Information Collection

Pediatric information in an original PMA or PDP

IC 192785 under ICR 202005-0910-007 · OMB 0910-0748.

Documents and Forms

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Information Collection (IC) Details

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IC Title:	Pediatric information in an original PMA or PDP	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 814.20

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: 4

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	11	-19	30
Annual IC Time Burden (Hours)	88	-152	240
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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