Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

ICR 201008-0910-003

OMB: 0910-0530

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0530 201008-0910-003
Historical Active 200702-0910-001
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Reinstatement without change of a previously approved collection   No
Approved without change 10/18/2010
Retrieve Notice of Action (NOA) 08/09/2010
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).

US Code: 21 USC 321 Name of Law: FFDCA

Not associated with rulemaking

  74 FR 57491 11/09/2009
75 FR 23779 05/04/2010

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 5,000 0 0 -14,603 4,889 14,714
Annual Time Burden (Hours) 6,250 0 0 -3,652 6,222 3,680
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Using Information Technology
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).

Eliazabeth Berbakos 3018271482


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.

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