The recordkeeping requirements serve
preventative and remedial purposes, and ensure that industry has
needed information to perform the #lookback# procedures. The
reporting requirements inform FDA or any deviations that occur and
that may require immediate corrective action. The disclosure
requirements identify the blood and blood components and their
important properties, that they meet the CGMP requirements, and
facilitate their source tracing. Consignee notification ensures
that the prior collections of products are appropriately
quarantined.
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.