Information Collection

PART 314: Subparts E through I

IC 184605 under ICR 201704-0910-006 · OMB 0910-0001.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0001 can be found here:

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Information Collection (IC) Details

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IC Title:	PART 314: Subparts E through I	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.200-314.650

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: 378	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,253	215	1,038
Annual IC Time Burden (Hours)	89,708	26,390	63,318
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.