Notice of Closed Meeting, 11992-11993 [2020-04098]
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Federal Register / Vol. 85, No. 40 / Friday, February 28, 2020 / Notices
are involved in an overdose or
encountered by first responders, as it is
critical to identify and classify the types
of drugs involved in an overdose, how
often they are involved, and how that
involvement may change over time. By
understanding which drugs are present,
appropriate prevention and response
activities can be implemented.
The Centers for Disease Control and
Prevention (CDC) is leading the
development of Traceable Opioid
Material* Kits (TOM Kits*) to support
detection of emerging opioids. CDC
maintains the contents of the TOM Kits*
based on new needs identified, in part,
through DEA Emerging Threat Reports.
The DEA 2018 mid-year data indicate
that fentanyl and fentanyl-related
compounds account for approximately
75 percent of their opioid
identifications. These kits are reference
materials and do not eliminate the need
to meet analytical method requirements
of other federal agencies. TOM Kits* are
not intended for diagnostic use. The kits
are free to laboratories in the public,
private, clinical, law enforcement,
research, and public health domains.
To equitably distribute these TOM
Kits*, the CDC conducted an emergency
information collection, titled
‘‘Distribution of Traceable Opioid
Material* Kits (TOM Kits*) across U.S.
Laboratories,’’ under the Health and
Human Services (HHS) Secretary’s
Public Health Emergency Paperwork
Reduction Act (PHE PRA) Waiver
mechanism for the period from 03/20/
2019 to 05/10/2019. From 05/10/2019,
CDC continued distributing kits using a
generic information collection (GenIC)
under ‘‘Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery’’ (OMB Control
No. 0923–0047; expiration date 01/31/
2022). To continue this collection, the
CDC is currently requesting a three-year
PRA clearance for a new information
collection request (ICR) under the same
title.
CDC is currently distributing a
product line of TOM Kits*. Examples of
products in this line include the: (1)
Opioid Certified Reference Material Kit
(Opioid CRM Kit); and (2) Fentanyl
Analog Screening Kit (FAS Kit).
Respondent laboratories requesting the
TOM Kits* can be from any sector
(academic, public, or private), must be
located in the U.S., must have a
verifiable business address, must have a
current DEA registration, must comply
with respective state and local
regulations, and must submit requests
directly to the respective vendor.
As the number of laboratories
requesting TOM Kits* is high, the
information collection will be used to
prioritize which laboratories will
receive kits when quantities are limited.
The brief six-minute web-based survey
will allow the CDC to (1) determine
what service the recipient laboratory
performs and the volume of samples the
laboratory processes, and to (2)
equitably distribute TOM Kits* based on
the analysis techniques, matrix, and
sample size used by the recipient
laboratory.
The annual number of respondents
(n=1,200) was based on the number of
2019 requests. The total time burden
requested is 120 hours per year. There
is no burden on the respondents other
than their time.
*TRACEABLE OPIOID MATERIAL,
TOM KITS, and the TOM KITS logo are
marks of the U.S. Department of Health
and Human Services.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Federal Laboratories ............................................
State, Local, and Tribal Government Laboratories.
Private or Not-for-Profit Institutions ......................
TOM Kits* Questions ....
TOM Kits* Questions ....
400
400
1
1
6/60
6/60
40
40
TOM Kits* Questions ....
400
1
6/60
40
Total ...............................................................
.......................................
........................
........................
........................
120
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–04083 Filed 2–27–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Closed Meeting
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Number of
respondents
Type of respondents
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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.,
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as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. 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: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
RFA–CE–20–001, Evaluating Practicedbased Programs, Policies, and Practices
from CDC’s Rape Prevention Education
Program.
Date: April 29–30, 2020.
Time: 8:30 a.m.–5:30 p.m., EDT.
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Place: Embassy Suites Buckhead,
3285 Peachtree Road NE, Atlanta,
Georgia 30305.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Kimberly Leeks, Ph.D., M.P.H.,
Scientific Review Official, National
Center for Injury Prevention and
Control, CDC, 4770 Buford Highway NE,
Building 106, MS S106–9, Atlanta,
Georgia 30341, Telephone (770) 488–
6562, KLeeks@cdc.gov.
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
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Federal Register / Vol. 85, No. 40 / Friday, February 28, 2020 / Notices
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. 2020–04098 Filed 2–27–20; 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).
ACTION: Notice of meeting.
AGENCY:
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 space available. The meeting
room accommodates approximately 100
people. The public is also welcome to
view the meeting by webcast. Check the
CLIAC website on the day of the
meeting for the webcast link
www.cdc.gov/cliac.
DATES: The meeting will be held on
April 16, 2020, 8:30 a.m. to 5:00 p.m.,
EDT and April 17, 2020, 8:30 a.m. to
11:30 a.m., EDT.
ADDRESSES: Food and Drug
Administration (FDA), White Oak
Campus, 10903 New Hampshire
Avenue, Building 31, Great Room,
Silver Spring, Maryland 20993 and via
webcast 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; 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
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SUMMARY:
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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.
All people attending the CLIAC
meeting in-person are required to
register for the meeting online at least
five business days in advance for U.S.
citizens and at least 10 business days in
advance for international registrants.
Register at: www.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 April 8, 2020, for U.S. registrants
and April 1, 2020, 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 5 business
days 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 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. Written comments should
be provided to the contact person at the
mailing or email address below, and
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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 website on the day of
the meeting for materials: www.cdc.gov/
cliac.
Matters to be Considered: The agenda
will include agency updates from CDC,
CMS, and FDA. Presentations and
discussions will focus on an update on
CLIAC recommendations; an update on
the Genetic Testing Reference Materials
Coordination Program (GeT–RM); an
update of the December 2019 CDC’s
Board of Scientific Counselors, Deputy
Director for Infectious Diseases meeting;
a report from the Office of the National
Coordinator for Health Information
Technology (ONC) Health Information
Technology Advisory Committee; the
laboratory response to the COVID–19
coronavirus disease outbreak; and
technological advances in digital
imaging. Agenda items are subject to
change as priorities dictate.
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. 2020–04068 Filed 2–27–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–0493; Docket No. CDC–2020–
0015]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 40 (Friday, February 28, 2020)]
[Notices]
[Pages 11992-11993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04098]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, 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, and the Determination of the Director, Strategic
Business Initiatives Unit, Office of the Chief Operating Officer, CDC,
pursuant to Public Law 92-463. 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: Disease, Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)--RFA-CE-20-001, Evaluating
Practiced-based Programs, Policies, and Practices from CDC's Rape
Prevention Education Program.
Date: April 29-30, 2020.
Time: 8:30 a.m.-5:30 p.m., EDT.
Place: Embassy Suites Buckhead, 3285 Peachtree Road NE, Atlanta,
Georgia 30305.
Agenda: To review and evaluate grant applications.
For Further Information Contact: Kimberly Leeks, Ph.D., M.P.H.,
Scientific Review Official, National Center for Injury Prevention and
Control, CDC, 4770 Buford Highway NE, Building 106, MS S106-9, Atlanta,
Georgia 30341, Telephone (770) 488-6562, [email protected].
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
[[Page 11993]]
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. 2020-04098 Filed 2-27-20; 8:45 am]
BILLING CODE 4163-18-P
