[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34588-34589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15524]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-18TH]


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 ``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, 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 <a href="/cdn-cgi/l/email-protection#4c23212e0c2f282f622b233a"><span class="__cf_email__" data-cfemail="6906040b290a0d0a470e061f">[email protected]</span></a>. 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 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.

[[Page 34589]]



                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Patients aged 18 years or older.......  Online surveys (18-month             960               1            7/60
                                         follow-up).
Patients aged 18 years or older who     Online surveys (30-month             660               1           10/60
 completed 18 mo survey.                 follow-up).
Patients aged 18 years or older who     Online surveys (30-month             220               1           10/60
 did not complete 18 mo survey.          follow-up).
----------------------------------------------------------------------------------------------------------------


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. 2018-15524 Filed 7-19-18; 8:45 am]
 BILLING CODE 4163-18-P


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