60 Day FRN

34586

Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents

Natural science managers ................
Postsecondary Teachers ..................
Industrial production managers ........
Total ...........................................

Semi-Structured Interview
(Subject Matter Experts).
Semi-Structured Interview
(Grantees).
Semi-Structured Interview
(Research users).

1

2

20

Guide

12

1

2

24

Guide

8

1

2

16

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

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

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

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

60

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–18ANU; Docket No. CDC–2018–
0058]

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 effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a 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 Communities Organized to
Prevent Arboviruses: Assessment of
Knowledge, Attitudes, and Vector
Control Practices and Sero-Prevalence
and Incidence of Arboviral Infection in
Ponce, Puerto Rico (COPA Study). The
purpose of this study is to establish
longitudinal follow-up of a community
cohort and evaluate the impact of vector
control interventions in 14 communities
in southern Puerto Rico.
DATES: CDC must receive written
comments on or before September 18,
2018.
SUMMARY:

daltland on DSKBBV9HB2PROD with NOTICES

Total burden
(in hours)

10

[FR Doc. 2018–15527 Filed 7–19–18; 8:45 am]

18:06 Jul 19, 2018

Average
burden per
response
(in hours)

Guide

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.

VerDate Sep<11>2014

Number of
responses per
respondent

Number of
respondents

Form name

Jkt 244001

You may submit comments,
identified by Docket No. CDC–2018–
0058 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.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 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,
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:
ADDRESSES:

PO 00000

Frm 00051

Fmt 4703

Sfmt 4703

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
Communities Organized To Prevent
Arboviruses: Assessment of Knowledge,
Attitudes, and Vector Control Practices
and Sero-Prevalence and Incidence of
Arboviral Infection in Ponce, Puerto
Rico (COPA Study)—NEW—National
Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Recent years have seen the emergence
of two epidemic arthropod-borne
viruses (arboviruses) that are
transmitted by Aedes aegypti
mosquitoes. Chikungunya virus was
introduced into the Caribbean in late
2013, and caused large epidemics of
fever with severe joint pain throughout
the Caribbean and Americas in 2014.
Zika virus was first detected in the
Americas in Brazil in 2014, spread
throughout the Americas, has since been
associated with devastating birth
defects, Guillain-Barre syndrome, and is
the first arbovirus that can also be

E:\FR\FM\20JYN1.SGM

20JYN1

34587

Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
transmitted through sexual contact. In
addition, the four viruses that cause
dengue were introduced to the Americas
over the past several hundred years and
have since become endemic, and yellow
fever virus has recently caused large
outbreaks in Brazil and there is risk of
importation to other counties in the
Americas.
In all of these cases, the public health
response to the spread of these
arboviruses throughout the tropics,
where their mosquito vectors thrive, has
been hampered by a lack of sustainable
and effective interventions to prevent
infection with any of these arboviruses
at the community level. Additionally,
the rapid speed with which new
arboviruses spread does not often
provide the time needed to plan and
implement community-level
interventions to decrease disease
transmission. Although several
candidate vaccines for chikungunya and
Zika are currently in clinical
development, none are yet available. A
dengue vaccine has been licensed in
several countries, but initial analyses
have suggested that decades will be
needed before it results in reduction in
transmission of dengue virus. In recent
years, community based strategies for
vector control have been studied and
implemented in different countries as
an alternative to vertical strategies (e.g.
insecticide spraying delivered by
government agencies). A new
intervention has recently been
demonstrated to reduce the rates of
infection with common tropical
arboviruses transmitted by Ae. aegypti
mosquitos (i.e., dengue, chikungunya,
and Zika viruses). The Camino Verde
approach utilizes community
mobilization to motivate clean-up
campaigns to reduce rates of dengue
virus infections in Nicaragua and
Mexico. However, the intervention
occurred in small communities, and has
not been evaluated in an urban setting.
There is therefore, a need to determine
the effectiveness of such types of
interventions in relatively large, urban
communities.
Research suggests that vector control
programs that have substantial
community participation can have
significant and lasting impacts on vector

time of the visit. The knowledge,
attitudes, and practices questionnaire
will be focused on vector control,
healthcare-seeking behavior, and
disease occurrence. We will collect
demographic information (e.g., age, sex,
duration of time residing in Puerto
Rico), travel history, and information on
recent illnesses from all participants via
household (and individual)
questionnaires. Parents or guardians
will serve as proxy respondents for
children aged <7 years. The
questionnaires will be administered
after written consent and verbal assent
(when appropriate) from those present
in the household at the time of the visit.
GPS coordinates will also be collected
for each household visited to later
assess for potential clustering of
arboviral infections within
communities. We will ask participants if
they have been ill with arbovirus-like
illness (i.e., fever, rash, joint pain, and
conjunctivitis) in the past year. If so, we
will collect details on the symptoms
experienced during their illness. The
questionnaires will be administered to
all randomly selected residents of the 14
communities in Ponce. At the time of
the questionnaire administration, ∼15
mL of blood will be collected to conduct
serological testing of arboviruses for a
sero-survey. The sero-survey and sociodemographic questionnaire will be
repeated every 12 months after the
initial assessment, up to a period of five
years. OMB clearance will be extended
after three years. This project will allow
the evaluation of a community based
approach for vector control strategies in
Ponce, Puerto Rico. The information
obtained will inform decision making
regarding the location, design, and
content of future interventions to be
implemented and evaluated to reduce
the burden of arboviral disease in Puerto
Rico. Incidence and prevalence of
arboviral disease will be estimated to
guide control programs development
and fill the current knowledge gaps.
There is no burden on respondents
other than the time needed to
participate. Estimated annual burden is
2,416 hours. Authorizing legislation
comes from Section 301 of the Public
Health Service Act.

density, and are more cost-effective than
vertically structured programs. In
addition, these types of programs have
been reported to readily integrate with
other health or development programs,
promote an enduring sense of pride in
the home and community, and make use
of politically viable vector control
strategies.
The purpose of this study is to
establish longitudinal follow-up of a
community cohort and evaluate the
impact of vector control interventions in
14 communities in southern Puerto
Rico. The study investigators have prior
experience working in these
communities; however, there is minimal
available information regarding the
prevalence or incidence of infection
with tropical arboviruses, density of Ae.
aegypti mosquitos, or community
members’ knowledge, attitudes, and
practices regarding behaviors intended
to avoid mosquitos. Such information
will be needed to inform decisionmaking regarding the location, design,
and content of interventions to be
implemented and evaluated to reduce
the burden of these pathogens.
The questionnaire section will vary
depending on age and day of birth of
each participant. A questionnaire with
general household questions will be
administered to one household
representative in each home with one or
more participants. This representative
should be 21 years or older or an
emancipated minor. If all eligible
household members are unemancipated
minors, a household member over the
age of 50 may act as household
representative and complete this section
of the survey only. A questionnaire on
socio-demographic information will be
administered to all participants. The
assessment of knowledge, attitudes, and
practices questionnaire will be
administered to all participants seven
years and older with questions adapted
for ages: 7–11 (younger child), 12–13
(older child), 14–50 (adult). A vector
control tools questionnaire will be
administered to all participants 21 years
or older born on an odd numbered day
of the month. The questionnaire will be
administered after written consent and
verbal assent (when appropriate) from
those present in the household at the

daltland on DSKBBV9HB2PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondents

Form name

Ponce residents .............

Household representative questionnaire .............
Socio-demographic questionnaire .......................
Knowledge, attitudes, and practices individual
questionnaire.

VerDate Sep<11>2014

18:06 Jul 19, 2018

Jkt 244001

PO 00000

Frm 00052

Fmt 4703

Sfmt 4703

Number of
responses per
respondent

2,506
2,996
2,996

E:\FR\FM\20JYN1.SGM

1
1
1

20JYN1

Average
burden per
response
(in hours)
10/60
15/60
15/60

Total burden
(in hours)
418
749
749

34588

Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued

Type of respondents

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

Total burden
(in hours)

600
2,996

1
1

25/60
5/60

250
250

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

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

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

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

2,416

[FR Doc. 2018–15529 Filed 7–19–18; 8:45 am]
BILLING CODE 4163–18–P

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

Agency Forms Undergoing Paperwork
Reduction Act Review

daltland on DSKBBV9HB2PROD with NOTICES

Average
burden per
response
(in hours)

Vector control tools questionnaire .......................
Specimen collection .............................................

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.

In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Assessment of
a Preventive Service Program in the
Context of a Zika Virus Outbreak in
Puerto Rico’’ 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 March 30,
2018 to obtain comments from the
public and affected agencies. CDC
received one non-substantive comment
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,

VerDate Sep<11>2014

Number of
responses per
respondent

Number of
respondents

Form name

18:06 Jul 19, 2018

Jkt 244001

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
Assessment of a Preventive Service
Program in the Context of a Zika Virus
Outbreak in Puerto Rico—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Puerto Rico has reported the highest
number of Zika virus infections in the
United States, including infections in
pregnant women. Zika virus infection
during pregnancy has been identified as
a cause of microcephaly and other
severe brain abnormalities, and has been
linked to other problems such as
miscarriage, stillbirth, defects of the eye,
hearing deficits, limb abnormalities, and
impaired growth. One strategy to
prevent these devastating outcomes is to

PO 00000

Frm 00053

Fmt 4703

Sfmt 4703

prevent unintended pregnancy among
women at risk of Zika virus infection.
To this end, an initiative was launched
in April 2016 to train physicians at
clinics across Puerto Rico to provide
patient-centered services to women who
chose to delay or avoid pregnancy
during the Zika virus outbreak.
As part of the public health response
to the Zika virus outbreak, CDC seeks to
assess approaches to mitigating the
effects of Zika virus infection and
determine which approaches have
utility. Previous assessment of the
prevention program indicated high
satisfaction of patients with program
services. The specific objectives of this
data collection are to assess (1)
prevention strategy adherence among
patients at approximately 18 months
after receipt of program services; and (2)
prevention strategy adherence, patient
satisfaction, and unmet need for
services among participants at
approximately 30 months after receipt
of program services. The practical utility
of the information to be collected as part
of this project is to assess services
delivered to women in Puerto Rico,
monitor outcomes of interest, and
determine potential for replication/
adaptation in other jurisdictions
similarly affected by the Zika virus or
during other emergency responses. For
the information collection, CDC plans to
conduct online surveys with 1,920
patients approximately 18 months after
receiving program services and 1,760
patients approximately 30 months after
receiving program services. The number
of patients surveyed is based on an
initial sample of 3,200 patients invited
to participate, anticipating a 60%
response rate at 18 months and a 55%
response rate at 30 months.
Participation in all data collection
activities will be completely voluntary.
OMB approval is requested for two
years. Total Annualized Burden Hours
are estimated to be 259, and there are no
costs to respondents other than their
time.

E:\FR\FM\20JYN1.SGM

20JYN1