Proposed Data Collection Submitted for Public Comment and Recommendations, 87585-87586 [2024-25553]
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87585
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
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57.602 Late Onset Sepsis/Meningitis Event Form: Data Table for Monthly Electronic Upload.
57.700 Medication Safety-Digital Measure Reporting Plan (HYPO, HAKI, ORAE)—
IT Initial Set up.
57.700 Medication Safety-Digital Measure Reporting Plan (HYPO, HAKI, ORAE)—
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57.701 Glycemic Control Module-HYPO Annual Survey ...........................................
57.800 Billing Code Data: 837I Upload .....................................................................
57.801 External Validation Summary Report .............................................................
57.802 Bed Capacity-IT Initial Set Up .......................................................................
57.803 All Hazards .....................................................................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2024–25552 Filed 11–1–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–25–25AU; Docket No. CDC–2024–
0088]
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 information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Risk factors,
clinical course, presence and
persistence of virus in various bodily
fluids, and risk of sexual transmission
among U.S. adults with Oropouche
virus (OROV) disease. This study will
assist in the response to this emerging
virus by; identifying risk factors for
infection to inform prevention guidance
and messaging, informing recognition,
diagnosis, follow-up care, and
counseling of patients with OROV
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:22 Nov 01, 2024
Jkt 265001
disease, and understanding risks of
sexual transmission to inform
prevention recommendations, especially
for pregnant people and their partners,
or those considering pregnancy.
DATES: CDC must receive written
comments on or before January 3, 2025.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2024–
0088 by either of the following methods:
• Federal eRulemaking Portal:
www.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 H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.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
H21–8, Atlanta, Georgia 30329;
Telephone: 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
PO 00000
Frm 00049
Number of
responses per
respondent
Average
burden per
response
(min./hour 60)
300
6
6/60
5,500
1
1,620/60
5,500
1
1,200/60
5,500
4
10/60
10
5,500
20
25
540
1
4
2
1
365
180/60
5/60
15/60
20/60
5/60
Number of
respondents
Form number & name
Fmt 4703
Sfmt 4703
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;
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; and
5. Assess information collection costs.
Proposed Project
Risk factors, clinical course, presence
and persistence of virus in various
bodily fluids, and risk of sexual
transmission among U.S. adults with
Oropouche virus (OROV) disease—
New—National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
E:\FR\FM\04NON1.SGM
04NON1
87586
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Notices
Background and Brief Description
Oropouche virus is an emerging virus
in the Americas that is spread by the
bite of midges and some species of
mosquitoes. Infection with Oropouche
virus generally causes a febrile illness,
but more severe disease such as
meningitis and hemorrhagic disease can
occur. Beginning in late 2023, the
geographic range of Oropouche virus
has expanded, with over 10,000 cases
from six countries reported in 2024 as
of October 15. The first U.S. cases were
reported in the summer of 2024, all
among returning international travelers.
This recent geographic expansion, along
with reports of deaths among cases,
vertical transmission leading to fetal
loss and birth defects, and identification
of live virus in semen raise concerns
about the broader threat this virus
represents to the United States. There
are numerous gaps in our understanding
of this emerging virus, including the
urgent need to evaluate the possibility
of sexual transmission to inform
prevention recommendations, especially
for pregnant people and their partners,
or those considering pregnancy.
The purpose of this investigation is to
better define the risk factors, clinical
course, viral shedding, and potential for
sexual transmission among patients
with Oropouche virus disease.
Participants will be interviewed about
their symptoms, medical and travel
history, potential risk factors for
infection, and sexual partners since
becoming ill. They will be followed over
time to see if their symptoms reoccur,
which has been highlighted as a unique
feature of Oropouche virus disease
among similar viruses. They will also
submit specimens of various bodily
fluids over a 12-week period to be tested
for Oropouche virus RNA. Lastly, sexual
contacts of people who have been
diagnosed with Oropouche virus disease
will be interviewed to see if they
experienced any symptoms consistent
with Oropouche virus disease after
these sexual encounters. Sexual contacts
that report symptoms will be asked to
have a blood sample collected and
tested for evidence of Oropouche virus
infection.
The findings of this investigation will
inform prevention guidance, improve
clinical recognition and diagnosis, and
prevent further illnesses of Oropouche
virus disease. Preliminary results will
be used immediately to inform agency
response activities and prevention
guidance to help people protect
themselves from Oropouche virus
disease. CDC requests Emergency OMB
approval for an estimated 663 annual
burden hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
General public .....................................
Baseline survey ..................................
Follow-up clinical survey ....................
Symptom Diary ...................................
Contact tracing survey .......................
Sexual contact interview form ............
200
200
200
100
150
1
6
6
1
1
30/60
15/60
10/60
15/60
15/60
100
300
200
25
38
Total .............................................
.............................................................
......................
..........................
....................
663
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2024–25553 Filed 11–1–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–25–0891; Docket No. CDC–2024–
0086]
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:
lotter on DSK11XQN23PROD with NOTICES1
Number of
respondents
Type of respondents
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
SUMMARY:
VerDate Sep<11>2014
17:28 Nov 01, 2024
Jkt 265001
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 World Trade Center (WTC) Health
Program Enrollment, Appeals &
Reimbursement. The WTC Health
Program is a Federal limited benefit
health care program providing medical
monitoring and treatment benefits to
eligible firefighters and related
personnel, law enforcement officers,
and rescue, recovery, and cleanup
workers who responded to the
September 11, 2001, attacks in New
York City, at the Pentagon, and in
Shanksville, Pennsylvania (responders),
and to eligible persons who were
present in the dust or dust cloud on
September 11, 2001, or who worked,
resided, or attended school, childcare,
or adult daycare in the New York City
disaster area (survivors).
CDC must receive written
comments on or before January 3, 2025.
DATES:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
You may submit comments,
identified by Docket No. CDC–2024–
0086 by either of the following methods:
• Federal eRulemaking Portal:
www.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 H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
ADDRESSES:
Please note: Submit all comments through
the Federal eRulemaking portal
(www.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 Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329;
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\04NON1.SGM
04NON1
]]>Agencies
[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Notices]
[Pages 87585-87586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25553]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-25-25AU; Docket No. CDC-2024-0088]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: 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 information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Risk factors, clinical course, presence and persistence of virus
in various bodily fluids, and risk of sexual transmission among U.S.
adults with Oropouche virus (OROV) disease. This study will assist in
the response to this emerging virus by; identifying risk factors for
infection to inform prevention guidance and messaging, informing
recognition, diagnosis, follow-up care, and counseling of patients with
OROV disease, and understanding risks of sexual transmission to inform
prevention recommendations, especially for pregnant people and their
partners, or those considering pregnancy.
DATES: CDC must receive written comments on or before January 3, 2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0088 by either of the following methods:
Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (www.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 H21-8, Atlanta, Georgia 30329; Telephone: 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;
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; and
5. Assess information collection costs.
Proposed Project
Risk factors, clinical course, presence and persistence of virus in
various bodily fluids, and risk of sexual transmission among U.S.
adults with Oropouche virus (OROV) disease--New--National Center for
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
[[Page 87586]]
Background and Brief Description
Oropouche virus is an emerging virus in the Americas that is spread
by the bite of midges and some species of mosquitoes. Infection with
Oropouche virus generally causes a febrile illness, but more severe
disease such as meningitis and hemorrhagic disease can occur. Beginning
in late 2023, the geographic range of Oropouche virus has expanded,
with over 10,000 cases from six countries reported in 2024 as of
October 15. The first U.S. cases were reported in the summer of 2024,
all among returning international travelers. This recent geographic
expansion, along with reports of deaths among cases, vertical
transmission leading to fetal loss and birth defects, and
identification of live virus in semen raise concerns about the broader
threat this virus represents to the United States. There are numerous
gaps in our understanding of this emerging virus, including the urgent
need to evaluate the possibility of sexual transmission to inform
prevention recommendations, especially for pregnant people and their
partners, or those considering pregnancy.
The purpose of this investigation is to better define the risk
factors, clinical course, viral shedding, and potential for sexual
transmission among patients with Oropouche virus disease. Participants
will be interviewed about their symptoms, medical and travel history,
potential risk factors for infection, and sexual partners since
becoming ill. They will be followed over time to see if their symptoms
reoccur, which has been highlighted as a unique feature of Oropouche
virus disease among similar viruses. They will also submit specimens of
various bodily fluids over a 12-week period to be tested for Oropouche
virus RNA. Lastly, sexual contacts of people who have been diagnosed
with Oropouche virus disease will be interviewed to see if they
experienced any symptoms consistent with Oropouche virus disease after
these sexual encounters. Sexual contacts that report symptoms will be
asked to have a blood sample collected and tested for evidence of
Oropouche virus infection.
The findings of this investigation will inform prevention guidance,
improve clinical recognition and diagnosis, and prevent further
illnesses of Oropouche virus disease. Preliminary results will be used
immediately to inform agency response activities and prevention
guidance to help people protect themselves from Oropouche virus
disease. CDC requests Emergency OMB approval for an estimated 663
annual burden hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in hours)
respondent (in hours)
----------------------------------------------------------------------------------------------------------------
General public.................. Baseline survey... 200 1 30/60 100
Follow-up clinical 200 6 15/60 300
survey.
Symptom Diary..... 200 6 10/60 200
Contact tracing 100 1 15/60 25
survey.
Sexual contact 150 1 15/60 38
interview form.
-----------------------------------------------------------
Total....................... .................. ............ ............... ........... 663
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2024-25553 Filed 11-1-24; 8:45 am]
BILLING CODE 4163-18-P
