60 day FRN

32333

Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices
This qualitative data collection is
needed by DGMQ because foreign-born
individuals are considered hard-toreach populations and are often missed
by routine information collection
systems in the United States. As a
consequence, limited information is
available about the health status,
knowledge, attitudes, health beliefs and
practices related to communicable
diseases and other emerging health
issues (e.g., tuberculosis, parasitic
diseases, lead poisoning, and mental
health issues) among foreign-born
populations in the United States.
Foreign-born populations are very
diverse in terms of countries of origin,
socio-demographic, cultural and
linguistic characteristics and geographic
destinations in the U.S. Data is
especially limited at the local level.

Form name

Foreign-born from specific country of birth in
the United States.

Screeners for focus groups (assuming 2
screenings for each recruited participant in
focus groups) (300X2 = 600).
Focus Groups (Approximately 30 focus
groups/year and 10 participants per focus
group).
Key informant interviews (Approximately 125
interviews/year).

Foreign-born community leaders and staff
from organizations serving those communities.

Leroy A. Richardson,
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. 2016–12010 Filed 5–20–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–0950; Docket No. CDC–2016–
0044]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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

SUMMARY:

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general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on the proposed revision of
the National Health and Nutrition
Examination Survey (NHANES).
NHANES programs produce descriptive
statistics which measure the health and
nutrition status of the general
population.
Written comments must be
received on or before July 22, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0044 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
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
DATES:

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increasing threat to global health
security.
Under the terms of this generic, CDC
will employ focus groups and key
informant interviews to collect
information. Depending on the specific
purpose, the information collection may
be conducted either in-person, by
telephone, on paper, or online. For each
generic information collection, CDC will
submit to OMB the project summary
and information collection tools.
Estimated Annualized Burden Hours
This requests entails a total of 1,025
respondents and 825 burden hours
annually. The respondents to these
information collections are foreign born
individuals in the United States. There
is no cost to respondents other than the
time required to provide the information
requested.
Number of
respondents

Type of respondent

Foreign-born from specific country of birth in
the United States.

sradovich on DSK3TPTVN1PROD with NOTICES

The purpose of the extension is to
continue efforts to improve the agency’s
understanding of the health status, risk
factors for disease, and other health
outcomes among foreign-born
individuals in the United States.
Numerous types of data will be
collected under the auspices of this
generic information collection. These
include, but are not limited to,
knowledge, attitudes, beliefs, behavioral
intentions, practices, behaviors, skills,
self-efficacy, and health information
needs and sources.
For example, CDC recently used this
generic to collect feedback on Mexicanborn audience’s preferences for
messaging and communication about
mosquito-borne diseases to develop
effective prevention campaigns as these
diseases—especially Zika—pose an

Number of
responses
per respondent

Average
burden per
response
(in hours)

600

1

10/60

300

1

2

125

1

1

to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the 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].

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

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Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices

collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.

sradovich on DSK3TPTVN1PROD with NOTICES

Proposed Project
The National Health and Nutrition
Examination Survey (NHANES), (OMB
No. 0920–0950, expires 12/31/2017)—
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. Annually,
approximately 14,410 respondents

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participate in some aspect of the full
survey. Up to 3,500 additional persons
might participate in tests of procedures,
special studies, or methodological
studies (Table 1). Participation in
NHANES is completely voluntary and
confidential. A three-year approval is
requested.
NHANES programs produce
descriptive statistics which measure the
health and nutrition status of the
general population. Through the use of
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 the health of the
U.S. population over time. 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 2017–2018
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+).
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
2017 we plan to add a liver elastography
(ultrasound) exam with a set of alcohol
questions to complement this exam, an
Oral Human Papilloma Virus (HPV)
follow-up, and cycle back in bone
density for hip and spine into the Dual
X-ray Absorptiometry (DXA) exam for
(ages 50+). The osteoporosis
questionnaire will also cycle back into
NHANES to complement the changes to
the DXA exam. These questions will be
asked of those 40+ In addition, the age
range for the existing DXA total body
scan will be changed from 6–59 years to
8–69 years.

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NHANES plans to conduct a blood
pressure methodology study. The study
population will be NHANES
participants aged 6 and older who agree
to come to the Mobile Examination
Center (MEC). The survey would also
like to conduct an Ambulatory Blood
Pressure Pilot Study among NHANES
participants ages 18 and older.
The bio-specimens collected for
laboratory tests include urine, blood,
vaginal and penile swabs, oral rinses
and household water collection. Serum,
plasma and urine specimens are stored
for future testing, including genetic
research, if the participant consents.
NHANES 2017–18 plans to add three
Phthalates in urine (ages 3+), nine
Urinary flame retardants in urine (ages
3+), one Insect repellant in urine (ages
3+), one Volatile organic compound
(VOC) metabolite in urine (ages 3+),
eighteen Tobacco biomarkers in urine
(ages 3+), two Metals in urine (ages 3+),
Vitamin C in serum (ages 6+), Vitamins
A, E, and carotenoids in serum (ages
6+), Unsaturated Iron Binding Capacity
(UIBC)/Total Iron Binding Capacity
(TIBC) in serum (ages 12+), and
Congenital cytomegalovirus (CMV) in
sera (ages 1–5). Consent to store DNA is
cycling back into NHANES.
In addition metals in whole blood are
changing from a one-half sample to a
full sample (ages 1+). Polycyclic
Aromatic Hydrocarbons (PAHs) are
being discontinued in the smoker
oversample subgroup, however testing
will continue in a 1⁄3 subsample of
general NHANES participants.
The 2017–18 survey will also bring
back the Flexible Consumer Behavior
Survey Phone follow-Up questionnaire
for participant ages 1+. This takes place
in the home after the second dietary
recall is completed.
The following major examination or
laboratory items, that had been included
in the 2015–2016 NHANES, were cycled
out for NHANES 2017–2018: Pubertal
maturation, oral glucose tolerance test
(OGTT), dual X-ray absorptiometry
scans for vertebral fractures and aortic
calcification, three metals in serum and
three hormones and binding proteins.
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

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Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices
NHANES, including questions about
food security and nutrition program
participation, dietary supplement use,
and weight history/self-image/related
behavior.

In 2017–2018, we also plan to
conduct a Dietary Supplement Imaging
pilot study, as well as implement multimode screening and electronic consent
procedures in NHANES. The consent for

birth certificate linkage that had been
included in previous NHANES will be
dropped from NHANES 2017–2018.
There is no cost to respondents other
than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

Individuals
Individuals
Individuals
Individuals
Individuals

in
in
in
in
in

households
households
households
households
households

Number of
responses per
respondent

Average
burden per response (in
hours)

Total burden
hours

14,410
1,404
2,000
1,200
2,880

1
1
1
1
1

2.5
30/60
30/60
25
10/60

36,025
702
1,000
30,000
480

2,520

1

10/60

420

2,160

1

10/60

360

1,800

1

10/60

300

5,000

1

20/60

1,667

Individuals in households

NHANES Questionnaire ......................................
Blood Pressure Methodology Study Phase 1 .....
Blood Pressure Methodology Study Phase 2 .....
Ambulatory Blood Pressure Pilot Study ..............
Oral HPV rinse Follow-up Study 6 months (estimated 80% of original sample of 3600).
Oral HPV rinse Follow-up Study 12 Months (estimated 70% of original sample).
Oral HPV rinse Follow-up Study 18 months (estimated 60% of original sample).
Oral HPV rinse Follow-up Study 24 Months (estimated 50% of original sample).
Flexible Consumer Behavior Survey Phone Follow-Up.
Special Studies ....................................................

3,500

1

3

10,500

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

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

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

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

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

81,454

Individuals in households
Individuals in households
Individuals in households
Individuals in households

Leroy A. Richardson,
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. 2016–12009 Filed 5–20–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Request for Information by
the Presidential Advisory Council on
Combating Antibiotic-Resistant
Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:

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including some stakeholders/sectors
relevant to this overall effort. This
Request for Information (RFI) offers the
opportunity for interested individuals,
organizations, associations, industries,
and others, to provide their feedback.
Responses to the questions must be
received by 11:59 p.m. on June 22, 2016
to be considered. The questions are also
available through an online form on the
Advisory Council Web page at
www.hhs.gov/ash/carb. Individuals who
wish to send in their responses via
email should send an email to CARB@
hhs.gov, indicating the question
number(s) for which they are
responding.
Comments must be received by
11:59 p.m. on June 22, 2016 to be
considered.

DATES:

Individuals are encouraged
to submit their responses through one of
the following methods. Utilization of
the online form available on
www.hhs.gov/ash/carb is the preferred
method of submission. Should you
choose to send in your responses via
email, please be sure to include the
question number(s) in the subject line.
Do not include in your response
information of a confidential nature,
such as sensitive personal information
or proprietary information. Responses to
this notice are not offers and cannot be
accepted by the federal government to
form a binding contract or issue a grant.
Please be aware that your comments
will not affirmatively be posted

ADDRESSES:

The Presidential Advisory
Council on Combating AntibioticResistant Bacteria (Advisory Council)
requests information from the general
public and stakeholders related to
efforts and strategies to combat
antibiotic-resistance. In the process of
developing their report, Initial
Assessments of the National Action
Plan for Combating Antibiotic-Resistant
Bacteria, the Advisory Council followed
the framework of the National Action
Plan for Combating Antibiotic Resistant
Bacteria (Action Plan) to hear about a
wide range of ongoing and planned
activities by the federal government,

SUMMARY:

sradovich on DSK3TPTVN1PROD with NOTICES

Number of
respondents

Form name

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publicly, however they may be made
available to the public, in part or in full,
subject to applicable laws and
regulations.
• Online Form: www.hhs.gov/ash/
carb. Online submissions will receive
an automatic confirmation
acknowledging receipt of your response,
but will not receive individualized
feedback on any suggestions.
• Email: [email protected]. Please
indicate the question number(s) in the
subject line of your email. Email
submissions will receive an electronic
confirmation acknowledging receipt of
your response, but will not receive
individualized feedback on any
suggestions.
SUPPLEMENTARY INFORMATION: Under
Executive Order 13676, dated
September 18, 2014, authority was given
to the Secretary of Health and Human
Services (HHS) to establish the Advisory
Council, in consultation with the
Secretaries of Defense and Agriculture.
Activities of the Advisory Council are
governed by the provisions of Public
Law 92–463, as amended (5 U.S.C.
App.), which sets forth standards for the
formation and use of federal advisory
committees.
The Advisory Council will provide
advice, information, and
recommendations to the Secretary of
HHS regarding programs and policies
intended to support and evaluate the
implementation of Executive Order
13676, including the National Strategy
for Combating Antibiotic-Resistant

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