Information Collection

398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)

IC 225108 under ICR 201705-0925-009 · OMB 0925-0001.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0925-0001 can be found here:

Documents and Forms

Document Name Document Type
Form 16 398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report) Form and Instruction
16 PHS Human Subjects and Clinical Trial Information - Land Attachment 5F PHS Human Subjects and Clinical Trial Information - Landing Page.pdf Form and Instruction
17 PHS Human Subjects and Clinical Trial Information - Incl Attachment 5F PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report.pdf Form
18 PHS Human Subjects and Clinical Trial Information - Sect Attachment 5F PHS Human Subjects and Clinical Trial Information - Sections 1-5.pdf Form
Attachment 5G PHS Human Subjects and Clinical Trial Information Instructions.docx Attachment 5G PHS Human Subjects and Clinical Trials Information Instructions IC Document

Information Collection (IC) Details

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	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	16	PHS Human Subjects and Clinical Trial Information - Landing Page	Attachment 5F PHS Human Subjects and Clinical Trial Information - Landing Page.pdf	Yes	Yes	Fillable Fileable
Form	17	PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report	Attachment 5F PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report.pdf	Yes	Yes	Fillable Fileable
Form	18	PHS Human Subjects and Clinical Trial Information - Sections 1-5	Attachment 5F PHS Human Subjects and Clinical Trial Information - Sections 1-5.pdf	Yes	Yes	Fillable Fileable

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	Previously Approved
Annual Number of Responses for this IC	54,838	54,838
Annual IC Time Burden (Hours)	767,732	767,732
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
Attachment 5G PHS Human Subjects and Clinical Trials Information Instructions	Attachment 5G PHS Human Subjects and Clinical Trial Information Instructions.docx	01/25/2017

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.