Terms of Clearance: None, however at OMB’s suggestion we are requesting that this collection be revised as a generic collection, as emerging events or issues may trigger periodic question modifications to the survey instrument.
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. Currently this collection
is approved as a traditional collection, however, FDA wishes to
employ future collections 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.
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), in the Federal
Register of July
14, 2014 (79 FR 40760), we published a 60-day notice requesting
public comment on the proposed collection of information. We
received two comments in response to the notice that we were unable
to address in our 30 day publication, however we do address them
here.
(Comment 1) One comment stated that the information collected will not benefit the public. The comment questioned whether the proposed survey would provide any meaningful data and said it was wasteful spending.
(Response) We respectfully disagree. This survey is intended to gauge and to track consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, physical activity, and product labeling. An example of the survey’s utility is FDA’s use of the Nutrition Facts label reading questions in its deliberations of proposed changes to the Nutrition Facts label to enhance the label’s usefulness. We believe consumers benefit from this information.
(Comment 2) One comment suggests that the Health and Diet Survey should include demographic questions to identify lesbian, gay, bisexual, and transgender (LGBT) individuals so LGBT health disparities may be addressed. The comment continued that the demographic questions should differentiate between sexual orientation and gender identity.
(Response) We appreciate the comment. We will take this suggestion under consideration for future surveys. We want to collect data for all populations. As mentioned in the comment, sexual orientation and gender identity questions are sensitive and potentially stigmatizing. We would need to research this topic further before fielding this line of questions and only when the subject matters warrant attention to potential disparities between individuals with different gender identities or sexual orientations.
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 confidential. The study instrument will contain a statement that responses will be kept confidential. Identifying information will not be included in the data files delivered by contractors to the agency. FDA will keep the study data confidential to the extent permitted by law.
Confidentiality 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
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.
12 a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1 |
|||||
Activity |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Responses |
Average Burden per Response |
Total Hours |
Cognitive interview screener |
100 |
1 |
100 |
0.083 (5 minutes) |
8 |
Cognitive interview |
18 |
1 |
18 |
1 |
18 |
Pretest screener
|
2,000 |
1 |
2,000 |
0.033 (2 minutes) |
66 |
Pretest
|
200 |
1 |
200 |
0.25 (15 minutes) |
50 |
Survey screener
|
30,000 |
1 |
30,000 |
0.033 (2 minutes) |
990 |
Survey
|
3,000 |
1 |
3,000 |
0.25 (15 minutes) |
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.
12 b. Annualized Cost Burden Estimate
We estimate that the average hourly wage of the respondents is $17 per hour. The overall estimated cost incurred by the respondents is $31,994. (1,882 burden hours X $17/hr = $31,994).
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 2016 and 2017.
15.
Explanation for Program Changes or Adjustments
This collection is being revised. The burden hours have been increased by 581 and the annual responses by 17,091. Although questions related to the Dietary Guidelines for Americans have been removed from this iteration of the survey, a cognitive interview and screeners for the pretest and cognitive interview have been added. We have also increased the number of respondents to allow for more than one survey deployment during the approval period as we will utilize this as a generic 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 |
Activity |
Audience |
Within 3 days after receipt of OMB approval of collection of information |
Notification to contractor to proceed with data collection activities |
Not applicable |
Within 135 days after notification to contractor |
Completion of data collection |
Not applicable |
Within 180 days after notification to contractor |
Delivery by contractor of final data files |
Not applicable |
Within 6 months after receipt of final data files |
Delivery of oral and written preliminary summaries |
FDA |
Within 18 months after receipt of final data files |
Delivery of written summaries and analytical findings |
FDA |
Within 18 months after receipt of final data files |
Response to information requests |
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, the data collection contractor will draw the sample, conduct the survey, and prepare the deliverables in accordance with the Quick Turnaround Research Services 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.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | Bean, Domini |
| File Modified | 2014-11-18 |
| File Created | 2014-09-28 |