Reporting - Waiver requests from electronic reporting

Postmarketing Adverse Drug Experience Reporting

Documents and Forms

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

Information Collection (IC) Details

IC Title:	Reporting - Waiver requests from electronic reporting	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 4 21 CFR 329.100(c) 21 CFR 310.305, 314.89, 314.98

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 Format—Postmarketing Safety Reports.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	1	1
Annual IC Time Burden (Hours)	24	24
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

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