National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Announcement of Expert Panel Meeting To Evaluate Revised Analyses and Proposed Reference Substances for In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants, 53676-53677 [05-17939]
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53676
Federal Register / Vol. 70, No. 174 / Friday, September 9, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine;
Cancellation of Meetings
Notice is hereby given of the
cancellation of the Commission on
Systemic Interoperability, September
13, 2005, 8 a.m. to 4 p.m., Hubert H.
Humphrey Building, Room 800, 200
Independence Avenue, Washington, DC
20201, cancellation of the Commission
on Systemic Interoperability
Teleconference, October 11, 2005,
3 p.m. to 4:30 p.m., National Library of
Medicine, Conference Room B, Building
38, 2nd Floor, Bethesda, Maryland
20894, and the cancellation of the
Commission on Systemic
Interoperability, October 24, 2005,
8 a.m. to 1 p.m., Hubert H. Humphrey
Building, Room 800, 200 Independence
Avenue, Washington, DC 20201, all of
which were published in the Federal
Register on July 13, 2005, 70 FR 40392.
These meetings are cancelled, as they
are no longer necessary to complete
Commission activities.
Dated: August 31, 2005.
Anthony M. Coelho, Jr.,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–17940 Filed 9–8–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP);
NTP Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM); Announcement
of Expert Panel Meeting To Evaluate
Revised Analyses and Proposed
Reference Substances for In Vitro Test
Methods for Identifying Ocular
Corrosives and Severe Irritants
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH), Department of Health and Human
Services (HHS).
ACTION: Meeting announcement and
opportunity for public comment.
AGENCY:
SUMMARY: NICEATM announces a
second meeting of an expert panel by
teleconference on September 19, 2005,
to evaluate (1) revised accuracy and
reliability analyses of four in vitro test
methods proposed for detecting ocular
corrosives and severe irritants and (2) a
revised list of proposed reference
VerDate Aug<18>2005
15:19 Sep 08, 2005
Jkt 205001
substances for validation studies on in
vitro test methods for identifying ocular
corrosives and severe irritants. The four
in vitro test methods under
consideration are the (1) Bovine Corneal
Opacity and Permeability (BCOP) assay,
(2) Hen’s Egg Test—Chorion Allantoic
Membrane (HET–CAM), (3) Isolated
Rabbit Eye (IRE) assay, and (4) Isolated
Chicken Eye (ICE) assay. The revised
analyses and revised list of proposed
reference substances are available in an
addendum to the draft Background
Review Documents (BRDs) for the four
methods (available at https://
iccvam.niehs.nih.gov/methods/ocudocs/
reanalysis.htm). A previous Federal
Register notice solicited public
comment on the revised analyses and
revised list of proposed reference
substances (Vol. 70, No. 142, pg. 43149,
July 26, 2005). Comments submitted in
response to the July 26, 2005 Federal
Register notice will be considered at the
expert panel meeting and do not need
to be resubmitted. The public is invited
to attend the teleconference and will be
provided with an opportunity to make
oral comments during the public
comment period. Interested individuals
can attend the meeting via a phone line
or in person at the NIEHS campus (see
ADDRESSES below). Participation is
limited only by the number of phone
lines available and by the number of
available seats at the teleconference site.
Additional meeting information may be
obtained on the ICCVAM/NICEATM
Web site (https://iccvam.niehs.nih.gov)
or by contacting NICEATM (see
ADDRESSES below).
DATES: The expert panel meeting will be
held via teleconference on Monday,
September 19, 2005, beginning at 9 a.m.
eastern daylight time (e.d.t.) and
continuing until adjournment
(approximately 12 p.m. e.d.t.).
Requests to attend the meeting via the
telephone or in person must be received
no later than September 12, 2005, to
ensure access (see ADDRESSES below).
We encourage all individuals who plan
to attend this meeting to register online
at the NICEATM Web site (https://
iccvam.niehs.nih.gov/), but requests
may also be submitted by e-mail,
telephone, fax, or through hand
delivery/courier (see ADDRESSES below).
Persons wishing to make oral
comments during the teleconference
must notify NICEATM no later than
September 12, 2005 (see ADDRESSES
below). In lieu of oral comments,
individuals may provide written
comments for distribution to the expert
panel prior to the meeting. Written
comments should be received by
September 15, 2005, in order to enable
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
consideration by the expert panel prior
to the meeting.
Persons with disabilities, such as
those who need sign language
interpreters and/or other reasonable
accommodation to participate in this
meeting at NIEHS, are asked to notify
NICEATM by September 8, 2005.
ADDRESSES: The teleconference will
originate from Room 3162, 3rd Floor,
NIEHS, 79 T.W. Alexander Drive, Bldg.
4401, Research Triangle Park, NC. A
government-approved photo ID is
required to access the meeting.
Correspondence should be sent by
mail, fax, e-mail, or through hand
delivery/courier to Dr. Raymond Tice at
NICEATM, NIEHS, PO Box 12233, MD
EC–17, Research Triangle Park, NC
27709, (phone) 919–541–4482, (fax)
919–541–0947, (e-mail)
niceatmcomments@niehs.nih.gov.
Courier address: NICEATM, 79 T.W.
Alexander Drive, Building 4401, Room
3129, Research Triangle Park, NC 27709.
SUPPLEMENTARY INFORMATION:
Background
On November 3, 2004, NICEATM
released draft BRDs that provided
information about the current validation
status of the four in vitro test methods
for detecting ocular corrosives and
severe irritants (Federal Register, Vol.
69, No. 212, pp. 64081–64082,
November 3, 2004). In conjunction with
ICCVAM, NICEATM convened an
expert panel meeting on January 11–12,
2005, to independently assess the
validation status of the four in vitro test
methods. The expert panel report and
background information for this meeting
are available at https://
iccvam.niehs.nih.gov/methods/
eyeirrit.htm. Public comments at the
meeting indicated that additional data
could be made available that had not
been provided in response to earlier
requests for data announced in the
Federal Register in March (Vol. 69, No.
57, pp. 13859–13861, March 24, 2004)
and November 2004). The expert panel
recommended that NICEATM conduct a
reanalysis of the accuracy and reliability
of each test method that would include
these data. In response to this
recommendation, NICEATM published
a notice in the Federal Register (Vol. 70,
No. 38, pp. 9661–9662, February 28,
2005) requesting additional in vitro data
on these four in vitro ocular irritancy
test methods, corresponding in vivo
rabbit eye test method data, as well as
any human ocular exposure/injury data
(either from ethical human studies or
accidental exposure). Subsequently,
NICEATM received additional in vitro
and in vivo data that were used for the
E:\FR\FM\09SEN1.SGM
09SEN1
Federal Register / Vol. 70, No. 174 / Friday, September 9, 2005 / Notices
revised accuracy and reliability analyses
and considered in revising the list of
proposed reference substances.
In preparation for this teleconference,
NICEATM released the revised accuracy
and reliability analyses and the revised
list of proposed reference substances as
an addendum to the draft BRDs and
announced its availability in the July 26,
2006 Federal Register notice. Following
the expert panel teleconference, a
second expert panel report will be
published and made available for public
comment. ICCVAM will consider both
expert panel reports, other relevant
background materials, and all comments
received from the public and the
Scientific Advisory Committee on
Alternative Toxicological Methods
(SACATM) on this topic in finalizing
ICCVAM recommendations for these
test methods.
Opportunity for Public Comment
Public comments may be made on the
revised accuracy and reliability analyses
for BCOP, HET–CAM, ICE, and IRE and
on the proposed list of reference
substances. In lieu of oral comments,
individuals may provide written
comments for distribution to the expert
panel prior to the meeting. Written
comments should be received no later
than September 15, 2005, to enable
consideration by the expert panel prior
to the meeting. Written comments
received in response to the July 26, 2005
Federal Register notice announcing
availability of the addendum to the draft
BRDs do not need to be resubmitted. If
written comments are submitted,
appropriate contact information (name,
affiliation, mailing address, phone, fax,
email and sponsoring organization, if
applicable) should be included. Written
comments will be posted on the
NICEATM/ICCVAM Web site and made
available to the expert panel and the
ICCVAM. Persons wishing to make oral
comments during the teleconference
(one speaker per organization) must
notify NICEATM by no later than
September 12, 2005. Speakers will be
assigned on a consecutive basis and
comments will be limited to no more
than four minutes per speaker. Due to
logistical issues it may not be possible
for persons who do not pre-register to
make oral comments.
Background Information on ICCVAM
and NICEATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that use or generate toxicological
information. ICCVAM conducts
technical evaluations of new, revised,
and alternative methods with regulatory
VerDate Aug<18>2005
15:19 Sep 08, 2005
Jkt 205001
applicability, and promotes the
scientific validation and regulatory
acceptance of toxicological test methods
that more accurately assess the safety
and hazards of chemicals and products
and that refine, reduce, and replace
animal use. The ICCVAM Authorization
Act of 2000 (Pub. L. 106–545, available
at https://iccvam.niehs.nih.gov/about/
PL106545.htm) establishes ICCVAM as a
permanent interagency committee of the
NIEHS under the NICEATM. NICEATM
administers the ICCVAM and provides
scientific and operational support for
ICCVAM-related activities. NICEATM
and ICCVAM work collaboratively to
evaluate new and improved test
methods applicable to the needs of
Federal agencies. Additional
information about ICCVAM and
NICEATM can be found at the following
Web site: https://
www.iccvam.niehs.nih.gov.
Dated: August 30, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences.
[FR Doc. 05–17939 Filed 9–8–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[CGD13–05–017]
Letter of Recommendation, Proposed
LNG Project Northern Star Natural Gas
LLC, Bradwood, Clatsop County, OR
Coast Guard, DHS.
Request for comments; notice of
public meeting.
AGENCY:
ACTION:
SUMMARY: In accordance with the
requirements in 33 CFR 127.009, the
U.S. Coast Guard Captain of the Port
(COTP) Portland, Oregon is preparing a
Letter of Recommendation (LOR) as to
the suitability of the Columbia River for
liquefied natural gas (LNG) marine
traffic. This LOR will encompass the
marine safety and security aspects
associated with the proposed Northern
Star Natural Gas LLC (Northern Star)
LNG facility. The LOR is in response to
a Letter of Intent (LOI) submitted by
Northern Star to operate an LNG facility
in Bradwood, Clatsop County, Oregon.
Because the proposed LNG facility
would be located in state waters, the
Federal Energy Regulatory Commission
(FERC) is the lead Federal agency for
this proposed project. The COTP
Portland, OR is soliciting written
comments and related material, and will
join FERC in holding a public meeting
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
53677
seeking comments, pertaining
specifically to maritime safety and
security aspects of the proposed LNG
facility. In preparation for issuance of an
LOR and the completion of certain other
regulatory mandates, the COTP
Portland, OR, will consider comments
received from the public as input into
a formalized risk assessment process.
This process will assess the safety and
security aspects of the facility, adjacent
port areas, and navigable waterways.
DATES: All written comments and
related material must reach the Coast
Guard on or before October 6, 2005. In
addition, a public meeting will be held
Thursday, September 29, 2005 at 7 p.m.
Those who plan to speak at the meeting
should provide their name by
September 22, 2005 to Lieutenant
Shadrack Scheirman using one of the
methods listed under FOR FURTHER
INFORMATION CONTACT. The comment
period associated with the public
meeting will remain open for seven days
following the meeting. The meeting
location is: Knappa High School, 41535
Old Highway 30, Astoria, OR 97102,
503–458–6166.
ADDRESSES: You may submit written
comments to Commanding Officer, U.S.
Coast Guard Sector Portland. Sector
Portland maintains a file for this notice.
Comments and material received will
become part of this file and will be
available for inspection and copying at
Sector Portland between 8 a.m. and 3
p.m. Monday through Friday, except
Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice,
contact Lieutenant Shadrack Scheirman
at Sector Portland by one of the methods
listed below:
(1) Phone at (503) 247–4015
(2) E-mail at
Shadrack.L.Scheirman@uscg.mil
(3) Fax to (503) 240–2586
SUPPLEMENTARY INFORMATION:
Request for Written Comments
We encourage you to submit written
comments and related material
pertaining specifically to marine safety
and security aspects associated with the
proposed Northern Star LNG facility. If
you do so, please include your name
and address, identify the docket number
for this notice ([CGD13–05–017]), and
give the reason for each comment. You
may submit your comments and related
material by mail, or hand delivery, as
described in ADDRESSES, or you may
send them by fax or e-mail using the
contact information under FOR FURTHER
INFORMATION CONTACT. To avoid
confusion and duplication, please
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 70, Number 174 (Friday, September 9, 2005)]
[Notices]
[Pages 53676-53677]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17939]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP); NTP Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM); Announcement
of Expert Panel Meeting To Evaluate Revised Analyses and Proposed
Reference Substances for In Vitro Test Methods for Identifying Ocular
Corrosives and Severe Irritants
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH), Department of Health and Human
Services (HHS).
ACTION: Meeting announcement and opportunity for public comment.
-----------------------------------------------------------------------
SUMMARY: NICEATM announces a second meeting of an expert panel by
teleconference on September 19, 2005, to evaluate (1) revised accuracy
and reliability analyses of four in vitro test methods proposed for
detecting ocular corrosives and severe irritants and (2) a revised list
of proposed reference substances for validation studies on in vitro
test methods for identifying ocular corrosives and severe irritants.
The four in vitro test methods under consideration are the (1) Bovine
Corneal Opacity and Permeability (BCOP) assay, (2) Hen's Egg Test--
Chorion Allantoic Membrane (HET-CAM), (3) Isolated Rabbit Eye (IRE)
assay, and (4) Isolated Chicken Eye (ICE) assay. The revised analyses
and revised list of proposed reference substances are available in an
addendum to the draft Background Review Documents (BRDs) for the four
methods (available at https://iccvam.niehs.nih.gov/methods/ocudocs/
reanalysis.htm). A previous Federal Register notice solicited public
comment on the revised analyses and revised list of proposed reference
substances (Vol. 70, No. 142, pg. 43149, July 26, 2005). Comments
submitted in response to the July 26, 2005 Federal Register notice will
be considered at the expert panel meeting and do not need to be
resubmitted. The public is invited to attend the teleconference and
will be provided with an opportunity to make oral comments during the
public comment period. Interested individuals can attend the meeting
via a phone line or in person at the NIEHS campus (see ADDRESSES
below). Participation is limited only by the number of phone lines
available and by the number of available seats at the teleconference
site. Additional meeting information may be obtained on the ICCVAM/
NICEATM Web site (https://iccvam.niehs.nih.gov) or by contacting NICEATM
(see ADDRESSES below).
DATES: The expert panel meeting will be held via teleconference on
Monday, September 19, 2005, beginning at 9 a.m. eastern daylight time
(e.d.t.) and continuing until adjournment (approximately 12 p.m.
e.d.t.).
Requests to attend the meeting via the telephone or in person must
be received no later than September 12, 2005, to ensure access (see
ADDRESSES below). We encourage all individuals who plan to attend this
meeting to register online at the NICEATM Web site (https://
iccvam.niehs.nih.gov/), but requests may also be submitted by e-mail,
telephone, fax, or through hand delivery/courier (see ADDRESSES below).
Persons wishing to make oral comments during the teleconference
must notify NICEATM no later than September 12, 2005 (see ADDRESSES
below). In lieu of oral comments, individuals may provide written
comments for distribution to the expert panel prior to the meeting.
Written comments should be received by September 15, 2005, in order to
enable consideration by the expert panel prior to the meeting.
Persons with disabilities, such as those who need sign language
interpreters and/or other reasonable accommodation to participate in
this meeting at NIEHS, are asked to notify NICEATM by September 8,
2005.
ADDRESSES: The teleconference will originate from Room 3162, 3rd Floor,
NIEHS, 79 T.W. Alexander Drive, Bldg. 4401, Research Triangle Park, NC.
A government-approved photo ID is required to access the meeting.
Correspondence should be sent by mail, fax, e-mail, or through hand
delivery/courier to Dr. Raymond Tice at NICEATM, NIEHS, PO Box 12233,
MD EC-17, Research Triangle Park, NC 27709, (phone) 919-541-4482, (fax)
919-541-0947, (e-mail) niceatmcomments@niehs.nih.gov. Courier address:
NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3129, Research
Triangle Park, NC 27709.
SUPPLEMENTARY INFORMATION:
Background
On November 3, 2004, NICEATM released draft BRDs that provided
information about the current validation status of the four in vitro
test methods for detecting ocular corrosives and severe irritants
(Federal Register, Vol. 69, No. 212, pp. 64081-64082, November 3,
2004). In conjunction with ICCVAM, NICEATM convened an expert panel
meeting on January 11-12, 2005, to independently assess the validation
status of the four in vitro test methods. The expert panel report and
background information for this meeting are available at https://
iccvam.niehs.nih.gov/methods/eyeirrit.htm. Public comments at the
meeting indicated that additional data could be made available that had
not been provided in response to earlier requests for data announced in
the Federal Register in March (Vol. 69, No. 57, pp. 13859-13861, March
24, 2004) and November 2004). The expert panel recommended that NICEATM
conduct a reanalysis of the accuracy and reliability of each test
method that would include these data. In response to this
recommendation, NICEATM published a notice in the Federal Register
(Vol. 70, No. 38, pp. 9661-9662, February 28, 2005) requesting
additional in vitro data on these four in vitro ocular irritancy test
methods, corresponding in vivo rabbit eye test method data, as well as
any human ocular exposure/injury data (either from ethical human
studies or accidental exposure). Subsequently, NICEATM received
additional in vitro and in vivo data that were used for the
[[Page 53677]]
revised accuracy and reliability analyses and considered in revising
the list of proposed reference substances.
In preparation for this teleconference, NICEATM released the
revised accuracy and reliability analyses and the revised list of
proposed reference substances as an addendum to the draft BRDs and
announced its availability in the July 26, 2006 Federal Register
notice. Following the expert panel teleconference, a second expert
panel report will be published and made available for public comment.
ICCVAM will consider both expert panel reports, other relevant
background materials, and all comments received from the public and the
Scientific Advisory Committee on Alternative Toxicological Methods
(SACATM) on this topic in finalizing ICCVAM recommendations for these
test methods.
Opportunity for Public Comment
Public comments may be made on the revised accuracy and reliability
analyses for BCOP, HET-CAM, ICE, and IRE and on the proposed list of
reference substances. In lieu of oral comments, individuals may provide
written comments for distribution to the expert panel prior to the
meeting. Written comments should be received no later than September
15, 2005, to enable consideration by the expert panel prior to the
meeting. Written comments received in response to the July 26, 2005
Federal Register notice announcing availability of the addendum to the
draft BRDs do not need to be resubmitted. If written comments are
submitted, appropriate contact information (name, affiliation, mailing
address, phone, fax, email and sponsoring organization, if applicable)
should be included. Written comments will be posted on the NICEATM/
ICCVAM Web site and made available to the expert panel and the ICCVAM.
Persons wishing to make oral comments during the teleconference (one
speaker per organization) must notify NICEATM by no later than
September 12, 2005. Speakers will be assigned on a consecutive basis
and comments will be limited to no more than four minutes per speaker.
Due to logistical issues it may not be possible for persons who do not
pre-register to make oral comments.
Background Information on ICCVAM and NICEATM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that use or generate
toxicological information. ICCVAM conducts technical evaluations of
new, revised, and alternative methods with regulatory applicability,
and promotes the scientific validation and regulatory acceptance of
toxicological test methods that more accurately assess the safety and
hazards of chemicals and products and that refine, reduce, and replace
animal use. The ICCVAM Authorization Act of 2000 (Pub. L. 106-545,
available at https://iccvam.niehs.nih.gov/about/PL106545.htm)
establishes ICCVAM as a permanent interagency committee of the NIEHS
under the NICEATM. NICEATM administers the ICCVAM and provides
scientific and operational support for ICCVAM-related activities.
NICEATM and ICCVAM work collaboratively to evaluate new and improved
test methods applicable to the needs of Federal agencies. Additional
information about ICCVAM and NICEATM can be found at the following Web
site: https://www.iccvam.niehs.nih.gov.
Dated: August 30, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-17939 Filed 9-8-05; 8:45 am]
BILLING CODE 4140-01-P