[Federal Register Volume 87, Number 248 (Wednesday, December 28, 2022)]
[Notices]
[Pages 79890-79891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


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