Proposed Data Collection Submitted for Public Comment and Recommendations, 81143-81144 [2016-27692]
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Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices
(Annex J), Washington, DC 20024. If
possible, submit your paper comment to
the Commission by courier or overnight
service.
The FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
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before January 17, 2017. You can find
more information, including routine
uses permitted by the Privacy Act, in
the Commission’s privacy policy, at
https://www.ftc.gov/ftc/privacy.htm.
David C. Shonka,
Acting General Counsel.
[FR Doc. 2016–27701 Filed 11–16–16; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–17ZQ; Docket No. CDC–2016–
0107]
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 Associated
Neurologic Illness Case Control Study.
This collection intends to identify
potential risk factors for the
development of severe neurologic
illnesses using a case-control
investigation.
SUMMARY:
Written comments must be
received on or before January 17, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0107 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,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
21:24 Nov 16, 2016
Jkt 241001
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
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
81143
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
Zika Virus Associated Neurologic
Illness Case Control Study—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
There is an urgent public health need
to understand the potential association
between neurological illness and Zika
Virus (ZIKV) infection. Currently,
increased numbers of neurologic illness
cases have been reported in ZIKVaffected contexts, but it is not known if
this is due to ZIKV, another etiologic
agent, or some combination/interaction
thereof. The Puerto Rico Department of
Health (PRDH) is establishing
neurologic illness surveillance and
defining baseline incidence toward
investigating the association between
neurologic illness and ZIKV infection in
Puerto Rico. More broadly, the results of
this investigation would be relevant to
other ZIKV-affected contexts, serving
toward enabling clinical and/or public
health action to manage and prevent
additional cases.
A case-control investigation will be
conducted to identify potential risk
factors for the development of
neurological illness. As part of the
investigation, blood specimens will be
collected from cases and matched
controls to evaluate for antibodies
against several pathogens known to
cause neurological illness (e.g.,
influenza) or pathogens hypothesized to
contribute to this illness cluster (e.g.,
ZIKV, dengue virus, chikungunya virus,
HIV, Campylobacter jejuni, Leptospira
species bacteria).
This information collection request is
a continuation on the work begun under
the following Emergency Clearance:
OMB 0920–1106 (Expiration date 9/30/
16). Specifically, beginning in March
2016, CDC collaborated with the PRDH
on the collection of very similar data for
a Guillain-Barre syndrome case-control
E:\FR\FM\17NON1.SGM
17NON1
81144
Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices
investigation. After clinical reports and
field observation of a broader range of
health endpoints, this larger
investigation is now being undertaken
to expand the exploration of the
association of Zika virus infection with
not only Guillain-Barre syndrome but
also other severe neurologic illnesses.
Under this request, case and control
interviews similar to those conducted
under the previously approved
information collection will be
conducted using the questionnaire
developed by the investigation team. All
cases and controls will be asked
questions about activities, antecedent
signs and symptoms of illness, and
exposures in the two months prior to
onset of neurologic illness for cases and
the same time period for their matched
controls. A calendar will be used to
orient cases and controls to the time
period of interest.
As in the previously approved
information collection activities, sera,
urine, and saliva will be collected from
cases and controls at the time of
possible additional testing for GBSassociated biological markers or other
infectious pathogens as clinically
indicated. If a participant does not
provide consent to store the specimens,
all specimens for that participant will be
destroyed once testing for infectious
disease pathogens has been completed.
As with cases, written consent will also
be obtained to review controls’ medical
records, where applicable and available,
using a standardized chart abstraction
form. Diagnostic test results will be
securely transmitted from CDC to PRDH,
which will then transmit diagnostic test
results to participants by telephone or
mail, as they prefer.
Data analysis will focus on potential
demographic, environmental, and/or
medical risk factors for developing
neurologic illness, as well as laboratory
evidence for infection with the
aforementioned pathogens.
The total number of estimated
annualized burden hours for this project
is 90. There are no other costs to
respondents other than their time.
interview using standard techniques.
The sera will be tested for antibodies
against suspected infectious pathogens,
such as ZIKV, dengue virus,
chikungunya virus, influenza virus,
human immunodeficiency virus, and
Leptospira species bacteria. Urine
specimens will be tested by rRT–PCR to
identify ZIKV, dengue virus, or
chikungunya virus.
If any residual specimens are
available from cases, those will also be
obtained and undergo testing for
infectious pathogens. It is not expected
that matched controls will have any
previously collected clinical specimens;
however, in cases where controls had
specimens collected while seeking
medical care for an acute illness
experienced within two months of GBS
symptom onset of the matching case,
these specimens will also be collected
and tested for evidence of infection with
the aforementioned pathogens.
Residual samples will be stored after
infectious testing is complete at the U.S.
CDC with an identification number for
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Public Health Personnel ...................
Severe Neurologic Illness Chart Abstraction Questionnaire.
Severe Neurologic Illness Questionnaire for Cases and Controls.
General Public ..................................
Total ...........................................
...........................................................
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. 2016–27692 Filed 11–16–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[60Day–17–16BGA; Docket No. CDC–2016–
0106]
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:
VerDate Sep<11>2014
21:24 Nov 16, 2016
Jkt 241001
6
1
60
120
1
15/60
30
........................
........................
........................
90
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 entitled ‘‘ZEN
Colombia Study: Zika in Pregnant
Women and Children in Colombia.’’
This collection intends to identify risk
factors for Zika virus (ZIKV) infection in
pregnant women and their infants,
assess the risk for adverse maternal,
fetal, and infant outcomes associated
with ZIKV infection and, assess
modifiers of the risk for adverse
outcomes among pregnant women and
their infants following ZIKV infection.
Written comments must be
received on or before January 17, 2017.
DATES:
Frm 00092
Fmt 4703
Total burden
(in hours)
10
SUMMARY:
PO 00000
Average
burden per
response
(in hours)
Number of
responses per
respondent
Sfmt 4703
You may submit comments,
identified by Docket No. CDC–2016–
0106 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
ADDRESSES:
E:\FR\FM\17NON1.SGM
17NON1
]]>Agencies
[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Notices]
[Pages 81143-81144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27692]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-17-17ZQ; Docket No. CDC-2016-0107]
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
Associated Neurologic Illness Case Control Study. This collection
intends to identify potential risk factors for the development of
severe neurologic illnesses using a case-control investigation.
DATES: Written comments must be received on or before January 17, 2017.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0107 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 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 Associated Neurologic Illness Case Control Study--New--
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
There is an urgent public health need to understand the potential
association between neurological illness and Zika Virus (ZIKV)
infection. Currently, increased numbers of neurologic illness cases
have been reported in ZIKV-affected contexts, but it is not known if
this is due to ZIKV, another etiologic agent, or some combination/
interaction thereof. The Puerto Rico Department of Health (PRDH) is
establishing neurologic illness surveillance and defining baseline
incidence toward investigating the association between neurologic
illness and ZIKV infection in Puerto Rico. More broadly, the results of
this investigation would be relevant to other ZIKV-affected contexts,
serving toward enabling clinical and/or public health action to manage
and prevent additional cases.
A case-control investigation will be conducted to identify
potential risk factors for the development of neurological illness. As
part of the investigation, blood specimens will be collected from cases
and matched controls to evaluate for antibodies against several
pathogens known to cause neurological illness (e.g., influenza) or
pathogens hypothesized to contribute to this illness cluster (e.g.,
ZIKV, dengue virus, chikungunya virus, HIV, Campylobacter jejuni,
Leptospira species bacteria).
This information collection request is a continuation on the work
begun under the following Emergency Clearance: OMB 0920-1106
(Expiration date 9/30/16). Specifically, beginning in March 2016, CDC
collaborated with the PRDH on the collection of very similar data for a
Guillain-Barre syndrome case-control
[[Page 81144]]
investigation. After clinical reports and field observation of a
broader range of health endpoints, this larger investigation is now
being undertaken to expand the exploration of the association of Zika
virus infection with not only Guillain-Barre syndrome but also other
severe neurologic illnesses.
Under this request, case and control interviews similar to those
conducted under the previously approved information collection will be
conducted using the questionnaire developed by the investigation team.
All cases and controls will be asked questions about activities,
antecedent signs and symptoms of illness, and exposures in the two
months prior to onset of neurologic illness for cases and the same time
period for their matched controls. A calendar will be used to orient
cases and controls to the time period of interest.
As in the previously approved information collection activities,
sera, urine, and saliva will be collected from cases and controls at
the time of interview using standard techniques. The sera will be
tested for antibodies against suspected infectious pathogens, such as
ZIKV, dengue virus, chikungunya virus, influenza virus, human
immunodeficiency virus, and Leptospira species bacteria. Urine
specimens will be tested by rRT-PCR to identify ZIKV, dengue virus, or
chikungunya virus.
If any residual specimens are available from cases, those will also
be obtained and undergo testing for infectious pathogens. It is not
expected that matched controls will have any previously collected
clinical specimens; however, in cases where controls had specimens
collected while seeking medical care for an acute illness experienced
within two months of GBS symptom onset of the matching case, these
specimens will also be collected and tested for evidence of infection
with the aforementioned pathogens.
Residual samples will be stored after infectious testing is
complete at the U.S. CDC with an identification number for possible
additional testing for GBS-associated biological markers or other
infectious pathogens as clinically indicated. If a participant does not
provide consent to store the specimens, all specimens for that
participant will be destroyed once testing for infectious disease
pathogens has been completed. As with cases, written consent will also
be obtained to review controls' medical records, where applicable and
available, using a standardized chart abstraction form. Diagnostic test
results will be securely transmitted from CDC to PRDH, which will then
transmit diagnostic test results to participants by telephone or mail,
as they prefer.
Data analysis will focus on potential demographic, environmental,
and/or medical risk factors for developing neurologic illness, as well
as laboratory evidence for infection with the aforementioned pathogens.
The total number of estimated annualized burden hours for this
project is 90. There are no other costs to respondents other than their
time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Public Health Personnel....... Severe 10 6 1 60
Neurologic
Illness Chart
Abstraction
Questionnaire.
General Public................ Severe 120 1 15/60 30
Neurologic
Illness
Questionnaire
for Cases and
Controls.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 90
----------------------------------------------------------------------------------------------------------------
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. 2016-27692 Filed 11-16-16; 8:45 am]
BILLING CODE 4163-18-P
