National Eye Institute; Amended Notice of Meeting, 5795 [2018-02565]
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Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
Abstract: HRSA is requesting the
Organ Procurement and Transplantation
Network (OPTN) perform a federally
sponsored data collection as part of a
pilot project to monitor the testing of
deceased potential donors possibly
exposed to the Zika virus (ZIKV). The
Zika Pilot Project will have a 12-month
performance period enabling OPTN to
develop a plan to collect data on ways
for organ procurement organizations
(OPOs) to deploy ZIKV donor screening
tests of blood products. The testing is
available under an investigational new
drug application for use on a voluntary
basis in the evaluation of deceased
persons as potential solid organ donors.
OPTN will conduct an analysis of the
data collected under this project to
determine the potential effect of making
available screening tests for ZIKV, when
appropriate, to improve transplant
safety. OPTN will convene a group of
stakeholders to provide guidance and
monitor progress on the ZIKV pilot
project.
Need and Proposed Use of the
Information: ZIKV is prevalent in
several areas of the United States.
Currently, there is not a ZIKV screening
procedure for OPOs to implement
during the organ allocation process.
HRSA requested OPTN to conduct a
pilot project to monitor the testing of
deceased donors potentially exposed to
ZIKV. The goals of the pilot project are
to:
• Collaborate with experts to define
necessary data elements to understand
the impact of ZIKV testing in deceased
organ donors;
• Deploy a data collection tool to a
limited number of OPOs that agree to
participate in the pilot project; and
• Assess the ability of OPTN to
respond to a public health situation by
collecting data from impacted members
of the transplant community to assess
the national experience.
Likely Respondents: Organ
Procurement Organizations.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
ZIKV Data Collection Tool ...................................................
20
167
3,340
.508
1,696.7
Total ..............................................................................
20
........................
3,340
........................
1,696.7
* Total number of responses determined by applying the percentage of OPOs participating to the total number of deceased donors in 2016.
Based on OPTN Data as of 11/09/2017.
** Donors screened for ZIKV will be based on OPO specific screening criteria.
HRSA specifically requests comments
on: (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.
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.
2018, 08:30 a.m. to January 22, 2018,
05:00 p.m., Hilton Garden Inn Bethesda,
7301 Waverly Street, Bethesda, MD
20814 which was published in the
Federal Register on December 28, 2017,
82 FR 61577. This meeting is being
amended to change the date from
January 22, 2018 to February 23, 2018.
The time has not changed. The meeting
is closed to the public.
Dated: February 5, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–02565 Filed 2–8–18; 8:45 am]
[FR Doc. 2018–02586 Filed 2–8–18; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Eye Institute; Amended Notice
of Meeting
Notice is hereby given of a change in
the meeting of the National Eye Institute
Special Emphasis Panel, January 22,
VerDate Sep<11>2014
16:57 Feb 08, 2018
Jkt 244001
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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The meetings 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 on
Drug Abuse Special Emphasis Panel; Multisite Clinical Trials.
Date: February 16, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Hiromi Ono, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, National Institutes
of Health, DHHS, 6001 Executive Boulevard,
Room 4238, MSC 9550, Bethesda, MD 20892,
301–827–5820, hiromi.ono@nih.gov.
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[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Page 5795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02565]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute; Amended Notice of Meeting
Notice is hereby given of a change in the meeting of the National
Eye Institute Special Emphasis Panel, January 22, 2018, 08:30 a.m. to
January 22, 2018, 05:00 p.m., Hilton Garden Inn Bethesda, 7301 Waverly
Street, Bethesda, MD 20814 which was published in the Federal Register
on December 28, 2017, 82 FR 61577. This meeting is being amended to
change the date from January 22, 2018 to February 23, 2018. The time
has not changed. The meeting is closed to the public.
Dated: February 5, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-02565 Filed 2-8-18; 8:45 am]
BILLING CODE 4140-01-P
