Notice of a Supplemental Award to the Emergency Medical Services for Children Innovation and Improvement Center at the Baylor College of Medicine, 17177-17178 [2019-08257]
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Federal Register / Vol. 84, No. 79 / Wednesday, April 24, 2019 / Notices
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Graham Thompson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993–0002, 301–
796–5003, Fax: 301–847–8443,
Graham.Thompson@fda.hhs.gov; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911, Stephen.Ripley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
This public meeting is intended to
satisfy a commitment included in
PDUFA VI. This PDUFA reauthorization
is part of the FDA Reauthorization Act
of 2017 signed by the President on
August 18, 2017. The complete set of
performance goals and procedures
documented in the PDUFA
Reauthorization Performance Goals and
Procedures Fiscal Years 2018 through
2022 (Goals Letter) is available at
https://www.fda.gov/downloads/
ForIndustry/UserFees/Prescription
DrugUserFee/UCM511438.pdf. These
goals were developed in consultation
with patient and consumer advocates,
healthcare professionals, and other
public stakeholders as part of
negotiations with industry. Section I.J.2
of the Goals Letter, ‘‘Enhancing BenefitRisk Assessment in Regulatory
Decision-Making,’’ outlines the
commitment for FDA to convene and/or
participate in a public meeting to gather
stakeholder input on key topics relating
to FDA’s benefit-risk assessment.
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II. Topics for Discussion at the Public
Meeting
This meeting will provide FDA the
opportunity to gather input from
stakeholders on their experiences and
perspectives regarding FDA’s benefitrisk assessment. Input from this meeting
will support development of the draft
guidance on benefit-risk assessment for
new drugs and biologics as outlined in
Section I.J.2 of the Goals Letter, which
FDA intends to issue by the end of June
2020. The meeting will allow
participants (including industry,
patients, researchers, and other
stakeholders) to provide input on key
topics, including the application of
FDA’s Benefit-Risk Framework
throughout the human drug lifecycle
and information that sponsors may
develop or collect at the various stages
of drug development that can inform the
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benefit-risk assessment and related
regulatory decisions. This includes
consideration of how relevant patient
experience data and related information
may inform the benefit-risk assessment.
In addition, the meeting will consider
appropriate approaches to communicate
to the public FDA’s thinking regarding
a product’s benefit-risk assessment.
For more information on meeting
topics and discussion questions, visit
https://healthpolicy.duke.edu/events/
benefit-risk-framework-publicworkshop. FDA will publish a
background document outlining the
topic areas that FDA plans to address in
the draft guidance to this site
approximately 2 weeks before the
meeting date. FDA will also post the
agenda and other meeting materials to
this site approximately 5 business days
before the meeting.
The format of the meeting will consist
of a series of presentations, panel
discussions, and audience Q&As. In
addition to input generated through this
public meeting, FDA is interested in
receiving input on the planned draft
guidance through written comments,
which can be submitted to the public
docket (see ADDRESSES).
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit the following
website: https://
events.r20.constantcontact.com/register/
eventReg?oeidk=a07eg01qxxd
45281872&oseq=&c=&ch. Please register
by May 10, 2019. If you are unable to
attend the meeting in person, you can
register to view a live webcast of the
meeting. You will be asked to indicate
in your registration if you plan to attend
in person or via the webcast. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public meeting must
register by May 10, 2019, 11:59 p.m.
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation once they have been
accepted. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning at 8 a.m. We will let
registrants know if registration closes
before the day of the public meeting.
If you need special accommodations
due to a disability, please contact
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17177
Graham Thompson no later than May
10, 2019, 11:59 p.m. Eastern Time.
Open Public Comment: There will be
time allotted during the meeting for
open public comment. Sign-up for this
session will be on a first-come, firstserved basis on the day of the meeting.
Individuals and organizations with
common interests are urged to
consolidate or coordinate and request
time for a joint presentation. No
commercial or promotional material
will be permitted to be presented or
distributed at the public meeting.
Streaming Webcast of the Public
Meeting: This public meeting will also
be webcast. Please register for the
webcast by visiting https://
events.r20.constantcontact.com/
register/eventReg?oeidk=a07eg01qxxd
45281872&oseq=&c=&ch.
FDA has verified the website
addresses in this document as of the
date this document publishes in the
Federal Register, but websites are
subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It also
may be viewed at the Dockets
Management Staff (see ADDRESSES).
Dated: April 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–08219 Filed 4–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of a Supplemental Award to the
Emergency Medical Services for
Children Innovation and Improvement
Center at the Baylor College of
Medicine
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of a supplemental award
to the Emergency Medical Services for
Children Innovation and Improvement
Center at the Baylor College of
Medicine—Grant Number
U07MC29829.
AGENCY:
HRSA announces the award
of a supplement for $500,000 to the
Emergency Medical Services for
Children (EMSC) Innovation and
Improvement Center. The supplement
will permit the Baylor College of
Medicine, the cooperative agreement
recipient, to establish and lead a new
SUMMARY:
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Federal Register / Vol. 84, No. 79 / Wednesday, April 24, 2019 / Notices
Quality Improvement Collaborative to
support the EMSC State Partnership
Program during the budget period of
07/1/2018–06/30/2019. EMSC plans to
increase the proportion of EMS agencies
that have a designated individual
responsible for the coordination of
pediatric emergency care by 2020 to 30
percent.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Baylor College of Medicine.
Amount of Non-Competitive Award:
$500,000.
Period of Supplemental Funding:
07/01/2018–06/30/2019.
CFDA Number: 93.127.
Authority: Public Health Service Act,
Title XIX, Section 1910 (42 U.S.C.
300w–9); as amended by the Emergency
Medical Services for Children
Reauthorization Act of 2014, Public Law
113–180.
Justification: Baylor College of
Medicine’s EMSC Innovation and
Grantee/organization name
Grant No.
State
Baylor College of Medicine .....................................................
U07MC29829 .........................
TX ..................
Dated: April 18, 2019.
George Sigounas,
Administrator.
[FR Doc. 2019–08257 Filed 4–23–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990-new]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before May 24, 2019.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
SUMMARY:
jbell on DSK30RV082PROD with NOTICES
best practices in outreach design
and implementation.
—Provide access to subject matter
expertise to advise the QI
collaborative on pediatric
emergency care coordination in the
pre-hospital EMS setting.
—Provide technical assistance to up to
10 participating states as they
implement the action plan designed
through the QI collaborative.
—Facilitate an assessment at the end of
the project to determine the number
of EMS agencies that newly report
having an individual responsible
for coordinating pediatric
emergency care.
FOR FURTHER INFORMATION CONTACT:
Theresa Morrison-Quinata, Division of
Child, Adolescent and Family Health,
Maternal and Child Health Bureau,
HRSA, 5600 Fishers Lane, Room 18N54,
Rockville, MD 20852, Phone: 301–443–
1527, Email: TMorrison-Quinata@
hrsa.gov.
Improvement Center (EIIC) provides
technical assistance to State Partnership
grantees on effective methods to
improve EMS for pediatric patients
within state and local EMS systems.
Participant states will be supported by
the EIIC through targeted technical
assistance, the provision of tools and
resources to support local efforts, and
sharing of best practices. The EIIC will
support the awarded states in
participation in the following activities:
—Convene up to 10 state project teams
awarded by HRSA comprised of the
state EMSC manager and their state
and local partners for one face-toface meeting and regular virtual
meetings.
—Facilitate the development of a
collective action plan representing
the common methods and aims
across the QI collaborative for
outreach to EMS agencies.
—Provide a venue for participating
states to share lessons learned and
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comments or requesting information,
please include the document identifier
0990-New-30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Cross-site
Study Data for Improving
Implementation Evaluation among
Office of Adolescent Health (OAH) TPP
Grantees to inform National
Implementations (IMAGIN).
Type of Collection: New.
OMB No.: 0990–NEW–Office of
Adolescent Health—OASH—OS.
Abstract: The Office of Adolescent
Health (OAH), U.S. Department of
Health and Human Services (HHS) is
requesting 3 years of approval by OMB
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FY 2018
authorized
funding level
$1,500,000
FY 2018
estimated
supplemental
funding
$500,000
on a new collection. The IMAGIN CrossSite Study will examine the process that
federal grantees follow to get their
programs and staff ready for full
implementation by exploring specific
factors related to the program models’
readiness for implementation and
evaluation, the grantee organizations’
capacity to operate and deliver the
program as intended, and the local
enabling context. The data from this
study will be used to identify
meaningful lessons, targeted resources,
and timely guidance that could help
both current and future federal grantees
get their programs ready to implement,
and add to the evidence on the
successes and challenges of
implementing a program. The cross-site
study will be conducted with
leadership, key program staff and
community stakeholders from Fiscal
Year 2018 and, if awarded Fiscal Year
2019, grantees of the OAH Teen
Pregnancy Prevention Program. It will
include semi-structured interviews with
grantee leadership, site visits that will
include in-person discussions with key
program staff and community
stakeholders, and a front-line staff web
survey with up to 8 front line staff per
grantee.
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[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Pages 17177-17178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08257]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of a Supplemental Award to the Emergency Medical Services
for Children Innovation and Improvement Center at the Baylor College of
Medicine
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice of a supplemental award to the Emergency Medical
Services for Children Innovation and Improvement Center at the Baylor
College of Medicine--Grant Number U07MC29829.
-----------------------------------------------------------------------
SUMMARY: HRSA announces the award of a supplement for $500,000 to the
Emergency Medical Services for Children (EMSC) Innovation and
Improvement Center. The supplement will permit the Baylor College of
Medicine, the cooperative agreement recipient, to establish and lead a
new
[[Page 17178]]
Quality Improvement Collaborative to support the EMSC State Partnership
Program during the budget period of 07/1/2018-06/30/2019. EMSC plans to
increase the proportion of EMS agencies that have a designated
individual responsible for the coordination of pediatric emergency care
by 2020 to 30 percent.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: Baylor College of Medicine.
Amount of Non-Competitive Award: $500,000.
Period of Supplemental Funding: 07/01/2018-06/30/2019.
CFDA Number: 93.127.
Authority: Public Health Service Act, Title XIX, Section 1910 (42
U.S.C. 300w-9); as amended by the Emergency Medical Services for
Children Reauthorization Act of 2014, Public Law 113-180.
Justification: Baylor College of Medicine's EMSC Innovation and
Improvement Center (EIIC) provides technical assistance to State
Partnership grantees on effective methods to improve EMS for pediatric
patients within state and local EMS systems. Participant states will be
supported by the EIIC through targeted technical assistance, the
provision of tools and resources to support local efforts, and sharing
of best practices. The EIIC will support the awarded states in
participation in the following activities:
--Convene up to 10 state project teams awarded by HRSA comprised of the
state EMSC manager and their state and local partners for one face-to-
face meeting and regular virtual meetings.
--Facilitate the development of a collective action plan representing
the common methods and aims across the QI collaborative for outreach to
EMS agencies.
--Provide a venue for participating states to share lessons learned and
best practices in outreach design and implementation.
--Provide access to subject matter expertise to advise the QI
collaborative on pediatric emergency care coordination in the pre-
hospital EMS setting.
--Provide technical assistance to up to 10 participating states as they
implement the action plan designed through the QI collaborative.
--Facilitate an assessment at the end of the project to determine the
number of EMS agencies that newly report having an individual
responsible for coordinating pediatric emergency care.
FOR FURTHER INFORMATION CONTACT: Theresa Morrison-Quinata, Division of
Child, Adolescent and Family Health, Maternal and Child Health Bureau,
HRSA, 5600 Fishers Lane, Room 18N54, Rockville, MD 20852, Phone: 301-
443-1527, Email: [email protected].
----------------------------------------------------------------------------------------------------------------
FY 2018
FY 2018 estimated
Grantee/organization name Grant No. State authorized supplemental
funding level funding
----------------------------------------------------------------------------------------------------------------
Baylor College of Medicine....... U07MC29829.......... TX..................... $1,500,000 $500,000
----------------------------------------------------------------------------------------------------------------
Dated: April 18, 2019.
George Sigounas,
Administrator.
[FR Doc. 2019-08257 Filed 4-23-19; 8:45 am]
BILLING CODE 4165-15-P
