[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78155-78156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26831]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-17-0950]
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 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 National Health and Nutrition Examination Survey (NHANES), (OMB
No. 0920-0950, expires 12/31/2017)--Revision--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.
The National Health and Nutrition Examination Survey (NHANES) have
been conducted periodically between 1970 and 1994, and continuously
since 1999 by the National Center for Health Statistics, CDC. Annually,
approximately 14,410 respondents participate in some aspect of the full
survey. Up to 13,104 additional persons might participate in tests of
procedures, special studies, or methodological studies. Participation
in NHANES is completely voluntary and confidential. A three-year
approval is requested.
The data collected through NHANES allows for the production
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
civilian noninstitutionalized population 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. NHANES also seeks to be responsive in
exploring emerging public health issues and new health related
technologies. 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. NHANES 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 (OMB
No. 0920-0124, expires 10/31/2016 and data from the Centers for
Medicare and Medicaid Services (CMS).
A variety of agencies sponsor data collection components on NHANES.
To keep burden down, NCHS cycles in and out various components. Health
interviews are conducted in the participants' household. Physical exams
are conducted in the Mobile Examination Center (MEC). The 2017-2018
NHANES physical examination includes the following components:
Anthropometry (all ages), 24-hour dietary recall (all ages),
physician's examination (all ages, blood pressure is collected here),
and oral health examination (ages 1 and older, body composition using
Dual X-ray Absorptiometry (DXA) exam (ages 8-59) and hearing (ages 6-19
and 70+ (and above)). The hearing age range for 2017-18 is a
modification (The 2015-16 hearing age range was 20-69 years).
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 conducted by phone 3-10 days later. In 2017 we plan to
add a liver elastography (ultrasound) exam for participants 12 years
and older. A set of alcohol and liver-related questions, and a hip
measurement will also be added to complement the liver exam. The age
range for liver-related blood test (serum ferritin) already collected
in NHANES is being expanded from female participants 12-49 to all
participants 12 years and older. The existing collection of serum
ferritin in children 1-5 years will continue. We will cycle bone
density for hip and spine back into the (DXA) exam for (ages 50+). The
Osteoporosis questionnaire will also cycle back into NHANES to
complement the changes to the DXA exam. These questions will be asked
of participants 50+.
[[Page 78156]]
NHANES plans to conduct a blood pressure methodology study. The
study population will be NHANES participants aged 6 and older who agree
to come to the Mobile Examination Center (MEC).
The bio-specimens collected for laboratory analytes include urine,
blood, vaginal and penile swabs, and household water collection. Serum,
plasma and urine specimens are stored for future testing, including
genetic research, if the participant consents. NHANES 2017-18 plans to
add the following lab tests: Three Phthalates in urine (ages 3+); nine
urinary flame retardants in urine (ages 3+); one insect repellant in
urine (ages 3+); one volatile organic compound (VOC) metabolite in
urine (ages 3+); eighteen tobacco biomarkers in urine (ages 3+); two
metals in urine (ages 3+); vitamin C in serum (ages 6+); vitamins A, E,
and carotenoids in serum (ages 6+); Unsaturated Iron Binding Capacity
(UIBC)/Total Iron Binding Capacity (TIBC) in serum (ages 12+);
congenital cytomegalovirus (CMV) in sera (ages 1-5); and a test in
urine for Mycoplasm genitalium (ages 14-59).
In addition metals in whole blood are changing from a one-half
sample to a full sample (ages 1+). Polycyclic Aromatic Hydrocarbons
(PAHs) are being discontinued in the smoker oversample subgroup,
however testing will continue in a \1/3\ subsample of general NHANES
participants.
The 2017-18 survey will also bring back the Flexible Consumer
Behavior Survey Phone follow-Up questionnaire for participant ages 1+.
This takes place in the home after the second dietary recall is
completed.
The following major examination or laboratory items, that had been
included in the 2015-2016 NHANES, were cycled out for NHANES 2017-2018:
Pubertal maturation, Oral Glucose Tolerance Test (OGTT), oral Human
Papilloma Virus (HPV) rinse, Sagittal Abdominal Diameter (SAD), dental
fluorosis assessment, dental fluorosis imaging (DFI), plasma, urine and
water fluoride, Apo B analysis, three metals in serum and three
hormones and binding proteins.
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.
In 2017-2018, we also plan to implement electronic consent
procedures in NHANES. The consent for birth certificate linkage that
had been included in previous NHANES will be dropped from NHANES 2017-
2018. The survey may conduct a Vaccination Providers' Records Check
project with an emphasis on Human Papilloma Virus (HPV), an Ambulatory
Blood Pressure Methodology (ABPM) study, test questions related to
Chronic Kidney Disease (CKD), adopt digital imaging technology to
enhance the existing collection of dietary supplement information,
implement multi-mode screening, conduct specimen collection for liver-
related DNA markers, and cycle back in consent to store DNA, if
resources permit, in the current or in a future cycle of NHANES.
There is no cost to respondents other than their time. Total burden
hours requested is 79,894.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in hours
respondent hours)
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Individuals in households..... NHANES 14,410 1 2.5 36,025
Questionnaire.
Individuals in households..... Blood Pressure 1,404 1 30/60 702
Methodology
Study Phase 1.
Individuals in households..... Blood Pressure 2000 1 30/60 1000
Methodology
Study Phase 2.
Individuals in households..... Flexible 5,000 1 20/60 1,667
Consumer
Behavior Survey
Phone Follow-Up.
Individuals in households..... Developmental 3,500 1 3 10,500
Projects &
Special Studies.
Individuals in households..... Wearable Device 1,200 1 25 30,000
Projects.
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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. 2016-26831 Filed 11-4-16; 8:45 am]
BILLING CODE 4163-18-P