82 FR 32554 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 82, Issue 134 (July 14, 2017)

[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Notices]
[Pages 32554-32556]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-1140]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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 [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Zika virus persistence in body fluids of patients with Zika virus 
infection in Puerto Rico (ZIPER Study) (OMB Control Number 0920-1140, 
Expiration Date 10/31/2017)--Revision--National Center for Emerging and 
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    CDC is seeking a one-year OMB approval to extend the ZIPER Study 
information collection.
    The Zika Persistence (ZIPER) study will help inform the presence 
and duration of ZIKV shedding in several body fluids among RT-PCR-
positive ZIKV cases from Puerto Rico. It will also provide information 
regarding the duration of detection of anti-ZIKV IgM antibodies and the 
time for development of IgG antibodies among the same population. In 
addition, this study will determine the prevalence of anti-ZIKV IgM and 
IgG, and virus shedding in body fluids among household contacts of ZIKV 
cases.
    We propose to investigate the persistence (shedding) of ZIKV in 
different body fluids and its relation to

[[Page 32555]]

immune response to provide a basis for development of non-blood-based 
diagnostic tools, and target and refine public health interventions to 
arrest ongoing spread of infection. To do so, we will conduct a 
prospective cohort study of individuals with reverse transcription-
polymerase chain reaction (RT-PCR) positive ZIKV infection and a cross-
sectional study of their household contacts. Results and analyses will 
be used to update relevant counseling messages and recommendations from 
the CDC.
    The study will include baseline and follow-up questionnaires and 
the collection of the following specimens: blood, saliva, urine from 
participants of all ages, and semen/vaginal secretions from adults 
(ages 21 years or older) and legally emancipated minors (support 
themselves financially, live independent of their parents, are 
pregnant, or have children).
    Individuals with RT-PCR positive ZIKV infection will be recruited 
through the Sentinel Enhanced Dengue Surveillance System (SEDSS) at 
Saint Luke's Episcopal Hospital in Ponce, Puerto Rico and through 
passive surveillance in selected municipalities in Puerto Rico. SEDSS 
was established in 2012 through a cooperative agreement between the 
hospital in Consortium with the Ponce School of Medicine and Ponce 
Research Institute from the Ponce Health Sciences University and the 
CDC (Protocol #6214).
    Specimens will be tested for the presence of ZIKV RNA by RT-PCR at 
the CDC Dengue Branch Laboratory in San Juan, and positive specimens 
will be further tested for virus isolation to evaluate infectivity. 
Each body fluid will be collected on a weekly basis for four weeks and 
biweekly thereafter until two consecutive negative RT-PCR results are 
obtained from all specimens. Irrespective of RNA detection, body fluids 
will also be collected for RT-PCT at 2, 4, and 6 months to investigate 
intermittent shedding. Analyses of antibody response through titers of 
IgM and IgG will be performed at baseline and repeated at 2, 4, and 6 
months.
    Among symptomatic participants seven milliliters of blood will be 
drawn at each study visit split into a tiger top tube (5ml) and a 
purple top tube (2ml) for a total not to exceed 50 ml during any given 
8-week period. At enrollment healthy non-pregnant adults will have 20 
ml of blood collected following standard procedures. Two tiger top 
tubes of 8.5 ml and one 3ml purple top tubes will be collected. These 
procedures will be repeated at each follow-up visit.
    RT-PCR-positive participants will be asked to refer up to five 
household members to establish the percentage of household members with 
detectable and potentially infectious Zika virus RNA in body fluids. 
Household members who are found to be ZIKV RT-PCR-positive in any body 
fluid will be invited to participate in the cohort study. A second 
study visit will be scheduled with household contact at 2 or 4 months, 
to detect new infections and estimate incidence. Because the original 
study consent forms do not include this visit, household contacts will 
be contacted by study staff and will be consented again using the same 
consent form.
    Since gaining OMB approval in October 2016, the project has 
enrolled 295 Zika virus-infected individuals into the Zika virus 
Persistence study, which is 55 individuals below the target enrollment 
of 350 individuals.
    Preliminary findings have been published in New England Journal of 
Medicine, where we also expect that the final report that includes the 
full sample size will be published.
    This is a request to continue information collection with minor 
modifications. Modifications have been made to reflect the developing 
nature of the science surrounding Zika virus infection and potential 
outcomes associated with infection, as well as additional questions 
that were best answered by taking advantage of the existing study 
platform. Specifically, CDC proposes the addition of two components to 
the collection of data under this study, one of which has already 
begun:
    1. A follow-up household visit has been added to determine how many 
household members of Zika virus-infected participants become infected 
during the 4 months following initial screening. For any household 
members that had no evidence of Zika virus infection at the initial 
visit, the same questionnaires used at the initial household visit will 
again be completed ~4 months later. Such information will provide 
additional information regarding the incidence of Zika virus infections 
among households with a Zika-positive household member.
    2. Additionally, CDC proposes following up with men with Zika 
virus-positive semen specimens to better understand the effect of Zika 
virus infection on sperm. To do this, 8-14 semen ejaculates from 10-20 
men participating in the ZIPER study will be used to determine the 
presence and/or detection of the Zika virus in different fractions of 
the semen ejaculate (i.e., seminal plasma, cellular debris, including 
White Blood Cells and spermatozoa). CDC has received Institutional 
Review Board approval for this modification, but information collection 
has not begun.
    Authorizing legislation comes from Section 301 of the Public Health 
Service Act (42 U.S.C. 241). The total estimated annualized number of 
burden hours is 243. There is no cost to respondents other than the 
time to participate.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                  Number of      Average  burden
       Type of respondents                Form name             Number of       responses per     per  response
                                                               respondents       respondent        (in hours)
----------------------------------------------------------------------------------------------------------------
Public health personnel.........  Shedding Questionnaire..                18                30             15/60
General public..................  Shedding Questionnaire                  55                 8             10/60
                                   (Symptomatics).
                                  Shedding Questionnaire                 100                 1             10/60
                                   (Cross-Sectional
                                   Asymptomatics).
                                  Questionnaire for men in                30                 1             20/60
                                   Semen sub-study.
                                  Shedding Eligibility                   160                 1              2/60
                                   Form.
                                  Contact Information Form                32                 1              2/60
----------------------------------------------------------------------------------------------------------------



[[Page 32556]]

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. 2017-14790 Filed 7-13-17; 8:45 am]
 BILLING CODE 4163-18-P