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

PHS Applications and Pre-award Related Reporting (OD)

⚠️ Notice: This information collection may be referencing outdated material.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

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: New

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	Program Change Due to Agency Discretion
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.