Notice2023-04493
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 6, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 43 (Monday, March 6, 2023)</title>
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[Federal Register Volume 88, Number 43 (Monday, March 6, 2023)]
[Notices]
[Pages 13827-13829]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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)
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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
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