60 day FRN

Attachment 2 60 Day FRN 17ACE_MAT.pdf

Evaluation of Medication- Assisted Treatment (MAT) for Opioid Use Disorders Study

60 day FRN

OMB: 0920-1218

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Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices

DGMQ will review a permit
application within 3–5 business days of
receiving the application and apply the
criteria in Federal Register notice
published at 79 FR 39403 (July 20,
2014). If the application is approved, a
permit will be emailed to the dog’s
owner. The owner must present the
permit to the Customs and Border
Protection (CBP) officer at the first
arriving port of entry into the United
States. The permit will be collected by
the CBP officer and sent to CDC.
If the permit application is denied,
DGMQ will email the reasons for the
denial to the dog’s owner within 3–5
business days of receiving the
application. The email will include
instructions on whom to contact,
including name, address, and telephone
number, if the dog’s owner has any
questions, as well as information on
how to submit an appeal. In accordance
with current procedures, individuals
who wish to contest CDC’s
determination will have five business
days after receiving the denial to submit
a written appeal. The individual must
submit the appeal via email to
[email protected], state the
reasons for the appeal, and show that
there is a genuine and substantial issue
of fact in dispute. CDC will issue a
response via email, which will
constitute final agency action. The
appeal will be reviewed and decided
upon by a CDC senior management
official who is senior to the employee
who denied the initial permit
application. In keeping with current
practice, a successful appeal of a denial
only permits the owner to import the
dog into the United States at a later date
under the requirements set forth in a
dog import permit. The appeal does not
entitle the owner to recover any costs
related to returning a dog that has been
denied entry to its country of origin and
reimporting the dog into the United
States. An owner or owner’s agent will
not be allowed to board a dog or arrange
for its confinement at a port of entry
pending a determination regarding the
importer’s application to import an
inadequately immunized dog.
Accordingly, inadequately immunized
dogs arriving at a port of entry without
an approved permit will be denied entry
into the United States and re-exported
to its country of origin at the owner’s
expense.
III. Paperwork Reduction Act
This change does not institute a new
collection of information. The collection
of information, has been previously
approved by the Office of Management
and Budget (OMB) in accordance with
the requirements of the Paperwork

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Reduction Act (44 U.S.C. 3507) and
assigned the following OMB control
number: Foreign Quarantine: OMB
Control No. 0920–0134, expiration date
5/31/2019.
Dated: June 12, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2017–12439 Filed 6–16–17; 8:45 am]
BILLING CODE 4163–18–P

Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment should be
submitted 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 Leroy A.
Richardson, 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 OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
FOR FURTHER INFORMATION CONTACT:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–17ACE; Docket No. CDC–2017–
0043]

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 efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection entitled ‘‘Evaluation of
Medication-Assisted Treatment (MAT)
for Opioid use disorder.’’ CDC will use
the collection to conduct an
epidemiologic study to assess the type
of MAT (methadone maintenance;
buprenorphine; naltrexone; or,
counseling, no MAT), and the
contextual, provider, and individual
factors that influence implementation
and improved patient wellbeing over a
two-year follow up period.
DATES: Written comments must be
received on or before August 18, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0043 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
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
SUMMARY:

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Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Evaluation of Medication-Assisted
Treatment (MAT) for Opioid use
disorder—New—National Center for
Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC seeks a three-year OMB approval
to collect evaluation information for
Medication-Assisted Treatment (MAT)
for Opioid use disorder.
About 2.4 million people aged 18 or
older have opioid use disorders (OUDs)

real-world outpatient settings. The
study aims to have 3,000 participants
from real-world outpatient settings to
better understand the relationship
between type of MAT and individual,
provider, and contextual characteristics
related to retention in treatment and
abstinence from opioid use. The sites
will be located across 10 diverse
metropolitan statistical areas (MSAs)
with four sites in each MSA. At each
site, about 75 participants are expected
to participate for a total of 300 per MSA.
Across all MSAs, the study will aim to
have 750 client participants in each of
the four treatment conditions (MMT,
BUP, NAL, and COUN).
The study will use a mixed-method
approach using quantitative methods
such as multilevel latent growth models,
propensity score matching, latent class
analysis and advance mediation
analysis and qualitative methods such
as interactive coding and analysis for
common themes. The only cost to
respondents will be time spent
responding to the survey/screener.

in the United States. At any given time,
only half of these people receive some
form of treatment, which may include
medication-assisted treatment (MAT) or
abstinence-based psychotherapy or selfhelp treatments (i.e., counseling without
medication [COUN]). The rise in opioid
overdose deaths, up from 2014–2015
due partly to a 72% rise in synthetic
opioid overdose deaths alone, shows
that engaging and retaining clients in
OUD treatment is an urgent public
health need. Only a few studies are
available to help clients and providers
make informed decisions about the risks
and benefits associated with the
different types of MATs. This
information is crucial because even
though each MAT drug helps prevent
withdrawal symptoms and decreases
cravings, differences in treatment
approach and settings influence how
people respond to the medication and,
thus, their long-term treatment success.
The purpose of this evaluation is to
conduct an epidemiologic, mixedmethods evaluation of OUD treatment in

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondents

Instrument name

Provider site staff ..............................

Client Permission Form ....................
Visit Form .........................................
Site Director Questionnaire ..............
Focus Groups ...................................
Client Screener ................................
Client Check-in .................................
Client Questionnaire .........................
Focus Groups ...................................

Client respondents ............................

Number of
responses per
respondent

15
15
15
27
1,333
1,000
2,412
27

100
525
2
1
1
2
1
1

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

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–12736 Filed 6–16–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

asabaliauskas on DSKBBXCHB2PROD with NOTICES

Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Administration for Native
Americans Objective Work Plan (OWP)
and Objective Progress Report (OPR).
OMB No.: 0970–0452.
Description: Content and formatting
changes are being made to the

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Administration for Native Americans’
(ANA) Objective Work Plan (OWP) and
Objective Progress Report (OPR). The
OWP is used by applicants when they
submit their proposals and then by
grantees to monitor their projects once
the award is made by ANA. Slight
content changes are proposed for the
OWP approved under information
collection OMB No. 0970–0452,
Expiration Date 6/30/2018. An
extension of expiration date is also
requested. This will streamline the
information collection and reduce the
number of elements.
OWP: The following are proposed
content changes to the document: ANA
proposes to eliminate Problem
Statement and Results and Benefits and
Criteria for Evaluation of results and
benefits from the OWP. These elements
will no longer be required by applicants
for ANA discretionary grants. ANA will

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Average
burden per
response
(hours)
5/60
10/60
1
90/60
5/60
15/60
49/60
90/60

Total burden
(hours)
125
1,313
30
41
111
500
1,978
41
4,139

consolidate staffing into one field for
both lead and support staff.
ANA will require applicants to
differentiate between administrative
activities and milestone activities.
Administrative activities are those
directly related to grant administration,
such as reporting and attending postaward training. Milestone activities are
key activities needed to complete
project objectives. These activities may
result in a single output; therefore ANA
will require applicants to identify
outputs related to milestone activities as
necessary.
OPR: Currently, ANA requires
grantees to report on the status of results
and benefits in the OPR. This section
will be deleted as ANA no longer
requires grantees to identify results or
benefits from their project, just
outcomes. Outcomes will be reported
annually in a separate OMB approved
form.

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