Information Collection

IC recommended in FDA guidance

IC 232749 under ICR 202501-0910-004 · OMB 0910-0686.

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Information Collection (IC) Details

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IC Title:	IC recommended in FDA guidance	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 202.1(b), (c), and (d) 21 CFR 201.10(g) and (h)

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: 747	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	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	129,231	-35,845	165,076
Annual IC Time Burden (Hours)	56,249	-531,301	587,550
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.