Agency Forms Undergoing Paperwork Reduction Act Review, 44865-44866 [2016-16297]
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Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
expressions of interest no later than
August 25, 2016.
ADDRESSES: Expressions of interest may
be directed electronically to Bryan
Beamer at zmy4@cdc.gov or mailed to
National Institute for Occupational
Safety and Health, Division of Applied
Research and Technology, 1090
Tusculum Avenue, MS C–27,
Cincinnati, OH 45226. Attention: Bryan
Beamer.
FOR FURTHER INFORMATION CONTACT:
Questions may be directed to Bryan
Beamer, National Institute for
Occupational Safety and Health,
Division of Applied Research and
Technology, 1090 Tusculum Ave., MS
C–27, Cincinnati, OH 45226. Email:
zmy4@cdc.gov.
SUPPLEMENTARY INFORMATION: NIOSH
has developed the Buy Quiet Web Tool
and the Database of Noise Levels for
Machinery and Power Tools with the
goal of reducing noise-induced hearing
loss among the nation’s workers by
providing information and tools to
facilitate, document, and track the
progress of Buy Quiet programs. NIOSH
is looking for one organization to host
and maintain either one or both of the
Buy Quiet Web Tool and the interactive
Database of Noise Levels for Machinery
and Power Tools. The grantee
organization would ideally possess the
following qualifications:
• Ability to promote the web tools
with national reach;
• access to subject matter experts in
information technologies related to
Web-based database development and
maintenance;
• access to subject matter experts in
occupational noise mitigation;
• access to appropriate information
technology hardware and software;
• ability to solicit, accept, vet and
maintain noise level data from
manufacturers for the Database of Noise
Levels for Machinery and Power Tools;
• ability to solicit and maintain Buy
Quiet program data for a variety of
companies; and
• ability to host and maintain the web
tools for a minimum period of 3 years
from the date the tools are made
available to the general public.
Furthermore, the organization is to
make these tools available to the general
public within 12 months of signing the
license agreement.
Links to the NIOSH Buy Quiet Web
site and the current NIOSH Power Tools
Database can be found here:
• https://www.cdc.gov/niosh/topics/
buyquiet/default.html—Buy Quiet
Web site
• https://wwwn.cdc.gov/niosh-soundvibration/—NIOSH Power Tools
Database
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44865
Information Needed: Expressions of
interest should outline the
organization’s ability to meet the
preferred qualifications mentioned
above and be no more than four pages
in length.
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.
Dated: July 5, 2016.
Frank Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention.
Proposed Project
Zika Virus Persistence in Body Fluids
of Patients with Zika Virus Infection in
Puerto Rico (ZIPER Study)—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
[FR Doc. 2016–16267 Filed 7–8–16; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–16ARP]
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
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
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Background and Brief Description
Zika virus (ZIKV) is a mosquito-borne
flavivirus that has recently emerged in
the Americas. Previously, outbreaks had
occurred in Asia and islands in the
South Pacific. In addition to mosquitoto-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 from 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. Characterizing these
parameters has implications both for
diagnosis of ZIKV infection using
specimens other than blood than may be
more convenient to collect, as well as
for potential human-to-human
transmission.
The Zika PERsistence (ZIPER) study
will help inform the presence and
duration of 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 IgM
antibodies and the time for development
of IgG antibodies among the same
population. In addition, this protocol
will determine the prevalence of antiZIKV 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
E:\FR\FM\11JYN1.SGM
11JYN1
44866
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
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.
There are no costs to the respondents
other than their time. The total
estimated annual burden hours are 374.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Public Health Personnel .........
Shedding Questionnaire (Symptomatics) ...............................
Shedding Questionnaire (Cross-Sectional Asymptomatics) ..
Shedding Eligibility Form ........................................................
Contact Information Form ......................................................
General Public ........................
Jeffrey M. Zirger,
Health Scientist, Acting 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. 2016–16297 Filed 7–8–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–16ASR]
sradovich on DSK3GDR082PROD 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
the collection of information on those
who are to respond, including through
VerDate Sep<11>2014
16:55 Jul 08, 2016
Jkt 238001
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
Persistence of Zika Virus in Semen
and Urine of Adult Men in the United
States with Confirmed Zika Virus
Infection—New—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Zika virus is an arthropod-borne
flavivirus that has recently emerged in
the Americas. Maternal infection has
been linked to congenital microcephaly,
fetal loss, and other adverse
reproductive health outcomes. Although
spread primarily by mosquitoes, recent
reports have highlighted the potential
for sexual transmission of Zika virus
through the semen of infected men.
Detection of viral RNA in semen 62 days
after illness onset has been reported;
however the frequency and duration of
virus shedding is largely unknown.
Information on these parameters is
needed urgently to better inform public
health recommendations, particularly
for couples contemplating pregnancy.
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
200
400
1,000
200
Number of
responses per
respondent
8
1
1
1
Average
burden per
response
(in hours)
10/60
10/60
2/60
2/60
This study will fill gaps in the
scientific knowledge base for Zika virus
regarding the persistence and
transmissibility of Zika virus in body
fluids, and determine the frequency and
duration of Zika virus shedding in
semen and urine of infected men.
Minimal health information and
specimens from consenting men with
recent Zika virus infection will be
collected once every two weeks for up
to 6 months post onset of symptoms (or
up to 12 collections). Specimens will be
tested for Zika RNA by reverse
transcriptase polymerase chain reaction
assay (RT–PCR) at CDC; those testing
positive may be further evaluated by
virus isolation techniques. Zika virus
disease is a nationally notifiable
condition, and participants will be
recruited through contact with CDC
personnel. Urine and semen specimens
will be self-collected using home
collection kits, a short questionnaire
will be self-administered, and
participants will be compensated for
their time. Results of testing will be
provided to participants at the
conclusion of testing. The results of this
study are expected to have immediate
implications for public health
recommendations and disease
prevention.
This is a prospective, descriptive
cohort study. The prospective nature of
the proposed cohort study allows for
determining the persistence of shedding
Zika virus in semen and urine through
serial specimen collection from
individuals with confirmed Zika virus.
The results of this study will be of
great relevance to provide evidencebased information to circumvent Zika
virus transmission. They will inform the
development of recommendations used
in the current epidemic setting, as well
as in future Zika virus situations.
Results and analysis will be used to
update and refine relevant counseling
messages and recommendations.
E:\FR\FM\11JYN1.SGM
11JYN1
]]>Agencies
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44865-44866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16297]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-16ARP]
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 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
Zika Virus Persistence in Body Fluids of Patients with Zika Virus
Infection in Puerto Rico (ZIPER Study)--New--National Center for
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Zika virus (ZIKV) is a mosquito-borne flavivirus that has recently
emerged in the Americas. Previously, outbreaks had occurred in Asia and
islands in the South Pacific. 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 from 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. Characterizing these parameters
has implications both for diagnosis of ZIKV infection using specimens
other than blood than may be more convenient to collect, as well as for
potential human-to-human transmission.
The Zika PERsistence (ZIPER) study will help inform the presence
and duration of 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 IgM antibodies and the
time for development of IgG antibodies among the same population. In
addition, this protocol 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
[[Page 44866]]
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.
There are no costs to the respondents other than their time. The
total estimated annual burden hours are 374.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Public Health Personnel............ Shedding Questionnaire 200 8 10/60
(Symptomatics).
Shedding Questionnaire 400 1 10/60
(Cross-Sectional
Asymptomatics).
General Public..................... Shedding Eligibility Form.. 1,000 1 2/60
Contact Information Form... 200 1 2/60
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Health Scientist, Acting 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. 2016-16297 Filed 7-8-16; 8:45 am]
BILLING CODE 4163-18-P
