[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Notices]
[Pages 43848-43850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15659]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-20-0950; Docket No. CDC-2020-0078]
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 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 September 18,
2020.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0078 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, 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 Federal 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 Jeffrey M. Zirger, Ph.D., Lead, 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.
[[Page 43849]]
Proposed Project
The National Health and Nutrition Examination Survey (NHANES), (OMB
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 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 and 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.
In 2021-22, the program is not considering any substantial changes
to NHANES content or procedures. The proposed changes being requested
are small additions and modifications to laboratory content,
introductions to and wording of existing questions, and the addition of
a conditional $40 incentive for the household interview. As in previous
years, the base sample will remain at approximately 5,000 interviewed
and examined individuals annually. It is possible that the survey may
have to adapt its plans in response to Novel Coronavirus Disease
(COVID-19) or related concerns.
NCHS collects personally identifiable information (PII).
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 sponsors data collection components on
NHANES. To keep burden down and respond to changing public health
research needs, NCHS cycles in and out various components. The 2021-22
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 one and older), dual X-ray absorptiometry
(DXA) (ages 50+ bone density; ages 8-69 total body scan) and audiometry
(ages 6-19 and 70+).
While at the examination center, additional interview questions are
asked (six and older) and a second 24-hour dietary recall (all ages) is
scheduled to be conducted by phone 3-10 days later.
The 2021-22 survey will be similar to what was fielded in 2019-20.
It is possible that content will be deleted, if collaborator focus
changes or resources are not available. 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, tests of different study modes, settings or technology,
outreach materials, incentive strategies, sample storage and processing
or sample designs.
The biospecimens 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.
In 2021 we plan to add 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.
In 2021, the following Laboratory Tests will be modified: Steroid
hormones in serum (11 steroid hormones).
Cycling out of NHANES in 2021-22 is 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.
In 2021-2022, 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 annually.
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 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.
Participation in NHANES is voluntary and confidential. There is no
cost to respondents other than their time. We are requesting a three-
year approval, with 68,417 annualized hours of burden.
[[Page 43850]]
Estimated Annualized Burden Hours
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Number of Average Burden
Type of respondent Form name Number of responses per per Response Total burden
respondents respondent (in hours) (in hours)
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Individuals in households...................... Screener............................... 15,000 1 5/60 1,250
Individuals in households...................... Household Interview.................... 5,000 1 1.5 7,500
Individuals in households...................... MEC Interview & Examination............ 5,000 1 4 20,000
Individuals in households...................... Telephone Dietary Recall & Dietary 5,000 1 30/60 2,500
Supplements.
Individuals in households...................... Flexible Consumer Behavior Survey Phone 5,000 1 20/60 1,667
Follow-Up.
Individuals in households...................... Developmental Projects & Special 3,500 1 3 10,500
Studies.
Individuals in households...................... 24-hour wearable device projects....... 1,000 1 25 25,000
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Total...................................... ....................................... .............. .............. .............. 68,417
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-15659 Filed 7-17-20; 8:45 am]
BILLING CODE 4163-18-P