Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
1271.10(b)(1) & (b)(2), 1271.21(a), and 1271.25(a)&(b) - Are my HCT/Ps regulated solely under section 361 of the PHS Act?/When do I register?/What info. is required for registration? Removed 0 0 0 Form and Instruction 3356 Establishment Registration and Listing for HCT/Ps
1271.10(b)(2), 1271.21(c)(ii) and 1271.25(c) - Are my HCT/Ps regulated solely under Section 361 of the PHS Act?/When do I register?/What info. is required for registration? Removed 0 0 0 Form and Instruction 3356 Establishment Registration and Listing for HCT/Ps
1271.155(a) - Exemptions and Alternatives Removed 0 0 0 Form and Instruction 3356 Establishment Registration and Listing for HCT/Ps
1271.155(f) - Exemptions and Alternatives Removed 0 0 0
1271.160(b)(3) and (b)(6) - Establishment and maintenance of a quality program Removed 0 0 0
1271.160(d) - Establishment and maintenance of a quality program Removed 0 0 0
1271.190(d)(2) - Facilities Removed 0 0 0
1271.195(d) - Environmental control and monitoring Removed 0 0 0
1271.200(e) - Equipment Removed 0 0 0
1271.210(d) - Supplies and Reagents Removed 0 0 0
1271.230(a) - Process Validation Removed 0 0 0
1271.230(c) - Process validation Removed 0 0 0
1271.26 - When must I amend my establishment registration? Removed 0 0 0
1271.260(d) - Storage Removed 0 0 0
1271.260(e) - Storage Removed 0 0 0
1271.265(c)(1) - Receipt, predistribution shipment, and distribution of an HCT/P Removed 0 0 0
1271.265(c)(3) - Receipt, predistribution0 shipment, and distribution of an HCT/P Removed 0 0 0
1271.265(e) - Receipt, predistribution shipment, and distribution of an HCT/P Removed 0 0 0
1271.270(a) - Records Removed 0 0 0
1271.270(e) - Records Removed 0 0 0
1271.290(c) - Tracking Removed 0 0 0
1271.290(d) and (e) - Tracking Removed 0 0 0
1271.290(f) - Tracking Removed 0 0 0
1271.320(b) - Complaint File Removed 0 0 0
1271.350(a)(1) & (a)(3) - Reporting Removed 0 0 0 Form and Instruction 3356 Establishment List and Registration for HCT/Ps
1271.47(d) - What procedures must I establish and maintain? Removed 0 0 0
1271.50(a) - How do I determine a donor is eligible? Removed 0 0 0
1271.55(a) - What records must accompany an HCT/P after the donor-eligibility determination is complete? Removed 0 0 0
1271.55(d)(1) - What records must accompany an HCT/Ps? Removed 0 0 0
1271.55(d)(2) - What records must accompany an HCT/Ps? Removed 0 0 0
1271.55(d)(4) - What records must accompany an HCT/P? Removed 0 0 0
1271.60(c) and (d)(2) - What quarantine and other requirements apply before the donor-eligibility determination is complete? Removed 0 0 0
1271.60(d)(3) & (d)(4), 1271.65(b)(3) - What quarantine & other requirements apply?/How do I store an HCT/P from a donor determined to be ineligible? Removed 0 0 0
Human Cells, Tissues, and Cellular- and Tissue-Based Products (HCT/P's) Modified 7267584 2068464 0
New SOPs Removed 0 0 0 Form and Instruction 3356 Establishment Regirstation and Listing for HCT/Ps
SOP Update Removed 0 0 0 Form and Instruction 3356 Establishment Registration and Listing for HCT/Ps
Third Party Disclosures for HCT/P's Modified 6914231 7267584 0
Total burden requested under this ICR: 14181815 9336048 0  
To view an IC, click on IC Title