Developing SOPs for new combination products

Postmarketing Safety Reporting for Combination Products

OMB: 0910-0834

IC ID: 191027

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Developing SOPs for new combination products
21 CFR 4

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

Health Consumer Health and Safety


100 85
Private Sector Businesses or other for-profits
   10 %

  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 100 0 100 0 0 0
Annual IC Time Burden (Hours) 1,000 0 1,000 0 0 0
Annual IC Cost Burden (Dollars) 42,000 0 42,000 0 0 0

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