Clinical Laboratory Improvement Advisory Committee Meeting, 70685-70686 [2016-24785]
Download as PDF
<![CDATA[
70685
Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices
use based on serovar determination, and
assess rodent, livestock, and wildlife
reservoirs of leptospirosis based on
infecting serovars found in dogs.
Findings from this study will aid in the
development of evidence-based,
targeted interventions for the prevention
of canine leptospirosis, be used to focus
human leptospirosis surveillance
efforts, and guide future investigations
on leptospirosis in humans and animals
in Puerto Rico.
The information collection for which
approval is sought is in accordance with
BSPB’s mission to prevent illness,
disability, or death caused by bacterial
zoonotic diseases through surveillance,
epidemic investigations, epidemiologic
and laboratory research, training and
public education. Authorizing
Legislation comes from Section 301 of
the Public Health Service Act (42 U.S.C.
241). Successful execution of BSPB’s
public health mission requires data
collection activities in collaboration
clinics and shelters, including
information about site capacity,
vaccination practices, origin of dogs,
and resources available at the sites.
Data collection tools will be
completed onsite. For dogs that have an
owner, information about the dog may
be collected by veterinarians and their
vet staff by interviewing the dog owner.
Otherwise, data collection tools may be
completed by reviewing administrative
and medical records, as necessary. Data
will be recorded on paper forms. Study
coordinators will enter collected data
into an electronic database.
BSPB estimates involvement of at
least 411 respondents (385 from the
general public and 26 veterinarians and
their veterinary technical staff) and
estimates a total of 168 hours of burden
for research activities each year. The
collected information will not impose a
cost burden on the respondents beyond
that associated with their time to
provide the required data.
with the state health department in
Puerto Rico and with local veterinary
clinics and animal shelters participating
in the study.
These activities include collecting
information about dogs that meet the
study case definition for a suspect case
of leptospirosis seen at participating
veterinary clinics and shelters. The
information is collected by veterinarians
or their veterinary technical staff by
interviewing the dog owner and
reviewing medical and administrative
records, as necessary. Basic information
about the participating sites will also be
collected for study management, as well
as to augment data analysis.
Approval of this data collection tool
will allow BSPB to collect information
from veterinarians, vet staff and dog
owners about the dog’s signalment, risk
factors, clinical signs and symptoms,
laboratory results, treatment, and
outcome. The study will also collect
basic site information from participating
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
Veterinarians or vet technical staff ...
Veterinarians or vet technical staff ...
Veterinarians or vet technical staff ...
Enrollment Questionnaire .................
Log Sheet .........................................
Case Questionnaire .........................
26
26
26
1
24
24
5/60
1/60
15/60
2
10
156
Total ...........................................
...........................................................
........................
........................
........................
168
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. 2016–24667 Filed 10–12–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Lhorne on DSK30JT082PROD with NOTICES
Clinical Laboratory Improvement
Advisory Committee Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following committee
meeting.
Times and Dates:
8:30 a.m.–5 p.m., EDT, November 2,
2016.
8:30 a.m.–12 p.m., EDT, November 3,
2016.
VerDate Sep<11>2014
14:07 Oct 12, 2016
Jkt 241001
Place: CDC, 1600 Clifton Road NE.,
Tom Harkin Global Communications
Center, Building 19, Auditorium B,
Atlanta, Georgia 30329.
Status: Open to the public, limited
only by the space available. The meeting
room accommodates approximately 100
people. This meeting will also be
webcast, please see information below.
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,
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
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 for Discussion: The agenda
will include agency updates from CDC,
CMS, and FDA. Presentations and
discussions will include a report on the
cytology workload assessment and time
measure study; an update on CLIAC
recommendations for laboratory
biosafety; laboratory preparedness and
response: The case of Zika; a report from
the Institute of Medicine (IOM) CLIAC
workgroup; and future CLIAC topics.
Agenda items are subject to change as
priorities dictate.
Webcast: The meeting will also be
webcast. Persons interested in viewing
E:\FR\FM\13OCN1.SGM
13OCN1
Lhorne on DSK30JT082PROD with NOTICES
70686
Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices
the webcast can access information at:
https://
cdclabtraining.adobeconnect.com/
novembercliac/.
Online Registration Required: All
people attending the CLIAC meeting inperson are required to register for the
meeting online at least 5 business days
in advance for U.S. citizens and at least
10 business days in advance for
international registrants. Register at:
https://wwwn.cdc.gov/cliac/Meetings/
MeetingDetails.aspx. 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 27, 2016 for U.S.
registrants and October 20, 2016 for
international registrants.
Providing Oral or Written Comments:
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.
Oral Comments: In general, each
individual or group requesting to make
oral comments will be limited to a total
time of five minutes (unless otherwise
indicated). Speakers must also submit
their comments in writing for inclusion
in the meeting’s Summary Report. 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.
Written Comments: 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.
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.
Availability of Meeting Materials: To
support the green initiatives of the
federal government, 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/
Meetings/MeetingDetails.aspx. Note: If
using a mobile device to access the
materials, please verify that the device’s
VerDate Sep<11>2014
14:07 Oct 12, 2016
Jkt 241001
browser is able to download the files
from the CDC’s Web site before the
meeting.
Alternatively, the files can be
downloaded to a computer and then
emailed to the portable device. An
internet connection, power source, and
limited hard copies may be available at
the meeting location, but cannot be
guaranteed.
Contact Person for Additional
Information: Nancy Anderson, 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; telephone (404)
498–2741; or via email at NAnderson@
cdc.gov.
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 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.
Office, CDC, pursuant to Public Law 92–
463.
Matters For Discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘PAR14–227, Workers’ Compensation
Surveillance, PAR14–227.’’
Contact Person For More Information:
Michael Goldcamp, Ph.D., Scientific
Review Officer, CDC, 1095 Willowdale
Road, Morg Building H, Room 1806,
Mailstop 1808, Morgantown, WV 26506,
Telephone: (304) 285–5951, EHG8@
CDC.GOV.
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. 2016–24786 Filed 10–12–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
[FR Doc. 2016–24785 Filed 10–12–16; 8:45 am]
Office of the Director, National
Institutes of Health; Notice of Closed
Meeting
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces a meeting for the initial
review of applications in response to
Funding Opportunity Announcement
(FOA) PAR14–227, Workers’
Compensation Surveillance.
Time and Date:
1:00 p.m.–6 p.m., EST, November 9,
2016 (Closed)
Place: Teleconference
Status: The meeting will be closed to
the public in accordance with
provisions set forth in section 552b(c)(4)
and (6), title 5 U.S.C., and the
Determination of the Director,
Management Analysis and Services
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Scientific and
Technical Review Board on Biomedical and
Behavioral Research Facilities.
Date: November 9, 2016.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ross D. Shonat, Ph.D.,
Scientific Review Officer, Center for
E:\FR\FM\13OCN1.SGM
13OCN1
]]>Agencies
[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Notices]
[Pages 70685-70686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24785]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Clinical Laboratory Improvement Advisory Committee Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) announces the following committee meeting.
Times and Dates:
8:30 a.m.-5 p.m., EDT, November 2, 2016.
8:30 a.m.-12 p.m., EDT, November 3, 2016.
Place: CDC, 1600 Clifton Road NE., Tom Harkin Global Communications
Center, Building 19, Auditorium B, Atlanta, Georgia 30329.
Status: Open to the public, limited only by the space available.
The meeting room accommodates approximately 100 people. This meeting
will also be webcast, please see information below.
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 for Discussion: The agenda will include agency updates from
CDC, CMS, and FDA. Presentations and discussions will include a report
on the cytology workload assessment and time measure study; an update
on CLIAC recommendations for laboratory biosafety; laboratory
preparedness and response: The case of Zika; a report from the
Institute of Medicine (IOM) CLIAC workgroup; and future CLIAC topics.
Agenda items are subject to change as priorities dictate.
Webcast: The meeting will also be webcast. Persons interested in
viewing
[[Page 70686]]
the webcast can access information at: https://cdclabtraining.adobeconnect.com/novembercliac/.
Online Registration Required: 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 10
business days in advance for international registrants. Register at:
https://wwwn.cdc.gov/cliac/Meetings/MeetingDetails.aspx. 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 27, 2016 for U.S. registrants and
October 20, 2016 for international registrants.
Providing Oral or Written Comments: 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.
Oral Comments: In general, each individual or group requesting to
make oral comments will be limited to a total time of five minutes
(unless otherwise indicated). Speakers must also submit their comments
in writing for inclusion in the meeting's Summary Report. 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.
Written Comments: 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. 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.
Availability of Meeting Materials: To support the green initiatives
of the federal government, 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/Meetings/MeetingDetails.aspx. Note: If using a mobile device to access
the materials, please verify that the device's browser is able to
download the files from the CDC's Web site before the meeting.
Alternatively, the files can be downloaded to a computer and then
emailed to the portable device. An internet connection, power source,
and limited hard copies may be available at the meeting location, but
cannot be guaranteed.
Contact Person for Additional Information: Nancy Anderson, 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; telephone (404) 498-2741; or via email at NAnderson@cdc.gov.
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 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. 2016-24785 Filed 10-12-16; 8:45 am]
BILLING CODE 4163-18-P
