Annual Report

Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

OMB: 0910-0594

IC ID: 43606

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

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Annual Report CBER
No Modified
21 CFR 803 21 CFR 864.9245

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Special Controls Guidance Document 0594 SCGD Blood Separator.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety


3 0
Private Sector Businesses or other for-profits
   50 %

  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 3 0 0 0 0 3
Annual IC Time Burden (Hours) 15 0 0 0 0 15
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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