View Information Collection Request (ICR) Package
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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:
0910-0393
ICR Reference No:
200811-0910-007
Status:
Historical Active
Previous ICR Reference No:
200506-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Prescription Drug Product Labeling; Medication Guide Requirements
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
04/10/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/28/2008
Terms of Clearance:
This ICR is approved as revised. When burden or cost estimates are changing--especially when the changes are large--FDA should provide a more fulsome explanation for why they are changing. In this case, this ICR is approved on the understanding that the number of responses is not actually increasing by 294 million but that the estimate is being revised in light of publicly available information on the annual use of commonly used drugs like antidepressants (and thus, the frequency with which Medication Guides must be dispensed). The additional 2,148,750 additional burden hours is in response to public comments that 208.24(c) does, in fact, carry burden. Finally, this ICR is approved on the understanding that no other changes are being made through this ICR. Per FDA memo of 3/28/09, FDA agrees that it will submit an ICR revision if the Medication Guide program is modified in such a way that results in new or different information collection requirements. This ICR revision should be submitted prior to the modifications taking effect.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2012
36 Months From Approved
04/30/2009
Responses
296,719,030
0
1,100,000
Time Burden (Hours)
16,907,110
0
4,248
Cost Burden (Dollars)
0
0
0
Abstract:
FDA regulations require the distribution of patient labeling, called Medication Guides, for certain prescription human drugs and biological products used primarily on an outpatient basis that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information. These Medication Guides inform patients about the most important information they should know about these products in order to use them safely and effectively.
Authorizing Statute(s):
US Code:
21 USC 314.70
Name of Law: FFDCA
US Code:
21 USC 208.20
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:
73 FR 14471
03/18/2008
30-day Notice:
Federal Register Citation:
Citation Date:
73 FR 72055
11/26/2008
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Prescription Drug PRoduct Labeling: Medication Guide Requirements
Prescription Drug PRoduct Labeling; Medication GUide Requirements
Prescription Drug Product Labeling: Medication Guide Requirements
Prescription Drug Product Labeling; Medication Guide Requirements
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
296,719,030
1,100,000
0
1,719,000
293,900,030
0
Annual Time Burden (Hours)
16,907,110
4,248
0
2,148,750
14,754,112
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:
$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]?
Uncollected
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:
11/28/2008
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