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
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
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