Approved
consistent with clarification in FDA memo of 11-25-02.
Inventory as of this Action
Requested
Previously Approved
12/31/2005
12/31/2005
11/30/2003
42,435
0
397
335,346
0
332,403
0
0
0
The information collection
requirements in the CGMP regulations and lookback requirements
provide FDA with the necessary information to perform its duty to
ensure the safety, purity, and potency of blood and blood
components. These requirements establish accountability and
traceability in the processing and handling of blood and blood
components and enable FDA to perform meaningful inspections. The
recordkeeping requirement serve preventative and remedial purposes.
The disclosure requirements identify the various blood and blood
components and important properties of the product, demonstrate
that the CGMP..........
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.