Information Collection

Certification--54.4(a)(1) and (a)(2)--Form FDA 3454

IC 6057 under ICR 202110-0910-010 · OMB 0910-0396.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0396 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3454 Certification--54.4(a)(1) and (a)(2)--Form FDA 3454	Form
3454 FDA Form 3454 0396_FDA_3454.pdf	Form
3454 FDA Form 3454 0396_FDA_3454.pdf	Form

IC Title:

Certification--54.4(a)(1) and (a)(2)--Form FDA 3454

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 54.4

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	3454	FDA Form 3454	0396_FDA_3454.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 715

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 10 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	715	-335	1,050
Annual IC Time Burden (Hours)	715	-335	1,050
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.