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Annual Report Submission of Revised Labeling for Applications Approved Before 6/30/01 that Contain a Pregnancy Category

IC 185244 under ICR 201802-0910-006 · OMB 0910-0624.

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Annual Report Submission of Revised Labeling for Applications Approved Before 6/30/01 that Contain a Pregnancy Category CDER
 
No Modified
 
Mandatory
 
21 CFR 601.12(f)(3) 21 CFR 314.70(d)

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

Health Public Health Monitoring

 

320 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 5,440 0 0 0 0 5,440
Annual IC Time Burden (Hours) 217,600 0 0 0 0 217,600
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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