Federal Register Recent Federal Regulation Documents - Justia Regulation Tracker - Justia Regulations Trackerhttps://regulations.justia.com/regulations/fedreg/agencies/alcohol-tobacco-firearms-and-explosives-bureau/2015/08?limit=200®isters=between&min-day=1&max-day=31&mode=atom2024-05-03T07:38:51-07:00Justia Inchttps://www.justia.com/Justia Regulations Trackerhttps://regulations.justia.com/images/justiafedregulations.gifCopyright 2011 Justia Inchttps://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21383.htmlNotice - Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability2015-08-28T00:00:00-07:002015-08-28T00:00:00-07:002015-21383Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21383.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21382.htmlProposed Rule - Designation of Official Names and Proper Names for Certain Biological Products2015-08-28T00:00:00-07:002015-08-28T00:00:00-07:002015-21382Proposed Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21382.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/28/2015-21271.htmlNotice - Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Guidance for Tobacco Retailers; Availability2015-08-28T00:00:00-07:002015-08-28T00:00:00-07:002015-21271Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21271.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21237.htmlRule - Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene Amplification Assay2015-08-27T00:00:00-07:002015-08-27T00:00:00-07:002015-21237Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-27/pdf/2015-21237.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21236.htmlNotice - Determination That BIAXIN XL Oral Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness2015-08-27T00:00:00-07:002015-08-27T00:00:00-07:002015-21236Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-27/pdf/2015-21236.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/27/2015-21235.htmlNotice - Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry; Availability2015-08-27T00:00:00-07:002015-08-27T00:00:00-07:002015-21235Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-27/pdf/2015-21235.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21149.htmlNotice - Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Extension of Comment Period2015-08-26T00:00:00-07:002015-08-26T00:00:00-07:002015-21149Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-26/pdf/2015-21149.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21095.htmlNotice - In Vitro Diagnostic Testing for Direct Oral Anticoagulants; Public Workshop; Request for Comments2015-08-26T00:00:00-07:002015-08-26T00:00:00-07:002015-21095Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-26/pdf/2015-21095.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/26/2015-21036.htmlNotice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting2015-08-26T00:00:00-07:002015-08-26T00:00:00-07:002015-21036Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-26/pdf/2015-21036.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/25/2015-20948.htmlNotice - Medical Device Epidemiology Network Registry Task Force Report; Availability, Web Site Location and Request for Comments2015-08-25T00:00:00-07:002015-08-25T00:00:00-07:002015-20948Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-25/pdf/2015-20948.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20833.htmlNotice - Use of Rare Pediatric Disease Priority Review Voucher; Approval of a Drug Product2015-08-24T00:00:00-07:002015-08-24T00:00:00-07:002015-20833Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20833.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20832.htmlNotice - Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Notice of Public Workshop; Correction2015-08-24T00:00:00-07:002015-08-24T00:00:00-07:002015-20832Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20832.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20820.htmlNotice - Science Board to the Food and Drug Administration; Notice of Meeting2015-08-24T00:00:00-07:002015-08-24T00:00:00-07:002015-20820Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20820.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20780.htmlNotice - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant2015-08-24T00:00:00-07:002015-08-24T00:00:00-07:002015-20780Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20780.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20760.htmlNotice - Agency Information Collection Activities; Proposed Collection; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act2015-08-24T00:00:00-07:002015-08-24T00:00:00-07:002015-20760Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20760.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/24/2015-20759.htmlProposed 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 Period2015-08-24T00:00:00-07:002015-08-24T00:00:00-07:002015-20759Proposed Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20759.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/21/2015-20676.htmlRule - Listing of Color Additives Exempt From Certification; Spirulina Extract2015-08-21T00:00:00-07:002015-08-21T00:00:00-07:002015-20676Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-21/pdf/2015-20676.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20562.htmlNotice - Agency Information Collection Activities; Proposed Collection; Comment Request; Comment Request; Interstate Shellfish Dealers Certificate2015-08-20T00:00:00-07:002015-08-20T00:00:00-07:002015-20562Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20562.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20561.htmlNotice - Lisa Marie Coroniti: Debarment Order2015-08-20T00:00:00-07:002015-08-20T00:00:00-07:002015-20561Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20561.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20557.htmlNotice - Collecting On-Farm Antimicrobial Use and Resistance Data; Public Meeting; Request for Comments2015-08-20T00:00:00-07:002015-08-20T00:00:00-07:002015-20557Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20557.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20556.htmlNotice - Technical Document for Using the Inactive Ingredient Database; Establishment of a Public Docket2015-08-20T00:00:00-07:002015-08-20T00:00:00-07:002015-20556Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20556.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20554.htmlRule - Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act2015-08-20T00:00:00-07:002015-08-20T00:00:00-07:002015-20554Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20554.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20541.htmlNotice - Pediatric Advisory Committee; Notice of Meeting; Correction2015-08-20T00:00:00-07:002015-08-20T00:00:00-07:002015-20541Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20541.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/20/2015-20540.htmlNotice - Bone, Reproductive, and Urologic Drugs Advisory Committee; Notice of Meeting2015-08-20T00:00:00-07:002015-08-20T00:00:00-07:002015-20540Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-20/pdf/2015-20540.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20430.htmlNotice - Center for Devices and Radiological Health Participation in International Medical Device Regulators Forum, Regulated Product Submission, Table of Contents Pilot Program2015-08-19T00:00:00-07:002015-08-19T00:00:00-07:002015-20430Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-19/pdf/2015-20430.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20429.htmlNotice - Medical Devices; Export Certificates; Food and Drug Administration Export Reform and Enhancement Act of 1996; Certification Fees2015-08-19T00:00:00-07:002015-08-19T00:00:00-07:002015-20429Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-19/pdf/2015-20429.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20398.htmlNotice - Arthritis Advisory Committee; Notice of Meeting2015-08-19T00:00:00-07:002015-08-19T00:00:00-07:002015-20398Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-19/pdf/2015-20398.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/19/2015-20397.htmlNotice - Obstetrics and Gynecology Device Panel of the Medical Device Advisory Committee; Correction2015-08-19T00:00:00-07:002015-08-19T00:00:00-07:002015-20397Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-19/pdf/2015-20397.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20317.htmlRule - Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device2015-08-18T00:00:00-07:002015-08-18T00:00:00-07:002015-20317Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20317.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20316.htmlNotice - Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.22015-08-18T00:00:00-07:002015-08-18T00:00:00-07:002015-20316Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20316.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20312.htmlNotice - Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines; Guidance for Industry; Availability2015-08-18T00:00:00-07:002015-08-18T00:00:00-07:002015-20312Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20312.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20309.htmlNotice - Pilot Program for Medical Device Reporting on Malfunctions2015-08-18T00:00:00-07:002015-08-18T00:00:00-07:002015-20309Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20309.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20308.htmlNotice - 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; Availability2015-08-18T00:00:00-07:002015-08-18T00:00:00-07:002015-20308Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20308.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/18/2015-20306.htmlNotice - Uncomplicated Gonorrhea: Developing Drugs for Treatment; Guidance for Industry; Availability2015-08-18T00:00:00-07:002015-08-18T00:00:00-07:002015-20306Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20306.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20235.htmlNotice - Rare Diseases: Common Issues in Drug Development; Draft Guidance for Industry; Availability2015-08-17T00:00:00-07:002015-08-17T00:00:00-07:002015-20235Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20235.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20230.htmlNotice - Botanical Drug Development; Draft Guidance for Industry; Availability2015-08-17T00:00:00-07:002015-08-17T00:00:00-07:002015-20230Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20230.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20229.htmlNotice - Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability2015-08-17T00:00:00-07:002015-08-17T00:00:00-07:002015-20229Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20229.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20228.htmlNotice - Qualification of Biomarker-Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease; Draft Guidance for Industry; Availability2015-08-17T00:00:00-07:002015-08-17T00:00:00-07:002015-20228Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20228.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20177.htmlRule - Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid2015-08-17T00:00:00-07:002015-08-17T00:00:00-07:002015-20177Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20177.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20174.htmlNotice - Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Extension of Comment Period2015-08-17T00:00:00-07:002015-08-17T00:00:00-07:002015-20174Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20174.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20130.htmlNotice - Disease Natural History Database Development-(U24)2015-08-17T00:00:00-07:002015-08-17T00:00:00-07:002015-20130Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20130.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20129.htmlNotice - Scientific Inquiry Into How Mobile Health and Social Data Sources May Inform Medical Product Safety and Efficacy; Public Workshop; Request for Comments2015-08-17T00:00:00-07:002015-08-17T00:00:00-07:002015-20129Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20129.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/17/2015-20127.htmlNotice - Physiological Closed-Loop Controlled Devices; Public Workshop; Request for Comments2015-08-17T00:00:00-07:002015-08-17T00:00:00-07:002015-20127Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20127.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/14/2015-20051.htmlNotice - Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting2015-08-14T00:00:00-07:002015-08-14T00:00:00-07:002015-20051Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-20051.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/14/2015-20050.htmlNotice - National Mammography Quality Assurance Advisory Committee, Renewal2015-08-14T00:00:00-07:002015-08-14T00:00:00-07:002015-20050Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-20050.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/14/2015-20005.htmlNotice - 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; Availability2015-08-14T00:00:00-07:002015-08-14T00:00:00-07:002015-20005Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-20005.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/14/2015-19991.htmlNotice - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 0402015-08-14T00:00:00-07:002015-08-14T00:00:00-07:002015-19991Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-19991.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/14/2015-19990.htmlNotice - Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop; Request for Comments2015-08-14T00:00:00-07:002015-08-14T00:00:00-07:002015-19990Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-19990.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/14/2015-19983.htmlNotice - 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: Availability2015-08-14T00:00:00-07:002015-08-14T00:00:00-07:002015-19983Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-14/pdf/2015-19983.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/13/2015-19884.htmlProposed Rule - Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use)2015-08-13T00:00:00-07:002015-08-13T00:00:00-07:002015-19884Proposed Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-13/pdf/2015-19884.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19768.htmlNotice - 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 Date2015-08-12T00:00:00-07:002015-08-12T00:00:00-07:002015-19768Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-12/pdf/2015-19768.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19741.htmlNotice - Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration2015-08-12T00:00:00-07:002015-08-12T00:00:00-07:002015-19741Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-12/pdf/2015-19741.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19740.htmlNotice - Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability2015-08-12T00:00:00-07:002015-08-12T00:00:00-07:002015-19740Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-12/pdf/2015-19740.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/12/2015-19729.htmlNotice - Pediatric Advisory Committee; Notice of Meeting2015-08-12T00:00:00-07:002015-08-12T00:00:00-07:002015-19729Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-12/pdf/2015-19729.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/11/2015-19681.htmlNotice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Irradiation in the Production, Processing and Handling of Food2015-08-11T00:00:00-07:002015-08-11T00:00:00-07:002015-19681Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-11/pdf/2015-19681.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/11/2015-19669.htmlNotice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations Under the Federal Import Milk Act2015-08-11T00:00:00-07:002015-08-11T00:00:00-07:002015-19669Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-11/pdf/2015-19669.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/10/2015-19548.htmlNotice - Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting2015-08-10T00:00:00-07:002015-08-10T00:00:00-07:002015-19548Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-10/pdf/2015-19548.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/10/2015-19547.htmlNotice - Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting2015-08-10T00:00:00-07:002015-08-10T00:00:00-07:002015-19547Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-10/pdf/2015-19547.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/07/2015-19487.htmlNotice - Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Correction2015-08-07T00:00:00-07:002015-08-07T00:00:00-07:002015-19487Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-07/pdf/2015-19487.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/07/2015-19418.htmlNotice - Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Reopening of Comment Period; Correction2015-08-07T00:00:00-07:002015-08-07T00:00:00-07:002015-19418Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-07/pdf/2015-19418.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/06/2015-19244.htmlNotice - 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); Availability2015-08-06T00:00:00-07:002015-08-06T00:00:00-07:002015-19244Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-06/pdf/2015-19244.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/05/2015-19179.htmlNotice - Use of Nanomaterials in Food for Animals; Guidance for Industry; Availability2015-08-05T00:00:00-07:002015-08-05T00:00:00-07:002015-19179Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-05/pdf/2015-19179.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/05/2015-19178.htmlNotice - Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen; Guidance for Industry; Availability2015-08-05T00:00:00-07:002015-08-05T00:00:00-07:002015-19178Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-05/pdf/2015-19178.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/05/2015-19177.htmlRule - Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker2015-08-05T00:00:00-07:002015-08-05T00:00:00-07:002015-19177Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-05/pdf/2015-19177.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/04/2015-19074.htmlRule - Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device2015-08-04T00:00:00-07:002015-08-04T00:00:00-07:002015-19074Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-04/pdf/2015-19074.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/04/2015-19072.htmlRule - Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas Vaginalis2015-08-04T00:00:00-07:002015-08-04T00:00:00-07:002015-19072Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-04/pdf/2015-19072.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/04/2015-19037.htmlNotice - Evidentiary Considerations for Integration of Biomarkers in Drug Development; Notice of Public Meeting; Request for Comments2015-08-04T00:00:00-07:002015-08-04T00:00:00-07:002015-19037Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-04/pdf/2015-19037.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/04/2015-18996.htmlRule - Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments; Confirmation of Effective Date2015-08-04T00:00:00-07:002015-08-04T00:00:00-07:002015-18996Rulehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-04/pdf/2015-18996.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18972.htmlNotice - Understanding Potential Intervention Measures To Reduce the Risk of Foodborne Illness From Consumption of Cheese Manufactured From Unpasteurized Milk2015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18972Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18972.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18969.htmlNotice - Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop; Public Workshop2015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18969Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18969.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18968.htmlNotice - 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; Availability2015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18968Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18968.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18960.htmlNotice - Joint Food and Drug Administration/Health Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada2015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18960Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18960.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18957.htmlNotice - Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop2015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18957Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18957.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18956.htmlNotice - 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; Availability2015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18956Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18956.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18919.htmlNotice - Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections; Public Meeting2015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18919Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18919.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18916.htmlNotice - Outsourcing Facility Fee Rates for Fiscal Year 20162015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18916Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18916.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18915.htmlNotice - 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 20162015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18915Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18915.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18914.htmlNotice - Prescription Drug User Fee Rates for Fiscal Year 20162015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18914Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18914.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18913.htmlNotice - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 20162015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18913Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18913.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18912.htmlNotice - 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 Capacities2015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18912Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18912.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18911.htmlNotice - 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 Act2015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18911Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18911.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18910.htmlNotice - Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments2015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18910Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18910.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18909.htmlNotice - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 20162015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18909Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18909.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18908.htmlNotice - Biosimilar User Fee Rates for Fiscal Year 20162015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18908Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18908.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18907.htmlNotice - Medical Device User Fee Rates for Fiscal Year 20162015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18907Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18907.pdfhttps://regulations.justia.com/regulations/fedreg/2015/08/03/2015-18906.htmlNotice - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 20162015-08-03T00:00:00-07:002015-08-03T00:00:00-07:002015-18906Noticehttp://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18906.pdf