60 Day FRN

Att_2a_60 Day Federal Register Notice.pdf

National Health and Nutrition Examination Survey

60 Day FRN

OMB: 0920-0950

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43848

Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents

Type of respondents

Form name

Experiment 2: Firefighter ................................

Sharpened Romberg Postural Stability Test
(F)x2 states x1 condition.
Acceptance of Advanced Driver Assistance
System (I)x1 condition.
Practice Roadmap—Driving practice in simulator (G)x1 condition.
Actual test—120 minutes (H)x1 condition .....
Pre-Enrollment Confirmation Email (A) ..........
Participation Data Collection Form (B) ..........
Informed Consent form—including participant
orientation (C).
Motion Sickness Screen Form (D) .................
Pre and post drive simulator sickness assessment (E)x5 scenarios x1 condition.
Sharpened Romberg Postural Stability Test
(F)x2 states x1 condition.
Acceptance of Advanced Driver Assistance
System (I)x1 condition.
Practice Roadmap—Driving practice in simulator (G)x1 condition.
Actual test—120 minutes (H)x1 condition .....

Experiment 2: Firefighter ................................
Experiment 2: Firefighter ................................
Experiment
Experiment
Experiment
Experiment

2:
2:
2:
2:

Firefighter ................................
General civilian ........................
General civilian ........................
General civilian ........................

Experiment 2: General civilian ........................
Experiment 2: General civilian ........................
Experiment 2: General civilian ........................
Experiment 2: General civilian ........................
Experiment 2: General civilian ........................
Experiment 2: General civilian ........................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–15652 Filed 7–17–20; 8:45 am]
BILLING CODE 4163–18–P

nutrition status of the general
population.
CDC must receive written
comments on or before September 18,
2020.

DATES:

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.

ADDRESSES:

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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

ACTION:

Notice with comment period.

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

SUMMARY:

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

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
FOR FURTHER INFORMATION CONTACT:

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Number of
responses per
respondent

Avg. burden
per response
(in hrs.)

11

1

10/60

11

1

40/60

11

1

16/60

11
11
11
11

1
1
1
1

2
1/60
1/60
20/60

11
11

1
1

2/60
20/60

11

1

10/60

11

1

40/60

11

1

16/60

11

1

2

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.

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Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Notices
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

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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);

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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.

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43850

Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent

Individuals
Individuals
Individuals
Individuals

in
in
in
in

households
households
households
households

Number of
responses per
respondent

Number of
respondents

Form name

Average
Burden per
Response
(in hours)

Total burden
(in hours)

15,000
5,000
5,000
5,000

1
1
1
1

5/60
1.5
4
30/60

1,250
7,500
20,000
2,500

5,000

1

20/60

1,667

Individuals in households
Individuals in households

Screener ..............................................................
Household Interview ............................................
MEC Interview & Examination .............................
Telephone Dietary Recall & Dietary Supplements.
Flexible Consumer Behavior Survey Phone Follow-Up.
Developmental Projects & Special Studies .........
24-hour wearable device projects .......................

3,500
1,000

1
1

3
25

10,500
25,000

Total ........................

..............................................................................

........................

........................

........................

68,417

Individuals in households

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–20JC]

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 ‘‘Delta Impact
Cooperative Agreement Evaluation data
collection Instruments’’ 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 02/28/
2020 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,

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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
DELTA Impact Cooperative
Agreement Evaluation Data Collection
Instruments—New—National Center for
Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) seeks OMB approval
for three years for a new information

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collection request to collect information
from all 10 recipients (State Domestic
Violence Coalitions) and all 17
subrecipients (Coordinated Community
Response teams) funded through CDC’s
Domestic Violence Prevention
Enhancements and Leadership Through
Alliances (DELTA) Impact Program
cooperative agreement (NOFO CDC–
RFA–CE18–1801). CDC will collect
information from DELTA Impact
recipients as part of its program
evaluation to assess the implementation
and impact of the NOFO and further
understand the facilitators, barriers, and
critical factors to implement specific
violence prevention strategies and
conduct program evaluation activities.
CDC’s DELTA Impact Program is an
initiative focused on decreasing IPV risk
factors and increasing IPV protective
factors by increasing strategic datadriven planning and sustainable use of
community and societal level primary
prevention activities that address the
social determinants of health (SDOH).
Strategies described in the NOFO are
based on the best available evidence and
are included in CDC’s technical package
on IPV prevention. In addition, the
program helps to further develop the
evidence-base for community and
societal level programs and policy
efforts to prevent IPV by increasing the
use of program evaluation and existing
surveillance data at the state and local
level. The goal of this information
collection is to support CDC’s program
evaluation of the implementation and
impact of the DELTA Impact NOFO and
further understand the facilitators,
barriers, and critical factors to
implement specific violence prevention
strategies and conduct related program
evaluation activities. CDC will use
information collected to inform its
technical assistance, program
improvement, and capacity building. It
will also use the information to assess
progress on NOFO goals and inform the

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