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
Accelerated Approval Patient Information
New
1500
90
0
Other-Survey Recruitment
Other-Survey Screener
Other-Survey Interview Guide
Other-Survey Stimuli
Other-Survey IRB Review
Other-ICR Request Memo
CDER Rapid Message Testing with Consumers – Prescription Stimulant Diversion Messaging
New
1500
98
0
Other-Screener
Other-Tweets and messages
Other-Interview guide
Combating the Infodemics Through Evidence-Based Misinformation Management Strategies – Phase I
New
6000
2760
0
Other-Recruitment email
Other-Recruitment invitation
Other-Screener
Other-Consent form
Other-Questionnaire
Other-Debrief statement
Dosage Form Presentations in Direct-to-Consumer Prescription Drug Television Advertisements: Semi-Structured Consumer Interviews
New
1500
150
0
Other-Recruit and screener
Other-Consent
Other-Interview confirmation
Other-Moderator's guide
Drug Disposal Message Communications
New
1500
90
0
Other-Recruitment Screener
Other-Participant Screener
Other-Interview Guide
Other-Message Stimuli
Other-IRB Approval Memo
Exploring Barriers to Buprenorphine Access for Opioid Use Disorder
New
2000
103
0
Other-Consent form
Other-Screener
Other-Questionnaire
Exploring Healthcare Providers' Practices, Perspectives, and Experiences Prescribing and Co-Prescribing Benzodiazepines and Opioid Analgesics
Unchanged
1958
471
0
Other-Focus Group Screener
Other-Interview Screener
Other-Recruitment Outreach
Other-Focus Group Moderator Guide
Other-Individual Interview Guide
Other-Focus Group Consent Form
Other-Individual Interview Consent Form
Exploring Healthcare Providers' Practices, Perspectives, and Experiences Prescribing and Co-Prescribing Benzodiazepines and Opioid Analgesics: Individual In-Depth Interviews
New
450
105
0
Other-Screener
Other-Recruitment email and post
Other-Interview guide
Other-Consent form
Exploring Healthcare Providers' Practices, Perspectives, and Experiences Prescribing and Co-Prescribing Benzodiazepines and Opioids (CDER)
Unchanged
3504
801
0
Other-Focus Group Screener
Other-Interview Screener
Other-Recruitment Outreach for FGs and IDIs
Other-Moderator Guide for Focus Groups
Other-Interview Guide for Individuals
Other-Consent Form for Focus Group
Other-Consent Form for Individual Interviews
Focus Groups: Adherence Potential and Patient Preference in Prescription Drug Promotion (CDER)
New
1450
157
0
Other-Screener
Other-Script
Other-Consent form
Other-Moderator guide
Other-IRB
Formative Research Study to Understand the Impact of Generic Substitutes for Various Patient and Caregiver Populations
Unchanged
32
48
0
Other-Sample Recruitment Media Advertisement Language
Other-Youth Screener
Other-Adult Screener
Other-Programmed pre-screener
Other-Adult Consent Form
Other-Youth Assent Form
Other-Parental Permission Form
Other-Moderator Guide
Other-Recruitment Confirmation and Reminder E-mails
Other-Advance Letter
Other-Mailed Instructions
Other-Workbook
One-On-One Interviews: Examination of Implied Claims in Direct-To-Consumer Prescription Drug Promotion
New
910
150
0
Other-Screener
Other-Consent form
Other-Interview guide
One-on-One Interviews: Tradeoff Analysis of Risk, Benefit, and Adherence Claims in Direct to Consumer and HCP Promotion (CDER)
Unchanged
105
126
0
Other-Screener
Other-Confirmation Email
Other-Consent Forms
Other-Reminder Script
Other-Moderator Guides
Prescription Drug Promotional Landscape Interviews
New
58
44
0
Other-Interview Guide Consumer
Other-Interview Guide HCP
Other-Consent Form
Other-Recruitment Script
Other-Screener
Prescription Drug Use Related Software Study (CDER)
Unchanged
186
54
0
Other-Screeners
Other-Confirmation and Reminder Emails
Other-Consent Form
Other-Moderator Guide
Rapid Message Testing CDER Tagline
New
200
25
0
Other-Recruitment
Other-Screener
Other-Interview guide
Other-Stimuli
Rapid Message Testing with Consumer Panel - Additional Testing of Drug Safety Communications About Misuse and Abuse of Over-the-Counter Medications (CDER)
Unchanged
750
45
0
Other-Interview Guide
Other-Screener
Other-Author Manuscript
Other-Drug Safety Communication - Benadryl
Other-Drug Safety Communication - Imodium
Other-Drug Safety Communication - Nasadrine
Rapid Message Testing with Consumer Panel - Drug Safety Communication Landing Page and Format (CDER)
Unchanged
1500
90
0
Other-Screener
Other-Cognitive Interview Guide
Other-DSC Mockup
Rapid Message Testing with Consumers - Interchangeable Biosimilars Information
New
340
27
0
Other-Screener
Other-Factsheet
Other-Interview guide
Rapid Message Testing with Consumers - Paxlovid Information
New
325
29
0
Other-Patient eligibility screening checklist
Other-Website content
Other-Screener
Other-Interview guide
Rapid Message Testing with Consumers - Terminology Routinely Used in CDER Communications
Unchanged
1500
98
0
Other-Screener
Other-Interview guide
Other-Video links to test
Other-FAQs ages 5-11
Other-FAQs ages 12-15
Other-FAQs adults
Rapid Message Testing with Consumers - Terminology Routinely Used in CDER Communications
Unchanged
1500
98
0
Other-Interview Guide
Other-Screener
Other-Terminology
Rapid Message Testing with Consumers Cannabis Consumer Update
New
1500
90
0
Other-Survey Recruitment
Other-Survey Screener
Other-Survey Interview Guide
Other-Survey Simuli
Other-Survey IRB review
Rapid Message Testing with Consumers Drug Shortage Infographic
New
1500
87
0
Other-Recruitment
Other-Screener
Other-Interview guide
Other-Stimuli
Rapid Message Testing with Consumers and Healthcare Professionals - Children's Cough and Cold Consumer Update (CDER)
Unchanged
1575
97
0
Other-Screener
Other-Interview Guide
Other-Mock Webpage
Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER)
Unchanged
30
65
0
Other-Advance Email
Other-Consent Form
Other-Invitation
Other-Confirmation Script
Other-Interview Guide
Other-Recruitment Screener - Web
Other-Recruitment Screener - Telephone
Other-Patience Infographic
Other-Diabetes Fact Sheet
Other-Patient Fact Sheet
Total Burden Actually Used for Information Collections Under Currently Approved ICR:
33373
5998
0
Total Burden Currently Requested for Information Collections Under Currently Approved ICR:
0
0
0
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