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Controlled Correspondence Related to Generic Drug Development

IC 217370 under ICR 202002-0910-011 · OMB 0910-0797.

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Controlled Correspondence Related to Generic Drug Development CDER
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 314.102

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

Health Health Care Services

 

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 1,482 0 0 0 0 1,482
Annual IC Time Burden (Hours) 7,480 0 0 0 0 7,480
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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