Clinical Laboratory Improvement Advisory Committee (CLIAC), 43543-43544 [2017-19498]

Download as PDF 43543 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices the study to read and sign an informed consent form, and then to complete a short health questionnaire. After completing the forms, researchers will measure the participant’s oral temperature and collect two nasopharyngeal mucus samples and five ml of blood. The researchers will then ask the participants to don elastomeric masks, and breathe and cough normally for 40 minutes into an aerosol particle collection system. The total time from initial verbal screening to completion will be about 95 minutes. The study will require 90 volunteer test subjects each year for 3 years, totaling 270 test participants. There are no costs to respondents other than their time. The total number of annual burden hours are 148. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents Potential participant Qualified participant Qualified participant Qualified participant ........................................ ........................................ ........................................ ........................................ Leroy Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2017–19748 Filed 9–15–17; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee (CLIAC) Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of meeting. AGENCY: In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. The public is also welcome to view the meeting by webcast https:// cdclabtraining.adobeconnect.com/cliac. DATES: The meeting will be held on November 1, 2017, 8:30 a.m. to 5:00 p.m., EDT and November 2, 2017, 8:30 a.m. to 12:00 p.m., EDT. ADDRESSES: CDC, 2500 Century Center Boulevard, Rooms 1200/1201, Atlanta, Georgia 30345 and https://cdclab training.adobeconnect.com/cliac. FOR FURTHER INFORMATION CONTACT: Nancy Anderson, MMSc, MT(ASCP), Chief, Laboratory Practice Standards Branch, Division of Laboratory Systems, sradovich on DSKBBY8HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:54 Sep 15, 2017 Jkt 241001 Number of respondents Form name Initial verbal screening ................................... Informed consent form ................................... Health questionnaire ...................................... Medical testing ............................................... Center for Surveillance, Epidemiology and Laboratory Services, Office of Public Health Scientific Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop F–11, Atlanta, Georgia 30329– 4018, telephone (404) 498–2741; NAnderson@cdc.gov. SUPPLEMENTARY INFORMATION: Purpose: This Committee is charged with providing scientific and technical advice and guidance to the Secretary of Health and Human Services (HHS); the Assistant Secretary for Health; the Director, Centers for Disease Control and Prevention; the Commissioner, Food and Drug Administration (FDA); and the Administrator, Centers for Medicare and Medicaid Services (CMS). The advice and guidance pertain to general issues related to improvement in clinical laboratory quality and laboratory medicine practice and specific questions related to possible revision of the Clinical Laboratory Improvement Amendment (CLIA) standards. Examples include providing guidance on studies designed to improve safety, effectiveness, efficiency, timeliness, equity, and patientcenteredness of laboratory services; revisions to the standards under which clinical laboratories are regulated; the impact of proposed revisions to the standards on medical and laboratory practice; and the modification of the standards and provision of nonregulatory guidelines to accommodate technological advances, such as new test methods, the electronic transmission of laboratory information, and mechanisms to improve the integration of public health and clinical laboratory practices. Matters To Be Considered: The agenda will include agency updates from CDC, Centers for Medicare and Medicaid Services (CMS), and The Food and Drug PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 180 90 90 90 Number of responses per respondent 1 1 1 1 Average burden per response (in hrs.) 3/60 15/60 5/60 72/60 Administration (FDA). Presentations and discussions will focus on laboratory testing in the era of telemedicine; antibiotic resistance testing issues; culture independent diagnostic tests; and a report from the Institute of Medicine (IOM) CLIAC workgroup. Agenda items are subject to change as priorities dictate. All people attending the CLIAC meeting in-person are required to register for the meeting online at least 5 business days in advance for U.S. citizens and at least 30 business days in advance for international registrants. Register at: https://wwwn.cdc.gov/ cliac/. Register by scrolling down and clicking the ‘‘Register for this Meeting’’ button and completing all forms according to the instructions given. Please complete all the required fields before submitting your registration and submit no later than October 25, 2017 for U.S. registrants and September 19, 2017 for international registrants. It is the policy of CLIAC to accept written public comments and provide a brief period for oral public comments on agenda items. Public comment periods for each agenda item are scheduled immediately prior to the Committee discussion period for that item. In general, each individual or group requesting to make oral comments will be limited to a total time of five minutes (unless otherwise indicated). To assure adequate time is scheduled for public comments, speakers should notify the contact person below at least one week prior to the meeting date. For individuals or groups unable to attend the meeting, CLIAC accepts written comments until the date of the meeting (unless otherwise stated). However, it is requested that comments be submitted at least one week prior to the meeting date so that the comments may be made available to the Committee for their consideration and public distribution. E:\FR\FM\18SEN1.SGM 18SEN1 43544 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices Written comments, one hard copy with original signature, should be provided to the contact person at the mailing or email address below, and will be included in the meeting’s Summary Report. The CLIAC meeting materials will be made available to the Committee and the public in electronic format (PDF) on the internet instead of by printed copy. Check the CLIAC Web site on the day of the meeting for materials: https:// wwwn.cdc.gov/cliac/. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2017–19498 Filed 9–15–17; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Solicitation of Nominations for Appointment to the Healthcare Infection Control Practices Advisory Committee (HICPAC) ACTION: Notice. The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the HICPAC. The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee’s objectives. Nominees will be selected based on expertise in the fields of infectious diseases, infection prevention, healthcare epidemiology, nursing, environmental and clinical microbiology, surgery, internal medicine, epidemiology, health policy, health services research, and public health. Federal employees will not be considered for membership. Members may be invited to serve for sradovich on DSKBBY8HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:54 Sep 15, 2017 Jkt 241001 four-year terms. Selection of members is based on candidates’ qualifications to contribute to the accomplishment of HICPAC objectives https:// www.cdc.gov/hicpac/. DATES: Nominations for membership on the HICPAC be received no later than November 30, 2017. Packages received after this time will not be considered for the current membership cycle. ADDRESSES: All nominations should be mailed to HICPAC, Division of Healthcare Quality Promotion, NCEZID, CDC, 1600 Clifton Road NE., Mailstop A–07, Atlanta, Georgia 30333, emailed (recommended) to hicpac@cdc.gov, or faxed to (404) 639–4043. FOR FURTHER INFORMATION CONTACT: Erin Stone, M.S., HICPAC, Division of Healthcare Quality Promotion, NCEZID, CDC, 1600 Clifton Road NE., Mailstop A–07, Atlanta, Georgia 30333; Telephone (404) 639–4045; hicpac@ cdc.gov. SUPPLEMENTARY INFORMATION: The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented, and the committee’s function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees, requiring the filing of financial disclosure reports at the beginning and annually during their terms. CDC reviews potential candidates for HICPAC membership each year, and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in July 2018, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items: D Current curriculum vitae, including complete contact information PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 (telephone numbers, mailing address, email address) D At least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services. (Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency (e.g., CDC, NIH, FDA, etc.). Nominations may be submitted by the candidate him- or herself, or by the person/organization recommending the candidate. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2017–19501 Filed 9–15–17; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–17–17ABE] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be E:\FR\FM\18SEN1.SGM 18SEN1

Agencies

[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43543-43544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19498]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Clinical Laboratory Improvement Advisory Committee (CLIAC)

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of meeting.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Federal Advisory Committee Act, the 
Centers for Disease Control and Prevention (CDC), announces the 
following meeting for the Clinical Laboratory Improvement Advisory 
Committee (CLIAC). This meeting is open to the public, limited only by 
the space available. The meeting room accommodates approximately 100 
people. The public is also welcome to view the meeting by webcast 
https://cdclabtraining.adobeconnect.com/cliac.

DATES: The meeting will be held on November 1, 2017, 8:30 a.m. to 5:00 
p.m., EDT and November 2, 2017, 8:30 a.m. to 12:00 p.m., EDT.

ADDRESSES: CDC, 2500 Century Center Boulevard, Rooms 1200/1201, 
Atlanta, Georgia 30345 and https://cdclabtraining.adobeconnect.com/cliac.

FOR FURTHER INFORMATION CONTACT: Nancy Anderson, MMSc, MT(ASCP), Chief, 
Laboratory Practice Standards Branch, Division of Laboratory Systems, 
Center for Surveillance, Epidemiology and Laboratory Services, Office 
of Public Health Scientific Services, Centers for Disease Control and 
Prevention, 1600 Clifton Road NE., Mailstop F-11, Atlanta, Georgia 
30329-4018, telephone (404) 498-2741; NAnderson@cdc.gov.

SUPPLEMENTARY INFORMATION: Purpose: This Committee is charged with 
providing scientific and technical advice and guidance to the Secretary 
of Health and Human Services (HHS); the Assistant Secretary for Health; 
the Director, Centers for Disease Control and Prevention; the 
Commissioner, Food and Drug Administration (FDA); and the 
Administrator, Centers for Medicare and Medicaid Services (CMS). The 
advice and guidance pertain to general issues related to improvement in 
clinical laboratory quality and laboratory medicine practice and 
specific questions related to possible revision of the Clinical 
Laboratory Improvement Amendment (CLIA) standards. Examples include 
providing guidance on studies designed to improve safety, 
effectiveness, efficiency, timeliness, equity, and patient-centeredness 
of laboratory services; revisions to the standards under which clinical 
laboratories are regulated; the impact of proposed revisions to the 
standards on medical and laboratory practice; and the modification of 
the standards and provision of non-regulatory guidelines to accommodate 
technological advances, such as new test methods, the electronic 
transmission of laboratory information, and mechanisms to improve the 
integration of public health and clinical laboratory practices.
    Matters To Be Considered: The agenda will include agency updates 
from CDC, Centers for Medicare and Medicaid Services (CMS), and The 
Food and Drug Administration (FDA). Presentations and discussions will 
focus on laboratory testing in the era of telemedicine; antibiotic 
resistance testing issues; culture independent diagnostic tests; and a 
report from the Institute of Medicine (IOM) CLIAC workgroup. Agenda 
items are subject to change as priorities dictate.
    All people attending the CLIAC meeting in-person are required to 
register for the meeting online at least 5 business days in advance for 
U.S. citizens and at least 30 business days in advance for 
international registrants. Register at: https://wwwn.cdc.gov/cliac/ cliac/. 
Register by scrolling down and clicking the ``Register for this 
Meeting'' button and completing all forms according to the instructions 
given. Please complete all the required fields before submitting your 
registration and submit no later than October 25, 2017 for U.S. 
registrants and September 19, 2017 for international registrants.
    It is the policy of CLIAC to accept written public comments and 
provide a brief period for oral public comments on agenda items. Public 
comment periods for each agenda item are scheduled immediately prior to 
the Committee discussion period for that item. In general, each 
individual or group requesting to make oral comments will be limited to 
a total time of five minutes (unless otherwise indicated). To assure 
adequate time is scheduled for public comments, speakers should notify 
the contact person below at least one week prior to the meeting date. 
For individuals or groups unable to attend the meeting, CLIAC accepts 
written comments until the date of the meeting (unless otherwise 
stated). However, it is requested that comments be submitted at least 
one week prior to the meeting date so that the comments may be made 
available to the Committee for their consideration and public 
distribution.

[[Page 43544]]

Written comments, one hard copy with original signature, should be 
provided to the contact person at the mailing or email address below, 
and will be included in the meeting's Summary Report.
    The CLIAC meeting materials will be made available to the Committee 
and the public in electronic format (PDF) on the internet instead of by 
printed copy. Check the CLIAC Web site on the day of the meeting for 
materials: https://wwwn.cdc.gov/cliac/.
    The Director, Management Analysis and Services Office, has been 
delegated the authority to sign Federal Register notices pertaining to 
announcements of meetings and other committee management activities, 
for both the Centers for Disease Control and Prevention and the Agency 
for Toxic Substances and Disease Registry.

Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 2017-19498 Filed 9-15-17; 8:45 am]
 BILLING CODE 4163-19-P
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