Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Comparing Data Obtained From Landline Telephone and Cell Phone Surveys, 76422-76424 [2011-31389]
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Federal Register / Vol. 76, No. 235 / Wednesday, December 7, 2011 / Notices
VII. Reference
The following reference has been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Kessler, D.A., ‘‘Introducing MEDWatch:
A New Approach to Reporting Medication
and Device Adverse Effects and Product
Problems,’’ Journal of the American Medical
Association, 269: 2765–2768, 1993.
Dated: December 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–31341 Filed 12–6–11; 8:45 am]
BILLING CODE 4160–01–P
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.
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.’’
SUMMARY:
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 https://
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
srobinson on DSK4SPTVN1PROD with NOTICES
DATES:
VerDate Mar<15>2010
17:00 Dec 06, 2011
Jkt 226001
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
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Sfmt 4703
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 (‘‘wirelessmostly 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 wirelessmostly 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 wirelessonly or wireless-mostly adults,
especially those in younger age groups,
in landline surveys can affect national
estimates of the prevalence of certain
E:\FR\FM\07DEN1.SGM
07DEN1
Federal Register / Vol. 76, No. 235 / Wednesday, December 7, 2011 / Notices
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 cellphone 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 healthrelated 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 listassisted landline telephone frame and
76423
(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 10minute 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 wirelessmostly; 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 respondents
srobinson on DSK4SPTVN1PROD with NOTICES
Activity
Number of responses per respondent
Total annual responses
Average burden
per response
Pretest ...............................................................
10
1
10
Survey ...............................................................
2,000
1
2,000
Total ...........................................................
............................
............................
............................
1 There
.167
(10 minutes)
.167
(10 minutes)
334
...........................
336
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 76, No. 235 / Wednesday, December 7, 2011 / Notices
II. References
srobinson on DSK4SPTVN1PROD with NOTICES
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,’’ (https://
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,’’ (https://
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
VerDate Mar<15>2010
17:00 Dec 06, 2011
Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0326]
Biologics Price Competition and
Innovation Act of 2009; Proposed
Recommendations for a User Fee
Program for Biosimilar and
Interchangeable Biological Product
Applications for Fiscal Years 2013
Through 2017; Notice of Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting to discuss the proposed
recommendations for a user fee program
for biosimilar biological products for
fiscal years (FYs) 2013 through 2017.
DATES: The public meeting will be held
on Friday, December 16, 2011, from
9 a.m. to 1 p.m. Registration to attend
the meeting must be received by
December 14, 2011. See section III.B of
this document for information on how
to register for the meeting. Submit either
electronic or written comments by
January 6, 2012.
ADDRESSES: The public meeting will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503, Silver Spring, MD, 20993–
0002. Please note that visitors to the
White Oak Campus must enter through
Building 1.
Submit electronic comments to
https://www.regulations.gov. Submit
written comments 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.
Transcripts of the meeting will be
available for review at the Division of
Dockets Management and on the
Internet at https://www.regulations.gov
approximately 30 days after the public
meeting (see section III.C of this
document).
FOR FURTHER INFORMATION CONTACT:
Rokhsana Safaai-Jazi, Food and Drug
Administration, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1164,
Silver Spring, MD 20993–0002, (301)
796–4463, Fax: (301) 847–8443, Email:
BiosimilarsUserFeeProgram@fda.
hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. Introduction
FDA is announcing a public meeting
to discuss proposed recommendations
for a user fee program for biosimilar
biological products (biosimilars user fee
program) for FYs 2013 through 2017. On
March 23, 2010, President Obama
signed into law the Affordable Care Act
(Pub. L. 111–148). The Affordable Care
Act contains a subtitle called the
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) that
amends the Public Health Service Act
(PHS Act) and other statutes to create an
abbreviated approval pathway for
biological products shown to be
biosimilar to or interchangeable with an
FDA-licensed reference biological
product. (See sections 7001 through
7003 of the Affordable Care Act.)
Section 351(k) of the PHS Act (42 U.S.C.
262(k)), added by the BPCI Act, allows
a company to submit an application for
licensure of a biosimilar or
interchangeable biological product.
The BPCI Act also amends section 735
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379g) to include 351(k)
applications in the definition of ‘‘human
drug application’’ for the purposes of
the prescription drug user fee
provisions. (See section 7002(f)(3)(A) of
the Affordable Care Act.) Accordingly,
under section 736 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
379h), the fee for a biologics license
application (BLA) is currently the same
regardless of whether the application is
submitted under the new 351(k)
approval pathway or the preexisting
351(a) approval pathway.
The authority conferred by the
Federal Food, Drug, and Cosmetic Act’s
prescription drug user fee provisions
expires in September 2012. The BPCI
Act directs FDA to develop
recommendations for a biosimilars user
fee program for FYs 2013 through 2017.
(See section 7002(f)(1) of the Affordable
Care Act.) The BPCI Act provides that
FDA must consult with a range of
groups, including scientific and
academic experts, health care
professionals, representatives of patient
and consumer advocacy groups (public
stakeholders), and regulated industry
(industry stakeholders), in developing
the recommendations. As described in
section II of this document, FDA
consulted with public and industry
stakeholders from June 2011 through
September 2011.
The BPCI Act requires that FDA must
publish the recommendations for a
biosimilars user fee program in the
Federal Register and provide a period of
30 days for the public to provide written
comments on the recommendations.
E:\FR\FM\07DEN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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,'' (https://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,'' (https://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
