Information Collection

Reporting - AER under 314.80 (marketing applications) - 15 day alerts

IC 188675 under ICR 202405-0910-001 · OMB 0910-0230.

Documents and Forms

Document Name Document Type
0230 Providing Submissions in Electronic Format—Postmarketing Safety Reports.pdf Other-Agency Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Reporting - AER under 314.80 (marketing applications) - 15 day alerts	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.80(c)(1)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0230 Providing Submissions in Electronic FormatâPostmarketing Safety Reports.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 682	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,250,000	1,249,995	5
Annual IC Time Burden (Hours)	1,250,000	1,249,995	5
Annual IC Cost Burden (Dollars)	5,000	5,000	0

Documents for IC

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