Information Collection

Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications

IC 6241 under ICR 200702-0910-006 · OMB 0910-0523.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0523 can be found here:

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Information Collection (IC) Details

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IC Title:	Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications	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 3..

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: 43	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	43	15	28
Annual IC Time Burden (Hours)	1,032	360	672
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.