80 FR 76992 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 238 (December 11, 2015)

[Federal Register Volume 80, Number 238 (Friday, December 11, 2015)]
[Notices]
[Pages 76992-76994]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0950]


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

[[Page 76993]]

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 11/30/2016)--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 Surveys (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 3,500 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 data collection 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 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.
    NHANES also plans to conduct a waist circumference methodology 
study. The study population will be NHANES participants aged 20 and 
over who participate in the body measurements component in the Mobile 
Examination Center (MEC).
    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.

                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent         hrs.)
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Individuals in households.............  NHANES Questionnaire....          14,410               1             2.5
Individuals in households.............  Waist Circumference                3,000               1            8/60
                                         Methodology Study.

[[Page 76994]]

 
Individuals in households.............  Special Studies.........           3,500               1               3
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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. 2015-31226 Filed 12-10-15; 8:45 am]
 BILLING CODE 4163-18-P