Notifications of suspensions

Biologics License Applications; Procedures & Requirements

OMB: 0910-0338

IC ID: 209328

Information Collection (IC) Details

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Notifications of suspensions
No Unchanged
21 CFR 601.6(a)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 356h Application to Market a New Drug or Biologic for Human Use FORM FDA 356h revised 2-28-14.pdf Yes Yes Fillable Printable

Health Consumer Health and Safety


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 20 0 0 0 0 20
Annual IC Time Burden (Hours) 7 0 0 0 0 7
Annual IC Cost Burden (Dollars) 924 0 0 0 0 924

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