Published 60-Day FRN

20204

Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–14–0950]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to LeRoy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
The National Health and Nutrition
Examination Survey (NHANES) (OMB
No. 0920–0950, expires 11/30/2015)—
Revision—National Center for Health
Statistics (NCHS), Centers for Disease
Control and Prevention (CDC).

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Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on the extent and nature of
illness and disability; environmental,
social and other health hazards; and
determinants of health of the population
of the United States.
The National Health and Nutrition
Examination Surveys (NHANES) have
been conducted periodically between

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1970 and 1994, and continuously since
1999 by the National Center for Health
Statistics, CDC. Annually,
approximately 15,613 respondents
participate in some aspect of the full
survey. About 10,735 respondents
complete the screener for the survey.
About 209 respondents complete the
household interview only. About 4,669
respondents complete both the
household interview and the Mobile
Exam Center (MEC) examination. Up to
2,500 additional persons might
participate in tests of procedures,
special studies, or methodological
studies (Table 1). Participation in
NHANES is completely voluntary and
confidential. A three-year approval is
requested.
NHANES programs produce
descriptive statistics which measure the
health and nutrition status of the
general population. Through the use of
physical examinations, laboratory tests,
and interviews NHANES studies the
relationship between diet, nutrition and
health in a representative sample of the
United States. NHANES monitors the
prevalence of chronic conditions and
risk factors. NHANES data are used to
produce national reference data on
height, weight, and nutrient levels in
the blood. Results from more recent
NHANES can be compared to findings
reported from previous surveys to
monitor changes in the health of the
U.S. population over time. NCHS
collects personal identification
information. Participant level data items
will include basic demographic
information, name, address, social
security number, Medicare number and
participant health information to allow
for linkages to other data sources such
as the National Death Index and data
from the Centers for Medicare and
Medicaid Services (CMS).
A variety of agencies sponsor datacollection components on NHANES. To
keep burden down, NCHS cycles in and
out various components. The 2015–2016
NHANES physical examination
includes the following components: oral
glucose tolerance test (ages 12 and
older), anthropometry (all ages), 24-hour
dietary recall (all ages), physician’s
examination (all ages, blood pressure is
collected here), oral health examination
(ages 1 and older), hearing (ages 20–59),
dual X-ray absorptiometry (total body
composition ages 6–59 and
osteoporosis, vertebral fractures and
aortic calcification ages 40 and older).
While at the examination center
additional interview questions are asked
(6 and older), a second 24-hour dietary
recall (all ages) is scheduled to be

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conducted by phone 3–10 days later,
and an appointment is made to return
to the MEC to begin a 24-hour urine
collection (one-half sample of ages 20–
69). In 2014, a 24-hour urine collection
was added to the NHANES protocol to
better understand sodium intake and
provide a population baseline for use in
monitoring trends in sodium intake in
the future. In 2015, FDA is scheduled to
implement a plan to promote broad,
gradual reduction of added sodium in
the food supply. One half of those
successfully completing the initial
collection will be asked to complete a
second 24-hour urine. After completing
the 24-hour urine participants are asked
to provide 2 home urine collections
(first morning and an evening) and mail
them back. The urines collected in the
morning and evening will be compared
to the 24-hour urine collection.
The bio-specimens collected for
laboratory tests include urine, blood,
vaginal and penile swabs, oral rinses
and household water collection. Serum,
plasma and urine specimens are stored
for future testing if the participant
consents.
The following major examination or
laboratory items, that had been included
in the 2013–2014 NHANES, were cycled
out for NHANES 2015–2016: physical
activity monitor, taste and smell
component and upper body muscle
strength (grip test).
Most sections of the NHANES
interviews provide self-reported
information to be used either in concert
with specific examination or laboratory
content, as independent prevalence
estimates, or as covariates in statistical
analysis (e.g., socio-demographic
characteristics). Some examples include
alcohol, drug, and tobacco use, sexual
behavior, prescription and aspirin use,
and indicators of oral, bone,
reproductive, and mental health.
Several interview components support
the nutrition monitoring objective of
NHANES, including questions about
food security and nutrition program
participation, dietary supplement use,
and weight history/self-image/related
behavior.
NHANES data users include the U.S.
Congress; numerous Federal agencies
such as other branches of the Centers for
Disease Control and Prevention, the
National Institutes of Health, and the
United States Department of
Agriculture; private groups such as the
American Heart Association; schools of
public health; and private businesses.
There is no cost to respondents other
than their time.

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Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Notices
TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
hours

Form

Individuals in households ..................
Individuals in households ..................

NHANES Questionnaire ...................
Special Studies ................................

15,613
2,500

1
1

2.5
3

39,033
7,500

Total ...........................................

...........................................................

........................

........................

........................

46,533

LeRoy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–08171 Filed 4–10–14; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–14–0889]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to [email protected]. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Using Traditional Foods and
Sustainable Ecological Approaches for
Health Promotion and Diabetes
Prevention in American Indian/Alaska
Native Communities (OMB No. 0920–
0889, exp. 6/30/2014)—Revision—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).

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Number of
responses per
respondent

Number of
respondents

Type of Respondent

Background and Brief Description
In 2008, the CDC’s Native Diabetes
Wellness Program (NDWP), in
consultation with American Indian/
Alaska Native (AI/AN) tribal elders,
issued a funding opportunity

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announcement (FOA) entitled, ‘‘Using
Traditional Foods and Sustainable
Ecological Approaches for Health
Promotion and Diabetes Prevention in
American Indian/Alaska Native
Communities.’’ The Traditional Foods
program was designed to build on what
is known about traditional ways in
order to inform culturally relevant,
contemporary approaches to diabetes
prevention for AI/AN communities. The
program supports activities that
enhance or re-introduce indigenous
foods and practices drawn from each
grantee’s landscape, history, and
culture. Example activities include the
cultivation of community gardens,
organization of local farmers’ markets,
and the dissemination of culturally
appropriate health messages through
storytelling, audio and video recordings,
and printed materials. In addition, the
program promotes physical activity
initiatives, provides social support for
healthy lifestyles, and supports
collaboration with other agencies and
programs.
Seventeen (17) tribal organizations
received cooperative agreement funding
under the initial FOA. Sixteen tribal
organizations applied for a one-year
extension that ends September 30, 2014.
CDC currently collects information
from awardees about the activities
supported with Traditional Foods
funding. Each awardee submits a shared
data elements (SDE) report to CDC
through a Web-based interface.
Information has been collected twice
per year, in spring and fall. CDC
anticipates that the spring 2014 report
will be submitted to CDC under the
current OMB clearance (OMB No. 0920–
0889, exp. 6/30/2014). In order to
receive a final report in the fall of 2014,
CDC is requesting a six-month
continuation of OMB approval, through
approximately December 31, 2014.
Because of the variety of food- and
lifestyle-related programs that take place
in the late spring, summer, and early
fall, CDC wants to ensure complete and

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accurate reporting of awardee activities
conducted the final months of
cooperative agreement funding.
There are no proposed changes to the
data collection instrument, data
collection methodology, or the
estimated burden per response. The SDE
will continue to be submitted to CDC
using Survey Monkey, an electronic
Web-based interface. The estimated
burden per response is two hours. Each
grantee will receive a personalized
advance notification letter, followed by
an email with a link to the Survey
Monkey site. Changes to be
implemented in this Revision request
include: 1) A reduction in the number
of respondents, from 17 to 16, 2) a
change in the frequency of reporting
(only one SDE report will be received
during the six-month extension period),
and 3) discontinuation of the one-time
retrospective data collection that was
part of the initial three-year clearance
request.
CDC will continue to use the SDE
reports to compile a systematic,
quantifiable inventory of activities,
products, and outcomes associated with
the Traditional Foods program. The SDE
also allow CDC to analyze aggregate data
for improved technical assistance and
overall program improvement,
reporting, and identification of
outcomes; allow CDC and grantees to
create a comprehensive inventory/
resource library of diabetes primary
prevention ideas and approaches for
AI/AN communities and identify
emerging best practices; and improve
dissemination of success stories.
Respondents will be 16 Tribes and
Tribal organizations that receive
funding through the Traditional Foods
program. Participation in this
information collection is required for
Traditional Foods program awardees.
There are no costs to respondents other
than their time.
The total estimated annualized
burden hours are 32.

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