Information Collection

One-time reporting burden for all facilities to comply w/new requirements

IC 216021 under ICR 201504-0910-003 · OMB 0910-0502.

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Information Collection (IC) Details

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IC Title:	One-time reporting burden for all facilities to comply w/new requirements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1.230-1.233

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: 172,274	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 99 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	172,274	172,274
Annual IC Time Burden (Hours)	31,584	31,584
Annual IC Cost Burden (Dollars)	9,698,111	9,698,111

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