[Federal Register Volume 85, Number 106 (Tuesday, June 2, 2020)]
[Notices]
[Pages 33678-33679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11794]



[[Page 33678]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-20-20JE]


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 ``Distribution of Traceable Opioid Material 
(TOM) Kits across U.S. 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 February 28, 2020 to obtain comments from 
the public and affected agencies. CDC received four comments 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 (TOM) Kits across U.S. 
Laboratories--New--National Center for Environmental Health (NCEH), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    For the first time in U.S. history, a drug class has been declared 
a national public health emergency; each day more than 140 Americans 
die from drug overdoses, 91 specifically because of opioids. Since 
2013, there have been significant increases in overdose deaths 
involving synthetic opioids--particularly those involving illicitly-
manufactured fentanyl. The U.S. Drug Enforcement Administration (DEA) 
estimates that 75% of all opioid identifications are illicit fentanyls. 
Laboratories are routinely asked to confirm which fentanyl or other 
opioids are involved in an overdose or encountered by first responders, 
as it is critical to identify and classify the types of drugs involved 
in an overdose, how often they are involved, and how that involvement 
may change over time. By understanding which drugs are present, 
appropriate prevention and response activities can be implemented.
    The Centers for Disease Control and Prevention (CDC) is leading 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 DEA Emerging 
Threat Reports. The DEA 2018 mid-year data indicate that fentanyl and 
fentanyl-related compounds account for approximately 75% of their 
opioid identifications. These kits are reference materials and do not 
eliminate the need to meet analytical method requirements of other 
federal agencies. TOM Kits* are not intended for diagnostic use. The 
kits are free to laboratories in the public, private, clinical, law 
enforcement, research, and public health domains.
    To equitably distribute these TOM Kits*, the CDC conducted an 
emergency information collection, titled ``Distribution of Traceable 
Opioid Material* Kits (TOM Kits*) across U.S. Laboratories,'' under the 
Health and Human Services (HHS) Secretary's Public Health Emergency 
Paperwork Reduction Act (PHE PRA) Waiver mechanism for the period from 
03/20/2019 to 05/10/2019. From 05/10/2019, CDC continued distributing 
kits using a generic information collection (GenIC) under ``Generic 
Clearance for the Collection of Qualitative Feedback on Agency Service 
Delivery'' (OMB Control No. 0923-0047; expiration date 01/31/2022). To 
continue this collection, the CDC is currently requesting a three-year 
PRA clearance for a new information collection request (ICR) under the 
same title.
    CDC is currently distributing a product line of TOM Kits*. Examples 
of products in this line include the: (1) Opioid Certified Reference 
Material Kit (Opioid CRM Kit); and (2) Fentanyl Analog Screening Kit 
(FAS Kit). Respondent laboratories requesting the TOM Kits* can be from 
any sector (academic, public, or private), must be located in the U.S., 
must have a verifiable business address, must have a current DEA 
registration, must comply with respective state and local regulations, 
and must submit requests directly to the respective vendor.
    As the number of laboratories requesting TOM Kits* is high, the 
information collection will be 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 the volume of samples the laboratory 
processes, and to (2) equitably distribute TOM Kits* based on the 
analysis techniques, matrix, and sample size used by the recipient 
laboratory.
    The annual number of respondents (n=1,200) was based on the number 
of 2019 requests. The total time burden requested is 120 hours per 
year. There is no burden on the respondents other than their time. 
*TRACEABLE OPIOID MATERIAL, TOM KITS, and the TOM KITS logo are marks 
of the U.S. Department of Health and Human Services.

[[Page 33679]]



                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Federal Laboratories..................  TOM Kits * Questions....             400               1            6/60
State, Local, and Tribal Government     TOM Kits * Questions....             400               1            6/60
 Laboratories.
Private or Not-for-Profit Institutions  TOM Kits * Questions....             400               1            6/60
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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. 2020-11794 Filed 6-1-20; 8:45 am]
BILLING CODE 4163-18-P