Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Accuracy of Opioid Product Ascertainment (CDER) Unchanged 96 96 0 Other-Survey Instrument
Other-Consent Form
Other-Interview Guide
Other-Study Design and Protocol
An Exploratory Assessment of Substances Used as Adjuncts or Alternatives to Prescription Opioids Unchanged 280 210 0 Other-Screener
Other-List of Prescription Opioids
Other-List of Prescription Benzodiazepines
Other-Consent Form
Other-Reminder
Other-Interview Guide
Other-Certificate of Confidentiality
Assessment of a Pharmacist-Led Transition of Care Service Utilizing an Admissions Enhanced, Patient Risk Evaluation Approach: the ICARE Program Unchanged 450 37 0 Other-Survey Instrument: Consent Form
Other-Survey Instrument: Pre-implementation Provider Perception and Demand Survey
Other-Survey Instrument: 12- and 18-month Provider Survey
Other-Other: Signed IRB Approval
Attitudes and Perceptions of People Living with Hepatitis B on Participation in Clinical Trials New 2000 1000 0 Other-Advertisement Africa 1
Other-Advertisement Africa 2
Other-Advertisement Africa 3
Other-Advertisement African T
Other-Advertisement All Audiences 1
Other-Advertisement All Audiences 2
Other-Advertisement All Audiences 3
Other-Advertisement All Audiences T
Other-Advertisement Asian T
Other-Advertisement Asian
Other-Advertisement Eastern Europe
Other-Advertisement India T
Other-Advertisement India
Other-Advertisement Middle East T
Other-Advertisement Middle East
Other-Emal invitation
Other-Online invitation
Other-Survey-Amharic
Other-Survey-Chinese
Other-Survey-English
Other-Survey-French
Other-Survey-Korean
Other-Survey-Marshallese
Other-Survey-Spanish
Other-Survey-Tagalog
Other-Survey-Vietnamese
Other-IRB
Collection of Data to Support Training Decay Selection for Medical Product Usability Validation Testing (CDER) Unchanged 139 348 0 Other-Moderator Script
Other-Initial Training Script
Other-Consent Forms
Other-Protocol
Other-post-survey questionnaire
Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products (CDER) Unchanged 192 384 0 Other-Consent Form
Other-Script
Other-Reminder Email
Other-Drug Safety Health Communication Tool
Other-Moderator Guide
Other-Guide on Medicine
Other-Screenshot of CDER Communications
Other-Screenshot of Vaccine Communication
Other-Medication Risk and Benefit Brochure
Other-Survey Instrument
Improving the Quality and Representativeness of the Treatment Center Program Data: Survey to Quantify the Magnitude of Misclassification of Opioid Product Identification (CDER) Unchanged 1100 275 0 Other-Survey Instrument
Multistate Pharmacist Survey for Methodologic Advances in Evaluating Abuse Deterrent Opioid Analgesics (CDER) Unchanged 2500 250 0 Other-Questionnaire
Other-Email Invitation and Cover Letter
Multistate Pharmacist Survey for Methodologic Advances in Evaluating Abuse Deterrent Opioid Analgesics (Maryland) Unchanged 1200 120 0 Other-Survey
Other-Survey
NMURx Express Survey to Evaluate Stimulant Abuse in the United States: Trajectories from Medical Use to Non-Medical Use (CDER) Unchanged 1400 233 0 Other-Questionnaire
Other-Consent Form
Other-Certification of Confidentiality
Perioperative Medication Safety Self-Assessment for Hospitals and Ambulatory Surgical Centers and Targeted Risk-Reduction Tool Development (CDER) Unchanged 1500 11171 0 Other-Survey Instrument
Other-Screenshot Webpage
Prescriber Decision-Making about Pain Management and Opioid Prescribing New 20 12 0 Other-E-mail invitation
Other-Verbal consent form
Other-Semi-structured interview protocol
Other-IRB exemption
Preventable Harm from Outpatient Pediatric Medication Errors: Measure Development New 225 240 0 Other-Org Leader Interviews Recruitment Email
Other-Idea Generation Recruitment Email
Other-Rating and Feasibility Recruitment Email
Other-Org Leader Interview Guide
Other-Idea Generation Questionnair
Other-Parent Interview Guide
Other-Sorting Measures Type Idea Recruitment Email
Other-Screenshots-Sorting of Measure Type Ideas
Other-Rating Sheet
Other-IRB Correspondence
Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising: Consumer Interviews New 80 36 0 Other-Interview guide
Other-Consent form
Other-Recruitment email
Other-Screener
Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Physician Experiences with REMS Programs (CDER) Unchanged 1200 400 0 Other-Invitation
Other-Consent Form
Other-Survey - Ambrisentan
Other-Survey - Bosentan
Other-Survey - Clozapine
Other-Survey - Isotretinoin
Other-Survey - Lenalidomide-Pomalidomide-Thalidomide
Other-Survey - Sodium Oxybate
Other-Reminder Letter
Other-IRB Letter
Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Physician Experiences with REMS Programs (CDER) Unchanged 1420 0 0 Other-Patient Guide
Other-Recruitment Messages-Email
Other-Recruitment Messages-Email Forward-Patient and Caretaker
Other-Recruitment Messages-Email-Patient Only
Other-Recruitment Messages-Email-Patient or Caretaker
Other-Recruitment Messages-Rally
Other-Recruitment Messages-Rally-Patient Only
Other-Recruitment Messages-Rally-Patient or Caretaker
Other-Patient Interview-Alvimopan Guide
Other-Fact Sheet
Other-Physician Survey - Ambrisentan
Other-Physician Survey-Bosentan
Other-Physician Survey-Clozapine
Other-Physician Survey-Isotretinoin
Other-Physician Survey-Lenalidomide-Pomalidomide-Thalidomide
Other-Physician Survey-Sodium Oxybate
Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Patient Experiences with REMS Programs (CDER) Unchanged 160 160 0 Other-Interview Guide
Other-Consent Form
Other-Recruitment Message-Email-All Drugs-Patient Only
Other-Recruitment Message-Email-Patient or Caretaker
Other-Recruitment Message-Email Forward- Patient Only
Other-Recruitment Message-Email Forward-Patient or Caretaker
Other-Recruitment Message-Rally-All Drugs-Patient Only
Other-Recruitment Message-Rally-C and P - Patient Only
Other-Recruitment Research Match-All Drugs - Patient Only
Other-Recruitment Research Match-Patient or Caretaker
Other-Drug Specific Content
Other-IRB Letter
Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Physician Interviews on Experiences with REMS Programs (CDER) Unchanged 60 60 0 Other-Recruitment Message - Physicians
Other-Recruitment Message - Professional Society
Other-Consent
Other-Interview Guide - Alemtuzumab
Other-Alvimopan
Other-Interview Guide - Pegvaliase
Other-IRB Letter
Training Decay for Medical Products: Insulin Pump Usability Study (CDER) Unchanged 150 285 0 Other-Initial Training Script
Other-Moderators Script
Other-End of Study Questionnaire
Other-Informed Consent
Other-IRB Letter
Total Burden Actually Used for Information Collections Under Currently Approved ICR: 14172 15317 0  
Total Burden Currently Requested for Information Collections Under Currently Approved ICR: 0 0 0  
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