Information Collection

MQSA Revisions Final Rule March 2023

IC 259087 under ICR 202303-0910-007 · OMB 0910-0309.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0309 can be found here:

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IC Title:	MQSA Revisions Final Rule March 2023	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 900 subpart A 900.2, 900.4 21 CFR 900 subpart B Qlty. standards 21 CFR 900.11, 900.12 21 CFR 900.15 & 16 (appeals)

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: 8,781	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	9,984,794	9,984,794
Annual IC Time Burden (Hours)	1,099,674	1,099,674
Annual IC Cost Burden (Dollars)	5,919,014	5,919,014

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