Information Collection

PHS Section 402 Submission Certification

IC 280875 under ICR 202606-0910-003 · OMB 0910-0338.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3674 Certification of Compliance (42 CFR part 11) PHS Section 402 Submission Certification	Form and Instruction
Section 402 submission cert authority.pdf	Other-Statutory Authority
FDA 3674 Certification of Compliance (42 CFR part 11) Form FDA 3674 Cert of Compliance 42 CFR part 11.pdf	Form and Instruction

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 601

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-Statutory Authority					Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3674				Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 371

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	371	371
Annual IC Time Burden (Hours)	105	105
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.

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