PRA IC List
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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Biosimilars Prescribing Survey
New
500
210
0
Other-Survey Instrument
Other-Screening Questions
Other-Informed Consent
Biosimilars Prescribing Survey
New
500
210
0
Other-Screening Questions
Other-Consent Form
Other-Survey Instrument
Educating Groups Influencing Generic Drug Use
New
327
137
0
Other-Recruitment Email
Other-Verbal Consents
Other-Consent Forms for Surveys
Other-Protocol for Formulary Managers
Other-Protocol for Large Purchasers
Other-Protocol for Policymakers
Other-Protocol for Prescribers
Other-Protocol for Pharmacists
Other-Protocol for Patients and Caregivers
Endorsement in Direct-to-Consumer Promotion: Cognitive Interviews
New
50
24
0
Other-Discussion Guides
Other-Interview Screener
Other-Consent Form - Study 1
Other-Consent Form - Study 2
Other-Example of Reminder Email
Formative Research Study to Understand the Impact of Generic Substitutes for Various Patient and Caregiver Populations
New
200
300
0
Other-Youth Screener
Other-Parental Permission Form
Other-Adult Screener
Other-Confirmation and Reminder Emails
Other-Adult Consent Form
Other-Youth Assent Form
Other-Worksheet
Other-Moderator Guide
Other-Cert. of Confidentiality
Healthcare Professional Ihterviews: Risk Processing for Newly Promoted Prescription Drugs
New
225
0
0
Other-Screener
Other-Moderator Guide
Other-Recruitment Flyer
Healthcare Professional Interviews: Data Disclosures in Communications About Prescription Drugs
New
140
87
0
Other-Email, Screener, and Invitation for Oncologists
Other-Email, Screener, and Invitation for PCPs
Other-Confirmation email
Other-Informed Consents
Other-Reminder email
Other-Interview Guide
Healthcare Professional Interviews: Risk Processing for Newly Promoted Prescription Drugs
New
225
158
0
Other-Screener
Other-Moderator Guide
Other-Consent Forms
Other-Reminder email
Healthcare Professional Interviews: Risk Processing for Newly Promoted Prescription Drugs (CDER)
New
225
0
0
Other-Screener
Other-Informed Consent - nonMedStar
Other-Informed Consent Form - NP and PA
Other-Informed Consent Form - PCP
Other-Informed Consent Form - Specialist
Other-Recruitment Flyer - MedStar
Other-Recruitment Flyer - nonMedStar
Identifying Messages to Promote Value and Education of Generic Prescribing
New
850
213
0
Other-Script
Other-Powerpoint
Other-Post Test
Other-Recruitment Email
Individual Interview Study of Healthcare Provider Perceptions of Boxed Warnings
New
100
60
0
Other-Screener
Other-Moderator Guide
Other-Consent Form for PCP
Other-Consent Form for Specialists
Individual Interview Study of Healthcare Provider Perceptions of Boxed Warnings
New
100
60
0
Other-Screener
Other-Moderator Guide
Other-Consent Form for PCP
Other-Consent Form for Specialists
Naloxone Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 3 - Adolescents)
New
1120
163
0
Other-Telephone Screener
Other-Interview Guide
Other-Script and Contact Information Sheets
Other-Permission Form
Other-Assent Form
Other-Injector Label
Other-Nasal Label
Naloxone Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 3 - Adult All Comers)
New
570
498
0
Other-Online Screener
Other-Telephone Screener (Group 1 and 2)
Other-Telephone Screener (Group 4)
Other-Interview Guide (Group 1 and 2)
Other-Interview Guide (Group 4)
Other-Information Sheet (Group 1 and 2)
Other-Study Flyer (Group 1 and 2)
Other-Palm Cards (Group 1 and 2)
Other-Description Table (Group 1 and 2)
Other-Online Advertisement (Group 1 and 2)
Other-Telephone and Email Scripts (Group 1 and 2)
Other-Closing Script (Group 1 and 2)
Other-Closing Script (Group 4)
Other-Consent Form (Group 1,2,&4)
Other-Label - Injector
Other-Label - Nasal
Other-Screenshot - Exhibit 3
Other-Screenshot of Exhibit 4
Other-Certificate of Confidentiality
Physician Interviews on FDA-Approved Labeling
New
330
97
0
Other-Script and Emails
Other-Screener
Other-Confirmation Email
Other-Informed Consent
Other-Interview Guide
Promotional Implications of Proprietary Prescription Drug Names
New
2460
276
0
Other-Survey Instrument
Other-Informed Consent
Rapid Message Testing With Consumer Panel - Asthma Fact Sheet
New
250
21
0
Other-Survey
Other-Interview Guide
Other-Factsheet in English
Other-Factsheet in Spanish
Rapid Message Testing With Consumer Panel - Medical Countermeasure Messages
New
75
18
0
Other-Recruitment Screener
Other-Interview Guide
Other-EUS MCM Message
Other-FDA Approved MCM Message
Other-No MCM Message
Rapid Message Testing with Consumer Panel - BeSafeRx Campaign Messages
New
50
14
0
Other-Participant Screener
Other-Interview Guide
Other-Message Testing
Rapid Message Testing with Consumer Panel - Drug Safety Communications About Misuse and Abuse of Over-the-Counter Medications (CDER)
New
1500
89
0
Other-Interview Guide
Other-Screener
Other-DSC - Benadryl
Other-DSC - Immodium
Other-DSC - Nasadine
Rapid Message Testing with Consumer Panel - FDA's Purple Book Website (CDER)
New
90
16
0
Other-Survey Instrument
Other-Interview Guide
Rapid Message Testing with Consumer Panel - Medication Guide Template for Buprenorphine Products (CDER)
New
100
13
0
Other-Survey Instrument
Other-Moderator Guide
Other-MG Template
Rapid Message Testing with Consumer Panel - Public Service Announcements About Safe Disposal of Opioids
New
250
21
0
Other-Screener
Other-English Interview Guide
Other-Script - English with Alternate Slide 8
Other-Spanish Interview Guide
Other-Script - Spanish with Alternate Slide 5
Other-Script - English with Alternate Slide 5
Rapid Message Testing with Consumer Panel - Retest of Warnings on Opioid Packaging
New
1600
88
0
Other-Interview Guide
Other-Screener
Other-Label - Version 1
Other-Label - Version 2
Rapid Message Testing with Consumer Panel - Safe Drug Disposal Notecard
New
100
16
0
Other-Recruitment Screener
Other-Interview Guide
Other-English Notecard
Other-Spanish Notecard
Rapid Message Testing with Consumer Panel - Storyboards About Safe Disposal of Opioids and Other Medicines
New
96
17
0
Other-Screener
Other-Moderator Guide - English
Other-English - Web Storyboard
Other-English - PSA Storyboard
Other-Moderator Guide - Spanish
Other-Spanish - Web Storyboard
Other-Spanish - PSA Storyboard
Rapid Message Testing with Consumer Panel - Testosterone Medication Guide
New
250
24
0
Other-Survey
Other-Interview Guide
Other-Medication Guide
Rapid Message Testing with Consumer Panel - Transmucosal Immediate Release Fentanyl Patient Presriber Agreement Form
New
400
31
0
Other-Participant Screener
Other-Patient Prescriber Agreement Form
Other-Interview Guide
Rapid Message Testing with Consumer Panel - Vaccines and Seniors Brochure
New
250
20
0
Other-Survey
Other-Consent Form
Other-Brochure
Rapid Message Testing with Consumer Panel - Warnings on Opioid Packaging
New
200
25
0
Other-Screener
Other-Interview Guide
Other-Labels
Rapid Message Testing with Consumer Panel -Messages About Cannabidiol (CBD)
New
75
12
0
Other-CBD messages with context
Other-FDA RAPID CBD Screener
Other-FDA RAPID CBD Interview Guide
Rapid Message Testing with Healthcare Professionals - Search and Rescue Website (CDER)
New
150
20
0
Other-Screener
Other-Interview Guide
Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups and INterviews with Healthcare Professionals
New
316
263
0
Other-Survey Instrument
Other-Consent form - focus groups
Other-Consent form - individual groups
Other-Invitation Email
Other-Appointment confirmation email
Other-Interview guide
Other-Moderator guide
Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups with Patients
New
1000
192
0
Other-Split Web and Phone Screener
Other-Consent Form
Other-Invitation Email
Other-Confirmation Email
Other-Moderator Guide
Other-InterVu Respondent Invitation Template
Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient Focus Groups 2020
New
144
292
0
Other-Advance Email
Other-Invitation
Other-Consent Form
Other-Moderator Guide
Other-Confirmation Script
Other-Screener - Web
Other-Screener - Telephone
Other-Infographic
Other-FDA Facts Article
Total Burden Actually Used for Information Collections Under Currently Approved ICR:
14818
3685
0
Total Burden Currently Requested for Information Collections Under Currently Approved ICR:
0
0
0
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The site is secure.
