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? New 218 164 0 Form and Instruction 3356 Establishment Registration and Listing for HCT/Ps
1271.10(b)(1) and 1271.21(b) - Are my HCT/P's Regulated Solely Under Section 361 of the PHS Act and the regulations in This Part and if so What Must I Do? Modified 2706 1353 0 Form and Instruction 3356 Establishment Registration & 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? New 3737 1869 0 Form and Instruction 3356 Establishment Registration and Listing for HCT/Ps
1271.155(a) - Exemptions and Alternatives New 40 120 0 Form and Instruction 3356 Establishment Registration and Listing for HCT/Ps
1271.155(f) - Exemptions and Alternatives New 40 10 0
1271.160(b)(3) and (b)(6) - Establishment and maintenance of a quality program New 20328 20328 0
1271.160(d) - Establishment and maintenance of a quality program New 20328 20328 0
1271.190(d)(2) - Facilities New 20328 20328 0
1271.195(d) - Environmental control and monitoring New 20328 20328 0
1271.200(e) - Equipment New 20328 20328 0
1271.210(d) - Supplies and Reagents New 20328 20328 0
1271.230(a) - Process Validation New 20328 20328 0
1271.230(c) - Process validation New 1694 1694 0
1271.26 - When must I amend my establishment registration? New 1222 306 0
1271.260(d) - Storage New 20328 5082 0
1271.260(e) - Storage New 618310 51320 0
1271.265(c)(1) - Receipt, predistribution shipment, and distribution of an HCT/P New 2026854 168229 0
1271.265(c)(3) - Receipt, predistribution0 shipment, and distribution of an HCT/P New 847 847 0
1271.265(e) - Receipt, predistribution shipment, and distribution of an HCT/P New 2026854 168229 0
1271.270(a) - Records New 2026854 506714 0
1271.270(e) - Records New 4330 2165 0
1271.290(c) - Tracking New 2026854 168229 0
1271.290(d) and (e) - Tracking New 86157 21539 0
1271.290(f) - Tracking New 1694 1694 0
1271.320(b) - Complaint File New 6765 6765 0
1271.350(a)(1) & (a)(3) - Reporting New 206 206 0 Form and Instruction 3356 Establishment List and Registration for HCT/Ps
1271.370(b) and (c) - Labeling New 2026854 506714 0
1271.47(d) - What procedures must I establish and maintain? New 1353 1353 0
1271.50(a) - How do I determine a donor is eligible? New 91760 458800 0
1271.55(a) - What records must accompany an HCT/P after the donor-eligibility determination is complete? New 2167395 1083698 0
1271.55(d)(1) - What records must accompany an HCT/Ps? Modified 91760 91760 0
1271.55(d)(2) - What records must accompany an HCT/Ps? Modified 2706 2706 0
1271.55(d)(4) - What records must accompany an HCT/P? Modified 2706 324720 0
1271.60(c) and (d)(2) - What quarantine and other requirements apply before the donor-eligibility determination is complete? New 286000 143000 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? New 812 1624 0
New SOPs New 218 10464 0 Form and Instruction 3356 Establishment Regirstation and Listing for HCT/Ps
SOP Update New 2706 64944 0 Form and Instruction 3356 Establishment Registration and Listing for HCT/Ps
Total burden requested under this ICR: 13672276 3938614 0  
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