Information Collection

Informed Consent (Main Study)

IC 235232 under ICR 201903-0910-004 · OMB 0910-0869.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Appendix D Informed Consent.docx	Other-Informed Consent

IC Title:

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Informed Consent			Appendix D Informed Consent.docx		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 2,000

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	2,000	2,000
Annual IC Time Burden (Hours)	160	160
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.