Clinical Laboratory Improvement Advisory Committee Meeting, 70685-70686 [2016-24785]

Download as PDF 70685 Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices use based on serovar determination, and assess rodent, livestock, and wildlife reservoirs of leptospirosis based on infecting serovars found in dogs. Findings from this study will aid in the development of evidence-based, targeted interventions for the prevention of canine leptospirosis, be used to focus human leptospirosis surveillance efforts, and guide future investigations on leptospirosis in humans and animals in Puerto Rico. The information collection for which approval is sought is in accordance with BSPB’s mission to prevent illness, disability, or death caused by bacterial zoonotic diseases through surveillance, epidemic investigations, epidemiologic and laboratory research, training and public education. Authorizing Legislation comes from Section 301 of the Public Health Service Act (42 U.S.C. 241). Successful execution of BSPB’s public health mission requires data collection activities in collaboration clinics and shelters, including information about site capacity, vaccination practices, origin of dogs, and resources available at the sites. Data collection tools will be completed onsite. For dogs that have an owner, information about the dog may be collected by veterinarians and their vet staff by interviewing the dog owner. Otherwise, data collection tools may be completed by reviewing administrative and medical records, as necessary. Data will be recorded on paper forms. Study coordinators will enter collected data into an electronic database. BSPB estimates involvement of at least 411 respondents (385 from the general public and 26 veterinarians and their veterinary technical staff) and estimates a total of 168 hours of burden for research activities each year. The collected information will not impose a cost burden on the respondents beyond that associated with their time to provide the required data. with the state health department in Puerto Rico and with local veterinary clinics and animal shelters participating in the study. These activities include collecting information about dogs that meet the study case definition for a suspect case of leptospirosis seen at participating veterinary clinics and shelters. The information is collected by veterinarians or their veterinary technical staff by interviewing the dog owner and reviewing medical and administrative records, as necessary. Basic information about the participating sites will also be collected for study management, as well as to augment data analysis. Approval of this data collection tool will allow BSPB to collect information from veterinarians, vet staff and dog owners about the dog’s signalment, risk factors, clinical signs and symptoms, laboratory results, treatment, and outcome. The study will also collect basic site information from participating ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Average burden per response (in hours) Total burden (in hours) Type of respondents Form name Veterinarians or vet technical staff ... Veterinarians or vet technical staff ... Veterinarians or vet technical staff ... Enrollment Questionnaire ................. Log Sheet ......................................... Case Questionnaire ......................... 26 26 26 1 24 24 5/60 1/60 15/60 2 10 156 Total ........................................... ........................................................... ........................ ........................ ........................ 168 Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2016–24667 Filed 10–12–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Lhorne on DSK30JT082PROD with NOTICES Clinical Laboratory Improvement Advisory Committee Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following committee meeting. Times and Dates: 8:30 a.m.–5 p.m., EDT, November 2, 2016. 8:30 a.m.–12 p.m., EDT, November 3, 2016. VerDate Sep<11>2014 14:07 Oct 12, 2016 Jkt 241001 Place: CDC, 1600 Clifton Road NE., Tom Harkin Global Communications Center, Building 19, Auditorium B, Atlanta, Georgia 30329. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. This meeting will also be webcast, please see information below. Purpose: This Committee is charged with providing scientific and technical advice and guidance to the Secretary of Health and Human Services (HHS); the Assistant Secretary for Health; the Director, Centers for Disease Control and Prevention; the Commissioner, Food and Drug Administration (FDA); and the Administrator, Centers for Medicare and Medicaid Services (CMS). The advice and guidance pertain to general issues related to improvement in clinical laboratory quality and laboratory medicine practice and specific questions related to possible revision of the Clinical Laboratory Improvement Amendment (CLIA) standards. Examples include providing guidance on studies designed to improve safety, effectiveness, efficiency, PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 timeliness, equity, and patientcenteredness of laboratory services; revisions to the standards under which clinical laboratories are regulated; the impact of proposed revisions to the standards on medical and laboratory practice; and the modification of the standards and provision of nonregulatory guidelines to accommodate technological advances, such as new test methods, the electronic transmission of laboratory information, and mechanisms to improve the integration of public health and clinical laboratory practices. Matters for Discussion: The agenda will include agency updates from CDC, CMS, and FDA. Presentations and discussions will include a report on the cytology workload assessment and time measure study; an update on CLIAC recommendations for laboratory biosafety; laboratory preparedness and response: The case of Zika; a report from the Institute of Medicine (IOM) CLIAC workgroup; and future CLIAC topics. Agenda items are subject to change as priorities dictate. Webcast: The meeting will also be webcast. Persons interested in viewing E:\FR\FM\13OCN1.SGM 13OCN1 Lhorne on DSK30JT082PROD with NOTICES 70686 Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices the webcast can access information at: http:// cdclabtraining.adobeconnect.com/ novembercliac/. Online Registration Required: All people attending the CLIAC meeting inperson are required to register for the meeting online at least 5 business days in advance for U.S. citizens and at least 10 business days in advance for international registrants. Register at: 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 VerDate Sep<11>2014 14:07 Oct 12, 2016 Jkt 241001 browser is able to download the files from the CDC’s Web site before the meeting. Alternatively, the files can be downloaded to a computer and then emailed to the portable device. An internet connection, power source, and limited hard copies may be available at the meeting location, but cannot be guaranteed. Contact Person for Additional Information: Nancy Anderson, Chief, Laboratory Practice Standards Branch, Division of Laboratory Systems, Center for Surveillance, Epidemiology and Laboratory Services, Office of Public Health Scientific Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop F–11, Atlanta, Georgia 30329; telephone (404) 498–2741; or via email at NAnderson@ cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register Notices pertaining to announcements of meetings and other committee management activities, for Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. Office, CDC, pursuant to Public Law 92– 463. Matters For Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘PAR14–227, Workers’ Compensation Surveillance, PAR14–227.’’ Contact Person For More Information: Michael Goldcamp, Ph.D., Scientific Review Officer, CDC, 1095 Willowdale Road, Morg Building H, Room 1806, Mailstop 1808, Morgantown, WV 26506, Telephone: (304) 285–5951, EHG8@ CDC.GOV. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2016–24786 Filed 10–12–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health [FR Doc. 2016–24785 Filed 10–12–16; 8:45 am] Office of the Director, National Institutes of Health; Notice of Closed Meeting BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Funding Opportunity Announcement (FOA) PAR14–227, Workers’ Compensation Surveillance. Time and Date: 1:00 p.m.–6 p.m., EST, November 9, 2016 (Closed) Place: Teleconference Status: The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), title 5 U.S.C., and the Determination of the Director, Management Analysis and Services PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities. Date: November 9, 2016. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ross D. Shonat, Ph.D., Scientific Review Officer, Center for E:\FR\FM\13OCN1.SGM 13OCN1

Agencies

[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Notices]
[Pages 70685-70686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24785]


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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 NAnderson@cdc.gov.
    The Director, Management Analysis and Services Office, has been 
delegated the authority to sign Federal Register Notices pertaining to 
announcements of meetings and other committee management activities, 
for Centers for Disease Control and Prevention and the Agency for Toxic 
Substances and Disease Registry.

Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 2016-24785 Filed 10-12-16; 8:45 am]
BILLING CODE 4163-18-P