81 FR 70685 - Clinical Laboratory Improvement Advisory Committee Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 198 (October 13, 2016)

Page Range		70685-70686
FR Document		2016-24785

Federal Register, Volume 81 Issue 198 (Thursday, October 13, 2016)

[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Notices]
[Pages 70685-70686]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24785]


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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: http://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: 
http://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: http://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 [email protected].
    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

Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices 70685

use based on serovar determination, and with the state health department in clinics and shelters, including
assess rodent, livestock, and wildlife Puerto Rico and with local veterinary information about site capacity,
reservoirs of leptospirosis based on clinics and animal shelters participating vaccination practices, origin of dogs,
infecting serovars found in dogs. in the study. and resources available at the sites.
Findings from this study will aid in the These activities include collecting Data collection tools will be
development of evidence-based, information about dogs that meet the completed onsite. For dogs that have an
targeted interventions for the prevention study case definition for a suspect case owner, information about the dog may
of canine leptospirosis, be used to focus of leptospirosis seen at participating be collected by veterinarians and their
human leptospirosis surveillance veterinary clinics and shelters. The vet staff by interviewing the dog owner.
efforts, and guide future investigations information is collected by veterinarians Otherwise, data collection tools may be
on leptospirosis in humans and animals or their veterinary technical staff by completed by reviewing administrative
in Puerto Rico. interviewing the dog owner and and medical records, as necessary. Data
The information collection for which reviewing medical and administrative will be recorded on paper forms. Study
approval is sought is in accordance with records, as necessary. Basic information coordinators will enter collected data
BSPB’s mission to prevent illness, about the participating sites will also be into an electronic database.
disability, or death caused by bacterial collected for study management, as well BSPB estimates involvement of at
zoonotic diseases through surveillance, as to augment data analysis. least 411 respondents (385 from the
epidemic investigations, epidemiologic Approval of this data collection tool general public and 26 veterinarians and
and laboratory research, training and will allow BSPB to collect information their veterinary technical staff) and
public education. Authorizing from veterinarians, vet staff and dog estimates a total of 168 hours of burden
Legislation comes from Section 301 of owners about the dog’s signalment, risk for research activities each year. The
the Public Health Service Act (42 U.S.C. factors, clinical signs and symptoms, collected information will not impose a
241). Successful execution of BSPB’s laboratory results, treatment, and cost burden on the respondents beyond
public health mission requires data outcome. The study will also collect that associated with their time to
collection activities in collaboration basic site information from participating provide the required data.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)

Veterinarians or vet technical staff ... Enrollment Questionnaire ................. 26 1 5/60 2
Veterinarians or vet technical staff ... Log Sheet ......................................... 26 24 1/60 10
Veterinarians or vet technical staff ... Case Questionnaire ......................... 26 24 15/60 156

Total ........................................... ........................................................... ........................ ........................ ........................ 168

Leroy A. Richardson, Place: CDC, 1600 Clifton Road NE., timeliness, equity, and patient-
Chief, Information Collection Review Office, Tom Harkin Global Communications centeredness of laboratory services;
Office of Scientific Integrity, Office of the Center, Building 19, Auditorium B, revisions to the standards under which
Associate Director for Science, Office of the Atlanta, Georgia 30329. clinical laboratories are regulated; the
Director, Centers for Disease Control and impact of proposed revisions to the
Prevention. Status: Open to the public, limited
only by the space available. The meeting standards on medical and laboratory
[FR Doc. 2016–24667 Filed 10–12–16; 8:45 am] practice; and the modification of the
room accommodates approximately 100
BILLING CODE 4163–18–P
people. This meeting will also be standards and provision of non-
webcast, please see information below. regulatory guidelines to accommodate
technological advances, such as new
DEPARTMENT OF HEALTH AND Purpose: This Committee is charged test methods, the electronic
HUMAN SERVICES with providing scientific and technical transmission of laboratory information,
advice and guidance to the Secretary of and mechanisms to improve the
Centers for Disease Control and Health and Human Services (HHS); the integration of public health and clinical
Prevention Assistant Secretary for Health; the laboratory practices.
Director, Centers for Disease Control Matters for Discussion: The agenda
Clinical Laboratory Improvement and Prevention; the Commissioner, will include agency updates from CDC,
Advisory Committee Meeting Food and Drug Administration (FDA); CMS, and FDA. Presentations and
and the Administrator, Centers for discussions will include a report on the
In accordance with section 10(a)(2) of
Medicare and Medicaid Services (CMS). cytology workload assessment and time
the Federal Advisory Committee Act
The advice and guidance pertain to measure study; an update on CLIAC
(Pub. L. 92–463), the Centers for Disease
general issues related to improvement in recommendations for laboratory
Control and Prevention (CDC)
clinical laboratory quality and biosafety; laboratory preparedness and
announces the following committee
Lhorne on DSK30JT082PROD with NOTICES

laboratory medicine practice and response: The case of Zika; a report from
meeting.
specific questions related to possible the Institute of Medicine (IOM) CLIAC
Times and Dates: revision of the Clinical Laboratory workgroup; and future CLIAC topics.
8:30 a.m.–5 p.m., EDT, November 2, Improvement Amendment (CLIA) Agenda items are subject to change as
2016. standards. Examples include providing priorities dictate.
8:30 a.m.–12 p.m., EDT, November 3, guidance on studies designed to Webcast: The meeting will also be
2016. improve safety, effectiveness, efficiency, webcast. Persons interested in viewing

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Document Created: 2016-10-13 00:53:52
Document Modified: 2016-10-13 00:53:52

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		81 FR 70685

81 FR 70685 - Clinical Laboratory Improvement Advisory Committee Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 81, Issue 198 (October 13, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention