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)

Page Range		18462-18464
FR Document		2017-07881

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 Issue 74 (Wednesday, April 19, 2017)

[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:
omb@cdc.gov.

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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Respondents Form name respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

[[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

Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices 18463

In addition to mosquito-to-human infection can be done by either using rRT–PCR positive 53 days after
transmission, ZIKV infections have been rRT–PCR to detect the presence of ZIKV returning from travel. This pattern has
documented through sexual RNA or by serologic testing to detect led to the hypothesis that persistent
transmission, blood transfusion, IgM and neutralizing antibodies. rRT– detection of ZIKV RNA in pregnant
laboratory exposure, intrauterine PCR testing has been the preferred and women may be a marker of fetal
transmission resulting in congenital suggested method for diagnosing ZIKV infection and thus potentially a marker
infection, and intrapartum transmission infection, but has a shorter testing of adverse fetal outcomes including
from a viremic mother to her newborn. window. microcephaly.
Along with serum, ZIKV RNA has been ZIKV RNA typically only persists in Additionally, researchers have
detected in semen, urine, breast milk, serum for 3–7 days and is thought to be
speculated that fetal infection might be
and amniotic fluid. ZIKV IgM antibodies cleared by 10 days. Currently, CDC
influenced by viral load as well as
are generally first detectable at 4 to 8 recommends that all pregnant women
persistence. The increasing number of
days after onset of illness and likely living in areas with active ZIKV
cases and stage of the outbreak in Puerto
persist for weeks to months; however, transmission such as Puerto Rico be
Rico provide an opportunity to collect
the duration of persistence of anti ZIKV tested. Symptomatic pregnant women
actionable information on a shorter
IgM antibodies is unknown as well as should have serum and urine tested for
timeframe than is possible elsewhere.
the timing form infection to the the presence of ZIKV RNA by rRT–PCR
development of IgG antibodies. The within two weeks of symptom onset. The ZIRP Puerto Rico study aims to
prevalence of ZIKV RNA in various Symptomatic pregnant women being determine the prevalence and duration
body fluids among patients with acute tested more than two weeks after of ZIKV RNA persistence in pregnant
ZIKV infection and the length of time symptom onset and symptomatic women and congenitally infected
that ZIKV RNA might persist in these women with negative rRT–PCR test infants. This information will be
body fluids is not well understood, nor results should have serologic testing. essential for establishing guidance for
the frequency with which it is Asymptomatic pregnant women are testing and clinical management of
infectious. recommended to have serologic testing pregnant women and congenitally
A few small studies have suggested at the initiation of prenatal care and infected infants with exposure to ZIKV.
that testing pregnant women for Zika again during their first and second Moreover, this study is expected to
virus (ZIKV) more than seven days from trimesters as a part of routine care; provide critical scientific information to
symptom onset might detect women serum and urine rRT–PCR testing help the United States prepare for the
with persistence of ZIKV RNA. Less is should be done after a positive or unprecedented challenges posed by
known about persistent ZIKV RNA in equivocal serological test result. Zika and possible clinical guidelines
congenitally-infected infants. Limited data from human studies related to ZIKV RNA testing.
The Puerto Rico Department of Health suggest that pregnant women have CDC is requesting emergency OMB
(PRDH) reported the first case of persistent detection of ZIKV RNA. In review for six months of clearance.
autochthonous transmission of Zika one case report, a pregnant woman However, because information
Virus (ZIKV) in December 2015. As of became symptomatic at 11 weeks collection is expected to take two years,
December 16, 2016, 35,648 confirmed gestation and was rRT–PCR-positive at CDC will submit a non-emergency
ZIKV cases had been reported in Puerto 16 weeks gestation. In another case information collection request to OMB
Rico, more than any other location in report, a pregnant woman tested for an additional two years of clearance.
the U.S., and the number is expected to positive by rRT–PCR 107 days after
rise. Among the confirmed cases, 2,864 symptom onset. A recent case series Authorizing Legislation for this
have been among pregnant women, and found persistent detection of ZIKV RNA information collection comes from
the first case of microcephaly in a fetus in five pregnant women. Symptomatic Section 301 of the Public Health Service
with confirmed ZIKV infection was women had detectable virus at 17, 23, Act (42 U.S.C. 241)
announced by the PRDH on May 13, 44, and 46 days post symptom onset and There is no cost to respondents other
2016. Currently, testing for ZIKV one asymptomatic woman was still than their time to participate.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per Total burden
Respondents Form name respondents per response hours
respondent (in hours)

ZIKV positive Pregnant women ........ Pregnant women screening form ..... 150 1 2/60 5
Pregnant women enrollment ques- 150 1 8/60 20
tionnaire.
Pregnant women symptom ques- 150 1 8/60 20
tionnaire.
Pregnant women follow-up question- 150 48 8/60 960
naire.
Parents of ZIKV positive Infants ....... Infant enrollment questionnaire ........ 150 1 8/60 20
Infant sample collection question- 150 1 8/60 20
jstallworth on DSK7TPTVN1PROD with NOTICES

naire.
Infant follow-up questionnaire .......... 150 6 8/60 120

Total ........................................... ........................................................... ........................ ........................ ........................ 1,165

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18464 Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices

Leroy A. Richardson, should be received within 30 days of Colombia’s Instituto Nacional de
Chief, Information Collection Review Office, this notice. Salud (INS) began surveillance for ZIKV
Office of Scientific Integrity, Office of the in 2015, reporting the first
Associate Director for Science, Office of the Proposed Project
autochthonous transmission in October
Director, Centers for Disease Control and ZEN Colombia Study: Zika in 2015 in the north of the country. As of
Prevention. Pregnant Women and Children in October 2016, Colombia has reported
[FR Doc. 2017–07881 Filed 4–18–17; 8:45 am] Colombia—New—Pregnancy and Birth over 105,000 suspected ZIKV cases,
BILLING CODE 4163–18–P Defects Task Force, National Center on with over 19,000 of them among
Birth Defects and Developmental pregnant women. With a causal link
Disabilities, Centers for Disease Control established between ZIKV infection in
DEPARTMENT OF HEALTH AND and Prevention (CDC). pregnancy and microcephaly, there is an
HUMAN SERVICES urgent need to understand: How ZIKV
Background and Brief Description
Centers for Disease Control and transmission can be prevented; the full
Zika virus (ZIKV) infection is a
Prevention spectrum of adverse maternal, fetal, and
mosquito-borne flavivirus transmitted
infant health outcomes associated with
by Aedes species mosquitoes, and also
ZIKV infection; and risk factors for
[30Day–17–17ABB] through sexual and mother-to-child
occurrence of these outcomes. To
transmission; laboratory-acquired
answer these questions, INS and CDC
Agency Forms Undergoing Paperwork infections have also been reported.
will follow 5,000 women enrolled in the
Reduction Act Review Evidence of human ZIKV infection was
first trimester of pregnancy, their male
observed sporadically in Africa and
The Centers for Disease Control and partners, and their infants, in various
Asia prior to 2007, when an outbreak of
Prevention (CDC) has submitted the ZIKV caused an estimated 5,000 cities in Colombia where ZIKV
following information collection request infections in the State of Yap, Federated transmission is currently ongoing.
to the Office of Management and Budget States of Micronesia. Since then, The primary research questions we
(OMB) for review and approval in evidence of ZIKV has been found in 65 aim to address with the ZEN Colombia
accordance with the Paperwork countries and territories, mostly in study are:
Reduction Act of 1995. The notice for Central and South America. Common 1. Evaluate associations between
the proposed information collection is symptoms of ZIKV in humans include ZIKV in pregnancy and adverse
published to obtain comments from the rash, fever, arthralgia, and nonpurulent pregnancy or maternal outcomes, such
public and affected agencies. conjunctivitis. The illness is usually as preterm birth, preeclampsia, maternal
Written comments and suggestions mild and self-limited, with symptoms death, postpartum hemorrhage, and
from the public and affected agencies lasting for several days to a week; intrapartum fetal demise, among others.
concerning the proposed collection of however, based on previous outbreaks, Effect modification by gestational age of
information are encouraged. Your some infections are asymptomatic. The infection will also be explored.
comments should address any of the prevalence of asymptomatic infection in 2. Quantify the magnitude of the
following: (a) Evaluate whether the the current Central and South American association between ZIKV infection in
proposed collection of information is epidemic is unknown. pregnancy and major birth defects, with
necessary for the proper performance of Although the clinical presentation of specific focus on microcephaly and
the functions of the agency, including ZIKV infection is typically mild, ZIKV congenital Zika syndrome. The
whether the information will have infection in pregnancy can cause prospective design of the study will
practical utility; (b) Evaluate the microcephaly and related brain allow estimation of both absolute and
accuracy of the agencies estimate of the abnormalities when fetuses are exposed relative risk for microcephaly for
burden of the proposed collection of in utero. Other adverse pregnancy women with ZIKV infection during
information, including the validity of outcomes related to ZIKV infection pregnancy.
the methodology and assumptions used; remain under study, and include 3. Identify risk factors for
(c) Enhance the quality, utility, and pregnancy loss, other major birth symptomatic ZIKV infection in
clarity of the information to be defects, arthrogryposis, eye pregnancy among all women with
collected; (d) Minimize the burden of abnormalities, and neurologic laboratory-confirmed ZIKV in
the collection of information on those abnormalities. pregnancy. A spectrum of risk factors
who are to respond, including through As the spectrum of adverse health will be considered, including maternal
the use of appropriate automated, outcomes potentially related to ZIKV demographics, ZIKV infection
electronic, mechanical, or other infection continues to grow, large gaps characteristics, and other potential risk
technological collection techniques or remain in our understanding of ZIKV factors such as smoking and medication
other forms of information technology, infection in pregnancy. These include use.
e.g., permitting electronic submission of the full spectrum of adverse health 4. Identify risk factors for ZIKV
responses; and (e) Assess information outcomes in pregnant women, fetuses, infection in infancy. A spectrum of risk
collection costs. and infants associated with ZIKV factors will be explored, including
To request additional information on infection; the relative contributions of maternal infection factors and birth and
the proposed project or to obtain a copy sexual transmission and mosquito-borne pregnancy factors.
of the information collection plan and transmission to occurrence of infections 5. Identify risk factors for
instruments, call (404) 639–7570 or in pregnancy; and variability in the risk symptomatic ZIKV infection in infancy
jstallworth on DSK7TPTVN1PROD with NOTICES

send an email to omb@cdc.gov. Direct of adverse fetal outcomes by gestational among infants with laboratory-
written comments and/or suggestions week of maternal infection or symptoms confirmed ZIKV born to women
regarding the items contained in this of infection. There is an urgency to fill enrolled in the study. A spectrum of risk
notice to the Attention: CDC Desk these large gaps in our understanding factors will be considered, including
Officer, Office of Management and given the rapidity of the epidemic’s maternal ZIKV infection in pregnancy
Budget, Washington, DC 20503 or by fax spread and the severe health outcomes factors, co-infections, sociodemographic
to (202) 395–5806. Written comments associated with ZIKV to date. characteristics and birth factors.

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Document Created: 2018-11-14 09:43:34
Document Modified: 2018-11-14 09:43:34

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 June 19, 2017.
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]
FR Citation		82 FR 18462

82 FR 18462 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 82, Issue 74 (April 19, 2017)

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