National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Workshop on Acute Chemical Safety Testing: Advancing In Vitro Approaches and Humane Endpoints for Systemic Toxicity Evaluations, 493-495 [E7-25536]
Download as PDF
<![CDATA[
493
Federal Register / Vol. 73, No. 2 / Thursday, January 3, 2008 / Notices
enhance understanding of the
psychology of participation and
response, to develop better standards for
project methodology and instrument
design, or to improve data collection
and other study procedures. Such
research could take the form of
experiments embedded within fielded
surveillance or research projects or
exploratory studies employing
individual interviews or focus groups.
(4) Research on utilizing computerassisted instruments (including webbased technology) for HIV surveillance
or research projects. This research uses
qualitative and quantitative data
collection methods with volunteer
respondents in order to assess the
design and use of computer-assisted
instruments.
(5) Pilot interviews. A limited number
of pilot interviews are conducted using
proposed instruments and data
respond to recruitment advertisements.
In addition to utilizing advertisements
for recruitment, respondents who will
participate in research on survey
methods may be selected purposively or
systematically from within an ongoing
surveillance or research project.
CDC estimates that an average of 1430
individuals will participate in HIV/
AIDS methods, intervention, and
instrument development activities in a
given year and the average annual
respondent burden is estimated to be
2135 hours. The estimates given below
cover the time that each respondent will
spend communicating with the
recruitment staff, in answering survey
questions and, in some cases, being
debriefed about the decision and recall
strategies they used. Participation of
respondents is voluntary and there is no
cost to the respondents other than their
time.
collection methodologies. Sources of
response error are identified through
examination of pilot data, observation
by methodologists, and techniques such
as the coding of the interviewerrespondent interaction. Respondents for
pilot interviews and interventions will
be selected using the methods
developed for the study that is being
piloted.
(6) Pilot testing of behavioral
interventions. Component testing will
assess acceptability and feasibility of
separate intervention activities. A
limited number of pilot tests are
conducted for behavioral interventions
prior to being tested in a ‘‘full
intervention trial.’’
Respondents who will participate in
individual and group interviews
(qualitative, cognitive, and computerassisted development activities) are
selected purposively from those who
ESTIMATE OF ANNUALIZED BURDEN TABLE
No. of respondents
Types of data collection
(1) Methods, interventions, and materials development—individual interviews ............................................................................................................
(2) Methods, interventions, and materials development—group interviews ...
(3) Research on survey methodology .............................................................
(4) Research on human-computer interface ....................................................
(5) Pilot interviewing ........................................................................................
(6) Pilot interventions .......................................................................................
Total ..........................................................................................................
Dated: December 26, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–25564 Filed 1–2–08; 8:45 am]
BILLING CODE 4163–18–P
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); Workshop on
Acute Chemical Safety Testing:
Advancing In Vitro Approaches and
Humane Endpoints for Systemic
Toxicity Evaluations
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
ACTION: Workshop announcement.
pwalker on PROD1PC71 with NOTICES
AGENCY:
The Interagency Committee
on the Validation of Alternative
SUMMARY:
VerDate Aug<31>2005
20:29 Jan 02, 2008
Jkt 214001
250
450
150
350
200
30
1,430
Methods (ICCVAM) and NICEATM
announce the upcoming ‘‘Scientific
Workshop on Acute Chemical Safety
Testing: Advancing In Vitro Approaches
and Humane Endpoints for Systemic
Toxicity Evaluations.’’ The goals of the
workshop are to:
(1) Review the state-of-the-science
and identify knowledge gaps regarding
the key pathways involved in acute
systemic toxicity.
(2) Recommend how these knowledge
gaps can be addressed by collecting
mechanistic biomarker data during
currently required in vivo safety testing.
(3) Recommend how key in vivo
pathway information can be used to
develop more predictive mechanismbased in vitro test systems and earlier,
more humane endpoints for in vivo test
methods.
(4) Recommend how mechanismbased in vitro test systems and earlier,
more humane endpoints can be used to
further reduce, refine, and eventually
replace animal use for acute systemic
toxicity testing while ensuring the
protection of human and animal health.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
No. of responses per
respondent
Average burden per response
(in hours)
1
1
1
1
1
6
........................
1
2
1
1
1
2
........................
Total burden
(in hours)
250
900
150
350
200
360
2,210
This workshop is open to the public
with attendance limited only by the
space available.
DATES: The workshop will be held on
February 6–7, 2008.
ADDRESSES: The workshop will be held
at the NIH, Natcher Conference Center,
45 Center Drive, Bethesda, MD 20892. A
draft agenda and other information are
available on the ICCVAM workshop
Web site (https://iccvam.niehs.nih.gov/
meetings/AcuteToxWksp08/
AcuteToxWksp08.htm) and can be
obtained from NICEATM (see FOR
FURTHER INFORMATION CONTACT below).
FOR FURTHER INFORMATION CONTACT: Dr.
William S. Stokes, NICEATM Director,
NIEHS, P.O. Box 12233, MD EC–17,
Research Triangle Park, NC 27709,
(telephone) 919–541–2384, (fax) 919–
541–0947, (e-mail)
niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
NICEATM and ICCVAM convened a
peer review panel meeting in 2006. The
panel was charged to determine the
E:\FR\FM\03JAN1.SGM
03JAN1
pwalker on PROD1PC71 with NOTICES
494
Federal Register / Vol. 73, No. 2 / Thursday, January 3, 2008 / Notices
usefulness and limitations of two in
vitro cytotoxicity test methods for
determining starting doses for two acute
oral toxicity test methods, the Up-andDown Procedure and the Acute Toxic
Class method, in order to reduce the
number of animals used in each of these
in vivo tests. The panel’s conclusions
and recommendations are described in
the Peer Review Panel Report: The Use
of In Vitro Basal Cytotoxicity Test
Methods for Estimating Starting Doses
for Acute Oral Systemic Toxicity Testing
(available at https://
iccvam.niehs.nih.gov/methods/
acutetox/inv_nru_scpeerrev.htm). The
panel recommended that ICCVAM
consider convening a working group to
explore mechanisms of action for acute
toxicity and to identify approaches for
acquiring additional information on
acute toxicity mechanisms when
conducting required in vivo acute
toxicity testing. The Scientific Advisory
Committee on Alternative Toxicological
Methods (SACATM) met by
teleconference on August 3, 2006, and
expressed support for the panel’s
recommendations (minutes of that
meeting are available at https://
ntp.niehs.nih.gov/files/
SACATMAug06MinutesVF081506.pdf).
NICEATM and ICCVAM included
activities in their draft Five-Year Plan
(2008–2012) (https://
iccvam.niehs.nih.gov/docs/
5yearplan.htm) to further reduce animal
use and potential pain and distress
associated with acute toxicity testing.
These included organizing an
international workshop to (1) identify
predictive and more humane endpoints
that may be used to terminate studies
earlier in order to further reduce the
severity and duration of pain and
distress and (2) identify and standardize
procedures for collecting mechanistic
information from in vivo acute oral
toxicity testing that will aid in
developing batteries of predictive in
vitro test methods that can further
reduce and eventually replace animals
for acute toxicity testing.
The ICCVAM Acute Toxicity Working
Group subsequently organized this
workshop in coordination with
NICEATM, the European Centre for the
Validation of Alternative Methods, and
the Japanese Center for the Validation of
Alternative Methods. The goals of the
workshop are to:
(1) Review the state-of-the-science
and identify knowledge gaps regarding
the key pathways involved in acute
systemic toxicity.
(2) Recommend how these knowledge
gaps can be addressed by collecting
mechanistic biomarker data during
currently required in vivo safety testing.
VerDate Aug<31>2005
20:29 Jan 02, 2008
Jkt 214001
(3) Recommend how key in vivo
pathway information can be used to
develop more predictive mechanismbased in vitro test systems and earlier
more humane endpoints for in vivo test
methods.
(4) Recommend how mechanismbased in vitro test systems and earlier,
more humane endpoints can be used to
further reduce, refine, and replace
animal use for acute systemic toxicity
testing while ensuring the protection of
human health.
Workshop Attendance and Registration
The workshop will be held on
February 6–7, 2008, at the NIH Natcher
Conference Center, 45 Center Drive,
Bethesda, MD 20892. Sessions will
begin at 8 a.m. and end at
approximately 5 p.m. on both days.
Persons needing special assistance in
order to attend, such as sign language
interpretation or other reasonable
accommodation, should contact 919–
541–2475 voice, 919–541–4644 TTY
(text telephone, through the Federal
TTY Relay System at 800–877–8339), or
e-mail niehsoeeo@niehs.nih.gov.
Requests should be made at least seven
days in advance of the event. This
workshop is open to the public with
attendance being limited only by the
space available. Individuals who plan to
attend are encouraged to register in
advance with NICEATM. Registration
information, an agenda, and additional
information are available on the
workshop Web site (https://
iccvam.niehs.nih.gov/meetings/
AcuteToxWksp08/
AcuteToxWksp08.htm) and upon
request to NICEATM (see FOR FURTHER
INFORMATION CONTACT above).
Preliminary Workshop Agenda
Day 1—Wednesday, February 6, 2008
• Opening Plenary Session—
Welcome and Overview of Workshop
Objectives.
• Session 1—Current Acute Systemic
Toxicity Injury and Toxicity
Assessments.
• Session 2—Key Pathways and
Biomarkers for Acute Systemic Toxicity.
• Concurrent Breakout Group (BG)
Discussions:
—BG 1: Acute Systemic Toxicity Injury
and Toxicity Assessments.
—BG 2: Key Pathways and Biomarkers
for Acute Systemic Toxicity.
• Adjournment.
Day 2—Thursday, February 7, 2008
• Plenary Session—Discussion of
Conclusions and Recommendations
from Breakout Groups 1 and 2.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
• Session 3—Developing Earlier
Humane Endpoints for Acute Systemic
Toxicity.
• Session 4—State of the Science:
Using In Vitro Methods to Predict Acute
Systemic Toxicity.
• Concurrent BG Discussions:
—BG 3: Developing Earlier Humane
Endpoints for Acute Systemic
Toxicity Testing.
—BG 4: Applying In Vivo Mechanistic
Pathway Information to the
Development and Validation of In
Vitro Methods for Assessing Acute
Systemic Toxicity.
—BG 5: Partnering with Industry to
Advance Acute Toxicity Alternative
Test Method Development,
Validation, and Use.
• Plenary Session—Discussion of
Conclusions and Recommendations
from Breakout Groups 3, 4, and 5.
• Workshop Adjournment.
Background Information on ICCVAM,
NICEATM, and SACATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that use, generate, or disseminate
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 (42 U.S.C. 285l–3)
established ICCVAM as a permanent
interagency committee of the NIEHS
under NICEATM. NICEATM
administers 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 on their Web
site (https://iccvam.niehs.nih.gov).
SACATM was established January 9,
2002, and is composed of scientists from
the public and private sectors (Federal
Register, Vol. 67, No. 49, page 11358,
March 13, 2002). SACATM provides
advice to the Director of the NIEHS,
ICCVAM, and NICEATM regarding the
statutorily mandated duties of ICCVAM
and activities of NICEATM. Additional
information about SACATM, including
the charter, roster, and records of past
meetings, can be found at https://
ntp.niehs.nih.gov/go/167.
E:\FR\FM\03JAN1.SGM
03JAN1
Federal Register / Vol. 73, No. 2 / Thursday, January 3, 2008 / Notices
Dated: December 19, 2007.
Samuel H. Wilson,
Acting Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E7–25536 Filed 1–2–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of Laboratories Which
Meet Minimum Standards To Engage in
Urine Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The Department of Health and
Human Services (HHS) notifies Federal
agencies of the laboratories currently
certified to meet the standards of
Subpart C of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
April 11, 1988 (53 FR 11970), and
subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908),
on September 30, 1997 (62 FR 51118),
and on April 13, 2004 (69 FR 19644).
A notice listing all currently certified
laboratories is published in the Federal
Register during the first week of each
month. If any laboratory’s certification
is suspended or revoked, the laboratory
will be omitted from subsequent lists
until such time as it is restored to full
certification under the Mandatory
Guidelines.
If any laboratory has withdrawn from
the HHS National Laboratory
Certification Program (NLCP) during the
past month, it will be listed at the end,
and will be omitted from the monthly
listing thereafter.
This notice is also available on the
Internet at https://
www.workplace.samhsa.gov and https://
www.drugfreeworkplace.gov.
Mrs.
Giselle Hersh, Division of Workplace
Programs, SAMHSA/CSAP, Room 2–
1042, One Choke Cherry Road,
Rockville, Maryland 20857; 240–276–
2600 (voice), 240–276–2610 (fax).
SUPPLEMENTARY INFORMATION: The
Mandatory Guidelines were developed
in accordance with Executive Order
12564 and section 503 of Pub. L. 100–
71. Subpart C of the Mandatory
Guidelines, ‘‘Certification of
pwalker on PROD1PC71 with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Aug<31>2005
20:29 Jan 02, 2008
Jkt 214001
Laboratories Engaged in Urine Drug
Testing for Federal Agencies,’’ sets strict
standards that laboratories must meet in
order to conduct drug and specimen
validity tests on urine specimens for
Federal agencies. To become certified,
an applicant laboratory must undergo
three rounds of performance testing plus
an on-site inspection. To maintain that
certification, a laboratory must
participate in a quarterly performance
testing program plus undergo periodic,
on-site inspections.
Laboratories which claim to be in the
applicant stage of certification are not to
be considered as meeting the minimum
requirements described in the HHS
Mandatory Guidelines. A laboratory
must have its letter of certification from
HHS/SAMHSA (formerly: HHS/NIDA)
which attests that it has met minimum
standards.
In accordance with Subpart C of the
Mandatory Guidelines dated April 13,
2004 (69 FR 19644), the following
laboratories meet the minimum
standards to conduct drug and specimen
validity tests on urine specimens:
ACL Laboratories, 8901 W. Lincoln
Ave., West Allis, WI 53227, 414–328–
7840/800–877–7016. (Formerly:
Bayshore Clinical Laboratory)
ACM Medical Laboratory, Inc., 160
Elmgrove Park, Rochester, NY 14624,
585–429–2264.
Advanced Toxicology Network, 3560
Air Center Cove, Suite 101, Memphis,
TN 38118, 901–794–5770/888–290–
1150.
Aegis Sciences Corporation, 345 Hill
Ave., Nashville, TN 37210, 615–255–
2400. (Formerly: Aegis Analytical
Laboratories, Inc.)
Baptist Medical Center—Toxicology
Laboratory, 9601 I–630, Exit 7, Little
Rock, AR 72205–7299, 501–202–2783.
(Formerly: Forensic Toxicology
Laboratory Baptist Medical Center)
Clinical Reference Lab, 8433 Quivira
Road, Lenexa, KS 66215–2802, 800–
445–6917.
Diagnostic Services, Inc., dba DSI,
12700 Westlinks Drive, Fort Myers,
FL 33913, 239–561–8200/800–735–
5416.
Doctors Laboratory, Inc., 2906 Julia
Drive, Valdosta, GA 31602, 229–671–
2281.
DrugScan, Inc., P.O. Box 2969, 1119
Mearns Road, Warminster, PA 18974,
215–674–9310.
Dynacare Kasper Medical Laboratories,*
10150–102 St., Suite 200, Edmonton,
Alberta, Canada T5J 5E2, 780–451–
3702/800–661–9876.
ElSohly Laboratories, Inc., 5 Industrial
Park Drive, Oxford, MS 38655, 662–
236–2609.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
495
Gamma-Dynacare Medical
Laboratories,* A Division of the
Gamma-Dynacare Laboratory
Partnership, 245 Pall Mall Street,
London, ONT, Canada N6A 1P4, 519–
679–1630.
Kroll Laboratory Specialists, Inc., 1111
Newton St., Gretna, LA 70053, 504–
361–8989/800–433–3823. (Formerly:
Laboratory Specialists, Inc.)
Kroll Laboratory Specialists, Inc., 450
Southlake Blvd., Richmond, VA
23236, 804–378–9130. (Formerly:
Scientific Testing Laboratories, Inc.;
Kroll Scientific Testing Laboratories,
Inc.)
Laboratory Corporation of America
Holdings, 7207 N. Gessner Road,
Houston, TX 77040, 713–856–8288/
800–800–2387.
Laboratory Corporation of America
Holdings, 69 First Ave., Raritan, NJ
08869, 908–526–2400/800–437–4986.
(Formerly: Roche Biomedical
Laboratories, Inc.)
Laboratory Corporation of America
Holdings, 1904 Alexander Drive,
Research Triangle Park, NC 27709,
919–572–6900/800–833–3984.
(Formerly: LabCorp Occupational
Testing Services, Inc., CompuChem
Laboratories, Inc.; CompuChem
Laboratories, Inc., A Subsidiary of
Roche Biomedical Laboratory; Roche
CompuChem Laboratories, Inc., A
Member of the Roche Group)
Laboratory Corporation of America
Holdings, 13112 Evening Creek Drive,
Suite 100, San Diego, CA 92128, 858–
668–3710/800–882–7272. (Formerly:
Poisonlab, Inc.).
Laboratory Corporation of America
Holdings, 550 17th Ave., Suite 300,
Seattle, WA 98122, 206–923–7020/
800–898–0180. (Formerly: DrugProof,
Division of Dynacare/Laboratory of
Pathology, LLC; Laboratory of
Pathology of Seattle, Inc.; DrugProof,
Division of Laboratory of Pathology of
Seattle, Inc.)
Laboratory Corporation of America
Holdings, 1120 Main Street,
Southaven, MS 38671, 866–827–8042/
800–233–6339. (Formerly: LabCorp
Occupational Testing Services, Inc.;
MedExpress/National Laboratory
Center)
LabOne, Inc. d/b/a Quest Diagnostics,
10101 Renner Blvd., Lenexa, KS
66219, 913–888–3927/800–873–8845.
(Formerly: Quest Diagnostics
Incorporated; LabOne, Inc.; Center for
Laboratory Services, a Division of
LabOne, Inc.,)
MAXXAM Analytics Inc.,* 6740
Campobello Road, Mississauga, ON,
Canada L5N 2L8, 905–817–5700.
(Formerly: NOVAMANN (Ontario),
Inc.)
E:\FR\FM\03JAN1.SGM
03JAN1
]]>Agencies
[Federal Register Volume 73, Number 2 (Thursday, January 3, 2008)]
[Notices]
[Pages 493-495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25536]
-----------------------------------------------------------------------
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); Workshop on
Acute Chemical Safety Testing: Advancing In Vitro Approaches and Humane
Endpoints for Systemic Toxicity Evaluations
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Workshop announcement.
-----------------------------------------------------------------------
SUMMARY: The Interagency Committee on the Validation of Alternative
Methods (ICCVAM) and NICEATM announce the upcoming ``Scientific
Workshop on Acute Chemical Safety Testing: Advancing In Vitro
Approaches and Humane Endpoints for Systemic Toxicity Evaluations.''
The goals of the workshop are to:
(1) Review the state-of-the-science and identify knowledge gaps
regarding the key pathways involved in acute systemic toxicity.
(2) Recommend how these knowledge gaps can be addressed by
collecting mechanistic biomarker data during currently required in vivo
safety testing.
(3) Recommend how key in vivo pathway information can be used to
develop more predictive mechanism-based in vitro test systems and
earlier, more humane endpoints for in vivo test methods.
(4) Recommend how mechanism-based in vitro test systems and
earlier, more humane endpoints can be used to further reduce, refine,
and eventually replace animal use for acute systemic toxicity testing
while ensuring the protection of human and animal health.
This workshop is open to the public with attendance limited only by
the space available.
DATES: The workshop will be held on February 6-7, 2008.
ADDRESSES: The workshop will be held at the NIH, Natcher Conference
Center, 45 Center Drive, Bethesda, MD 20892. A draft agenda and other
information are available on the ICCVAM workshop Web site (https://
iccvam.niehs.nih.gov/meetings/AcuteToxWksp08/AcuteToxWksp08.htm) and
can be obtained from NICEATM (see FOR FURTHER INFORMATION CONTACT
below).
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, NICEATM
Director, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC
27709, (telephone) 919-541-2384, (fax) 919-541-0947, (e-mail)
niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
NICEATM and ICCVAM convened a peer review panel meeting in 2006.
The panel was charged to determine the
[[Page 494]]
usefulness and limitations of two in vitro cytotoxicity test methods
for determining starting doses for two acute oral toxicity test
methods, the Up-and-Down Procedure and the Acute Toxic Class method, in
order to reduce the number of animals used in each of these in vivo
tests. The panel's conclusions and recommendations are described in the
Peer Review Panel Report: The Use of In Vitro Basal Cytotoxicity Test
Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity
Testing (available at https://iccvam.niehs.nih.gov/methods/acutetox/
inv_nru_scpeerrev.htm). The panel recommended that ICCVAM consider
convening a working group to explore mechanisms of action for acute
toxicity and to identify approaches for acquiring additional
information on acute toxicity mechanisms when conducting required in
vivo acute toxicity testing. The Scientific Advisory Committee on
Alternative Toxicological Methods (SACATM) met by teleconference on
August 3, 2006, and expressed support for the panel's recommendations
(minutes of that meeting are available at https://ntp.niehs.nih.gov/
files/SACATMAug06MinutesVF081506.pdf).
NICEATM and ICCVAM included activities in their draft Five-Year
Plan (2008-2012) (https://iccvam.niehs.nih.gov/docs/5yearplan.htm) to
further reduce animal use and potential pain and distress associated
with acute toxicity testing. These included organizing an international
workshop to (1) identify predictive and more humane endpoints that may
be used to terminate studies earlier in order to further reduce the
severity and duration of pain and distress and (2) identify and
standardize procedures for collecting mechanistic information from in
vivo acute oral toxicity testing that will aid in developing batteries
of predictive in vitro test methods that can further reduce and
eventually replace animals for acute toxicity testing.
The ICCVAM Acute Toxicity Working Group subsequently organized this
workshop in coordination with NICEATM, the European Centre for the
Validation of Alternative Methods, and the Japanese Center for the
Validation of Alternative Methods. The goals of the workshop are to:
(1) Review the state-of-the-science and identify knowledge gaps
regarding the key pathways involved in acute systemic toxicity.
(2) Recommend how these knowledge gaps can be addressed by
collecting mechanistic biomarker data during currently required in vivo
safety testing.
(3) Recommend how key in vivo pathway information can be used to
develop more predictive mechanism-based in vitro test systems and
earlier more humane endpoints for in vivo test methods.
(4) Recommend how mechanism-based in vitro test systems and
earlier, more humane endpoints can be used to further reduce, refine,
and replace animal use for acute systemic toxicity testing while
ensuring the protection of human health.
Workshop Attendance and Registration
The workshop will be held on February 6-7, 2008, at the NIH Natcher
Conference Center, 45 Center Drive, Bethesda, MD 20892. Sessions will
begin at 8 a.m. and end at approximately 5 p.m. on both days. Persons
needing special assistance in order to attend, such as sign language
interpretation or other reasonable accommodation, should contact 919-
541-2475 voice, 919-541-4644 TTY (text telephone, through the Federal
TTY Relay System at 800-877-8339), or e-mail niehsoeeo@niehs.nih.gov.
Requests should be made at least seven days in advance of the event.
This workshop is open to the public with attendance being limited only
by the space available. Individuals who plan to attend are encouraged
to register in advance with NICEATM. Registration information, an
agenda, and additional information are available on the workshop Web
site (https://iccvam.niehs.nih.gov/meetings/AcuteToxWksp08/
AcuteToxWksp08.htm) and upon request to NICEATM (see FOR FURTHER
INFORMATION CONTACT above).
Preliminary Workshop Agenda
Day 1--Wednesday, February 6, 2008
Opening Plenary Session--Welcome and Overview of Workshop
Objectives.
Session 1--Current Acute Systemic Toxicity Injury and
Toxicity Assessments.
Session 2--Key Pathways and Biomarkers for Acute Systemic
Toxicity.
Concurrent Breakout Group (BG) Discussions:
--BG 1: Acute Systemic Toxicity Injury and Toxicity Assessments.
--BG 2: Key Pathways and Biomarkers for Acute Systemic Toxicity.
Adjournment.
Day 2--Thursday, February 7, 2008
Plenary Session--Discussion of Conclusions and
Recommendations from Breakout Groups 1 and 2.
Session 3--Developing Earlier Humane Endpoints for Acute
Systemic Toxicity.
Session 4--State of the Science: Using In Vitro Methods to
Predict Acute Systemic Toxicity.
Concurrent BG Discussions:
--BG 3: Developing Earlier Humane Endpoints for Acute Systemic Toxicity
Testing.
--BG 4: Applying In Vivo Mechanistic Pathway Information to the
Development and Validation of In Vitro Methods for Assessing Acute
Systemic Toxicity.
--BG 5: Partnering with Industry to Advance Acute Toxicity Alternative
Test Method Development, Validation, and Use.
Plenary Session--Discussion of Conclusions and
Recommendations from Breakout Groups 3, 4, and 5.
Workshop Adjournment.
Background Information on ICCVAM, NICEATM, and SACATM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that use, generate, or
disseminate 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
(42 U.S.C. 285l-3) established ICCVAM as a permanent interagency
committee of the NIEHS under NICEATM. NICEATM administers 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 on their
Web site (https://iccvam.niehs.nih.gov).
SACATM was established January 9, 2002, and is composed of
scientists from the public and private sectors (Federal Register, Vol.
67, No. 49, page 11358, March 13, 2002). SACATM provides advice to the
Director of the NIEHS, ICCVAM, and NICEATM regarding the statutorily
mandated duties of ICCVAM and activities of NICEATM. Additional
information about SACATM, including the charter, roster, and records of
past meetings, can be found at https://ntp.niehs.nih.gov/go/167.
[[Page 495]]
Dated: December 19, 2007.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E7-25536 Filed 1-2-08; 8:45 am]
BILLING CODE 4140-01-P
