OMB notes FDA's
efforts to re-assess the estimated number of respondents.
Inventory as of this Action
Requested
Previously Approved
10/31/2013
36 Months From Approved
5,000
0
0
6,250
0
0
0
0
0
The information collection requires
the electronic submission of the content of labeling (i.e., the
content of the package insert or professional labeling, including
all text, tables and figures) in NDA's, certain BLA's, ANDA's,
supplements, and annual reports electronically in a form that FDA
can process, review, and archive. The form that FDA can accept for
processing, reviewing, and archiving under the final rule is
portable dcoument format (PDF).
The changes in burden are the
result of a re-calculation by FDA. In 2006, we estimated
approximately 14,714 labeling submissions based on the number
NDA's, ANDA's, supplements, and annual reports we received (in some
of these submissions they may not have contained labeling). In
2009, the estimate in this submission (as explained in section 12
above) is an actual number of content of labeling SPL files FDA
receives per year (we were able to use an actual number of
submissions rather than estimate).
$0
No
No
No
No
No
Uncollected
Eliazabeth Berbakos
3018271482
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.
pra0530 final SS 2010.doc
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format