Agency Forms Undergoing Paperwork Reduction Act Review, 33678-33679 [2020-11794]
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33678
Federal Register / Vol. 85, No. 106 / Tuesday, June 2, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–20JE]
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
20:46 Jun 01, 2020
Jkt 250001
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 illicitlymanufactured 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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\02JNN1.SGM
02JNN1
33679
Federal Register / Vol. 85, No. 106 / Tuesday, June 2, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Federal Laboratories ...............................................................
State, Local, and Tribal Government Laboratories .................
Private or Not-for-Profit Institutions .........................................
TOM Kits * Questions .............
TOM Kits * Questions .............
TOM Kits * Questions .............
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–0260]
Agency Forms Undergoing Paperwork
Reduction Act Review
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Health Hazard
Evaluations/Technical Assistance and
Emerging Problems 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
10, 2020 to obtain comments from the
public and affected agencies. CDC did
not receive 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
VerDate Sep<11>2014
20:46 Jun 01, 2020
Jkt 250001
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
Health Hazard Evaluations/Technical
Assistance and Emerging Problems
(OMB Control No. 0920–0260, Exp. 10/
31/2020)—Revision—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
In accordance with its mandates
under the Occupational Safety and
Health Act of 1970 and the Federal
Mine Safety and Health Act of 1977,
NIOSH responds to requests for HHE to
identify chemical, biological or physical
hazards in workplaces throughout the
United States. Each year, NIOSH
receives approximately 250 such
requests. Most HHE requests come from
workplaces in the following industrial
sectors: Services, manufacturing, health
and social services, transportation, and
construction.
A printed HHE request form is
available in English and in Spanish. The
form is also available on the internet
and differs from the printed version
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
400
400
400
Number of
responses per
respondent
1
1
1
Average
burden per
response
(in hours)
6/60
6/60
6/60
only in format and in the fact that it can
be submitted directly from the website.
The request form takes an estimated 12
minutes to complete. The form provides
the mechanism for employees,
employers, and other authorized
representatives to supply the
information required by the regulations
governing the NIOSH HHE program (42
CFR 85.3–1). NIOSH reviews the HHE
request to determine if an on-site
evaluation is needed. The primary
purpose of an on-site evaluation is to
help employers and employees identify
and eliminate occupational health
hazards. For 25% of the requests
received NIOSH determines an on-site
evaluation is needed.
In about 70% of on-site evaluations,
employees are interviewed in an
informal manner to help further define
concerns. Interviews may take
approximately 15 minutes per
respondent. The interview questions are
specific to each workplace and its
suspected diseases and hazards.
However, interviews are based on
standard medical practices. In
approximately 30% of on-site
evaluations questionnaires are
distributed to the employees (averaging
about 100 employees per site).
Questionnaires may require
approximately 30 minutes to complete.
The survey questions are specific to
each workplace and its suspected
diseases and hazards, however, items in
the questionnaires are derived from
standardized or widely used medical
and epidemiologic data collection
instruments.
About 70% of the on-site evaluations
involve employee exposure monitoring
in the workplace. Employees
participating in on-site evaluations by
wearing a sampler or monitoring device
to measure personal workplace
exposures are offered the opportunity to
get notification of their exposure results.
To indicate their preference and, if
interested, provide contact information,
employees complete a contact
information post card. Completing the
contact card may take five minutes or
less. The number of employees
monitored for workplace exposures per
E:\FR\FM\02JNN1.SGM
02JNN1
]]>Agencies
[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]]
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
