Information Collection

511.1(b)(4) NCIE for clinical investigations

IC 5728 under ICR 201207-0910-001 · OMB 0910-0117.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0117 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3458 511.1(b)(4) NCIE for clinical investigations	Form and Instruction
3458 Notice of Claimed Investigational Exemption FDA Form 3458.pdf	Form and Instruction

IC Title:

511.1(b)(4) NCIE for clinical investigations

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 511.1(b)(4)

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
Form and Instruction	3458	Notice of Claimed Investigational Exemption	FDA Form 3458.pdf		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 206

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	1,238	1,234	4
Annual IC Time Burden (Hours)	1,238	-22,567	23,805
Annual IC Cost Burden (Dollars)	0	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.