Information Collection

Records under 21 CFR 113.100 and 114.100

IC 185242 under ICR 202009-0910-001 · OMB 0910-0037.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0037 can be found here:

Documents and Forms

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Information Collection (IC) Details

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IC Title:	Records under 21 CFR 113.100 and 114.100	Agency IC Tracking Number:	CFSAN

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 113.100 & 114.100

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: 10,392	Number of Respondents for Small Entity: 1,039

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

Percentage of Respondents Reporting Electronically: 80 %

	Approved	Previously Approved
Annual Number of Responses for this IC	10,392	10,392
Annual IC Time Burden (Hours)	2,598,000	2,598,000
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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