Human Tissue Intended for Transplantation

ICR 201312-0910-010

OMB: 0910-0302

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-12-17
ICR Details
0910-0302 201312-0910-010
Historical Active 201011-0910-003
HHS/FDA 21075
Human Tissue Intended for Transplantation
Extension without change of a currently approved collection   No
Regular
Approved without change 01/27/2014
Retrieve Notice of Action (NOA) 12/20/2013
  Inventory as of this Action Requested Previously Approved
01/31/2017 36 Months From Approved 01/31/2014
806,011 0 1,079,817
806,770 0 1,080,760
0 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
  
None

Not associated with rulemaking

  78 FR 41403 07/10/2013
78 FR 72895 12/04/2013
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 806,011 1,079,817 0 0 -273,806 0
Annual Time Burden (Hours) 806,770 1,080,760 0 0 -273,990 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The previous burden estimate in 2011 was 1,080,760 hours. The decrease in burden to 806,770 (-273,990) hours is mostly attributed to a decrease in the number of establishments and a corresponding decrease in the number of total annual records under all the listed regulations.

$401,850
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@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.
12/20/2013


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