Information Collection

Reporting - AER Rx products not subject of marketing application

IC 5821 under ICR 202405-0910-001 · OMB 0910-0230.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0230 Providing Submissions in Electronic Format—Postmarketing Safety Reports.pdf	Other-Agency Guidance

IC Title:

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 310.305

Information Collection Instruments:

table that charts list of 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: 36

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	3,197	3,194	3
Annual IC Time Burden (Hours)	3,197	3,194	3
Annual IC Cost Burden (Dollars)	5,000	5,000	0

Documents for IC

table that charts IC Documents
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.