[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Notices]
[Pages 50934-50936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22008]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-0950]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled The National Health and Nutrition Examination
Survey (NHANES) to the Office of Management and Budget (OMB) for review
and approval. CDC previously published a ``Proposed Data Collection
Submitted for Public Comment and Recommendations'' notice on May 11,
2018 to obtain comments from the public and affected agencies. CDC
received five comments related to the previous notice. This notice
serves to allow an additional 30 days for public and affected agency
comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
The National Health and Nutrition Examination Survey (NHANES), (OMB
No. 0920-0950, expires 12/31/2019)--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
[[Page 50935]]
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 1970 and 1994, and
continuously since 1999 by the National Center for Health Statistics,
CDC.
NHANES programs produce descriptive statistics, which measure the
health and nutrition status of the general population. With 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 and 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.
In 2019, we will implement a new data collection schedule. To
increase operational efficiency, NHANES will survey a nationally
representative sample over the course of a two-year cycle instead of
annually. The change to a two-year cycle will permit more days
allocated to each primary sampling unit (PSU). This results in less
travel time, which allows more time to screen and recruit potential
participants, and allows for more exam slots. As in previous years, the
base sample will remain at approximately 5,000 interviewed and examined
individuals annually.
NCHS collects personally identifiable information (PII).
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 sponsors data collection components on
NHANES. To keep burden down and respond to changing public health
research needs, NCHS cycles in and out various components. The 2019-20
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),
oral health examination (age one and older), dual X-ray absorptiometry
(DXA) (ages 50+ bone density; ages 8-69 total body scan) and audiometry
(ages 6-19 and 70+).
While at the examination center, additional interview questions are
asked (six and older)and a second 24-hour dietary recall (all ages) is
scheduled to be conducted by phone 3-10 days later.
Starting in 2019, we will collect blood pressure using an automated
device, instead of using manual devices. The 2019-20 survey will bring
back the cognitive function test (ages 60+). We plan to add a Words-In-
Noise (ages 70+) exam to the audiometry component, genetic testing
related to the liver elastography exam, and a standing balance exam
(ages 40+,) which includes two vision tests (contrast sensitivity and
visual acuity).
NHANES also plans to conduct developmental projects during NHANES
2019-20. These may include a 24-hour blood pressure measurement pilot
among NHANES participants ages 18 and older, creating and testing a
social media campaign and testing modifications to incentive amounts or
how incentives are provided.
The biospecimens collected for laboratory tests include urine,
blood, and vaginal and penile swabs. Serum, plasma and urine specimens
are stored for future testing, including genetic research, if the
participant consents. Consent to store DNA is continuing in NHANES.
Collecting an oral rinse for HPV analyses is cycling back into the
survey (ages 8-69 years). In addition, we will again collect a water
sample in the home for fluoride.
The following analytes have been discontinued in 2018 for
participants from the smoking sample subset: Aromatic Amines,
Heterocyclic Amines, Urine Cotinine, Tobacco-Specific Nitrosamines,
Perchlorate, Nitrates, and Thiocyanate, Urinary Arsenic, Mercury,
Iodine and Metals.
Cycling out of NHANES in 2019-20 are the blood pressure methodology
project, Human Papillomavirus (HPV) in serum, Aldehydes in serum,
Volatile N-nitrosamines (VNAs) tobacco biomarkers, Urine heterocyclic
amines, urine aromatic amines and urine tobacco-specific nitrosamines
New additions to the survey questionnaires include two questions on
WIC participation, a birth to less than 24-month questionnaire module,
collecting information on infant and toddler formula. We are also
modifying multiple questionnaire sections so they better align with
questions asked in the National Health Interview Survey (NHIS) (OMB
Control No. 0920-0214, Exp. Date 12/31/2019), compliment exam or lab
content, or in order to reduce respondent burden.
Most sections of the NHANES interviews provide self-reported
information to be used in combination 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 2019-2020, we plan to continue or expand upon existing multi-
mode screening and electronic consent procedures in NHANES. Our yearly
goal for interview, exam and post exam components is 5,000
participants. To achieve this goal we may need to screen up to 15,000
individuals annually.
Burden for individuals will vary based on their level of
participation. For example, infants and children tend to have shorter
interviews and exams than adults. This is because young people may have
fewer health conditions or medications to report so their interviews
take less time or because certain exams are only conducted on
individuals 18 and older, etc. In addition, adults often serve as proxy
respondents for young people in their families.
Participation in NHANES is voluntary and confidential. There is no
cost to respondents other than their time. We are requesting a three-
year approval, with 68,417 annualized hours of burden.
[[Page 50936]]
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
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Individuals in households............. Screener................ 15,000 1 5/60
Individuals in households............. Household Interview..... 5,000 1 1.5
Individuals in households............. MEC Interview & 5,000 1 4
Examination.
Individuals in households............. Telephone Dietary Recall 5,000 1 30/60
& Dietary Supplements.
Individuals in households............. Flexible Consumer 5,000 1 20/60
Behavior Survey Phone
Follow-Up.
Individuals in households............. Developmental Projects & 3,500 1 3
Special Studies.
Individuals in households............. 24 hour Blood Pressure 1,000 1 25
Pilot.
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Jeffrey M. Zirger,
Acting 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. 2018-22008 Filed 10-9-18; 8:45 am]
BILLING CODE 4163-18-P