81 FR 96461 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 251 (December 30, 2016)

Page Range		96461-96462
FR Document		2016-31737

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.

Federal Register, Volume 81 Issue 251 (Friday, December 30, 2016)

[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Notices]
[Pages 96461-96462]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31737]



[[Page 96461]]

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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

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 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 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 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), 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

[[Page 96462]]

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 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, 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.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in     (in hrs.)
                                                                    respondent         hrs.)
----------------------------------------------------------------------------------------------------------------
Pregnant WIC participant......  Initial                    2,000               1           20/60             667
                                 Telephone
                                 Interview.
WIC participants, other         Focus group.....              70               1          120/60             140
 families affected by Zika.
WIC participants, other         In-depth                      20               1           60/60              20
 families.                       Interviews.
General population in Zika      Brief intercept               75               1           10/60              13
 affected neighborhood.          interview.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             840
----------------------------------------------------------------------------------------------------------------


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. 2016-31737 Filed 12-29-16; 8:45 am]
 BILLING CODE 4163-18-P

96462 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices

find out if interventions are reaching about vector control activities, and the contraception, mental health/emotional
pregnant women and having the Zika Prevention kit. support, service/support needs of
intended effects along with getting The following factors will be assessed: families with babies affected by Zika, or
feedback from pregnant women about • Knowledge about Zika virus and vaccine communications (if applicable).
the Zika prevention activities that have related prevention behaviors While pregnant women will be the main
been implemented (e.g., Zika education • Self-efficacy in engaging in Zika focus of most inquiry, other audiences
sessions and prevention kits, vector prevention behaviors could include community leaders,
control activities, and communication • Engagement in Zika prevention community members, and health care
activities). behaviors (e.g., protective clothing providers. The goal is to identify
Findings will be used to improve the use, condom use, and bed net use) specific unmet needs, which can then
• Knowledge about, attitudes about, and be shared with the Department of Health
delivery of interventions and to inform
use of the Zika Prevention Kit and other human service agencies. The
decisions about future Zika prevention
materials plan is to hold up to 7 focus groups
activities for pregnant women in Puerto • Knowledge about, attitudes about, and
Rico. The plan is to conduct up to 500 (with up to 10 persons each), or up to
use of environmental vector control 20 in-depth individual interviews or up
telephone interviews every two months activities
over a 9-month period, (a total of four to 75 brief intercept interviews. A
• Risk perceptions of Zika maximum of 75 individuals would
rounds), analyze the data, and generate • Exposures to communications along
a report for leaders of the response to participate in this part.
with other factors that may be
offer insights on the delivery of important considerations in their Results of this project will have
interventions to pregnant women. The taking action or not (e.g., does their limited generalizability. However,
information will be used to make house have screens, etc.) results of this evaluation should provide
recommendations for improving CDC will conduct telephone information that can be used to enhance
interventions. Information may also be interviews with a mix of closed-ended and revise the existing program as well
used to develop presentations, reports, and open-ended questions with as offer lessons learned to inform
and manuscripts to document the pregnant women. We estimate 2,000 infectious disease control programs that
program and lessons learned in order to pregnant women will participate in the use education materials.
inform future programs of this sort. project over a nine month period. Authorizing legislation comes from
The purpose of this assessment is also Another component of this project is Section 301 of the Public Health Service
to assess core components of CDC’s Zika to conduct qualitative inquiry to explore Act (42 U.S.C. 241). There is no cost to
response in communicating prevention emerging issues related to vector respondents other than their time to
behaviors, risk messages to the public control, sexual transmission, participate.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hrs.)
respondent (in hrs.)

Pregnant WIC participant ..................................... Initial Telephone Inter- 2,000 1 20/60 667
view.
WIC participants, other families affected by Zika Focus group ................. 70 1 120/60 140
WIC participants, other families ............................ In-depth Interviews ....... 20 1 60/60 20
General population in Zika affected neighbor- Brief intercept interview 75 1 10/60 13
hood.

Total ............................................................... ....................................... ........................ ........................ ........................ 840

Leroy A. Richardson, DEPARTMENT OF HEALTH AND 1995 (the PRA), Federal Agencies are
Chief, Information Collection Review Office, HUMAN SERVICES required to publish notice in the
Office of Scientific Integrity, Office of the Federal Register concerning each
Associate Director for Science, Office of the Food and Drug Administration proposed collection of information,
Director, Centers for Disease Control and including each proposed extension of an
[Docket No. FDA–2013–N–1155]
Prevention. existing collection of information, and
[FR Doc. 2016–31737 Filed 12–29–16; 8:45 am] Agency Information Collection to allow 60 days for public comment in
BILLING CODE 4163–18–P Activities; Proposed Collection; response to the notice. This notice
Comment Request; Food Labeling solicits comments on the information
Regulations collection provisions of our food
AGENCY: Food and Drug Administration, labeling regulations and on Form FDA
HHS. 3570, Model Small Business Nutrition
srobinson on DSK5SPTVN1PROD with NOTICES

ACTION: Notice. Labeling Exemption Notice, which
small businesses may use to claim the
SUMMARY: The Food and Drug small business exemption from
Administration (FDA or we) is nutrition labeling.
announcing an opportunity for public
comment on the proposed collection of DATES: Submit either electronic or
certain information by the Agency. written comments on the collection of
Under the Paperwork Reduction Act of information by February 28, 2017.

VerDate Sep<11>2014 19:18 Dec 29, 2016 Jkt 241001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1

Document Created: 2016-12-30 05:16:05
Document Modified: 2016-12-30 05:16:05

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before February 28, 2017.
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 Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation		81 FR 96461

81 FR 96461 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 81, Issue 251 (December 30, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention