60d FRN - published

32705

Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices
Background and Brief Description
Overdose deaths involving
prescription opioids and heroin have
reached epidemic levels in the U.S. and
continue to rise. To address the
prescription drug/opioid overdose
crisis, the federal government has
recently allocated funding to improve
access to treatment for opioid use
disorders, reduce opioid related deaths,
and strengthen drug misuse prevention
efforts. One program resulting from the
federal government’s efforts to address
the opioid crisis is, the Substance Abuse
and Mental Health Services Agency
(SAMHSA) Grants to Prevent
Prescription Drug/Opioid OverdoseRelated Deaths (PDO/naloxone grant).
This collection will be to evaluate the
Substance Abuse and Mental Health
Services Agency (SAMHSA) Grants to
Prevent Prescription Drug/Opioid
Overdose-Related Deaths.
This evaluation will seek to describe
and understand the scope and impact of
the program on overdose. To address the
prescription drug/opioid overdose

The intended use of the resulting data
is to increase CDC and SAMHSA
understanding of the scope and impact
of the program on overdose fatalities
and how program effectiveness may
vary among different sub-populations
and settings, and to increase knowledge
of barriers and facilitators to program
implementation. Key informant
interviews and focus groups with
participants in the activities enacted by
the twelve state grant recipients will be
methodology used. This will include
state administrators of the grant and
other PDO/Naloxone stakeholders
including advisory council members,
first responders, social service
providers, laypersons including end
users and their family and friend. All
focus groups and interviews will be
analyzed through qualitative content
analysis, including utilization of a
systematic coding scheme.
Total burden in hours for this
collection is 381. There are no costs to
respondents other than their time.

crisis, the federal government has
recently allocated funding to improve
access to treatment for opioid use
disorders, reduce opioid related deaths,
and strengthen drug misuse prevention
efforts. One program resulting from the
federal government’s efforts to address
the opioid crisis is, the Substance Abuse
and Mental Health Services Agency
(SAMHSA) Grants to Prevent
Prescription Drug/Opioid OverdoseRelated Deaths (PDO/naloxone grant).
Through this program, SAMHSA
awarded funding to 12 states. The
funding is aimed at reducing the
number of prescription drug/opioid
overdose-related deaths and adverse
events among individuals 18 years of
age and older through educating and
training first responders and other key
community sectors on the prevention of
prescription drug/opioid overdoserelated deaths, including the purchase
and distribution of naloxone. SAMHSA
is funding the grant and CDC is
responsible for conducting the grantee
evaluation.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

PDO/Naloxone Advisory Committee
Members and Grantees.
PDO/Naloxone Grantees ..................

Focus Group Discussion Guide .......

140

1

1.5

210

Individual
Interview
Discussion
Guide for Grantees.
Individual
Interview
Discussion
Guide for Partners.
Individual
Interview
Discussion
Guide for Laypersons.
Recruitment contact script ...............

36

1

1

36

84

1

1

84

24

1

1

24

284

1

5/60

24

Key Informant Selection Tool ...........

12

1

15/60

3

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

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

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

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

381

PDO/Naloxone Stakeholders and
Partners.
PDO/Naloxone Laypersons ..............
All participants (PDO Naloxone
grantees, advisory committee,
stakeholders
and
partners,
laypersons).
PDO/Naloxone Grantees ..................
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. 2017–14914 Filed 7–14–17; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–1054; Docket No. CDC–2017–
0055]

BILLING CODE 4163–18–P

asabaliauskas on DSKBBXCHB2PROD with NOTICES

Number of
responses per
respondent

Type of respondents

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

SUMMARY:

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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 ‘‘Drug Overdose
Response Investigation (DORI) Data
Collections.’’ CDC will use the
information collected to respond to
urgent requests from state and local
health authorities to provide
epidemiological information that allows

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asabaliauskas on DSKBBXCHB2PROD with NOTICES

32706

Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices

for the selection of interventions to curb
local epidemics of drug overdose.
DATES: Written comments must be
received on or before September 15,
2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0055 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
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.
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 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:
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 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

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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
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
Drug Overdose Response Investigation
(DORI) Data Collections (OMB control
number 0920–1054, Expiration 03/31/
218)—Extension—National Center for
Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
In 2015, CDC received OMB approval
(OMB control number 0920–1054) for a
new OMB generic clearance for a threeyear period to collect information to
respond to urgent requests from state
and local health authorities to provide
epidemiological information that allows
for the selection of interventions to curb
local epidemics of drug overdose. CDC
seeks OMB approval for an extension of
this generic plan for another three-year
period.
Drug Overdose Response Investigation
(DORI) are to be conducted in response
to urgent requests from state and local
health authorities to provide
epidemiological information that allows
for the selection of interventions to curb

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local epidemics of drug overdose. Of
particular interest is response to
increasing trends in, or changing
characteristics of, overdose from
prescription drugs (with a special
interest in opioid analgesics such as
oxycodone or methadone;
benzodiazepines such as alprazolam)
and/or illicit drugs (e.g., heroin). CDC’s
National Center for Injury Prevention
and Control (NCIPC) is frequently called
upon to conduct DORIs at the request of
state or local health authorities seeking
support to respond to urgent public
health problems resulting from drug
use, misuse, abuse, and overdose. Such
requests are typically, but not always,
made through CDC’s Epi-Aid
mechanism; in most investigations,
CDC’s epidemiological response entails
rapid and flexible collection of data that
evolves during the investigation period.
Generic clearance is requested to
ensure that timely information is
collected during a DORI, which allows
NCIPC to maintain critical mission
function by working with state and local
health authorities to protect the public’s
health. During an unanticipated rise in
nonfatal or fatal drug overdose where
the substances responsible for the health
event need to be identified, drivers and
risk factors are undetermined, and/or
subgroups at risk need to be identified,
immediate action by CDC is necessary to
minimize or prevent public harm. CDC
must have the ability to rapidly deploy
data collection tools to understand the
scope of the problem and determine
appropriate action. Procedures for each
investigation, including specific data
collection plans, depend on the time
and resources available, number of
persons involved, and other
circumstances unique to the urgent
conditions at hand. Data are collected
by epidemiologists, psychologists,
medical professionals, subject matter
experts, and biostatisticians.
Data collected during a DORI are used
to understand sudden increases in drug
use and misuse associated with fatal
and nonfatal overdoses, understand the
drivers and risk factors associated with
those trends, and identify the groups
most affected. This allows CDC to
effectively advise states on actions that
could be taken to control the local
epidemic. During a DORI, data are
collected once, with the rare need for
follow-up. There are no costs to
respondents other than their time.

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Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

Form name

Drug Overdose Response Investigation Participants.

Drug Overdose Response Investigation Data Collection Instruments.

2,700

1

30/60

1,350

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

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

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

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

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

1350

[FR Doc. 2017–14915 Filed 7–14–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Fees for Sanitation Inspection of
Cruise Ships
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: General notice.
AGENCY:

VSP helps the cruise line industry fulfill
its responsibility for developing and
implementing comprehensive sanitation
programs to minimize the risk for acute
gastroenteritis. Every vessel that has a
foreign itinerary and carries 13 or more
passengers is subject to twice-yearly
unannounced inspections and, when
necessary, reinspection.
DATES: These fees are effective October
1, 2017, through September 30, 2018.
FOR FURTHER INFORMATION CONTACT: CDR
Aimee Treffiletti, Chief, Vessel
Sanitation Program, National Center for
Environmental Health, Centers for
Disease Control and Prevention, 4770
Buford Highway NE., MS F–59, Atlanta,
Georgia 30341–3717; phone: 800–323–
2132, 770–488–7070, or 954–356–6650;
email: vsp@cdc.gov.
SUPPLEMENTARY INFORMATION:

The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS) announces fees
for vessel sanitation inspections for
Fiscal Year (FY) 2018. These
inspections are conducted by HHS/
CDC’s Vessel Sanitation Program (VSP).

Purpose and Background

Total cost of VSP = Total cost of
operating the program, such as
administration, travel, staffing,
sanitation inspections, and outbreak
response.
Weighted number of annual inspections
= Total number of ships and inspections
per year accounting for vessel size,
number of inspectors needed for vessel
size, travel logistics to conduct
inspections, and vessel location and
arrivals in U.S. jurisdiction per year.

Fee

SUMMARY:

The fee schedule was originally
established and published in the
Federal Register on July 17, 1987 (52 FR
27060). It was most recently published
in the Federal Register on August 19,
2016 (81 FR 55460). The fee schedule
for FY 2018 is presented in Appendix A.

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HHS/CDC established the Vessel
Sanitation Program (VSP) in the 1970s
as a cooperative activity with the cruise
ship industry. VSP helps the cruise ship
industry prevent and control the
introduction, transmission, and spread
of gastrointestinal illnesses on cruise

The fee schedule (Appendix A) will
be effective October 1, 2017, through
September 30, 2018.

ships. VSP operates under the authority
of the Public Health Service Act
(Section 361 of the Public Health
Service Act; 42 U.S.C. 264, ‘‘Control of
Communicable Diseases’’). Regulations
found at 42 CFR 71.41 (Foreign
Quarantine—Requirements Upon
Arrival at U.S. Ports: Sanitary
Inspection; General Provisions) state
that carriers arriving at U.S. ports from
foreign areas are subject to sanitary
inspections to determine whether
rodent, insect, or other vermin
infestations exist, contaminated food or
water, or other sanitary conditions
requiring measures for the prevention of
the introduction, transmission, or
spread of communicable diseases are
present.
The fee schedule for sanitation
inspections of passenger cruise ships by
VSP was first published in the Federal
Register on November 24, 1987 (52 FR
45019). HHS/CDC began collecting fees
on March 1, 1988. This notice
announces fees that are effective for FY
2018, beginning on October 1, 2017,
through September 30, 2018.
The following formula will be used to
determine the fees:

Dated: July 12, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.

Appendix A

Applicability
The fees will apply to all passenger
cruise vessels for which inspections are
conducted as part of HHS/CDC’s VSP.
Inspections and reinspections involve
the same procedures, require the same
amount of time, and are therefore
charged at the same rates.

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FEE SCHEDULE FOR EACH VESSEL
SIZE
Vessel size
(GRT 1)
Extra Small (<3,000 GRT) ....
Small (3,001–15,000 GRT) ..
Medium (15,001–30,000
GRT) .................................
Large (30,001–60,000 GRT)
Extra Large (60,001–120,000
GRT) .................................

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Inspection
fee
US$1,495
2,990
5,980
8,970
11,960

EN17JY17.000

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.

asabaliauskas on DSKBBXCHB2PROD with NOTICES

Number of
respondents

Type of respondent