Information Collection

Reporting; Substantial Equivalence (SE) Report

IC 195793 under ICR 202402-0910-004 · OMB 0910-0673.

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IC Title:	Reporting; Substantial Equivalence (SE) Report	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 1107.18

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,139	Number of Respondents for Small Entity: 126

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 83 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,139	456	683
Annual IC Time Burden (Hours)	341,700	136,800	204,900
Annual IC Cost Burden (Dollars)	0	0	0

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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.