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CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145)

IC 189332 under ICR 202509-0910-004 · OMB 0910-0014.

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Document Name
Document Type
Other-Agency Guidance
Other-Agency Guidance
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CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145)
 
No Unchanged
 
Mandatory
 
21 CFR 312.110-312.145

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance ICH Guidance - Good Clinical Practice March 2018.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

2,187 0
   
Private Sector Businesses or other for-profits
 
   99 %

  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 24,359 0 0 0 0 24,359
Annual IC Time Burden (Hours) 630,299 0 0 0 0 630,299
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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