Health Center Program, 55189 [2018-24008]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices
levels for gene therapy products, discuss
the need for long-term safety
assessments in gene therapy clinical
trials, and discern when to enroll
pediatric patients in gene therapy trials.
II. Topics for Discussion at the Public
Workshop
The workshop will feature
presentations and panel discussions on
hemophilia product development. The
presentations will include an overview
of product development in hemophilia,
and the regulatory challenges in the
development of novel hemophilia
therapies. Five sessions include
presentations to frame panel discussions
to cover the following topics:
1. Overview of product development
in hemophilia;
2. Efficacy endpoints related to
bleeding outcomes and considerations
for factor activity as a surrogate
endpoint;
3. Patient and caregiver perspectives
on developing outcomes for clinical
trials;
4. Discrepancies in the factor activity
measurements by different assays
observed in gene therapy trials and root
causes for the discrepancies; and
5. Clinical trial design considerations
for follow up on safety, efficacy,
enrollment of pediatric patients in gene
therapy trials, and the applicability of
on-demand treatment as a control group
in the evolving landscape of treatment
options in hemophilia.
III. Participating in the Public
Workshop
Registration: Persons interested in
attending this public workshop must
register online at https://
fdaoce.formstack.com/forms/
pdh120618 before 5 p.m. on December
3, 2018. 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. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted.
If you need special accommodations
due to a disability, please contact Joan
Ferlo Todd at Joan.Todd@fda.hhs.gov
no later than 5 p.m., on November 21,
2018.
Streaming Webcast of the Public
Workshop: This public workshop will
also be web-streamed on the day of the
workshop.
VerDate Sep<11>2014
17:57 Nov 01, 2018
Jkt 247001
If you have never attended a webcast
event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Adobe
webcast program, visit https://
www.adobe.com/go/connectpro_
overview. 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
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A link to the transcript will
be available on the internet at https://
www.fda.gov/NewsEvents/Meetings
ConferencesWorkshops/
ucm620602.htm.
Dated: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23947 Filed 11–1–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
55189
to provide T/TA addressing the critical
health needs of MSAW in alignment
with HRSA priorities. T/TA provided at
the Migrant Stream Forums is targeted
to a broad range of health center staff
positions, and covers diverse topics that
address the needs of migrant health
centers and the patients they serve.
Supplemental funds are necessary to
support their timely and successful
implementation.
This supplemental funding will
augment the current NCA investment
for these T/TA opportunities through
support of enhanced personnel
presence, the availability of continuing
education unit-bearing educational
sessions to meet the diverse needs of
multidisciplinary health center staff,
and speaker and participant stipends
that underscore the unique value these
in-person regional T/TA sessions
provide.
FOR FURTHER INFORMATION CONTACT:
Tracey Orloff, Strategic Partnerships
Division Director in the Bureau of
Primary Health Care, Office of Quality
Improvement, at TOrloff@hrsa.gov.
Dated: October 26, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018–24008 Filed 11–1–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Center Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Announcement of Supplemental
Award.
AGENCY:
HRSA provided supplemental
grant funds to a currently funded
National Training and Technical
Assistance Cooperative Agreement
(NCA) award recipient to coordinate
and provide training and technical
assistance (T/TA) to health centers that
serve migrant and seasonal agricultural
workers (MSAW) and their families
through three regional forums.
SUPPLEMENTARY INFORMATION:
Recipient of the Award: The National
Center for Farmworker Health, Inc.
Amount of Non-Competitive Awards:
$150,000.
Period of Supplemental Funding:
Fiscal years 2018 and 2019 (contingent
upon available funding and satisfactory
performance).
CFDA Number: 93.129.
Authority: Section 330(l) of the Public
Health Service Act, as amended.
JUSTIFICATION: The award recipient will
lead the coordination and management
of three regional Migrant Stream Forums
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: November 20, 2018.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Notices]
[Page 55189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24008]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Health Center Program
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Announcement of Supplemental Award.
-----------------------------------------------------------------------
SUMMARY: HRSA provided supplemental grant funds to a currently funded
National Training and Technical Assistance Cooperative Agreement (NCA)
award recipient to coordinate and provide training and technical
assistance (T/TA) to health centers that serve migrant and seasonal
agricultural workers (MSAW) and their families through three regional
forums.
SUPPLEMENTARY INFORMATION:
Recipient of the Award: The National Center for Farmworker Health,
Inc.
Amount of Non-Competitive Awards: $150,000.
Period of Supplemental Funding: Fiscal years 2018 and 2019
(contingent upon available funding and satisfactory performance).
CFDA Number: 93.129.
Authority: Section 330(l) of the Public Health Service Act, as
amended.
JUSTIFICATION: The award recipient will lead the coordination and
management of three regional Migrant Stream Forums to provide T/TA
addressing the critical health needs of MSAW in alignment with HRSA
priorities. T/TA provided at the Migrant Stream Forums is targeted to a
broad range of health center staff positions, and covers diverse topics
that address the needs of migrant health centers and the patients they
serve. Supplemental funds are necessary to support their timely and
successful implementation.
This supplemental funding will augment the current NCA investment
for these T/TA opportunities through support of enhanced personnel
presence, the availability of continuing education unit-bearing
educational sessions to meet the diverse needs of multidisciplinary
health center staff, and speaker and participant stipends that
underscore the unique value these in-person regional T/TA sessions
provide.
FOR FURTHER INFORMATION CONTACT: Tracey Orloff, Strategic Partnerships
Division Director in the Bureau of Primary Health Care, Office of
Quality Improvement, at [email protected].
Dated: October 26, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018-24008 Filed 11-1-18; 8:45 am]
BILLING CODE 4165-15-P
