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⚠️ Notice: This information collection may be referencing outdated material.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 Landing Page Attachment 5F PHS Human Subjects and Clinical Trial Information - Sections 1-6_Includes Inclusion Enrollment Report_FORMS-G.pdf Form and Instruction
16 Landing Page Attachment 5F PHS Human Subjects and Clinical Trial Information - Sections 1-6_Includes Inclusion Enrollment Report_FORMS-G.pdf Form and Instruction
17 Inclusion Enrollment Report Attachment 5F PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report_FORMS-G_combined.pdf Form and Instruction
17 Inclusion Enrollment Report Attachment 5F PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report_FORMS-G_combined.pdf 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-G.pdf 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-G.pdf Form and Instruction
Attachment 5G_PHS Human Subjects Clinical Trial Information_Instructions_FORMS-F.pdf PHS Human Subjects and Clinical Trials Information Instructions IC Document
Attachment 5G_PHS Human Subjects Clinical Trial Information_Instructions_FORMS-F.pdf 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: 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	Landing Page	Attachment 5F PHS Human Subjects and Clinical Trial Information - Sections 1-6_Includes Inclusion Enrollment Report_FORMS-G.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-G_combined.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-G.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)	712,894	712,894
Annual IC Cost Burden (Dollars)	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.