Notice2022-28164
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 28, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 87 Issue 248 (Wednesday, December 28, 2022)</title>
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[Federal Register Volume 87, Number 248 (Wednesday, December 28, 2022)]
[Notices]
[Pages 79890-79891]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-28164]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-1313]
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 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 fentanyl-related 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, 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 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 four-minute survey on laboratory
information on the CDC vendor website.
[[Page 79891]]
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
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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U.S. Federal Laboratories............. Test Kit Application and 200 1 6/60
Questions for US
Laboratories (online).
State, Local, and Tribal Government Test Kit Application and 200 1 6/60
Laboratories. Questions for US
Laboratories (online).
Private or Not-for-Profit US Test Kit Application and 200 1 6/60
Institutions. Questions for US
Laboratories (online).
International Laboratories............ Test Kit Questions for 300 1 4/60
International
Laboratories.
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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
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