60 day FRN

Attachment 2a: 60-Day Federal Register Notice
Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices

22069

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents

Responder/Survivor/Advocate (physician).
Total ...........................................

Form name

Petition for the addition of health
conditions.
..........................................................

Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–10067 Filed 5–10–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–0950; Docket No. CDC–2018–
0040]

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.
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 July 10, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0040 by any of the following methods:
 Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
 Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and

Number of
responses per
respondent

Number of
respondents

Average
burden per
response
(in hours)

Total burden
(in hours)

60

1

60/60

60

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

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

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

14,061

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 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 Leroy A.
Richardson, 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.
Proposed Project
The National Health and Nutrition
Examination Survey (NHANES), (OMB
Control Number 0920–0950, Expiration
Date 12/31/2019)—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.
NHANES data 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

22070

Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices

the health of the U.S. population over
time.
In 2019, a new sampling strategy is
being implemented. To increase
operational efficiency, NHANES will
survey a nationally representative
sample over the course of a two-year
cycle instead of annually. The change to
a two-year cycle will permit more days
allocated to each primary sampling unit
(PSU), which will result in more time to
screen and recruit potential
participants, and allow for more exam
slots. As in previous years, the base
sample will remain at approximately
5,000 interviewed and examined
individuals annually.
NCHS collects personal identification
information. 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 sponsor data
collection components on NHANES. To
keep burden down, NCHS cycles in and
out various components. The 2019–20
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 1 and older), and hearing (ages 6–
19 and 70+). Starting in 2019, we will
collect blood pressure using an
automated device, instead of using
manual devises.
While at the examination center
additional interview questions are asked
(6 and older), a second 24-hour dietary
recall (all ages) is scheduled to be
conducted by phone 3–10 days later. In
2019, we plan to add a Words-In-Noise

(ages 70+) exam, genetic testing related
to the liver elastography exam, and a
balance exam (ages 40+).
The 2019–20 survey will bring back
the cognitive function test (ages 60+).
NHANES also plans to conduct a 24hour blood pressure measurement pilot
among NHANES participants ages 18
and older.
The bio specimens 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. Oral rinse samples for HPV
analyses is cycling back into the survey
(ages 8–69 years).
The following analytes are being
discontinued in 2018 for participants
from the smoking sample subset:
Aromatic Amines, Heterocyclic Amines,
Urine Cotinine, Tobacco-Specific
Nitrosamines, Perchlorate, Nitrates, and
Thiocyanate, Urinary Arsenic, Mercury,
Iodine and Metals.
Cycling out of NHANES 2019–20 are
the blood pressure methodology project,
Human Papillomavirus (HPV) in serum,
Aldehydes in serum, Volatile Nnitrosamines (VNAs) tobacco
biomarkers, Urine heterocyclic amines,
urine aromatic amines and urine
tobacco-specific nitrosamines
New additions to the survey
questionnaires include two questions on
WIC participation, a birth to less than
24-month questionnaire module and
collecting information on infant formula
ingredients. We are also considering
modifications to multiple existing
questionnaire sections in order to better
align with questions asked in the
National Health Interview Survey
(NHIS) (OMB Control No. 0920–0214,
Exp. 12/31/2019) or to streamline the

instruments to reduce respondent
burden.
Most sections of the NHANES
interviews provide self-reported
information to be used either in concert
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 2019–2020, 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.
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 occurs 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. The
total estimated annual burden hours are
72,917. We are requesting a three-year
approval.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
burden
(in hours)

Type of respondent

Form name

Individuals in households ..................
Individuals in households ..................
Individuals in households ..................
Individuals in households ..................
Individuals in households ..................

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

1
1
1
1
1

3/60
1.5
4
30/60
20/60

750
7,500
20,000
2,500
1,667

3,500

1

3

10,500

Individuals in households ..................

Screener ...........................................
Household Interview .........................
MEC Exam .......................................
Dietary Interview Phone Follow-Up
Flexible Consumer Behavior Survey
Phone Follow-Up.
Developmental Projects & Special
Studies.
24 hour Blood Pressure Pilot ...........

1,200

1

25

30,000

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

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

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

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

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

72,917

Individuals in households ..................

22071

Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–10066 Filed 5–10–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–0314]

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 National Survey
of Family Growth (NSFG) 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 December
26, 2017 to obtain comments from the
public and affected agencies. CDC
received four 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 or
send an email to [email protected]. 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 Survey of Family
Growth (NSFG)(OMB Control Number
0920–0314, Expiration Date 05/31/
2018)—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 ‘‘family formation, growth,
and dissolution,’’ as well as
‘‘determinants of health’’ and
‘‘utilization of health care’’ in the
United States. This clearance request
includes the data collection in 2018
forward for the continuous NSFG.
The National Survey of Family
Growth (NSFG) was conducted
periodically between 1973 and 2002,
continuously in 2006–2010, and
continuously starting in September
2011, by the National Center for Health
Statistics, CDC. Each year, about 15,000
households are screened, with about
5,000 participants interviewed annually.
Participation in the NSFG is completely
voluntary and confidential. Interviews
average 60 minutes for males and 80
minutes for females. The response rate
since 2011 has ranged from 69 percent
to 77 percent, and the cumulative
response rate for the entire fieldwork

period so far (September 2011 through
the most current quarter which ended in
May 2017) is 69 percent.
The NSFG program produces
descriptive statistics which document
factors associated with birth and
pregnancy rates, including
contraception, infertility, marriage,
divorce, and sexual activity, in the US
household population 15–49 years (15–
44 years in survey periods before 2015);
and behaviors that affect the risk of
sexually transmitted diseases (STD),
including HIV, and the medical care
associated with contraception,
infertility, and pregnancy and
childbirth.
NSFG data users include the DHHS
programs that fund it, including CDC/
NCHS and eleven others (The Eunice
Kennedy Shriver National Institute for
Child Health and Human Development
(NIH/NICHD); the Office of Population
Affairs (DHHS/OPA); the Children’s
Bureau (DHHS/ACF/CB); the ACF’s
Office of Planning, Research, and
Evaluation; the CDC’s Division of HIV/
AIDS Prevention (CDC/DHAP); the
CDC’s Division of STD Prevention
(CDC/DSTD); the CDC’s Division of
Adolescent and School Health (CDC/
DASH); the CDC’s Division of
Reproductive Health (CDC/DRH); the
CDC’s Division of Cancer Prevention
and Control (CDC/DCPC); the CDC’s
Division of Nutrition, Physical Activity,
and Obesity (CDC/DNPAO); and the
CDC’s Division of Birth Defects and
Developmental Disabilities (CDC/
DBDDD)). The NSFG is also used by
state and local governments (primarily
for benchmarking to national data);
private research and action
organizations focused on men’s and
women’s health, child well-being, and
marriage and the family; academic
researchers in the social and public
health sciences; journalists, and many
others.
This submission requests approval to
continue NSFG fieldwork for three
years. While no questionnaire revisions
are requested, two methodological
studies are proposed. The total
estimated annualized time burden to
respondents is 6,759 hours. There is no
cost to respondents other than their
time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Form name

Household member .................................................................
Household ...............................................................................
Female 15–49 years of age ....................................................

Screener Interview .................
Female Interview ....................

Number of
respondents
15,000
2,750

Number of
responses per
respondent
1
1

Average
burden per
response
(in hours)
3/60
80/60