Human Tissue Intended for Transplantation

ICR 202001-0910-004

OMB: 0910-0302

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-01-23
ICR Details
0910-0302 202001-0910-004
Active 201701-0910-011
HHS/FDA CBER
Human Tissue Intended for Transplantation
Extension without change of a currently approved collection   No
Regular
Approved without change 02/18/2020
Retrieve Notice of Action (NOA) 01/24/2020
  Inventory as of this Action Requested Previously Approved
02/28/2023 36 Months From Approved 03/31/2020
625,999 0 625,999
626,735 0 626,735
28,203,075 0 0

The information collection requirements help prevent the transmission of communicable diseases through human tissue transplantation by requiring that written SOPs be prepared and followed for the following: (1) infectious disease testing; (2) determining the medical history of the donor; (3) designating and identifying quarantined tissue; and (4) preventing infectious disease contamination or cross-contamination of tissue during processing. The regulations require maintenance of records of all significant steps in the infectious disease testing, and screening, and require that these records be made available for FDA inspection. Adequate donor screening and testing must be recorded so that the suitability of the tissue can be determined. If FDA is unable to ascertain how a tissue donor was screened or tested, or if the tissue was distributed in violation of the regulations, then recall, retention, and/or destruction orders may be issued by FDA in accordance with codified administrative procedures.

US Code: 42 USC 264 Name of Law: Public Health Service Act; Regulations to control communicable diseases
  
None

Not associated with rulemaking

  84 FR 50039 09/24/2019
85 FR 1167 01/09/2020
No

  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 625,999 625,999 0 0 0 0
Annual Time Burden (Hours) 626,735 626,735 0 0 0 0
Annual Cost Burden (Dollars) 28,203,075 0 0 0 28,203,075 0
No
No
There is no adjustment to the burden hours from the previous estimate, however, we have uploaded cost information to appear at omb.report.

$595,200
No
    Yes
    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.
01/24/2020


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