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:
0910-0865
ICR Reference No:
201812-0910-007
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Generic Clearance for Quantitative Testing for the Development of FDA Communications (CFSAN)
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:
02/08/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/05/2019
Terms of Clearance:
FDA will submit individual collections under this generic clearance to OMB. Individual collections will also undergo review by FDA’s Research Involving Human Subjects Committee (RIHSC), senior leadership in the Center for Food Safety and Applied Nutrition, and Paperwork Reduction Act (PRA) specialists. FDA will prepare a report during the OMB collection renewal summarizing the number of hours used, as well as the nature and results of the activities completed under this clearance.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2022
36 Months From Approved
Responses
93,744
0
0
Time Burden (Hours)
10,498
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
This ICR supports the creation of an information collection for the development of a “Generic Clearance for Quantitative Testing for the Development of FDA Communications.” The generic studies covered by this request will be used to quantitatively test FDA communications and educational messages related to FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed as they are being developed and before they are released to the public. Data will be collected using consumer panels or mall intercepts for surveys and experimental studies.
Authorizing Statute(s):
US Code:
21 USC 393
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:
83 FR 44888
09/04/2018
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 67300
12/28/2018
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
6
IC Title
Form No.
Form Name
Cognitive Interviews
Cognitive Interviews Screener
Pre-Test Study Screener
Pre-Testing Study
Self-Administered Surveys/Experimental Studies
Self-Administered Surveys/Experimental Studies Screener
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
93,744
0
0
93,744
0
0
Annual Time Burden (Hours)
10,498
0
0
10,498
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new information collection request.
Annual Cost to Federal Government:
$939,150
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
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:
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:
02/05/2019
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