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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:
0910-0572
ICR Reference No:
201204-0910-001
Status:
Historical Active
Previous ICR Reference No:
200901-0910-004
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
08/15/2012
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/04/2012
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2015
36 Months From Approved
08/31/2012
Responses
105
0
973
Time Burden (Hours)
351,645
0
471,295
Cost Burden (Dollars)
0
0
0
Abstract:
FDA regulations governing the format and content of labeling for human prescription drug and biological products requiring that the labeling of new and recently approved products contain highlights of prescribing information, a table of contents for prescribing information, reordering of certain sections, minor content changes, and minimum graphical requirements.
Authorizing Statute(s):
Statute at Large:
52 Stat. 1040
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 78668
12/19/2011
30-day Notice:
Federal Register Citation:
Citation Date:
77 FR 16234
03/20/2012
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Annual Burden for Labeling Requirement in 201.56 and 201.57
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule
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
105
973
0
-866
-2
0
Annual Time Burden (Hours)
351,645
471,295
0
-112,952
-6,698
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The changes in burden from the information collection in the final rule are the result of reductions in the number of submissions that have occurred because 6 years have expired under the implementation plan.
Annual Cost to Federal Government:
$210,000
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:
Johnny Vilela 301 796-3792 juanmanuel.vilela@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:
04/04/2012
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