Requirements for Submission of In Vivo Bioequivalence Data

OMB: 0910-0630

IC ID: 214120

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Information Collection (IC) Details

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314.96(a)(1) CDER
No New
21 CFR 314.96(a)(1)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Public Health Monitoring


1 0
Private Sector Businesses or other for-profits
   75 %

  Requested 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 0 1 0 0
Annual IC Time Burden (Hours) 72 0 0 72 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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