View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0543
ICR Reference No:
201703-0910-007
Status:
Historical Active
Previous ICR Reference No:
201401-0910-008
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CBER
Title:
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
06/27/2017
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/31/2017
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2020
36 Months From Approved
06/30/2017
Responses
14,181,815
0
13,672,276
Time Burden (Hours)
9,336,048
0
3,938,614
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
42 USC 264
Name of Law: Public Health Service Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
81 FR 60170
08/31/2016
30-day Notice:
Federal Register Citation:
Citation Date:
82 FR 16040
03/31/2017
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
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?
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?
3356
Establishment Registration and Listing for HCT/Ps
1271.155(a) - Exemptions and Alternatives
3356
Establishment Registration and Listing for HCT/Ps
1271.155(f) - Exemptions and Alternatives
1271.160(b)(3) and (b)(6) - Establishment and maintenance of a quality program
1271.160(d) - Establishment and maintenance of a quality program
1271.190(d)(2) - Facilities
1271.195(d) - Environmental control and monitoring
1271.200(e) - Equipment
1271.210(d) - Supplies and Reagents
1271.230(a) - Process Validation
1271.230(c) - Process validation
1271.26 - When must I amend my establishment registration?
1271.260(d) - Storage
1271.260(e) - Storage
1271.265(c)(1) - Receipt, predistribution shipment, and distribution of an HCT/P
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
1271.290(c) - Tracking
1271.290(d) and (e) - Tracking
1271.290(f) - Tracking
1271.320(b) - Complaint File
1271.350(a)(1) & (a)(3) - Reporting
3356
Establishment List and Registration for HCT/Ps
1271.47(d) - What procedures must I establish and maintain?
1271.50(a) - How do I determine a donor is eligible?
1271.55(a) - What records must accompany an HCT/P after the donor-eligibility determination is complete?
1271.55(d)(1) - What records must accompany an HCT/Ps?
1271.55(d)(2) - What records must accompany an HCT/Ps?
1271.55(d)(4) - What records must accompany an HCT/P?
1271.60(c) and (d)(2) - What quarantine and other requirements apply before the donor-eligibility determination is complete?
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?
Human Cells, Tissues, and Cellular- and Tissue-Based Products (HCT/P's)
New SOPs
3356
Establishment Regirstation and Listing for HCT/Ps
SOP Update
3356
Establishment Registration and Listing for HCT/Ps
Third Party Disclosures for HCT/P's
ICR Summary of Burden
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
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$3,906,619
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
03/31/2017
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