82_FR_13166 82 FR 13121 - Clinical Laboratory Improvement Advisory Committee

82 FR 13121 - Clinical Laboratory Improvement Advisory Committee

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

Federal Register Volume 82, Issue 45 (March 9, 2017)

Page Range13121-13122
FR Document2017-04621

Federal Register, Volume 82 Issue 45 (Thursday, March 9, 2017) 
[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Notices]
[Pages 13121-13122]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Clinical Laboratory Improvement Advisory Committee

    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.-5:00 p.m., EDT, April 12, 2017
8:30 a.m.-12:00 p.m., EDT, April 13, 2017

    Place: CDC, 1600 Clifton Road NE., Tom Harkin Global Communications 
Center, Building 19, Auditorium B, Atlanta, Georgia 30333.
    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 focus on the 
implementation of next generation sequencing in clinical laboratories; 
laboratory testing in the era of telemedicine; and a report from the 
Institute of Medicine (IOM) CLIAC workgroup.
    Agenda items are subject to change as priorities dictate.
    Webcast: The meeting will also be webcast. Persons interested in 
viewing the webcast can access information at: http://cdclabtraining.adobeconnect.com/aprilcliac/.
    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 April 5, 2017 for U.S. registrants and March 
29, 2017 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, CDC, 1600 Clifton Road NE., 
Mailstop F-11, Atlanta, Georgia 30329-4018; telephone

[[Page 13122]]

(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 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. 2017-04621 Filed 3-8-17; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices 13121 Status: The meeting will be closed to Purpose: This Committee is charged and March 29, 2017 for international the public in accordance with with providing scientific and technical registrants. provisions set forth in Section 552b(c) advice and guidance to the Secretary of Providing Oral or Written Comments: (4) and (6), Title 5 U.S.C., and the Health and Human Services (HHS); the It is the policy of CLIAC to accept Determination of the Director, Assistant Secretary for Health; the written public comments and provide a Management Analysis and Services Director, Centers for Disease Control brief period for oral public comments on Office, CDC, pursuant to Public Law 92– and Prevention; the Commissioner, agenda items. Public comment periods 463. Food and Drug Administration (FDA); for each agenda item are scheduled Matters for Discussion: The meeting and the Administrator, Centers for immediately prior to the Committee will include the initial review, Medicare and Medicaid Services (CMS). discussion period for that item. discussion, and evaluation of The advice and guidance pertain to Oral Comments: In general, each applications received in response to general issues related to improvement in individual or group requesting to make ‘‘Validation of Survey Questions to clinical laboratory quality and oral comments will be limited to a total Distinguish Type 1 and Type 2 Diabetes laboratory medicine practice and time of five minutes (unless otherwise among Adults with Diabetes’’, FOA specific questions related to possible indicated). Speakers must also submit DP17–002. revision of the Clinical Laboratory their comments in writing for inclusion Contact Person for More Information: Improvement Amendment (CLIA) in the meeting’s Summary Report. To Jaya Raman Ph.D., Scientific Review standards. Examples include providing assure adequate time is scheduled for Officer, CDC, 4770 Buford Highway, guidance on studies designed to public comments, speakers should Mailstop F80, Atlanta, Georgia 30341, improve safety, effectiveness, efficiency, notify the contact person below at least Telephone: (770) 488–6511, kva5@ timeliness, equity, and patient- one week prior to the meeting date. cdc.gov. centeredness of laboratory services; Written Comments: For individuals or The Director, Management Analysis revisions to the standards under which groups unable to attend the meeting, and Services Office, has been delegated clinical laboratories are regulated; the CLIAC accepts written comments until the authority to sign Federal Register impact of proposed revisions to the the date of the meeting (unless notices pertaining to announcements of standards on medical and laboratory otherwise stated). However, it is meetings and other committee practice; and the modification of the requested that comments be submitted management activities, for both the standards and provision of non- at least one week prior to the meeting Centers for Disease Control and regulatory guidelines to accommodate date so that the comments may be made Prevention and the Agency for Toxic technological advances, such as new available to the Committee for their Substances and Disease Registry. test methods, the electronic consideration and public distribution. transmission of laboratory information, Written comments, one hard copy with Elaine L. Baker, and mechanisms to improve the original signature, should be provided Director, Management Analysis and Services integration of public health and clinical to the contact person at the mailing or Office, Centers for Disease Control and laboratory practices. Prevention. email address below, and will be Matters for Discussion: The agenda included in the meeting’s Summary [FR Doc. 2017–04623 Filed 3–8–17; 8:45 am] will include agency updates from CDC, Report. BILLING CODE 4163–18–P CMS, and FDA. Presentations and discussions will focus on the Availability of Meeting Materials: To implementation of next generation support the green initiatives of the DEPARTMENT OF HEALTH AND sequencing in clinical laboratories; federal government, the CLIAC meeting HUMAN SERVICES laboratory testing in the era of materials will be made available to the telemedicine; and a report from the Committee and the public in electronic Centers for Disease Control and Institute of Medicine (IOM) CLIAC format (PDF) on the internet instead of Prevention workgroup. by printed copy. Check the CLIAC Web Agenda items are subject to change as site on the day of the meeting for Clinical Laboratory Improvement priorities dictate. materials: http://wwwn.cdc.gov/cliac/ Advisory Committee Webcast: The meeting will also be Meetings/MeetingDetails.aspx. Note: If webcast. Persons interested in viewing using a mobile device to access the In accordance with section 10(a)(2) of materials, please verify that the device’s the Federal Advisory Committee Act the webcast can access information at: http:// browser is able to download the files (Pub. L. 92–463), the Centers for Disease from the CDC’s Web site before the Control and Prevention (CDC) cdclabtraining.adobeconnect.com/ aprilcliac/. meeting. announces the following committee Alternatively, the files can be Online Registration Required: All meeting. downloaded to a computer and then people attending the CLIAC meeting in- Times and Dates: emailed to the portable device. An person are required to register for the 8:30 a.m.–5:00 p.m., EDT, April 12, meeting online at least 5 business days internet connection, power source, and 2017 in advance for U.S. citizens and at least limited hard copies may be available at 8:30 a.m.–12:00 p.m., EDT, April 13, 10 business days in advance for the meeting location, but cannot be 2017 international registrants. Register at: guaranteed. Place: CDC, 1600 Clifton Road NE., http://wwwn.cdc.gov/cliac/Meetings/ Contact Person for Additional asabaliauskas on DSK3SPTVN1PROD with NOTICES Tom Harkin Global Communications MeetingDetails.aspx. Register by Information: Nancy Anderson, Chief, Center, Building 19, Auditorium B, scrolling down and clicking the Laboratory Practice Standards Branch, Atlanta, Georgia 30333. ‘‘Register for this Meeting’’ button and Division of Laboratory Systems, Center Status: Open to the public, limited completing all forms according to the for Surveillance, Epidemiology and only by the space available. The meeting instructions given. Please complete all Laboratory Services, Office of Public room accommodates approximately 100 the required fields before submitting Health Scientific Services, CDC, 1600 people. This meeting will also be your registration and submit no later Clifton Road NE., Mailstop F–11, webcast, please see information below. than April 5, 2017 for U.S. registrants Atlanta, Georgia 30329–4018; telephone VerDate Sep<11>2014 17:43 Mar 08, 2017 Jkt 241001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1

13122 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices (404) 498–2741; or via email at bsc/) or call (404–498–2539) at least five Prevention and the Agency for Toxic NAnderson@cdc.gov. business days in advance of the Substances and Disease Registry. The Director, Management Analysis meeting. Teleconference is available Elaine L. Baker, and Services Office, has been delegated toll-free; please dial (888) 397–9578, the authority to sign Federal Register Director, Management Analysis and Services Participant Pass Code 63257516. Adobe Office, Centers for Disease Control and Notices pertaining to announcements of Connect webcast will be available at Prevention (CDC). meetings and other committee https://odniosh.adobeconnect.com/ [FR Doc. 2017–04620 Filed 3–8–17; 8:45 am] management activities, for the Centers nioshbsc/ for participants wanting to BILLING CODE 4163–18–P for Disease Control and Prevention and connect remotely. the Agency for Toxic Substances and Purpose: The Secretary, the Assistant Disease Registry. Secretary for Health, and by delegation DEPARTMENT OF HEALTH AND Elaine L. Baker, the Director, Centers for Disease Control HUMAN SERVICES Director, Management Analysis and Services and Prevention, are authorized under Office, Centers for Disease Control and Sections 301 and 308 of the Public Centers for Disease Control and Prevention. Health Service Act to conduct directly Prevention [FR Doc. 2017–04621 Filed 3–8–17; 8:45 am] or by grants or contracts, research, [Docket Number CDC–2017–0017, NIOSH BILLING CODE 4163–18–P experiments, and demonstrations 153–D] relating to occupational safety and health and to mine health. The Board of Proposed Revised Definitions for the DEPARTMENT OF HEALTH AND Scientific Counselors provides guidance Levels of Evidence for NIOSH Skin HUMAN SERVICES to the Director, National Institute for Notation Profiles; Request for Occupational Safety and Health on Comment Centers for Disease Control and research and prevention programs. Prevention Specifically, the Board provides AGENCY: National Institute for guidance on the Institute’s research Occupational Safety and Health Board of Scientific Counselors, (NIOSH) of the Centers for Disease National Institute for Occupational activities related to developing and evaluating hypotheses, systematically Control and Prevention (CDC), Safety and Health (BSC, NIOSH) Department of Health and Human documenting findings and In accordance with section 10(a)(2) of disseminating results. The Board Services (HHS). the Federal Advisory Committee Act evaluates the degree to which the ACTION: Request for comments. (Pub. L. 92–463), the Centers for Disease activities of the National Institute for Control and Prevention (CDC) Occupational Safety and Health: (1) SUMMARY: The National Institute for announces the following meeting for the Conform to appropriate scientific Occupational Safety and Health aforementioned committee: standards, (2) address current, relevant (NIOSH) of the Centers for Disease Time and Date: 8:30 a.m.–12:45 p.m., needs, and (3) produce intended results. Control and Prevention (CDC) proposes EDT, April 12, 2017. to clarify the definitions for ‘sufficient’, Place: 1095 Willowdale Road, Matters for Discussion: NIOSH ‘limited’, and ‘insufficient’ levels of Morgantown, WV 26505. The meeting is Director’s update; occupational motor evidence for the designation of NIOSH also available via webcast. vehicle safety, the nanotoxicolgy skin notations. In NIOSH Current Status: This meeting is open to the program, flu-related research, and mold Intelligence Bulletin (CIB) 61—A public, limited only by the space investigations. Strategy for Assigning New NIOSH Skin available. The meeting room Agenda items are subject to change as Notations, Appendix E.2, Evaluation of accommodates approximately 50 priorities dictate. data, pp. 41–42 [http://www.cdc.gov/ people. The public is welcome to An agenda is also posted on the niosh/docs/2009-147/pdfs/2009- participate during the public comment NIOSH Web site (http://www.cdc.gov/ 147.pdf] these levels of evidence are period, 9:20 a.m.–9:30 a.m. EDT, April niosh/bsc/). Members of the public who defined as the following: 12, 2017. Please note that the public wish to address the NIOSH BSC are ‘‘Data sets classified as sufficient are comment period ends at the time requested to contact the Executive those that include human and/or animal indicated above or following the last Secretary for scheduling purposes (see toxicity studies conducted according to call for comments, whichever is earlier. contact information below). standardized protocols and that provide Members of the public who want to Alternatively, written comments to the in-depth descriptions of the exposure comment must sign up by providing BSC may be submitted via an on-line conditions and study findings. Data sets their name by mail, email, or telephone, form at the following Web site: http:// classified as limited via the qualitative at the addresses provided below by www.cdc.gov/niosh/bsc/contact.html. ranking scheme contain either human April 7, 2017. Each commenter will be and/or animal studies conducted by provided up to five minutes for Contact Person for More Information: non-standardized protocols or contain comment. A limited number of time Paul J. Middendorf, Ph.D., Executive incomplete descriptions of the exposure slots are available and will be assigned Secretary, BSC, NIOSH, CDC, 1600 conditions and study findings. Data sets on a first come-first served basis. Clifton Road NE., MS–E20, Atlanta, GA classified as insufficient include studies Written comments will also be accepted 30329–4018, telephone (404) 498–2500, that primarily either did not apply asabaliauskas on DSK3SPTVN1PROD with NOTICES from those unable to attend the public fax (404) 498–2526. standard protocols or did not provide an session via an on-line form at the The Director, Management Analysis in-depth description of the exposure following Web site: http://www.cdc.gov/ and Services Office has been delegated conditions or study findings. Data sets niosh/bsc/contact.html. The meeting is the authority to sign Federal Register that receive the insufficient ranking will also open to the public via webcast. If notices pertaining to announcements of not be used as the basis for the NIOSH you wish to attend in person or by meetings and other committee skin notation.’’ webcast, please see the NIOSH Web site management activities, for both the NIOSH proposes to clarify the to register (http://www.cdc.gov/niosh/ Centers for Disease Control and definitions for the sufficient, limited, VerDate Sep<11>2014 17:43 Mar 08, 2017 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1


Document Created: 2017-03-09 04:58:51
Document Modified: 2017-03-09 04:58:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation82 FR 13121 
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