511.1(b)(4) NCIE for clinical investigations

New Animal Drugs for Investigational Use

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

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

Information Collection (IC) Details

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:

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 %

	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

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.