30 Day FRN

30 Day FRN 0920-1313.pdf

[NCEH] Distribution of Traceable Opioid Material* Kits (TOM Kits*) across U.S. Laboratories

30 Day FRN

OMB: 0920-1313

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79890

Federal Register / Vol. 87, No. 248 / Wednesday, December 28, 2022 / Notices

acting in concert, to retain voting shares
of Bancorp of Okolona, Inc., and thereby
indirectly retain voting shares of
BankOkolona, both of Okolona,
Mississippi.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2022–28264 Filed 12–27–22; 8:45 am]
BILLING CODE P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–23–1313]

ddrumheller on DSK6VXHR33PROD with NOTICES

Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request (ICR) titled
‘‘Distribution of Traceable Opioid
Material Kits (TOM Kits) across U.S.
and International Laboratories’’ to the
Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on 09/16/2022 to obtain
comments from the public and affected
agencies. CDC received one comment
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(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
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or

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other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Distribution of Traceable Opioid
Material Kits (TOM Kits) across U.S.
and International Laboratories (OMB
Control No. 0920–1313, expiration date
12/31/2022)—Revision—National
Center for Environmental Health
(NCEH), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
In response to the Health and Human
Services (HHS) Acting Secretary’s 2017
and ongoing public health emergency
declaration on opioids, the Centers for
Disease Control and Prevention (CDC)
has led 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 the U.S. Drug Enforcement
Agency (DEA) Emerging Threat Reports.
For example, the DEA 2018 data
indicated that fentanyl and fentanylrelated compounds accounted for
approximately 76 percent of their opioid
identifications.
The CDC is requesting a three-year
Paperwork Reduction Act (PRA)
clearance for a revision of this ICR
(formerly known as ‘‘Distribution of
Traceable Opioid Material Kits [TOM
Kits] across U.S. Laboratories’’)(OMB
Control No. 0920–1313). As part of the
proposed revisions, CDC will be
expanding its program to include a new
line of TOM Kits, the Emerging Drug
Panel (EDP) Kits. For the EDP Kits, nonopioid compounds will be identified
and updated by searching recent lists
put out by the DEA and the Center for

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Forensic Science Research and
Education (CFSRE). These lists provide
data on all classes of drugs that were
recently identified in the field and
provide recommendations on which
drugs should be included in testing.
They are updated several times a year
and keep up with the changing drug
landscape in the United States. For the
current round, EDP Kits will include
synthetic cannabinoids, stimulants,
hallucinogens, and benzodiazepines.
CDC will distribute TOM Kits through
a single vendor, which will manufacture
the test kits. The CDC vendor will
distribute these kits to domestic
laboratories, as previously approved
under CDC contract. As a revision, the
CDC vendor will distribute these test
kits to international laboratories in
partnership with the United Nations
and under a separate contract with the
International Narcotics Control Board
(INCB) (hereafter, collectively coined
the ‘‘UN’’). The UN, and not the CDC,
is paying the vendor to ship the kits to
international requesters.
TOM Kits are not intended for
diagnostic use and are free to domestic
and international laboratories in the
public, private, clinical, law
enforcement, research, and public
health domains. The CDC vendor
collects both application and laboratory
information on domestic laboratories
when they apply for test kits.
International laboratories that apply for
test kits through the UN will be directed
to complete and share their laboratory
information with the vendor, but not
with the CDC. This information is used
to prioritize which laboratories will
receive kits when quantities are limited.
The brief web-based surveys will allow
the CDC to: (1) determine what service
the recipient laboratory performs; and to
(2) equitably distribute test kits based on
the analysis techniques and matrices
used by the recipient laboratory.
Over the past three years, CDC has
received 1,472 requests from interested
laboratories (approximately 490 requests
per year) and has distributed 3,007 TOM
Kits. Based on this experience and with
the addition of EDP Kits, we anticipate
that up to 600 domestic laboratories will
request test kits per year. Given that
each application will take six minutes,
the annual time burden for 600
domestic laboratories will be 60 hours.
CDC will add 20 additional annual
burden hours for the international
distribution of test kits. We estimate that
300 international partner laboratories
will apply for test kits per year with the
UN, which in turn will direct these
laboratories to complete the brief fourminute survey on laboratory
information on the CDC vendor website.

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Federal Register / Vol. 87, No. 248 / Wednesday, December 28, 2022 / Notices
There is no burden on the
respondents other than their time. CDC

estimates a total estimated time burden
of 80 hours per year.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

U.S. Federal Laboratories ...............................
State, Local, and Tribal Government Laboratories.
Private or Not-for-Profit US Institutions ..........
International Laboratories ...............................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–28164 Filed 12–27–22; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0915–0322—Extension]

Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Data
Collection Tool for State Offices of
Rural Health Grant Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 27,
2023.

ddrumheller on DSK6VXHR33PROD with NOTICES

SUMMARY:

Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance

ADDRESSES:

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Number of
respondents

Form name

Test Kit Application and Questions
Laboratories (online).
Test Kit Application and Questions
Laboratories (online).
Test Kit Application and Questions
Laboratories (online).
Test Kit Questions for International
tories.

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Average
burden per
response
(in hours)

for US

200

1

6/60

for US

200

1

6/60

for US

200

1

6/60

Labora-

300

1

4/60

Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email [email protected]
or call Samantha Miller, the HRSA
Information Collection Clearance Officer
at (301) 594–4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Data Collection Tool for State Offices of
Rural Health Grant Program, OMB No.
0915–0322—Extension.
Abstract: The HRSA, Federal Office of
Rural Health Policy (FORHP), is
requesting OMB approval to continue
use of a Technical Assistance (TA) Data
Form for the State Offices of Rural
Health (SORH) Grant program
established by section 338J of the Public
Health Service Act (42 U.S.C. 254r). In
its authorizing language (sec. 711 of the
Social Security Act [42 U.S.C. 912]),
Congress charged FORHP with
administering grants, cooperative
agreements, and contracts to provide TA
and other activities as necessary to
support activities related to improving
health care in rural areas. The mission
of FORHP is to sustain and improve
access to quality health care services for
rural communities. This electronic form
is used to collect information from
SORH grantees on the amount of direct
TA they provide to clients within their
state.
Need and Proposed Use of the
Information: FORHP seeks to continue
gathering information from grantees on
their efforts to provide TA to clients

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Number of
responses per
respondent

within their state. SORH grantees
submit a TA Report that includes: (1)
the total number of TA encounters
provided directly by the grantee, and (2)
the total number of unduplicated clients
that received direct TA from the grantee.
These measures will continue in these
three categories: (1) information
disseminated, (2) information created,
and (3) collaborative efforts by (a) topic
area and (b) type of audience. These
measures are used to obtain an accurate
depiction of the breadth of SORH work
based on recommendations from the
grantees. Submission of the TA Report
is submitted via the HRSA Electronic
Handbook no later than 60 days after the
end of each 12-month budget period.
Grant dollars are awarded annually;
therefore, this information is needed
annually by the program in order to
measure effective use of grant dollars
consistently among all the grantees.
Likely Respondents: Fifty SORH
award recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.

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