Agency Forms Undergoing Paperwork Reduction Act Review, 43542-43543 [2017-19748]
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43542
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices
drawn, as in the past, in large measure
from the ranks of other executive branch
agencies. The board shall review and
evaluate the initial appraisal of each
OGE senior executive’s performance by
his or her supervisor, along with any
recommendations in each instance to
the appointing authority relative to the
performance of the senior executive.
This notice updates the membership of
OGE’s SES Performance Review Board
as it was most recently published at 78
FR 76148 (December 16, 2013).
Approved: September 13, 2017.
David J. Apol,
Acting Director, U.S. Office of Government
Ethics.
The following officials have been
appointed members of the SES
Performance Review Board of the Office
of Government Ethics: Shelley K.
Finlayson, [Chair], Chief of Staff and
Program Counsel, Office of Government
Ethics; Stuart Bender, Director, Office of
Ethics, U.S. Department of Agriculture;
Judith S. Kaleta, Deputy General
Counsel, U.S. Department of
Transportation; and Shira Pavis Minton,
Ethics Counsel, Office of the Ethics
Counsel, Securities and Exchange
Commission.
[FR Doc. 2017–19835 Filed 9–15–17; 8:45 am]
BILLING CODE 6345–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–0888]
sradovich on DSKBBY8HB2PROD 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
VerDate Sep<11>2014
16:54 Sep 15, 2017
Jkt 241001
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. Within
30 days of this notice, direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Proposed Project
Factors Influencing the Transmission
of Influenza (OMB Control Number
0920–0888; Expired 6–30–2017)—
Reinstatement with change—National
Institute for Occupational Safety and
Health (NIOSH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The National Institute for
Occupational Safety and Health
(NIOSH) is authorized to conduct
research to advance the health and
safety of workers under Section 20(a)(1)
of the 1970 Occupational Safety and
Health Act. Influenza continues to be a
major public health concern because of
the substantial health burden from
seasonal influenza and the potential for
a severe pandemic. Although influenza
is known to be transmitted by infectious
secretions, these secretions can be
transferred from person to person in
many different ways, and the relative
importance of the different pathways is
not known. The likelihood of the
transmission of influenza virus by small
infectious airborne particles produced
during coughing and breathing is
particularly unclear. The question of
airborne transmission is especially
important in healthcare facilities, where
influenza patients tend to congregate
during influenza season, because it
directly impacts the infection control
and personal protective measures that
should be taken by healthcare workers.
Work under the previous approval
showed that patients infected with
influenza virus produce airborne
particles containing viable airborne
influenza virus during both breathing
PO 00000
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Fmt 4703
Sfmt 4703
and coughing, but that breathing may
generate more airborne infectious
material than coughing over time.
However, this work was hampered
because the amounts of influenza virus
in almost all of the aerosol samples were
below the limit of quantification. Thus,
CDC made the following changes to the
project:
(1) CDC will modify the cough and
exhalation-aerosol collection system to
collect aerosol particles continuously
for 40 minutes, rather than collecting
particles from discrete coughs and
exhalations as in the previous study.
This will increase the amount of
influenza virus that is collected.
(2) Researchers will collect a blood
sample from each participant to allow
testing for blood markers of influenza
infection and a comparison of the levels
of these markers to the amount of
expelled influenza in aerosol particles.
(3) Researchers increased the time
required for participation from 63
minutes to 95 minutes to allow for a
longer aerosol collection period and for
the blood collection.
(4) Researchers will recruit and test an
equal number of control subjects
without symptoms of respiratory illness
in addition to subjects with influenzalike illness. This will allow the
determination of the differences in
blood biomarker levels between healthy
and infected subjects.
(5) Because of the longer participation
time and because blood collection has
been found to be a strong disincentive
for participation, the token of
appreciation for participating in the
study has been increased from $25 to
$40.
The purpose of the proposed study is
to gain a better understanding of the
production of infectious aerosols by
patients with influenza, and to compare
this to the levels of biomarkers of
influenza infection in the blood of these
patients. To do this, researchers will
collect airborne particles produced by
volunteer subjects with influenza to test
for influenza virus. Researchers will
also measure the levels of influenza
infection-associated biomarkers in blood
samples from these subjects.
A test coordinator will recruit
volunteer adult participants by using a
poster and flyers describing the study.
Researchers will verbally screen
interested potential participants to
verify that they have influenza-like
symptoms and that they do not have any
medical conditions that would preclude
their participation. Researchers will also
recruit a matching number of healthy
control participants.
Researchers will ask qualified
participants who agree to participate in
E:\FR\FM\18SEN1.SGM
18SEN1
43543
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices
the study to read and sign an informed
consent form, and then to complete a
short health questionnaire. After
completing the forms, researchers will
measure the participant’s oral
temperature and collect two
nasopharyngeal mucus samples and five
ml of blood. The researchers will then
ask the participants to don elastomeric
masks, and breathe and cough normally
for 40 minutes into an aerosol particle
collection system. The total time from
initial verbal screening to completion
will be about 95 minutes.
The study will require 90 volunteer
test subjects each year for 3 years,
totaling 270 test participants. There are
no costs to respondents other than their
time. The total number of annual
burden hours are 148.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Potential participant
Qualified participant
Qualified participant
Qualified participant
........................................
........................................
........................................
........................................
Leroy 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. 2017–19748 Filed 9–15–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee (CLIAC)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
Centers for Disease Control and
Prevention (CDC), announces the
following meeting for the Clinical
Laboratory Improvement Advisory
Committee (CLIAC). This meeting is
open to the public, limited only by the
space available. The meeting room
accommodates approximately 100
people. The public is also welcome to
view the meeting by webcast https://
cdclabtraining.adobeconnect.com/cliac.
DATES: The meeting will be held on
November 1, 2017, 8:30 a.m. to 5:00
p.m., EDT and November 2, 2017, 8:30
a.m. to 12:00 p.m., EDT.
ADDRESSES: CDC, 2500 Century Center
Boulevard, Rooms 1200/1201, Atlanta,
Georgia 30345 and https://cdclab
training.adobeconnect.com/cliac.
FOR FURTHER INFORMATION CONTACT:
Nancy Anderson, MMSc, MT(ASCP),
Chief, Laboratory Practice Standards
Branch, Division of Laboratory Systems,
sradovich on DSKBBY8HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:54 Sep 15, 2017
Jkt 241001
Number of
respondents
Form name
Initial verbal screening ...................................
Informed consent form ...................................
Health questionnaire ......................................
Medical testing ...............................................
Center for Surveillance, Epidemiology
and Laboratory Services, Office of
Public Health Scientific Services,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE.,
Mailstop F–11, Atlanta, Georgia 30329–
4018, telephone (404) 498–2741;
NAnderson@cdc.gov.
SUPPLEMENTARY INFORMATION: Purpose:
This Committee is charged with
providing scientific and technical
advice and guidance to the Secretary of
Health and Human Services (HHS); the
Assistant Secretary for Health; the
Director, Centers for Disease Control
and Prevention; the Commissioner,
Food and Drug Administration (FDA);
and the Administrator, Centers for
Medicare and Medicaid Services (CMS).
The advice and guidance pertain to
general issues related to improvement in
clinical laboratory quality and
laboratory medicine practice and
specific questions related to possible
revision of the Clinical Laboratory
Improvement Amendment (CLIA)
standards. Examples include providing
guidance on studies designed to
improve safety, effectiveness, efficiency,
timeliness, equity, and patientcenteredness of laboratory services;
revisions to the standards under which
clinical laboratories are regulated; the
impact of proposed revisions to the
standards on medical and laboratory
practice; and the modification of the
standards and provision of nonregulatory guidelines to accommodate
technological advances, such as new
test methods, the electronic
transmission of laboratory information,
and mechanisms to improve the
integration of public health and clinical
laboratory practices.
Matters To Be Considered: The agenda
will include agency updates from CDC,
Centers for Medicare and Medicaid
Services (CMS), and The Food and Drug
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180
90
90
90
Number of
responses per
respondent
1
1
1
1
Average
burden per
response
(in hrs.)
3/60
15/60
5/60
72/60
Administration (FDA). Presentations
and discussions will focus on laboratory
testing in the era of telemedicine;
antibiotic resistance testing issues;
culture independent diagnostic tests;
and a report from the Institute of
Medicine (IOM) CLIAC workgroup.
Agenda items are subject to change as
priorities dictate.
All people attending the CLIAC
meeting in-person are required to
register for the meeting online at least 5
business days in advance for U.S.
citizens and at least 30 business days in
advance for international registrants.
Register at: https://wwwn.cdc.gov/
cliac/. Register by scrolling down and
clicking the ‘‘Register for this Meeting’’
button and completing all forms
according to the instructions given.
Please complete all the required fields
before submitting your registration and
submit no later than October 25, 2017
for U.S. registrants and September 19,
2017 for international registrants.
It is the policy of CLIAC to accept
written public comments and provide a
brief period for oral public comments on
agenda items. Public comment periods
for each agenda item are scheduled
immediately prior to the Committee
discussion period for that item. In
general, each individual or group
requesting to make oral comments will
be limited to a total time of five minutes
(unless otherwise indicated). To assure
adequate time is scheduled for public
comments, speakers should notify the
contact person below at least one week
prior to the meeting date. For
individuals or groups unable to attend
the meeting, CLIAC accepts written
comments until the date of the meeting
(unless otherwise stated). However, it is
requested that comments be submitted
at least one week prior to the meeting
date so that the comments may be made
available to the Committee for their
consideration and public distribution.
E:\FR\FM\18SEN1.SGM
18SEN1
]]>Agencies
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43542-43543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19748]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-17-0888]
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. Within 30 days of this
notice, direct written comments and/or suggestions regarding the items
contained in this notice to the Attention: CDC Desk Officer, Office of
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806.
Proposed Project
Factors Influencing the Transmission of Influenza (OMB Control
Number 0920-0888; Expired 6-30-2017)--Reinstatement with change--
National Institute for Occupational Safety and Health (NIOSH), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
The National Institute for Occupational Safety and Health (NIOSH)
is authorized to conduct research to advance the health and safety of
workers under Section 20(a)(1) of the 1970 Occupational Safety and
Health Act. Influenza continues to be a major public health concern
because of the substantial health burden from seasonal influenza and
the potential for a severe pandemic. Although influenza is known to be
transmitted by infectious secretions, these secretions can be
transferred from person to person in many different ways, and the
relative importance of the different pathways is not known. The
likelihood of the transmission of influenza virus by small infectious
airborne particles produced during coughing and breathing is
particularly unclear. The question of airborne transmission is
especially important in healthcare facilities, where influenza patients
tend to congregate during influenza season, because it directly impacts
the infection control and personal protective measures that should be
taken by healthcare workers.
Work under the previous approval showed that patients infected with
influenza virus produce airborne particles containing viable airborne
influenza virus during both breathing and coughing, but that breathing
may generate more airborne infectious material than coughing over time.
However, this work was hampered because the amounts of influenza virus
in almost all of the aerosol samples were below the limit of
quantification. Thus, CDC made the following changes to the project:
(1) CDC will modify the cough and exhalation-aerosol collection
system to collect aerosol particles continuously for 40 minutes, rather
than collecting particles from discrete coughs and exhalations as in
the previous study. This will increase the amount of influenza virus
that is collected.
(2) Researchers will collect a blood sample from each participant
to allow testing for blood markers of influenza infection and a
comparison of the levels of these markers to the amount of expelled
influenza in aerosol particles.
(3) Researchers increased the time required for participation from
63 minutes to 95 minutes to allow for a longer aerosol collection
period and for the blood collection.
(4) Researchers will recruit and test an equal number of control
subjects without symptoms of respiratory illness in addition to
subjects with influenza-like illness. This will allow the determination
of the differences in blood biomarker levels between healthy and
infected subjects.
(5) Because of the longer participation time and because blood
collection has been found to be a strong disincentive for
participation, the token of appreciation for participating in the study
has been increased from $25 to $40.
The purpose of the proposed study is to gain a better understanding
of the production of infectious aerosols by patients with influenza,
and to compare this to the levels of biomarkers of influenza infection
in the blood of these patients. To do this, researchers will collect
airborne particles produced by volunteer subjects with influenza to
test for influenza virus. Researchers will also measure the levels of
influenza infection-associated biomarkers in blood samples from these
subjects.
A test coordinator will recruit volunteer adult participants by
using a poster and flyers describing the study. Researchers will
verbally screen interested potential participants to verify that they
have influenza-like symptoms and that they do not have any medical
conditions that would preclude their participation. Researchers will
also recruit a matching number of healthy control participants.
Researchers will ask qualified participants who agree to
participate in
[[Page 43543]]
the study to read and sign an informed consent form, and then to
complete a short health questionnaire. After completing the forms,
researchers will measure the participant's oral temperature and collect
two nasopharyngeal mucus samples and five ml of blood. The researchers
will then ask the participants to don elastomeric masks, and breathe
and cough normally for 40 minutes into an aerosol particle collection
system. The total time from initial verbal screening to completion will
be about 95 minutes.
The study will require 90 volunteer test subjects each year for 3
years, totaling 270 test participants. There are no costs to
respondents other than their time. The total number of annual burden
hours are 148.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
----------------------------------------------------------------------------------------------------------------
Potential participant................. Initial verbal screening 180 1 3/60
Qualified participant................. Informed consent form... 90 1 15/60
Qualified participant................. Health questionnaire.... 90 1 5/60
Qualified participant................. Medical testing......... 90 1 72/60
----------------------------------------------------------------------------------------------------------------
Leroy 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. 2017-19748 Filed 9-15-17; 8:45 am]
BILLING CODE 4163-18-P
