81 FR 32333 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 81, Issue 99 (May 23, 2016)

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the National Health and Nutrition Examination Survey (NHANES). NHANES programs produce descriptive statistics which measure the health and nutrition status of the general population.

[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Notices]
[Pages 32333-32335]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12009]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0950; Docket No. CDC-2016-0044]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the proposed 
revision of the National Health and Nutrition Examination Survey 
(NHANES). NHANES programs produce descriptive statistics which measure 
the health and nutrition status of the general population.

DATES: Written comments must be received on or before July 22, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0044 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION:  Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information

[[Page 32334]]

collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.
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 
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 
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), oral health examination (ages 1 and older), and hearing (ages 6-
19 and 70+).
    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 with a set of alcohol 
questions to complement this exam, an Oral Human Papilloma Virus (HPV) 
follow-up, and cycle back in bone density for hip and spine into the 
Dual X-ray Absorptiometry (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 those 40+ In 
addition, the age range for the existing DXA total body scan will be 
changed from 6-59 years to 8-69 years.
    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 survey would also 
like to conduct an Ambulatory Blood Pressure Pilot Study among NHANES 
participants ages 18 and older.
    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, including genetic research, if the participant consents. 
NHANES 2017-18 plans to add 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+), and 
Congenital cytomegalovirus (CMV) in sera (ages 1-5). Consent to store 
DNA is cycling back into NHANES.
    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), dual X-ray 
absorptiometry scans for vertebral fractures and aortic calcification, 
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

[[Page 32335]]

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 conduct a Dietary Supplement Imaging 
pilot study, as well as implement multi-mode screening and 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.
    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     Total burden
               Type of respondent                               Form name                   respondents    responses per   response (in        hours
                                                                                                            respondent        hours)
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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            2,000               1           30/60           1,000
                                                  2.
Individuals in households......................  Ambulatory Blood Pressure Pilot Study..           1,200               1              25          30,000
Individuals in households......................  Oral HPV rinse Follow-up Study 6 months           2,880               1           10/60             480
                                                  (estimated 80% of original sample of
                                                  3600).
Individuals in households......................  Oral HPV rinse Follow-up Study 12                 2,520               1           10/60             420
                                                  Months (estimated 70% of original
                                                  sample).
Individuals in households......................  Oral HPV rinse Follow-up Study 18                 2,160               1           10/60             360
                                                  months (estimated 60% of original
                                                  sample).
Individuals in households......................  Oral HPV rinse Follow-up Study 24                 1,800               1           10/60             300
                                                  Months (estimated 50% of original
                                                  sample).
Individuals in households......................  Flexible Consumer Behavior Survey Phone           5,000               1           20/60           1,667
                                                  Follow-Up.
Individuals in households......................  Special Studies........................           3,500               1               3          10,500
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............          81,454
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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. 2016-12009 Filed 5-20-16; 8:45 am]
 BILLING CODE 4163-18-P