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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:
0910-0686
ICR Reference No:
201706-0910-014
Status:
Historical Active
Previous ICR Reference No:
201405-0910-012
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Prescription Drug Advertisements
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 without change
Conclusion Date:
11/14/2017
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/17/2017
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2020
36 Months From Approved
11/30/2017
Responses
21,804
0
25,839
Time Burden (Hours)
18,162,706
0
10,076,426
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection supports FDA regulations regarding prescription drug advertising. Under authority of the Federal Food, Drug, and Cosmetic Act, FDA is responsible for ensuring that advertisements published in journals, magazines, newspapers, or other periodicals, as well as advertisements broadcast through media such as radio, television, and telephone communication systems comply with the public health protection provisions therein. Respondents to the information collection are sponsors of prescription drug product promotional material.
Authorizing Statute(s):
US Code:
21 USC 301 et seq.
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:
82 FR 23574
05/23/2017
30-day Notice:
Federal Register Citation:
Citation Date:
82 FR 36799
08/07/2017
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
202.1(j)(1) - Including information about the drug's fatalities or serious damage in the advertisement
202.1(j)(1) - Submission of advertisement to FDA for prior approval
202.1(j)(1)(iii) - Providing a program to FDA for assuring that adverse information about the drug will be publicized
202.1(j)(4) - Voluntarily submitting the advertisement to FDA prior to publication for comment
Prescription Drug Advertisements 3rd Party Disclosure Requirements
Prescription Drug Advertisements Reporting 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
21,804
25,839
0
0
-4,035
0
Annual Time Burden (Hours)
18,162,706
10,076,426
0
0
8,086,280
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:
The information collection reflects agency adjustments. While the number of annual burden hours increased from 10,076,426 hours to 18,162,706 hours (+8,086,280), the number of annual responses has decreased from 25,839 to 21,804 (-4,035). This is discussed more fully in the agency's supporting statement at Q15.
Annual Cost to Federal Government:
$5,700,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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:
Domini Bean 301 796-5733 domini.bean@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:
08/17/2017
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