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