82 FR 18462 - 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 74 (April 19, 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 a proposed information collection project titled ``ZIRP Puerto Rico Study: Zika Virus RNA Persistence in Pregnant Women and Congenitally-Infected Infants in Puerto Rico.''

[Federal Register Volume 82, Number 74 (Wednesday, April 19, 2017)]
[Notices]
[Pages 18462-18464]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17NF; Docket No. CDC-2017-0006]


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 a proposed 
information collection project titled ``ZIRP Puerto Rico Study: Zika 
Virus RNA Persistence in Pregnant Women and Congenitally-Infected 
Infants in Puerto Rico.''

DATES: Written comments must be received on or before June 19, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0006 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 Leroy A. Richardson, 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

    ZIRP Puerto Rico Study: Zika Virus RNA Persistence in Pregnant 
Women and Congenitally-Infected Infants in Puerto Rico--New--National 
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    Zika virus (ZIKV) infection is a mosquito-borne flavivirus 
transmitted by Aedes species mosquitoes, and also through sexual and 
mother-to-child transmission; laboratory-acquired infections have also 
been reported. Evidence of human ZIKV infection was observed 
sporadically in Africa and Asia prior to 2007 when an outbreak of ZIKV 
caused an estimated 5,000 infections in the State of Yap, Federated 
States of Micronesia.

[[Page 18463]]

    In addition to mosquito-to-human transmission, ZIKV infections have 
been documented through sexual transmission, blood transfusion, 
laboratory exposure, intrauterine transmission resulting in congenital 
infection, and intrapartum transmission from a viremic mother to her 
newborn. Along with serum, ZIKV RNA has been detected in semen, urine, 
breast milk, and amniotic fluid. ZIKV IgM antibodies are generally 
first detectable at 4 to 8 days after onset of illness and likely 
persist for weeks to months; however, the duration of persistence of 
anti ZIKV IgM antibodies is unknown as well as the timing form 
infection to the development of IgG antibodies. The prevalence of ZIKV 
RNA in various body fluids among patients with acute ZIKV infection and 
the length of time that ZIKV RNA might persist in these body fluids is 
not well understood, nor the frequency with which it is infectious.
    A few small studies have suggested that testing pregnant women for 
Zika virus (ZIKV) more than seven days from symptom onset might detect 
women with persistence of ZIKV RNA. Less is known about persistent ZIKV 
RNA in congenitally-infected infants.
    The Puerto Rico Department of Health (PRDH) reported the first case 
of autochthonous transmission of Zika Virus (ZIKV) in December 2015. As 
of December 16, 2016, 35,648 confirmed ZIKV cases had been reported in 
Puerto Rico, more than any other location in the U.S., and the number 
is expected to rise. Among the confirmed cases, 2,864 have been among 
pregnant women, and the first case of microcephaly in a fetus with 
confirmed ZIKV infection was announced by the PRDH on May 13, 2016. 
Currently, testing for ZIKV infection can be done by either using rRT-
PCR to detect the presence of ZIKV RNA or by serologic testing to 
detect IgM and neutralizing antibodies. rRT-PCR testing has been the 
preferred and suggested method for diagnosing ZIKV infection, but has a 
shorter testing window.
    ZIKV RNA typically only persists in serum for 3-7 days and is 
thought to be cleared by 10 days. Currently, CDC recommends that all 
pregnant women living in areas with active ZIKV transmission such as 
Puerto Rico be tested. Symptomatic pregnant women should have serum and 
urine tested for the presence of ZIKV RNA by rRT-PCR within two weeks 
of symptom onset. Symptomatic pregnant women being tested more than two 
weeks after symptom onset and symptomatic women with negative rRT-PCR 
test results should have serologic testing. Asymptomatic pregnant women 
are recommended to have serologic testing at the initiation of prenatal 
care and again during their first and second trimesters as a part of 
routine care; serum and urine rRT-PCR testing should be done after a 
positive or equivocal serological test result.
    Limited data from human studies suggest that pregnant women have 
persistent detection of ZIKV RNA. In one case report, a pregnant woman 
became symptomatic at 11 weeks gestation and was rRT-PCR-positive at 16 
weeks gestation. In another case report, a pregnant woman tested 
positive by rRT-PCR 107 days after symptom onset. A recent case series 
found persistent detection of ZIKV RNA in five pregnant women. 
Symptomatic women had detectable virus at 17, 23, 44, and 46 days post 
symptom onset and one asymptomatic woman was still rRT-PCR positive 53 
days after returning from travel. This pattern has led to the 
hypothesis that persistent detection of ZIKV RNA in pregnant women may 
be a marker of fetal infection and thus potentially a marker of adverse 
fetal outcomes including microcephaly.
Additionally, researchers have speculated that fetal infection might be 
influenced by viral load as well as persistence. The increasing number 
of cases and stage of the outbreak in Puerto Rico provide an 
opportunity to collect actionable information on a shorter timeframe 
than is possible elsewhere.
    The ZIRP Puerto Rico study aims to determine the prevalence and 
duration of ZIKV RNA persistence in pregnant women and congenitally 
infected infants. This information will be essential for establishing 
guidance for testing and clinical management of pregnant women and 
congenitally infected infants with exposure to ZIKV. Moreover, this 
study is expected to provide critical scientific information to help 
the United States prepare for the unprecedented challenges posed by 
Zika and possible clinical guidelines related to ZIKV RNA testing.
    CDC is requesting emergency OMB review for six months of clearance. 
However, because information collection is expected to take two years, 
CDC will submit a non-emergency information collection request to OMB 
for an additional two years of clearance.
    Authorizing Legislation for this information collection 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
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
          Respondents               Form name       respondents   responses  per   response  (in       hours
                                                                     respondent       hours)
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ZIKV positive Pregnant women..  Pregnant women               150               1            2/60               5
                                 screening form.
                                Pregnant women               150               1            8/60              20
                                 enrollment
                                 questionnaire.
                                Pregnant women               150               1            8/60              20
                                 symptom
                                 questionnaire.
                                Pregnant women               150              48            8/60             960
                                 follow-up
                                 questionnaire.
Parents of ZIKV positive        Infant                       150               1            8/60              20
 Infants.                        enrollment
                                 questionnaire.
                                Infant sample                150               1            8/60              20
                                 collection
                                 questionnaire.
                                Infant follow-up             150               6            8/60             120
                                 questionnaire.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,165
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[[Page 18464]]

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. 2017-07881 Filed 4-18-17; 8:45 am]
 BILLING CODE 4163-18-P