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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:
0910-0545
ICR Reference No:
201712-0910-003
Status:
Historical Inactive
Previous ICR Reference No:
201409-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Health and Diet Survey
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Withdrawn and continue
Conclusion Date:
01/16/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/28/2017
Terms of Clearance:
Upon resubmission, the agency must clarify why the collection is requested to be extended given that there are no records of GenICs being submitted over the past several years. Previous terms continue: This generic clearance for the Health and Diet Survey is approved for 3-years under the following conditions: (1) For individual collections, FDA shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template agreed to by OMB and FDA (including a statement of need, intended use of information, description of respondents, date(s) and location(s), collection procedures, number of surveys or interviews, justification for any proposed incentive, and estimated burden); (b) the participant screener, and (c) any moderator guides. (2) OMB will respond with clearance or questions within 10 working days.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2017
36 Months From Approved
01/31/2018
Responses
35,318
0
35,318
Time Burden (Hours)
1,882
0
1,882
Cost Burden (Dollars)
0
0
0
Abstract:
The Health and Diet Survey is a voluntary consumer survey intended to gauge and track consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition and physical activity. The authority for FDA to collect the information derives from the FDA Commissioner's authority provided in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). FDA and other Federal agencies will use the information from the Health and Diet Survey to evaluate and develop strategies and programs to encourage and help consumers adopt healthy lifestyles. The information will also help the FDA and other Federal agencies evaluate and track consumer awareness and behavior as outcome measures of their achievement in improving public health.
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 32832
07/18/2017
30-day Notice:
Federal Register Citation:
Citation Date:
82 FR 52053
11/06/2017
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 Interview
Cognitive interview screener
Pretest
Pretest screener
Survey
Survey screener
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:
$460,000
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:
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:
12/28/2017
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