Information Collection

Reporting: Affirmation by Importer of Record That the Human Food or Cosmetic Was Manufactured in Accordance With The Applicable Requirements of 21 CFR 189.5 and 700.27

IC 45775 under ICR 201104-0910-008 · OMB 0910-0597.

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Information Collection (IC) Details

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IC Title:	Reporting: Affirmation by Importer of Record That the Human Food or Cosmetic Was Manufactured in Accordance With The Applicable Requirements of 21 CFR 189.5 and 700.27	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 700.27 ( c )( 6 ) 21 CFR 189.5( c )( 6 )

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: 54,825	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	54,825	54,128	697
Annual IC Time Burden (Hours)	1,809	-29,089	30,898
Annual IC Cost Burden (Dollars)	0	0	0

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