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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:
201005-0910-007
Status:
Historical Inactive
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:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Improperly submitted and continue
Conclusion Date:
06/14/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/18/2010
Terms of Clearance:
In accordance with 5 CFR 1320 OMB notes that this collection has been improperly submitted. The collection has been submitted as an extension but appears to contain a discretionary change in burden. Please correct this error and resubmit this collection to OMB.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2010
36 Months From Approved
06/30/2010
Responses
14,714
0
14,714
Time Burden (Hours)
3,680
0
3,680
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
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:
Miscellaneous Actions
Short Statement:
The changes in burden are the result of a re-calculation based on the guidance for industry entitled "Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Listing."
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]?
Uncollected
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:
05/18/2010
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