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
Alternative Presentations of Clinical Pharmacology Section of Approved Drug Labeling and Effect on Comprehension, Memory, and Action
New
150
75
0
Other-Survey Instrument
Other-Consent
Other-Recruitment Email
Other-Screener
Animation in DTC Promotion
Unchanged
480
57
0
Other-Interview Screener
Other-Interview Guide
Other-Interview Consent
CONFER Study; Comprehension of Over-the-Counter Naloxone for Emergency Response
Unchanged
2778
599
0
Other-Study Screener
Other-Study Screener 2
Other-Study Document: Provider Info. Sheet
Other-Study Document: Recruitment Flyer
Other-Study Document: Recruitment Card
Other-Study Document: Partipation Agreement
Other-Study Document: Sample Drug Facts Label
Other-Study Document: Moderator Guide
CONFER: Comprehension of Over-the-Counter Naloxone for Emergency Response (Task 2 - Adolescents)
Unchanged
99
15
0
Other-Study Screener
Other-Closing Script and Contact Information
Other-Interview Guide
Other-Parental Permission Form
Other-Assent Form
Other-Drug Facts Label
Other-Drugs Facts Label
Clinical Trial Data in Professional Prescription Drug Promotion
Unchanged
372
96
0
Other-Survey
Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements (Cognitive Interviews)
Unchanged
498
32
0
Other-Screener
Other-Testing Guide
Educating Groups Influencing Generic Drug Use
Unchanged
60
60
0
Other-Informational Letters
Other-Interview Guides
Other-Interview Screeners
Other-Revised Study Instruments
IMPROVE Study Phase 2
Unchanged
850
170
0
Other-IMPROVE Survey Instrument
Other-IMPROVE Survey Screener
Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-To-Consumer Prescription Drug Ads (Cognitive Interviews)
Unchanged
498
50
0
Other-Questionnaire
Interviews/Surveys
Unchanged
19822
4625
0
Naloxone Pilot Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 2)
Unchanged
177
40
0
Other-Study Screener
Other-Closing Script and Contact Info 1-2
Other-Study Screener
Other-Closing Script and Contact Info 4
Other-Interview Guide
Other-Provider Info
Other-Recruitment Flyer
Other-Recruitment Cards
Other-Online Screener
Other-Online Ad
Other-Consent Form 1-2
Other-Consent Form 4
Other-Label: Injector Supine
Other-Label: Nasal Supine
Pretest for a Study on Quantitative Information in Direct-to-Consumer Television Advertisements
Unchanged
270
112
0
Other-Recruitment email
Other-Screener
Other-Survey
Other-Consent form
Pretests for a Study on Quantitative Information in Direct-to-Consumer Television Advertisements
Unchanged
1010
419
0
Other-Survey - Pretest 1
Other-Survey - Pretest 2
Other-Survey - Pretest 3 & 4
Rapid Message Testing with Consumer Panel - Opioid Analgesics Patient Counseling Guide
New
265
24
0
Other-Survey
Other-Consent
Other-Patient Counseling Guide
Rapid Message Testing with Consumer Panel - Public Service Announcement Video about Generic Drugs
Unchanged
250
20
0
Other-Screener for Panel Participants
Other-Interview Protocol
Rapid Message Testing with Consumer Panel-Caregiver Tipsheet
Unchanged
265
20
0
Other-
Other-
Other-
Rapid Message Testing with Consumer Panel; Clinical Trials Brochure
Unchanged
250
24
0
Other-Interview Screening Document - English
Other-Interview Screening Document - Spanish
Other-Study Brochure - English
Other-Study Brochure - Spanish
Other-Study Interview Guide
Studies to Enhance FDA Communications Addressing Medical Countermeasures Prescription Drug Products
Unchanged
2469
823
0
Other-Invitation
Other-Online Informed Consent Form
Other-Privacy Statement for KnowledgePanel Members
Studies to Enhance FDA Communications Addressing Opioids and Other Potentially Addictive Pain Medications
Unchanged
1365
744
0
Other-Consumer survey
Other-Email invitation for Consumers
Other-Intro for Consumers
Other-Consent Form for Consumers
Other-HCP Survey
Other-Email invitation for HCPs
Other-Intro for HCPs
Other-Consent Form for HCPs
Studies to Enhance FDA Communications Addressing Opioids and Other Potentially Addictive Pain Medications
Unchanged
1090
203
0
Other-Physician Screener
Other-Gen Pop Screener
Other-Opioid User Screener
Other-Consent Forms
Other-Intro Discussion
Other-Friends Family Discussion
Other-General Population Group
Other-Opioid User Group
Testing FDA's Drug Safety Communications with Consumers to Improve Consumer Knowledge About How FDA Communicates Risks and Benefits of Prescription Medicines
Unchanged
2600
1083
0
Other-Survey
Other-Screener Questions
The Influence of Brand and Prinicple Display for Safe Consumer Use of OTC Drugs - Advancing the Science
Unchanged
400
300
0
Other-Study Recruitment Post
Other-Study Screener Document
Other-Study Task Document
Other-Study Consent Document
Other-IRB Approval
Total Burden Actually Used for Information Collections Under Currently Approved ICR:
36018
9591
0
Total Burden Currently Requested for Information Collections Under Currently Approved ICR:
0
0
0
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