National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Non-Animal Methods and Approach for Evaluating Eye Irritation Potential for Antimicrobial Cleaning Products (AMCPs): Request for Nominations for an Independent Expert Panel and Submission of Relevant Data, 18535-18536 [E8-6969]
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Federal Register / Vol. 73, No. 66 / Friday, April 4, 2008 / Notices
the record and specify the information
to be contested and corrective action
sought with supporting justification.
(These procedures are in accordance
with Department Regulations (45 CFR
5b.7).)
RECORD SOURCES CATEGORIES:
The information for this system is
obtained through a number of sources
including OCIG attorney, exchange of
legal pleadings, documents, formal and
informal discovery, program offices and
component agencies, private attorneys,
State and local governments, their
agencies and instrumentalities, and
officers of other Federal agencies and
the individuals involved.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E8–7034 Filed 4–3–08; 8:45 am]
BILLING CODE 4152–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
NTP Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM); Non-Animal
Methods and Approach for Evaluating
Eye Irritation Potential for
Antimicrobial Cleaning Products
(AMCPs): Request for Nominations for
an Independent Expert Panel and
Submission of Relevant Data
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
ACTION: Request nominations for an
independent expert panel and
submission of relevant data.
ebenthall on PRODPC61 with NOTICES
AGENCY:
SUMMARY: At the request of the U.S.
Environmental Protection Agency
(EPA), the Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM) is
planning to assess the validation status
of a proposed non-animal approach for
evaluating the eye irritation potential of
AMCPs that meets hazard classification
and labeling requirements. On behalf of
ICCVAM, NICEATM requests:
1. Nominations of expert scientists to
serve as members of an independent
peer review panel.
2. Submission of relevant data and
information on AMCPs or related
substances obtained from (1) human
testing or experience including reports
from accidental exposures, (2) rabbits
using the standard eye test or the low
volume eye test (LVET), and (3) in vitro
test methods for assessing ocular
VerDate Aug<31>2005
15:24 Apr 03, 2008
Jkt 214001
irritation, such as the Bovine Corneal
Opacity and Permeability (BCOP) test,
the Cytosensor Microphysiometer (CM)
test, and the EpiOcular test, and data
supporting the accuracy and
reproducibility of these methods.
DATES: Submit nominations and data by
May 19, 2008. Data submitted after this
date will be considered in the
evaluation, if feasible.
ADDRESSES: Submit nominations and
data to Dr. William S. Stokes, NICEATM
Director, NIEHS, P.O. Box 12233, MD
EC–17, Research Triangle Park, NC,
27709, (fax) 919–541–0947 (e-mail)
niceatm@niehs.nih.gov. Courier address:
NICEATM, 79 T.W. Alexander Drive,
Building 4401, Room 3128, Research
Triangle Park, NC, 27709. Responses
can also be submitted electronically via
the ICCVAM–NICEATM Web site
(https://iccvam.niehs.nih.gov/contact/
FR_pubcomment.htm).
FOR FURTHER INFORMATION CONTACT:
Other correspondence should be
directed to Dr. William S. Stokes (919–
541–2384 or niceatm@niehs.nih.gov).
SUPPLEMENTARY INFORMATION:
Background
In June 2004, the EPA Office of
Pesticide Programs informed NICEATM
that they were developing, via a
subgroup of the Pesticide Program
Dialogue Committee, a non-animal
assessment approach for evaluating eye
irritation potential and labeling
requirements for AMCPs. Subsequently,
the EPA in collaboration with the
Alternative Testing Working Group
(ATWG) developed a non-animal
approach for this limited group of
products. The ATWG is comprised of
seven consumer product companies
(Clorox, Colgate Palmolive, Dial,
EcoLabs, Johnson Diversey, Procter &
Gamble, and SC Johnson). The Institute
for In Vitro Sciences, Inc. (IIVS), which
coordinated the EPA–ATWG
collaboration, performed additional
testing to complete parallel sets of in
vivo and in vitro data, and prepared a
background review document (BRD)
describing the final approach. More
information concerning this submission
is available at: https://
iccvam.niehs.nih.gov/methods/ocutox/
AMCP.htm.
In January 2008, IIVS submitted the
BRD, An In Vitro Approach for EPA
Toxicity Labeling of Anti-Microbial
Cleaning Products, to NICEATM. The
EPA and the ATWG requested that
NICEATM and ICCVAM use
information within the BRD to conduct
a technical review of the proposed
approach to determine whether
ICCVAM could assure the EPA, with a
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
18535
reasonable degree of certainty, that the
approach would be useful for making
labeling decisions for AMCPs that
appropriately inform the user.
NICEATM and ICCVAM are now
conducting a preliminary evaluation of
the submission to determine its
completeness and adherence to
ICCVAM guidelines, which are available
at https://iccvam.niehs.nih.gov/
SuppDocs/SubGuidelines/SD_
subg034508.pdf. If they decide to move
forward with an evaluation, NICEATM
and ICCVAM will convene an
independent peer review panel to
review the validation status of the
proposed approach.
Request for Nominations of Scientific
Experts
NICEATM requests nominations of
scientists with relevant knowledge and
experience to serve on the peer review
panel should it be convened. Areas of
relevant expertise include, but are not
limited to:
• Biostatistics
• Human and veterinary
ophthalmology, with an emphasis on
evaluation and treatment of chemical
injuries
• In vivo ocular toxicity testing
• In vitro ocular toxicology
• Test method validation
Each nomination should include the
nominee’s name, affiliation, contact
information (i.e., mailing address,
e-mail address, telephone and fax
numbers), curriculum vitae, and a brief
summary of relevant experience and
qualifications. Nominations previously
submitted to NICEATM in response to
an earlier request for scientific experts
for a possible peer panel review of in
vitro ocular test methods used to
evaluate AMCPs (Federal Register Vol.
70, No. 53, pp. 13512–13513, available
at https://iccvam.niehs.nih.gov) do not
need to be resubmitted.
Request for Data
NICEATM invites the submission of
relevant data and information on
AMCPs or related substances obtained
from (1) human testing or experience
including reports from accidental
exposures, (2) rabbits using the standard
eye test or the low volume eye test
(LVET), and (3) in vitro test methods for
assessing ocular irritation, such as the
Bovine Corneal Opacity and
Permeability (BCOP) test, the
Cytosensor Microphysiometer (CM) test,
and the EpiOcular test, including data
supporting the accuracy and
reproducibility of these methods.
Although data can be accepted at any
time, data received by May 19, 2008 will
be considered during the ICCVAM
E:\FR\FM\04APN1.SGM
04APN1
18536
Federal Register / Vol. 73, No. 66 / Friday, April 4, 2008 / Notices
ebenthall on PRODPC61 with NOTICES
evaluation process. Relevant data
received after this date will be
considered during the ICCVAM
evaluation process, if feasible. All
information submitted in response to
this notice will be made publicly
available and may be incorporated into
future NICEATM and ICCVAM reports
and publications as appropriate.
When submitting data, please
reference this Federal Register notice
and provide appropriate contact
information (name, affiliation, mailing
address, phone, fax, e-mail, and
sponsoring organization, as applicable).
NICEATM prefers that data be
submitted as copies of pages from study
notebooks and/or study reports, if
available. Raw data and analyses
available in electronic format may also
be submitted. Each submission for a
substance should preferably include the
following information, as appropriate:
• Common and trade name
• Chemical Abstracts Service Registry
Number (CASRN)
• Chemical and/or product class
• Commercial source
• In vivo or in vitro test protocol used
• Individual animal or in vitro
responses at each observation time (i.e.,
raw data)
• The extent to which the study
complied with national/international
Good Laboratory Practice (GLP)
guidelines
• Date and testing organization
• Physical and chemical properties
(e.g. molecular weight, pH, water
solubility, etc.)
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
(42 U.S.C. 2851–3, available at (https://
iccvam.niehs.nih.gov/docs/about_docs/
PL106545.pdf) 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
VerDate Aug<31>2005
15:24 Apr 03, 2008
Jkt 214001
information about ICCVAM and
NICEATM is available on the following
Web site: https://iccvam.niehs.nih.gov.
Dated: March 24, 2008.
Samuel H. Wilson,
Acting Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E8–6969 Filed 4–3–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control; Special
Emphasis Panel (SEP): Identification,
Surveillance and Control of VectorBorne and Zoonotic Infectious
Diseases in Uganda, Funding
Opportunity Announcement (FOA)
CK08–004
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 12 p.m.–2 p.m., May
16, 2008 (Closed).
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section 552b(c)
(4) and (6), Title 5 U.S.C., and the
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters to be Discussed: The meeting
will include the review, discussion, and
evaluation of ‘‘Identification,
Surveillance and Control of VectorBorne and Zoonotic Infectious Diseases
in Uganda,’’ FOA CK08–004.
Contact Person for More Information:
Shoukat Qari, D.V.M., PhD, Scientific
Review Administrator, Strategic Science
and Program Unit, Office of the Director,
Coordinating Center for Infectious
Diseases, CDC, 1600 Clifton Road,
Mailstop C–19, Atlanta, GA, Telephone
(404) 639–8942.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Dated: March 28, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–7032 Filed 4–3–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control; Special
Emphasis Panel (SEP): Mining
Occupational Safety and Health
Research (R01), Request for
Application (RFA) OH08–003
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Times and Dates: 5 p.m.–7 p.m., May
7, 2008 (Closed). 8 a.m.–5 p.m., May 8,
2008 (Closed). 8 a.m.–5 p.m., May 9,
2008 (Closed).
Place: Radisson Plaza-Warwick Hotel
Philadelphia, 1701 Locust Street #411,
Philadelphia, PA 19103.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section
552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters to be Discussed: The meeting
will include the review, discussion, and
evaluation of ‘‘Mining Occupational
Safety and Health Research (R01), RFA
OH08–003.’’
Contact Person for More Information:
Charles N. Rafferty, PhD, Assistant
Director for Review and Policy Office of
Extramural Programs, CDC, 1600 Clifton
Road, NE., Mailstop E74, Atlanta, GA
30333, Telephone: (404) 498–2530.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: March 28, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–7033 Filed 4–3–08; 8:45 am]
BILLING CODE 4163–18–P
E:\FR\FM\04APN1.SGM
04APN1
]]>Agencies
[Federal Register Volume 73, Number 66 (Friday, April 4, 2008)]
[Notices]
[Pages 18535-18536]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6969]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); NTP Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM); Non-Animal
Methods and Approach for Evaluating Eye Irritation Potential for
Antimicrobial Cleaning Products (AMCPs): Request for Nominations for an
Independent Expert Panel and Submission of Relevant Data
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Request nominations for an independent expert panel and
submission of relevant data.
-----------------------------------------------------------------------
SUMMARY: At the request of the U.S. Environmental Protection Agency
(EPA), the Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) is planning to assess the validation
status of a proposed non-animal approach for evaluating the eye
irritation potential of AMCPs that meets hazard classification and
labeling requirements. On behalf of ICCVAM, NICEATM requests:
1. Nominations of expert scientists to serve as members of an
independent peer review panel.
2. Submission of relevant data and information on AMCPs or related
substances obtained from (1) human testing or experience including
reports from accidental exposures, (2) rabbits using the standard eye
test or the low volume eye test (LVET), and (3) in vitro test methods
for assessing ocular irritation, such as the Bovine Corneal Opacity and
Permeability (BCOP) test, the Cytosensor Microphysiometer (CM) test,
and the EpiOcular test, and data supporting the accuracy and
reproducibility of these methods.
DATES: Submit nominations and data by May 19, 2008. Data submitted
after this date will be considered in the evaluation, if feasible.
ADDRESSES: Submit nominations and data to Dr. William S. Stokes,
NICEATM Director, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle
Park, NC, 27709, (fax) 919-541-0947 (e-mail) niceatm@niehs.nih.gov.
Courier address: NICEATM, 79 T.W. Alexander Drive, Building 4401, Room
3128, Research Triangle Park, NC, 27709. Responses can also be
submitted electronically via the ICCVAM-NICEATM Web site (https://
iccvam.niehs.nih.gov/contact/FR_pubcomment.htm).
FOR FURTHER INFORMATION CONTACT: Other correspondence should be
directed to Dr. William S. Stokes (919-541-2384 or
niceatm@niehs.nih.gov).
SUPPLEMENTARY INFORMATION:
Background
In June 2004, the EPA Office of Pesticide Programs informed NICEATM
that they were developing, via a subgroup of the Pesticide Program
Dialogue Committee, a non-animal assessment approach for evaluating eye
irritation potential and labeling requirements for AMCPs. Subsequently,
the EPA in collaboration with the Alternative Testing Working Group
(ATWG) developed a non-animal approach for this limited group of
products. The ATWG is comprised of seven consumer product companies
(Clorox, Colgate Palmolive, Dial, EcoLabs, Johnson Diversey, Procter &
Gamble, and SC Johnson). The Institute for In Vitro Sciences, Inc.
(IIVS), which coordinated the EPA-ATWG collaboration, performed
additional testing to complete parallel sets of in vivo and in vitro
data, and prepared a background review document (BRD) describing the
final approach. More information concerning this submission is
available at: https://iccvam.niehs.nih.gov/methods/ocutox/AMCP.htm.
In January 2008, IIVS submitted the BRD, An In Vitro Approach for
EPA Toxicity Labeling of Anti-Microbial Cleaning Products, to NICEATM.
The EPA and the ATWG requested that NICEATM and ICCVAM use information
within the BRD to conduct a technical review of the proposed approach
to determine whether ICCVAM could assure the EPA, with a reasonable
degree of certainty, that the approach would be useful for making
labeling decisions for AMCPs that appropriately inform the user.
NICEATM and ICCVAM are now conducting a preliminary evaluation of
the submission to determine its completeness and adherence to ICCVAM
guidelines, which are available at https://iccvam.niehs.nih.gov/
SuppDocs/SubGuidelines/SD_subg034508.pdf. If they decide to move
forward with an evaluation, NICEATM and ICCVAM will convene an
independent peer review panel to review the validation status of the
proposed approach.
Request for Nominations of Scientific Experts
NICEATM requests nominations of scientists with relevant knowledge
and experience to serve on the peer review panel should it be convened.
Areas of relevant expertise include, but are not limited to:
Biostatistics
Human and veterinary ophthalmology, with an emphasis on
evaluation and treatment of chemical injuries
In vivo ocular toxicity testing
In vitro ocular toxicology
Test method validation
Each nomination should include the nominee's name, affiliation,
contact information (i.e., mailing address, e-mail address, telephone
and fax numbers), curriculum vitae, and a brief summary of relevant
experience and qualifications. Nominations previously submitted to
NICEATM in response to an earlier request for scientific experts for a
possible peer panel review of in vitro ocular test methods used to
evaluate AMCPs (Federal Register Vol. 70, No. 53, pp. 13512-13513,
available at https://iccvam.niehs.nih.gov) do not need to be
resubmitted.
Request for Data
NICEATM invites the submission of relevant data and information on
AMCPs or related substances obtained from (1) human testing or
experience including reports from accidental exposures, (2) rabbits
using the standard eye test or the low volume eye test (LVET), and (3)
in vitro test methods for assessing ocular irritation, such as the
Bovine Corneal Opacity and Permeability (BCOP) test, the Cytosensor
Microphysiometer (CM) test, and the EpiOcular test, including data
supporting the accuracy and reproducibility of these methods.
Although data can be accepted at any time, data received by May 19,
2008 will be considered during the ICCVAM
[[Page 18536]]
evaluation process. Relevant data received after this date will be
considered during the ICCVAM evaluation process, if feasible. All
information submitted in response to this notice will be made publicly
available and may be incorporated into future NICEATM and ICCVAM
reports and publications as appropriate.
When submitting data, please reference this Federal Register notice
and provide appropriate contact information (name, affiliation, mailing
address, phone, fax, e-mail, and sponsoring organization, as
applicable).
NICEATM prefers that data be submitted as copies of pages from
study notebooks and/or study reports, if available. Raw data and
analyses available in electronic format may also be submitted. Each
submission for a substance should preferably include the following
information, as appropriate:
Common and trade name
Chemical Abstracts Service Registry Number (CASRN)
Chemical and/or product class
Commercial source
In vivo or in vitro test protocol used
Individual animal or in vitro responses at each
observation time (i.e., raw data)
The extent to which the study complied with national/
international Good Laboratory Practice (GLP) guidelines
Date and testing organization
Physical and chemical properties (e.g. molecular weight,
pH, water solubility, etc.)
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 (42 U.S.C. 2851-3,
available at (https://iccvam.niehs.nih.gov/docs/about_docs/
PL106545.pdf) 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 is available on the following Web
site: https://iccvam.niehs.nih.gov.
Dated: March 24, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E8-6969 Filed 4-3-08; 8:45 am]
BILLING CODE 4140-01-P
