83 FR 22069 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 83, Issue 92 (May 11, 2018)

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 the opportunity to comment on proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled 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 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22069-22071]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10066]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-0950; Docket No. CDC-2018-0040]


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.

-----------------------------------------------------------------------

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 the opportunity to comment on proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled National Health and Nutrition 
Examination Survey (NHANES). NHANES programs produce descriptive 
statistics, which measure the health and nutrition status of the 
general population.

DATES: CDC must receive written comments on or before July 10, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0040 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. CDC will post, without change, all relevant comments 
to Regulations.gov.

    Please note:
     Submit all comments through the Federal eRulemaking portal 
(regulations.gov) or by U.S. mail to the address listed above.


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 Leroy A. Richardson, 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 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    The National Health and Nutrition Examination Survey (NHANES), (OMB 
Control Number 0920-0950, Expiration Date 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 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. 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

[[Page 22070]]

the health of the U.S. population over time.
    In 2019, a new sampling strategy is being implemented. 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), which will result in more time to screen 
and recruit potential participants, and allow for more exam slots. As 
in previous years, the base sample will remain at approximately 5,000 
interviewed and examined individuals annually.
    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 
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 (ages 1 and older), and hearing (ages 6-19 and 
70+). Starting in 2019, we will collect blood pressure using an 
automated device, instead of using manual devises.
    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 2019, we plan to 
add a Words-In-Noise (ages 70+) exam, genetic testing related to the 
liver elastography exam, and a balance exam (ages 40+).
    The 2019-20 survey will bring back the cognitive function test 
(ages 60+). NHANES also plans to conduct a 24-hour blood pressure 
measurement pilot among NHANES participants ages 18 and older.
    The bio specimens 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. 
Oral rinse samples for HPV analyses is cycling back into the survey 
(ages 8-69 years).
    The following analytes are being 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 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 
and collecting information on infant formula ingredients. We are also 
considering modifications to multiple existing questionnaire sections 
in order to better align with questions asked in the National Health 
Interview Survey (NHIS) (OMB Control No. 0920-0214, Exp. 12/31/2019) or 
to streamline the instruments to reduce respondent burden.
    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 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.
    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 occurs 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. The total estimated annual 
burden hours are 72,917. We are requesting a three-year approval.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Individuals in households.....  Screener........          15,000               1            3/60             750
Individuals in households.....  Household                  5,000               1             1.5           7,500
                                 Interview.
Individuals in households.....  MEC Exam........           5,000               1               4          20,000
Individuals in households.....  Dietary                    5,000               1           30/60           2,500
                                 Interview Phone
                                 Follow-Up.
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.....  24 hour Blood              1,200               1              25          30,000
                                 Pressure Pilot.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          72,917
----------------------------------------------------------------------------------------------------------------



[[Page 22071]]

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. 2018-10066 Filed 5-10-18; 8:45 am]
 BILLING CODE 4163-18-P