82 FR 16837 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 82, Issue 65 (April 6, 2017)

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 Zika virus persistence in body fluids of patients with Zika virus infection in Puerto Rico (ZIPER Study) to fill gaps in the scientific knowledge base for ZIKV regarding the persistence and transmissibility of ZIKV in body fluids. This information assist ongoing public health response activities, as well as advance the scientific understanding of ZIKV illness and transmission.

[Federal Register Volume 82, Number 65 (Thursday, April 6, 2017)]
[Notices]
[Pages 16837-16839]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06864]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-1140; Docket No. CDC-2017-0030]


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.

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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 Zika virus 
persistence in body fluids of patients with Zika virus infection in 
Puerto Rico (ZIPER Study) to fill gaps in the scientific knowledge base 
for ZIKV regarding the persistence and transmissibility of ZIKV in body 
fluids. This information assist ongoing public health response 
activities, as well as advance the scientific understanding of ZIKV 
illness and transmission.

DATES: Written comments must be received on or before June 5, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0030 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

[[Page 16838]]

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

    Zika virus persistence in body fluids of patients with Zika virus 
infection in Puerto Rico (ZIPER Study)--Revision--National Center for 
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    CDC plans to seek a one-year OMB approval to extend information 
collection covered under OMB Control Number 0920-1140, expiration date 
10/31/2017.
    The Zika PERsistence (ZIPER) study will help inform the presence 
and duration of Zika virus (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 
Immunoglobulin M (IgM) antibodies and the time for development of 
Immunoglobulin G (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 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 ribonucleic acid (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 4 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 (ml) 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, see below. 
RT-PCR-positive participants will be asked to refer up to 5 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 receipt of the initial OMB information collection approval in 
October 2016, the project has enrolled 295 Zika virus-infected 
individuals into the Zika virus Persistence study, which are 55 
individuals below the target enrollment of 350 individuals. 
Nonetheless, 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 [WBCs] and spermatozoa). CDC's Institutional Review 
Board (IRB) has approved this modification, but information collection 
has not begun.

    There is no cost to respondents other than the time to participate.
    Authorizing legislation comes from Section 301 of the Public Health 
Service Act (42 U.S.C. 241).

[[Page 16839]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of        Average
      Type of respondents           Form name        Number of     responses per    burden per     Total burden
                                                    respondents     respondent    response (hrs)       (hrs)
----------------------------------------------------------------------------------------------------------------
Public health personnel.......  Shedding                      55               8           10/60              74
                                 Questionnaire
                                 (Symptomatics).
                                Shedding                     100               1           10/60              17
                                 Questionnaire
                                 (Cross-
                                 Sectional
                                 Asymptomatics).
                                Questionnaire                 30               1           20/60              10
                                 for men semen
                                 sub-study.
General public................  Shedding                     160               1            2/60               6
                                 Eligibility
                                 Form.
                                Contact                       32               1            2/60               1
                                 Information
                                 Form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             108
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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. 2017-06864 Filed 4-5-17; 8:45 am]
 BILLING CODE 4163-18-P