82_FR_43722 82 FR 43543 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

82 FR 43543 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

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

Federal Register Volume 82, Issue 179 (September 18, 2017)

Page Range43543-43544
FR Document2017-19498

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 http://cdclabtraining.adobeconnect.com/cliac.

Federal Register, Volume 82 Issue 179 (Monday, September 18, 2017)
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43543-43544]
From the Federal Register Online  [www.thefederalregister.org]
[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 
http://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 http://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; [email protected].

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



                                                                            Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices                                                                    43543

                                                the study to read and sign an informed                              ml of blood. The researchers will then                              The study will require 90 volunteer
                                                consent form, and then to complete a                                ask the participants to don elastomeric                           test subjects each year for 3 years,
                                                short health questionnaire. After                                   masks, and breathe and cough normally                             totaling 270 test participants. There are
                                                completing the forms, researchers will                              for 40 minutes into an aerosol particle                           no costs to respondents other than their
                                                measure the participant’s oral                                      collection system. The total time from                            time. The total number of annual
                                                temperature and collect two                                         initial verbal screening to completion                            burden hours are 148.
                                                nasopharyngeal mucus samples and five                               will be about 95 minutes.

                                                                                                                   ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                        Average
                                                                                                                                                                                                        Number of
                                                                                                                                                                                      Number of                       burden per
                                                             Type of respondents                                                          Form name                                                   responses per
                                                                                                                                                                                     respondents                       response
                                                                                                                                                                                                        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,                                                   Center for Surveillance, Epidemiology                             Administration (FDA). Presentations
                                                Chief, Information Collection Review Office,                        and Laboratory Services, Office of                                and discussions will focus on laboratory
                                                Office of Scientific Integrity, Office of the                       Public Health Scientific Services,                                testing in the era of telemedicine;
                                                Associate Director for Science, Office of the                       Centers for Disease Control and                                   antibiotic resistance testing issues;
                                                Director, Centers for Disease Control and                           Prevention, 1600 Clifton Road NE.,                                culture independent diagnostic tests;
                                                Prevention.                                                         Mailstop F–11, Atlanta, Georgia 30329–                            and a report from the Institute of
                                                [FR Doc. 2017–19748 Filed 9–15–17; 8:45 am]                         4018, telephone (404) 498–2741;                                   Medicine (IOM) CLIAC workgroup.
                                                BILLING CODE 4163–18–P                                              NAnderson@cdc.gov.                                                Agenda items are subject to change as
                                                                                                                    SUPPLEMENTARY INFORMATION: Purpose:
                                                                                                                                                                                      priorities dictate.
                                                                                                                                                                                         All people attending the CLIAC
                                                DEPARTMENT OF HEALTH AND                                            This Committee is charged with
                                                                                                                                                                                      meeting in-person are required to
                                                HUMAN SERVICES                                                      providing scientific and technical
                                                                                                                                                                                      register for the meeting online at least 5
                                                                                                                    advice and guidance to the Secretary of
                                                                                                                                                                                      business days in advance for U.S.
                                                Centers for Disease Control and                                     Health and Human Services (HHS); the
                                                                                                                                                                                      citizens and at least 30 business days in
                                                Prevention                                                          Assistant Secretary for Health; the
                                                                                                                                                                                      advance for international registrants.
                                                                                                                    Director, Centers for Disease Control
                                                                                                                                                                                      Register at: https://wwwn.cdc.gov/
                                                Clinical Laboratory Improvement                                     and Prevention; the Commissioner,
                                                                                                                                                                                      cliac/. Register by scrolling down and
                                                Advisory Committee (CLIAC)                                          Food and Drug Administration (FDA);
                                                                                                                                                                                      clicking the ‘‘Register for this Meeting’’
                                                                                                                    and the Administrator, Centers for
                                                AGENCY: Centers for Disease Control and                                                                                               button and completing all forms
                                                                                                                    Medicare and Medicaid Services (CMS).                             according to the instructions given.
                                                Prevention (CDC), Department of Health                              The advice and guidance pertain to
                                                and Human Services (HHS).                                                                                                             Please complete all the required fields
                                                                                                                    general issues related to improvement in                          before submitting your registration and
                                                ACTION: Notice of meeting.                                          clinical laboratory quality and                                   submit no later than October 25, 2017
                                                                                                                    laboratory medicine practice and                                  for U.S. registrants and September 19,
                                                SUMMARY:   In accordance with the
                                                                                                                    specific questions related to possible                            2017 for international registrants.
                                                Federal Advisory Committee Act, the
                                                                                                                    revision of the Clinical Laboratory                                  It is the policy of CLIAC to accept
                                                Centers for Disease Control and
                                                                                                                    Improvement Amendment (CLIA)                                      written public comments and provide a
                                                Prevention (CDC), announces the
                                                                                                                    standards. Examples include providing                             brief period for oral public comments on
                                                following meeting for the Clinical
                                                                                                                    guidance on studies designed to                                   agenda items. Public comment periods
                                                Laboratory Improvement Advisory
                                                                                                                    improve safety, effectiveness, efficiency,                        for each agenda item are scheduled
                                                Committee (CLIAC). This meeting is
                                                                                                                    timeliness, equity, and patient-                                  immediately prior to the Committee
                                                open to the public, limited only by the
                                                                                                                    centeredness of laboratory services;                              discussion period for that item. In
                                                space available. The meeting room
                                                                                                                    revisions to the standards under which                            general, each individual or group
                                                accommodates approximately 100
                                                                                                                    clinical laboratories are regulated; the                          requesting to make oral comments will
                                                people. The public is also welcome to
                                                                                                                    impact of proposed revisions to the                               be limited to a total time of five minutes
                                                view the meeting by webcast http://
                                                                                                                    standards on medical and laboratory                               (unless otherwise indicated). To assure
                                                cdclabtraining.adobeconnect.com/cliac.
                                                                                                                    practice; and the modification of the                             adequate time is scheduled for public
                                                DATES: The meeting will be held on                                  standards and provision of non-                                   comments, speakers should notify the
                                                November 1, 2017, 8:30 a.m. to 5:00                                 regulatory guidelines to accommodate                              contact person below at least one week
                                                p.m., EDT and November 2, 2017, 8:30                                technological advances, such as new                               prior to the meeting date. For
                                                a.m. to 12:00 p.m., EDT.                                            test methods, the electronic                                      individuals or groups unable to attend
                                                ADDRESSES: CDC, 2500 Century Center                                 transmission of laboratory information,                           the meeting, CLIAC accepts written
sradovich on DSKBBY8HB2PROD with NOTICES




                                                Boulevard, Rooms 1200/1201, Atlanta,                                and mechanisms to improve the                                     comments until the date of the meeting
                                                Georgia 30345 and http://cdclab                                     integration of public health and clinical                         (unless otherwise stated). However, it is
                                                training.adobeconnect.com/cliac.                                    laboratory practices.                                             requested that comments be submitted
                                                FOR FURTHER INFORMATION CONTACT:                                       Matters To Be Considered: The agenda                           at least one week prior to the meeting
                                                Nancy Anderson, MMSc, MT(ASCP),                                     will include agency updates from CDC,                             date so that the comments may be made
                                                Chief, Laboratory Practice Standards                                Centers for Medicare and Medicaid                                 available to the Committee for their
                                                Branch, Division of Laboratory Systems,                             Services (CMS), and The Food and Drug                             consideration and public distribution.


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                                                43544                     Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices

                                                Written comments, one hard copy with                    four-year terms. Selection of members is              (telephone numbers, mailing address,
                                                original signature, should be provided                  based on candidates’ qualifications to                email address)
                                                to the contact person at the mailing or                 contribute to the accomplishment of                      D At least one letter of
                                                email address below, and will be                        HICPAC objectives https://                            recommendation from person(s) not
                                                included in the meeting’s Summary                       www.cdc.gov/hicpac/.                                  employed by the U.S. Department of
                                                Report.                                                 DATES: Nominations for membership on                  Health and Human Services.
                                                  The CLIAC meeting materials will be                   the HICPAC be received no later than                  (Candidates may submit letter(s) from
                                                made available to the Committee and                     November 30, 2017. Packages received                  current HHS employees if they wish,
                                                the public in electronic format (PDF) on                after this time will not be considered for            but at least one letter must be submitted
                                                the internet instead of by printed copy.                the current membership cycle.                         by a person not employed by an HHS
                                                Check the CLIAC Web site on the day                     ADDRESSES: All nominations should be                  agency (e.g., CDC, NIH, FDA, etc.).
                                                of the meeting for materials: https://                  mailed to HICPAC, Division of                            Nominations may be submitted by the
                                                wwwn.cdc.gov/cliac/.                                    Healthcare Quality Promotion, NCEZID,                 candidate him- or herself, or by the
                                                  The Director, Management Analysis                     CDC, 1600 Clifton Road NE., Mailstop                  person/organization recommending the
                                                and Services Office, has been delegated                 A–07, Atlanta, Georgia 30333, emailed                 candidate.
                                                the authority to sign Federal Register                  (recommended) to hicpac@cdc.gov, or                      The Director, Management Analysis
                                                notices pertaining to announcements of                  faxed to (404) 639–4043.                              and Services Office, has been delegated
                                                meetings and other committee                            FOR FURTHER INFORMATION CONTACT: Erin                 the authority to sign Federal Register
                                                management activities, for both the                     Stone, M.S., HICPAC, Division of                      notices pertaining to announcements of
                                                Centers for Disease Control and                         Healthcare Quality Promotion, NCEZID,                 meetings and other committee
                                                Prevention and the Agency for Toxic                     CDC, 1600 Clifton Road NE., Mailstop                  management activities for both CDC and
                                                Substances and Disease Registry.                        A–07, Atlanta, Georgia 30333;                         the Agency for Toxic Substances and
                                                Elaine L. Baker,                                        Telephone (404) 639–4045; hicpac@                     Disease Registry.
                                                Director, Management Analysis and Services              cdc.gov.                                              Elaine L. Baker,
                                                Office, Centers for Disease Control and                 SUPPLEMENTARY INFORMATION: The U.S.                   Director, Management Analysis and Services
                                                Prevention.                                             Department of Health and Human                        Office, Centers for Disease Control and
                                                [FR Doc. 2017–19498 Filed 9–15–17; 8:45 am]             Services policy stipulates that                       Prevention.
                                                BILLING CODE 4163–19–P                                  committee membership be balanced in                   [FR Doc. 2017–19501 Filed 9–15–17; 8:45 am]
                                                                                                        terms of points of view represented, and              BILLING CODE 4163–18–P
                                                                                                        the committee’s function. Appointments
                                                DEPARTMENT OF HEALTH AND                                shall be made without discrimination
                                                HUMAN SERVICES                                          on the basis of age, race, ethnicity,                 DEPARTMENT OF HEALTH AND
                                                                                                        gender, sexual orientation, gender                    HUMAN SERVICES
                                                Centers for Disease Control and                         identity, HIV status, disability, and
                                                Prevention                                              cultural, religious, or socioeconomic                 Centers for Disease Control and
                                                                                                        status. Nominees must be U.S. citizens,               Prevention
                                                Solicitation of Nominations for
                                                                                                        and cannot be full-time employees of
                                                Appointment to the Healthcare                                                                                 [30Day–17–17ABE]
                                                                                                        the U.S. Government. Current
                                                Infection Control Practices Advisory
                                                                                                        participation on federal workgroups or                Agency Forms Undergoing Paperwork
                                                Committee (HICPAC)
                                                                                                        prior experience serving on a federal                 Reduction Act Review
                                                ACTION:   Notice.                                       advisory committee does not disqualify
                                                                                                        a candidate; however, HHS policy is to                   The Centers for Disease Control and
                                                SUMMARY:   The Centers for Disease                      avoid excessive individual service on                 Prevention (CDC) has submitted the
                                                Control and Prevention (CDC) is seeking                 advisory committees and multiple                      following information collection request
                                                nominations for membership on the                       committee memberships. Committee                      to the Office of Management and Budget
                                                HICPAC. The HICPAC consists of 14                       members are Special Government                        (OMB) for review and approval in
                                                experts in fields including but not                     Employees, requiring the filing of                    accordance with the Paperwork
                                                limited to, infectious diseases, infection              financial disclosure reports at the                   Reduction Act of 1995. The notice for
                                                prevention, healthcare epidemiology,                    beginning and annually during their                   the proposed information collection is
                                                nursing, clinical microbiology, surgery,                terms. CDC reviews potential candidates               published to obtain comments from the
                                                hospitalist medicine, internal medicine,                for HICPAC membership each year, and                  public and affected agencies.
                                                epidemiology, health policy, health                     provides a slate of nominees for                         Written comments and suggestions
                                                services research, public health, and                   consideration to the Secretary of HHS                 from the public and affected agencies
                                                related medical fields. Nominations are                 for final selection. HHS notifies selected            concerning the proposed collection of
                                                being sought for individuals who have                   candidates of their appointment near                  information are encouraged. Your
                                                expertise and qualifications necessary to               the start of the term in July 2018, or as             comments should address any of the
                                                contribute to the accomplishments of                    soon as the HHS selection process is                  following: (a) Evaluate whether the
                                                the committee’s objectives. Nominees                    completed. Note that the need for                     proposed collection of information is
                                                will be selected based on expertise in                  different expertise varies from year to               necessary for the proper performance of
                                                the fields of infectious diseases,                      year and a candidate who is not selected              the functions of the agency, including
                                                infection prevention, healthcare                                                                              whether the information will have
sradovich on DSKBBY8HB2PROD with NOTICES




                                                                                                        in one year may be reconsidered in a
                                                epidemiology, nursing, environmental                    subsequent year.                                      practical utility; (b) Evaluate the
                                                and clinical microbiology, surgery,                        Nominees must be U.S. citizens, and                accuracy of the agencies estimate of the
                                                internal medicine, epidemiology, health                 cannot be full-time employees of the                  burden of the proposed collection of
                                                policy, health services research, and                   U.S. Government. Candidates should                    information, including the validity of
                                                public health. Federal employees will                   submit the following items:                           the methodology and assumptions used;
                                                not be considered for membership.                          D Current curriculum vitae, including              (c) Enhance the quality, utility, and
                                                Members may be invited to serve for                     complete contact information                          clarity of the information to be


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Document Created: 2017-09-16 00:51:31
Document Modified: 2017-09-16 00:51:31
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
ActionNotice of meeting.
DatesThe 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.
ContactNancy 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; [email protected]
FR Citation82 FR 43543 

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