Agency Forms Undergoing Paperwork Reduction Act Review, 7377-7378 [2019-03774]
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Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Proposed Project
[30 Day–19–19BN]
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 Emergency
Cruise Ship Outbreak Investigations
(CSOIs) 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 November
27, 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;
(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 omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
VerDate Sep<11>2014
17:33 Mar 01, 2019
Jkt 247001
Emergency Cruise Ship Outbreak
Investigations (CSOIs)—Existing
Collection in Use without an OMB
Control Number—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
7377
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
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
E:\FR\FM\04MRN1.SGM
04MRN1
7378
Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices
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.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Cruise Ship Passengers or Crew ...................
Questionnaire .................................................
Interview .........................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–03774 Filed 3–1–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–1143; Docket No. CDC–2019–
0009]
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 US Zika Pregnancy registry, is to
seek Paperwork Reduction Act (PRA)
clearance to monitor the frequency and
types of adverse birth outcomes for
women with laboratory evidence of Zika
virus infection during pregnancy and
their infants and to strengthen the
public health response to the Zika virus
disease outbreak.
DATES: CDC must receive written
comments on or before May 3, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0009 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
SUMMARY:
VerDate Sep<11>2014
17:33 Mar 01, 2019
Jkt 247001
• Mail: Jeffrey M. Zirger, Lead,
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.
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 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.
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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
24,750
250
1
1
Average
burden per
response
(in hours)
15/60
15/60
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
US Zika Pregnancy Registry (OMB
Control No. 0920–1143, Expiration 11/
30/2019)—Extension—National Center
on Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In May 2015, the World Health
Organization reported the first local
transmission of Zika virus in the
Western Hemisphere, with
autochthonous cases identified in
Brazil. As of March 16, 2016, local
transmission has been identified in at
least 32 countries or territories in the
Americas. Further spread to other
countries in the region is likely. Local
vector-borne transmission of Zika virus
has not been documented in the 50 U.S.
states or the District of Columbia, but
has occurred in US territories, including
in Puerto Rico, the US Virgin Islands,
and American Samoa. However, Zika
virus infections have been reported in
travelers returning to the United States
from areas with active Zika virus
transmission. Zika virus infection also
has occurred through sexual
transmission, which may pose an
additional risk to non-travelling
pregnant women whose partners may
have traveled to areas at high risk for
Zika virus acquisition. With the ongoing
outbreak in the Americas, the number of
Zika virus disease cases among travelers
returning to the United States likely will
E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7377-7378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03774]
[[Page 7377]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-19-19BN]
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 Emergency Cruise Ship Outbreak Investigations
(CSOIs) 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 November
27, 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;
(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 omb@cdc.gov. 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
Emergency Cruise Ship Outbreak Investigations (CSOIs)--Existing
Collection in Use without an OMB Control Number--National Center for
Environmental Health (NCEH), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
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 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
[[Page 7378]]
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.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Cruise Ship Passengers or Crew..... Questionnaire.............. 24,750 1 15/60
Interview.................. 250 1 15/60
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-03774 Filed 3-1-19; 8:45 am]
BILLING CODE 4163-18-P
