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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0530
ICR Reference No:
201008-0910-003
Status:
Historical Active
Previous ICR Reference No:
200702-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Type of Information Collection:
Reinstatement without change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/18/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/09/2010
Terms of Clearance:
OMB notes FDA's efforts to re-assess the estimated number of respondents.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2013
36 Months From Approved
Responses
5,000
0
0
Time Burden (Hours)
6,250
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
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).
Authorizing Statute(s):
US Code:
21 USC 321
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
74 FR 57491
11/09/2009
30-day Notice:
Federal Register Citation:
Citation Date:
75 FR 23779
05/04/2010
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
ICR Summary of Burden
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
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Using Information Technology
Short Statement:
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).
Annual Cost to Federal Government:
$0
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Eliazabeth Berbakos 3018271482
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
08/09/2010
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