[Federal Register Volume 85, Number 40 (Friday, February 28, 2020)]
[Notices]
[Pages 11991-11992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-20JE; Docket No. CDC-2020-0025]


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 proposed and/or 
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 (TOM Kits*) across U.S. Laboratories.'' CDC will 
use a brief web-based survey to collect information from laboratories 
submitting requests for TOM Kits*. CDC will use this information to 
prioritize which laboratories will receive kits when quantities are 
limited.
    * TRACEABLE OPIOID MATERIAL, TOM KITS, and the TOM KITS logo are 
marks of the U.S. Department of Health and Human Services.

DATES: CDC must receive written comments on or before April 28, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0025 by any of the following methods:
     Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.

    Please note:  Submit all comments through the Federal 
eRulemaking portal (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-D74, Atlanta, Georgia 30329; phone: 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; and
    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.
    5. Assess information collection costs.

Proposed Project

    Distribution of Traceable Opioid Material* Kits (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 percent of all opioid identifications are illicit 
fentanyls. Laboratories are routinely asked to confirm which fentanyl 
or other opioids

[[Page 11992]]

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 percent 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.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
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Federal Laboratories..........  TOM Kits*                    400               1            6/60              40
                                 Questions.
State, Local, and Tribal        TOM Kits*                    400               1            6/60              40
 Government Laboratories.        Questions.
Private or Not-for-Profit       TOM Kits*                    400               1            6/60              40
 Institutions.                   Questions.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             120
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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. 2020-04083 Filed 2-27-20; 8:45 am]
 BILLING CODE 4163-18-P