Processing, labeling, or repacking agreement--801.150(a)(2)

Medical Device Labeling Regulations

OMB: 0910-0485

IC ID: 6187

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Processing, labeling, or repacking agreement--801.150(a)(2)
No Modified
21 CFR 801.150(a)(2)

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

Health Consumer Health and Safety


4,870 0
Private Sector Businesses or other for-profits
   5 %

  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 3,598,930 0 1,166,794 0 0 2,432,136
Annual IC Time Burden (Hours) 1,799,465 0 -1,985,219 0 0 3,784,684
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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