[Federal Register Volume 88, Number 43 (Monday, March 6, 2023)]
[Notices]
[Pages 13827-13829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04493]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-23-0950]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) is submitting 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 November 21, 2022 to obtain comments from the public and 
affected agencies. CDC received two 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 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. 04/30/2023)--Extension--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) is 
designed to study the relationship between diet, nutrition, and health 
in a representative sample of the civilian, non-institutionalized 
population of the United States. Information collection involves a 
variety of modes and sources including physical examinations, 
laboratory tests, and interviews. Findings are used to produce 
descriptive statistics that measure the health and nutrition status of 
the general population, generate national reference data on height, 
weight, and nutrient levels in the blood, and monitor the prevalence of 
chronic conditions and risk factors for those conditions.
    The NHANES was conducted periodically between 1970 and 1994 and has 
been conducted continuously since 1999 by the NCHS, CDC, in 
collaboration with a variety of agencies that sponsor specific 
components of NHANES. To manage participant burden and respond to 
changing public health research needs, NCHS cycles in and out various 
components, however, the study design generally allows results from 
more recent NHANES to be compared to findings reported from previous 
surveys. NCHS collects personally identifiable information (PII) to 
allow for linkages to other data sources such as the National Death 
Index and data from the Centers for Medicare and Medicaid Services. 
Participant-level data items include basic demographic information, 
name, address, Social Security Number, Medicare number and participant 
health information.

[[Page 13828]]

    Data collection for the 2021/2022 cycle of NHANES began in August 
2021. The 2021/2022 NHANES physical examination includes the following 
components: anthropometry (all ages), liver elastography (ages 12 and 
older), standing balance (ages 20-69), 24-hour dietary recall via phone 
(all ages), blood pressure measurement (ages eight and older), and dual 
X-ray absorptiometry (DXA) (ages 8-69, total body scan). While at the 
examination center, additional interview questions are asked of 
participants and a second 24-hour dietary recall (all ages) is 
scheduled to be conducted by phone 3-10 days later. The bio specimens 
collected for laboratory tests include urine and blood. 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.
    Beginning in 2021, NHANES added the following laboratory tests: 
Acetylcholinesterase Enzyme Activity in whole blood; an Environmental 
Toxicant in Washed Red Blood Cells (Hemoglobin Adducts); Environmental 
Toxicants in serum (seven terpenes); Environmental Toxicants in urine 
(seven volatile organic compound (VOC) metabolites); Infectious Disease 
Markers in serum (Enterovirus 68 (EV-D68) and Human Papilloma Virus 
(HPV) in serum); Nutritional Biomarkers in plasma (Four trans-fatty 
acids (TFA)); and two Nutritional Biomarkers in serum. Additionally, at 
the start of the 2021 survey year, the following Laboratory Tests were 
modified: Steroid hormones in serum (eleven steroid hormones).
    NHANES components that were cycled out in 2021-22 are the Blood 
Pressure Methodology Study and laboratory tests of Adducts of 
Hemoglobin (Acrylamide, Glycidamide) and Urine flow rate.
    Most sections of the NHANES interviews provide self-reported 
information to be used 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 and nutrition program participation, 
dietary supplement use, and weight history/self-image/related behavior.
    Burden for individuals varies based on their level of 
participation. For example, infants and children tend to have shorter 
interviews and exams than adults. This is 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. Finally, the burden 
estimate for NHANES includes developmental projects that support the 
planning process for future cycles of information collection. 
Developmental projects 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.
    The 2021/2022 cycle of NHANES includes a number of modifications 
necessitated by the ongoing COVID-19 pandemic, such as additional 
COVID-19 screening tests and procedures, additional laboratory content 
for COVID-19 serology, decreased use of in-person interviews, and 
increased use of telephone interviews and/or audio-computer assisted 
self-interview (ACASI). Selected data collection components were 
discontinued from the NHANES survey and physical exams in order to 
manage participant risk and burden. Some modifications were described 
in the Revision request for NHANES 2021/2022 and further adjustments 
were incorporated through the Change Request mechanism.
    The COVID-19 pandemic also resulted in operational delays. CDC 
therefore requests OMB approval to extend information collection for 18 
months in order to complete the 2021/2022 NHANES as previously 
approved, with the COVID-19 modifications such as multi-mode screening 
and electronic consent procedures. The base sample will remain at 
approximately 5,000 interviewed and examined individuals annually. The 
yearly goal for interview, exam and post exam components is 5,600 
participants. To achieve this goal, NHANES may need to screen up to 
8,300 individuals annually. Participation in NHANES is voluntary and 
confidential. There is no cost to respondents other than their time. 
The total estimated annualized burden is 65,630 hours.

                                        Estimated Annualized Burden Hours
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                                                                                     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 & Examination           5,600               1             2.5
Individuals in households..........  Telephone Dietary Recall &            5,600               1             1.3
                                      Dietary Supplements.
Individuals in households..........  Flexible Consumer Behavior            5,600               1           20/60
                                      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.
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[[Page 13829]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2023-04493 Filed 3-3-23; 8:45 am]
BILLING CODE 4163-18-P