60d FRN - published

Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–17IX; Docket No. CDC–2016–
0124]

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
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 a proposed information
collection project entitled ‘‘Assessment
of Interventions Intended to Protect
Pregnant Women in Puerto Rico from
Zika Infections.’’ This project consists of
telephone interviews with pregnant WIC
participants in Puerto Rico.
DATES: Written comments must be
received on or before February 28, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0124 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.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
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment
should be submitted 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 the Information
Collection Review Office, Centers for

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SUMMARY:

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Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
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 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.
Proposed Project
Assessment of Interventions Intended
to Protect Pregnant Women in Puerto
Rico from Zika Infections—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),

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Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC proposes to continue the
information collection initially cleared
by OMB as an emergency ICR in June,
2016 (OMB Control No. 0920–1118).
The expiration date for 0920–1118 is
December 31, 2016. However, CDC
intends to continue information
collection for an additional nine months
and is seeking OMB clearance to do so.
In December 2015, the
Commonwealth of Puerto Rico, a United
States territory, reported its first
confirmed locally transmitted Zika virus
case.
Starting in March 2016, The Centers
for Disease Control and Prevention’s
(CDC) National Center for Emerging and
Zoonotic Infections Diseases (NCEZID)
initiated several interventions targeting
pregnant women. The ultimate goal of
these interventions is/was to protect
pregnant women from Zika virus and
encourage Zika prevention behaviors
among pregnant women. The
interventions include the following:
1. Zika Education Sessions (at WIC
clinics;
2. Zika Prevention Kits;
3. Communication activities; and
4. Vector control services in the
community.
This ICR is for data collection over the
next nine months related to Zika
prevention efforts that have been and
will be implemented in Puerto Rico.
Specifically, CDC needs this assessment
to ensure that Zika prevention activities
effectively educate, equip, and
encourage women to participate in as
many Zika prevention behaviors as
possible. On-going evaluation is an
important part of this program because
it can reveal novel ways that women
protect themselves from Zika, how
effective the distribution of the Zika
Prevention Kit has been in Puerto Rico,
perceived severity and susceptibility to
Zika, pregnant women’s self-efficacy in
protecting themselves from Zika after
the interventions have been
implemented, as well as the extent to
which target populations are using
contents of the Zika Prevention Kit.
Interviews with pregnant women in
Puerto Rico can help articulate
motivations for and against engaging in
Zika prevention behaviors that are
critical for preventing Zika-associated
birth defects and morbidities.
Implementing changes based on results
from this assessment is expected to
facilitate program improvement and
ensure the most efficient allocation of
resources for this public health
emergency. The goal of this project is to

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Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices

find out if interventions are reaching
pregnant women and having the
intended effects along with getting
feedback from pregnant women about
the Zika prevention activities that have
been implemented (e.g., Zika education
sessions and prevention kits, vector
control activities, and communication
activities).
Findings will be used to improve the
delivery of interventions and to inform
decisions about future Zika prevention
activities for pregnant women in Puerto
Rico. The plan is to conduct up to 500
telephone interviews every two months
over a 9-month period, (a total of four
rounds), analyze the data, and generate
a report for leaders of the response to
offer insights on the delivery of
interventions to pregnant women. The
information will be used to make
recommendations for improving
interventions. Information may also be
used to develop presentations, reports,
and manuscripts to document the
program and lessons learned in order to
inform future programs of this sort.
The purpose of this assessment is also
to assess core components of CDC’s Zika
response in communicating prevention
behaviors, risk messages to the public

contraception, mental health/emotional
support, service/support needs of
families with babies affected by Zika, or
vaccine communications (if applicable).
While pregnant women will be the main
focus of most inquiry, other audiences
could include community leaders,
community members, and health care
providers. The goal is to identify
specific unmet needs, which can then
be shared with the Department of Health
and other human service agencies. The
plan is to hold up to 7 focus groups
(with up to 10 persons each), or up to
20 in-depth individual interviews or up
to 75 brief intercept interviews. A
maximum of 75 individuals would
participate in this part.
Results of this project will have
limited generalizability. However,
results of this evaluation should provide
information that can be used to enhance
and revise the existing program as well
as offer lessons learned to inform
infectious disease control programs that
use education materials.
Authorizing legislation comes from
Section 301 of the Public Health Service
Act (42 U.S.C. 241). There is no cost to
respondents other than their time to
participate.

about vector control activities, and the
Zika Prevention kit.
The following factors will be assessed:
• Knowledge about Zika virus and
related prevention behaviors
• Self-efficacy in engaging in Zika
prevention behaviors
• Engagement in Zika prevention
behaviors (e.g., protective clothing
use, condom use, and bed net use)
• Knowledge about, attitudes about, and
use of the Zika Prevention Kit
materials
• Knowledge about, attitudes about, and
use of environmental vector control
activities
• Risk perceptions of Zika
• Exposures to communications along
with other factors that may be
important considerations in their
taking action or not (e.g., does their
house have screens, etc.)
CDC will conduct telephone
interviews with a mix of closed-ended
and open-ended questions with
pregnant women. We estimate 2,000
pregnant women will participate in the
project over a nine month period.
Another component of this project is
to conduct qualitative inquiry to explore
emerging issues related to vector
control, sexual transmission,

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hrs.)

Total burden
(in hrs.)

Form name

Pregnant WIC participant .....................................

Initial Telephone Interview.
Focus group .................
In-depth Interviews .......
Brief intercept interview

2,000

1

20/60

667

70
20
75

1
1
1

120/60
60/60
10/60

140
20
13

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

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

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

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

840

WIC participants, other families affected by Zika
WIC participants, other families ............................
General population in Zika affected neighborhood.
Total ...............................................................

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.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2016–31737 Filed 12–29–16; 8:45 am]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling
Regulations

BILLING CODE 4163–18–P

Food and Drug Administration
[Docket No. FDA–2013–N–1155]

AGENCY:
srobinson on DSK5SPTVN1PROD with NOTICES

Number of
respondents

Type of respondents

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of

SUMMARY:

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1995 (the PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of our food
labeling regulations and on Form FDA
3570, Model Small Business Nutrition
Labeling Exemption Notice, which
small businesses may use to claim the
small business exemption from
nutrition labeling.
Submit either electronic or
written comments on the collection of
information by February 28, 2017.

DATES:

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