[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