Draft NTP Research Report on the CLARITY-BPA Core Study; Availability of Document; Request for Comments; Notice of Peer-Review Meeting, 7488-7490 [2018-03472]
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Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Program Project Grant P01.
Date: March 12, 2018.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Ana Olariu, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3208,
MSC 9529, Bethesda, MD 20892–9529, 301–
496–9223, Ana.olariu@nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NeuroNEXT 1.
Date: March 22–23, 2018.
Time: 8:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Alexandrian, 480 King Street,
Alexandria, VA 22314.
Contact Person: Ana Olariu, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3208,
MSC 9529, Bethesda, MD 20892–9529, 301–
496–9223, Ana.olariu@nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NeuroNEXT 2.
Date: March 23, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Alexandrian, 480 King Street,
Alexandria, VA 22314.
Contact Person: Ana Olariu, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3208,
MSC 9529, Bethesda, MD 20892–9529, 301–
496–9223, Ana.olariu@nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Wellstone Review.
Date: March 27–28, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott Wardman Park, Washington
DC Hotel, 2660 Woodley Road NW,
Washington, DC 20008.
Contact Person: Joel A. Saydoff, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3205,
MSC 9529, Bethesda, MD 20892–9529, 301–
496–9223, joel.saydoff@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: February 15, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–03474 Filed 2–20–18; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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.
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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Epidemiology of Chronic and
Infectious Disease.
Date: March 5, 2018.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Heidi B. Friedman, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1012A,
MSC 7770, Bethesda, MD 20892, 301–379–
5632, hfriedman@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Enhancing
Developmental Biology Research at AREA
Eligible Institutions.
Date: March 7, 2018.
Time: 10:30 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Jonathan Arias, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5170,
MSC 7840, Bethesda, MD 20892, 301–435–
2406, ariasj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Biomedical Sensing, Measurement
and Instrument.
Date: March 15–16, 2018.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bahia Resort Hotel, 998 West
Mission Bay Drive, San Diego, CA 92109.
Contact Person: Inna Gorshkova, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, 301–435–1784, gorshkoi@csr.nih.gov.
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: February 14, 2018.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–03440 Filed 2–20–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Draft NTP Research Report on the
CLARITY–BPA Core Study; 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 a meeting to
peer review the Draft NTP Research
Report on the CLARITY–BPA Core
Study. This report presents the results
of the core, guideline-compliant,
chronic, extended-dose-range study of
bisphenol A (BPA) in rats conducted as
part of the CLARITY–BPA Research
Program. The U.S. Food and Drug
Administration’s National Center for
Toxicological Research (NCTR)
conducted the study under the auspices
of the National Toxicology Program and
prepared the draft report in
collaboration with the National Institute
of Environmental Health Sciences
(NIEHS). The peer-review meeting will
be held at NIEHS in Research Triangle
Park, NC and is open to the public.
Registration is requested for attendance
at the meeting either in-person or by
webcast and to present oral comments.
Information about the meeting and
registration is available at https://
ntp.niehs.nih.gov/go/rrprp.
DATES:
Meeting: Tentatively scheduled for
April 26, 2018, 8:30 a.m. to adjournment
at approximately 5:00 p.m. Eastern
Daylight Time (EDT). The meeting may
end earlier or later than 5:00 p.m. EDT.
The preliminary agenda of topics is
available at https://ntp.niehs.nih.gov/
go/rrprp and will be updated one week
before the meeting.
Document Availability: The draft NTP
Research Report should be available by
February 23, 2018, at https://
ntp.niehs.nih.gov/go/rrprp.
Written Public Comment
Submissions: Deadline is April 12, 2018.
SUMMARY:
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Federal Register / Vol. 83, No. 35 / Wednesday, February 21, 2018 / Notices
Registration for Oral Comments:
Deadline is April 12, 2018.
Registration to Attend Meeting Inperson or to View Webcast: Deadline is
April 26, 2018.
ADDRESSES:
Meeting Location: Rodbell
Auditorium, Rall Building, NIEHS, 111
T.W. Alexander Drive, Research
Triangle Park, NC 27709.
Meeting web page: The draft NTP
Research Report, preliminary agenda,
registration, and other meeting materials
will be available at https://
ntp.niehs.nih.gov/go/rrprp.
Webcast: The URL for viewing the
peer-review meeting webcast will be
provided to registrants.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
Background: Bisphenol A (BPA) is a
chemical produced in large quantities
for use primarily in the production of
polycarbonate plastics and epoxy resins.
BPA also is used in the production of
certain flame retardants and as a color
developer in some thermal paper. BPA
has been detected in air, soil, water,
landfill leachate, and the human body.
The primary source of human exposure
to BPA is thought to be through the diet.
More than 800 studies were published
on the health effects of BPA between the
mid-1990s and the mid-2000s. Although
BPA is a well-studied chemical, few
existing, chronic toxicity studies have
included exposure during the perinatal
period. There is also inconsistency
among BPA toxicological studies with
regard to findings and their
interpretation for human health. Given
the uncertainty regarding the potential
health effects from BPA exposure, NTP,
NIEHS, and U.S. Food and Drug
Administration (FDA) established the
consortium-based research program,
called Consortium Linking Academic
and Regulatory Insights on Toxicity of
BPA (CLARITY–BPA).
The aim of the CLARITY–BPA
program was to attempt to bridge
guideline-compliant research conducted
at the FDA with hypothesis-based
research investigations conducted by
academia on the toxicity of BPA. A
detailed description of the CLARITY–
BPA program has been published
(https://www.ncbi.nlm.nih.gov/pubmed/
26232693). The CLARITY–BPA research
program has two components: (1) A
‘‘core,’’ guideline-compliant, chronic
study conducted at NCTR according to
FDA Good Laboratory Practice (GLP)
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regulations (2-year perinatal only or
chronic BPA exposure, including
perinatal), and (2) CLARITY–BPA
grantee studies of various health
endpoints, conducted by NIEHS–funded
researchers at academic institutions
using animals born to the same exposed
pregnant rats as the core GLP study.
The draft NTP Research Report
presents the results of the core GLP
chronic study. The interpretation of
biological and toxicological responses
described in the draft NTP Research
Report is based only on the results of
the core GLP study. Integration of these
data with other data from the granteestudies conducted as part of the
CLARITY–BPA research program or
extrapolation of the results to other
species, including characterization of
hazards and risks to humans, is outside
of the scope of the draft NTP Research
Report.
Meeting Attendance Registration: The
meeting is open to the public with time
set aside for oral public comment; inperson attendance at NIEHS is limited
by the space available (∼100 attendees).
Registration for in-person attendance is
on a first-come, first-served basis. After
the first 100 registrants, persons will be
placed on a wait list and notified should
an opening become available.
Registration to attend the meeting inperson or view the webcast is by April
26, 2018, at https://ntp.niehs.nih.gov/
go/rrprp. The URL for the webcast will
be provided in the email confirming
registration. Visitor and security
information for those attending in
person is available at https://
www.niehs.nih.gov/about/visiting/
index.cfm. 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 Research
Report. 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 April 12, 2018.
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
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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 allows for one oral public
comment period (12 commenters, up to
5 minutes per speaker). Registration to
provide oral comments is on or before
April 12, 2018, at https://
ntp.niehs.nih.gov/go/rrprp. Registration
is on a first-come, first-served basis.
Each organization is allowed one time
slot. Oral comments may be presented
in person at NIEHS or by teleconference
line. The access number for the
teleconference line will be provided to
registrants by email prior to the meeting.
After the maximum number of speakers
is exceeded, individuals registered to
provide oral comment will be placed on
a wait list (6 slots on wait list) and
notified should an opening become
available. Commenters will be notified
after April 12, 2018, the deadline to
register for oral public comments, about
the actual time allotted per speaker.
If possible, oral public commenters
should send a copy of their slides and/
or statement or talking points to Canden
Byrd by email: NTP-Meetings@icf.com
by April 12, 2018.
Meeting Materials: The draft NTP
Research Report and preliminary agenda
will be available on the NTP website at
https://ntp.niehs.nih.gov/go/rrprp. The
draft NTP Research Report should be
available by February 23, 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. The preliminary
meeting agenda is available on the
meeting web page and will be updated
one week before the meeting.
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
information to regulatory agencies about
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Federal Register / Vol. 83, No. 35 / Wednesday, February 21, 2018 / Notices
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: February 7, 2018.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
[FR Doc. 2018–03472 Filed 2–20–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
daltland on DSKBBV9HB2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Jackson Heart Study Field Center (FC).
Date: March 14, 2018.
Time: 8:00 a.m. to 8:30 a.m.
Agenda: To review and evaluate contract
proposals.
Place: Holiday Inn National Airport Hotel,
2650 Jefferson Davis Highway, Arlington, VA
22202.
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–827–
7938, johnsonw@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Jackson Heart Study Community Engagement
Center (CEC).
Date: March 14, 2018.
Time: 8:30 a.m. to 9:00 a.m.
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Agenda: To review and evaluate contract
proposals.
Place: Holiday Inn National Airport Hotel,
2650 Jefferson Davis Highway, Arlington, VA
22202.
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–827–
7938, johnsonw@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Jackson Heart Study Training and Education
Center (TEC).
Date: March 14, 2018.
Time: 9:00 a.m. to 9:30 a.m.
Agenda: To review and evaluate contract
proposals.
Place: Holiday Inn National Airport Hotel,
2650 Jefferson Davis Highway, Arlington, VA
22202.
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–827–
7938, johnsonw@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Jackson Heart Study Coordinating Center
(CC).
Date: March 14, 2018.
Time: 9:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Holiday Inn National Airport Hotel,
2650 Jefferson Davis Highway, Arlington, VA
22202.
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–827–
7938, johnsonw@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: February 14, 2018.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–03441 Filed 2–20–18; 8:45 am]
BILLING CODE 4140–01–P
The National Park Service is
soliciting comments on the significance
of properties nominated before January
20, 2018, for listing or related actions in
the National Register of Historic Places.
DATES: Comments should be submitted
by March 8, 2018.
ADDRESSES: Comments may be sent via
U.S. Postal Service and all other carriers
to the National Register of Historic
Places, National Park Service, 1849 C St.
NW, MS 7228, Washington, DC 20240.
SUPPLEMENTARY INFORMATION: The
properties listed in this notice are being
considered for listing or related actions
in the National Register of Historic
Places. Nominations for their
consideration were received by the
National Park Service before January 20,
2018. Pursuant to section 60.13 of 36
CFR part 60, written comments are
being accepted concerning the
significance of the nominated properties
under the National Register criteria for
evaluation.
Before including your address, phone
number, email address, or other
personal identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
Nominations submitted by State
Historic Preservation Officers:
SUMMARY:
ARIZONA
Maricopa County
Ponderosa II, 602 S. Edgewater Dr., Mesa,
SG100002146
ILLINOIS
Coles County
Burgess–Osborne Memorial Auditorium,
1701 Wabash Ave., Mattoon, SG100002149
Kankakee County
Kankakee Downtown Historic District,
Roughly bounded by West Ave., Oak,
Indiana & Station Sts., Kankakee,
SG100002150
KENTUCKY
DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NRNHL–24925;
PPWOCRADI0, PCU00RP14.R50000]
National Register of Historic Places;
Notification of Pending Nominations
and Related Actions
National Park Service, Interior.
ACTION: Notice.
AGENCY:
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Allen County
Halcomb, Dr. Francis Joseph (F.J.) Jr., House,
253 Franklin Rd., Scottsville, SG100002152
Campbell County
Bonnie Leslie Historic District, Bounded by
Memorial Pkwy., Taylor, Wilson, Berry &
Anspaugh Aves., Bellevue, SG100002153
Edmonson County
Chalybeate Springs Hotel Springhouse, 2327
Chalybeate Rd., Smiths Grove vicinity,
SG100002154
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]]>Agencies
[Federal Register Volume 83, Number 35 (Wednesday, February 21, 2018)]
[Notices]
[Pages 7488-7490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Draft NTP Research Report on the CLARITY-BPA Core Study;
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 a meeting to
peer review the Draft NTP Research Report on the CLARITY-BPA Core
Study. This report presents the results of the core, guideline-
compliant, chronic, extended-dose-range study of bisphenol A (BPA) in
rats conducted as part of the CLARITY-BPA Research Program. The U.S.
Food and Drug Administration's National Center for Toxicological
Research (NCTR) conducted the study under the auspices of the National
Toxicology Program and prepared the draft report in collaboration with
the National Institute of Environmental Health Sciences (NIEHS). The
peer-review meeting will be held at NIEHS in Research Triangle Park, NC
and is open to the public. Registration is requested for attendance at
the meeting either in-person or by webcast and to present oral
comments. Information about the meeting and registration is available
at https://ntp.niehs.nih.gov/go/rrprp.
DATES:
Meeting: Tentatively scheduled for April 26, 2018, 8:30 a.m. to
adjournment at approximately 5:00 p.m. Eastern Daylight Time (EDT). The
meeting may end earlier or later than 5:00 p.m. EDT. The preliminary
agenda of topics is available at https://ntp.niehs.nih.gov/go/rrprp and
will be updated one week before the meeting.
Document Availability: The draft NTP Research Report should be
available by February 23, 2018, at https://ntp.niehs.nih.gov/go/rrprp.
Written Public Comment Submissions: Deadline is April 12, 2018.
[[Page 7489]]
Registration for Oral Comments: Deadline is April 12, 2018.
Registration to Attend Meeting In-person or to View Webcast:
Deadline is April 26, 2018.
ADDRESSES:
Meeting Location: Rodbell Auditorium, Rall Building, NIEHS, 111
T.W. Alexander Drive, Research Triangle Park, NC 27709.
Meeting web page: The draft NTP Research Report, preliminary
agenda, registration, and other meeting materials will be available at
https://ntp.niehs.nih.gov/go/rrprp.
Webcast: The URL for viewing the peer-review meeting webcast will
be provided to registrants.
FOR FURTHER INFORMATION CONTACT: 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: Bisphenol A (BPA) is a chemical produced in large
quantities for use primarily in the production of polycarbonate
plastics and epoxy resins. BPA also is used in the production of
certain flame retardants and as a color developer in some thermal
paper. BPA has been detected in air, soil, water, landfill leachate,
and the human body. The primary source of human exposure to BPA is
thought to be through the diet. More than 800 studies were published on
the health effects of BPA between the mid-1990s and the mid-2000s.
Although BPA is a well-studied chemical, few existing, chronic toxicity
studies have included exposure during the perinatal period. There is
also inconsistency among BPA toxicological studies with regard to
findings and their interpretation for human health. Given the
uncertainty regarding the potential health effects from BPA exposure,
NTP, NIEHS, and U.S. Food and Drug Administration (FDA) established the
consortium-based research program, called Consortium Linking Academic
and Regulatory Insights on Toxicity of BPA (CLARITY-BPA).
The aim of the CLARITY-BPA program was to attempt to bridge
guideline-compliant research conducted at the FDA with hypothesis-based
research investigations conducted by academia on the toxicity of BPA. A
detailed description of the CLARITY-BPA program has been published
(https://www.ncbi.nlm.nih.gov/pubmed/26232693). The CLARITY-BPA
research program has two components: (1) A ``core,'' guideline-
compliant, chronic study conducted at NCTR according to FDA Good
Laboratory Practice (GLP) regulations (2-year perinatal only or chronic
BPA exposure, including perinatal), and (2) CLARITY-BPA grantee studies
of various health endpoints, conducted by NIEHS-funded researchers at
academic institutions using animals born to the same exposed pregnant
rats as the core GLP study.
The draft NTP Research Report presents the results of the core GLP
chronic study. The interpretation of biological and toxicological
responses described in the draft NTP Research Report is based only on
the results of the core GLP study. Integration of these data with other
data from the grantee-studies conducted as part of the CLARITY-BPA
research program or extrapolation of the results to other species,
including characterization of hazards and risks to humans, is outside
of the scope of the draft NTP Research Report.
Meeting Attendance Registration: The meeting is open to the public
with time set aside for oral public comment; in-person attendance at
NIEHS is limited by the space available (~100 attendees). Registration
for in-person attendance is on a first-come, first-served basis. After
the first 100 registrants, persons will be placed on a wait list and
notified should an opening become available. Registration to attend the
meeting in-person or view the webcast is by April 26, 2018, at https://ntp.niehs.nih.gov/go/rrprp. The URL for the webcast will be provided in
the email confirming registration. Visitor and security information for
those attending in person is available at https://www.niehs.nih.gov/about/visiting/index.cfm. 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 Research Report. 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 April 12, 2018.
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 allows for one oral public comment period (12
commenters, up to 5 minutes per speaker). Registration to provide oral
comments is on or before April 12, 2018, at https://ntp.niehs.nih.gov/go/rrprp. Registration is on a first-come, first-served basis. Each
organization is allowed one time slot. Oral comments may be presented
in person at NIEHS or by teleconference line. The access number for the
teleconference line will be provided to registrants by email prior to
the meeting. After the maximum number of speakers is exceeded,
individuals registered to provide oral comment will be placed on a wait
list (6 slots on wait list) and notified should an opening become
available. Commenters will be notified after April 12, 2018, the
deadline to register for oral public comments, about the actual time
allotted per speaker.
If possible, oral public commenters should send a copy of their
slides and/or statement or talking points to Canden Byrd by email: [email protected] by April 12, 2018.
Meeting Materials: The draft NTP Research Report and preliminary
agenda will be available on the NTP website at https://ntp.niehs.nih.gov/go/rrprp. The draft NTP Research Report should be
available by February 23, 2018. Additional information will be posted
when available or may be requested in hardcopy; contact Canden Byrd by
phone: (919) 293-1660 or email: NTP-Meet[email protected]. The preliminary
meeting agenda is available on the meeting web page and will be updated
one week before the meeting. 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 information to regulatory agencies
about
[[Page 7490]]
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: February 7, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-03472 Filed 2-20-18; 8:45 am]
BILLING CODE 4140-01-P
