Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
5 day report (21 CFR 4.103(b)(1)) New 5 8 0
Blood Fatality report (21 CFR 4.103(b)(5) New 5 8 0
Developing SOPs for new combination products New 100 1000 42000
Field Alert report (21 CFR 4.103(b)(4)) New 5 8 0
Malfunction report (21 CFR 4.103(b)(2)) New 300 450 0
Postmarketing 15-day Alert report (21 CFR 4.103(b)(3)) New 300 450 0
Total burden requested under this ICR: 715 1924 42000  
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