Reconsideration request

Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0776

IC ID: 212977

Information Collection (IC) Details

View Information Collection (IC)

Reconsideration request 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 USER FEES 8-28-14.doc Yes Yes Paper Only
Form and Instruction 3908 Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request FDA FORM 3908 USER FEE 8-29-14.pdf Yes Yes Fillable Fileable Signable

Health Health Care Services

 

6 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 6 0 6 0 0 0
Annual IC Time Burden (Hours) 6 0 6 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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