Supplemental Evidence and Data Request on Emergency Medical Service/911 Workforce Infection Control and Prevention Issues, 70127-70129 [2021-26630]
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Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Notices
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[FR Doc. 2021–26620 Filed 12–8–21; 8:45 am]
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electronically to MA@mpls.frb.org:
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Rauenhorst 2004 Children’s Trust u/a/d
December 23, 2004, and the
Grandchildren’s Fidelity Trust u/a/d
February 24, 2015, both of Minnetonka,
VerDate Sep<11>2014
17:41 Dec 08, 2021
Jkt 256001
Minnesota; to acquire voting shares of
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Board of Governors of the Federal Reserve
System, December 6, 2021.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2021–26689 Filed 12–8–21; 8:45 am]
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FEDERAL RESERVE SYSTEM
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have applied to the Board for approval,
pursuant to the Bank Holding Company
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(BHC Act), Regulation Y (12 CFR part
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and regulations to become a bank
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applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank(s) indicated below and at
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on an expedited basis, upon request, by
contacting the appropriate Federal
Reserve Bank and from the Board’s
Freedom of Information Office at
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
70127
https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
standards enumerated in the BHC Act
(12 U.S.C. 1842(c)).
Comments regarding each of these
applications must be received at the
Reserve Bank indicated or the offices of
the Board of Governors, Ann E.
Misback, Secretary of the Board, 20th
Street and Constitution Avenue NW,
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than January 10, 2022.
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(Erien O. Terry, Assistant Vice
President) 1000 Peachtree Street NE,
Atlanta, Georgia 30309. Comments can
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Applications.Comments@atl.frb.org:
1. Fourth Capital Holdings, Inc.,
Nashville, Tennessee; to become a bank
holding company by acquiring Fourth
Capital Bank, Nashville, Tennessee.
B. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. First internet Bancorp, Fishers,
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Bancorp, Roswell, Georgia, and thereby
indirectly acquire First Century Bank,
N.A., Commerce, Georgia.
2. First Merchants Corporation,
Muncie, Indiana; to merge with Level
One Bancorp, Inc., and thereby
indirectly acquire Level One Bank, both
of Farmington Hills, Michigan.
Board of Governors of the Federal Reserve
System, December 6, 2021.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2021–26694 Filed 12–8–21; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Emergency Medical
Service/911 Workforce Infection
Control and Prevention Issues
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Emergency Medical Service/911
Workforce Infection Control and
Prevention Issues, which is currently
SUMMARY:
E:\FR\FM\09DEN1.SGM
09DEN1
70128
Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Notices
being conducted by the AHRQ’s
Evidence-based Practice Centers (EPC)
Program. Access to published and
unpublished pertinent scientific
information will improve the quality of
this review.
DATES: Submission Deadline on or
before January 10, 2022.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane,
Mail Stop 06E77D, Rockville, MD
20857.
khammond on DSKJM1Z7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Emergency Medical
Service/911 Workforce Infection Control
and Prevention Issues. AHRQ is
conducting this technical brief pursuant
to Section 902 of the Public Health
Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Emergency Medical
Service/911 Workforce Infection Control
and Prevention Issues, including those
that describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/ems-911-workforce-infectioncontrol/protocol.
This is to notify the public that the
EPC Program would find the following
information on Emergency Medical
Service/911 Workforce Infection Control
and Prevention Issues helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
VerDate Sep<11>2014
17:41 Dec 08, 2021
Jkt 256001
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: Study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on indications not included
in the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://
www.effectivehealthcare.ahrq.gov/
email-updates.
The technical brief will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
Guiding Questions
1. What are the characteristics,
incidence, prevalence, and severity of
occupationally-acquired exposures to
infectious diseases for the EMS/911
workforce?
a. How do the incidence, prevalence,
and severity of exposures vary by
demographic characteristics (e.g., age,
sex, race, ethnicity) of the workforce?
b. How do the incidence, prevalence,
and severity of exposures vary by
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
workforce characteristics (e.g., training,
experience, level of practice, geographic
region)?
2. What are the characteristics and
reported effectiveness (i.e., benefits and
harms) in studies of EMS/911 workforce
practices to prevent infectious diseases?
a. How do workforce practices to
prevent infectious diseases vary by
demographic characteristics (e.g., age,
sex, race, ethnicity)?
b. How do workforce practices to
prevent infectious diseases vary by
workforce characteristics (e.g., training,
experience, geographic region etc.)?
c. How do workforce practices to
prevent infectious diseases vary by
practice characteristics (e.g., training,
personal protective equipment (PPE),
personnel, and budget requirements)?
d. What is the reported effectiveness
(i.e. benefits and harms) in studies of
EMS/911 workforce practices to prevent
infectious diseases? (Outcomes of
interest include but are not limited to,
incidence, prevalence, duration,
severity, missed work, healthcare
utilization, separation from the
workforce, disability, and death from
infections.)
3. What are the characteristics and
reported effectiveness (i.e., benefits and
harms) in studies of EMS/911 workforce
practices to recognize and control (e.g.,
chemoprophylaxis, but excluding
treatment) infectious diseases?
a. How do workforce practices to
recognize and control infectious
diseases vary by demographic
characteristics (e.g., age, sex, race,
ethnicity) of the EMS/911 workforce?
b. How do workforce practices to
recognize and control infectious
diseases vary by workforce
characteristics (e.g., training,
experience, level of practice, geographic
region)?
c. How do workforce practices to
recognize and control infectious
diseases vary by infection recognition
and control practice characteristics
(e.g., training, PPE, personnel, and
budget requirements)?
d. What is the reported effectiveness
(i.e., benefits and harms) in studies of
EMS/911 workforce practices to
recognize and control infectious
disease? (Outcomes of interest include
but are not limited to, incidence,
prevalence, duration, severity, missed
work, healthcare utilization, separation
from the workforce, disability, and
death from infections.)
E:\FR\FM\09DEN1.SGM
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Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Notices
4. What are the context and
implementation factors of studies with
effective EMS/911 workforce practices
to prevent, recognize and treat
occupationally-acquired infectious
diseases? This description might
include distinguishing factors such as
workforce training, surveillance,
protective equipment, pre- and postexposure prophylaxis, occupational
health services, preparedness for
emerging infectious diseases, and
program funding.
70129
5. What future research is needed to
close existing evidence gaps regarding
preventing, recognizing, and treating
occupationally-acquired infectious
diseases in the EMS/911 workforce?
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTINGS)
Inclusion criteria
Population ..........
Intervention ........
Comparison .......
Outcomes ..........
Timing ................
Setting ...............
Study design ......
Exclusion criteria
• Emergency medical service workforce including 911 dispatchers
exposed to or at risk of exposure to an occupationally-acquired
infectious disease as contact exposure, respiratory exposure, or
blood-borne exposure.*
• One or more of the following types of interventions:
Æ Training or education.
Æ PPE protocols.
Æ Personnel policies.
Æ Budget allocations.
Æ Vaccines.
Æ Equipment.
• Any comparison group (for studies that evaluate the effectiveness
of an EMS/911 workforce practice).
•
•
•
•
•
•
•
•
•
•
•
Incidence
Prevalence.
Duration.
Severity.
Missed work.
Healthcare utilization.
Separation from the workforce.
Disability.
Death from infections.
Published after 2006 and includes data after 2006.
Conducted in the United States ......................................................
• Experimental and non-experimental studies with comparison
groups, including pre-post studies.
• Relevant systematic reviews.
• Fire fighters and police personnel not involved in
medical care.
• NA.
• Studies without a comparison group (for studies that
evaluate the effectiveness of an EMS/911 workforce
practice).
• NA.
• Military exercises and drills.
• Live evacuations from another country.
• No original data (Narrative reviews, commentaries,
simulation studies).
* Organisms of interest included but are not limited to SARS–COV2, influenza, tuberculosis, HIV, and Hepatitis B and C.
Dated: December 3, 2021.
Marquita Cullom,
Associate Director.
guidance provides information in
response to frequently asked questions
related to tobacco product user fees
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Federal Food, Drug, and Cosmetic Act
(FD&C Act).
DATES: The announcement of the
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ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
[FR Doc. 2021–26630 Filed 12–8–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
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Food and Drug Administration
[Docket No. FDA–2021–D–0373]
Tobacco Product User Fees:
Responses to Frequently Asked
Questions; Guidance for Industry;
Availability
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AGENCY:
Electronic Submissions
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry entitled ‘‘Tobacco
Product User Fees: Responses to
Frequently Asked Questions.’’ This
SUMMARY:
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Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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confidential information that you or a
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such as medical information, your or
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as a manufacturing process. Please note
that if you include your name, contact
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• If you want to submit a comment
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Submit written/paper submissions as
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Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Pages 70127-70129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26630]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Emergency Medical
Service/911 Workforce Infection Control and Prevention Issues
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Emergency
Medical Service/911 Workforce Infection Control and Prevention Issues,
which is currently
[[Page 70128]]
being conducted by the AHRQ's Evidence-based Practice Centers (EPC)
Program. Access to published and unpublished pertinent scientific
information will improve the quality of this review.
DATES: Submission Deadline on or before January 10, 2022.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Emergency Medical
Service/911 Workforce Infection Control and Prevention Issues. AHRQ is
conducting this technical brief pursuant to Section 902 of the Public
Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Emergency Medical Service/911 Workforce Infection
Control and Prevention Issues, including those that describe adverse
events. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/ems-911-workforce-infection-control/protocol.
This is to notify the public that the EPC Program would find the
following information on Emergency Medical Service/911 Workforce
Infection Control and Prevention Issues helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: Study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the EPC Program. This is a
voluntary request for information, and all costs for complying with
this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
The technical brief will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Guiding Questions
1. What are the characteristics, incidence, prevalence, and
severity of occupationally-acquired exposures to infectious diseases
for the EMS/911 workforce?
a. How do the incidence, prevalence, and severity of exposures vary
by demographic characteristics (e.g., age, sex, race, ethnicity) of the
workforce?
b. How do the incidence, prevalence, and severity of exposures vary
by workforce characteristics (e.g., training, experience, level of
practice, geographic region)?
2. What are the characteristics and reported effectiveness (i.e.,
benefits and harms) in studies of EMS/911 workforce practices to
prevent infectious diseases?
a. How do workforce practices to prevent infectious diseases vary
by demographic characteristics (e.g., age, sex, race, ethnicity)?
b. How do workforce practices to prevent infectious diseases vary
by workforce characteristics (e.g., training, experience, geographic
region etc.)?
c. How do workforce practices to prevent infectious diseases vary
by practice characteristics (e.g., training, personal protective
equipment (PPE), personnel, and budget requirements)?
d. What is the reported effectiveness (i.e. benefits and harms) in
studies of EMS/911 workforce practices to prevent infectious diseases?
(Outcomes of interest include but are not limited to, incidence,
prevalence, duration, severity, missed work, healthcare utilization,
separation from the workforce, disability, and death from infections.)
3. What are the characteristics and reported effectiveness (i.e.,
benefits and harms) in studies of EMS/911 workforce practices to
recognize and control (e.g., chemoprophylaxis, but excluding treatment)
infectious diseases?
a. How do workforce practices to recognize and control infectious
diseases vary by demographic characteristics (e.g., age, sex, race,
ethnicity) of the EMS/911 workforce?
b. How do workforce practices to recognize and control infectious
diseases vary by workforce characteristics (e.g., training, experience,
level of practice, geographic region)?
c. How do workforce practices to recognize and control infectious
diseases vary by infection recognition and control practice
characteristics (e.g., training, PPE, personnel, and budget
requirements)?
d. What is the reported effectiveness (i.e., benefits and harms) in
studies of EMS/911 workforce practices to recognize and control
infectious disease? (Outcomes of interest include but are not limited
to, incidence, prevalence, duration, severity, missed work, healthcare
utilization, separation from the workforce, disability, and death from
infections.)
[[Page 70129]]
4. What are the context and implementation factors of studies with
effective EMS/911 workforce practices to prevent, recognize and treat
occupationally-acquired infectious diseases? This description might
include distinguishing factors such as workforce training,
surveillance, protective equipment, pre- and post-exposure prophylaxis,
occupational health services, preparedness for emerging infectious
diseases, and program funding.
5. What future research is needed to close existing evidence gaps
regarding preventing, recognizing, and treating occupationally-acquired
infectious diseases in the EMS/911 workforce?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Settings)
------------------------------------------------------------------------
Inclusion criteria Exclusion criteria
------------------------------------------------------------------------
Population........... Emergency medical Fire
service workforce fighters and police
including 911 dispatchers personnel not
exposed to or at risk of involved in medical
exposure to an care.
occupationally-acquired
infectious disease as
contact exposure,
respiratory exposure, or
blood-borne exposure.*
Intervention......... One or more of NA.
the following types of
interventions:
[cir] Training or
education.
[cir] PPE protocols....
[cir] Personnel
policies.
[cir] Budget
allocations.
[cir] Vaccines.........
[cir] Equipment........
Comparison........... Any comparison Studies
group (for studies that without a comparison
evaluate the group (for studies
effectiveness of an EMS/ that evaluate the
911 workforce practice). effectiveness of an
EMS/911 workforce
practice).
Outcomes............. Incidence NA.
Prevalence.......
Duration.........
Severity.........
Missed work......
Healthcare
utilization.
Separation from
the workforce.
Disability.......
Death from
infections.
Timing............... Published after
2006 and includes data
after 2006.
Setting.............. Conducted in the Military
United States. exercises and
drills.
Live
evacuations from
another country.
Study design......... Experimental and No original
non-experimental studies data (Narrative
with comparison groups, reviews,
including pre-post commentaries,
studies. simulation studies).
Relevant
systematic reviews..
------------------------------------------------------------------------
* Organisms of interest included but are not limited to SARS-COV2,
influenza, tuberculosis, HIV, and Hepatitis B and C.
Dated: December 3, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-26630 Filed 12-8-21; 8:45 am]
BILLING CODE 4160-90-P
