Requirement for Maintenance of Complaint Files for Type A Medicated Articles for Two Years

Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0154 can be found here:

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Requirement for Maintenance of Complaint Files for Type A Medicated Articles for Two Years	Agency IC Tracking Number:	CVM

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 226.115

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: 65	Number of Respondents for Small Entity: 49

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

Percentage of Respondents Reporting Electronically: 90 %

	Approved	Previously Approved
Annual Number of Responses for this IC	650	650
Annual IC Time Burden (Hours)	325	325
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.