Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin; Availability of Document; Request for Comments; Notice of Peer-Review Meeting, 63662-63664 [2018-26745]
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accessing the ACBTSA website at https://
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SUPPLEMENTARY INFORMATION: The
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advises on a range of policy issues to
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members are selected from State and
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selected from the following groups: The
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Association of Blood Banks); American
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one of either the American Red Cross or
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Committee composition can include
additional representation from either
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of blood, plasma, or other tissue/organ
test kits; a manufacturer of blood,
plasma or other tissue/organ equipment;
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Where more than one company
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expenses that are incurred to attend
meetings and conduct Committeerelated business, in accordance with
Standard Government Travel
Regulations. Individuals who are
appointed to serve as public members
are authorized also to receive a stipend
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for attending Committee meetings and
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This announcement is to solicit
nominations of qualified candidates to
five public member positions on the
ACBTSA.
Nominations
In accordance with the charter,
persons nominated for appointment as
members of the ACBTSA should be
among authorities knowledgeable in
blood banking, tissue banking,
transfusion medicine, organ or tissue
transplantation, plasma therapies,
transfusion and transplantation safety,
bioethics, socioeconomics, health
policy/law, and/or related disciplines.
Nominations should be typewritten. The
following information should be
included in the package of material
submitted for each individual being
nominated for consideration of
appointment: (a) The name, return
address, daytime telephone number and
affiliation(s) of the individual being
nominated, the basis for the individual’s
nomination, the category for which the
individual is being nominated, and a
statement bearing an original signature
of the nominated individual that, if
appointed, he or she is willing to serve
as a member of the Committee; (b) the
name, return address, and daytime
telephone number at which the
nominator may be contacted.
Organizational nominators must
identify a principal contact person in
addition to the contact; and (c) a copy
of a current curriculum vitae or resume
for the nominated individual.
Individuals can nominate themselves
for consideration of appointment to the
Committee. All nominations must
include the required information.
Incomplete nominations will not be
processed for consideration. The letter
from the nominator and certification of
the nominated individual must bear
original signatures; reproduced copies
of these signatures are not acceptable.
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Federal advisory committees is fairly
balanced in terms of points of view
represented and the functions to be
performed by the advisory committee.
Every effort is made to ensure that the
views of women, all ethnic and racial
groups, and people with disabilities are
represented on HHS Federal Advisory
committees and, therefore, the
Department encourages nominations of
qualified candidates from these groups.
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The Department also encourages
geographic diversity in the composition
of the committee. Appointment to this
Committee shall be made without
discrimination on the basis of age, race,
ethnicity, gender, sexual orientation,
disability, and cultural, religious, or
socioeconomic status.
The Standards of Ethical Conduct for
Employees of the Executive Branch are
applicable to individuals who are
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review. The ethics review is conducted
to determine if the individual has any
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sector that may conflict with
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member of the Committee. Individuals
appointed to serve as public members of
the committee will be required to
disclose information regarding financial
holdings, consultancies, and research
grants and/or contracts.
Dated: October 19, 2018.
James J. Berger,
Senior Advisor for Blood and Tissue Policy,
Designated Federal Officer, Advisory
Committee on Blood and Tissue Safety and
Availability.
[FR Doc. 2018–26756 Filed 12–10–18; 8:45 am]
BILLING CODE 4150–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Draft NTP Monograph on the
Systematic Review of Evidence of
Long-Term Neurological Effects
Following Acute Exposure to the
Organophosphorus Nerve Agent Sarin;
Availability of Document; Request for
Comments; Notice of Peer-Review
Meeting
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Toxicology
Program (NTP) announces availability of
the Draft NTP Monograph on the
Systematic Review of Evidence of LongTerm Neurological Effects Following
Acute Exposure to the
Organophosphorus Nerve Agent Sarin
for public comment prior to peer
review. In partnership with the National
SUMMARY:
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amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices
Institutes of Health (NIH)
Countermeasures Against Chemical
Threats (CounterACT) Program, the
Office of Health Assessment and
Translation (OHAT), Division of the
National Toxicology Program (DNTP),
National Institute of Environmental
Health Sciences (NIEHS), conducted a
systematic review to evaluate the
evidence of long-term neurological
damage in humans after acute, sublethal exposure to sarin. The date for the
peer review is not yet set; however, it
is anticipated to occur in early 2019.
The peer-review meeting will be held by
webcast only and open to the public;
registration will be required for
attendance by webcast and to present
oral comments. Information about the
meeting and registration is available at
https://ntp.niehs.nih.gov/go/36051.
DATES:
Meeting: When set, the peer-review
meeting date will be announced on the
meeting web page at https://ntp.niehs.
nih.gov/go/36051 along with deadlines
for registration to present oral public
comments and to view the webcast. The
anticipated timeframe is early 2019.
NTP will also announce the meeting
date in an email Listserv notice. Persons
can subscribe to news updates at
https://tools.niehs.nih.gov/webforms/
index.cfm/main/formViewer/form_id/
361.
Document Availability: The draft NTP
monograph should be available by
December 5, 2018, at https://
ntp.niehs.nih.gov/go/36051.
Written Public Comment
Submissions: Deadline is January 17,
2019.
Registration for Oral Comments:
Please monitor the meeting web page at
https://ntp.niehs.nih.gov/go/36051 for
updates pertaining to the oral public
comment registration deadline.
Registration to View Webcast: Please
monitor the meeting web page at https://
ntp.niehs.nih.gov/go/36051 for updates
pertaining to the webcast registration
deadline.
ADDRESSES:
Meeting Location: Webcast.
Meeting web page: The draft NTP
monograph, preliminary agenda,
registration, and other meeting materials
will be available at https://ntp.niehs.
nih.gov/go/36051.
Webcast: The URL for viewing the
peer-review meeting webcast will be
provided to registrants.
FOR FURTHER INFORMATION CONTACT: Ms.
Canden Byrd, ICF, 2635 Meridian
Parkway, Suite 200, Durham, NC, USA
27713. Phone: (919) 293–1660, Fax:
(919) 293–1645, Email: NTP-Meetings@
icf.com.
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SUPPLEMENTARY INFORMATION:
Background: OHAT serves as an
environmental health resource to the
public and to regulatory and health
agencies. This office conducts
evaluations to assess the evidence that
environmental chemicals, physical
substances, or mixtures (collectively
referred to as ‘‘substances’’) cause
adverse health effects and provides
opinions on whether these substances
may be of concern given what is known
about current human exposure levels.
Sarin is a highly toxic
organophosphorus nerve agent that was
developed for chemical warfare during
World War II and continues to be used
as a weapon. The draft NTP monograph
presents the results of the systematic
review to evaluate the evidence for longterm neurological effects in humans
following acute, sub-lethal exposure to
sarin with consideration of human,
experimental animal, and mechanistic
date.
Long-term neurological effects of
acute exposure to sarin are not well
characterized. Previous reviews of
potential health effects of sarin have
generally not assessed individual study
quality or considered multiple evidence
streams (human, animal, and
mechanistic data). In addition, the
interpretation of effects of sarin in some
previous reviews was compounded by
concurrent exposure to multiple
chemicals, such as assessments of
health effects in military personnel
during the Gulf War or other conflicts.
Meeting Attendance Registration: The
meeting is open to the public with time
set aside for oral public comment.
Registration is required to view the
webcast; the URL for the webcast will be
provided in the email confirming
registration. Please monitor the meeting
web page at https://ntp.niehs.nih.gov/
go/36051 for updates pertaining to the
webcast registration deadline.
Individuals with disabilities who need
accommodation to view the webcast
should contact Canden Byrd by phone:
(919) 293–1660 or email: NTPMeetings@icf.com. TTY users should
contact the Federal TTY Relay Service
at (800) 877–8339. Requests should be
made at least five business days in
advance of the event.
Public Comment Registration: NTP
invites written and oral public
comments on the draft NTP monograph
that address scientific or technical
issues. Guidelines for public comments
are at https://ntp.niehs.nih.gov/ntp/
about_ntp/guidelines_public_
comments_508.pdf.
The deadline for submission of
written comments is January 17, 2019.
Written public comments should be
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submitted through the meeting website.
Persons submitting written comments
should include name, affiliation,
mailing address, phone, email, and
sponsoring organization (if any). Written
comments received in response to this
notice will be posted on the NTP
website, and the submitter will be
identified by name, affiliation, and
sponsoring organization (if any).
Comments that address scientific or
technical issues will be forwarded to the
peer-review panel and NTP staff prior to
the meeting.
The agenda will allow for one oral
public comment period (up to 12
commenters, up to 5 minutes per
speaker). The deadline for registration to
provide oral comments will be
announced at https://ntp.niehs.nih.gov/
go/36051 after the meeting date is set.
Registration will be on a first-come,
first-served basis. Each organization will
be allowed one time slot. Oral
comments will be presented by
teleconference line. The access number
for the teleconference line will be
provided to registrants by email prior to
the meeting. Commenters will be
notified approximately one week before
the peer-review meeting about the
actual time allotted per speaker.
If possible, oral public commenters
will be asked to send a copy of their
slides and/or statement or talking points
to Canden Byrd by email: NTPMeetings@icf.com by the registration
deadline.
Meeting Materials: The draft NTP
monograph and preliminary agenda will
be available on the NTP website at
https://ntp.niehs.nih.gov/go/36051. The
draft NTP monograph should be
available by December 5, 2018.
Additional information will be posted
when available or may be requested in
hardcopy, contact Canden Byrd by
phone: (919) 293–1660 or email: NTPMeetings@icf.com. Individuals are
encouraged to access the meeting web
page to stay abreast of the most current
information regarding the meeting.
Following the meeting, a report of the
peer review will be prepared and made
available on the NTP website.
Background Information on NTP PeerReview Panels: NTP panels are
technical, scientific advisory bodies
established on an ‘‘as needed’’ basis to
provide independent scientific peer
review and advise NTP on agents of
public health concern, new/revised
toxicological test methods, or other
issues. These panels help ensure
transparent, unbiased, and scientifically
rigorous input to the program for its use
in making credible decisions about
human hazard, setting research and
testing priorities, and providing
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Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices
information to regulatory agencies about
alternative methods for toxicity
screening. NTP welcomes nominations
of scientific experts for upcoming
panels. Scientists interested in serving
on an NTP panel should provide their
current curriculum vitae to Canden
Byrd by email: NTP-Meetings@icf.com.
The authority for NTP panels is
provided by 42 U.S.C. 217a; section 222
of the Public Health Service Act, as
amended. The panel is governed by the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), which
sets forth standards for the formation
and use of advisory committees.
Dated: November 28, 2018.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
[FR Doc. 2018–26745 Filed 12–10–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request National Cancer
Institute (NCI) Future Fellows Resume
Databank
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
SUMMARY:
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: National Cancer
Institute Future Fellows Resume
Databank, 0925–XXXX, Exp., Date XX/
XXXX, EXISTING COLLECTION IN USE
WITHOUT OMB NUMBER, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The National Cancer
Institute, Center for Cancer Training
mission is to catalyze the development
of the 21st century workforce capable of
advancing cancer research through a
scientifically integrated approach. This
is accomplished by, (1) coordinating
and providing research training and
career development activities for fellows
and trainees in NCI’s laboratories,
clinics, and other research groups, (2)
developing, coordinating, and
implementing opportunities in support
of cancer research training, career
development, and education at
institutions nationwide, and (3)
identifying workforce needs in cancer
research and adapting NCI’s training
and career development programs and
funding opportunities to address these
needs. The proposed information
collection involves a website to collect
and maintain resumes of interested
candidates to be considered for
postdoctoral fellowships and
internships in science. After posting
their resume in the database, NCI
Scientists can view and select
candidates for current fellowship and
internship opportunities offered at NCI.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden are 200
hours.
within 30-days of the date of this
publication.
Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT:
To request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Angela Jones,
Program Coordinator, Center for Cancer
Training, National Cancer Institute,
9609 Medical Center Drive, Room 2W–
236, Bethesda, Maryland, 20892 or call
non-toll-free number (240) 276–5659 or
Email your request, including your
address to: jonesangel@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on August 13, 2018, page 40071
(83 FR 40071) and allowed 60 days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Cancer Institute (NCI), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
ADDRESSES:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
amozie on DSK3GDR082PROD with NOTICES1
Category of respondent
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hours
Individual ..........................................................................................................
200
2
30/60
200
Totals ........................................................................................................
200
400
........................
200
Patricia M. Busche,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–26765 Filed 12–10–18; 8:45 am]
National Institutes of Health
BILLING CODE 4140–01–P
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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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,
E:\FR\FM\11DEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Pages 63662-63664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26745]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Draft NTP Monograph on the Systematic Review of Evidence of Long-
Term Neurological Effects Following Acute Exposure to the
Organophosphorus Nerve Agent Sarin; Availability of Document; Request
for Comments; Notice of Peer-Review Meeting
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Toxicology Program (NTP) announces availability
of the Draft NTP Monograph on the Systematic Review of Evidence of
Long-Term Neurological Effects Following Acute Exposure to the
Organophosphorus Nerve Agent Sarin for public comment prior to peer
review. In partnership with the National
[[Page 63663]]
Institutes of Health (NIH) Countermeasures Against Chemical Threats
(CounterACT) Program, the Office of Health Assessment and Translation
(OHAT), Division of the National Toxicology Program (DNTP), National
Institute of Environmental Health Sciences (NIEHS), conducted a
systematic review to evaluate the evidence of long-term neurological
damage in humans after acute, sub-lethal exposure to sarin. The date
for the peer review is not yet set; however, it is anticipated to occur
in early 2019. The peer-review meeting will be held by webcast only and
open to the public; registration will be required for attendance by
webcast and to present oral comments. Information about the meeting and
registration is available at https://ntp.niehs.nih.gov/go/36051.
DATES:
Meeting: When set, the peer-review meeting date will be announced
on the meeting web page at https://ntp.niehs.nih.gov/go/36051 along
with deadlines for registration to present oral public comments and to
view the webcast. The anticipated timeframe is early 2019.
NTP will also announce the meeting date in an email Listserv
notice. Persons can subscribe to news updates at https://tools.niehs.nih.gov/webforms/index.cfm/main/formViewer/form_id/361.
Document Availability: The draft NTP monograph should be available
by December 5, 2018, at https://ntp.niehs.nih.gov/go/36051.
Written Public Comment Submissions: Deadline is January 17, 2019.
Registration for Oral Comments: Please monitor the meeting web page
at https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the
oral public comment registration deadline.
Registration to View Webcast: Please monitor the meeting web page
at https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the
webcast registration deadline.
ADDRESSES:
Meeting Location: Webcast.
Meeting web page: The draft NTP monograph, preliminary agenda,
registration, and other meeting materials will be available at https://ntp.niehs.nih.gov/go/36051.
Webcast: The URL for viewing the peer-review meeting webcast will
be provided to registrants.
FOR FURTHER INFORMATION CONTACT: Ms. Canden Byrd, ICF, 2635 Meridian
Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1660, Fax:
(919) 293-1645, Email: [email protected].
SUPPLEMENTARY INFORMATION:
Background: OHAT serves as an environmental health resource to the
public and to regulatory and health agencies. This office conducts
evaluations to assess the evidence that environmental chemicals,
physical substances, or mixtures (collectively referred to as
``substances'') cause adverse health effects and provides opinions on
whether these substances may be of concern given what is known about
current human exposure levels.
Sarin is a highly toxic organophosphorus nerve agent that was
developed for chemical warfare during World War II and continues to be
used as a weapon. The draft NTP monograph presents the results of the
systematic review to evaluate the evidence for long-term neurological
effects in humans following acute, sub-lethal exposure to sarin with
consideration of human, experimental animal, and mechanistic date.
Long-term neurological effects of acute exposure to sarin are not
well characterized. Previous reviews of potential health effects of
sarin have generally not assessed individual study quality or
considered multiple evidence streams (human, animal, and mechanistic
data). In addition, the interpretation of effects of sarin in some
previous reviews was compounded by concurrent exposure to multiple
chemicals, such as assessments of health effects in military personnel
during the Gulf War or other conflicts.
Meeting Attendance Registration: The meeting is open to the public
with time set aside for oral public comment. Registration is required
to view the webcast; the URL for the webcast will be provided in the
email confirming registration. Please monitor the meeting web page at
https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the
webcast registration deadline. Individuals with disabilities who need
accommodation to view the webcast should contact Canden Byrd by phone:
(919) 293-1660 or email: [email protected]. TTY users should contact
the Federal TTY Relay Service at (800) 877-8339. Requests should be
made at least five business days in advance of the event.
Public Comment Registration: NTP invites written and oral public
comments on the draft NTP monograph that address scientific or
technical issues. Guidelines for public comments are at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
The deadline for submission of written comments is January 17,
2019. Written public comments should be submitted through the meeting
website. Persons submitting written comments should include name,
affiliation, mailing address, phone, email, and sponsoring organization
(if any). Written comments received in response to this notice will be
posted on the NTP website, and the submitter will be identified by
name, affiliation, and sponsoring organization (if any). Comments that
address scientific or technical issues will be forwarded to the peer-
review panel and NTP staff prior to the meeting.
The agenda will allow for one oral public comment period (up to 12
commenters, up to 5 minutes per speaker). The deadline for registration
to provide oral comments will be announced at https://ntp.niehs.nih.gov/go/36051 after the meeting date is set. Registration
will be on a first-come, first-served basis. Each organization will be
allowed one time slot. Oral comments will be presented by
teleconference line. The access number for the teleconference line will
be provided to registrants by email prior to the meeting. Commenters
will be notified approximately one week before the peer-review meeting
about the actual time allotted per speaker.
If possible, oral public commenters will be asked to send a copy of
their slides and/or statement or talking points to Canden Byrd by
email: [email protected] by the registration deadline.
Meeting Materials: The draft NTP monograph and preliminary agenda
will be available on the NTP website at https://ntp.niehs.nih.gov/go/36051. The draft NTP monograph should be available by December 5, 2018.
Additional information will be posted when available or may be
requested in hardcopy, contact Canden Byrd by phone: (919) 293-1660 or
email: [email protected]. Individuals are encouraged to access the
meeting web page to stay abreast of the most current information
regarding the meeting.
Following the meeting, a report of the peer review will be prepared
and made available on the NTP website.
Background Information on NTP Peer-Review Panels: NTP panels are
technical, scientific advisory bodies established on an ``as needed''
basis to provide independent scientific peer review and advise NTP on
agents of public health concern, new/revised toxicological test
methods, or other issues. These panels help ensure transparent,
unbiased, and scientifically rigorous input to the program for its use
in making credible decisions about human hazard, setting research and
testing priorities, and providing
[[Page 63664]]
information to regulatory agencies about alternative methods for
toxicity screening. NTP welcomes nominations of scientific experts for
upcoming panels. Scientists interested in serving on an NTP panel
should provide their current curriculum vitae to Canden Byrd by email:
[email protected]. The authority for NTP panels is provided by 42
U.S.C. 217a; section 222 of the Public Health Service Act, as amended.
The panel is governed by the Federal Advisory Committee Act, as amended
(5 U.S.C. Appendix 2), which sets forth standards for the formation and
use of advisory committees.
Dated: November 28, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-26745 Filed 12-10-18; 8:45 am]
BILLING CODE 4140-01-P
