0545 Health and Diet Survey 2017 SSA Extension

U.S. Food and Drug Administration
Health and Diet Survey
OMB Control No. 0910-0545
SUPPORTING STATEMENT Part A: Justification
Terms of Clearance: This generic clearance for the Health and Diet Survey is approved for 3years 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.
1. Circumstances Making the Collection of Information Necessary
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, physical activity, and product labeling. This collection has been approved
as an information collection under the generic collection process. The authority for FDA to
collect the information derives from FDA’s Commissioner of Food and Drugs authority
provided in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
393(d)(2)).
2. Purpose and Use of the Information Collection
The information to be collected with the Health and Diet Survey will include, but is not
limited to: (1) awareness of diet-disease relationships, including topics such as dietary fats;
(2) awareness, understanding, and use of food and dietary supplement labels; (3) dietary
practices including strategies to lose or maintain weight; and, (4) dietary practices related to
other topics such as energy drinks and sodium reduction. We have repeated this survey
every three years over the course of the past several years for the purpose of tracking
changes and trends in public opinions and consumer behavior, with some new questions
added or omitted or partially modified each iteration in response to current events and our
needs. At this time we plan to administer the survey more frequently, approximately 2-3
times, over the next three years to meet the increasing need for consumer information. Each
survey will contain a set of core questions while certain question modules will be revised to
target topics that might be particularly relevant to current public health issues. Additionally,
we plan to use the same sampling and interview approaches each time the survey is
administered. Being able to conduct a timely survey with both repeated and targeted
questions will be very useful to us. Within the broad context of our public health mission,
information gained from the survey will provide a basis with which we can test and refine
ideas to encourage and help consumers adopt and maintain healthy lifestyles.

Description of Respondents: The respondents are adults, age 18 and older, drawn from the
50 states and the District of Columbia. Participation will be voluntary.
3. Use of Improved Information Technology and Burden Reduction
The telephone interviewing methodology proposed for this collection of information is the
most cost-effective approach to acquiring the needed information. Given the rise in cell
phone usage, we will include cell phone users, in addition to landline telephone users, to our
future surveys. The survey will be administered using a Computer Assisted Telephone
Interviewing (CATI) system, since this methodology will minimize possible errors of
administration and expedite the timeliness of data processing. Compared to face-to-face
interviews, telephone interviews are less intrusive and less costly. Mail surveys are not
appropriate for a questionnaire with complicated skip patterns as used in this collection of
information. In addition, mail surveys generally have a much lower response rate than
telephone surveys. We will also consider using other modes of data collection, such as
multi-mode (telephone and web), when appropriate.
4. Efforts to Identify Duplication and Use of Similar Information
There is no duplicative collection of this information. Many of the topics included in the
Survey, particularly product labeling, are of special interest to us, but are not covered by any
other public- or private-sponsored national surveys.
5. Impact on Small Businesses or Other Small Entities
The collection of information does not involve small businesses. None of the respondents
are small businesses.
6. Consequences of Collecting the Information Less Frequently
We plan to field the survey 2 to 3 times in the next three years. If this information is
collected less frequently, current, essential, and national data of consumer knowledge,
perceptions, attitudes, and practices pertinent to current and emerging public health issues
will not be available to the FDA. The lack of information will severely limit our capabilities
in performing its functions properly to promote and protect the public health.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice soliciting public
comment in the Federal Register of July 18, 2017 (82 FR 32832). No comments were
received

2

9. Explanation of Any Payment or Gift to Respondents
Respondents will not receive any type of payment or gift for participation in this collection
of information.
10. Assurance of Confidentiality Provided to Respondents
All data will be collected with an assurance that the respondents' answers will remain private
to the fullest extent allowed by law. The study instrument will contain a statement that
responses will be kept private to the fullest extent allowed by law. Identifying information
will not be included in the data files delivered by contractors to the agency. FDA will keep
the study data private to the extent permitted by law.
Privacy will be assured by using an independent contractor to collect the information, by
enacting procedures to prevent unauthorized access to respondent data, and by preventing
the public disclosure of the responses of individual participants. The contractors will only
share data and/or information with the agency in an aggregated form or format, which does
not permit the agency to identify individual respondents.
All electronic data will be maintained in a manner that is consistent with the Department of
Health and Human Services ADP Systems Security Policy as described in DHHS ADP
Systems Manual, Part 6, chapters 6-30 and 6-35. All data will also be maintained in
accordance with the FDA Privacy Act System of Records #09-10-0009 (Special Studies and
Surveys on FDA Regulated Products).
11. Justification for Sensitive Questions
The Health and Diet Survey proposes to ask respondents their height, weight, and self
assessment of weight status, and risk perception of chronic illnesses. The agency’s
experience with these questions suggests that the overwhelming majority of respondents feel
comfortable in providing this information. For example, in the last Health and Diet Survey
(2008), the item non-response rates due to refusal were lower than 3% among these
questions.
To mitigate potential privacy concerns, the following sentence is read immediately prior to
the group of questions concerning health status: “The next few questions may seem a bit
personal. But we need this information because this survey is about nutrition and health.” It
is likely that the low item non-response rates mentioned above were attributable to this
sentence.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:

3

Activity

Cognitive interview
screener
Cognitive interview
Pretest screener
Pretest
Survey screener
Survey

Table 1.--Estimated Annual Reporting Burden1
No. of
No. of
Total Annual Average Burden
Respondents
Responses per
Responses
per Response
Respondent
100
1
100
0.083
(5 minutes)
18
1
18
1
2,000
1
2,000
0.033
(2 minutes)
200
1
200
0.25
(15 minutes)
30,000
1
30,000
0.033
(2 minutes)
3,000
1
3,000
0.25
(15 minutes)

Total
Hours
8
18
66
50
990
750

Total
1,882
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

We base our estimate of the number of respondents and the average burden per response on
our experience with previous Health and Diet Surveys. We will use a cognitive interview
screener with 100 individuals to recruit prospective interview participants. We estimate that
it will take a screener respondent approximately 5 minutes (0.083 hours) to complete the
cognitive interview screener, for a total of 8 hours, rounded down from 8.3 hours. We will
conduct cognitive interviews with 18 participants. We estimate that it will take a participant
approximately 1 hour to complete the interview, for a total of 18 hours. Prior to the
administration of the Health and Diet Survey, the agency plans to conduct a pretest to
identify and resolve potential survey administration problems. We will use a pretest
screener with 2,000 individuals; we estimate that it will take a respondent approximately 2
minutes (0.033 hours) to complete the pretest screener, for a total of 66 hours. The pretest
will be conducted with 200 participants; we estimate that it will take a participant 15
minutes (0.25 hours) to complete the pretest, for a total of 50 hours. We will use a survey
screener to select an eligible adult respondent in each household reached by landline
telephone numbers to participate in the survey. A total of 30,000 individuals in the 50 states
and the District of Columbia will be screened by telephone. We estimate that it will take a
respondent 2 minutes (0.033 hours) to complete the screening, for a total of 990 hours. We
estimate that 3,000 eligible adults will participate in the survey, each taking 15 minutes
(0.25 hours), for a total of 750 hours. Thus, the total estimated burden is 1,882 hours.
We are requesting this burden for unplanned surveys so as not to restrict our ability to gather
information on consumer attitudes, awareness, knowledge, and behavior regarding various
topics related to health, nutrition, physical activity, and product labeling. This ability will
help the agency identify and respond to emerging issues in a more timely manner.

4

12b. Annualized Cost Burden Estimate
We estimate that the average hourly wage of the respondents is $20 per hour. The
overall estimated cost incurred by the respondents is $37,640. (1,882 burden hours X $20/hr
= $37,640).
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this
collection.
14. Annualized Cost to the Federal Government
The estimated total cost to the Federal government for this information collection $460,000.
This estimate consists of (1) $160,000 for 1.5 FTE of FDA professional staff to manage the
project, develop the survey, analyze the data, and prepare reports and other informational
products to be described in A.16, and (2) $300,000 for data collection. These costs would
increase in the event that the agency has a need for additional follow-up surveys in 2018 and
2019.
15. Explanation for Program Changes or Adjustments
There is no change in the estimated burden for this collection.
16. Plans for Tabulation and Publication and Project Time Schedule
For the Health and Diet Survey, the planned schedule for the project activities is shown in
Table 2.
Table 2. Project Schedule
Date

Within 3 days after receipt of
OMB approval of collection of
information
Within 135 days after notification
to contractor
Within 180 days after notification
to contractor
Within 6 months after receipt of
final data files
Within 18 months after receipt of
final data files
Within 18 months after receipt of
final data files

Activity

Audience

Notification to contractor to proceed with
data collection activities

Not
applicable

Completion of data collection

Not
applicable
Not
applicable
FDA

Delivery by contractor of final data files
Delivery of oral and written preliminary
summaries
Delivery of written summaries and
analytical findings
Response to information requests

5

FDA
FDA and
public

Within 24 months after receipt of
final data files

Dissemination of findings through
submissions of journal manuscript(s) and
conference presentations

Public

Following OMB approval, when the survey is conducted during the three year OMB
approval period, the data collection contractor will draw the sample, conduct the survey, and
prepare the deliverables in accordance with their contract. The duration of information
collection is estimated to be approximately 135 days to allow (1) a 15-day lead time to
prepare for pretests, advance letters, and field operations, and (2) a 120-day field period to
conduct interviews and to send conversion letters to initial refusals to encourage
participation. Data files and all other deliverables will be delivered to the FDA within 180
days of written notification to the contractor that OMB approval has been granted.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
No exemption is requested.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

6