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Promotional Implications of Proprietary Prescription Drug Names
Data to Support Drug Product Communications
OMB: 0910-0695
IC ID: 236797
OMB.report
HHS/FDA
OMB 0910-0695
ICR 201712-0910-001
IC 236797
( )
⚠️ Notice: This information collection may be referencing outdated material.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
Pretest Questionnaire.docx
Other-Survey Instrument
Proprietary Name Consent Form.docx
Other-Informed Consent
0695 OMB Approval Memo - Pro Implications of PP Drug Names 2019.docx
OMB Approval Memo
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Promotional Implications of Proprietary Prescription Drug Names
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-Survey Instrument
Pretest Questionnaire.docx
Yes
Yes
Fillable Fileable
Other-Informed Consent
Proprietary Name Consent Form.docx
Yes
Yes
Fillable Fileable
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:
2,460
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
100 %
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
2,460
0
2,460
0
0
0
Annual IC Time Burden (Hours)
276
0
276
0
0
0
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
OMB Approval Memo
0695 OMB Approval Memo - Pro Implications of PP Drug Names 2019.docx
07/02/2019
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.