83 FR 55189 - Health Center Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 213 (November 2, 2018)

Page Range		55189-55189
FR Document		2018-24008

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.

Federal Register, Volume 83 Issue 213 (Friday, November 2, 2018)

[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Notices]
[Page 55189]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24008]


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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.

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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

Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices 55189

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

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Document Created: 2018-11-02 01:09:27
Document Modified: 2018-11-02 01:09:27

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Announcement of Supplemental Award.
Contact		Tracey Orloff, Strategic Partnerships Division Director in the Bureau of Primary Health Care, Office of Quality Improvement, at [email protected]
FR Citation		83 FR 55189

83 FR 55189 - Health Center Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 83, Issue 213 (November 2, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration