Information Collection

Postmarketing 15-day Alert report (21 CFR 4.103(b)(3))

IC 191024 under ICR 200910-0910-001 · OMB 0910-0834.

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Documents and Forms

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Information Collection (IC) Details

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IC Title:	Postmarketing 15-day Alert report (21 CFR 4.103(b)(3))	Agency IC Tracking Number:

Is this a Common Form?		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 4.103(b)(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: 20	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 10 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	300	300
Annual IC Time Burden (Hours)	450	450
Annual IC Cost Burden (Dollars)	0	0

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