60 day FRN

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Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices

years old (76 hours); and 10 minutes for
191 children aged 12–17 years old who
assent for themselves (32 hours).
Exposure Assessment Questionnaires
for Biological and Environmental
Testing for Adults, Parents, or Children:
ATSDR/NCEH will administer an
exposure questionnaire to all consented
respondents that includes questions
associated with potential exposure to
PFAS both inside and outside the home
(e.g., work or school). The adult
questionnaire also includes several
questions associated with water use and
flooring type while the child
questionnaire includes questions
regarding playing in soil; these
questions are intended to evaluate
potential exposure and to support the
environmental testing. The time
associated with administering the
questionnaire and completing the
biological sampling is approximately 30

minutes for 1,440 adults (720 hours); 15
minutes for 264 parents responding for
their children, 3–11 years old (66
hours); and 15 minutes for 191 children,
12–17 years old, who respond for
themselves (48 hours).
Household Recruitment Script for
Environmental Sampling: The
households providing environmental
samples (tap water and indoor dust) will
be a random 10 percent subset of
households that report using tap water
for drinking water. Assuming a 65
percent response rate, ATSDR/NCEH
will administer a five-minute
recruitment script to 23 heads-of
households who are eligible to take part
in each EA (152/10 * 100/65). This will
result in annual recruitment from 117
heads-of-households and 10 hours for
five EAs.
Consent for Environmental Testing:
ATSDR/NCEH will consent a 10 percent

subset of households deemed eligible
for the EA for testing of tap water and
indoor dust samples; therefore, the
desired number of households is 15 per
EA, or 76 per year (152 * 10/100 * 5).
The time associated with consenting to
the environmental sampling is 10
minutes, resulting in a burden of 13
hours annually for five EAs.
Environmental Sample Collection
Form: ATSDR will collect samples from
approximately 15 households per EA or
76 households annually (152*10/100*5)
and fill out a sample collection form.
The average time burden is estimated as
15 minutes per response for the sample
collection forms (19 hours annually).
ATSDR estimates the total annualized
time burden is 1,390 hours.
Participation is voluntary, and there are
no costs to respondents other than their
time.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

EA Community Members .......
EA Adults ...............................

Community Event Evaluation Survey .....................................
Household Eligibility Screener ................................................
Consent ...................................................................................
Exposure Questionnaire (Adult)for Biological and Environmental Testing.
Parental Permission ................................................................
Exposure Questionnaire (Child)for Biological Testing (Parent
Proxy).
Assent .....................................................................................
Exposure Questionnaire (Child)for Biological Testing (Child
completed).
Household Recruitment Script for Environmental Sampling ..
Environmental Sampling Consent Form .................................
Environmental Sample Collection Form .................................

EA Parents .............................
EA Children ............................
EA Heads-of-Households .......

Jeffrey M. Zirger,
Acting Team Lead, Information Collection
Review Office, Office of Scientific Integrity,
Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2018–25626 Filed 11–26–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

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Number of
respondents

Type of respondents

[60Day–19–19BN; Docket No. CDC–2018–
0104]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

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ACTION:

Notice with comment period.

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 ‘‘Emergency Cruise Ship Outbreak
Investigations (CSOIs)’’. The purpose of
this study is to allow the CDC Vessel
Sanitation Program (VSP) to prevent the
introduction, transmission, or spread of
acute gastroenteritis (AGE) via cruise
ships entering the United States from
foreign countries.

SUMMARY:

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Number of
responses per
respondent

Average
burden per
response
(in hours)

815
1,170
1,440
1,440

1
1
1
1

5/60
5/60
10/60
30/60

455
264

1
1

10/60
15/60

191
191

1
1

10/60
15/60

117
76
76

1
1
1

5/60
10/60
15/60

CDC must receive written
comments on or before January 28,
2019.

DATES:

You may submit comments,
identified by Docket No. CDC–2018–
0104 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.

ADDRESSES:

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Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices
FOR FURTHER INFORMATION CONTACT:

Background and Brief Description

Proposed Project
Emergency Cruise Ship Outbreak
Investigations (COIs)—Existing
Collection in Use without an OMB
Control Number—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).

Established in 1975 as a cooperative
activity with the cruise ship industry,
the Centers for Disease Control and
Prevention (CDC) Vessel Sanitation
Program (VSP) develops and
implements comprehensive sanitation
programs to minimize the risk of
gastrointestinal diseases, by
coordinating and conducting
operational inspections, ongoing
surveillance of gastrointestinal illness,
and outbreak investigations on vessels.
Under the authority of the Public
Health Service Act (42 U.S.C. Sections
264 and 269), the VSP is requesting a
three-year approval for a new generic
clearance information collection request
(ICR). This ICR will provide the quick
turn-around necessary to conduct
emergency cruise ship outbreak
investigations (CSOIs) in response to
acute gastroenteritis (AGE) outbreaks.
CSOIs are used to determine the
causative agents and their sources,
modes of transmission, or risk factors.
The VSP’s jurisdiction includes
passenger vessels carrying 13 or more
people sailing from foreign ports and
within 15 days of arriving at a U.S. port.
VSP uses its syndromic surveillance
system called the Maritime Illness and
Death Reporting System (MIDRS)
(approved under ‘‘Foreign Quarantine
Regulations’’ [OMB Control No. 0920–
0134, expiration date 05/31/2019]) to
collect aggregate data about the number
of people onboard ships in VSP’s
jurisdiction who are experiencing AGE
symptoms. When the levels of illness
meet VSP’s alert threshold (i.e., at least
2% in either the passenger or crew
populations), a special report is made to
VSP via MIDRS and remote
environmental health and
epidemiologic assistance is provided.
VSP considers an outbreak to be ≥3% of
reportable AGE cases in either guest or
crew populations. When assistance is
needed due to AGE outbreaks on cruise
ships, this often requires VSP to deploy
a response team to meet the ship in port
within 24 hours of reaching the
outbreak threshold, and in some cases
deploying the response team to board
the ship before its U.S. arrival and sail
back to the U.S. port of disembarkation
to conduct a more detailed and
comprehensive epidemiologic and
environmental health evaluation of the
outbreak.
Causative agent, sources of exposure,
modes of transmission, and risk factors
can be ascertained by gathering the

amozie on DSK3GDR082PROD with NOTICES1

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.

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60869

following types of information from
both the affected and (seemingly)
unaffected populations:
• Demographic information,
• Pre-embarkation travel information,
• Symptoms, including type, onset,
duration,
• Contact with people who were sick
or their body fluids,
• Participation in ship and shore
activities,
• Locations of eating and drinking,
and
• Foods and beverages consumed
both on the ship and on shore.
Rapid and flexible data collection is
imperative given the mobile
environment, the remaining duration of
the voyage left for investigation, and the
loss to follow-up if delays allow
passengers to disembark and leave the
ship, including those returning to
locations outside of the U.S.
This new generic clearance will cover
investigations that meet all of the
following criteria:
• The investigation is urgent in
nature (i.e., timely data are needed to
inform rapid public health action to
prevent or reduce morbidity or
mortality).
• The investigation is characterized
by undetermined agents, undetermined
sources, undetermined modes of
transmission, or undetermined risk
factors.
• One or more CDC staff (including
trainees and fellows) will be deployed
to the field.
• Most CSOIs involve two to five days
of data collection; data collection is
completed in 30 days or less.
This new generic clearance excludes
each of the following:
• Investigations related to non-urgent
outbreaks or events.
• Investigations conducted for the
primary purpose of program evaluation,
surveillance, needs assessment, or
research (e.g., to contribute to
generalizable knowledge).
• Investigations with data collection
expected for greater than 30 days.
The VSP estimates 10 CSOIs annually
in response to cruise ship AGE
outbreaks. The estimated number of
respondents is 2,500 per CSOI, for a
total of 25,000 respondents per year.
The average time burden is 15 minutes
for each respondent. Therefore, the total
estimated annual burden in hours is
6,250. There is no cost to respondents
other than their time.

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60870

Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
(in hours)

Form name

Cruise Ship Passengers or Crew ...................................
Cruise Ship Passengers or Crew ...................................

Questionnaire ......
Interview ..............

24,750
250

1
1

15/60
15/60

6,188
62

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

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

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

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

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

6,250

Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018–25752 Filed 11–26–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–0134]

Agency Forms Undergoing Paperwork
Reduction Act Review

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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 Foreign
Quarantine Regulations (42 CFR 71) 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 September 7, 2018 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;

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(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 or
send an email to [email protected]. 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
Foreign Quarantine Regulations (42
CFR 71) (OMB Control No. 0920–0134)
(Exp 5/31/2019)—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Section 361 of the Public Health
Service Act (PHSA) (42 U.S.C. 264)
authorizes the Secretary of Health and
Human Services to make and enforce
regulations necessary to prevent the
introduction, transmission or spread of
communicable diseases from foreign
countries into the United States. Statute
and the existing regulations governing
foreign quarantine activities (42 CFR 71)
authorize quarantine officers and other
personnel to inspect and undertake
necessary control measures with respect
to conveyances, persons, and shipments
of animals and etiologic agents in order
to protect the public’s health. Other
inspection agencies, such as Customs
and Border Protection (CBP), assist
quarantine officers in public health
screening of persons, pets, and other
importations of public health
importance and make referrals to
quarantine station staff when indicated.

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These practices and procedures ensure
protection against the introduction and
spread of communicable diseases into
and within the United States with a
minimum of recordkeeping and
reporting procedures, as well as a
minimum of interference with trade and
travel.
U.S. Quarantine Stations are located
at 20 ports of entry and land-border
crossings where international travelers
arrive. The jurisdiction of each station
includes air, maritime, and/or landborder ports of entry. Quarantine
Station staff work in partnership with
international, federal, state, and local
agencies and organizations to fulfill
their mission to reduce morbidity and
mortality among globally mobile
populations. This work is performed to
prevent the introduction, transmission,
and spread of communicable diseases
from foreign countries into the United
States or from one State or possession to
another State or possession. When an
illness suggestive of a communicable
disease is reported by conveyance
operators or port partners (e.g. Customs
and Border Protection), Quarantine
Officers respond to carry out an onsite
public health assessment and collect
data from the individual. This response
may occur jointly with port partners.
The collection of comprehensive,
pertinent public health information
during these responses enables
Quarantine Officers to make an accurate
public health assessment and identify
appropriate next steps. For this reason,
quarantine station staff need to
systematically interview ill travelers
and collect relevant health and
epidemiologic information.
CDC is making a number of changes
and adjustments to this information
collection. The changes are as follows:
• CDC is merging this information
collection with another, 0920–0821
Illness Response Forms: Airline,
Maritime, and Land/Border Crossing.
• CDC is disaggregating the
information collection 42 CFR 71.21(a)
report of illness or death from ships so
that the influenza like illness (ILI)
report, which is voluntary, is separate

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