Proposed Data Collection Submitted for Public Comment and Recommendations

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Published

September 16, 2022

Issuing agencies

Health and Human Services DepartmentCenters for Disease Control and Prevention

Abstract

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.

Full Text

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<title>Federal Register, Volume 87 Issue 179 (Friday, September 16, 2022)</title>
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[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Notices]
[Pages 56957-56958]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20122]

[[Page 56957]]

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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.

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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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#b2dddfd0f2d1d6d19cd5ddc4"><span class="__cf_email__" data-cfemail="e28d8f80a2818681cc858d94">[email&#160;protected]</span></a>.

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
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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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.
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Total..................... ................ .............. .............. .............. 90
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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. 2022-20122 Filed 9-15-22; 8:45 am]
BILLING CODE 4163-18-P

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