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Federal Register / Vol. 85, No. 40 / Friday, February 28, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

DELTA Impact Program Recipients
State Domestic Violence Coalitions.

Total ...........................................

Key Informant
Lead (Att. 3).

1

1

10

Key Informant Interview—Evaluator
(Att. 4).
Subrecipient Survey (Att. 5) .............
Prevention Infrastructure Assessment (Att. 6).

10

1

45/60

8

17
10

1
2

30/60
1

9
20

...........................................................

........................

........................

........................

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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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 webbased 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.
SUMMARY:

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Total burden
(in hours)

10

[FR Doc. 2020–04082 Filed 2–27–20; 8:45 am]

17:27 Feb 27, 2020

Average
burden per
response
(in hours)

Interview—Project

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.

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Number of
responses per
respondent

Number of
respondent

Form name

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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.

ADDRESSES:

Please note: Submit all comments through
the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.

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: omb@cdc.gov.
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.
FOR FURTHER INFORMATION CONTACT:

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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 illicitlymanufactured 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

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Federal Register / Vol. 85, No. 40 / Friday, February 28, 2020 / Notices

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
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Federal Laboratories ............................................
State, Local, and Tribal Government Laboratories.
Private or Not-for-Profit Institutions ......................

TOM Kits* Questions ....
TOM Kits* Questions ....

400
400

1
1

6/60
6/60

40
40

TOM Kits* Questions ....

400

1

6/60

40

Total ...............................................................

.......................................

........................

........................

........................

120

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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Closed Meeting
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Number of
respondents

Type of respondents

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

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Jkt 250001

as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
RFA–CE–20–001, Evaluating Practicedbased Programs, Policies, and Practices
from CDC’s Rape Prevention Education
Program.
Date: April 29–30, 2020.
Time: 8:30 a.m.–5:30 p.m., EDT.

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Place: Embassy Suites Buckhead,
3285 Peachtree Road NE, Atlanta,
Georgia 30305.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Kimberly Leeks, Ph.D., M.P.H.,
Scientific Review Official, National
Center for Injury Prevention and
Control, CDC, 4770 Buford Highway NE,
Building 106, MS S106–9, Atlanta,
Georgia 30341, Telephone (770) 488–
6562, KLeeks@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and

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