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Providing Waiver-Related Materials in Accordance with Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format

OMB: 0910-0771

IC ID: 211857

Documents and Forms
Document Name
Document Type
Other-Guidance
Information Collection (IC) Details

View Information Collection (IC)

Applicants that have a Periodic Safety Update Report Waiver for an Approved Application CDER
 
No New
 
Voluntary
 
21 CFR 600.80(c)(2) 21 CFR 314.80(c)(2)

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

Health Health Care Services

 

55 0
   
Private Sector Businesses or other for-profits
 
   0 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 187 0 187 0 0 0
Annual IC Time Burden (Hours) 187 0 187 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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.

© 2024 OMB.report | Privacy Policy