Labeling Requirements

Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products

OMB: 0910-0572

IC ID: 6295

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

View Information Collection (IC)

Labeling Requirements CDER
 
No Modified
 
Mandatory
 
21 CFR 201.56 21 CFR 201.57

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Public Health Monitoring

 

131 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 197 0 0 92 0 105
Annual IC Time Burden (Hours) 659,753 0 0 308,108 0 351,645
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