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RULE: One-Time Declaration of Label Update in Annual Report

IC 279478 under ICR 202603-0910-008 · OMB 0910-0045.

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RULE: One-Time Declaration of Label Update in Annual Report CDER
 
No New
 
Mandatory
 
21 CFR 314.81(b)(2)(iii)

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

Health Consumer Health and Safety

 

1,324 132
   
Private Sector Businesses or other for-profits, Not-for-profit institutions
 
   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 11,916 0 11,916 0 0 0
Annual IC Time Burden (Hours) 1,990 0 1,990 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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