Information Collection

3rd PARTY DISCLOSURE: Sterility Test Failure Notices

IC 207965 under ICR 202509-0910-003 · OMB 0910-0667.

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Information Collection (IC) Details

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IC Title:	3rd PARTY DISCLOSURE: Sterility Test Failure Notices	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 211 21 CFR 210 21 CFR 212

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: 11	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	33	12	21
Annual IC Time Burden (Hours)	83	30	53
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.

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