Waiver Request From Electronic Submission of Registration Information

Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0777

IC ID: 212963

Documents and Forms
Document Name
Document Type
Other-Guidance
Information Collection (IC) Details

View Information Collection (IC)

Waiver Request From Electronic Submission of Registration Information CDER
 
No New
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance FINAL GUIDANCE FOR REGISTRATION 8-28-14.doc Yes Yes Paper Only

Health Health Care Services

 

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

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