Registration and Listing under 21 CFR Part 207

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Inlcuding Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; Final Rule

OMB: 0910-0829

IC ID: 45561

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Registration and Listing under 21 CFR Part 207
No Modified
21 CFR 207

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

Health Consumer Health and Safety


18,514 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 131,371 0 131,371 0 0 0
Annual IC Time Burden (Hours) 106,106 0 -75,049 181,155 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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