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Alternative Presentations of Clinical Pharmacology Section of Approved Drug Labeling and Effect on Comprehension, Memory, and Action
Data to Support Drug Product Communications as Used by the FDA
OMB: 0910-0695
IC ID: 228995
OMB.report
HHS/FDA
OMB 0910-0695
ICR 201711-0910-001
IC 228995
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0695 can be found here:
2024-03-07 - Extension without change of a currently approved collection
2022-06-30 - No material or nonsubstantive change to a currently approved collection
Documents and Forms
Document Name
Document Type
OCP.LabelingProject Survey.docx
Other-Survey Instrument
Consent Form.docx
Other-Consent
Participant Recruitment.docx
Other-Recruitment Email
Participant Screener.docx
Other-Screener
0695 OMB Approval Memo OCP Labeling 2017.docx
OMB Approval request memorandum
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Alternative Presentations of Clinical Pharmacology Section of Approved Drug Labeling and Effect on Comprehension, Memory, and Action
Agency IC Tracking Number:
CDER
IC Status:
New
Obligation to Respond:
Voluntary
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Screener
Participant Screener.docx
Yes
No
Paper Only
Other-Survey Instrument
OCP.LabelingProject Survey.docx
Yes
Yes
Fillable Fileable
Other-Consent
Consent Form.docx
Yes
Yes
Fillable Fileable
Other-Recruitment Email
Participant Recruitment.docx
Yes
No
Paper Only
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Health Care Services
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
150
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
0 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
150
0
150
0
0
0
Annual IC Time Burden (Hours)
75
0
75
0
0
0
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
OMB Approval request memorandum
0695 OMB Approval Memo OCP Labeling 2017.docx
11/13/2017
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.