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Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

IC 183136 under ICR 201801-0910-010 · OMB 0910-0629.

Documents and Forms
Document Name
Document Type
Other-Guidance
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Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics CBER
 
No Unchanged
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance GUIDANCE 0629 12-23-14.pdf Yes No Paper Only

Health Consumer Health and Safety

 

1 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 0 0 0 0 1
Annual IC Time Burden (Hours) 1 0 0 0 0 1
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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