Applicants that have a Periodic Safety Update Report Waiver for an Approved Application

Providing Waiver-Related Materials in Accordance with Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0771 can be found here:

Documents and Forms

Document Name Document Type
ICH PBRER GUIDANCE.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Applicants that have a Periodic Safety Update Report Waiver for an Approved Application	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 600.80(c)(2) 21 CFR 314.80(c)(2)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			ICH PBRER GUIDANCE.pdf		Yes	No	Paper Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 55	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	187	187
Annual IC Time Burden (Hours)	187	187
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.