Information Collection

Reporting - AER under 314.80 (marketing applications) - quarterly reports

IC 188676 under ICR 202405-0910-001 · OMB 0910-0230.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0230 Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).pdf	Other-Agency Guidance
0230 Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).pdf	Other-Agency Guidance
0230 Providing Submissions in Electronic Format—Postmarketing Safety Reports.pdf	Other-Agency Guidance
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 314.80(c)(2)

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					Yes	Yes	Fillable Fileable
Other-Agency Guidance					Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

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 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	838,000	823,798	14,202
Annual IC Time Burden (Hours)	50,280,000	49,427,880	852,120
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.

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