Proposed Data Collection Submitted for Public Comment and Recommendations, 16837-16839 [2017-06864]
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16837
Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Notices
who drive a company vehicle will also
be asked to complete ‘‘Module 4: Motor
Vehicle.’’ An estimated 75% of the
workers will complete the driving
portion of the survey (187 workers).
This module will take approximately 5
additional minutes to complete for those
using the tablet (approximately 168
workers per year) as well as 5 minutes
for those completing the hardcopy
version (19 workers per year).
Comments submitted in response to
this notice will be reviewed and
addressed prior to OMB application
submission. The total estimated burden
hours are 151.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Form name
Screening of Workers ........................................
O&G Extraction Workers ...................................
O&G Extraction Workers ...................................
Module 1: Screening .........................................
Non Respondent Questionnaire .......................
Tablet Version, Modules 2: General, Module 3:
Well Site Work, and, Module 5: Closing
Questions.
Hardcopy, Version, Modules 2: General, Module 3: Well Site Work, and, Module 5: Closing Questions.
Tablet Version, Module 4: Motor Vehicle .........
Hardcopy Version, Module 4: Motor Vehicle ....
O&G Extraction Workers ...................................
O&G Extraction Workers who drive at work .....
O&G Extraction Workers who drive at work .....
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. 2017–06874 Filed 4–5–17; 8:45 am]
BILLING CODE 4163–18–P
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:51 Apr 05, 2017
Jkt 241001
Number of
respondents
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: 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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
313
63
225
1
1
1
5/60
5/60
25/60
25
1
25/60
168
19
1
1
5/60
5/60
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
E:\FR\FM\06APN1.SGM
06APN1
16838
Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Notices
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.
mstockstill on DSK3G9T082PROD with NOTICES
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
VerDate Sep<11>2014
18:51 Apr 05, 2017
Jkt 241001
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–PCRpositive 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.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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 virusinfected 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 viruspositive 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).
E:\FR\FM\06APN1.SGM
06APN1
16839
Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Public health personnel
General public ...............
Total .......................
Total burden
(hrs)
55
100
8
1
10/60
10/60
74
17
30
160
32
1
1
1
20/60
2/60
2/60
10
6
1
..............................................................................
........................
........................
........................
108
[FR Doc. 2017–06864 Filed 4–5–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–17ZX; Docket No. CDC–2017–
0032]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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 ‘‘Childhood Blood Lead
Surveillance (CBLS) and Adult Blood
Lead Epidemiology and Surveillance
(ABLES).’’ The National Center for
Environmental Health (NCEH) is leading
a new three-year information collection
request (ICR) that covers two CDC
information collections, one for
childhood blood lead surveillance by
NCEH and another for adult blood lead
surveillance by the National Institute for
Occupational Safety and Health
(NIOSH). CDC requests an annual time
burden of 1,120 burden hours for both
collections.
SUMMARY:
mstockstill on DSK3G9T082PROD with NOTICES
Average
burden per
response
(hrs)
Shedding Questionnaire (Symptomatics) ............
Shedding
Questionnaire
(Cross-Sectional
Asymptomatics).
Questionnaire for men semen sub-study ............
Shedding Eligibility Form .....................................
Contact Information Form ....................................
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.
VerDate Sep<11>2014
Number of
responses per
respondent
Number of
respondents
Form name
18:51 Apr 05, 2017
Jkt 241001
Written comments must be
received on or before June 5, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0032 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: 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
DATES:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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
Childhood Blood Lead Surveillance
(CBLS) and Adult Blood Lead
Epidemiology and Surveillance
(ABLES)—New—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
E:\FR\FM\06APN1.SGM
06APN1
]]>Agencies
[Federal Register Volume 82, Number 65 (Thursday, April 6, 2017)]
[Notices]
[Pages 16837-16839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06864]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 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
[[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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
