398/424 PHS Human Subjects and Clinical Trial Information

PHS Applications and Pre-award Related Reporting (OD)

Documents and Forms

Document Name Document Type
Form 1 398/424 PHS Human Subjects and Clinical Trial Information Form
Attachment 5G_PHS HSCT Form_Instructions_FORMS-I.docx Instruction
1 Form Attachment 5F_HumanSubjectStudy_3_0-V3.0_Sections 1-6.pdf Form
2 Form Attachment 5F_PHSHumanSubjectsAndClinicalTrialsInfo_3_0-V3.0.pdf Form
3 Form Attachment 5F_PHSInclusionEnrollmentReport-V1.0.pdf Form

Information Collection (IC) Details

IC Title:	398/424 PHS Human Subjects and Clinical Trial Information	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

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	1	Form	Attachment 5F_HumanSubjectStudy_3_0-V3.0_Sections 1-6.pdf	Yes	Yes	Fillable Fileable
Form	2	Form	Attachment 5F_PHSHumanSubjectsAndClinicalTrialsInfo_3_0-V3.0.pdf	Yes	Yes	Fillable Fileable
Form	3	Form	Attachment 5F_PHSInclusionEnrollmentReport-V1.0.pdf	Yes	Yes	Fillable Fileable
Instruction			Attachment 5G_PHS HSCT Form_Instructions_FORMS-I.docx	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 %

	Requested	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
No associated records found

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