[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)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


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