FDA requires all licensed
manufacturers of human blood and blood components, including Source
Plasma, unlicensed registered blood establishments, and transfusion
services to report all biological product deviations in
manufacturing for distributed products. It provides a more accurate
surveillance of the nation's blood supply, thereby enabling FDA to
monitor actions taken in response to biological product deviations
detected for all establishments; and facilitates a rapid response
by FDA where public health may be a risk.
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.