Information Collection

Applicants That Do Not Have a Periodic Safety Update Report Waiver For an Approved Applications

IC 211858 under ICR 201406-0910-008 · OMB 0910-0771.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
ICH PBRER GUIDANCE.pdf	Other-Guidance

IC Title:

Applicants That Do Not Have a Periodic Safety Update Report Waiver For an Approved Applications

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314.80(c)(2) 21 CFR 600.80(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-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: 29

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	67	67
Annual IC Time Burden (Hours)	134	134
Annual IC Cost Burden (Dollars)	0	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.