Clinical Laboratory Improvement Advisory Committee (CLIAC), 43543-43544 [2017-19498]
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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
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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
PO 00000
Frm 00030
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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
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43544
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices
Written comments, one hard copy with
original signature, should be provided
to the contact person at the mailing or
email address below, and will be
included in the meeting’s Summary
Report.
The CLIAC meeting materials will be
made available to the Committee and
the public in electronic format (PDF) on
the internet instead of by printed copy.
Check the CLIAC Web site on the day
of the meeting for materials: https://
wwwn.cdc.gov/cliac/.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2017–19498 Filed 9–15–17; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Solicitation of Nominations for
Appointment to the Healthcare
Infection Control Practices Advisory
Committee (HICPAC)
ACTION:
Notice.
The Centers for Disease
Control and Prevention (CDC) is seeking
nominations for membership on the
HICPAC. The HICPAC consists of 14
experts in fields including but not
limited to, infectious diseases, infection
prevention, healthcare epidemiology,
nursing, clinical microbiology, surgery,
hospitalist medicine, internal medicine,
epidemiology, health policy, health
services research, public health, and
related medical fields. Nominations are
being sought for individuals who have
expertise and qualifications necessary to
contribute to the accomplishments of
the committee’s objectives. Nominees
will be selected based on expertise in
the fields of infectious diseases,
infection prevention, healthcare
epidemiology, nursing, environmental
and clinical microbiology, surgery,
internal medicine, epidemiology, health
policy, health services research, and
public health. Federal employees will
not be considered for membership.
Members may be invited to serve for
sradovich on DSKBBY8HB2PROD with NOTICES
SUMMARY:
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four-year terms. Selection of members is
based on candidates’ qualifications to
contribute to the accomplishment of
HICPAC objectives https://
www.cdc.gov/hicpac/.
DATES: Nominations for membership on
the HICPAC be received no later than
November 30, 2017. Packages received
after this time will not be considered for
the current membership cycle.
ADDRESSES: All nominations should be
mailed to HICPAC, Division of
Healthcare Quality Promotion, NCEZID,
CDC, 1600 Clifton Road NE., Mailstop
A–07, Atlanta, Georgia 30333, emailed
(recommended) to hicpac@cdc.gov, or
faxed to (404) 639–4043.
FOR FURTHER INFORMATION CONTACT: Erin
Stone, M.S., HICPAC, Division of
Healthcare Quality Promotion, NCEZID,
CDC, 1600 Clifton Road NE., Mailstop
A–07, Atlanta, Georgia 30333;
Telephone (404) 639–4045; hicpac@
cdc.gov.
SUPPLEMENTARY INFORMATION: The U.S.
Department of Health and Human
Services policy stipulates that
committee membership be balanced in
terms of points of view represented, and
the committee’s function. Appointments
shall be made without discrimination
on the basis of age, race, ethnicity,
gender, sexual orientation, gender
identity, HIV status, disability, and
cultural, religious, or socioeconomic
status. Nominees must be U.S. citizens,
and cannot be full-time employees of
the U.S. Government. Current
participation on federal workgroups or
prior experience serving on a federal
advisory committee does not disqualify
a candidate; however, HHS policy is to
avoid excessive individual service on
advisory committees and multiple
committee memberships. Committee
members are Special Government
Employees, requiring the filing of
financial disclosure reports at the
beginning and annually during their
terms. CDC reviews potential candidates
for HICPAC membership each year, and
provides a slate of nominees for
consideration to the Secretary of HHS
for final selection. HHS notifies selected
candidates of their appointment near
the start of the term in July 2018, or as
soon as the HHS selection process is
completed. Note that the need for
different expertise varies from year to
year and a candidate who is not selected
in one year may be reconsidered in a
subsequent year.
Nominees must be U.S. citizens, and
cannot be full-time employees of the
U.S. Government. Candidates should
submit the following items:
D Current curriculum vitae, including
complete contact information
PO 00000
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(telephone numbers, mailing address,
email address)
D At least one letter of
recommendation from person(s) not
employed by the U.S. Department of
Health and Human Services.
(Candidates may submit letter(s) from
current HHS employees if they wish,
but at least one letter must be submitted
by a person not employed by an HHS
agency (e.g., CDC, NIH, FDA, etc.).
Nominations may be submitted by the
candidate him- or herself, or by the
person/organization recommending the
candidate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the Agency for Toxic Substances and
Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2017–19501 Filed 9–15–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–17ABE]
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
E:\FR\FM\18SEN1.SGM
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Agencies
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43543-43544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19498]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Clinical Laboratory Improvement Advisory Committee (CLIAC)
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: 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://cdclabtraining.adobeconnect.com/cliac.
FOR FURTHER INFORMATION CONTACT: Nancy Anderson, MMSc, MT(ASCP), Chief,
Laboratory Practice Standards Branch, Division of Laboratory Systems,
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 patient-centeredness
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 non-regulatory 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 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/ 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.
[[Page 43544]]
Written comments, one hard copy with original signature, should be
provided to the contact person at the mailing or email address below,
and will be included in the meeting's Summary Report.
The CLIAC meeting materials will be made available to the Committee
and the public in electronic format (PDF) on the internet instead of by
printed copy. Check the CLIAC Web site on the day of the meeting for
materials: https://wwwn.cdc.gov/cliac/.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2017-19498 Filed 9-15-17; 8:45 am]
BILLING CODE 4163-19-P