Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
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
To view an IC, click on IC Title