FEDERAL REGISTER INDEX January–November 2020

Food and Drug Administration Approval of New Animal Drug Applications; Withdrawal of Approval of RULES New Animal Drug Applications; Change of Sponsor – 45306 ( Jul 28) New Animal Drugs; Approval of New Animal Drug Applications; Banned Devices: Withdrawal of Approval of New Animal Drug Applications; Change of Electrical Stimulation Devices for Self-Injurious or Aggressive Sponsor; Change of Sponsors' Name and Addresses – 18114 ( Apr 1) Behavior – 13312 ( Mar 6) New Animal Drugs; Approval of New Animal Drug Applications; Definition of the Term Biological Product – 10057 ( Feb 21) Withdrawal of Approval of New Animal Drug Applications; Changes of Food Additive Regulation: Sponsor; Change of Sponsor's Address – 4204 ( Jan 24) Synthetic Flavoring Agents and Adjuvants; Confirmation of Effective New Animal Drugs; Withdrawal of Approval of a New Animal Drug Date – 5555 ( Jan 31) Application; Withdrawal of Approval of Abbreviated New Animal Drug Food Additives Permitted in Feed and Drinking Water of Animals: Applications – 4210 ( Jan 24) Chromium Propionate – 48650 ( Aug 12) New Animal Drugs; Withdrawal of Approval of New Animal Drug Food Additives Permitted: Applications – 18125 ( Apr 1) Chromium Propionate; Feed and Drinking Water of Animals – 14565 Withdrawal of Approval of Abbreviated New Animal Drug ( Mar 13) Application – 45311 ( Jul 28) Silicon Dioxide; Feed and Drinking Water of Animals – 33538 ( Jun 2) Office of Regulatory Affairs Division Director; Technical Vitamin D2 Mushroom Powder; Direct Addition to Food for Human Amendments – 16549 ( Mar 24); 50780 ( Aug 18) Consumption – 41916 ( Jul 13) Postmarketing Safety Reports for Approved New Animal Drugs – 45505 Food Labeling: ( Jul 29) Gluten-Free Labeling of Fermented or Hydrolyzed Foods – 49240 ( Aug 13) Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Submission Requirements; Correction – 59427 ( Sep 22) Correction – 55587 ( Sep 9) Revision of the Nutrition and Supplement Facts Labels; Small Entity Radiology Devices: Reclassification of Medical Image Analyzers – 3545 ( Jan 22) Compliance Guide – 6045 ( Feb 4) Guidance: Regulatory Clean Up Initiative – 72899 ( Nov 16) Classification of Posterior Cervical Screw Systems: Small Entity Compliance Revocation of the Test for Mycoplasma – 51635 ( Aug 21) Guide – 26350 ( May 4) Tobacco Products; Required Warnings for Cigarette Packages and Regulatory Considerations for Human Cells, Tissues, and Cellular and Advertisements – 15638 ( Mar 18); 32293 ( May 29) Tissue-Based Products: Minimal Manipulation and Homologous Veterinary Feed Directive Drugs: Use – 43989 ( Jul 21) Contact Information – 50783 ( Aug 18) Required Warnings for Cigarette Packages and Advertisements: Small PROPOSED RULES Entity Compliance Guide – 15710 ( Mar 18) Annual Summary Reporting Requirements under the Right to Try Temporary Policy During the COVID-19 Public Health Emergency Act – 44803 ( Jul 24) Regarding the Qualified Exemption from the Standards for the Annual Summary Reporting Requirements under the Right to Try Act: Growing, Harvesting, Packing, and Holding of Produce for Human Correction – 55802 ( Sep 10) Consumption – 34508 ( Jun 5) Cheeses and Related Cheese Products; Proposal to Permit the Use of Temporary Policy Regarding Accredited Third-Party Certification Program Ultrafiltered Milk – 20891 ( Apr 15) Onsite Observation and Certificate Duration Requirements During the Color Additive Petition: COVID-19 Public Health Emergency – 23919 ( Apr 30) CooperVision, Inc.; Withdrawal – 52081 ( Aug 24) Temporary Policy Regarding Preventive Controls and Foreign Supplier Filing of Color Additive Petition: Verification Programs Food Supplier Verification Onsite Audit Colorcon, Inc. – 74304 ( Nov 20) Requirements During the COVID-19 Public Health Emergency – 17008 Ecoflora SAS – 74304 ( Nov 20) ( Mar 26) GNT USA, Inc. – 27340 ( May 8) The Declaration of Allulose and Calories from Allulose on Nutrition and Filing of Food Additive Petition: Supplement Facts Labels – 66217 ( Oct 19) Adisseo France S.A.S. – 27692 ( May 11) Unique Device Identification: Policy Regarding Compliance Dates for Class Biomin GmbH – 26902 ( May 6) I and Unclassified Devices and Certain Devices Requiring Direct LANXESS Corp. – 7682 ( Feb 11) Marking – 39477 ( Jul 1) Unilever – 10632 ( Feb 25) Importation of Prescription Drugs – 62094 ( Oct 1) Food Additive Petition: Medical Devices – 18439, 18444 ( Apr 2) Ag Chem Resources, LLC – 75971 ( Nov 27) Medical Devices: Food Additives Permitted in Feed and Drinking Water of Animals: Exemption From Premarket Notification; Class II Devices; Powered Spent Bleaching Clay – 28898 ( May 14) Wheeled Stretcher – 2018 ( Jan 14) Food Standards: Exemptions From Premarket Notification: Class II Devices – 44186 ( Jul 22) General Principles and Food Standards Modernization – 10107 ( Feb 21); Immunology and Microbiology Devices; Classification of Human 21795 ( Apr 20) Immunodeficiency Virus Drug Resistance Genotyping Assay Using Import Data in the Automated Commercial Environment for Veterinary Next Generation Sequencing Technology – 7215 ( Feb 7) Devices – 46566 ( Aug 3) Petition for an Administrative Stay of Action; Electrical Stimulation Devices Laboratory Accreditation for Analyses of Foods – 11893 ( Feb 28); 19114 for Self-Injurious or Aggressive Behavior – 50950 ( Aug 19) ( Apr 6) Medical Devices; Radiology Devices: Meetings: Classification of the Radiological Computer Aided Triage and Notification Requirements for Additional Traceability Records for Certain Software – 3543 ( Jan 22) Foods – 62632 ( Oct 5) Classification of the Radiological Computer-Assisted Diagnostic Software Microbiology Devices: for Lesions Suspicious for Cancer – 3540 ( Jan 22) Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To New Animal Drug: Be Renamed Hepatitis C Virus Antibody Tests – 18490 ( Apr 2)

1 Food and Drug Administration

Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Color Additive Certification Requests and Recordkeeping – 21250 ( Apr 16); Assay Devices Intended for Transplant Patient Management, To Be 45890 ( Jul 30) Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Combination Products: How to Prepare a Pre-Request for Transplant Patient Management – 58300 ( Sep 18) Designation – 16369 ( Mar 23) Reclassification of Human Immunodeficiency Virus Serological Diagnostic Communication Readership Survey; Withdrawal. – 21246 ( Apr 16) and Supplemental Tests and Human Immunodeficiency Virus Nucleic Cosmetic Labeling Regulations and Voluntary Cosmetic Registration Acid Diagnostic and Supplemental Tests – 10110 ( Feb 21) Program – 18993 ( Apr 3); 44539 ( Jul 23) Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Current Good Manufacturing Practice Regulations for Medicated Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Feeds – 12790 ( Mar 4); 41594 ( Jul 10) Ribonucleic Acid Tests – 18483 ( Apr 2) Current Good Manufacturing Practice Regulations for Type A Medicated Physical Medicine Devices: Articles – 10170 ( Feb 21); 41596 ( Jul 10) Reclassification of Non-Invasive Bone Growth Stimulators – 49986 ( Aug 17) Customer/Partner Service Surveys – 3389 ( Jan 21); 51449 ( Aug 20) Premarket Tobacco Product Applications and Recordkeeping Data To Support Drug Product Communications as Used by the Food and Requirements – 13840 ( Mar 10) Drug Administration – 36591 ( Jun 17) Regulations Regarding Intended Uses – 59718 ( Sep 23) Dispute Resolution Procedures for Science-Based Decisions on Products Request for Information: by the Center for Veterinary Medicine – 50827 ( Aug 18) Consumption of Certain Uncommon Produce Commodities in the United Donor Risk Assessment Questionnaire for the Food and Drug States; Establishment of a Public Docket – 48124 ( Aug 10) Administration/National Heart, Lung, and Blood Institute-Sponsored Consumption of Certain Uncommon Produce Commodities in the United Transfusion-Transmissible Infections Monitoring System--Risk Factor States; Extension of Comment Period – 71294 ( Nov 9) Elicitation – 922 ( Jan 8) Requirements for Additional Traceability Records for Certain Foods – 59984 Donor Risk Assessment Questionnaire for the Food and Drug ( Sep 23) Administration/National Heart, Lung, and Blood Institute-Sponsored NOTICES Transfusion-Transmissible Infections Monitoring System; Risk Factor 21st Century Cures Act: Elicitation – 42001 ( Jul 13) Annual Compilation of Notices of Updates from the Susceptibility Test Drug Supply Chain Security Act Implementation – 23050 ( Apr 24) Interpretive Criteria Web Page – 67353 ( Oct 22) Electronic Products – 3925 ( Jan 23); 28958 ( May 14) Agency Information Collection Activities; Proposals, Submissions, and Electronic Records; Electronic Signatures – 49381 ( Aug 13) Approvals – 5446 ( Jan 30); 15187 ( Mar 17); 29459 ( May 15); 30965 Electronic Submission Process for Voluntary Allegations to the Center for ( May 21); 31190 ( May 22); 41591 ( Jul 10); 53822 ( Aug 31); 71922, 71925 Devices and Radiological Health – 7562 ( Feb 10); 55300 ( Sep 4) ( Nov 12) Empirical Study of Promotional Implications of Proprietary Prescription Agency Information Collection Activities; Proposals, Submissions, and Drug Names – 3392 ( Jan 21) Approvals: Endorser Status and Explicitness of Payment in Direct-to-Consumer Accreditation Scheme for Conformity Assessment Pilot Program – 23521 Promotion – 4994 ( Jan 28) ( Apr 28) Establishing and Maintaining a List of Manufacturers/Processors of Feed Additional Criteria and Procedures for Classifying Over-the-Counter Drugs Additives, Premixes, Compound Feed, Distillers' Dried Grains, and as Generally Recognized as Safe and Effective and Not Misbranded - Distillers' Dried Grains with Solubles for Use with Animals with Time and Extent Applications for Nonprescription Drug Interest in Exporting to The People's Republic of China – 47796 ( Aug 6) Products – 45892 ( Jul 30) Establishing and Maintaining a List of U.S. Manufacturers/Processors of Additional Criteria and Procedures for Classifying Over-the-Counter Drugs Feed Additives, Premixes, Compound Feed, Distillers' Dried Grains, as Generally Recognized as Safe and Effective and Not Misbranded-- and Distillers' Dried Grains with Solubles for Use with Animals with Time and Extent Applications for Nonprescription Drug Interest in Exporting to The People's Republic of China – 21242 Products – 67352 ( Oct 22) ( Apr 16) Adverse Event Program for Medical Devices (Medical Product Safety Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Network) – 28954 ( May 14) Prescription Drug Promotional Materials – 40659 ( Jul 7) Adverse Experience Reporting for Licensed Biological Products; and Exceptions or Alternatives to Labeling Requirements for Products Held by General Records – 54385 ( Sep 1) the Strategic National Stockpile – 39914 ( Jul 2); 70180 ( Nov 4) Advisory Committee Nomination Applications – 718 ( Jan 7); 21249 ( Apr 16) Expedited Programs for Serious Conditions; Drugs and Biologics – 73487 Animal Feed Regulatory Program Standards – 907 ( Jan 8) ( Nov 18) Annual Reporting for Custom Device Exemption – 10175 ( Feb 21); 41593 Extralabel Drug Use in Animals – 47794 ( Aug 6) ( Jul 10) Focus Groups as Used by the Food and Drug Administration (All Food and Application for Food and Drug Administration Approval to Market a New Drug Administration-Regulated Products) – 916 ( Jan 8); 51450 ( Aug 20) Drug – 73057 ( Nov 16) Food Additive, Color Additive (Including Labeling), Submission of Application for Participation in Food and Drug Administration Fellowship Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 – 15188 and Traineeship Programs – 5966 ( Feb 3) Assessment of Terms and Phrases Commonly Used in Prescription Drug ( Mar 17) Food Allergen Labeling and Reporting – 68333 ( Oct 28) Promotion – 58362 ( Sep 18) Biologics License Application, Changes to an Approved Application, Food and Drug Administration Safety Communication Readership Labeling, Revocation and Suspension, Postmarketing Studies Status Survey – 13171 ( Mar 6) Reports, and Form FDA 356h – 3053 ( Jan 17) Food Canning Establishment Registration, Process Filing, and Center for Tobacco Products, Food and Drug Administration Funded Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers – 18995 ( Apr 3); 44905 Trainee/Scholar Survey – 713 ( Jan 7) ( Jul 24) Certificates of Confidentiality – 36602 ( Jun 17) Certification of Identity for Freedom of Information Act and Privacy Act Food Labeling Regulations – 6551 ( Feb 5); 30711 ( May 20) Requests – 18984 ( Apr 3) Foods Derived From New Plant Varieties – 74734 ( Nov 23) Certification to Accompany Drug, Biological Product, and Device General Administrative Practice and Procedures – 1169 ( Jan 9) Applications or Submissions – 28955 ( May 14) Generic Clearance for Data to Support Cross-Center Collaboration for Channels of Trade Policy for Commodities With Residues of Pesticide Social Behavioral Sciences Associated with Disease Prevention, Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Treatment, and the Safety, Efficacy, and Usage of Food and Drug Modified by the Environmental Protection Agency Pursuant to Dietary Administration Regulated Products – 40655 ( Jul 7) Risk Considerations – 28639 ( May 13) Generic Clearance for Qualitative Data to Support Social and Behavioral Channels of Trade Policy for Commodities with Residues of Pesticide Research for Food, Dietary Supplements, Cosmetics, and Animal Food Chemicals, for which Tolerances have been Revoked, Suspended, or and Feed – 7564 ( Feb 10); 40299 ( Jul 6) Modified by the Environmental Protection Agency Pursuant to Dietary Generic Clearance for the Collection of Qualitative Data on Tobacco Risk Considerations – 47801 ( Aug 6) Products and Communications – 60999 ( Sep 29)

2 Food and Drug Administration

Generic Clearance for the Collection of Qualitative Feedback on Agency Registration of Human Drug Compounding Outsourcing Facilities and Service Delivery – 18989 ( Apr 3) Associated Fees under the Federal Food, Drug, and Cosmetic Good Laboratory Practice for Non-Clinical Laboratory Studies – 44900 Act – 51442 ( Aug 20) ( Jul 24) Registration of Human Drug Compounding Outsourcing Facilities of the Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Federal Food, Drug, and Cosmetic Act and Associated Fees – 73483 Holding Operations for Dietary Supplements – 18998 ( Apr 3) ( Nov 18) Guidance for Industry on E6(R2) Good Clinical Practice; International Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Council for Harmonisation; Integrated Addendum to International Monitoring – 71923 ( Nov 12) Council for Harmonisation E6(R1) – 44902 ( Jul 24) Regulations under the Federal Import Milk Act – 70182 ( Nov 4) Hazard Analysis and Critical Control Point Procedures for the Safe and Reporting Associated with Animal Drug and Animal Generic Drug User Sanitary Processing and Importing of Juice – 6555 ( Feb 5) Fees – 3929 ( Jan 23); 39917 ( Jul 2) Health Care Providers' Understanding of Opioid Analgesic Abuse Special Protocol Assessment – 320 ( Jan 3) Deterrent Formulations – 6562 ( Feb 5); 40663 ( Jul 7) Special Protocol Assessment; Guidance for Industry – 18991 ( Apr 3) Healthcare Provider Perception of Boxed Warning Information State Petitions for Exemption From Preemption – 54385 ( Sep 1) Survey – 40292 ( Jul 6) Study of Disclosures to Health Care Providers – 40300 ( Jul 6) Human Cells, Tissues, and Cellular and Tissue-Based Products: Study of Multiple Indications in Direct-to-Consumer Television Establishment Registration and Listing; Eligibility Determination for Advertisements – 40296 ( Jul 6) Donors; and Current Good Tissue Practice – 18985 ( Apr 3) Study of Oncology Indications in Direct-to-Consumer Television Human Drug Compounding Under Sections 503A and 503B of the Federal Advertising – 5213 ( Jan 29) Food, Drug, and Cosmetic Act – 28961 ( May 14) Submission of Petitions--Food Additive, Color Additive (Including Labeling), Human Tissue Intended for Transplantation – 1167 ( Jan 9) Submission of Information to a Master File in Support of Petitions; Imports and Electronic Import Entries – 318 ( Jan 3); 23048 ( Apr 24) and Electronic Submission Using Food and Drug Administration Form Index of Legally Marketed Unapproved New Animal Drugs for Minor 3503 – 52353 ( Aug 25) Species – 714 ( Jan 7); 23969 ( Apr 30) Survey of Drug Product Manufacturing, Processing, and Packing Infant Formula Recall Regulations – 23367 ( Apr 27); 48705 ( Aug 12) Facilities – 58370 ( Sep 18) Irradiation in the Production, Processing, and Handling of Food – 65825 Temporary Marketing Permit Applications – 21247 ( Apr 16); 47793 ( Aug 6) ( Oct 16) Testing Communications on Medical Devices and Radiation-Emitting Medical Conference Attendees' Observations about Prescription Drug Products – 7566 ( Feb 10) Promotion – 58366 ( Sep 18) Third Party Disclosure and Recordkeeping Requirements for Reportable Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Food – 28951 ( May 14); 48542 ( Aug 11) Sheet – 35939 ( Jun 12) Tracking Network for PETNet, LivestockNet, and SampleNet – 17583 Medical Devices; Device Tracking – 70634 ( Nov 5) ( Mar 30) Medical Devices; Humanitarian Use Devices – 49379 ( Aug 13) Use of Public Human Genetic Variant Databases to Support Clinical Medical Devices; Reports of Corrections and Removals – 10168 ( Feb 21); Validity for Genetic and Genomic-Based In Vitro Diagnostics – 59801 51451 ( Aug 20) ( Sep 23) Nonbinding Feedback After Certain Food and Drug Administration Voluntary Disclosure of Sesame as an Allergen – 71920 ( Nov 12) Inspections of Device Establishments – 14684 ( Mar 13) Voluntary National Retail Food Regulatory Program Standard – 10172 Obtaining Information to Understand Challenges and Opportunities ( Feb 21) Encountered by Compounding Outsourcing Facilities – 36857 ( Jun 18); Voluntary National Retail Food Regulatory Program Standards – 41588 75328 ( Nov 25) ( Jul 10) Office of Management and Budget Approvals – 57220 ( Sep 15) Voluntary Qualified Importer Program – 6556 ( Feb 5); 35937 ( Jun 12) Orphan Drugs – 62306 ( Oct 2) Amendment of Temporary Marketing Permit: Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Canned Pacific Salmon Deviating From Identity Standard – 23047 ( Apr 24) Content of Petitions – 3934 ( Jan 23) Animal Drug User Fee Rates and Payment Procedures for Fiscal Year Pediatric Uses of Medical Devices – 21241 ( Apr 16) 2021 – 46635 ( Aug 3) Planning for the Effects of High Absenteeism to Ensure Availability of Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Medically Necessary Drug Products – 5965 ( Feb 3) Year 2021 – 46647 ( Aug 3) Postmarketing Safety Information Sharing by Constituent Part Applicants Approval of Product under Voucher: for Combination Products – 23971 ( Apr 30); 47389 ( Aug 5) Rare Pediatric Disease Priority Review Voucher – 33163 ( Jun 1) Potential Tobacco Product Violations Reporting Form – 36597 ( Jun 17) Assessing the Resource Needs of the Generic Drug User Fee Premarket Approval of Medical Devices – 7311 ( Feb 7) Amendments – 46658 ( Aug 3) Premarket Notification for a New Dietary Ingredient – 65830 ( Oct 16) Assessing the Resource Needs of the Prescription Drug User Fee Act and Premarket Notification Procedures – 21244 ( Apr 16) Biosimilar User Fee Act – 19149 ( Apr 6) Prior Notice of Imported Food – 30713 ( May 20) Authorization of Emergency Use of Certain Medical Devices during Prior Notice of Imported Food under the Public Health Security and COVID-19 – 34638 ( Jun 5); 42407 ( Jul 14); 74346 ( Nov 20) Bioterrorism Preparedness and Response Act of 2002 – 6955 ( Feb 6) Authorizations and Revocation of Emergency Use of Drugs During the Product Jurisdiction and Combination Products – 75338 ( Nov 25) COVID-19 Pandemic; Availability – 56231 ( Sep 11) Qualitative Feedback on Agency Service Delivery – 70181 ( Nov 4) Best Practices in Drug and Biological Product Postmarket Safety Radioactive Drug Research Committees – 3390 ( Jan 21); 39913 ( Jul 2) Surveillance for Food and Drug Administration Staff; Draft Rapid Response Surveys – 6559 ( Feb 5); 50030 ( Aug 17) Document – 13170 ( Mar 6) Recommendations to Reduce the Risk of Transfusion-Transmitted of Biosimilar User Fee Rates for Fiscal Year 2021 – 47220 ( Aug 4) Infection in Whole Blood and Blood Components; Agency Charter Renewal: Guidance – 716 ( Jan 7); 18983 ( Apr 3) Advisory Committee; Arthritis Advisory Committee – 30966 ( May 21) Record Retention Requirements for the Soy Protein and Risk of Coronary Advisory Committee; Vaccines and Related Biological Products Advisory Heart Disease Health Claim – 66999 ( Oct 21) Committee – 5964 ( Feb 3) Recordkeeping and Records Access Requirements for Food Blood Products Advisory Committee – 61003 ( Sep 29) Facilities – 19489 ( Apr 7); 45888 ( Jul 30) Cardiovascular and Renal Drugs Advisory Committee – 61003 ( Sep 29) Recordkeeping and Reporting Requirements for Human Food and Gastrointestinal Drugs Advisory Committee – 13905 ( Mar 10) Cosmetics Manufactured From, Processed With, or Otherwise Pharmaceutical Science and Clinical Pharmacology Advisory Containing Material From Cattle – 49657 ( Aug 14) Committee – 509 ( Jan 6) Recordkeeping and Reporting Requirements for Human Food and Decision Not to Designate an Addition to the Current List of Tropical Cosmetics Manufactured from, Processed with, or Otherwise Diseases in the Federal Food, Drug, and Cosmetic Act: Containing Material from Cattle – 75330 ( Nov 25) Clonorchiasis – 42868 ( Jul 15) Coccidioidomycosis – 42871 ( Jul 15)

3 Food and Drug Administration

Designating Additions to the Current List of Tropical Diseases in the Approved Drug Products With Therapeutic Equivalence Evaluations (the Federal Food, Drug, and Cosmetic Act – 42860, 42883 ( Jul 15) "Orange Book") – 33165 ( Jun 1) Determination of Regulatory Review Period for Purposes of Patent Listing of Patent Information in the Orange Book – 33169 ( Jun 1) Extension: Post-Marketing Pediatric-Focused Product Safety Reviews – 54580 ( Sep 2) CARTIVA – 41999 ( Jul 13) Risk Evaluation and Mitigation Strategy Assessment Summary for Web ELZONRIS – 53824 ( Aug 31) Posting – 70639 ( Nov 5) EVERSENSE Continuous Glucose Monitoring System – 56229 ( Sep 11) Use of Codeine-Containing Analgesics in Children Under 12 Years of Age FASENRA – 12793 ( Mar 4) Subsequent to Genetic Testing – 38901 ( Jun 29) ILUMYA – 12565 ( Mar 3) Fee Rate for Using a Material Threat Medical Countermeasure Priority INGREZZA – 12928 ( Mar 5) Review Voucher in Fiscal Year 2021 – 63282 ( Oct 7) INTRAROSA – 8879 ( Feb 18) Fee Rate for Using a Rare Pediatric Disease Priority Review Voucher in ISTENT INJECT TRABECULAR MICRO-BYPASS SYSTEM – 42863 ( Jul 15) Fiscal Year 2021 – 63280 ( Oct 7) Lumoxiti – 54388 ( Sep 1) Fee Rate for Using a Tropical Disease Priority Review Voucher in Fiscal Year MAVYRET – 3694 ( Jan 22) 2021 – 63286 ( Oct 7) OXERVATE – 51446 ( Aug 20) Final Debarment Order: POTELIGEO – 53823 ( Aug 31) Barry J. Cadden – 76582 ( Nov 30) TAKHZYRO – 56622 ( Sep 14) Brenda Elise Edwards – 15791 ( Mar 19) VYLEESI – 51448 ( Aug 20) Captain Neill's Seafood, Inc. – 67552 ( Oct 23) XEPI – 41996 ( Jul 13) Charles Jeffrey Edwards – 15481 ( Mar 18) Determination that Products Were Not Withdrawn from Sale for Reasons Euton M. Laing – 44898 ( Jul 24) of Safety or Effectiveness: Gerald Tighe – 15790 ( Mar 19) CARDENE (Nicardipine Hydrochloride) Injection, 25 Milligrams/10 Jagen D. Lewicki – 15190 ( Mar 17) Milliliters – 3933 ( Jan 23) Jin Su Park – 44904 ( Jul 24) NEO TECT KIT (Kit for the Preparation of Technetium TC-99m Depreotide John Kapoor – 76581 ( Nov 30) Injection) – 12565 ( Mar 3) John Seil Lee – 44907 ( Jul 24) Potassium Chloride in 5 percent Dextrose and 0.225 percent Sodium Keith Komar – 66568 ( Oct 20) Chloride Injection, 5 Milliequivalents, 10 Milliequivalents, 15 Matthew Dailey – 15193 ( Mar 17) Milliequivalents, 20 Milliequivalents, 30 Milliequivalents, and 40 Michael L. Babich – 76084 ( Nov 27) Milliequivalents, in Plastic Containers – 15194 ( Mar 17) Michael P. Casey – 15480 ( Mar 18) Drug Products Not Withdrawn from Sale for Reasons of Safety or Paul J. Elmer – 44899 ( Jul 24) Effectiveness: Phillip R. Carawan – 67553 ( Oct 23) MICRO-K LS (Potassium Chloride) Extended-Release Liquid Suspension, 20 Richard M. Simon – 73726 ( Nov 19) Milliequivalents/Packet – 54579 ( Sep 2) Robert Richard Jodoin – 15195 ( Mar 17) PREXXARTAN (Valsartan) Oral Solution, 20 Milligrams/5 Milliliters and 80 Stephen Kalinoski – 15792 ( Mar 19) Milligrams/20 Milliliters – 59803 ( Sep 23) Tuan Anh Tran – 76583 ( Nov 30) ZOVIRAX (Acyclovir) Oral Capsules, 200 Milligrams – 39918 ( Jul 2) Zhang Xiao Dong – 15191 ( Mar 17) Drug Products not Withdrawn from Sale for Reasons of Safety or Food and Drug Administration Modernization Act of 1997: Effectiveness: Modifications to the List of Recognized Standards, Recognition List BUTISOL SODIUM (Butabarbital Sodium) Oral Tablets, 15 Milligrams, 50 Number: 053 – 17584 ( Mar 30) Milligrams, and 100 Milligrams – 66994 ( Oct 21) Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Drug Products Not Withdrawn from Sale for Reasons Other Than Safety or Recall, and Importer Reinspection Fee Rates for Fiscal Year Effectiveness: 2021 – 46669 ( Aug 3) DEXTROSE in Plastic Container (Dextrose) Injectable, 30 Grams/100 Food Safety Modernization Act Third-Party Certification Program User Fee Milliliters, 40 Grams/100 Milliliters, 60 Grams/100 Milliliters, and 70 Rate for Fiscal Year 2021 – 46659 ( Aug 3) Grams/100 Milliliters – 37954 ( Jun 24) Food Safety Modernization Act Voluntary Qualified Importer Program User TENEX (Guanfacine Hydrochloride) Tablets, 1 Milligram, 2 Milligrams, and Fee Rate for Fiscal Year 2021 – 46666 ( Aug 3) 3 Milligrams – 37953 ( Jun 24) Generic Drug User Fee Rates for Fiscal Year 2021 – 46662 ( Aug 3) Electronic Common Technical Document: Guidance Documents Related to Coronavirus Disease 2019 – 28010 Data Standards – 65827 ( Oct 16) ( May 12) Electronic Study Data Submission: Guidance: Data Standards; Support and Requirement Begin for Study Data Acute Myeloid Leukemia: Developing Drugs and Biological Products for Tabulation Model Version 1.7 Implementation Guide 3.3 and for Treatment – 49383 ( Aug 13) Define-Extensible Markup Language Version 2.1; Requirement Ends Adaptive and Other Innovative Designs for Effectiveness Studies of New for Study Data Tabulation Model Version 1.3 Implementation Guide Animal Drugs – 42887 ( Jul 15) 3.1.3 – 40658 ( Jul 7) Amendments and Requests for Final Approval to Tentatively Approved Electronic Study Data Submission; Data Standards: Abbreviated New Drug Applications – 61014 ( Sep 29) Support and Requirement Begin for Study Data Tabulation Model Version Annual Status Report Information and Other Submissions for 1.7 Implementation Guide 3.3 and for Define-Extensible Markup Postmarketing Requirements and Commitments – 66995 ( Oct 21) Language Version 2.1; Requirement Ends for Study Data Tabulation Appeal Options Available to Mammography Facilities Concerning Adverse Model Version 1.3 Implementation Guide 3.1.3; Correction – 51450 Accreditation Decisions, Suspension/Revocation of Certificates, or ( Aug 20) Patient and Physician Notification Orders – 44097 ( Jul 21) Support and Requirement Begin for Study Data Tabulation Model Version Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use-- 1.8 with Standard for Exchange of Nonclinical Data Implementation Premarket Notification (510(k)) Submissions – 4997 ( Jan 28) Guide--Animal Rule Version 1.0 – 14205 ( Mar 11) Assessing COVID-19-Related Symptoms in Outpatient Adult and Electronic Submissions; Data Standards: Adolescent Subjects in Clinical Trials of Drugs and Biological Products Support for Standard for the Exchange of Nonclinical Data – 42411 ( Jul 14) for COVID-19 Prevention or Treatment – 61008 ( Sep 29) Support for the International Institute of Electrical and Electronics Assessing User Fees under the Prescription Drug User Fee Amendments Engineers Bioinformatics Computations and Analyses Standard for of 2017 – 71658 ( Nov 10) Bioinformatic Workflows – 44304 ( Jul 22) Biological Product Deviation Reporting for Blood and Plasma Equivalence Determination: Establishments – 14682 ( Mar 13) Implementation by Spain and the Netherlands of the European Union Biomarkers and Surrogate Endpoints in Clinical Studies to Support System of Food Safety Control Measures for Raw Bivalve Molluscan Effectiveness of New Animal Drugs – 42879 ( Jul 15) Shellfish with Additional Controls – 60172 ( Sep 24) Establishment of a Public Docket:

4 Food and Drug Administration

Biosimilarity and Interchangeability: Additional Draft Q-and-As on Drug-Drug Interaction Assessment for Therapeutic Proteins – 48259 Biosimilar Development and the Biologics Price Competition and ( Aug 10) Innovation Act of 2009 – 74345 ( Nov 20) E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Biosimilars and Interchangeable Biosimilars: Licensure for Fewer than All Prolongation and Proarrhythmic Potential--Questions and Answers; Conditions of Use for Which the Reference Product Has Been International Council for Harmonisation – 61753 ( Sep 30) Licensed – 7313 ( Feb 7) Electromagnetic Compatibility of Medical Devices – 73276 ( Nov 17) Bladder Cancer: Developing Drugs and Biologics for Adjuvant Elemental Impurities in Animal Drug Products; Questions and Treatment – 62309 ( Oct 2) Answers – 74736 ( Nov 23) Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Enforcement Priorities for Electronic Nicotine Delivery Systems and Other Use – 61004 ( Sep 29) Deemed Products on the Market without Premarket Bone Anchors--Premarket Notification (510(k)) Submissions – 12563 Authorization – 720 ( Jan 7) ( Mar 3) Enforcement Priorities for Electronic Nicotine Delivery Systems and Other Breast Implants; Certain Labeling Recommendations to Improve Patient Deemed Products on the Market without Premarket Authorization Communication – 61001 ( Sep 29) (Revised) – 23973 ( Apr 30) Bridging for Drug-Device and Biologic-Device Combination Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Products – 8597 ( Feb 14) Enrollment Practices, and Trial Designs – 71654 ( Nov 10) Cancer Clinical Trial Eligibility Criteria: Brain Metastases – 41992 ( Jul 13) Eosinophilic Esophagitis: Developing Drugs for Treatment – 57866 ( Sep 16) Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Evaluating Cancer Drugs in Patients with Central Nervous System Inclusion of Pediatric Patients – 41989 ( Jul 13) Metastases – 53007 ( Aug 27) Cancer Clinical Trial Eligibility Criteria: Patients with Human Exocrine Pancreatic Insufficiency Drug Products--Submitting New Drug Immunodeficiency Virus, Hepatitis B Virus, or Hepatitis C Virus Applications; Withdrawal of Guidance – 12932 ( Mar 5) Infections – 41990 ( Jul 13) Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Products – 45889 ( Jul 30) Prior or Concurrent Malignancies – 41993 ( Jul 13) Extension of Certain Tobacco Product Compliance Deadlines Related to Cannabis and Cannabis-Derived Compounds: Quality Considerations for the Final Deeming Rule; Withdrawal – 23968 ( Apr 30) Clinical Research – 44305 ( Jul 22) Failure to Respond to an Abbreviated New Drug Application Complete Certificates of Confidentiality – 73056 ( Nov 16) Response Letter Within the Regulatory Timeframe – 61006 ( Sep 29) Certificates of Confidentiality; Extension of Comment Period – 921 ( Jan 8) Fit for Use Pilot Program Invitation for the Clinical Data Interchange Chemistry, Manufacturing, and Control Information for Human Gene Standards Consortium for Standard for Exchange of Nonclinical Data Therapy Investigational New Drug Applications – 5447 ( Jan 30) Implementation Guide Developmental and Reproductive Toxicology: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank – 50028 Version 1.1 – 67355 ( Oct 22) ( Aug 17) Formal Meetings Between the Food and Drug Administration and Clinical Drug Interaction Studies and In Vitro Drug Interaction Studies; Abbreviated New Drug Application Applicants of Complex Products Cytochrome P450 Enzyme- and Transporter-Mediated Drug Under Generic Drug User Fee Amendments – 75336 ( Nov 25) Interactions – 3932 ( Jan 23) Geriatric Information in Human Prescription Drug and Biological Product Clinical Drug Interaction Studies With Combined Oral Labeling – 57864 ( Sep 16) Contraceptives – 74737 ( Nov 23) Hematologic Malignancies: Regulatory Considerations for Use of Minimal Clinical Investigations for Prostate Tissue Ablation Devices – 42858 ( Jul 15) Residual Disease in Development of Drug and Biological Products for Community-Acquired Bacterial Pneumonia – 38143 ( Jun 25) Treatment – 4668 ( Jan 27) Competitive Generic Therapies – 14948 ( Mar 16) Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Compliance Policy for the Quantity of Bioavailability and Bioequivalence Bacterial Pneumonia – 38142 ( Jun 25) Samples – 51036 ( Aug 19) Human Gene Therapy for Hemophilia – 5444 ( Jan 30) Compounding Animal Drugs From Bulk Drug Substances – 9783 ( Feb 20) Human Gene Therapy for Rare Diseases – 5451 ( Jan 30) Compounding Animal Drugs from Bulk Drug Substances – 35936 ( Jun 12) Human Gene Therapy for Retinal Disorders – 5454 ( Jan 30) Contact Dermatitis from Topical Drug Products for Cutaneous Application: Importation of Certain Food and Drug Administration-Approved Human Human Safety Assessment – 13657 ( Mar 9) Prescription Drugs, Including Biological Products, and Combination Control of Nitrosamine Impurities in Human Drugs – 55017 ( Sep 3) Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Coronavirus Disease 2019 – 55678 ( Sep 9) Cosmetic Act – 61955 ( Oct 1) Coronavirus Disease 2019 (COVID-19) – 65820 ( Oct 16) In-Use Stability Studies and Associated Labeling Statements for Multiple- COVID-19: Developing Drugs and Biological Products for Treatment or Dose Injectable Animal Drug Products – 76085 ( Nov 27) Prevention – 29949 ( May 19) Inclusion of Older Adults in Cancer Clinical Trials – 13167 ( Mar 6) Cross Labeling Oncology Drugs in Combination Drug Regimens – 74352 Inorganic Arsenic in Rice Cereals for Infants – 47797 ( Aug 6) ( Nov 20) Insanitary Conditions at Compounding Facilities – 71348 ( Nov 9) Cytomegalovirus in Transplantation; Developing Drugs to Treat or Prevent Institutional Review Board Review of Individual Patient Expanded Access Disease – 27418 ( May 8) Requests for Investigational Drugs and Biological Products During the Demonstrating Substantial Evidence of Effectiveness for Human Drug and COVID-19 Public Health Emergency – 35311 ( Jun 9) Biological Products – 4670 ( Jan 27) International Cooperation on Harmonisation of Technical Requirements Developing and Labeling In vitro Companion Diagnostic Devices for a for Registration of Veterinary Medicinal Products; Stability Testing of Specific Group of Oncology Therapeutic Products – 20696 ( Apr 14) New Veterinary Drug Substances and Medicinal Products in Climatic Development of a Shared System Risk Evaluation and Mitigation Strategy; Zones III and IV – 20693 ( Apr 14) Reopening of Comment Period – 15788 ( Mar 19) Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Development of Anti-Infective Drug Products for the Pediatric Regulations – 5445 ( Jan 30) Population – 39193 ( Jun 30) Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Documenting Electronic Data Files and Statistical Analysis Regulations; Extension of Comment Period – 22740 ( Apr 23) Programs – 72671 ( Nov 13) Investigational COVID-19 Convalescent Plasma, Withdrawal; Documents Related to Coronavirus Disease 2019 – 31513 ( May 26); 73485 Correction – 63277 ( Oct 7) ( Nov 18) Investigational COVID-19 Convalescent Plasma; Availability – 59319 Documents Related to Coronavirus Disease 2019 (COVID-19) – 38372 ( Sep 21) ( Jun 26) Investigational COVID-19 Convalescent Plasma; Withdrawal – 59320 Documents Related to Coronavirus Disease 2019; Availability – 46641 ( Sep 21) ( Aug 3) Levonorgestrel; Intrauterine Device – 3924 ( Jan 23) Draft Guidance for Cannabidiol – 59804 ( Sep 23) Limited Population Pathway for Antibacterial and Antifungal Drug Products Labeled as Homeopathic – 918 ( Jan 8); 14947 ( Mar 16) Drugs – 47799 ( Aug 6)

5 Food and Drug Administration

Long Term Follow-Up After Administration of Human Gene Therapy Public Availability of Lists of Retail Consignees to Effectuate Certain Products – 5452 ( Jan 30) Human and Animal Food Recalls – 74732 ( Nov 23) M7 Assessment and Control of Deoxyribonucleic Acid Reactive Q3C(R8) Recommendations for the Permitted Daily Exposures for Three (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Solvents--2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Carcinogenic Risk – 61009 ( Sep 29) Tert-Butyl Alcohol--According to the Maintenance Procedures for the Male Breast Cancer: Developing Drugs for Treatment – 48706 ( Aug 12) Guidance Q3C Impurities: Residual Solvents; International Council for Marketing Status Notifications under Section 506I of the Federal Food, Harmonisation – 31785 ( May 27); 34638 ( Jun 5) Drug, and Cosmetic Act; Content and Format – 48541 ( Aug 11) Q3D(R1) Elemental Impurities; International Council for Mitigation Strategies to Protect Food Against Intentional Harmonisation – 14203 ( Mar 11) Adulteration – 8599 ( Feb 14) Qualification Process for Drug Development Tools – 75334 ( Nov 25) Mitigation Strategies to Protect Food against Intentional Recognition and Withdrawal of Voluntary Consensus Standards – 57218 Adulteration – 32040 ( May 28) ( Sep 15) Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs Recommendations for Clinical Laboratory Improvement Amendments of for Treatment – 6561 ( Feb 5) 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Multiple Function Device Products: Policy and Considerations – 45640 Devices – 11091 ( Feb 26) ( Jul 29) Recommendations for Dual 510(k) and Clinical Laboratory Improvement Necessary Automated External Defibrillator Accessories: Policy Regarding Amendments Waiver by Application Studies – 11089 ( Feb 26) Compliance Date – 68344 ( Oct 28) Recommendations to Reduce the Possible Risk of Transmission of Non-Clinical and Clinical Investigation of Devices Used for the Treatment Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by of Benign Prostatic Hyperplasia – 42406 ( Jul 14) Blood and Blood Components – 5668 ( Jan 31) Nonbinding Feedback After Certain Food and Drug Administration Recommendations to Reduce the Possible Risk of Transmission of Inspections of Device Establishments – 22429 ( Apr 22) Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Blood and Blood Components; – 36593 ( Jun 17) Biologics – 9784 ( Feb 20) Referencing Approved Drug Products in Abbreviated New Drug Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Application Submissions – 68336 ( Oct 28) Products – 68582 ( Oct 29) Regulatory Considerations for Microneedling Products – 71656 ( Nov 10) Notifying the Food and Drug Administration of a Permanent Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Discontinuance or Interruption in Manufacturing under Section 506C Treatment – 62310 ( Oct 2) of the Federal Food, Drug, and Cosmetic Act – 18247 ( Apr 1) Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs Products – 15478 ( Mar 18) for Treatment – 62305 ( Oct 2) Review and Update of Device Establishment Inspection Processes and Orange Book - Questions and Answers – 33167 ( Jun 1) Standards – 38900 ( Jun 29) Patient-Focused Drug Development: Collecting Comprehensive and Revised Recommendations for Reducing the Risk of Human Representative Input – 36600 ( Jun 17) Immunodeficiency Virus Transmission by Blood and Blood Pediatric Study Plans for Oncology Drugs: Questions and Answers – 2746 Products – 36595 ( Jun 17) ( Jan 16) Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Peripheral Percutaneous Transluminal Angioplasty and Specialty Malaria – 36598 ( Jun 17) Catheters--Premarket Notification (510(k)) Submissions – 1812 ( Jan 13) Safety and Performance Based Pathway Device-Specific Peripheral Vascular Atherectomy Devices--Premarket Notification Guidances – 49655 ( Aug 14) Submissions – 8296 ( Feb 13) Select Updates for Biocompatibility of Certain Devices in Contact with Pharmacokinetics in Patients with Impaired Renal Function; Study Design, Intact Skin – 65410 ( Oct 15) Data Analysis, and Impact on Dosing – 55303 ( Sep 4) Select Updates for Peripheral Vascular Atherectomy Devices - Premarket Policy for Diagnostics Testing in Laboratories Certified to Perform High Notification Submissions – 41987 ( Jul 13) Complexity Testing under the Clinical Laboratory Improvement Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Amendments Prior to Emergency Use Authorization for Coronavirus Use – 61011 ( Sep 29) Disease-2019 During the Public Health Emergency – 13169 ( Mar 6) Setting Endotoxin Limits During Development of Investigational Oncology Policy for Temporary Compounding of Certain Alcohol-Based Hand Drugs and Biological Products – 45643 ( Jul 29) Sanitizer Products During the Public Health Emergency – 16370 Slowly Progressive, Low-Prevalence Rare Diseases with Substrate ( Mar 23) Deposition that Results from Single Enzyme Defects: Providing Pre-Submission Consultation Process for Animal Food Additive Petitions Evidence of Effectiveness for Replacement or Corrective or Generally Recognized as Safe Notices – 8297 ( Feb 13) Therapies – 14949 ( Mar 16) Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Soft (Hydrophilic) Daily Wear Contact Lenses--Performance Criteria for Prescription Drug and Biological Products--Content and Safety and Performance Based Pathway – 12788 ( Mar 4) Format – 45894 ( Jul 30) Special Considerations, Incentives, and Programs to Support the Approval Premenopausal Women with Breast Cancer: Developing Drugs for of New Animal Drugs for Minor Uses and for Minor Species – 42876 Treatment – 63559 ( Oct 8) ( Jul 15); 71659 ( Nov 10) Principles for Selecting, Developing, Modifying, and Adapting Patient- Standardized Medicated Feed Assay Limits – 11369 ( Feb 27); 23369 Reported Outcome Instruments for Use in Medical Device ( Apr 27) Evaluation – 53820 ( Aug 31) Submission of Plans for Cigarette Packages and Cigarette Product Labeling for Laparoscopic Power Morcellators – 11093 ( Feb 26) Advertisements – 16103 ( Mar 20) Product-Specific Guidance – 12567 ( Mar 3); 20694 ( Apr 14); 34453 ( Jun 4); Submission of Plans for Cigarette Packages and Cigarette Advertisements 73725 ( Nov 19) (Revised) – 32401 ( May 29) Product-Specific Guidances – 53826 ( Aug 31) Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Promotional Labeling and Advertising Considerations for Prescription Study Plans – 46672 ( Aug 3) Biological Reference and Biosimilar Products--Questions and Technical Considerations for Demonstrating Reliability of Emergency-Use Answers – 6201 ( Feb 4) Injectors Submitted under a Biologics License Application, New Drug Proprietary Names for New Animal Drugs – 33162 ( Jun 1) Application, or Abbreviated New Drug Application – 22427 ( Apr 22) Providing Regulatory Submissions for Medical Devices in Electronic Technical Considerations for Non-Clinical Assessment of Medical Devices Format – 42864 ( Jul 15) Containing Nitinol – 65409 ( Oct 15) Providing Regulatory Submissions in Alternate Electronic Format – 14202 Testing for Biotin Interference in In Vitro Diagnostic Devices – 65817 ( Mar 11) ( Oct 16) Providing Regulatory Submissions in Electronic Format--Certain Human Testing of Retroviral Vector-Based Human Gene Therapy Products for Pharmaceutical Product Applications and Related Submissions Using Replication Competent Retrovirus During Product Manufacture and the eCTD Specifications (Revision 7) – 10448 ( Feb 24) Patient Follow-up – 5448 ( Jan 30)

6 Food and Drug Administration

The 510(k) Third Party Review Program – 14489 ( Mar 12) Financial Transparency and Efficiency of the Prescription Drug User Fee The Accreditation Scheme for Conformity Assessment Pilot Act, Biosimilar User Fee Act, and Generic Drug User Fee Program – 60471 ( Sep 25) Amendments – 31783 ( May 27) The Deemed To Be a License Provision of the Biologics Price Competition Fiscal Year 2020 Generic Drug Regulatory Science Initiatives; Public and Innovation Act: Questions and Answers – 12930 ( Mar 5) Workshop – 13905 ( Mar 10) The Use of Physiologically Based Pharmacokinetic Analyses; Fiscal Year 2020 Generic Drug Regulatory Science Initiatives; Public Biopharmaceutics Applications for Oral Drug Product Development, Workshop; Remote Only – 23968 ( Apr 30) Manufacturing Changes, and Controls – 61953 ( Oct 1) Food and Drug Administration Hiring and Retention Interim Tiotropium Bromide – 73482 ( Nov 18) Assessment – 41995 ( Jul 13) Tobacco Products: Principles for Designing and Conducting Tobacco Food and Drug Administration Rare Disease Day 2020: Supporting the Product Perception and Intention Studies – 68341 ( Oct 28) Future of Rare Disease Product Development – 3384 ( Jan 21) Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Food and Drug Administration/Federal Trade Commission Workshop on a Improving Glycemic Control – 13903 ( Mar 10) Competitive Marketplace for Biosimilars – 6203 ( Feb 4) Use of Data from Foreign Investigational Studies to Support Effectiveness Generic Drug User Fee Amendments – 38378 ( Jun 26) of New Animal Drugs – 42867 ( Jul 15) Generic Drug User Fee Amendments of 2017 Reauthorization – 57219 Use of Real-World Data and Real-World Evidence to Support Effectiveness ( Sep 15) of New Animal Drugs – 42880 ( Jul 15) Independent Third-Party Assessment of Investigational New Drug Food Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted and Drug Administration-Sponsor Communication Practices in Human T-Lymphotropic Virus Types I and II – 6957 ( Feb 6) Prescription Drug User Fee Act VI – 44098 ( Jul 21) Use of The Seafood List to Determine Acceptable Seafood Names – 42412 March 10 through April 30, 2020, Public Meetings; Postponement, ( Jul 14) Cancellation, or Remote Only – 15789 ( Mar 19) Website Location of Center for Devices and Radiological Health Fiscal Year Medical Device User Fee Amendments for Fiscal Years 2023 Through 2021 Proposed Guidance Development – 66333 ( Oct 19) 2027 – 13165 ( Mar 6); 55462 ( Sep 8) Wholesale Distributor Verification Requirement for Saleable Returned Medical Device User Fee Amendments for Fiscal Years 2023 through Drug Product and Dispenser Verification Requirements When 2027 – 18992 ( Apr 3) Investigating a Suspect or Illegitimate Product; Compliance Medical Device User Fee Amendments for Fiscal Years 2023 Through Policies – 67550 ( Oct 23) 2027; Postponement – 21445 ( Apr 17) Hearing: Medical Imaging Drugs Advisory Committee – 9782 ( Feb 20) Devices Proposed for a New Use With an Approved, Marketed Drug; Modernizing the Food and Drug Administration's Data Strategy – 924 Followup – 27419 ( May 8) ( Jan 8); 23832 ( Apr 29) International Drug Scheduling: New Drugs Regulatory Program Modernization: Implementation of the Convention on Psychotropic Substances; Single Convention on Narcotic Integrated Assessment of Marketing Applications and Integrated Drugs; Isotonitazene; MDMB-4en-PINACA; CUMYL-PEGACLONE; Review Documentation; Public Workshop – 49377 ( Aug 13) Flubromazolam; Clonazolam; Diclazepam; 3-MeO-PCP; DIPHENIDINE; Nonprescription Drugs Advisory Committee – 6565 ( Feb 5) 2-MEO-DIPHENIDINE; 5-MEO-DALT; and 3-FLUOROPHENMETRAZINE Oncologic Drugs Advisory Committee – 4326 ( Jan 24); 33686 ( Jun 2); 44100 (3-FPM); – 47217 ( Aug 4) ( Jul 21) Issuance of Priority Review Voucher: Oncologic Drugs Advisory Committee; Establishment of a Public Rare Pediatric Disease Product – 55304 ( Sep 4); 57217 ( Sep 15); 57864 Docket – 37458 ( Jun 22) ( Sep 16) Ophthalmic Devices Panel of the Medical Devices Advisory List of Bulk Drug Substances for which there is a Clinical Need under Committee – 18249 ( Apr 1); 55016 ( Sep 3) Section 503B of the Federal Food, Drug, and Cosmetic Act – 46126 Ophthalmic Devices Panel of the Medical Devices Advisory Committee; ( Jul 31) Postponement – 23970 ( Apr 30) Listing of Patent Information in the Orange Book – 65819 ( Oct 16) Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Medical Device User Fee Rates for Fiscal Year 2021 – 46673 ( Aug 3) Advisory Committee – 10447 ( Feb 24); 45642 ( Jul 29) Meetings: Patient Engagement Advisory Committee – 508 ( Jan 6); 53382 ( Aug 28) Advancing Animal Models for Antibacterial Drug Development; Public Patient-Focused Drug Development for Stimulant Use Disorder – 8877 Workshop – 6549 ( Feb 5) ( Feb 18); 61756 ( Sep 30) Allergenic Products Advisory Committee – 10451 ( Feb 24) Patient-Focused Drug Development for Vitiligo – 8004 ( Feb 12) Allergenic Products Advisory Committee; Cancellation – 17583 ( Mar 30) Pediatric Advisory Committee – 44541 ( Jul 23); 49657 ( Aug 14) Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Peripheral and Central Nervous System Drugs Advisory Safety and Risk Management Advisory Committee – 63284 ( Oct 7) Committee – 61013 ( Sep 29) Blood Products Advisory Committee – 8299 ( Feb 13) Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed: Blood Products Advisory Committee; Postponed – 16368 ( Mar 23) Opportunity for Hearing; Withdrawal – 43852 ( Jul 20) Cannabidiol and Other Cannabinoids: Sex and Gender Differences in Use Potential Approach for Ranking of Antimicrobial Drugs According to Their and Responses – 59804 ( Sep 23) Importance in Human Medicine – 64481 ( Oct 13) Cardiovascular and Renal Drugs Advisory Committee – 41053 ( Jul 8); Preparation for International Cooperation on Cosmetics Regulation 14th 68338, 68339 ( Oct 28) Annual Meeting; Cancellation – 17088 ( Mar 26) Cellular, Tissue, and Gene Therapies Advisory Committee – 14951 ( Mar 16) Preparation for International Cooperation on Cosmetics Regulation Center for Drug Evaluation and Research Standard Core Sets; Clinical Fourteenth Annual Meeting – 12569 ( Mar 3) Outcome Assessments and Endpoints Grant Program – 51445 Prescription Drug User Fee Act of 2017; Electronic Submissions and Data ( Aug 20) Standards – 6547 ( Feb 5) Circulatory System Devices Panel of the Medical Devices Advisory Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Committee – 14681 ( Mar 13); 51453 ( Aug 20); 57867 ( Sep 16); 62746 Risk Management Advisory Committee – 53383 ( Aug 28); 55301 ( Sep 4) ( Oct 5) Pulmonary-Allergy Drugs Advisory Committee – 9780 ( Feb 20); 48539 Cosmetic Products Containing Talc – 51035 ( Aug 19) ( Aug 11) Drug Safety and Risk Management Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee; Postponed – 19491 ( Apr 7) Anesthetic and Analgesic Drug Products Advisory Committee – 52609 Reauthorization of the Biosimilar User Fee Act – 68886 ( Oct 30) ( Aug 26) Reauthorization of the Prescription Drug User Fee Act – 35096 ( Jun 8) Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Science Advisory Board to the National Center for Toxicological Research Mitigation Strategy Education Program on Prescribing Behaviors and Advisory Committee – 43587 ( Jul 17) Patient Outcomes; Exploring the Path Forward for Scientific and Ethical Considerations for the Inclusion of Pregnant Women Assessment – 70637 ( Nov 5) in Clinical Trials – 14207 ( Mar 11) Stakeholder Engagement on ICH E6: Guideline for Good Clinical Practice; Public Web Conference – 30965 ( May 21)

7 Food and Drug Administration

Testing Methods for Asbestos in Talc and Cosmetic Products Containing Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Talc – 1317 ( Jan 10) Program for Foreign Facilities – 65828 ( Oct 16) The Drug Supply Chain Security Act Pilot Project Program and Enhanced Quality Management Maturity for Finished Dosage Forms Pilot Program for Drug Distribution Security – 68342 ( Oct 28) Domestic Drug Product Manufacturers – 65824 ( Oct 16) United States Food and Drug Administration and Health Canada Joint Rare Disease Clinical Trial Networks – 33163 ( Jun 1) Regional Consultation on the International Council for Harmonisation Report on the Performance of Drug and Biologics Firms in Conducting of Technical Requirements for Pharmaceuticals for Human Postmarketing Requirements and Commitments – 47799 ( Aug 6) Use – 13659 ( Mar 9) Request for Comments: Vaccines and Related Biological Products Advisory Committee – 507 Electronic Common Technical Document v4.0 Technical Conformance ( Jan 6); 48544 ( Aug 11); 53385 ( Aug 28); 61755 ( Sep 30); 76082 ( Nov 27) Guide; Food and Drug Administration Electronic Common Technical Memorandum of Understanding: Document v4.0 Module 1 Implementation Package – 10449 ( Feb 24) Certain Distributions of Compounded Human Drug Products between the Improving 510(k) Submission Preparation and Review: Voluntary State Board of Pharmacy or Other Appropriate State Agency and the Electronic Submission Template and Resource Pilot Program – 11371 Food and Drug Administration – 68074 ( Oct 27) ( Feb 27) New Animal Drug Application: Office of Women's Health Strategic Priorities; Establishment of a Public Alaco, Inc., et al.; Proposal to Withdraw Approval of Seven; Opportunity for Docket – 41591 ( Jul 10) a Hearing – 919 ( Jan 8) Request for Information: New Drug Application: Labeling of Foods Comprised of or Containing Cultured Seafood Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Cells – 63277 ( Oct 7) Abbreviated – 909 ( Jan 8) Vaping Products Associated With Lung Injuries – 8875 ( Feb 18); 20692 Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 ( Apr 14) Abbreviated; Opportunity for a Hearing – 1160 ( Jan 9) Request for Nomination: Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 – 915 Individuals and Consumer Organizations for Advisory Committees – 3386 ( Jan 8) ( Jan 21); 41050 ( Jul 8) New Drug Applications: Individuals and Industry Organizations for the Patient Engagement InvaGen Pharmaceuticals, Inc.; Withdrawal of Approval; Trandolapril Advisory Committee – 8298 ( Feb 13) Tablets – 41998 ( Jul 13) Nonvoting Industry Representatives and Request for Nominations for Pan American Laboratories, LLC, et al.; Withdrawal of Approval of Nonvoting Industry Representatives on the Blood Products Advisory Three – 15192 ( Mar 17) Committee – 3923 ( Jan 23) Roerig Division of Pfizer Inc., et.al.; Withdrawal of Approval of 10 – 44096 Tobacco Products Scientific Advisory Committee – 31192 ( May 22) ( Jul 21) Voting Members for the Patient Engagement Advisory Committee – 5450 Wockhardt Ltd., et.al.; Withdrawal of Approval of Nine ( Jan 30) Abbreviated – 64150 ( Oct 9) Voting Members on a Public Advisory Committee; Pharmacy New Drug Applications; Withdrawal: Compounding Advisory Committee – 36594 ( Jun 17) Pentaerythritol Tetranitrate – 42002 ( Jul 13) Voting Members on a Public Advisory Committee; Technical Electronic Office of Minority Health and Health Equity Strategic Priorities – 23366 Product Radiation Safety Standards Committee – 3052 ( Jan 17) ( Apr 27) Request for Notification of Stakeholder Intention to Participate: Office of Minority Health and Health Equity Strategic Priorities; Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Establishment of a Public Docket – 316 ( Jan 3) Prescription Drug User Fee Act Reauthorization – 40662 ( Jul 7) Outsourcing Facility Fee Rates for Fiscal Year 2021 – 47225 ( Aug 4) Requests for Nominations: Pilot Program for Request for Designation and Pre-Request for Designation Public Advisory Panels of the Medical Devices Advisory Committee – 65832 Electronic Submissions – 47389 ( Aug 5) ( Oct 16) Pilot Program: Voting Members on Public Advisory Panels or Committees; Device Good Alignment of Third-Party Food Safety Standards with Food Safety Manufacturing Practice Advisory Committee and the Medical Devices Regulations – 67744 ( Oct 26) Advisory Committee – 65412 ( Oct 15) Policy for Coronavirus Disease-2019 Tests During the Public Health Revocation of Approved Method: Emergency: Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed – 43853 Immediately in Effect Guidance for Clinical Laboratories, Commercial ( Jul 20) Manufacturers, and Food and Drug Administration Staff – 29461 Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; ( May 15) Correction – 47798 ( Aug 6) Post-Marketing Pediatric-Focused Product Safety Reviews; Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Correction – 57217 ( Sep 15) Device for Detection and/or Diagnosis of Zika Virus – 44908 ( Jul 24) Potential Approach for Ranking of Antimicrobial Drugs According to Their Revocation of Authorization: Importance in Human Medicine: Emergency Use of an In Vitro Diagnostic Device for Detection of A Risk Management Tool for Antimicrobial New Animal Drugs – 76081 Antibodies Against SARS-CoV-2, the Virus that Causes Coronavirus ( Nov 27) Disease 2019 (COVID-19) – 42414 ( Jul 14) Prescription Drug User Fee Rates for Fiscal Year 2021 – 46651 ( Aug 3) Emergency Use of In Vitro Diagnostic Devices for Detection of and/or Priority Review Voucher: Diagnosis of Zika or Ebola Virus – 910 ( Jan 8) Rare Pediatric Disease Product – 3935 ( Jan 23); 52354 ( Aug 25) Revocation of Authorizations of Emergency Use of In Vitro Diagnostic Process for Making Available Guidance Documents Related to Coronavirus Devices for Detection of Antibodies Against SARS-CoV-2 – 62739 ( Oct 5) Disease 2019 – 16949 ( Mar 25) Revocation of Biologics License: Process for Publishing Emergency Use Authorizations for Medical Devices Eli Lilly and Co.; LARTRUVO – 43587 ( Jul 17) During Coronavirus Disease 2019 – 33685 ( Jun 2) Scientific Data and Information About Products Containing Cannabis or Proposal To Withdraw Approval of Five Abbreviated New Drug Cannabis-Derived Compounds; Reopening of the Comment Applications: Period – 14206 ( Mar 11) Lavipharm Laboratories, Inc., et al. – 60474 ( Sep 25) Sugars That are Metabolized Differently Than Traditional Sugars – 66335 Prospective Grant of an Exclusive Patent License: ( Oct 19) Development, Production, and Commercialization of a Seasonal Influenza Termination of the Food and Drug Administration's Unapproved Drugs Vaccine – 23365 ( Apr 27) Initiative – 75331 ( Nov 25) Field-Deployable Mass Spectrometer Diagnostic for SARS, SARS-CoV-2 and Training Program for Regulatory Project Managers; Information Available Other Viruses, Bacteria and Bacterial Serovar, and Drug to Industry – 13164 ( Mar 6) Impurities – 72672 ( Nov 13) Withdrawal of Approval New Drug Applications: Purple Book Enhancement; Establishment of a Public Docket – 12927 Pharmacia and Upjohn Co., et al.; Correction – 73483 ( Nov 18) ( Mar 5) Withdrawal of Approval of 11 Abbreviated New Drug Applications:

8 Food and Drug Administration

Sanofi-Aventis U.S., LLC, et.al. – 68888 ( Oct 30) Mylan Institutional, LLC et al. – 13661 ( Mar 9) Withdrawal of Approval of 16 New Drug Applications: Pfizer Inc., et.al. – 38144 ( Jun 25) Janssen Pharmaceuticals, Inc., et al.; Correction – 54581 ( Sep 2) Vasodilan Injection and Tablets Containing Isoxsuprine Withdrawal of Approval of Abbreviated New Drug Applications: Hydrochloride – 42882 ( Jul 15) Roerig Division of Pfizer Inc., et al.; Correction – 61004 ( Sep 29) Vioform-Hydrocortisone Cream, Ointment, and Lotion Containing Watson Laboratories, Inc.; Oxycodone Hydrochloride and Ibuprofen Iodochlorhydroxyquin and Hydrocortisone – 42877 ( Jul 15) Tablets – 46657 ( Aug 3) Wockhardt Limited, et al. – 8598 ( Feb 14) Withdrawal of Approval of Abbreviated New Drug Applications; Correction: ZECUITY (sumatriptan iontophoretic transdermal system); Teva Branded Mylan Institutional LLC et al. – 36598 ( Jun 17) Pharmaceutical Products R and D, Inc. – 39913 ( Jul 2) Withdrawal of Approval of New Drug Application: Withdrawal of Approval of New Drug Applications: Eisai, Inc.; BELVIQ (lorcaserin hydrochloride) and BELVIQ XR (lorcaserin Novartis Pharmaceuticals Corp., et al. – 64150 ( Oct 9) hydrocholoride) – 58063 ( Sep 17) Withdrawal of Approval of New Drug Applications; Correction: Hospira Inc., et al.; – 28016 ( May 12) Elite Laboratories, Inc. – 19491 ( Apr 7) Hospira, Inc., et al. – 10177 ( Feb 21) Hospira, Inc., et al. – 37459 ( Jun 22) Janssen Pharmaceuticals, Inc., et al. – 28950 ( May 14)

9