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
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.