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Label Comprehension Study
Label Comprehension Study
OMB: 0910-0612
IC ID: 181099
OMB.report
HHS/FDA
OMB 0910-0612
ICR 200707-0910-003
IC 181099
( )
Documents and Forms
Document Name
Document Type
Label Comp. Study Questionnaire Current Label ( revision).DOC
Other-Study Questionnaire
Label Comp. Study Proposed Label ( Revision).DOC
LABEL COMP STUDY QUESTIONNAIRE PROPOSED LABEL
IC Document
Informed Consent- Label Comp Study.DOC
Informed Consent- Label Comp Study
IC Document
Label Comp. Study Power Analysis ( Revision).DOC
LABEL COMP STUDY POWER ANALYSIS
IC Document
LABEL COMP STUDY CURRENT PKG INSERT.DOC
LABEL COMP STUDY CURRENT PKG INSERT
IC Document
LABEL COMP STUDY PROPOSED PKG INSERT-DRAFT GUIDANCE.DOC
LABEL COMP STUDY PROPOSED PKG INSERT-DRAFT GUIDANCE
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Label Comprehension Study
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
New
Obligation to Respond:
Voluntary
CFR Citation:
21 CFR 393
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Study Questionnaire
Label Comp. Study Questionnaire Current Label ( revision).DOC
No
No
Paper Only
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
1,200
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
1,200
0
1,200
0
0
0
Annual IC Time Burden (Hours)
705
0
705
0
0
0
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
LABEL COMP STUDY QUESTIONNAIRE PROPOSED LABEL
Label Comp. Study Proposed Label ( Revision).DOC
10/10/2007
Informed Consent- Label Comp Study
Informed Consent- Label Comp Study.DOC
07/02/2007
LABEL COMP STUDY POWER ANALYSIS
Label Comp. Study Power Analysis ( Revision).DOC
10/10/2007
LABEL COMP STUDY CURRENT PKG INSERT
LABEL COMP STUDY CURRENT PKG INSERT.DOC
07/02/2007
LABEL COMP STUDY PROPOSED PKG INSERT-DRAFT GUIDANCE
LABEL COMP STUDY PROPOSED PKG INSERT-DRAFT GUIDANCE.DOC
07/02/2007
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.