Supplements to Applications Approved 6/30/01 to Effective Date

Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling

OMB: 0910-0624

IC ID: 185243

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Supplements to Applications Approved 6/30/01 to Effective Date CDER
 
No Modified
 
Mandatory
 
21 CFR 601.12(f)(1) 21 CFR 314.70(b)

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

Health Public Health Monitoring

 

390 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 10,140 0 0 0 0 10,140
Annual IC Time Burden (Hours) 1,216,800 0 0 0 0 1,216,800
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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