Proposed Data Collection Submitted for Public Comment and Recommendations, 44128-44129 [2015-18147]
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44128
Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
By order of the Board of Governors of the
Federal Reserve System, July 20, 2015.
Robert deV. Frierson,
Secretary of the Board.
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.
[FR Doc. 2015–18124 Filed 7–23–15; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 6210–01–P
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–FY–15AWA; Docket No. CDC–
2015–0055]
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 a proposed information
collection entitled ‘‘Screening and
Counseling of Male EVD Survivors to
reduce Risk of Sexually Transmitting
Ebola Virus’’. This activity will collect
information on participants’ laboratory
results and sexual activity prior to and
during participation in the screening
program.
SUMMARY:
Written comments must be
received on or before September 22,
2015.
DATES:
You may submit comments,
identified by Docket No. CDC–2015–
0055 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ADDRESSES:
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21:12 Jul 23, 2015
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To
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Screening and Counseling of Male
EVD Survivors to reduce Risk of
Sexually Transmitting Ebola Virus—
New—Center for Global Health (CGH),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Much progress has been made in the
year since the CDC first responded to
the Ebola outbreak in West Africa, but
the agency’s efforts must continue until
there are zero new cases of Ebola virus
disease (EVD). In order to reach the
international goal of zero new EVD
cases in 2015, the agency must intensify
its efforts to identify and prevent every
potential route of human disease
transmission and to understand the
most current community barriers to
reaching that final goal.
The ‘‘Screening and Counseling of
Male EVD Survivors to reduce Risk of
Sexually Transmitting Ebola Virus’’
information collection will help inform
male Ebola infection survivors ≥15 years
of age of Ebola virus detected in their
semen through voluntary laboratory
testing performed in each country.
Participants for the semen testing
program will be recruited by trained
study staff from Ebola treatment units
and survivor registries in Sierra Leone.
Participants will be followed up at
study sites in government hospitals.
Specimens will be tested for Ebola
Virus ribonucleic acid (RNA) by reverse
transcription polymerase chain reaction
test (RT–PCR). Semen specimens will be
collected and tested every two weeks
until two consecutive negative RT–PCR
results are obtained.
Participants will be asked follow-up
questions until their semen specimens
test negative twice consecutively. They
will receive tokens of appreciation for
their participation at the initial visit and
again at every subsequent follow-up
visit and a supply of condoms. A
trained study data manager will collect
test results for all participants in a
laboratory results form. Results and
analyses are needed to update relevant
counseling messages and
recommendations from the Sierra Leone
Ministry of Health, World Health
Organization, and CDC.
This program will provide the
information that is critical to the
development of public health measures,
such as recommendations about sexual
activity and approaches to evaluation of
survivors to determine whether they can
safely resume sexual activity. These
E:\FR\FM\24JYN1.SGM
24JYN1
44129
Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
approaches in turn are expected to
reduce the risk of Ebola resurgence and
mitigate stigma for thousands of
survivors. The information is likewise
critical to reducing the risk that Ebola
would be introduced in a location that
has not previously been affected.
CGH requests a three-year OMB
approval for this information collection
request. The total burden hours for each
semen testing program are 1,664 hours
incurred by 1,000 participants. There
are no other costs to the respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
Number of responses per
respondent
Baseline Questionnaire .........................
1,000
1
20/30
667
Follow-up Questionnaire ........................
1,000
8
10/60
1,334
Consent Form ........................................
1,000
1
2/30
67
................................................................
........................
........................
........................
2,067
Type of respondents
Form name
Male Ebola Survivors ≥15 years
old.
Male Ebola Survivors ≥15 years
old.
Male Ebola Survivors ≥15 years
old.
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. 2015–18147 Filed 7–23–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–15CT]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
VerDate Sep<11>2014
19:59 Jul 23, 2015
Jkt 235001
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Sudden Death in the Young
Registry—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Sudden Death in the Young (SDY)
Every year, infants, children and
adolescents die suddenly and
unexpectedly from previously
undiagnosed conditions. Sudden Death
in the Young (SDY) is defined as any
death of an infant, child, or young adult
(up to the age mandated by each state),
investigated by the medical examiner or
coroner office, except homicides,
suicides, overdoses, poisonings, or other
external injury deaths, for example from
fire or as a passenger in a motor vehicle
accident.
SDY deaths are not routinely or
systematically reported, so estimates of
the annual incidence of SDY vary
PO 00000
Frm 00111
Fmt 4703
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Avg. burden
per response
(in hrs.)
Total burden
(in hrs.)
broadly due to differences in
definitions, inconsistencies in
classifying cause of death on death
certificates, variable ages and types of
study populations, and differing case
ascertainment methodologies. Because
complete information has not been
collected on the incidences, causes, and
risk factors, lack of evidence fuels
disagreements about the best prevention
approaches.
SDY Registry
To address this knowledge gap, the
Centers for Disease Control and
Prevention (CDC), in collaboration with
the National Heart, Lung, and Blood
Institute (NHLBI) and the National
Institute of Neurological Disorders and
Stroke (NINDS) at the National
Institutes of Health (NIH) have
implemented the Sudden Death in the
Young (SDY) Registry (DP14–1403) to
provide technical assistance to improve
the current work of existing Child Death
Review (CDR) programs. The SDY
Registry is an expansion of the CDC’s
Sudden Unexpected Infant Death (SUID)
Case Registry (currently DP12–1202),
which provides technical assistance to
state grantees so they can monitor
sudden unexpected deaths in children
up to age one in their state.
By building on CDC’s successful SUID
Case Registry, the SDY Registry also
provides technical assistance to grantees
so they can improve their state’s
information on infant and child deaths.
This includes two additions to their
usual CDR program: (1) Entering new
SDY information from sources already
available at CDR reviews, (2) conducting
an advanced clinical review of a sub-set
of SDY cases to allow for a more
technical and medical review of
information already compiled. The
intended result will be complete and
timely grantee-based infant and child
E:\FR\FM\24JYN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44128-44129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18147]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-FY-15AWA; Docket No. CDC-2015-0055]
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 a proposed
information collection entitled ``Screening and Counseling of Male EVD
Survivors to reduce Risk of Sexually Transmitting Ebola Virus''. This
activity will collect information on participants' laboratory results
and sexual activity prior to and during participation in the screening
program.
DATES: Written comments must be received on or before September 22,
2015.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0055 by any of the following methods:
Federal eRulemaking Portal: Regulation.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
Screening and Counseling of Male EVD Survivors to reduce Risk of
Sexually Transmitting Ebola Virus--New--Center for Global Health (CGH),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Much progress has been made in the year since the CDC first
responded to the Ebola outbreak in West Africa, but the agency's
efforts must continue until there are zero new cases of Ebola virus
disease (EVD). In order to reach the international goal of zero new EVD
cases in 2015, the agency must intensify its efforts to identify and
prevent every potential route of human disease transmission and to
understand the most current community barriers to reaching that final
goal.
The ``Screening and Counseling of Male EVD Survivors to reduce Risk
of Sexually Transmitting Ebola Virus'' information collection will help
inform male Ebola infection survivors >=15 years of age of Ebola virus
detected in their semen through voluntary laboratory testing performed
in each country. Participants for the semen testing program will be
recruited by trained study staff from Ebola treatment units and
survivor registries in Sierra Leone. Participants will be followed up
at study sites in government hospitals.
Specimens will be tested for Ebola Virus ribonucleic acid (RNA) by
reverse transcription polymerase chain reaction test (RT-PCR). Semen
specimens will be collected and tested every two weeks until two
consecutive negative RT-PCR results are obtained.
Participants will be asked follow-up questions until their semen
specimens test negative twice consecutively. They will receive tokens
of appreciation for their participation at the initial visit and again
at every subsequent follow-up visit and a supply of condoms. A trained
study data manager will collect test results for all participants in a
laboratory results form. Results and analyses are needed to update
relevant counseling messages and recommendations from the Sierra Leone
Ministry of Health, World Health Organization, and CDC.
This program will provide the information that is critical to the
development of public health measures, such as recommendations about
sexual activity and approaches to evaluation of survivors to determine
whether they can safely resume sexual activity. These
[[Page 44129]]
approaches in turn are expected to reduce the risk of Ebola resurgence
and mitigate stigma for thousands of survivors. The information is
likewise critical to reducing the risk that Ebola would be introduced
in a location that has not previously been affected.
CGH requests a three-year OMB approval for this information
collection request. The total burden hours for each semen testing
program are 1,664 hours incurred by 1,000 participants. There are no
other costs to the respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
----------------------------------------------------------------------------------------------------------------
Male Ebola Survivors >=15 Baseline 1,000 1 20/30 667
years old. Questionnaire.
Male Ebola Survivors >=15 Follow-up 1,000 8 10/60 1,334
years old. Questionnaire.
Male Ebola Survivors >=15 Consent Form.... 1,000 1 2/30 67
years old.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 2,067
----------------------------------------------------------------------------------------------------------------
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. 2015-18147 Filed 7-23-15; 8:45 am]
BILLING CODE 4163-18-P
