Per FDAs
request, this ICR was withdrawn and continued to permit the
correction of a technical problem in ROCIS. HHS/FDA will resubmit
this collection by late November 2010.
Inventory as of this Action
Requested
Previously Approved
08/31/2010
36 Months From Approved
01/31/2011
782,562
0
782,562
783,332
0
783,332
0
0
0
These information collection
requirements help prevent the transmission of communicable diseases
through human tissue transplantation by requiring written SOPs and
the maintenance of records of all significant steps in testing,
processing, distribution, and final disposition of the tissue, and
which FDA investigators can review to evaluate whether the SOPs are
consistent with the regulations and to determine that an
establishment is following the procedures documented in the SOPs.
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
The previous burden estimate
was 783,332 hours. The increase in burden is attributed to an
increase in the number of establishments and number of total annual
records received by FDA.
$367,650
No
No
No
No
No
Uncollected
Eliazabeth Berbakos
3018271482
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.