New SOPs

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

OMB: 0910-0543

IC ID: 210165

Documents and Forms
Document Name
Document Type
Form and Instruction
Form and Instruction
Information Collection (IC) Details

View Information Collection (IC)

New SOPs
 
No New
 
Required to Obtain or Retain Benefits
 
21 CFR 1271.47(a) 21 CFR 1271.160(b)(2)&(d)(1) 21 CFR 1271.180(a) 21 CFR 1271.85(b)(2) 21 CFR 1271.190(d)(1) 21 CFR 1271.200(b) 21 CFR 1271.200(c) 21 CFR 1271.230(a)&(c) 21 CFR 1271.250(a) 21 CFR 1271.265(e)&(f) 21 CFR 1271.270(b)&(d) 21 CFR 1271.290(b)(1) 21 CFR 1271.320(a)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 3356 Establishment Regirstation and Listing for HCT/Ps FORM FDA 3356.pdf Yes Yes Fillable Fileable Signable

Health Consumer Health and Safety

 

218 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 218 0 0 218 0 0
Annual IC Time Burden (Hours) 10,464 0 0 10,464 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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