
[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Notices]
[Pages 76422-76424]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31389]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study on Comparing Data Obtained From 
Landline Telephone and Cell Phone Surveys

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a study entitled ``Experimental Study on 
Comparing Data Obtained From Landline Telephone and Cell Phone 
Surveys.''

DATES: Submit either electronic or written comments on the collection 
of information by February 6, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, II, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-3793.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 three-fold: (1) To generate nationally representative 
estimates of knowledge, perception, and practice 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 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 under-representation 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

[[Page 76423]]

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 of 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.
    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  .167                                                2
                                                                                                   (10 minutes).......................
Survey.....................................             2,000                 1             2,000  .167                                              334
                                                                                                   (10 minutes).......................
                                            ------------------------------------------------------------------------------------------------------------
    Total..................................  ................  ................  ................  ...................................              336
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 76424]]

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,'' (http://www.cdc.gov/nchs/nhis.htm), National 
Center for Health Statistics, June 2011.
2. Lee, S., J.M. Brick, E.R. Brown, et al., ``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 U.S. 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 United States With Respondents Reached 
via Cell Phone Numbers,'' (http://www.aapor.org/Cell_Phone_Task_Force_Report.htm), 2010.
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: December 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31389 Filed 12-6-11; 8:45 am]
BILLING CODE 4160-01-P


