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

ICR 201703-0910-007

OMB: 0910-0543

Federal Form Document

IC Document Collections
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6263
Modified
210192
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179932
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179931
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179930
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ICR Details
0910-0543 201703-0910-007
Historical Active 201401-0910-008
HHS/FDA CBER
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Extension without change of a currently approved collection   No
Regular
Approved without change 06/27/2017
Retrieve Notice of Action (NOA) 03/31/2017
  Inventory as of this Action Requested Previously Approved
06/30/2020 36 Months From Approved 06/30/2017
14,181,815 0 13,672,276
9,336,048 0 3,938,614
0 0 0

The information collection supports agency regulations regarding eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Respondents to the collection are manufacturers of these products subject to public health protection provisions under the Federal Food, Drug, and Cosmetic Act.

US Code: 42 USC 264 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  81 FR 60170 08/31/2016
82 FR 16040 03/31/2017
No

2
IC Title Form No. Form Name
Human Cells, Tissues, and Cellular- and Tissue-Based Products (HCT/P's)
1271.350(a)(1) & (a)(3) - Reporting 3356 Establishment List and Registration for HCT/Ps
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 SOPs 3356 Establishment Regirstation and Listing for HCT/Ps
1271.55(d)(4) - What records must accompany an HCT/P?
1271.290(d) and (e) - Tracking
1271.320(b) - Complaint File
1271.60(c) and (d)(2) - What quarantine and other requirements apply before the donor-eligibility determination is complete?
1271.290(c) - Tracking
1271.290(f) - Tracking
Third Party Disclosures for HCT/P's
1271.55(d)(1) - What records must accompany an HCT/Ps?
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? 3356 Establishment Registration and Listing for HCT/Ps
1271.55(d)(2) - What records must accompany an HCT/Ps?
SOP Update 3356 Establishment Registration and Listing for HCT/Ps
1271.47(d) - What procedures must I establish and maintain?
1271.50(a) - How do I determine a donor is eligible?
1271.155(f) - Exemptions and Alternatives
1271.160(d) - Establishment and maintenance of a quality program
1271.190(d)(2) - Facilities
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? 3356 Establishment Registration and Listing for HCT/Ps
1271.195(d) - Environmental control and monitoring
1271.210(d) - Supplies and Reagents
1271.230(c) - Process validation
1271.260(d) - Storage
1271.260(e) - Storage
1271.265(c)(1) - Receipt, predistribution shipment, and distribution of an HCT/P
1271.26 - When must I amend my establishment registration?
1271.155(a) - Exemptions and Alternatives 3356 Establishment Registration and Listing for HCT/Ps
1271.160(b)(3) and (b)(6) - Establishment and maintenance of a quality program
1271.200(e) - Equipment
1271.230(a) - Process Validation
1271.55(a) - What records must accompany an HCT/P after the donor-eligibility determination is complete?
1271.265(c)(3) - Receipt, predistribution0 shipment, and distribution of an HCT/P
1271.265(e) - Receipt, predistribution shipment, and distribution of an HCT/P
1271.270(a) - Records
1271.270(e) - Records

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 14,181,815 13,672,276 0 0 509,539 0
Annual Time Burden (Hours) 9,336,048 3,938,614 0 0 5,397,434 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$3,906,619
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
03/31/2017


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