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Agenda
Reg Review
ICR
View Information Collection (IC)
View Information Collection (IC)
IC Title:
398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)
Agency IC Tracking Number:
Is this a Common Form?
No
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
Form and Instruction
16
Landing Page
Attachment 5F PHS Human Subjects and Clinical Trial Information - Landing Page_FORMS-F.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
17
Inclusion Enrollment Report
Attachment 5F PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report_FORMS-F.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
18
HSCT Sections 1-6
Attachment 5F PHS Human Subjects and Clinical Trial Information - Sections 1-6_Includes Inclusion Enrollment Report_FORMS-F-js edits2 (002).pdf
Yes
Yes
Fillable Fileable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Public Health Monitoring
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
54,838
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
54,838
0
0
0
0
54,838
Annual IC Time Burden (Hours)
767,732
0
0
0
0
767,732
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
PHS Human Subjects and Clinical Trials Information Instructions
Attachment 5G_PHS Human Subjects Clinical Trial Information_Instructions_FORMS-F.pdf
12/27/2019
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.