[Federal Register Volume 86, Number 9 (Thursday, January 14, 2021)]
[Notices]
[Pages 3153-3155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00691]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-21-0950]


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 July 20, 
2020 to obtain comments from the public and affected agencies. CDC 
received two non-substantive 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

[[Page 3154]]

of the information collection plan and instruments, call (404) 639-
7570. Comments and recommendations for the proposed information 
collection should be sent within 30 days of publication of this notice 
to www.reginfo.gov/public/do/PRAMain Find this particular information 
collection by selecting ``Currently under 30-day Review--Open for 
Public Comments'' or by using the search function. 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 
Control No. 0920-0950, Exp. 11/30/2021)--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 the Secretary of Health and Human 
Services (DHHS), acting through NCHS, to 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 (U.S.). 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 (NCHS), CDC. Due to the Coronavirus (COVID-19) pandemic, 
NHANES 2019-20 paused data collection operations, making this the first 
time since 1999 that NHANES did not operate on a continuous basis.
    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 U.S. NHANES monitors the prevalence of chronic conditions 
and risk factors and produces national reference data on height, 
weight, and nutrient levels in the blood. Results from the 2021-22 
NHANES will be used to assess current health measures in the U.S. 
population.
    The program is making changes to NHANES content and procedures for 
2021-22. The proposed changes include modifications to sample design, 
questionnaires, exam components, laboratory content, outreach 
materials, changes in select interview and exam modes, and changes to 
operational procedures. NHANES proposes these changes in response to 
COVID-19 and to address issues such as low response rates. The program 
consulted with collaborators, stakeholders, and the NCHS Board of 
Scientific Counselors (BSC). Due to these changes, largely driven by 
the pandemic, NHANES 2021-22 may not be comparable with previous or 
future NHANES cycles.
    NCHS collects personally identifiable information (PII). 
Participant level data items 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 low and respond to changing public health needs, NCHS 
cycles in and out various components. In 2021-22, NHANES plans to 
continue electronic consent procedures and implement multi-mode 
eligibility screening. Our yearly goal for interview, exam, and post 
exam components is 5,000 participants. To achieve the goal of 5,000 
participants interviewed and examined, we need to screen approximately 
7,000 individuals annually, a number lower than the approximately 
15,000 screened in previous NHANES because NHANES 2021-22 will not 
oversample based on race, Hispanic origin, or income. In addition, 
there will be approximately 600 volunteers as part of a dress rehearsal 
that takes place in two locations (300 volunteers per location.)
    In NHANES 2021-22, the interviews that would historically occur via 
in-person interviews (i.e., screening, family, and sampled participant) 
will be conducted primarily over the phone. A significant reduction in 
interview content will occur in 2021-22 so the length of the interviews 
is feasible for the designed interview modes with reasonable burden to 
the respondents. Changes will also be made to focus on retaining 
questions directly related to the interpretation of examination or lab 
data collected in the survey and relevant to assess the effect of the 
pandemic. The program plans to add questions related to COVID-19 to the 
survey to complement NHANES laboratory measures. The program will drop 
select questions related to examination and laboratory content cycled 
out of the survey in 2021-22.
    Most sections of the NHANES interviews provide self-reported 
information for use 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, nutrition program participation, and 
dietary supplement use.
    In 2021-22, NHANES will initiate screening for COVID-19 prior to 
participants entering the Mobile Examination Center (MEC). Participants 
will be reminded via text or telephone call not to report for their 
examination appointment if they have been exposed or have tested 
positive. When participants arrive for the examination appointment, 
they will answer questions to determine if they have been potentially 
exposed, they will have their temperature checked and finally will have 
a COVID antibody test, prior to being allowed in the MEC.
    The NHANES examinations that will remain unchanged include 
anthropometry (all ages), blood pressure (8+), and liver elastography 
(40).
    The program is modifying select examination components in 2021-22. 
These changes include dropping the DXA spine and femur scans while 
continuing DXA whole body scans (ages 8-69), dropping all visual 
assessment subcomponents of the standing balance examination, and 
modifying the phlebotomy component.
    Examination components cycled out in 2021-22 include: Oral Health, 
Audiometry and Words-in Noise (4 audiometry questions are retained in 
the Household Interview), and Cognitive Functioning assessment. NHANES 
does not plan to conduct a Blood Pressure Methodology Study.
    In previous NHANES cycles, while at the examination center, 
participants were administered a Day 1 dietary recall interview via in-
person interview, and additional interview questions were asked (six 
and older) both in-person and through Audio Computer-Assisted Self-
Interview (ACASI). A second 24-hour dietary recall (all ages) was also 
scheduled to be conducted by phone 3-10 days later. In NHANES 2021-22, 
both the Day 1 dietary recall and the second 24-hour dietary recall 
will be completed as telephone interviews. The interview questions will 
be completed

[[Page 3155]]

in the examination center primarily via ACASI.
    The biospecimens collected for laboratory testing include urine and 
blood. Serum, plasma, and urine specimens are stored for future 
testing, including genetic studies, if the participant consents. 
Consent to store DNA will continue in NHANES.
    In 2021-22, we plan to add the following laboratory tests: Serum 
Terpenes: [alpha]-Pinene, [beta]-Pinene, [beta]-Myrcene, [Delta]-3-
Carene, Limonene, [beta]-Caryophyllene, [alpha]-Humulene; Magnesium; 
HPV, serum; Alpha-1-acid-glycoprotein (AGP); Vitamin D; Vitamin A; 
Vitamin C; Acrylonitrile; Trans-fatty Acids; Blood 
butyrylcholinesterase activity, blood butyrylcholinesterase 
concentration, and red blood cell acetylcholinesterase activity; 
Enterovirus D68; and COVID-19 serology.
    In 2021-22, the following laboratory tests will be modified: 
Hepatitis D (new testing method, reportable findings); Sex steroid 
hormone panel (now starting at 3+); Urine VOC metabolites (adding as 
additional 7); trans, trans-Muconic acid; N-Acetyl-S-phenyl-L-cysteine; 
N-2-Furoylglycine; 2,5-Furandicarboxylic acid; 5-Hydroxymethyl-2-
furancarboxylic acid; 5-Hydroxymethyl-2-furoylglycine; and 5-Hydroxy-N-
methyl-2-pyrrolidone.
    The laboratory tests cycling out for 2021-22 include: HPV swabs 
(male and female); HPV oral rinse; Home water sample collection to test 
for fluoride; Salt home collection for iodine assessment; Chromium/
Cobalt; Tuberculosis (TB); and Urine flow rate.
    NHANES plans to conduct a dress rehearsal prior to fielding the 
survey as usual. This will be conducted in two locations, among a 
sample of approximately 300 volunteers per location (approximately 600 
total). The program is taking this step to assure it maintains the 
consistent quality associated with data collection, given the necessary 
pause in field operations in 2020. The data collected during dress 
rehearsal will be used for quality control and training purposes. Dress 
rehearsal data will not be part of the 2021-22 public release.
    NHANES plans to conduct developmental projects during NHANES 2021-
22 with a focus on planning for NHANES 2023 and beyond. These may 
include activities such as tests of new equipment, crossover studies 
between current and proposed methods, test of different study modes, 
settings, or technology, outreach materials, incentive strategies, 
sample storage and processing, or sample designs.
    Burden for individuals varies based on their level of 
participation. For example, infants and children tend to have shorter 
interviews and exams than adults because young people may have fewer 
health conditions or medications to report, 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. CDC requests a three-year 
approval, with 65,630 annualized hours of burden.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Individuals in households.............  Screener................           8,300               1           10/60
Individuals in households.............  Household Interview.....           5,600               1               1
Individuals in households.............  MEC Interview &                    5,600               1             2.5
                                         Examination.
Individuals in households.............  Day 1 and Day 2                    5,600               1             1.3
                                         Telephone Dietary
                                         Recall & Dietary
                                         Supplements.
Individuals in households.............  Flexible Consumer                  5,600               1           20/60
                                         Behavior Survey Phone
                                         Follow-Up.
Individuals in households.............  Developmental Projects &           3,500               1               3
                                         Special Studies.
Individuals in households.............  24-hour wearable device            1,000               1              25
                                         projects.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-00691 Filed 1-13-21; 8:45 am]
BILLING CODE 4163-18-P