FDA will provide
the PRA-mandated burden notice on the guidance document.
Inventory as of this Action
Requested
Previously Approved
01/31/2010
36 Months From Approved
01/31/2007
180
0
164
51,120
0
46,576
0
0
0
Guidance to assist sponsors in
submitting responses to clinical holds so that they may be
identified as complete responses and the agency can track the time
to respond.
The change in burden estimates
is based on more recent data reflecting the number of
receipts.
$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
No
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.