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2017 Federal Register Index

In 2017, the Health and Human Services Department published 3191 documents.


Document Type Documents Published Subjects Covered
Rule 148 51
Proposed Rule 90 46
Notice 2953 193
2017 Federal Register Index

This index provides descriptive entries and Federal Register page numbers for documents published by Health and Human Services Department in the daily Federal Register. It includes entries, with select metadata for all documents published in the 2017 calendar year.

Rules

340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties 1

340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties 3

340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties; Delay of Effective Date 1

Adjustment of Civil Monetary Penalties for Inflation:

Correcting Amendment 1

Advisory Committee; Food Advisory Committee; Termination 1

Affordable Care Act:

Annual Civil Monetary Penalties Inflation Adjustment 1

Cardiovascular Devices; CFR Correction 1

Child Care and Development Fund Program; Correction 1

Civil Money Penalty Definitions; Technical Amendment 1

Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses'; Further Delayed Effective Date 1

Clinical Laboratory Improvement Amendments of 1988:

Fecal Occult Blood Testing 1

Confidentiality of Substance Use Disorder Patient Records 1

Confidentiality of Substance Use Disorder Patient Records; Delay of Effective Date 1

Control of Communicable Diseases 1

Control of Communicable Diseases; Correction 1

Control of Communicable Diseases; Delay of Effective Date 1

Federal Policy for Protection of Human Subjects 1

Food Additives Permitted in Feed and Drinking Water of Animals:

Ammonium Formate and Formic Acid 1
Gamma-Linolenic Acid Safflower Oil 1

Food Labeling:

Guidance:

Mitigation Strategies to Protect Food Against Intentional Adulteration; What You Need To Know About the Food and Drug Administration Regulation - Small Entity Compliance Guide 1
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use 1
Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception 1
Sanitary Transportation of Human and Animal Food: What You Need to Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide 1
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the Food and Drug Administration Regulation 1
Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food 1
Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products 1

Head Start Program 1

Health Care Programs:

Humanitarian Use Devices; 21st Century Cures Act:

Technical Amendment 1

Immunology and Microbiology Devices:

Classification of Genetic Health Risk Assessment System 1

Indirect Food Additives:

Polymers 1

Listing of Color Additives Exempt from Certification:

Calcium Carbonate 1
Spirulina Extract 2
Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; Confirmation of Effective Date 1

Medicaid Program:

Medicaid and Children's Health Insurance Programs:

Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Correction 2

Medicaid/CHIP Program:

Medical Device Classification Procedures; Change of Address; Technical Amendment 1

Medical Devices:

Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid 1
Cardiovascular Devices; Classification of Adjunctive Cardiovascular Status Indicator 1
Cardiovascular Devices; Classification of Balloon Aortic Valvuloplasty Catheter 1
Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator; Correction 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of Acute Kidney Injury Test System 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of Organophosphate Test System 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of Reagents for Molecular Diagnostic Instrument Test Systems 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of Total 25-hydroxyvitamin D Mass Spectrometry Test System 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use 1
Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System 1
Gastroenterology-Urology Devices; Classification of Enzyme Packed Cartridge 1
Gastroenterology-Urology Devices; Classification of Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss 2
Gastroenterology-Urology Devices; Classification of the High Intensity Ultrasound System for Prostate Tissue Ablation 1
Gastroenterology-Urology Devices; Classification of the Prostatic Artery Embolization Device 1
Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories 1
General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss 1
Hematology and Pathology Devices; Classification of Flow Cytometric Test System for Hematopoietic Neoplasms 1
Immunology and Microbiology Devices; Classification of Aquaporin-4 Autoantibody Immunological Test System 1
Immunology and Microbiology Devices; Classification of Assayed Quality Control Material for Clinical Microbiology Assays 1
Immunology and Microbiology Devices; Classification of Automated Image Assessment System for Microbial Colonies on Solid Culture Media 1
Immunology and Microbiology Devices; Classification of BCR-ABL Quantitation Test 1
Immunology and Microbiology Devices; Classification of Newborn Screening Test for Severe Combined Immunodeficiency Disorder 1
Immunology and Microbiology Devices; Classification of Nucleic Acid-Based Device for Amplification, Detection, and Identification of Microbial Pathogens Directly from Whole Blood Specimens 1
Immunology and Microbiology Devices; Classification of Streptococcus SPP. Nucleic Acid-Based Assay 1
Immunology and Microbiology Devices; Classification of the Automated Indirect Immunofluorescence Microscope and Software-Assisted System 1
Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis 1
Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid 1
Immunology and Microbiology Devices; Classification of the Mass Spectrometer System for Clinical Use for the Identification of Microorganisms 1
Immunology and Microbiology Devices; Classification of the Zinc Transporter 8 Autoantibody Immunological Test System 1
Neurological Devices, Classification of the Vibratory Counter-Stimulation Device 1
Neurological Devices; Classification of Computerized Behavioral Therapy Device for Psychiatric Disorders 1
Neurological Devices; Classification of Cranial Motion Measurement Device 1
Neurological Devices; Classification of Cranial Motion Measurement Device; Correction 1
Neurological Devices; Classification of External Vagal Nerve Stimulator for Headache 1
Neurological Devices; Classification of Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System 1
Obstetrical and Gynecological Devices; Classification of Closed Loop Hysteroscopic Insufflator with Cutter-Coagulator 1
Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator 1
Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery 1
Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh 1
Ophthalmic Devices; Classification of the Tear Electrostimulation Device 1
Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth to be known as Thoracolumbosacral Pedicle Screw Systems, including Semi-Rigid Systems 1
Radiology Devices; Classification of Rectal Balloon for Prostate Immobilization 1

Medicare Program:

Advancing Care Coordination Through Episode Payment Models; Cardiac Rehabilitation Incentive Payment Model; Changes to the Comprehensive Care for Joint Replacement Model; Delay of Effective Date 2
Advancing Care Coordination through Episode Payment Models; Cardiac Rehabilitation Incentive Payment Model; Changes to the Comprehensive Care for Joint Replacement Model 2
Cancellation of Advancing Care Coordination through Episode Payment and Cardiac Rehabilitation Incentive Payment Models, etc. 1
Changes to Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures 1
End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program 1
FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements 1
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Elec 1
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; etc. 1
Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction 1
Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; etc. 2
Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2018 1
Medicare Shared Savings Program: Extreme and Uncontrollable Circumstances Policies for Performance Year 2017 1
Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, and Correction of the Performance Period for the NHSN HCP Influenza 1
Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, etc. 1
Revisions to Payment Policies under Physician Fee Schedule and Other Revisions to Part B for CY 2017, etc.; Correction 1

Medicare Programs:

Medicare and Medicaid Programs:

Medicare, Medicaid, and Children's Health Insurance Programs:

Microbiology Devices:

National Vaccine Injury Compensation Program:

Revisions to Vaccine Injury Table; Delay of Effective Date 1
Vaccine Injury Table Revisions 1

New Animal Drugs:

Approval of New Animal Drug Applications 1
Approval of New Animal Drug Applications; Change of Sponsor's Address 1
Investigational Use; Disqualification of a Clinical Investigator 1
Withdrawal Approval of New Animal Drug Applications; Change of Sponsor-Change of Sponsor's Name 1
Withdrawal Use in Animal Feed; Approval of New Animal Drug Applications 1
Withdrawal of Approval of New Animal Drug Applications 4
Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor-Change of Sponsor's Address 1
Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship 1

Patient Protection and Affordable Care Act; Market Stabilization 1

Possession, Use, and Transfer of Select Agents and Toxins-Addition of Bacillus Cereus Biovar Anthracis to HHS List of Select Agents and Toxins 1

Possession, Use, and Transfer of Select Agents and Toxins:

Presiding Officer for an Appeal and Informal Hearing 1

Refuse to Accept Procedures for Premarket Tobacco Product Submissions 1

Regulations Regarding "Intended Uses" Amendments:

Requirements to Submit Prior Notice of Imported Food; Technical Amendments 1

Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use 1

Sanitary Transportation of Human and Animal Food Rule:

Waivers from Requirements 1

Select Agents and Toxins; CFR Correction 1

Use of Ozone-Depleting Substances 1

Waivers Requirements of Sanitary Transportation of Human and Animal Food Rule; Correction 1

Proposed Rules

340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation 1

Administrative Simplification:

Animal Food Additive Petitions:

Akzo Nobel Surface Chemistry AB 1
Idemitsu Kosan, Cp. Ltd. 1
Zinpro Corp.; Reopening of the Comment Period 1

Approach to Evaluating Nicotine Replacement Therapies:

Public Hearing; Request for Comments 1

CLASS Condition of the Head Start Designation Renewal System 1

Center for Devices and Radiological Health:

Color Additive Petitions:

Colorcon, Inc. 1
DSM Biomedical 1
Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, et al. 1
Glo Eyes, LLC 1

Confidentiality of Substance Use Disorder Patient Records 1

Food Additive Petitions (Animal Use):

Akzo Nobel Surface Chemistry AB 1

Food Additive Petitions:

Akzo Nobel Surface Chemistry AB 2
Arcadia Biosciences, Inc. 1
BASF Corp. 1
Canadian Oilseed Processor Association 1
DSM Nutritional Products, Inc.; Withdrawal 2
Juice Products Association 1
Juice Products Association; Correction 1
Zinpro Corp. 2

Food Additive Petitions; Denials:

Natural Resources Defense Council et al. 1

Food Labeling:

Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation Regulations 1

Fruit Juice and Vegetable Juice as Color Additives in Food 1

General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device 1

Guidance:

Labeling of Human Food Products:

Use of the Term Healthy; Public Meeting 1

Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products 1

Medicaid Program:

State Disproportionate Share Hospital Allotment Reductions 1

Medicaid and Children's Health Insurance Programs:

Medical Devices:

Medicare Program:

CY 2018 Updates to the Quality Payment Program 1
Cancellation of Advancing Care Coordination through Episode Payment and Cardiac Rehabilitation Incentive Payment Models; Changes to Comprehensive Care for Joint Replacement Payment Model (CMS-5524-P) 1
Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-For-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Correction 1
Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program 1
End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program 1
Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom Fabricated Orthotics 1
Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom Fabricated Orthotics; Withdrawal 1
FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements 1
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Long Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates; etc. 1
Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs 1
Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2018 2
Part B Drug Payment Model; Withdrawal 1
Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, etc. 1
Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities: Revisions to Case-mix Methodology 2
Revisions to Payment Policies under Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program 1

Medicare and Medicaid Programs:

National Vaccine Injury Compensation Program:

Statement of Reasons for Not Conducting Rulemaking Proceeding 1

Obstetrical and Gynecological Devices:

Patient Protection and Affordable Care Act:

Patient Protection and Affordable Care Act; Market Stabilization 1

Possession, Use, and Transfer of Select Agents and Toxins:

Prescribing Intervention--Exploring Strategy for Implementation

Opioid Policy Steering Committee; Public Hearing 1

Regulatory Agenda:

Semiannual Regulatory Agenda 1

Removing Barriers for Religious and Faith-Based Organizations to Participate in HHS Programs and Receive Public Funding 1

Review of Existing Center for Biologics Evaluation and Research Regulatory and Information Collection Requirements 1

Review of Existing Center for Devices and Radiological Health Regulatory and Information Collection Requirements 1

Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements 1

Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements 1

Review of Existing Center for Tobacco Products Regulatory and Information Collection Requirements 1

Review of Existing Center for Veterinary Medicine Regulatory and Information Collection Requirements 1

Review of Existing General Regulatory and Information Collection Requirements of Food and Drug Administration 1

Review of Existing Regulatory and Information Collection Requirements; Extension of Comment Period 1

Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition 1

Solicitation of New Safe Harbors and Special Fraud Alerts 2

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Correction 1

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates 1

Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products 2

Total Inward Leakage Requirements for Respirators 1

World Trade Center Health Program:

Notices

21st Century Cures Act:

Abbreviated New Drug Applications; Approval Withdrawals:

Administration for Native Americans Program Policies and Procedures 2

Advice About Eating Fish; Revised Fish Advice 1

Advisory Committee Nominations:

Agency Information Collection Activities; Proposals, Submissions, and Approvals 454

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

513(g) Request for Information 1
AIDS Drug Assistance Program Data Report 2
Accredited Person under Accredited Persons Inspection Program 1
Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded 2
Adoption and Foster Care Analysis Reporting System for title IV-B and title IV-E; Correction 1
Advance Planning Document Process 1
Advanced Education Nursing Traineeship Program Specific Data Collection Forms 1
Adverse Event Program for Medical Devices 1
Adverse Event Program for Medical Devices (Medical Product Safety Network) 1
Adverse Experience Reporting for Licensed Biological Products; and General Records 1
Advisory Committee Nomination Applications 1
Animal Drug Adverse Event Reporting and Recordkeeping 1
Animal Drug User Fee Act Waivers and Reductions 1
Animal Drug User Fee Cover Sheet 1
Animal Generic Drug User Fee Act Cover Sheet 1
Announcement of Office of Management and Budget Approvals 2
Annual Performance Reports for the Centers for Independent Living, Designated State Entities (DSEs), and Statewide Independent Living Councils 1
Annual Reporting for Custom Device Exemption 2
Application Process for Clinical Research Training and Medical Education at NIH Clinical Center and its Impact on Course and Training Program Enrollment and Effectiveness 2
Application and Other Forms Used by the National Health Service Corps Scholarship Program, the Students to Service Loan Repayment Program, and the Native Hawaiian Health Scholarship Program 1
Application and Other Forms Utilized by the National Health Service Corps Scholarship Program, the Students to Service Loan Repayment Program, and the Native Hawaiian Health Scholarship Program 1
Application for Participation in Fellowship Programs 1
Application for Participation in Food and Drug Administration Fellowship Programs 1
Application to Participate in National Institutes of Health Technical Assistance Programs: Commercialization Accelerator Program 1
Application to Participate in the National Institutes of Health Technical Assistance Programs: Commercialization Accelerator Program 1
Applications for Approval To Market a New Drug 1
Applications for Food and Drug Administration Approval to Market a New Drug 2
Assessing Client Factors Associated with Detectable HIV Viral Loads and Models of Care and the Ryan White HIV/AIDS Program 1
Assessing Client Factors Associated with Detectable HIV Viral Loads; and Models of Care and the Ryan White HIV/AIDS Program 1
Assessments to Inform Program Refinement for HIV, other STD, and Pregnancy Prevention among Middle and High-School Aged Youth 1
Be The Match Patient Services Survey 1
Blood Establishment Registration and Product Listing 1
Bureau of Primary Health Care Uniform Data System 2
Calorie Labeling of Articles of Food in Vending Machines 1
Cancer Therapy Evaluation Program Support Contracts Forms and Surveys, NCI, NIH 1
CareerTrac 1
Centers for Independent Living Annual Performance Report 1
Centers for Independent Living Annual Performance Report; Correction 2
Certification of Identity for Freedom of Information Act and Privacy Act Requests 1
Certification on Maintenance of Effort under Title III; Certification of Long-Term Care Ombudsman Program Expenditures 1
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions 1
Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals, for Which Tolerances have been Revoked, Suspended, or Modified, etc. 1
Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals, for which Tolerances have been Revoked, Suspended, or Modified by the Environmental Protection Agency pursuant to Dietary Risk Considerations 1
Character-Space-Limited Online Prescription Drug Communications 1
Child Care and Development Fund Plan for States/Territories for FFY 2019-2021 1
Child Care and Development Fund Quality Progress Report 1
Child Support Enforcement Program Annual Data Report 1
Child and Family Services Plan, Annual Progress and Services Review, and Annual Budget Expenses Request and Estimated Expenditures 1
Chimpanzee Research Use Form 2
Citizen Petitions and Petitions for Stay of Action 1
Citizen Petitions and Petitions for Stay of Action Subject to the Federal Food, Drug, and Cosmetic Act 1
Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms 1
Client-Level Data Reporting System 1
Collection of Nominations for Candidates to Serve on Food and Drug Administration's Advisory Committees 1
Color Additive Certification Requests and Recordkeeping 2
Community Services Block Grant State Plan Application 1
Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion 2
Content and Format of Labeling for Human Prescription Drugs and Biological Products; Requirements for Pregnancy and Lactation Labeling 1
Cosmetic Labeling Regulations 2
Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals 1
Current Good Manufacturing Practice Regulations for Medicated Feeds 1
Current Good Manufacturing Practice Regulations for Type A Medicated Articles 1
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements 1
Customer/Partner Service Surveys 2
Data Collection Materials for Evaluation of Administration for Community Living's American Indian, Alaska Natives and Native Hawaiian Programs 1
Data System for Organ Procurement and Transplantation Network 1
Data To Support Drug Product Communications as Used by the Food and Drug Administration 1
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration 1
Data to Support Drug Product Communications as Used by Food and Drug Administration 1
De Novo Classification Process 1
Delta States Rural Development Network Grant Program 2
Disclosures in Professional and Consumer Prescription Drug Promotion 1
Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion 1
Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine 1
Division of Cancer Epidemiology and Genetics Fellowship Program and Summer Student Applications 1
Draft Guidance for Industry and Review Staff on Target Product Profile--A Strategic Development Process Tool 1
Draft Guidance for Industry; How to Prepare a Pre-Request for Designation 1
Early Career Reviewer Program Application and Vetting System 1
Electronic Case Management System 1
Electronic Products 1
Electronic Records; Electronic Signatures 1
Electronic Signatures 1
Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health 2
Environmental Health Assessment of Tribal Child Care Centers in the Pacific Northwest 1
Establishing and Maintaining Lists of U.S. Milk Product 1
Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting 1
Establishing and Maintaining Lists of United States Manufacturers/Processors with Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products to China 2
Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Blood Establishment Registration and Product Listing 1
Evaluation of Administration for Community Living's American Indian, Alaska Natives and Native Hawaiian Programs 1
Evaluation of Employment Coaching for TANF and Other Low-Income Populations 1
Evaluation of Maternal and Child Health Bureau's Autism CARES Act Initiative 1
Evaluation of National Tobacco Prevention and Control Public Education Campaign; Correction 1
Evaluation of the Food and Drug Administration's 'Fresh Empire' Multicultural Youth Tobacco Prevention Campaign 1
Evaluation of the Food and Drug Administration's Education at the Point of Sale Campaign 1
Evaluation of the National Tobacco Prevention and Control Public Education Campaign; Correction 1
Evidence-Based Falls Prevention Program 1
Exception from General Requirements for Informed Consent 1
Exceptions or Alternatives to Labeling Requirements for Products Held by Strategic National Stockpile 2
Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads 1
Experimental Study on Warning Statements for Cigarette Graphic Health Warnings 2
Export of Food and Drug Administration-Regulated Products - Export Certificates 1
Extralabel Drug Use in Animals 1
Family Violence Prevention and Services: Grants to States; Native American Tribes and Alaskan Native Villages; and State Domestic Violence Coalitions 1
Federal Tort Claims Act Program Deeming Applications for Free Clinics 2
Federal Tort Claims Act Program Deeming Applications for Health Center Volunteer Health Professionals 2
Federal Tort Claims Act Program Deeming Applications for Health Centers 1
Focus Groups about Drug Products as Used by Food and Drug Administration 1
Focus Groups as Used by Food and Drug Administration 1
Focus Groups as Used by the Food and Drug Administration 1
Food Additive, Color Additive (Including Labeling), Submission of Information to Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 1
Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration 1
Food Allergen Labeling and Reporting 1
Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers 2
Food Labeling Regulations 1
Food Safety Survey 2
Food and Drug Administration Rapid Response Surveys 1
Food and Drug Administration Rapid Response Surveys (Generic Clearance) 1
Food and Drug Administration Recall Regulations 1
Food and Drug Administration Safety Communication Readership Survey 1
Funding Opportunity Announcement and Grant Application Instructions Template for ACL Discretionary Grant Programs 1
Funding Opportunity Announcement and Grant Application Template for ACL Discretionary Grant Programs; Correction 1
Funding Opportunity Announcement and Grant Application Template for Discretionary Grant Programs 1
Generic Clearance for Collection of Qualitative Feedback on Agency Service Delivery 4
Generic Clearance for Collection of Qualitative Feedback on Agency Service Delivery, National Cancer Institute 1
Generic Clearance for Collection of Qualitative Feedback on Agency Service Delivery: Customer Service Satisfaction and Similar Surveys 1
Generic Clearance for Collection of Qualitative Feedback on Agency Service Delivery: IHS Customer Service Satisfaction and Similar Surveys 1
Generic Clearance for Surveys of Customers and Partners 1
Generic Clearance for Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of Health 1
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications 1
Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery 8
Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery; Correction 1
Generic Clearance for the Collection of Routine Customer Feedback on HHS Communications 1
Generic Clearance to Conduct Formative Research 2
Generic Clearance to Support Safe to Sleep Campaign 1
Generic Clearance to Support Safe to Sleep Campaign (Eunice Kennedy Shriver National Institute of Child Health and Human Development) 1
Generic Clearance to Support the Safe to Sleep Campaign; Correction 1
Generic Submission for Formative Research, Pre-testing, Stakeholder 1
Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at National Cancer Institute 1
Good Clinical Practice; International Council for Harmonisation 1
Good Laboratory Practice Regulations for Nonclinical Studies 2
Grant Reviewer Recruitment 1
Grant Reviewer Recruitment Form 1
Grants.gov 2
Guidance for Industry -- User Fee Waivers, Reductions, and Refunds for Drug and Biological Products 1
Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics 1
Guidance for Industry on Expedited Programs for Serious Conditions: Drugs and Biologics 1
Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities under Federal Food, Drug, and Cosmetic Act 1
Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities under the Federal Food, Drug, and Cosmetic Act 1
Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice 1
Guidance for Industry on Pharmacogenomic Data Submissions 2
Guidance for Industry on Planning for Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products 1
Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic 1
Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities under Federal Food, Drug, and Cosmetic Act 1
Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities under Section 503B of Federal Food, Drug, and Cosmetic Act 1
Guidance for Industry on Special Protocol Assessment 1
Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development 1
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics 1
Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products 1
Guidance for Tribal TANF 1
Guidance on Consultation Procedures - Foods Derived from New Plant Varieties 1
Hazard Analysis and Critical Control Point Procedures for Safe and Sanitary Processing and Importing of Juice 1
Health Profession Opportunity Grant Program 1
Health Professions Student Loan Program and Nursing Student Loan Program Administrative Requirements (Regulations and Policy) 1
Health Risks to Workers Associated With Occupational Exposures to Peracetic Acid 1
Health Workforce Connector 1
Health and Diet Survey, as Used by Food and Drug Administration 1
Health and Diet Survey, as Used by the Food and Drug Administration 1
Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice 1
Identifying Experts in Prevention Science Methods to Include on NIH Review Panels, Office of Disease Prevention 1
Implementation Grants to Develop a Model Intervention for Youth/Young Adults with Child Welfare Involvement at Risk of Homelessness--Phase II 1
Import Trade Auxiliary Communication System 1
Imported Food under Public Health Security and Bioterrorism Preparedness and Response 1
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 1
Infant Formula Recall Regulations 2
Infant Formula Requirements 1
Information Security Ticketing and Incident Reporting 1
Information from United States Firms and Processors That Export to the European Union 1
Institutional Review Boards 1
Interstate Administrative Subpoena and Notice of Interstate Lien 1
Loan Repayment Program 1
Low Income Home Energy Assistance Program (LIHEAP) Leveraging Report 1
Maintenance of Effort for Title III and Extension of, and Minor Revisions Due to Statutory Language Changes to the Certification of Long-Term Care Ombudsman Program Expenditures 1
Mashpee Wampanoag Indian Health Service Unit Community Health Assessment 1
Mashpee Wampanoag Indian Health Service Unit Community Health Assessment 1
Medical Complaint Form, Contact Investigation Form: Non-TB Illness, and Contact Investigation Form: Active/Suspect TB 1
Medical Devices; Device Tracking 1
Medical Devices; Exception from General Requirements for Informed Consent 1
Medical Devices; Humanitarian Use Devices 1
Medical Devices; Reports of Corrections and Removals 1
Multistate Financial Institution Data Match and Federally Assisted State Transmitted Levy 1
NURSE Corps Loan Repayment Program 2
NURSE Corps Loan Repayment Program; Region 1
NURSE Corps Scholarship Program 1
National Cancer Institute Cancer Genetics Services Directory Web-Based Application and Update Mailer 2
National Cancer Institute Genomic Data Commons (GDC) Data Submission Request Form 1
National Center on Law and Elder Rights 1
National Health Service Corps Ambassador Portal 1
National Health Service Corps Loan Repayment Program 1
National Health Service Corps and NURSE Corps Interest Capture Form 1
National Hospital Ambulatory Medical Care Survey; Correction 1
National Hospital Organ Donation Campaign's Activity Scorecard 1
National Institute of Mental Health Data Archive 1
National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners 1
National Survey of Older Americans Act Participants 1
National Survey of Older Americans Act Participants; Correction 2
National Survey on Drug Use and Health Redesign 1
Nurse Anesthetist Traineeship Program 1
Nurse Faculty Loan Program 1
Nurse Faculty Loan Program – Revised Program Specific Data Form 1
Nurse Faculty Loan Program, Annual Performance Report Financial Data Form 2
Office of Patient Advocacy/Be the Match Patient Services Survey 1
Organ Procurement and Transplantation Network 1
Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Administration Form for Orphan Medicinal Product Designation 1
Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Drug Medicinal Product Designation 1
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions 1
Pathways for Advancing Careers and Education: Third Follow-Up Data Collection 1
Personal Responsibility Education Program Multi-Component Evaluation Extension 2
Personal Responsibility Education Program Promising Youth Programs 1
Poison Help General Population Survey 2
Post-Award Reporting Requirements Including Research Performance Progress Report Collection 1
Postmarketing Safety Reports for Human Drug and Biological Products 1
Potential Tobacco Product Violations Reporting Form 1
Premarket Approval of Medical Devices 1
Premarket Notification 1
Premarket Notification for a New Dietary Ingredient 1
Prenatal Alcohol and Other Drug Exposures in Child Welfare Study 1
Prescription Drug Advertisements 2
Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements 1
Prior Notice of Imported Food under Public Health Security and Bioterrorism Preparedness and Response Act of 2002 1
Procedural Justice Informed Alternatives to Contempt 1
Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices 1
Proposed Extension with No Changes of a Currently Approved Collection; National Survey of Older Americans Act Participants 1
Protection and Advocacy Annual Program Performance Report and Statement of Goals and Priorities 1
Protection and Advocacy for Traumatic Brain Injury Program Performance Report 2
Protection and Advocacy for Traumatic Brain Injury Program Performance Report; Correction 1
Providing Information About Pediatric Uses of Medical Devices 1
Providing Waiver-Related Materials in Accordance with Guidance for Industry on Providing Post-market Periodic Safety Reports in International Conference on Harmonisation E2C(R2) Format 2
Public Health Service Applications and Pre-award Reporting Requirements 1
Questionnaire and Data Collection Testing, Evaluation, and Research 1
Questionnaire and Data Collection Testing, Evaluation, and Research for the Health Resources and Services Administration 1
Radioactive Drug Research Committees 2
Recommended Glossary and Educational Outreach to Support use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use 1
Reconciliation Tool for Teaching Health Center Graduate Medical Education Program 1
Reconciliation Tool for the Teaching Health Center Graduate Medical Education Program 1
Recordkeeping and Records Access Requirements for Food Facilities 2
Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle 1
Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured from, Processed with, or Otherwise Containing Material from Cattle 1
Redesign of Existing Data Collection; National Survey of Older Americans Act Participants 1
Refugee Assistance Program Estimates 1
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring 1
Renewal of the Low Income Home Energy Assistance Program Performance Data Form 1
Reports of Corrections and Removals 1
Request for Assistance for Child Victims of Human Trafficking 1
Request for Specific Consent to Juvenile Court Jurisdiction 1
Requirement for Submission of Information on Pediatric Subpopulations That Suffer from a Disease or Condition That Device is Intended to Treat, Diagnose, or Cure 1
Revised Annual and Final Reports for Performance Reporting Data from NIDILRR Grantees 1
Revised Annual and Final Reports for Performance Reporting Data from National Institute on Disability, Independent Living and Rehabilitation Research Grantees 1
Revision to Identifying Experts in Prevention Science Methods to Include on NIH Review Panels, Office of Disease Prevention 1
Runaway and Homeless Youth – Homeless Management Information System 1
Rural Health Care Services Outreach Program Performance Improvement and Measurement Systems Measures 1
Rural Health Network Development Planning Performance Improvement and Measurement System Database 2
Rural Health Network Development Program 1
Rural Health Opioid Program Grant Performance Measures 1
Ryan White HIV/AIDS Program Client-Level Data Reporting System 2
Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements 1
Ryan White HIV/AIDS Program Outcomes and Expanded Insurance Coverage 1
Ryan White HIV/AIDS Program Part F Dental Services Report 2
Ryan White HIV/AIDS Program: Allocation and Expenditure Forms 2
Safety Assurance Case 1
Safety Assurance Case; Withdrawal 1
Safety Communication Readership Survey 1
Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation 2
Semiannual Performance Measures for the ACL Traumatic Brain Injury State Partnership Program 1
Small Health Care Provider Quality Improvement Program 1
Social Services Block Grant Post-Expenditure Report 1
Special Volunteer and Guest Researcher Assignment 2
Specimen Resource Locator 2
State Developmental Disabilities Council - Annual Program Performance Report 1
State Grant for Assistive Technology Program Annual Progress Report 1
State Grants for Assistive Technology Program Annual Progress Report 1
State Grants for Assistive Technology Program State Plan for Assistive Technology 1
State Petitions for Exemption From Preemption 2
State Plan Child Support Collection and Establishment of Paternity Title IV-D, OCSE-100 1
State Plan for Assistive Technology 1
State Plan for Grants to States for Refugee Resettlement 2
State Program Performance Report 1
Study of Coaching Practices in Early Care and Education Settings 1
Substances Prohibited From Use in Animal Food or Feed 1
Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act 1
Supplemental Form to Financial Status Report 1
Survey of Alumni Commissioner's Fellowship Program Fellows 1
Survey of Engineered Nanomaterial Occupational Safety and Health Practices 1
Temporary Assistance for Needy Families Quarterly Financial Report 1
Temporary Marketing Permit Applications 2
Testing Communications on Medical Devices and Radiation-Emitting Products 1
The Early Head Start Family and Child Experiences Survey 2018 1
The National Health Service Corps and NURSE Corps Interest Capture Form 1
Third Party Disclosure and Recordkeeping Requirements for Reportable Food 2
Title III Supplemental Form to Financial Status Report 1
Title V Maternal and Child Health Services Block Grant to States Program: Guidance and Forms for the Title V Application/Annual Report 1
Title V Maternal and Child Health Services Block Grant to States Program; Guidance and Forms for the Title V Application/Annual Report 1
Tracking Network for PETNet, LivestockNet, and SampleNet 1
Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion 1
Utilization of Adequate Provision Among Low to Non-Internet Users 1
Variations in Implementation of Quality Interventions Project 2
Voluntary Acknowledgement of Paternity and Required Data Elements for Paternity Establishment Affidavits 1
Voluntary Cosmetic Registration Program 2
Voluntary National Retail Food Regulatory Program Standards 2
Voluntary Partner Surveys to Implement Executive Order 12862 in the Health Resources and Services Administration 1

Analysis Data Reviewer's Guide 1

Analysis of Carbon Nanotubes and Nanofibers on Filters by Transmission Electron Microscopy 1

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2018 1

Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2018 1

Announcement of Requirements and Registration for Healthy Behavior Challenge 1

Applications for Approvals of Surgical Center Accreditations:

Approval of Entities That Certify Medical Review Officers 1

Behavioral Health Integration Initiative (BH2I); Extension of Due Dates 1

Biosimilar User Fee Rates for Fiscal Year 2018 1

Center for Devices and Radiological Health Premarket Approval Application Critical to Quality Pilot Program 1

Center for Devices and Radiological Health:

Experiential Learning Program 2

Certified Laboratories and Instrumented Initial Testing Facilities:

Urine Drug Testing for Federal Agencies 12

Challenge Competitions:

COMPETES Reauthorization Act 2
Improving Remote Monitoring of Pregnancy 1
Using Technology to Prevent Childhood Obesity in Low-Income Families and Communities 1

Charter Amendments:

Advisory Committee on Immunization Practices 1

Charter Renewals:

Advisory Committee on Infant Mortality 1
Advisory Committee on Training in Primary Care Medicine and Dentistry 1
Advisory Committee to Deputy Director for Intramural Research 1
Advisory Committee to Director 1
Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee 1
Advisory Council for Elimination of Tuberculosis 1
Advisory Panel on Outreach and Education 1
Board of Scientific Counselors 1
Board of Scientific Counselors, National Center for Health Statistics 1
Board of Scientific Counselors, National Center for Injury Prevention and Control; Correction 1
Board of Scientific Counselors, National Institute for Occupational Safety and Health 1
Board of Scientific Counselors, Office of Infectious Diseases 1
Board of Scientific Counselors, Office of Public Health Preparedness and Response 1
Center for Scientific Review Advisory Council 1
Healthcare Infection Control Practices Advisory Committee 1
Interagency Committee on Smoking and Health 1
Medical Imaging Drugs Advisory Committee 1
National Advisory Committee on Rural Health and Human Services 2
National Cancer Institute 2
National Mammography Quality Assurance Advisory Committee 1
National Toxicology Program Special Emphasis Panel 1
National Vaccine Advisory Committee 1
Nonprescription Drugs Advisory Committee 1
Patient Engagement Advisory Committee 1
PubMed Central National Advisory Committee 1
Sickle Cell Disease Advisory Council 1
World Trade Center Health Program Scientific/Technical Advisory Committee 1

Committee Establishments:

Common Formats for Reporting:

Health Care Quality and Patient Safety 1

Community Based Model of PHN Case Management Services (Behavioral Health) 1

Confidentiality Pledges; Revisions:

National Center for Health Statistics 1

Content of Risk Information in Major Statement in Prescription Drug Direct-to-Consumer Broadcast Advertisements 1

Debarment Orders:

Karis Copper Delong 1
Keith J. Pierce 1
Matthew Schroeder 1
Raymond Sean Brown 1
Trand Doan Nguyen 1

Decisions to Evaluate Petitions to Designate Classes of Employees for Inclusion in Special Exposure Cohorts:

Idaho Chemical Processing Plant in Scoville, ID 1

Decisions to Evaluate Petitions to Designate Classes of Employees for Inclusion in the Special Exposure Cohort:

Santa Susana Field Laboratory, Ventura County, CA 1

Declarations:

Delegations of Authority 3

Delegations of Authority:

Assistant Secretary for Mental Health and Substance Use 1
Public Health Service Act 1

Delivery Area Designations:

Pamunkey Indian Tribe 1

Designations of Classes of Employees for Additions to Special Exposure Cohort 3

Designations of Public Bodies:

State Title IV-D Child Support Agencies 1

Determination of Number of Entities and Recruitment of Entities for Assignment of Corps Personnel Obligated under National Health Service Corps Scholarship Program 1

Determinations and Declarations Regarding Emergency Uses of Injectable Treatments for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning 1

Determinations of Regulatory Review Periods for Purposes of Patent Extensions:

ADVANTAME 1
ADYNOVATE 1
EMPLICITI 1
HETLIOZ 1
IMPELLA 2.5 SYSTEM 1
INSPIRE UPPER AIRWAY STIMULATION SYSTEM 1
KENGREAL 1
KOVALTRY 1
MITRACLIP CDS 1
NATPARA 1
NEUROPACE RNS SYSTEM 1
OBIZUR 1
RAPIVAB 1
RECUVYRA 1
RECUVYRA; Affirmation 1
SIVEXTRO 1
STRIVERDI RESPIMAT 1
TECFIDERA 1
XTORO 1
ZYKADIA 1

Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:

CALCIJEX (Calcitriol) Injectable, 1 Microgram/Milliliter and 2 Micrograms/Milliliter 1
CARDENE SR (Nicardipine HCl) Extended-Release Capsules, 30 Milligrams, 45 Milligrams, and 60 Milligrams 1
CEDAX (Ceftibuten Dihydrate) for Oral Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5 Milliliters 1
CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 Milligrams, 0.45 Milligrams, 0.625 Milligrams, 0.9 Milligrams, and 1.25 Milligrams 1
CORDARONE (Amiodarone Hydrochloride) Tablets, 200 milligrams 1
CORTONE (Cortisone Acetate) Tablets and Other Drug Products 1
CYANOCOBALAMIN INJECTION, 1Milligram per Milliliter in a 10 Milliliter Vial 1
DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug Products 1
ELAVIL (Amitriptyline Hydrochloride) Oral Tablets, 10, 25, 50, 75, 100, and 150 Milligrams 1
ENJUVIA (estrogens, conjugated synthetic B) Tablets, 0.625 Milligrams and 1.25 Milligrams 1
FLONASE (Fluticasone Propionate) Nasal Spray, 0.05 Milligram 1
GYNOREST (Dydrogesterone) Oral Tablets, 5 Milligrams and 10 Milligrams 1
METICORTEN (Prednisone) Tablets, 1 Milligram and 5 Milligrams 1
NIZORAL (Ketoconazole) Tablets, 200 Milligrams 1
NOROXIN (Norfloxacin) Tablets, 400 Milligrams 1
OVRETTE (Norgestrel) Tablet, 0.075 Milligrams 1
REVEX (Nalmefene Hydrochloride Injection), 0.1 Milligram Base/Milliliter and 1.0 Milligram Base/Milliliter 1
RITALIN LA (Methylphenidate Hydrochloride) Extended-Release Capsules, 60 Milligrams 1
SPECTAZOLE (Econazole Nitrate) Topical Cream, 1% 1
SYMMETREL (Amantadine Hydrochloride), Syrup, 50 milligrams/5 Milliliters 1
TIMOPTIC (Timolol Maleate Ophthalmic Solution), 0.25 Percent and 0.5 Percent 1
TRINTELLIX (Vortioxetine Hydrobromide) Oral Tablet, EQ 15 Milligram Base 1

Determinations that Products Were Withdrawn from Sale for Reasons of Safety or Effectiveness:

Development of Healthy People 2030 1

Docket Establishments:

Draft Current Intelligence Bulletins:

Draft Department Strategic Plan for FY 2018-2022 1

Draft National Occupational Research Agenda:

Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention 1
Construction 1
Manufacturing 1
Traumatic Injury Prevention 1

Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids; Availability 1

Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies 1

Draft Toxicological Profiles:

Antimony; 2,4-D; Molybdenum; Silica 1

Electronic Study Data Submission; Data Standards:

Emergency Use Authorizations:

In Vitro Diagnostic Devices for Detection of Zika Virus 1

Emergency Use; Authorizations:

Emergency Uses; Authorizations:

In Vitro Diagnostic Devices for Detection of Zika Virus 1

Enhancing Patient Engagement Efforts Across the Food and Drug Administration 1

Environmental Assessments; Availability, etc.:

Environmental Impact Statements; Availability, etc.:

Establishment of Committees:

Exclusive Patent Licenses:

Apparatus for Microarray Binding Sensors Having Biological Probe Materials Using Carbon Nanotube Transistors 1
Chimeric L1/L2 Protein and Virus-Like Particles Based Human Papillomavirus Vaccines 1
Commercialization of Cerclage Annuloplasty Devices for Treating Mitral Valve Regurgitation 1
Composition and Methods for Delivering Inhibitory Oligonucleotides for Treatment of Pancreatic Cancer 1
Computer-Aided Diagnosis of Prostate Cancer in Multi-parametric MRI 1
Development of Gene Signature Predictive of Hepatocellular Carcinoma Patient Response to Transcatheter Arterial Chemoembolization 1
Development of Monospecific and Bispecific Antibodies to GPC3 for the Treatment of Human Liver Cancers 1
Development of a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the Treatment of Human Liver Cancers 1
Development of an Anti-CD30 Chimeric Antigen Receptor for the Treatment of Human Cancer 1
Development of an Anti-mesothelin Recombinant Immunotoxin (RIT) for the Treatment of Human Cancers 1
Development, Commercial Application and Use of Fulvestrant in Combination Therapy for the Treatment of Cancers 1
Development, Manufacture and Commercialization of Gene Therapy Products for Human Gene Therapy Use to Treat and/or Prevent Methylmalonic Acidemia 1
Devices and Systems for Treating Valvular Regurgitation 1
Inhibition of Plasmodial Surface Anion Channels for Treatment or Prevention of Malaria 1
Manufacturing and Testing of PVSRIPO in the Treatment of Solid, Non-lymphoid Tumors expressing Poliovirus Receptor CD155 1
MicroRNA Therapeutics For Treating Squamous Cell Carcinomas 1
Monamine Transporters; Methods of Making; and Uses Thereof 1
Mutant IDH1 Inhibitors Useful for Treating Cancer 1

Extension of the Timetable Requirement to Submit Study Data in Logical Observation Identifiers Names and Codes 1

Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2018 through September 30, 2019 1

Fee Rates:

Fees for Sanitation Inspection of Cruise Ships 1

Filing of Advisory Committees Closed Meeting Reports 1

Final Effect of Designations:

Class of Employees for Addition to the Special Exposure Cohort 2

Final National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention 1

Final Skin Notation Profiles 1

Findings of Research Misconduct 7

Findings of Research Misconduct; Correction 1

Fiscal Year 2017 Performance Review Board Members 1

Flavor Developer and Manufacturer Site Tours Program 1

Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 201 1

Food and Drug Administration Modernization Act:

Fostering Medical Innovation - Plan for Digital Health Devices; Software Precertification Pilot Program 1

Fostering Medical Innovation:

Funding Availability:

Funding Awards:

National Association of Area Agencies on Aging; The Eldercare Locator 1
Native American Elder Justice Initiative 1
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant 1
Ryan White HIV/AIDS Program, Part F AIDS Education and Training Centers 1
University of Colorado 1
University of Massachusetts 1
University of Minnesota 1

Funding Opportunities:

Behavioral Health Integration Initiative (BH2I) 1
Domestic Violence Prevention Initiative 1
Epidemiology Program for American Indian/Alaska Native Tribes and Urban Indian Communities 1
Indian Health Professions Preparatory, Indian Health Professions Pre-Graduate and Indian Health Professions Scholarship Programs 1
Injury Prevention Program 1
Loan Repayment Program for Repayment of Health Professions Educational Laons 1
Medicare Beneficiary Outreach and Assistance Program: Funding for Title VI Native American Programs 1
National Centers on Health Promotion for People with Disabilities 1
National Urban Indian Behavioral Health Awareness 1
Negotiation Cooperative Agreement; Office of Tribal Self-Governance 1
Planning Cooperative Agreement 1
Preventing Alcohol-Related Deaths through Social Detoxification 1
Tribal Management Grant Program 1
Tribal Management Grant Program; Extension of Due Dates 1

Generic Drug User Fee Amendments II Program Fee:

Generic Drug User Fee Rates for Fiscal Year 2018 1

Government-Owned Inventions; Availability for Licensing 38

Grant Awards:

Guidance:

180-Day Exclusivity -- Questions and Answers 1
Abbreviated New Drug Applications - Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) 1
Abbreviated New Drug Applications Submissions--Amendments to Abbreviated New Drug Applications under Generic Drug User Fee Act 1
Abbreviated New Drug Applications Submissions--Refuse-to-Receive Standards: Questions and Answers 1
Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin 2
Acceptance Review for De Novo Classification Requests 1
Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization 1
Amendment to "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products" 1
Animal Drug User Fees and Fee Waivers and Reductions 1
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers 1
Antibacterial Therapies for Patients with Unmet Medical Need for Treatment of Serious Bacterial Diseases 1
Application of Biological Monitoring Methods for Chemical Exposures in Occupational Health 1
Application of the "Solely Engaged" Exemptions 1
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 1
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 1
Assessing User Fees under Generic Drug User Fee Amendments of 2017 1
Assessment of Abuse Potential of Drugs 1
Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability; Correction 1
Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration 1
Bioequivalence Recommendations for Difluprednate 1
Breakthrough Devices Program 1
Categorization of Investigational Device Exemption Devices to Assist the Centers for Medicare and Medicaid Services with Coverage Decisions 1
Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act 1
Chemistry, Manufacturing, and Controls Changes to an Approved Application - Certain Biological Products 1
Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports 1
Child-Resistant Packaging Statements in Drug Product Labeling 1
Chronic Hepatitis C Virus Infection; Developing Direct-Acting Antiviral Drugs for Treatment 1
Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases 1
Clarification of the Food and Drug Administration and Environmental Protection Agency Jurisdiction Over Mosquito-Related Products 1
Classification and Requirements for Laser Illuminated Projectors 1
Classification of Products as Drugs and Devices and Additional Product Classification Issues 1
Clinical and Patient Decision Support Software 1
Closed-Circuit Escape Respirators 1
Comparative Analyses and Related Comparative Use Human Factors Studies for Drug-Device Combination Product Submitted in Abbreviated New Drug Application 1
Compliance Policy for Required Warning Statements on Small-Packaged Cigars 2
Considerations in Demonstrating Interchangeability with Reference Product 2
Consumer Antiseptic Wash Final Rule Questions and Answers; Small Entity Compliance Guide 1
Controlled Correspondence Related to Generic Drug Development 1
Controlled Correspondence Related to Generic Drug Development; Correction 1
Current Good Manufacturing Practice Requirements for Combination Products 1
Current Good Manufacturing Practice Requirements for Food for Animals 1
Current Good Manufacturing Practice for Medical Gases 1
De Novo Classification Process (Evaluation of Automatic Class III Designation) 1
Deciding When To Submit a 510(k) for a Change to an Existing Device 1
Deciding When To Submit a 510(k) for a Software Change to an Existing Device 1
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention 1
Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices 1
Determining Whether to Submit an Abbreviated New Drug Application or a 505(b)(2) Application 1
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease 1
Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products 1
Diagnosis and Management of Pediatric Mild Traumatic Brain Injury 1
Display Devices for Diagnostic Radiology 1
Drug Products Labeled as Homeopathic 1
Drug Products, Including Biological Products, that Contain Nanomaterials 1
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities: Questions and Answers 1
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act 1
Electronic Study Data Submission; Data Standards; Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1 1
Electronic Study Data Submission; Data Standards; Support for Analysis Data Model Implementation Guide Version 1.1 1
Electronic Study Data Submission; Data Standards; Support for Standard for Exchange of Nonclinical Data Implementation Guide Version 3.1 1
Electronic Study Data Submission; Data Standards; Support for Version Update of Medical Dictionary for Regulatory Activities 1
Emergency Use Authorization of Medical Products and Related Authorities 1
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses 1
Evaluating Drug Effects on Ability to Operate Motor Vehicle 1
Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies 1
Evaluation of Devices Used With Regenerative Medicine Advanced Therapies 1
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions 1
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products 1
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles 1
Extension of Certain Tobacco Product Compliance Deadlines Related to Final Deeming Rule 1
Extension of Effective Date of NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research 1
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions 1
Formal Dispute Resolution: Sponsor Appeals Above the Division Level 1
Formal Meetings Between Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products under Generic Drug User Fee Act 1
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products 1
Format and Content of a Risk Evaluation and Mitigation Strategy Document 1
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products 1
Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance 1
Genome Editing in New Plant Varieties Used For Foods 1
Genome Editing in New Plant Varieties Used for Foods 1
Gluten in Drug Products and Associated Labeling Recommendations 1
Grandfathering Policy for Packages and Homogenous Cases of Product Without Product Identifier 1
How to Prepare a Pre-Request for Designation 1
Identifying Trading Partners under Drug Supply Chain Security Act 3
Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers 1
In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies, and Clinical Drug Interaction Studies--Study Design, Data Analysis, and Clinical Implications 1
In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products 1
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments 1
Institutional Review Board Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects 1
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose 1
Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops 1
Investigational In Vitro Diagnostics Used in Clinical Investigations of Therapeutic Products 1
Labeling of Red Blood Cell Units with Historical Antigen Typing Results 1
M4 Organization of Common Technical Document for Registration of Pharmaceuticals for Human Use; International Council for Harmonisation 1
M4E(R2): Common Technical Document--Efficacy; International Council for Harmonisation 1
Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients upon Request 1
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers 1
Medical Product Communications Consistent with Required Labeling: Questions and Answers 1
Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations 1
Minutes of Institutional Review Board Meetings; Institutions and Institutional Review Boards 1
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application 1
Multiple Endpoints in Clinical Trials 1
Nonproprietary Naming of Biological Products 1
Oncology Drugs for Companion Animals 1
Oncology Pharmaceuticals - Reproductive Toxicity Testing and Labeling Recommendations 1
Pediatric Gastroesophageal Reflux Disease; Developing Drugs for Treatment 1
Pediatric Information for X-ray Imaging Device Premarket Notifications 1
Pediatric Rare Diseases: Collaborative Approach for Drug Development Using Gaucher Disease as Model 1
Policy Clarification and Premarket Notification (510(k)) Submissions for Ultrasonic Diathermy Devices 1
Post-Complete Response Letter Meetings between Food and Drug Administration and Abbreviated New Drug Application Applicants under Generic Drug User Fee Act 1
Premarket Notification Submissions for Bone Anchors 1
Procedures for Meetings of Medical Devices Advisory Committee 1
Product Identifier Requirements under Drug Supply Chain Security Act: Compliance Policy 1
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices 1
Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements 1
Product-Specific Guidance for Digoxin 1
Product-Specific Guidance for Methylphenidate Hydrochloride 1
Product-Specific Guidance for Naloxone Hydrochloride 1
Product-Specific Guidance for Tiotropium Bromide 1
Product-Specific Guidances 2
Product-Specific Guidances for Rifaximin 1
Product-Specific Guidances for Salmeterol Xinafoate and Fluticasone Propionate 1
Product-Specific Guidances; Availability 1
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry 1
Prohibition of Distributing Free Samples of Tobacco Products 2
Proposed Method for Adjusting Data on Antimicrobials Sold or Distributed for Use in Food-Producing Animals Using a Biomass Denominator 1
Providing Regulatory Submissions in Electronic Format--Content of Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling 1
Q11 Development and Manufacture of Drug Substances--Questions and Answers (Selection and Justification of Starting Materials); International Council for Harmonisation 1
Qualification of Medical Device Development Tools 1
Questions and Answers on Nutrition and Supplement Facts Labels Related to Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals 1
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus 1
Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies 1
Recommendations for Permitted Daily Exposures for Two Solvents, Triethylamine and Methylisobutylketone. etc. 1
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery 1
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled with Cardiovascular-Related Imagery 1
Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions 1
Recurrent Herpes Labialis - Developing Drugs for Treatment and Prevention 1
Reference Amounts Customarily Consumed: List of Products for Each Product Category 1
Referencing Approved Drug Products in Abbreviated New Drug Application Submissions 1
Refusal of Inspection by a Foreign Food Establishment or Foreign Government 1
Refuse to File - New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research 1
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments 2
Regulation of Intentionally Altered Genomic DNA in Animals 2
Regulation of Mosquito-Related Products 1
Regulatory Considerations for Microneedling Devices 1
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities 1
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices 1
Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Act 1
Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment 1
S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals; International Council for Harmonisation 1
Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices 1
Software as a Medical Device - Clinical Evaluation 1
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research 1
Statistical Approaches to Evaluate Analytical Similarity 1
Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation 1
Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods 1
Submission of Quality Metrics Data; Extension of Comment Period 1
Technical Considerations for Additive Manufactured Medical Devices 1
The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 1
The Least Burdensome Provisions; Concept and Principles 1
Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule 1
Unique Device Identification: Direct Marking of Devices 1
Use of Drug Master File for Shared System Risk Evaluation and Mitigation Strategy Submissions 1
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices 1
Use of Serological Tests to Reduce Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components 1
Utilizing Animal Studies to Evaluate Organ Preservation Devices 1
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System 1

HHS Poverty Guidelines; Update 1

Health Center Program Compliance Manual 1

Healthy Lifestyles in Youth Project:

Hearings:

Hospital Accreditation Programs:

Center for Improvement in Healthcare Quality 1

Information Available to Industry:

Training Program for Regulatory Project Managers 1

Interest Rate on Overdue Debts 3

Interest Rates:

Overdue Debts 1

International Drug Scheduling:

International Drug Scheduling; Convention on Psychotropic Substances:

Invitation to Manufacturers of Pertussis Serological Kits 1

Issuance of Final Guidance Publications 2

Issuance of Final Policies:

Issuance of Priority Review Voucher; Rare Pediatric Disease Product 1

List of Petitions:

National Vaccine Injury Compensation Program 8

Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas 1

Lists of Petitions Received:

National Vaccine Injury Compensation Program 1

Low-Income Levels Used for Various Health Professions and Nursing Programs Authorized in the Public Health Service Act 1

Mandatory Guidelines for Federal Workplace Drug Testing Programs 1

Medicaid Program:

Medical Devices:

Medicare Program:

Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances: October through December 2016 1
CY 2018 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts 1
CY 2018 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement 1
Extension of Prior Authorization for Repetitive Scheduled Non Emergent Ambulance Transports 1
FY 2018 Inpatient Psychiatric Facilities Prospective Payment System - Rate Update 1
Funding in Support of Pennsylvania Rural Health Model - Cooperative Agreement 1
Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2018 1
Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2018 1
Public Meetings in Calendar Year 2017 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System Coding and Payment Determinations 1
Recognition of Revised National Association of Insurance Commissioners Model Standards for Regulation of Medicare Supplemental Insurance 1

Medicare and Medicaid Programs:

Application by Community Health Accreditation Partner for Continued CMS Approval of its Home Health Agency Accreditation Program 1
Application from the Center for Improvement in Healthcare Quality for Continued Approval of its Hospital Accreditation Program 1
Application from the Joint Commission for Continued Approval of its Critical Access Hospital Accreditation Program 1
Application from the Joint Commission for Continued Approval of its Critical Access Hospital Accreditation Program; Approval 1
Continued Approval of the American Osteopathic Association/Healthcare Facilities Accreditation Program's Ambulatory Surgical Center Accreditation Program 1
Quarterly Listing of Program Issuances: April through June 2017 1
Quarterly Listing of Program Issuances: January through March 2017 1
Quarterly Listing of Program Issuances: July through September 2017 1
Quarterly Listing of Program Issuances: October through December 2016 1

Medicare, Medicaid, and Children's Health Insurance Programs:

Meetings:

2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System 1
2018 Physical Activity Guidelines Advisory Committee 3
Administering Hatch-Waxman Amendments - Ensuring Balance Between Innovation and Access 1
Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access 1
Administration on Intellectual and Developmental Disabilities, President's Committee for People with Intellectual Disabilities 1
Advancing Development of Pediatric Therapeutics: Application of Big Data to Pediatric Safety Studies; Public Workshop 1
Advisory Board on Radiation and Worker Health 2
Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health 2
Advisory Board on Radiation and Worker Health, Subcommittee for Dose Reconstruction Reviews, National Institute for Occupational Safety and Health 1
Advisory Commission on Childhood Vaccines 2
Advisory Committee for Women's Services 2
Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment 2
Advisory Committee on Heritable Disorders in Newborns and Children 4
Advisory Committee on Immunization Practices 2
Advisory Committee on Immunization Practices; Correction 1
Advisory Committee on Minority Health 5
Advisory Committee on Research on Women's Health 2
Advisory Committee on Training in Primary Care Medicine and Dentistry 2
Advisory Committee to Director 1
Advisory Committee to Director; State, Tribal, Local and Territorial Subcommittee 1
Advisory Committee to the Director 2
Advisory Committee to the Director -- State, Tribal, Local and Territorial Subcommittee 1
Advisory Committee to the Director, Centers for Disease Control and Prevention - Health Disparities Subcommittee 1
Advisory Committee to the Director, Health Disparities Subcommittee 1
Advisory Council for Elimination of Tuberculosis 1
Advisory Council for the Elimination of Tuberculosis 1
Advisory Council on Alzheimer's Research, Care, and Services 2
Advisory Council on Alzheimer’s Research, Care, and Services 1
Advisory Panel on Clinical Diagnostic Laboratory Tests; Charter Renewal, Membership 1
Advisory Panel on Outreach and Education 1
Agricultural Biotechnology Education and Outreach Initiative 1
Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee 1
Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Establishment of a Public Docket 1
Anesthetic and Analgesic Drug Products Advisory Committee, Drug Safety and Risk Management Advisory Committee; Establishment of Public Docket 1
Animal Drug User Fee Act 1
Animal Generic Drug User Fee Act 1
Antibody Mediated Rejection in Kidney Transplantation; Public Workshop 1
Antimicrobial Drugs Advisory Committee 1
Antimicrobial Drugs Advisory Committee; Establishment of Public Docket 1
Antimicrobial Drugs Advisory Committee; Establishment of a Public Docket 1
Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices; Public Workshop 1
Arthritis Advisory Committee 1
Arthritis Advisory Committee; Establishment of Public Docket; Request for Comments 1
Arthritis and Musculoskeletal and Skin Diseases 1
Assessment of Food and Drug Administration Hiring and Retention 1
Bacteriophage Therapy: Scientific and Regulatory Issues; Public Workshop 1
Battery Safety Concerns in Electronic Nicotine Delivery Systems; Public Workshop 1
Benefit-Risk Assessments in Drug Regulatory Decision-Making 1
Blood Products Advisory Committee 1
Blood Products Advisory Committee Advisory Committee 1
Board of Scientific Counselors BSC National Center for Injury Prevention 1
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry 1
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, Lead Poisoning Prevention Subcommittee 1
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry; Cancellation 1
Board of Scientific Counselors, National Center for Health Statistics 1
Board of Scientific Counselors, National Center for Injury Prevention and Control 1
Board of Scientific Counselors, National Institute for Occupational Safety and Health 2
Board of Scientific Counselors, Office of Infectious Diseases 2
Board of Scientific Counselors, Office of Infectious Diseases; Correction 1
Board of Scientific Counselors, Office of Public Health Preparedness and Response 1
Board of Scientific Counselors, Office of Public Health Preparedness and Response 1
Bone, Reproductive and Urologic Drugs Advisory Committee 2
Bone, Reproductive and Urologic Drugs Advisory Committee; Establishment of a Public Docket 1
Breast and Cervical Cancer Early Detection and Control Advisory Committee 1
Breast and Cervical Cancer Early Detection and Control Advisory Committee; Correction 1
CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment 1
Cardiac Troponin Assays; Public Workshop 1
Cardiac Troponin Assays; Workshop 1
Cellular, Tissue, and Gene Therapies Advisory Committee 1
Center for Drug Evaluation and Research Small Business and Industry Assistance Regulatory Education for Industry Generic Drugs Forum 1
Center for Mental Health Services 4
Center for Scientific Review 213
Center for Scientific Review; Cancellation 1
Center for Substance Abuse Prevention 6
Center for Substance Abuse Prevention National Advisory Council 3
Center for Substance Abuse Treatment 7
Center for Substance Abuse Treatment National Advisory Council 2
Centers for Disease Control and Prevention Advisory Committee on Immunization Practices 1
Chronic Fatigue Syndrome Advisory Committee 3
Circulatory System Devices Panel of the Medical Devices Advisory Committee 1
Clinical Center Research Hospital Board 2
Clinical Center Research Hospital Board; Amendment 1
Clinical Laboratory Improvement Advisory Committee 2
Clinical Laboratory Improvement Advisory Committee; Cancellation 1
Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop 1
Community Preventive Services Task Force 2
Council of Councils 2
Council on Graduate Medical Education 1
Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa; Public Workshop 1
Cybersecurity of Medical Devices - A Regulatory Science Gap Analysis; Public Workshop 1
Data and Methods for Evaluating the Impact of Opioid Formulations With Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper 1
Dermatologic and Ophthalmic Drugs Advisory Committee; Establishment of a Public Docket; Request for Comments 1
Developing Rabies Monoclonal Antibody Products as Component of Rabies Post-Exposure Prophylaxis; Public Workshop 1
Developing a Framework for Regulatory Use of Real-World Evidence; Public Workshop 1
Development of New Tuberculosis Treatment Regimens--Scientific and Clinical Trial Design Considerations; Public Workshop 1
Development of a List of Pre-Dietary Supplement Health and Education Act Dietary Ingredients 1
Devices Proposed for New Use with Approved, Marketed Drug; Public Hearing 1
Diabetes Mellitus Interagency Coordinating Committee 3
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel; Correction 1
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Secondary Review 1
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel 27
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel; Cancellation 1
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel; Initial Review 14
Draft Current Intelligence Bulletin: Occupational Exposure Banding Process; Guidance for Evaluation of Chemical Hazards 2
Draft National Toxicology Program Technical Reports; Availability of Documents; Request for Comments 1
Draft Report on Carcinogens Monograph on Antimony Trioxide 1
Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints; Public Workshop 1
Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee; Correction 1
Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee 1
Emerging Tick-Borne Diseases and Blood Safety; Public Workshop 1
Endocrinologic and Metabolic Drugs Advisory Committee 2
Enhanced Drug Distribution Security under the Drug Supply Chain Security Act 1
Enviro Health App Challenge and Challenge Kick-off Webinar 1
Equivalence of Complex Products; Public Workshop 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development 35
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Correction 2
Eunice Kenney Shriver National Institute of Child Health and Human Development 2
FY 2019 Applications for New Medical Services and Technologies Add-On Payments 1
Fogarty International Center 1
Fogarty International Center Advisory Board 2
Food and Drug Administration Small Business and Industry Assistance Regulatory Education for Industry Spring Conference; Public Conference 1
Food and Drug Administration, Center for Drug Evaluation and Research Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development 1
Food and Drug Administration/Xavier University Medical Device Conference (MedCon) 1
Food and Drug Administration/Xavier University PharmaLink Conference--Leadership in a Global Supply Chain 1
Fostering Digital Health Innovation: Developing the Software Precertification Program; Public Workshop 1
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee 1
Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop 1
Health Care Research and Training Subcommittee, et al. 1
Health Disparities Subcommittee, Advisory Committee to Director 1
Health Insurance MarketplaceSM, Medicare, Medicaid, and Children's Health Insurance Program; Advisory Panel on Outreach and Education 1
Health Services Research Initial Review Group Committee 1
Healthcare Infection Control Practices Advisory Committee 4
Healthcare Infection Control Practices Advisory Committee; Correction 1
ICD-10 Coordination and Maintenance Committee 1
Identification and Characterization of Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop; Correction 1
Interagency Coordinating Committee on the Validation of Alternative Methods 1
Interagency Pain Research Coordinating Committee 1
Interdepartmental Serious Mental Illness Coordinating Committee 2
Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee 1
Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 1
Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review; Public Workshop 1
Medical Gas Regulation; Public Workshops 1
Medical Imaging Drugs Advisory Committee 2
Medicare Evidence Development and Coverage Advisory Committee 2
Medicare Program: Advisory Panel on Clinical Diagnostic Laboratory Tests 1
Medicare Program: Announcement of Advisory Panel on Hospital Outpatient Payment 1
Medicare, Medicaid and Children's Health Insurance Program: Behavioral Health Payment and Care Delivery 1
Mine Safety and Health Research Advisory Committee 1
Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health 1
Multi-Agency Informational Meeting Concerning Compliance with the Federal Select Agent Program; Public Webcast 1
Muscular Dystrophy Coordinating Committee 3
Muscular Dystrophy Coordinating Committee; Cancellation 1
National Advisory Committee on Children and Disasters 2
National Advisory Committee on Rural Health and Human Services 2
National Advisory Council 2
National Advisory Council for Complementary and Integrative Health 2
National Advisory Council for Healthcare Research and Quality 3
National Advisory Council for Healthcare Research and Quality; Cancellation 1
National Advisory Council on Aging 1
National Advisory Council on Migrant Health 2
National Advisory Council on the National Health Service Corps 2
National Advisory Councils and Advisory Committees 1
National Arthritis and Musculoskeletal and Skin Diseases 1
National Cancer Advisory Board 1
National Cancer Institute 70
National Cancer Institute; Amendment 5
National Cancer Institute; Cancellation 1
National Center for Advancing Translational Sciences 22
National Center for Chronic Disease Prevention and Health Promotion, Interagency Committee on Smoking and Health 1
National Center for Complementary and Integrative Health 15
National Center for Health Statistics, ICD-10 Coordination and Maintenance Committee 1
National Committee on Vital and Health Statistics 4
National Committee on Vital and Health Statistics, Standards Subcommittee 1
National Committee on Vital and Health Statistics, Teleconference 1
National Committee on Vital and Health Statistics; Teleconference 2
National Deafness and Other Communication Disorders 1
National Eye Institute 21
National Heart, Lung, and Blood Advisory Council 1
National Heart, Lung, and Blood Institute 72
National Heart, Lung, and Blood Institute; Amendment 1
National Human Genome Research Institute 18
National Institute of Allergy and Infectious Diseases 103
National Institute of Arthritis & Musculoskeletal and Skin Diseases 1
National Institute of Arthritis and Musculoskeletal and Skin Diseases 17
National Institute of Biomedical Imaging and Bioengineering 17
National Institute of Child Health and Human Development 3
National Institute of Dental and Craniofacial Research 14
National Institute of Diabetes and Digestive and Kidney Diseases 51
National Institute of Environmental Health Science 1
National Institute of Environmental Health Sciences 25
National Institute of General Medical Sciences 30
National Institute of Mental Health 37
National Institute of Mental Health; Correction 1
National Institute of Neurological Disorder and Stroke 1
National Institute of Neurological Disorders and Stroke 34
National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee 1
National Institute of Nursing Research 13
National Institute on Aging 58
National Institute on Alcohol Abuse and Alcoholism 22
National Institute on Alcohol Abuse and Alcoholism; Amendment 1
National Institute on Deafness and Other Communication Disorders 10
National Institute on Drug Abuse 31
National Institute on Minority Health and Health Disparities 13
National Institute on Minority Health and Heath Disparities 1
National Institutes of General Medical Sciences 2
National Institutes of Health 1
National Library of Medicine 21
National Library of Medicine; Cancellation 1
National Preparedness and Response Science Board 1
National Preparedness and Response Science Board and National Advisory Committee on Children and Disasters 1
National Preparedness and Response Science Board and the National Advisory Committee on Children and Disasters 1
National Research Service Award Institutional Research Training Grant 1
National Science Advisory Board for Biosecurity 1
National Toxicology Program Board of Scientific Counselors 3
National Vaccine Advisory Committee 1
Neurological Devices Panel of the Medical Devices Advisory Committee 1
New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products; Public Workshop 1
New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2018 1
Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee 1
Office for State, Tribal, Local and Territorial Support 1
Office for State, Tribal, Local and Territorial Support, Tribal Advisory Committee 1
Office of AIDS Research Advisory Council 3
Office of Director 2
Office of the Director 3
Oncologic Drugs Advisory Committee 2
Oncologic Drugs Advisory Committee; Establishment of Public Docket 5
Oncology Center of Excellence Listening Session 1
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee 1
Over-the-Counter Monograph User Fees 1
Packaging, Storage, and Disposal Options to Enhance Opioid Safety--Exploring the Path Forward; Public Workshop 1
Partnering to Prevent Hypoglycemia; Listening Session 1
Pathways to Prevention Workshop -- Methods for Evaluating Natural Experiments in Obesity 1
Patient Engagement Advisory Committee 1
Patient Engagement Advisory Committee; Amendment 1
Patient-Focused Drug Development for Alopecia Areata 1
Patient-Focused Drug Development for Autism 1
Patient-Focused Drug Development for Hereditary Angioedema 1
Patient-Focused Drug Development for Sarcopenia; Correction 1
Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop 1
Patient-Focused Drug Development: Guidance 1--Collecting Comprehensive and Representative Input; Public Workshop 1
Pediatric Advisory Committee 2
Pediatric Advisory Committee, Pediatric Ethics Subcommittee 1
Pediatric Advisory Committee; Establishment of Public Docket; Request for Comments 1
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee 1
Peer Review of Draft National Toxicology Program Approach to Genomic Dose-Response Modeling 1
Peripheral and Central Nervous System Drugs Advisory Committee; Establishment of Public Docket; Request for Comments 1
Pharmacy Compounding Advisory Committee 2
Physician-Focused Payment Model Technical Advisory Committee 3
Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act of 2015 1
Preparation for International Cooperation on Cosmetics Regulation Eleventh Annual Meeting 1
Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards 1
Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria 3
Presidential Advisory Council on HIV/AIDS 2
Psychopharmacologic Drugs Advisory Committee 1
Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee 2
Public Stakeholder Listening Session on Strategies for Improving Parity for Mental Health and Substance Use Disorder Coverage 1
Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; Public Workshop 1
Roadmap for Engaging with Food and Drug Administration's Center for Drug Evaluation and Research; Public Workshop 1
Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting 1
Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop 1
Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop; Correction 1
Safety and Occupational Health Study Section 3
Safety and Occupational Health Study Section, National Institute for Occupational Safety and Health 1
Science Advisory Board to National Center for Toxicological Research Advisory Committee 1
Science Board to Food and Drug Administration Advisory Committee 1
Science Board to the Food and Drug Administration Advisory Committee 1
Scientific Advisory Committee on Alternative Toxicological Methods 1
Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials; Public Workshop 1
Secretary's Advisory Committee on Human Research Protections 4
Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 5
Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030; Webinar 1
Self-Collection Devices for Pap Test; Public Workshop; Request for Comments 1
Sentinel Training; Public Workshop 1
Stakeholder Listening Session in Preparation for the 70th World Health Assembly 1
State, Tribal, Local and Territorial Subcommittee 1
Strategic Partnerships to Enhance Safety of Imported Foods: Capacity Building, Risk-Based Decisionmaking, Recognition of Commodity Food Control Programs, and Systems Recognition 1
Subcommittee for Dose Reconstruction Reviews, Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health 2
Subcommittee on Procedures Review of the Advisory Board on Radiation and Worker Health 1
Subcommittees 2
Sunshine Act 5
Task Force on Research Specific to Pregnant Women and Lactating Women 3
Technical Advisory Panel on Medicare Trustee Reports 2
Tenth Annual Sentinel Initiative; Public Workshop 1
Tick-Borne Disease Working Group 1
Tobacco Products Scientific Advisory Committee 2
Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access 1
Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics--Exploring Path Forward; Public Workshop 1
Tribal Consultation 1
United States Food and Drug Administration and Health Canada Joint Regional Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 1
Vaccines and Related Biological Products Advisory Committee 6
Voluntary Medical Device Manufacturing and Product Quality Program 1
Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop 1
Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology; Public Workshop 1

Members of Senior Executive Service 2017 Performance Review Board 1

Modified Risk Tobacco Product Applications:

Modified Risk Tobacco Products; Applications:

NIH Guidelines:

National Health and Nutrition Examination Survey, Stored Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals to Use Serum, Plasma, and Urine Samples. 1

National Institute for Occupational Safety and Health Center for Motor Vehicle Safety; Final Publications:

Results from 2016 Midcourse Review 1

National Institute for Occupational Safety and Health; Immediately Dangerous to Life or Health Value Profiles:

Acetonitrile, Chloroacetonitrile, Methacrylonitrile, and Nitrogen Dioxide 2

National Institute of Dental and Craniofacial Research's 2030 Strategic Visioning Initiative 1

National Vaccine Injury Compensation Program:

Petitions 3
Revised Amount of Average Cost of Health Insurance Policy 1

New Animal Drugs:

Withdrawal of Approval of Application 1

New Drug Applications:

Barr Laboratories, Inc. et al.; Withdrawal of Approval 1
Bayer Healthcare Pharmaceuticals; BAYCOL (cerivastatin sodium) Tablets; Withdrawal of Approval 1
Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications 1
Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications; Correction 1
Guerbet Group; Withdrawal of Approval 1
Hospira, Inc. et al.; Withdrawal of Approval; Correction 1
Mepergan Fortis Capsules 1
Pre-Submission Facility Correspondence Associated with Priority Submissions; Draft Guidance for Industry; Availability 1
Roxane Laboratories, Inc.; Withdrawal of Approval 1
Upsher-Smith Laboratories, Inc.; Withdrawal of Approval for PROPRANOLOL HYDROCHLORIDE 1
Upsher-Smith Laboratories, Inc.; Withdrawal of Approval for ZALEPLON 1
Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval 1

Non-Competitive, Supplemental Funding Awards:

ONC Health IT Certification Program IT Certification Program:

ONC-Approved Accreditor Status Request 1

Office of Dietary Supplements Strategic Plan for 2017-2021 1

Opioid State Targeted Response Grants 1

Organizational Changes:

National Institute of General Medical Sciences 1

Outsourcing Facility Fee Rates for Fiscal Year 2018 1

Patent Extension Regulatory Review Periods:

Intercept Blood System for Plasma 1
Intercept Blood System for Platelets 1

Patent Infringement Complaints Filed Against a Biosimilar Applicant 3

Patient Safety Organizations:

Patient Safety Organizations; Delistings:

Catholic Health Initiatives Patient Safety Organization, LLC 1
Fresenius Medical Care PSO, LLC 1
Regenstrief Center for Healthcare Engineering at Purdue University 1
Surgical Momentum PSO 1
Voluntary Relinquishment from Specialty Benchmarks PSO 1
Voluntary Relinquishment from MagMutual Patient Safety Institute, LLC 1
Voluntary Relinquishment from the Empire State Patient Safety Assurance Network PSO 1
Voluntary Relinquishment from the Healogics Patient Safety Institute 1

Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews 2

Pediatric Studies of Ampicillin Conducted in Accordance With the Public Health Service Act 1

Performance Review Board Members 2

Performance Test Protocols:

Permit Applications; Changes:

Import Dog Inadequately Immunized Against Rabies 1

Personal Protective Equipment Information Database 1

Petitions to Add a Class of Employees to the Special Exposure Cohort 6

Phase Four of the National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination; Coordination among Federal Partners to Leverage HAI Prevention and Antibiotic Stewardship 1

Pilot Project Program under the Drug Supply Chain Security Act 1

Prescription Drug User Fee Act VI Commitment to Assess Current Practices of the Food and Drug Administration and Sponsors in Communicating During Investigational New Drug Development; Establishment of a Public Docket 1

Preventing Alcohol-Related Deaths (PARD) through Social Detoxification; Extension of Due Dates 1

Priority Review Vouchers:

Rare Pediatric Disease Product 4

Privacy Act; Matching Programs 2

Program Applications:

Instructions for MIPPA Program Funds 1

Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II 1

Proposed Adoption of Administration for Native Americans Program Policies and Procedures 1

Proposed Changes to Black Lung Clinics Program for Consideration for FY 2017 Funding Opportunity Announcement Development 1

Proposed Exclusive Patent Licenses:

Proposed Re-Designations of Service Delivery Areas:

Passamaquoddy Tribe at Indian Township 1
Tolowa Dee-ni' Nation (Smith River Rancheria) 2

Proposed Standards for Children's Hospitals Graduate Medical Education Payment Program's Quality Bonus System 1

Proposed Start-Up Exclusive Evaluation Patent Licenses:

Prospective Grant of Exclusive Patent Licenses:

Prospective Grants of Exclusive Patent Licenses:

Protecting Our Infants Act Report to Congress:

Summary of Public Comment and Final Strategy 1

Public Dockets; Establishments:

Opioid Policy Steering Committee 1

Re-Designation of the Delivery Areas:

Passamaquoddy Tribe at Indian Township 1
Tolowa Dee-ni Nation, formerly known as Smith River Rancheria 1

Reallotment of Fiscal Year 2016 Funds:

Low Income Home Energy Assistance Program 1

Reallotment of Fiscal Year 2017 Funds 1

Regulatory Review Period for Patent Extensions:

CINQAIR 1
VONVENDI 1

Regulatory Review Periods for Purposes of Patent Extensions:

REXULTI 1
SAVAYSA 1
SENZA SPINAL CORD STIMULATION SYSTEM 1
SOLX SYSTEM 1
VELTASSA 1
XURIDEN 1
YONDELIS 1
ZERBAXA 1

Reimbursement Rates for Calendar Year 2017 1

Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments 1

Request for Comments:

Requests for Applications:

Health Information Technology Advisory Committee 1

Requests for Comments:

Requests for Information:

Development of Fiscal Year 2019 Trans-NIH Plan for HIV-Related Research 1
Effect of Stockpiling Conditions on Performance of Medical N95 Respirators and High-Level Protective Surgical Gowns 1
Effective Methods for Implementing Water Management Programs to Reduce Growth of Transmission of Legionella spp 1
Effective, Large-Scale, Sustainable Approaches to Help People Quit Using Tobacco by Employing Evidence-based Treatment Options 1
Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates 1
Future Work with and on Behalf of American Indian and Alaska Native Leadership, Tribes, Tribal Organizations, and Populations 1
Health Risks to Workers Associated with Occupational Exposures to Peracetic Acid 1
Healthcare Delivery Organizations 1
Input on Opportunities of Engagement of External Stakeholders with "Illuminating Druggable Genome" Program 1
Office of Disease Prevention Strategic Plan for Fiscal Years 2019–2023 1
Organizations Utilizing Business Models Supporting Private Sector Vaccine Management 1
Pharmaceutical Distribution Supply Chain Pilot Projects 1
Protecting Our Infants Act Report to Congress 1
Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by Food and Drug Administration 1

Requests for Letters of Interest:

NCI-MATCH Laboratories 1

Requests for Nominations:

Advisory Committee on Minority Health 1
Advisory Council on Alzheimer's Research, Care, and Services 1
Appointment to Tick-Borne Disease Working Group; Amendment 1
Appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria 1
Clinical Laboratory Improvement Advisory Committee 1
Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative 1
Community Preventive Services Task Force 1
Device Good Manufacturing Practice Advisory Committee 1
Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee; Voting Members 1
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel 1
Healthcare Infection Control Practices Advisory Committee 1
Individuals and Consumer Organizations for Advisory Committees 2
Interdepartmental Serious Mental Illness Coordinating Committee 1
Medicare Program: Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests 1
Medicare Program; Medicare Evidence Development and Coverage Advisory Committee 1
Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health 1
National Advisory Council for Healthcare Research and Quality 1
National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee 1
National Preparedness and Response Science Board 1
Pain Management Best Practices Inter-Agency Task Force 1
Pediatric Advisory Committee 1
Presidential Advisory Council on HIV/AIDS 1
Public Advisory Panels of Medical Devices Advisory Committee 1
Scientific Peer Reviewers of Proposed Additions to List of World Trade Center-Related Health Conditions 1
Secretary's Advisory Committee on Human Research Protections 1
Three Organizations to Serve as Non-Voting Liaison Representatives to the Chronic Fatigue Syndrome Advisory Committee 1
Tick-Borne Disease Working Group 1
Tick-Borne Disease Working Group; Correction 1
Tobacco Products Scientific Advisory Committee 1
U.S. Preventive Services Task Force 1
Voting Members; National Mammography Quality Assurance Advisory Committee 1
Voting Members; Technical Electronic Product Radiation Safety Standards Committee 1
World Trade Center Health Program Scientific/Technical Advisory Committee 1

Requests for Scientific Information Submissions:

Requests for Supplemental Evidence and Data Submissions:

Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries 1
Drug Therapy for Early Rheumatoid Arthritis in Adults – Update 1
Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factor 1
Lower Limb Prosthesis 1
Mobile Health Technology for Diabetes 1
Noninvasive, Nonpharmacological Treatment for Chronic Pain 1
Nonsurgical Treatments for Urinary Incontinence in Adult Women 1
Physiologic Predictors of Need for Trauma Center Care: Systematic Review 1
Psychological and Pharmacological Treatments for Adults with Posttraumatic Stress Disorder: Systematic Review Update. 1
Stroke Prevention in Atrial Fibrillation Patients: Systematic Review Update 1
Telehealth for Acute and Chronic Care Consultations 1

Requirements and Registration for Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test Challenge 1

Requirements and Registration:

Million Hearts Hypertension Control Challenge 1

Secretarial Review and Publication of National Quality Forum Report of 2016 Activities to Congress and Secretary of Department of Health and Human Services 1

Senior Executive Service Performance Review Board:

Prospective Members 1

Single-Award Deviations from Competition Requirements:

Single-Source Awards:

Single-Source Grants:

Office of Refugee Resettlement's Unaccompanied Alien Children's Program 2
Office of Refugee Resettlement's Unaccompanied Children's Program 2
Professionalism and Integrity in Research Program 2
Unaccompanied Alien Children's Program 1
Unaccompanied Children's Program 1

Site Visit Training Program for Office of Pharmaceutical Quality Staff 1

Specification for Postal Security Devices and Indicia (Postmarks); Correction 1

Statement of Organization, Functions, and Delegations of Authority 4

Statements of Organization, Functions, and Delegations of Authority 8

Supplemental Award to National Network for Oral Health Access 1

Supplemental Grant Awards:

Tribal Consultation Policy 1

Upcoming Challenge Competition 1

Vaccines Adverse Event Reporting System 2.0 Form 1

Website Location of Center for Devices and Radiological Health Fiscal Year 2018 Proposed Guidance Development 1

Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications:

Johnson and Johnson Consumer, Inc. et al. 1

Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application; Correction:

B. Braun Medical, Inc.; 1

Withdrawal of New Drug Applications; Approvals:

B. Braun Medical, Inc. 1

World Trade Center Health Program:

Petition 015: Neuropathy; Finding of Insufficient Evidence 1

Youth Regional Treatment Center Aftercare Pilot Project 1

Youth Regional Treatment Center Aftercare Pilot Project; Correction 1

Zero Suicide Initiative - Support 1