OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

Reporting - ICH E2C(R2) Guidance: Providing periodic safety updates (applicants with and without waiver for an approved application)

IC 250441 under ICR 202405-0910-001 · OMB 0910-0230.

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

View Information Collection (IC)

Reporting - ICH E2C(R2) Guidance: Providing periodic safety updates (applicants with and without waiver for an approved application)
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0230 Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).pdf Yes Yes Fillable Fileable
Other-Agency Guidance 0230 Providing Submissions in Electronic Format—Postmarketing Safety Reports.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

1,586 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested 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 22,308 0 0 22,054 0 254
Annual IC Time Burden (Hours) 40,431 0 0 40,110 0 321
Annual IC Cost Burden (Dollars) 5,000 0 0 5,000 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.