Clinical Laboratory Improvement Advisory Committee (CLIAC), 56621-56622 [2020-20182]

Download as PDF 56621 Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices causes of death and disability, as well as the ability to respond rapidly to emerging health issues, including outbreaks of food-borne infections and water-borne diseases. CSTLTS ensures that the CDC PHHS Block Grant Program Manager and recipients account for funds in accordance with legislative mandates. Each recipient is required to submit a work plan with its selected health outcome objectives, as well as descriptions of the health problems, identified target populations (including portions of those populations disproportionately affected by the health problems), and activities to be addressed in the planned work. CDC will use the Block Grant Information System to collect recipient data, monitor recipients’ progress, identify activities and personnel supported with Block Grant funding, conduct compliance reviews of Block Grant recipients, and promote the use of evidence-based guidelines and interventions. CDC requests OMB approval for revision of this existing information collection request to accommodate the needed updates to the system and templates used to collect the information. As specified in the authorizing legislation, CDC currently collects information from Block Grant recipients to monitor their objectives and activities. Recipients will submit information on the following: • Recipient information: Unique identifying information about each recipient. • Work plan: Information about objectives, activities, and the populations to be addressed each year. • Annual Progress Report: Information about success and progress toward meeting health objectives. Since 2008, CDC has collected this information using a web-based electronic system, the Block Grant Management Information System (BGMIS). Beginning with the FY2021 award, CDC will begin using a new information management system, the Block Grant Information System (BGIS) to collect this information. The new system will essentially collect the same information as the old system, but will offer a variety of updates and improvements. Examples of improvements include updated technological infrastructure, updated Healthy People Objectives (from 2020 to 2030) for recipients to use when planning programs, usability improvements, and redesigned instruments to capture data in more useful formats for both the recipients and reporting purposes. The respondent universe will include PHHS Block Grant Coordinators(n=61). All modules will be accessed electronically through the BGIS system. CDC requests approval for an estimated 1,525 burden hours annually. ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Average burden per response (in hours) Form name PHHS Block Grant Coordinator ...................... PHHS Block .................................................... Grant Coordinator ........................................... PHHS Block .................................................... Grant Coordinator ........................................... Recipient Information ..................................... Work Plan ....................................................... 61 61 1 1 2 12 PHHS Block ................................................... Annual Progress Report ................................. 61 1 11 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–20213 Filed 9–11–20; 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). AGENCY: ACTION: khammond on DSKJM1Z7X2PROD with NOTICES Number of respondents Type of respondents Notice of meeting. In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This meeting is open to the public, limited only by the webcast lines available. Check the CLIAC website on the day of SUMMARY: VerDate Sep<11>2014 17:51 Sep 11, 2020 Jkt 250001 the meeting for the web conference link www.cdc.gov/cliac. DATES: The meeting will be held on October 28, 2020, from 11:00 a.m. to 6:30 p.m., EDT and October 29, 2020, from 11:00 a.m. to 3:00 p.m., EDT. ADDRESSES: This is a virtual meeting. Meeting times are tentative and subject to change. The confirmed meeting times, agenda items, and meeting materials including instructions for accessing the live meeting broadcast will be available on the CLIAC website at www.cdc.gov/cliac. FOR FURTHER INFORMATION CONTACT: Nancy Anderson, MMSc, MT(ASCP), Senior Advisor for Clinical Laboratories, 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 V24–3, Atlanta, Georgia 30329–4018, Telephone: (404) 498–2741; Email: NAnderson@cdc.gov. SUPPLEMENTARY INFORMATION: Purpose: This Committee is charged with providing scientific and technical PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 advice and guidance to the Secretary, HHS; the Assistant Secretary for Health; the Director, CDC; 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 Amendments of 1988 (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 E:\FR\FM\14SEN1.SGM 14SEN1 khammond on DSKJM1Z7X2PROD with NOTICES 56622 Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices improve the integration of public health and clinical laboratory practices. Matters To Be Considered: The agenda will include agency updates from CDC, CMS, and FDA. The focus of the meeting is Clinical Laboratory Medicine in the Age of COVID–19 and will include presentations and discussions on preparedness and response: the partnership between clinical laboratories and public health; laboratory data exchanges during COVID–19; and the clinical laboratory’s role in identifying health inequities during the COVID–19 response. Agenda items are subject to change as priorities dictate. It is the policy of CLIAC to accept written public comments and provide a brief period for oral public comments pertinent to agenda items. Procedure for Public Comment: 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 present an oral comment will be limited to a total time of five minutes (unless otherwise indicated). Speakers should email CLIAC@cdc.gov or notify the contact person at least 5 business days prior to the meeting date. Procedure for Written Public Comment: 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 5 business days prior to the meeting date so that the comments may be made available to the Committee for their consideration and public distribution. All written comments will be included in the meeting Summary Report posted on the CLIAC website. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, 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. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2020–20182 Filed 9–11–20; 8:45 am] BILLING CODE 4163–18–P VerDate Sep<11>2014 17:51 Sep 11, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–E–1943] Determination of Regulatory Review Period for Purposes of Patent Extension; TAKHZYRO Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TAKHZYRO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. DATES: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by November 13, 2020. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 15, 2021. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 13, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–E–1943 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; TAKHZYRO.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management E:\FR\FM\14SEN1.SGM 14SEN1

Agencies

[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Pages 56621-56622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20182]


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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 CDC 
announces the following meeting for the Clinical Laboratory Improvement 
Advisory Committee (CLIAC). This meeting is open to the public, limited 
only by the webcast lines available. Check the CLIAC website on the day 
of the meeting for the web conference link www.cdc.gov/cliac.

DATES: The meeting will be held on October 28, 2020, from 11:00 a.m. to 
6:30 p.m., EDT and October 29, 2020, from 11:00 a.m. to 3:00 p.m., EDT.

ADDRESSES: This is a virtual meeting. Meeting times are tentative and 
subject to change. The confirmed meeting times, agenda items, and 
meeting materials including instructions for accessing the live meeting 
broadcast will be available on the CLIAC website at www.cdc.gov/cliac.

FOR FURTHER INFORMATION CONTACT: Nancy Anderson, MMSc, MT(ASCP), Senior 
Advisor for Clinical Laboratories, 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 V24-3, Atlanta, Georgia 
30329-4018, Telephone: (404) 498-2741; Email: [email protected].

SUPPLEMENTARY INFORMATION:
    Purpose: This Committee is charged with providing scientific and 
technical advice and guidance to the Secretary, HHS; the Assistant 
Secretary for Health; the Director, CDC; 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 Amendments of 1988 
(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

[[Page 56622]]

improve the integration of public health and clinical laboratory 
practices.
    Matters To Be Considered: The agenda will include agency updates 
from CDC, CMS, and FDA. The focus of the meeting is Clinical Laboratory 
Medicine in the Age of COVID-19 and will include presentations and 
discussions on preparedness and response: the partnership between 
clinical laboratories and public health; laboratory data exchanges 
during COVID-19; and the clinical laboratory's role in identifying 
health inequities during the COVID-19 response. Agenda items are 
subject to change as priorities dictate.
    It is the policy of CLIAC to accept written public comments and 
provide a brief period for oral public comments pertinent to agenda 
items.
    Procedure for Public Comment: 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 present an oral comment will be limited to a total time of five 
minutes (unless otherwise indicated). Speakers should email 
[email protected] or notify the contact person at least 5 business days 
prior to the meeting date.
    Procedure for Written Public Comment: 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 5 business days prior to the 
meeting date so that the comments may be made available to the 
Committee for their consideration and public distribution. All written 
comments will be included in the meeting Summary Report posted on the 
CLIAC website.
    The Director, Strategic Business Initiatives Unit, Office of the 
Chief Operating Officer, Centers for Disease Control and Prevention, 
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.

Kalwant Smagh,
Director, Strategic Business Initiatives Unit, Office of the Chief 
Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2020-20182 Filed 9-11-20; 8:45 am]
BILLING CODE 4163-18-P


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