81 FR 78155 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 81, Issue 215 (November 7, 2016)

Page Range		78155-78156
FR Document		2016-26831
Federal Register, Volume 81 Issue 215 (Monday, November 7, 2016)
[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78155-78156]
From the Federal Register Online  [www.thefederalregister.org]
[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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response (in        hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


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
78156 Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices

NHANES plans to conduct a blood Aromatic Hydrocarbons (PAHs) are and indicators of oral, bone,
pressure methodology study. The study being discontinued in the smoker reproductive, and mental health.
population will be NHANES oversample subgroup, however testing Several interview components support
participants aged 6 and older who agree will continue in a 1⁄3 subsample of the nutrition monitoring objective of
to come to the Mobile Examination general NHANES participants. NHANES, including questions about
Center (MEC). The 2017–18 survey will also bring food security and nutrition program
The bio-specimens collected for back the Flexible Consumer Behavior participation, dietary supplement use,
laboratory analytes include urine, blood, Survey Phone follow-Up questionnaire and weight history/self-image/related
vaginal and penile swabs, and for participant ages 1+. This takes place behavior.
household water collection. Serum, in the home after the second dietary In 2017–2018, we also plan to
plasma and urine specimens are stored recall is completed. implement electronic consent
The following major examination or
for future testing, including genetic procedures in NHANES. The consent for
laboratory items, that had been included
research, if the participant consents. birth certificate linkage that had been
in the 2015–2016 NHANES, were cycled
NHANES 2017–18 plans to add the included in previous NHANES will be
out for NHANES 2017–2018: Pubertal
following lab tests: Three Phthalates in dropped from NHANES 2017–2018. The
maturation, Oral Glucose Tolerance Test
urine (ages 3+); nine urinary flame survey may conduct a Vaccination
(OGTT), oral Human Papilloma Virus
retardants in urine (ages 3+); one insect Providers’ Records Check project with
(HPV) rinse, Sagittal Abdominal
repellant in urine (ages 3+); one volatile an emphasis on Human Papilloma Virus
Diameter (SAD), dental fluorosis
organic compound (VOC) metabolite in assessment, dental fluorosis imaging (HPV), an Ambulatory Blood Pressure
urine (ages 3+); eighteen tobacco (DFI), plasma, urine and water fluoride, Methodology (ABPM) study, test
biomarkers in urine (ages 3+); two Apo B analysis, three metals in serum questions related to Chronic Kidney
metals in urine (ages 3+); vitamin C in and three hormones and binding Disease (CKD), adopt digital imaging
serum (ages 6+); vitamins A, E, and proteins. technology to enhance the existing
carotenoids in serum (ages 6+); Most sections of the NHANES collection of dietary supplement
Unsaturated Iron Binding Capacity interviews provide self-reported information, implement multi-mode
(UIBC)/Total Iron Binding Capacity information to be used either in concert screening, conduct specimen collection
(TIBC) in serum (ages 12+); congenital with specific examination or laboratory for liver-related DNA markers, and cycle
cytomegalovirus (CMV) in sera (ages 1– content, as independent prevalence back in consent to store DNA, if
5); and a test in urine for Mycoplasm estimates, or as covariates in statistical resources permit, in the current or in a
genitalium (ages 14–59). analysis (e.g., socio-demographic future cycle of NHANES.
In addition metals in whole blood are characteristics). Some examples include There is no cost to respondents other
changing from a one-half sample to a alcohol, drug, and tobacco use, sexual than their time. Total burden hours
full sample (ages 1+). Polycyclic behavior, prescription and aspirin use, requested is 79,894.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents response hours
respondent (in hours)

Individuals in households ...... NHANES Questionnaire ............................... 14,410 1 2.5 36,025
Individuals in households ...... Blood Pressure Methodology Study Phase 1,404 1 30/60 702
1.
Individuals in households ...... Blood Pressure Methodology Study Phase 2000 1 30/60 1000
2.
Individuals in households ...... Flexible Consumer Behavior Survey Phone 5,000 1 20/60 1,667
Follow-Up.
Individuals in households ...... Developmental Projects & Special Studies 3,500 1 3 10,500
Individuals in households ...... Wearable Device Projects ............................ 1,200 1 25 30,000

Leroy A. Richardson, DEPARTMENT OF HEALTH AND the proposed information collection is
Chief, Information Collection Review Office, HUMAN SERVICES published to obtain comments from the
Office of Scientific Integrity, Office of the public and affected agencies.
Associate Director for Science, Office of the Centers for Disease Control and Written comments and suggestions
Director, Centers for Disease Control and Prevention from the public and affected agencies
Prevention.
concerning the proposed collection of
[FR Doc. 2016–26831 Filed 11–4–16; 8:45 am] [30Day–17–16BBS] information are encouraged. Your
BILLING CODE 4163–18–P comments should address any of the
Agency Forms Undergoing Paperwork
Reduction Act Review following: (a) Evaluate whether the
proposed collection of information is
sradovich on DSK3GMQ082PROD with NOTICES

The Centers for Disease Control and necessary for the proper performance of
Prevention (CDC) has submitted the the functions of the agency, including
following information collection request whether the information will have
to the Office of Management and Budget practical utility; (b) Evaluate the
(OMB) for review and approval in accuracy of the agencies estimate of the
accordance with the Paperwork burden of the proposed collection of
Reduction Act of 1995. The notice for information, including the validity of

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Document Created: 2018-02-14 08:21:38
Document Modified: 2018-02-14 08:21:38
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		81 FR 78155
81 FR 78155 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 81, Issue 215 (November 7, 2016)

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