Submission of Administrative Changes for Any Manufacturer

Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations

OMB: 0915-0327

IC ID: 203460

Information Collection (IC) Details

View Information Collection (IC)

Submission of Administrative Changes for Any Manufacturer
 
No Modified
 
Required to Obtain or Retain Benefits
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 5 340B Manufacturer Change Form.pdf 340B Manufacturer Change Form.pdf Yes Yes Fillable Fileable

Health Health Care Services

 

350 120
   
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 350 0 0 0 0 350
Annual IC Time Burden (Hours) 175 0 0 0 0 175
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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