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Studies to Enhance FDA Communications Addressing Medical Countermeasures Prescription Drug Products
Data to Support Drug Product Communications as Used by the FDA
OMB: 0910-0695
IC ID: 226226
OMB.report
HHS/FDA
OMB 0910-0695
ICR 201711-0910-001
IC 226226
( )
⚠️ Notice: This information collection may be referencing outdated material.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
0695 Appendix 1 - Email Invitation.doc
Other-Invitation
0695 Appendix 2 - Consent Form.doc
Other-Online Informed Consent Form
0695 Appendix 3 - Privacy Statement for Members.doc
Other-Privacy Statement for Knowledg
0695 MEDICAL COUNTERMEASURES Study Re Medical Products OMB Approval Request Memo.doc
Communications Addressing Medical Countermeasures PDP OMB Approval Request Memo
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Studies to Enhance FDA Communications Addressing Medical Countermeasures Prescription Drug Products
Agency IC Tracking Number:
CDER
IC Status:
Unchanged
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-Invitation
0695 Appendix 1 - Email Invitation.doc
Yes
Yes
Fillable Fileable
Other-Online Informed Consent Form
0695 Appendix 2 - Consent Form.doc
Yes
Yes
Fillable Fileable
Other-Privacy Statement for KnowledgePanel Members
0695 Appendix 3 - Privacy Statement for Members.doc
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:
2,469
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
100 %
Requested
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
2,469
0
0
0
0
2,469
Annual IC Time Burden (Hours)
823
0
0
0
0
823
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
Communications Addressing Medical Countermeasures PDP OMB Approval Request Memo
0695 MEDICAL COUNTERMEASURES Study Re Medical Products OMB Approval Request Memo.doc
03/29/2017
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.