The CGMP and related regulations
establish accountability and traceability in the processing and
handling of blood and blood components and enable FDA to perform
meaningful inspections. The recordkeeping requirements serve
preventative and remedial purposes, and the reporting requirements
inform FDA of any deviations that occur and that may require
immediate corrective action. The disclosure requirements identify
the various blood and blood components and important properties of
the product, demonstrate that the CGMP requirements have been met,
and facilitate the tracing of a product back to its original
source..
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.