Production of New Label Statement on Immediate Container Label or Outside Package (Web site and Toll-Free Number)

Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products - Proposed Rule

OMB: 0910-0794

IC ID: 216755

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Production of New Label Statement on Immediate Container Label or Outside Package (Web site and Toll-Free Number)
 
No New
 
Mandatory
 
21 CFR 606.121(c)(8)(ii) 21 CFR 610.60(a)(8) 21 CFR 610.61(t) 21 CFR 201.100(b)(8)

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

Health Health Care Services

 

3,550 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 175,015 0 175,015 0 0 0
Annual IC Time Burden (Hours) 4,200,360 0 4,200,360 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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