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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:
0910-0734
ICR Reference No:
201211-0910-007
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
03/20/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/26/2012
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2016
36 Months From Approved
Responses
203
0
0
Time Burden (Hours)
824
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The guidance provides information on the implementation of the new statutory provisions, including a description of the types of safety labeling changes that ordinarily might be required under the new legislation; how the Food and Drug Administration plans to determine what constitutes new safety information; the procedures involved in requiring safety labeling changes; and enforcement of the requirements for safety labeling changed.
Authorizing Statute(s):
US Code:
21 USC 355(o)(4)(B)
Name of Law: Federal Food, Drug, and Cosmetic Act
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:
76 FR 20686
04/13/2011
30-day Notice:
Federal Register Citation:
Citation Date:
77 FR 68787
11/16/2012
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Guidance for Industry on Safety Labeling Changes; Implementation of Section 505(o)(4) of the FD&C Act-- Rebuttal Statement
Guidance for Industry on Safety Labeling Changes; Post Approved Labeling on Application Holder's Web site
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
203
0
0
203
0
0
Annual Time Burden (Hours)
824
0
0
824
0
0
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:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$212,090,000
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:
ILa Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
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:
11/26/2012
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