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