Agency Forms Undergoing Paperwork Reduction Act Review, 2518-2520 [2019-01324]
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Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices
(EEI) Generic ICR (OMB Control
Number 0920–1011, exp 1/31/2020). A
full OMB package is being submitted to
allow for continuation of the project.
Rocky Mountain spotted fever
(RMSF), a life-threatening and rapidly
progressive tickborne disease, is caused
by infection with the bacterium
Rickettsia rickettsii. Infection begins
with non-specific symptoms like fever,
headache, and muscle pain, but when
left untreated the bacteria can cause
damage to blood vessels throughout the
body leading to organ and tissue
damage. Delay in recognition and
treatment of RMSF can result in
irreparable damage leading to
amputation of extremities, neurological
charts, patient interviews, and
neurological exams with a cognitive/
developmental assessment for children.
Resulting data will provide information
to healthcare providers, patients, and
policy makers about the long term
consequences of severe RMSF,
including time to recovery, self-reported
impact to daily function, and will look
to identify risk factors during acute
illness which may be associated with
long term impairment.
There is no cost to respondents other
than the time to participate. Total
estimated burden is 126 hours.
Authorizing Legislation comes from
Section 301 of the Public Health Service
Act (42 U.S.C. 241).
deficits (such as hearing loss, paralysis,
and encephalopathy), and death.
Case series in the peer-reviewed
literature document long term sequelae
(LTS) from RMSF in anywhere from 3–
55% of cases, yet characterization of the
long-term impacts is still not well
understood, and only a handful of
studies have examined them in detail.
Results of neurologic damage caused
during acute RMSF illness may include
symptoms ranging from paresthesia,
insomnia and behavioral concerns to
loss of hearing, motor or language
dysfunction, and chronic pain.
This study will gather information
related to neurologic sequela following
RMSF illness. Information for this study
will come from three sources: Medical
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
General Public ...................................
Patient screening questionnaire ......
Neurological exam form ...................
250
125
1
1
10/60
40/60
42
84
Total ...........................................
..........................................................
........................
........................
........................
126
Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019–01333 Filed 2–6–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–19–18AXG]
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 Maritime Illness
Database and Reporting System
(MIDRS). CDC previously published a
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on
September 25, 2018 to obtain comments
from the public and affected agencies.
CDC did not receive public comment
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
VerDate Sep<11>2014
17:23 Feb 06, 2019
Jkt 247001
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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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
Maritime Illness Database and
Reporting System (MIDRS)—NEW—
National Center for Environmental
Health (NCEH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The purpose of this new information
collection request (ICR) is to request a
three-year Paperwork Reduction Act
(PRA) clearance for CDC’s Maritime
Illness Database and Reporting System
(MIDRS). MIDRS is currently approved
under Foreign Quarantine Regulations
(42 CFR part 71) (OMB Control No.
0920–0134, Expiration Date: 05/31/
2019), sponsored by the National Center
for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Operationally, CDC has divided the
responsibilities for enforcing foreign
quarantine regulations between the
Vessel Sanitation Program (VSP) and the
Division of Global Migration and
Quarantine (DGMQ). VSP takes the lead
on overseeing acute gastroenteritis
(AGE) illness surveillance and outbreak
investigation activities on passenger
E:\FR\FM\07FEN1.SGM
07FEN1
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Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices
ships, while DGMQ monitors all nonAGE illnesses and deaths on passenger
vessels as well as all diseases of public
health concern on all other conveyances
with international itineraries bound for
the United States. From 2012 to 2014 all
ships submitted their AGE, non-AGE,
and death reports to MIDRS using a
common web portal; however program
and reporting needs changed and
dictated a need to move non-AGE
illness and death reporting to a separate
system. As of June 10, 2014, DGMQ has
changed its routing method for receiving
reports from ships. It no longer accepts
non-AGE illness and death reports via
MIDRS.
To complete the separation of
shipboard quarantine and inspection
functions across the two CDC national
centers, the VSP seeks to transition all
federally mandated AGE illness
reporting activities to a new ICR housed
within its own Center, since MIDRS is
housed in and used exclusively by VSP.
DGMQ will continue to surveil nonAGE illnesses on cruise ships and all
illnesses on other foreign to U.S.
conveyances under Foreign Quarantine
Regulations (42 CFR part 71) (OMB
Control No. 0920–0134, expiration date
05/31/2019).
The MIDRS data collection system
consists of a surveillance system that
receives information electronically
through a web-based reporting portal;
data can also be submitted by phone,
email or fax and entered into MIDRS by
VSP. AGE cases reported to MIDRS are
totals for the entire voyage and do not
represent the number of active AGE
cases at any given port of call or at
disembarkation. The AGE log, 72-hour
food/activity history and other required
documentation are completed and
maintained on the ship.
Data collected will allow VSP to
quickly detect AGE outbreaks, provide
epidemiologic and sanitation guidance
to stop the outbreak, craft public health
recommendations to prevent future
outbreaks, and monitor AGE illness
trends to identify important changes
over time.
There are two types of respondents for
this data collection: Cruise ship medical
staff or other designated personnel who
report AGE cases, and AGE cases who
provide information for the 72-hour
food/activity histories. Of note, VSP will
not receive any information from or
about the AGE cases; this information is
collected and owned by the cruise line
and maintained on the ship as part of
the AGE case’s medical record. VSP
reviews these records during
operational inspections to confirm they
are available if needed, and if there is
an AGE outbreak or report of unusual
AGE illness for a particular voyage.
CDC estimates the total annualized
time burden is 1,537 hours. A summary
of the estimated annualized burden
hours is shown in the table below.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Cruise ship medical staff or other designated
personnel.
71.21(c) Gastrointestinal Illnesses reports 24
and 4 hours before arrival (MIDRS).
71.21(c) Recordkeeping—Gastrointestinal Illnesses reports 24 and 4 hours before arrival (MIDRS).
71.21(c) AGE Logs ........................................
71.21 (c) Recordkeeping—medical records
(AGE Logs).
71.21(c) Interviews with AGE crew case
cabin mates and immediate contacts to
determine AGE illness status and documentation of interview dates/times.
71.21(c) Recordkeeping—medical records
(Interviews with AGE crew case cabin
mates and immediate contacts to determine AGE illness status and documentation of interview dates/times).
71.21(c) Documentation of 3-day pre-embarkation AGE illness assessment for all crew
members.
71.21(c) Recordkeeping—medical records
(Documentation of 3-day pre-embarkation
AGE illness assessment for all crew members).
71.21(c) Documentation of date/time of last
symptom and clearance to return to work
for food and nonfood employees.
71.21(c) Recordkeeping—medical records
(Documentation of date/time of last symptom and clearance to return to work for
food and nonfood employees).
71.21(c) Recordkeeping—medical records
(72 hour food/activity histories).
71.21(c) 72-hour food/activity history .............
AGE passenger and crew cases ....................
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E:\FR\FM\07FEN1.SGM
Number of
responses per
respondent
Average
burden per
response
(in hours)
250
10
3/60
250
1
1/60
250
250
10
1
10/60
1/60
250
3
5/60
250
1
1/60
250
5
3/60
250
1
1/60
250
1
3/60
250
1
1/60
250
1
1/60
5,000
1
10/60
07FEN1
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Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices
Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019–01324 Filed 2–6–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–19–19GH; Docket No. CDC–2018–
0116]
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 ‘‘Evaluating the implementation
and impact of a fall prevention program,
including opioid medication
management, in a hospital discharge
setting.’’ This study will evaluate the
implementation and impact of a fall
prevention program in a hospital
discharge setting. Components of the
program will target opioid medication
management in the acute and post-acute
settings, and referral to clinically
effective programs to reduce the risk of
falls and opioid misuse.
DATES: CDC must receive written
comments on or before April 8, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0116 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.
SUMMARY:
VerDate Sep<11>2014
17:23 Feb 06, 2019
Jkt 247001
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 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 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.
Proposed Project
Evaluating the implementation and
impact of a fall prevention program,
including opioid medication
management, in a hospital discharge
setting—New—National Center for
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Falls are the leading cause of injury,
and injuries leading to death in older
adults. Medications which affect the
central nervous system can cause side
effects that increase the chances of
falling, such as dizziness, sedation,
confusion, blurred vision, and
orthostatic hypotension. Opioids are
strongly associated with increased fall
risk in older adults. When opioids are
taken with other medications, like
benzodiazepines, there can be a
synergistic effect on cognition and
physical function, potentially leading to
a more pronounced injury or
unintentional overdose.
A key intervention in the Centers for
Disease Control and Prevention (CDC)’s
fall prevention program STEADI
(Stopping Elderly Accidents, Deaths,
and Injuries) initiative is medication
management to reduce the fall risk.
Medication review and management,
especially upon care transitions, can
reduce inappropriate opioid use, the
risk of injury, and improve patient
health. This data collection will
evaluate the implementation and impact
of a fall prevention program, including
opioid medication management, in a
hospital discharge setting. Components
of the program will target opioid
medication management in the acute
and post-acute settings and referral to
clinically effective programs to reduce
the risk of falls and opioid misuse. This
data collected will be used to: (1)
Examine post-discharge use of opioids
or alternative therapies for pain
management among older adult
patients, (2) examine post-discharge
compliance and follow up by older
adults with primary care doctors and/or
specialist referrals for pain management
and fall prevention efforts, (3) identify
rate of readmission for a fall by level of
patient compliance and follow-up postdischarge, (4) evaluate the uptake of the
program by clinical staff, and (5)
identify opportunities for program and
process improvement.
The study population will be limited
to older adults (65 years and older)
considered high risk due to opioid use
identified during discharge at a specific
Medical Center inpatient. The study
population for the clinical staff
evaluation questionnaire will be limited
to the same Medical Center clinical staff
(i.e., nurses, pharmacists, physicians)
involved in older-adult patient pain
management and post-discharge
planning that work in hospital units
where this program has been
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2518-2520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01324]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-19-18AXG]
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 Maritime Illness Database and Reporting
System (MIDRS). CDC previously published a ``Proposed Data Collection
Submitted for Public Comment and Recommendations'' notice on September
25, 2018 to obtain comments from the public and affected agencies. CDC
did not receive public comment 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
Maritime Illness Database and Reporting System (MIDRS)--NEW--
National Center for Environmental Health (NCEH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The purpose of this new information collection request (ICR) is to
request a three-year Paperwork Reduction Act (PRA) clearance for CDC's
Maritime Illness Database and Reporting System (MIDRS). MIDRS is
currently approved under Foreign Quarantine Regulations (42 CFR part
71) (OMB Control No. 0920-0134, Expiration Date: 05/31/2019), sponsored
by the National Center for Emerging and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control and Prevention (CDC).
Operationally, CDC has divided the responsibilities for enforcing
foreign quarantine regulations between the Vessel Sanitation Program
(VSP) and the Division of Global Migration and Quarantine (DGMQ). VSP
takes the lead on overseeing acute gastroenteritis (AGE) illness
surveillance and outbreak investigation activities on passenger
[[Page 2519]]
ships, while DGMQ monitors all non-AGE illnesses and deaths on
passenger vessels as well as all diseases of public health concern on
all other conveyances with international itineraries bound for the
United States. From 2012 to 2014 all ships submitted their AGE, non-
AGE, and death reports to MIDRS using a common web portal; however
program and reporting needs changed and dictated a need to move non-AGE
illness and death reporting to a separate system. As of June 10, 2014,
DGMQ has changed its routing method for receiving reports from ships.
It no longer accepts non-AGE illness and death reports via MIDRS.
To complete the separation of shipboard quarantine and inspection
functions across the two CDC national centers, the VSP seeks to
transition all federally mandated AGE illness reporting activities to a
new ICR housed within its own Center, since MIDRS is housed in and used
exclusively by VSP. DGMQ will continue to surveil non-AGE illnesses on
cruise ships and all illnesses on other foreign to U.S. conveyances
under Foreign Quarantine Regulations (42 CFR part 71) (OMB Control No.
0920-0134, expiration date 05/31/2019).
The MIDRS data collection system consists of a surveillance system
that receives information electronically through a web-based reporting
portal; data can also be submitted by phone, email or fax and entered
into MIDRS by VSP. AGE cases reported to MIDRS are totals for the
entire voyage and do not represent the number of active AGE cases at
any given port of call or at disembarkation. The AGE log, 72-hour food/
activity history and other required documentation are completed and
maintained on the ship.
Data collected will allow VSP to quickly detect AGE outbreaks,
provide epidemiologic and sanitation guidance to stop the outbreak,
craft public health recommendations to prevent future outbreaks, and
monitor AGE illness trends to identify important changes over time.
There are two types of respondents for this data collection: Cruise
ship medical staff or other designated personnel who report AGE cases,
and AGE cases who provide information for the 72-hour food/activity
histories. Of note, VSP will not receive any information from or about
the AGE cases; this information is collected and owned by the cruise
line and maintained on the ship as part of the AGE case's medical
record. VSP reviews these records during operational inspections to
confirm they are available if needed, and if there is an AGE outbreak
or report of unusual AGE illness for a particular voyage.
CDC estimates the total annualized time burden is 1,537 hours. A
summary of the estimated annualized burden hours is shown in the table
below.
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 medical staff or other 71.21(c) 250 10 3/60
designated personnel. Gastrointestinal
Illnesses reports 24
and 4 hours before
arrival (MIDRS).
71.21(c) Recordkeeping-- 250 1 1/60
Gastrointestinal
Illnesses reports 24
and 4 hours before
arrival (MIDRS).
71.21(c) AGE Logs....... 250 10 10/60
71.21 (c) Recordkeeping-- 250 1 1/60
medical records (AGE
Logs).
71.21(c) Interviews with 250 3 5/60
AGE crew case cabin
mates and immediate
contacts to determine
AGE illness status and
documentation of
interview dates/times.
71.21(c) Recordkeeping-- 250 1 1/60
medical records
(Interviews with AGE
crew case cabin mates
and immediate contacts
to determine AGE
illness status and
documentation of
interview dates/times).
71.21(c) Documentation 250 5 3/60
of 3-day pre-
embarkation AGE illness
assessment for all crew
members.
71.21(c) Recordkeeping-- 250 1 1/60
medical records
(Documentation of 3-day
pre-embarkation AGE
illness assessment for
all crew members).
71.21(c) Documentation 250 1 3/60
of date/time of last
symptom and clearance
to return to work for
food and nonfood
employees.
71.21(c) Recordkeeping-- 250 1 1/60
medical records
(Documentation of date/
time of last symptom
and clearance to return
to work for food and
nonfood employees).
71.21(c) Recordkeeping-- 250 1 1/60
medical records (72
hour food/activity
histories).
AGE passenger and crew cases.......... 71.21(c) 72-hour food/ 5,000 1 10/60
activity history.
----------------------------------------------------------------------------------------------------------------
[[Page 2520]]
Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-01324 Filed 2-6-19; 8:45 am]
BILLING CODE 4163-18-P
