Approved. FDA
shall monitor use of this process over the next 3 years to better
estimate the burden in its next submission.
Inventory as of this Action
Requested
Previously Approved
04/30/2006
04/30/2006
10
0
0
400
0
0
0
0
0
FDA is revising the administrative
procedure to obtain an exemption because the General Safety Test
(GST) may not be relevant or necessary for all biological products.
FDA anticipate that manufacturers requesting exemptions would have
a demonstrated record of GST compliance supported by long-term
compliance with current good manufacturing procedures,
well-documented in-process safety controls, and use of
sophisticated analytical techniques to adequately characterize the
final products and validate its safety. The Director, CBER, may
grant the exemption if its determined that...
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.