[Federal Register Volume 82, Number 40 (Thursday, March 2, 2017)]
[Notices]
[Pages 12361-12363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04046]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-17-16AJE]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of
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the methodology and assumptions used; (c) Enhance the quality, utility,
and clarity of the information to be collected; (d) Minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: 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
The NHANES Longitudinal Study--Feasibility Component--New--National
Center for Health Statistics (NCHS), Centers for Disease Control and
Prevention (CDC).
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. Under this authorization, NCHS has conducted the
National Health and Nutrition Examination Surveys periodically between
1970 and 1994, and continuously since 1999 (NHANES, see OMB Control No.
0920-0237 and OMB Control No. 0920-0950). The NHANES survey is based on
a cross-sectional design employing a stratified, multistage probability
sample. Information collection methods include interviews and direct
physical measurements. NCHS uses NHANES data to produce descriptive
statistics on the health and nutrition status of the general
population, including estimates of the prevalence of numerous chronic
diseases and conditions.
To enhance the information collected through NHANES, NCHS has
initiated planning activities for a future NHANES Longitudinal Study,
with a target starting date for data collection in 2020. A longitudinal
cohort design is needed to examine changes in participants' health
conditions, their utilization of healthcare since the time of their
original NHANES exam, and the long-term impact of risk factors on the
development of morbidity. Participants in the NHANES Longitudinal Study
will be individuals who participated in NHANES between 2007 and 2014.
The survey's extensive baseline data on health conditions, nutritional
status, and risk behaviors, analyzed in conjunction with information
from a longitudinal cohort, will support the estimation of incidence
for a wide range of chronic conditions as well as tracking of progress
on national goals for prevention.
The NHANES Longitudinal Study planned for 2020 will be the first
nationally representative cohort in more than two decades. The last
cohort of this type was the NHANES Epidemiologic Follow-up Studies (OMB
Control No. 0920-0218) conducted in 1984-1985, 1988, and 1992-1993.
Since then, response rates in major federal surveys have declined and
obtaining cooperation from the household population has become more
difficult. Therefore, before attempting to launch a full scale data
collection effort among all examined adults from NHANES 2007-2014, we
propose to conduct a feasibility study in 2017-2018 to determine
whether previously examined participants can be successfully traced,
interviewed, and examined.
The Feasibility Component of the NHANES Longitudinal Study is
comprised of two elements: (1) A field feasibility test for the core
interview and examination module of the NHANES Longitudinal Study; and
(2) a series of targeted methodological tests of additional components
and procedures. Information will be collected to evaluate the
operational feasibility of the core module and to assess the
performance of these components administered in the home setting. The
core module currently planned for the NHANES Longitudinal Study will
focus on chronic conditions including obesity, diabetes, cardiovascular
disease, and kidney disease.
An annual sample of 400 respondents (total of 800 participants over
the two-year period) will be selected from the 2007-2014 NHANES
examinees (20 years and older) to participate in the field feasibility
test. Of these, we expect approximately 11% to be deceased prior to the
re-contact, resulting in a target annual sample of 356 living examinees
and 44 decedent proxy interview respondents.
As part of the preparation efforts for a longitudinal study of all
examined adults from NHANES 2007-2014, up to 375 additional persons per
year (750 participants over the two-year period) may be asked to
participate in targeted tests of proposed methods and procedures such
as bio-specimen collections, cognitive testing for questions, or
protocol tests for additional exam components. These targeted tests
will only occur if resources permit and if tracing and participation in
the field feasibility test is successful. These targeted methodological
studies will be conducted with volunteers who are not from the NHANES
cohort, or past NHANES participants who are not part of the potential
NHANES Longitudinal Study sample (for example, past NHANES participants
from the 1999-2006 cycle).
The estimated average burden for the field feasibility test is 84
minutes per respondent (1.5 hours per respondent for 356 living
participants and 35 minutes per respondent for 44 proxy of deceased
participants, annually). The average burden for the targeted
methodological study respondents is one hour.
Demographic information such as name, address, phone numbers, and
social security number collected in the baseline NHANES will be used to
locate the sampled 800 field feasibility test participants (annual
sample of 400). Prior to the re-contact, a review of the NHANES linked
mortality files will be conducted to assist in determining the vital
status of sampled participants.
Trained Health Representatives will visit the sampled participants
at home to conduct an in-person interview and a health examination.
Information that will be collected through the interview includes
health status and medical conditions, health care services, health
behaviors, and sociodemographic characteristics. In addition,
permission for collecting hospital discharge data, including diagnoses
at discharge and procedures performed during hospitalization will be
obtained during the interview.
Following the interview, a health examination will be conducted as
part of the home visit. The respondent's weight, waist circumference,
and sitting blood pressure will be measured, and a monofilament
assessment will be conducted for neuropathy. In addition, blood and
urine will be collected. Examples of laboratory tests planned include
hemoglobin A1c from the blood specimen, and albumin and creatinine from
the urine collection. This proposed project will assess the feasibility
of conducting these tests and procedures in the home setting.
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A proxy interview will be conducted via telephone for sampled
participants who died prior to the re-contact. Information on medical
conditions and overnight hospital stays since baseline will be
collected.
Although permission will be sought from all field feasibility test
participants, hospitalization records will be obtained only for 120
participants annually (240 participants over the two-year period) to
evaluate the record retrieval protocol for the study cohort among
different medical facilities. An average of three hospital stays per
person is anticipated among this cohort, therefore, an estimated 360
requests (120 persons x 3 stays) will be made annually. The estimated
burden for hospital record provider is 20 minutes per record.
OMB approval is requested for two years to conduct the feasibility
component of the NHANES Longitudinal Study. Participation is voluntary
and there are no costs to respondents other than their time. The total
estimated annualized burden hours are 1,055.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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2007-2014 NHANES examinees, and Field feasibility test 400 1 15/60
proxies of deceased 2007-2014 registration form--contact
NHANES examinees. confirmation and
scheduling preference.
2007-2014 NHANES examinees......... Field feasibility test home 356 1 1
visit.
2007-2014 NHANES examinees......... Field feasibility test home 356 1 15/60
urine collection.
Proxies of deceased 2007-2014 Field feasibility test 44 1 20/60
NHANES examinees. decedent proxy interview.
Hospital record providers.......... Field feasibility test 360 1 20/60
hospital records form.
Adult volunteers (non-field Targeted methodological 375 1 1
feasibility test participants). studies.
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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. 2017-04046 Filed 3-1-17; 8:45 am]
BILLING CODE 4163-18-P