pdf Notice - Public Meeting on Patient-Focused Drug Development for Huntington's and Parkinson's Diseases https://regulations.justia.com/regulations/fedreg/2015/07/17/2015-17556.html https://regulations.justia.com/regulations/fedreg/2015/07/17/2015-17556.html Fri, 17 Jul 2015 00:00:00 -0700 2015-17556 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-17/pdf/2015-17556.pdf Proposed Rule - Alzchem AG; Filing of Food Additive Petition (Animal Use) https://regulations.justia.com/regulations/fedreg/2015/07/16/2015-17379.html https://regulations.justia.com/regulations/fedreg/2015/07/16/2015-17379.html Thu, 16 Jul 2015 00:00:00 -0700 2015-17379 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-07-16/pdf/2015-17379.pdf Rule - Canned Pacific Salmon; Technical Amendment https://regulations.justia.com/regulations/fedreg/2015/07/15/2015-17249.html https://regulations.justia.com/regulations/fedreg/2015/07/15/2015-17249.html Wed, 15 Jul 2015 00:00:00 -0700 2015-17249 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-07-15/pdf/2015-17249.pdf Notice - Preparation for International Cooperation on Cosmetics Regulation https://regulations.justia.com/regulations/fedreg/2015/07/15/2015-17248.html https://regulations.justia.com/regulations/fedreg/2015/07/15/2015-17248.html Wed, 15 Jul 2015 00:00:00 -0700 2015-17248 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-07-15/pdf/2015-17248.pdf