[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Notices]
[Pages 29353-29355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-11934]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0858]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study on 
Comparing Data Obtained From Landline Telephone and Cell Phone Surveys

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 
18, 2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Experimental Study on Comparing Data Obtained From Landline 
Telephone and Cell Phone Surveys.'' Also include the FDA docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Experimental Study on Comparing Data Obtained From Landline Telephone 
and Cell Phone Surveys--(OMB Control Number 0910-NEW)

I. Background

    Since the early 1980s, the Center for Food Safety and Applied 
Nutrition at FDA has been commissioning several waves of two national 
consumer surveys, the Food Safety Survey (FSS) and the Health and Diet 
Survey (HDS), to gather data on consumer knowledge, perceptions, and 
behaviors regarding food safety and nutrition. The purposes of the 
surveys are threefold: (1) To generate nationally representative 
estimates of knowledge, perceptions, and practices of interest at a 
given point in time; (2) to track trends of the estimates over time; 
and (3) to understand the relationships among knowledge, perceptions, 
and practices regarding food safety and nutrition, and how these relate 
to demographic characteristics.
    Traditionally, all waves of the surveys have been administered via 
landline telephones and have used the random digit dialing (RDD) 
technique to recruit national samples of adults (18 years old or above) 
from households with landline telephone numbers. A noticeable 
phenomenon that has appeared in our recent surveys is a precipitous 
decline of younger respondents in completed interviews. For example, 
the proportion of respondents in the 18 to 29 age group for the FSS has 
dropped from 17 percent in 2001, to 11 percent in 2006, to only 4 
percent in 2010; the corresponding proportion for the HDS has gone from 
14 percent in 2002, to 15 percent in 2004, to only 6 percent in 2008.
    One possible reason for the decline is the rapid adoption of cell 
phones in recent years. During the second half of 2010, 28 percent of 
American adults lived in households with only wireless service 
(``wireless-only households'' or ``cell-phone only households''), 
compared to 15 percent in the second half of 2007 and 5 percent in the 
second half of 2004 (Ref. 1). During the second half of 2010, 17 
percent of adults lived

[[Page 29354]]

in households that received all or almost all calls on cell phones 
despite having a landline phone (``wireless-mostly households'' or 
``cell-phone mostly households''), an increase of 3 percentage points 
from the first half of 2008 (Ref. 1). Thus, the number of adults 
reachable by landline phone calls has decreased in recent years. The 
rate of cell phone adoption, however, has been uneven among adults with 
different demographic characteristics. In 2010, adults living in 
wireless-only households were more likely to be 18 to 34 year olds, 
living in poorer households, without a college or higher educational 
degree, or Hispanics or Latinos (Ref. 1). Meanwhile, adults who live in 
landline households differ from those who live in wireless-only 
households as well those in wireless-mostly households (Ref. 2), and 
the demographic characteristics of adults living in wireless-mostly 
households are much less diverse than that of adults living in 
wireless-only households (Ref. 1).
    The underrepresentation of wireless-only or wireless-mostly adults, 
especially those in younger age groups, in landline surveys can affect 
national estimates of the prevalence of certain consumer perceptions, 
knowledge or behaviors, and understanding of the relationships between 
certain survey responses and demographic characteristics. For example, 
previous research found different prevalence rates of drinking and 
smoking between respondents reached on a landline call versus 
respondents from wireless-only households (Ref. 1). Wireless-mostly 
adults were less likely than landline adults to say their health is 
fair or poor and were less likely to be a current smoker than wireless-
only adults (Ref. 2). Voigt et al. (Ref. 3) reported that cell phone 
users were less likely to have fathered or given birth to a child than 
their landline telephone counterparts. The differences observed in 
these studies are pertinent and potentially problematic for the HDS and 
FSS because past surveys have shown that age variations were associated 
with, among other things, consumers' knowledge of dietary fats, and 
awareness and concern about pesticide and antibiotic residues (Refs. 4 
and 5).
    Thus, our recent surveys may have become vulnerable to a 
noncoverage problem due to the fact that many eligible respondents are 
not included in the survey samples because they do not own landline 
phones or because they receive calls only or mostly on cell phones. 
Adults living in wireless-only and wireless-mostly households are less 
likely to appear in landline telephone samples and often possess 
characteristics that differ from those of adults in landline 
households. Thus, a telephone survey that still relies exclusively on 
landline phone calls to interview respondents may not produce results 
that are reliable and valid (Refs. 2 and 6), may not yield results that 
are comparable to results from past landline surveys when this 
noncoverage problem was absent, or both.
    One common approach to addressing potential impacts of cell phone 
use on landline telephone survey results is to supplement a landline 
telephone survey with a cell phone survey to achieve a wider coverage 
of population in the sample of respondents. Existing evidence on the 
usefulness of this approach varies between national estimates and 
population subgroup estimates. Many studies conducted around the mid-
2000s (for example, Ref. 7), when the use of cell phones was not as 
common as today, and a 2007 study (Ref. 2) suggested that general 
population estimates of certain social and political attitudes, voting 
behavior, and media use and attitudes did not always vary when a 
landline survey was supplemented or was not supplemented with a cell-
phone only survey, especially when the response to a landline survey 
was weighted to reflect population characteristics. On the other hand, 
this research also suggested that among young adults and low-income 
adults, estimates of certain health-related behaviors, such as smoking 
and binge drinking, differ between those living in households with and 
without landlines (Ref. 8). In addition, young adults who had a 
landline phone were less likely to report drinking alcohol or to agree 
that marijuana smoking is acceptable (Ref. 9). We are, however, not 
aware of any research that has examined whether food safety or 
nutrition related perceptions, attitudes, and behaviors differ when 
landline telephone surveys miss respondents who are not reachable by 
landline telephone calls.
    Therefore, we are concerned that the diminishing survey 
participation among consumers who are not easily reached by landline 
telephones may lead to unreliable or biased estimates of critical 
information and the relationships among knowledge, perceptions, and 
other food safety and nutrition-related variables. These concerns 
warrant a systematic examination of the impacts of cell phone use on 
the quality of the FSS and HDS data.
    The objective of this data collection is to provide data for an 
experimental study that compares demographic distributions in and 
responses to selected FSS and HDS questions by samples of respondents 
drawn from an overlapping dual frame (Ref. 6), i.e., two overlapping 
sampling frames: (1) A list-assisted landline telephone frame and (2) a 
cell-phone frame. Using this approach, we will not screen out any 
households or individuals because of their type(s) of telephone service 
(landline or cell phone). The study plans to interview 2,000 
respondents in English, half of them (1,000) using a 10-minute HDS 
questionnaire and half of them (1,000) using a 10-minute FSS 
questionnaire. Each respondent will be randomly assigned to one of the 
questionnaires. The target distributions within each of the HDS and FSS 
samples are:
     700 respondents who are drawn from the landline frame and 
complete the questionnaire on a landline telephone;
     150 respondents who are drawn from the cell phone frame 
and complete the questionnaire on a cell phone, regardless whether they 
are wireless-only or wireless-mostly; and
     150 respondents who are drawn from the cell phone frame, 
complete the questionnaire on a cell phone, and do not have a landline 
phone to receive personal calls.
    The HDS questionnaire will focus on knowledge of dietary fats, use 
of food labels, awareness of diet-health relationships, and use and 
understanding of dietary supplements. The FSS questionnaire will focus 
on perceptions of general food safety risks, food handling practices, 
perceived personal vulnerability to food safety risks, consumption of 
risky foods, and awareness of mercury and fish. All questions have been 
asked in previous surveys.
    The Agency will use the study to assess the impacts of cell phone 
use on population estimates of nutrition and food safety related 
perceptions, attitudes, and behaviors. The assessment will help the 
Agency determine whether and how future administrations of the FSS and 
HDS should be adjusted to produce reliable, valid, and historically 
comparable results in response to the growing prevalence of cell phone 
use.
    In the Federal Register of December 7, 2011 (76 FR 76422), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. The Agency received two comments in response 
to the notice. Both responses dealt with topics outside the scope of 
the proposed collection of information described in the 60-day notice 
and are therefore not addressed here.

[[Page 29355]]

    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest......................................              10               1              10  0.167 (10 minutes).......................               2
Survey.......................................           2,000               1           2,000  0.167 (10 minutes).......................             334
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................             336
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

1. Blumberg, S.J. and J.V. Luke, ``Wireless Substitution: Early 
Release of Estimates From the National Health Interview Survey, 
July-December 2010.'' National Center for Health Statistics, June 
2011. Available at: http://www.cdc.gov/nchs/nhis.htm.
2. Lee, S., J.M. Brick, E.R. Brown, and D. Grant, ``Growing Cell-
Phone Population and Noncoverage Bias in Traditional Random Digit 
Dialing Telephone Health Surveys,'' Health Services Research, 45: 
1121-1139, 2010.
3. Voigt, L.F., S.M. Schwartz, D.R. Doody, et al., ``Feasibility of 
Including Cellular Telephone Numbers in Random Digit Dialing for 
Epidemiologic Case-Control studies,'' American Journal of 
Epidemiology, 173: 118-126, 2011.
4. Yen, S.T., K.L. Jensen, and C.-T.J. Lin, ``Awareness and 
Perceived Risk of Pesticide and Antibiotic Residues in Food: 
Socioeconomic Variations Among United States' Consumers,'' Food 
Protection Trends, 26: 654-661, 2006.
5. Lin, C.-T.J. and S.T. Yen, ``Knowledge of Dietary Facts Among 
U.S. Consumers,'' Journal of the American Dietetic Association, 110: 
613-618, 2010.
6. American Association for Public Opinion Research (AAPOR), ``New 
Considerations for Survey Researchers When Planning and Conducting 
RDD Telephone Surveys in the U.S. With Respondents Reached via Cell 
Phone Numbers,'' 2010. Available at: http://www.aapor.org/Cell_Phone_Task_Force_Report.htm.
7. Keeter, S., ``The Impact of Cellular Phone Noncoverage Bias on 
Polling in the 2004 Presidential Election,'' Public Opinion 
Quarterly, 70: 88-98, 2006.
8. Blumberg, S.J. and J.V. Luke, ``Reevaluating the Need for Concern 
Regarding Noncoverage Bias in Landline Surveys,'' American Journal 
of Public Health, 99: 1806-1810, 2009.
9. Keeter, S., C. Kennedy, A. Clark, et al., ``What's Missing From 
National Landline RDD Surveys? The Impact of the Growing Cell-Only 
Population,'' Public Opinion Quarterly, 71: 772-792, 2007.

    Dated: May 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11934 Filed 5-16-12; 8:45 am]
BILLING CODE 4160-01-P