Proposed Data Collection Submitted for Public Comment and Recommendations, 56957-56958 [2022-20122]
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Federal Register / Vol. 87, No. 179 / Friday, September 16, 2022 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–22–1313; Docket No. CDC–2022–
0109]
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
general public and other federal
agencies the opportunity to comment on
a continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Distribution of
Traceable Opioid Material* Kits and
Emerging Drug Panel Kits across U.S.
and International Laboratories. CDC will
collect information from domestic and
international laboratories submitting
requests for TOM Kits* and EDP Kits,
and will use this information to
prioritize which laboratories will
receive kits when quantities are limited.
DATES: CDC must receive written
comments on or before November 15,
2022.
SUMMARY:
You may submit comments,
identified by Docket No. CDC–2022–
0109 by either of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.regulations.gov) or by U.S. mail to
the address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
khammond on DSKJM1Z7X2PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
16:43 Sep 15, 2022
Jkt 256001
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7570; Email: omb@
cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. 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
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Distribution of Traceable Opioid
Material* Kits and Emerging Drug Panel
Kits across U.S. and International
Laboratories (OMB Control No. 1313,
Exp. 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
(PHE) declaration on opioids, the
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
56957
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% of their opioid
identifications.
TOM Kits* are not intended for
diagnostic use and are free to
laboratories in the public, private,
clinical, law enforcement, research, and
public health domains. The CDC
collects information on laboratories
when they apply for test kits. This
information is used to prioritize which
laboratories will receive kits when
quantities are limited. The brief sixminute web-based survey will allow the
CDC to: (1) determine what service the
recipient laboratory performs; and (2)
equitably distribute test kits based on
the analysis techniques and matrices
used by the recipient laboratory.
The CDC is requesting a three-year
Paperwork Reduction Act (PRA)
clearance for a Revision information
collection request (ICR) titled
‘‘Distribution of Traceable Opioid
Material* Kits and Emerging Drug Panel
Kits across U.S. and International
Laboratories’’ (OMB Control No. 0920–
1313; Expiration Date 12/31/2022). As
part of the proposed revisions, CDC will
be expanding its program to include
both TOM Kits* and the new Emerging
Drug Panel (EDP) Kits. For the EDP Kits,
non-opioid compounds will be
identified and updated by searching
recent lists put out by the DEA and the
Center for 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* and
EDP Kits through a single vendor. The
CDC vendor will distribute these kits to
domestic laboratories, as previously
approved, and as a revision, to
E:\FR\FM\16SEN1.SGM
16SEN1
56958
Federal Register / Vol. 87, No. 179 / Friday, September 16, 2022 / Notices
international laboratories in partnership
with the United Nations Office on Drugs
and Crimes (UNODC). The CDC vendor
will bulk ship these kits to UNODC for
international distribution, or the vendor
may direct ship these kits to select
international laboratories upon UNODC
request.
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.
We will add 30 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
UNODC, assuming the same six minutes
per application. The UNODC will
compile and report this information to
CDC twice a year (15 burden hours per
response).
We estimate a total time burden of 90
hours per year, which is a decrease of
30 hours over the previously approved
120 hours. There is no cost to the
respondents other than their time to
participate.
* 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
Type of
respondents
Form name
U.S. Federal Laboratories .....
Test Kit Application and Questions for U.S.
Laboratories (online).
Test Kit Application and Questions for U.S.
Laboratories (online).
Test Kit Application and Questions for U.S.
Laboratories (online).
Test Kit Distribution Report for International
Laboratories.
State, Local, and Tribal Government Laboratories.
Private or Not-for-Profit U.S.
Institutions.
United Nations Office on
Drugs and Crimes
(UNODC).
Total ...............................
.......................................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–20122 Filed 9–15–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–22–22AW]
khammond on DSKJM1Z7X2PROD 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 titled ‘‘NCEH DLS
Laboratory Quality Assurance
Programs’’ 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 December
27, 2021, to obtain comments from the
public and affected agencies. CDC
received four non-substantive comments
related to the previous notice. This
notice serves to allow an additional 30
VerDate Sep<11>2014
16:43 Sep 15, 2022
Jkt 256001
Number of
responses per
respondent
Number of
respondents
Frm 00033
Fmt 4703
Total burden
(in hours)
200
1
6/60
20
200
1
6/60
20
200
1
6/60
20
1
2
15
30
........................
........................
........................
90
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
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.
PO 00000
Average
burden per
response
(in hours)
Sfmt 4703
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
NCEH DLS Quality Assurance
Programs—Existing Collection in Use
Without an OMB Control Number—
National Center for Environmental
Health (NCEH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Laboratory quality assurance (QA)
encompasses a range of activities that
enable laboratories to achieve and
maintain high levels of accuracy and
proficiency despite changes in test
methods, instrumentation, analytes,
source materials, and the volume of
specimens tested. The Centers for
Disease Control and Prevention (CDC),
E:\FR\FM\16SEN1.SGM
16SEN1
]]>Agencies
[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Notices]
[Pages 56957-56958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20122]
[[Page 56957]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-22-1313; Docket No. CDC-2022-0109]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: 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 general public and other
federal agencies the opportunity to comment on a continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Distribution of Traceable Opioid Material* Kits and Emerging
Drug Panel Kits across U.S. and International Laboratories. CDC will
collect information from domestic and international laboratories
submitting requests for TOM Kits* and EDP Kits, and will use this
information to prioritize which laboratories will receive kits when
quantities are limited.
DATES: CDC must receive written comments on or before November 15,
2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0109 by either of the following methods:
Federal eRulemaking Portal: www.regulations.gov. Follow
the instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (www.regulations.gov) or by U.S. mail to the address listed
above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. 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
other forms of information technology, e.g., permitting electronic
submissions of responses; and
5. Assess information collection costs.
Proposed Project
Distribution of Traceable Opioid Material* Kits and Emerging Drug
Panel Kits across U.S. and International Laboratories (OMB Control No.
1313, Exp. 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 (PHE) 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 fentanyl-related compounds
accounted for approximately 76% of their opioid identifications.
TOM Kits* are not intended for diagnostic use and are free to
laboratories in the public, private, clinical, law enforcement,
research, and public health domains. The CDC collects information on
laboratories when they apply for test kits. This information is 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 (2)
equitably distribute test kits based on the analysis techniques and
matrices used by the recipient laboratory.
The CDC is requesting a three-year Paperwork Reduction Act (PRA)
clearance for a Revision information collection request (ICR) titled
``Distribution of Traceable Opioid Material* Kits and Emerging Drug
Panel Kits across U.S. and International Laboratories'' (OMB Control
No. 0920-1313; Expiration Date 12/31/2022). As part of the proposed
revisions, CDC will be expanding its program to include both TOM Kits*
and the new Emerging Drug Panel (EDP) Kits. For the EDP Kits, non-
opioid compounds will be identified and updated by searching recent
lists put out by the DEA and the Center for 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* and EDP Kits through a single vendor.
The CDC vendor will distribute these kits to domestic laboratories, as
previously approved, and as a revision, to
[[Page 56958]]
international laboratories in partnership with the United Nations
Office on Drugs and Crimes (UNODC). The CDC vendor will bulk ship these
kits to UNODC for international distribution, or the vendor may direct
ship these kits to select international laboratories upon UNODC
request.
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.
We will add 30 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 UNODC, assuming the
same six minutes per application. The UNODC will compile and report
this information to CDC twice a year (15 burden hours per response).
We estimate a total time burden of 90 hours per year, which is a
decrease of 30 hours over the previously approved 120 hours. There is
no cost to the respondents other than their time to participate.
* 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 Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
U.S. Federal Laboratories..... Test Kit 200 1 6/60 20
Application and
Questions for
U.S.
Laboratories
(online).
State, Local, and Tribal Test Kit 200 1 6/60 20
Government Laboratories. Application and
Questions for
U.S.
Laboratories
(online).
Private or Not-for-Profit U.S. Test Kit 200 1 6/60 20
Institutions. Application and
Questions for
U.S.
Laboratories
(online).
United Nations Office on Drugs Test Kit 1 2 15 30
and Crimes (UNODC). Distribution
Report for
International
Laboratories.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 90
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-20122 Filed 9-15-22; 8:45 am]
BILLING CODE 4163-18-P
