National Toxicology Program (NTP); National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health (NIH); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Second Request for Data on Chemicals Evaluated by In Vitro or In Vivo Ocular Irritancy Test Methods, 9661-9662 [05-3831]
Download as PDF
<![CDATA[
Federal Register / Vol. 70, No. 38 / Monday, February 28, 2005 / Notices
have been performed using a
commercial formulation (KenalogTM) as
a comparator with the invention. No
ocular toxicity was seen with TAC–PF.
The inventors have an IND in place and
have positive results in the treatment of
diabetic macular edema with a single
dose of TAC–PF. The targeted
indications for the present novel TAC
formulation include diabetic
retinopathy and macular edema, uveitis
and age-related macular degeneration.
Additionally, this formulation, which
benefits from an improved safety
profile, could possibly be used in other
indications where steroid injections are
used to control inflammation.
This formulation is available for
licensing and claims are directed to a
pharmaceutical composition free of
classical preservatives and comprising a
glucocorticoid or angiostatic steroid.
Claims are also directed to methods of
making and treating a variety of ocular
conditions and other inflammatory
conditions including pain by a variety
of routes of administration, including
intravitreally, intrathecally, etc.
In addition to licensing, this
technology is available for further
development through collaborative
research with the inventors.
Dated: February 17, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 05–3832 Filed 2–25–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Mental Health Special Emphasis Panel,
January 25, 2005, 1 p.m. to January 25,
2005, 4 p.m. National Institutes of
Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD,
20852 which was published in the
Federal Register on January 12, 2005, 70
FR 2178.
The meeting will be held on March 8,
2005, at the Neuroscience Center,
Rockville, MD, from 1 p.m. to 5 p.m. as
a telephone conference call. The
meeting is closed to the public.
VerDate jul<14>2003
16:34 Feb 25, 2005
Jkt 205001
Dated: February 22, 2005.
Laverne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–3881 Filed 2–28–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
National Institute of Environmental
Health Sciences (NIEHS); National
Institutes of Health (NIH); NTP
Interagency Center for the Evaluation
of Alternative Toxicological Methods
(NICEATM); Second Request for Data
on Chemicals Evaluated by In Vitro or
In Vivo Ocular Irritancy Test Methods
Summary
The Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM) and
NICEATM are collaborating with the
European Center for the Validation of
Alternative Methods (ECVAM) to
evaluate the validation status of in vitro
methods for assessing ocular irritation/
corrosion. Data was previously
requested (Federal Register, Vol. 69, No.
57, pp. 13859–13861, March 24, 2004,
available at https://iccvam.niehs.nih.
gov/) and used to prepare draft
Background Review Documents (BRD)
for four methods [(1) The Bovine
Corneal Opacity and Permeability
(BCOP) test; (2) the Isolated Rabbit Eye
(IRE) test or the Rabbit Enucleated Eye
Test (REET); (3) the Isolated Chicken
Eye (ICE) test or the Chicken Enucleated
Eye Test (CEET); and (4) the Hen’s Egg
Test—Chorion Allantoic Membrane
(HET–CAM)], and to compile a database
of in vivo data. ICCVAM and NICEATM
are now finalizing these BRDs and want
to ensure the inclusion of all available
data. NICEATM is therefore issuing this
second request for data generated using
standardized in vitro and in vivo test
methods used to identify severe,
moderate, mild, or non-irritating
substances. Test methods for identifying
severe (irreversible) ocular irritation/
corrosion for which data are sought
include, but are not limited to: (1) The
BCOP test; (2) the IRE test; (3) the ICE
test; and (4) the HET–CAM. In addition,
high quality data from standardized
ocular irritancy test methods using
rabbits (e.g., EPA 1998; UN 2003) and in
vivo data generated from procedures/
protocols that might alleviate or reduce
pain and suffering (e.g., topical and
systemic analgesic) in test animals are
requested. These data will be used to
evaluate the validation status of existing
in vitro test methods for ocular
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
9661
irritancy/corrosion and to develop a list
of substances with high quality in vivo
data that can be considered as reference
chemicals for future validation studies.
Data from other in vitro methods used
to assess reversible ocular irritation
effects or non-irritation are also
requested.
Submission of Chemical and Protocol
Information and Test Data
Data and other information submitted
in response to this notice should be sent
to NICEATM [Dr. William S. Stokes,
Director, NICEATM, NIEHS, 79 T. W.
Alexander Drive, P.O. Box 12233, MD
EC–17, Research Triangle Park, NC
27709, (phone) 919–541–2384, (fax)
919–541–0947, iccvam@niehs.nih.gov]
and received by March 30, 2005. Data
and other information received by this
date will be compiled and added to the
database maintained by NICEATM and
utilized where appropriate for the final
BRDs on the four methods listed above.
Data received after this date will also be
considered and used where applicable
for future evaluation activities. All
information submitted in response to
this notice will be made publicly
available upon request to NICEATM.
When submitting data or information
on protocols, 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 data to be
submitted as copies of pages from study
notebooks and/or study reports, if
available. Each submission for a
chemical 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 vitro test protocol used
• Rabbit eye test protocol used
• Human eye test protocol used
• Individual animal/human or in
vitro responses at each observation time
(i.e., raw data).
• The extent to which the study
complies with national/international
Good Laboratory Practice (GLP)
guidelines
• Date and testing organization
Those persons submitting data on
chemicals tested for ocular irritancy in
rabbits are referred to the ICCVAM/
NICEATM Web site (https://
iccvam.niehs.nih.gov/methods/
eyeirrit.htm) for an example of the type
of experimental animal study
information and data requested in this
notice.
E:\FR\FM\28FEN1.SGM
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9662
Federal Register / Vol. 70, No. 38 / Monday, February 28, 2005 / Notices
In Vitro Ocular Irritancy Chemical
Tests: BCOP, HET–CAM, ICE, and IRE
NICEATM is especially interested in
data from four in vitro test methods used
to identify severe (irreversible) ocular
irritation/corrosion: BCOP, HET–CAM,
ICE, and IRE. Because test methods for
identifying severe eye irritants/
corrosives are of high priority,
NICEATM especially requests data on
chemicals identified by these four
methods as severe irritants, although
data on mildly irritating and nonirritating substances are also welcome.
Other In Vitro Ocular Irritancy
Methods
NICEATM also requests the
submission of data and information for
standardized in vitro ocular irritancy
methods, other than the four identified
above, and methods that might be used
to identify non-irritating and mild to
moderate irritants. Detailed test method
protocols and other related information
for these potential test methods should
be submitted along with the data.
In Vivo Test Methods for Ocular
Irritancy
NICEATM requests the submission of
high quality in vivo data that might be
used to identify appropriate reference
chemicals for future validation studies
of in vitro ocular irritancy test methods.
Data are sought from studies conducted
to comply with federal or other
national/international testing
requirements, but may not be publicly
available because: (1) The data were
submitted to regulatory authorities, but
are proprietary and cannot be released
to the public by regulatory authorities,
or (2) there is no requirement to submit
the data to regulatory authorities. In
addition to data from studies in animals,
NICEATM also welcomes the
submission of data from human studies
including any human post-marketing or
occupational exposure/surveillance data
that might be available.
Procedures for Reducing or Eliminating
Pain and Suffering during In Vivo
Ocular Irritancy Testing
NICEATM requests the submission of
information and data from in vivo
methods, procedures, and/or strategies
that may reduce or eliminate the pain
and suffering associated with current in
vivo eye irritation methods, such as
those using topical or systemic
analgesics.
Background Information
In August 2003, the Scientific
Advisory Committee on Alternative
Toxicological Methods (SACATM)
unanimously recommended that
VerDate jul<14>2003
18:21 Feb 25, 2005
Jkt 205001
NICEATM focus efforts on test methods
for ocular irritancy and possibly hold a
workshop and/or develop a background
document on available methods. In
October 2003, the U.S. Environmental
Protection Agency nominated the
following activities to ICCVAM: (1)
Evaluate the validation status of the four
in vitro ocular toxicity test methods
(BCOP, IRE, ICE, and HET–CAM), (2)
identify and develop in vivo ocular
toxicity reference data to support the
validation of in vitro test methods, (3)
explore ways of alleviating pain and
suffering from current in vivo ocular
toxicity testing, and (4) review the state
of the science and the availability of in
vitro test methods for assessing mild or
moderate ocular irritants. ICCVAM
endorsed the review of these methods as
a high priority and recommended that
NICEATM develop Background Review
Documents for BCOP, IRE, ICE, and
HET–CAM. NICEATM convened an
independent expert panel on January
11–12, 2005, to review the validation
status of these four methods and
develop conclusions and
recommendations on standardized
protocols and reference chemicals for
future testing and validation studies.
Availability of the expert panel’s report
will be announced in a future Federal
Register notice.
Background Information on ICCVAM
and NICEATM
ICCVAM is an interagency committee
composed of representatives from
fifteen 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 (P.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 and provides scientific
support for the ICCVAM. 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.
References
EPA 1998. Health Effects Test
Guidelines, OPPTS 870.2400, Acute Eye
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Irritation, EPA 712–C–98–195.
Available: https://www.epa.gov/opptsfrs/
OPPTS_Harmonized/
870_Health_Effects_Test_Guidelines/
Series/870-2400.pdf.
UN 2003. Globally Harmonized
System of Classification and Labelling
of Chemicals (GHS). [ST/SG/AC.10/30].
United Nations, New York and Geneva.
Available: https://www.unece.org/trans/
danger/publi/ghs/officialtext.html.
Dated: February 17, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences.
[FR Doc. 05–3831 Filed 2–25–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Center for Substance Abuse
Prevention; Notice of Meeting
Pursuant to Pub. L. 92–463, notice is
hereby given of the meeting of the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
Drug Testing Advisory Board to be held
in March 2005.
The Drug Testing Advisory Board
meeting will be open and will include
a Department of Health and Human
Services drug testing program update, a
Department of Transportation drug
testing program update, and a Nuclear
Regulatory Commission drug testing
program update. Attendance by the
public will be limited to space available.
Public comments are welcome. Please
communicate with the individual listed
as contact below to make arrangements
to comment or to arrange special
accommodations for persons with
disabilities.
The Board will also meet to develop
the analytical and administrative
policies for the final Revisions to the
Mandatory Guidelines for Federal
Workplace Drug Testing Program that
were published as proposed revisions in
the Federal Register on April 13, 2004
(69 FR 19673). The submissions from
285 commentors have been made
available to the public on the Web site
https://workplace.samhsa.gov. This
meeting will be conducted in closed
session since discussing such public
comments in open session and then
developing the policies will
significantly frustrate the Department’s
ability to develop the Final Notice of
Revisions to the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs. The HHS Office of General
E:\FR\FM\28FEN1.SGM
28FEN1
]]>Agencies
[Federal Register Volume 70, Number 38 (Monday, February 28, 2005)]
[Notices]
[Pages 9661-9662]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3831]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); National Institute of
Environmental Health Sciences (NIEHS); National Institutes of Health
(NIH); NTP Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM); Second Request for Data on Chemicals
Evaluated by In Vitro or In Vivo Ocular Irritancy Test Methods
Summary
The Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) and NICEATM are collaborating with the
European Center for the Validation of Alternative Methods (ECVAM) to
evaluate the validation status of in vitro methods for assessing ocular
irritation/corrosion. Data was previously requested (Federal Register,
Vol. 69, No. 57, pp. 13859-13861, March 24, 2004, available at https://
iccvam.niehs.nih. gov/) and used to prepare draft Background Review
Documents (BRD) for four methods [(1) The Bovine Corneal Opacity and
Permeability (BCOP) test; (2) the Isolated Rabbit Eye (IRE) test or the
Rabbit Enucleated Eye Test (REET); (3) the Isolated Chicken Eye (ICE)
test or the Chicken Enucleated Eye Test (CEET); and (4) the Hen's Egg
Test--Chorion Allantoic Membrane (HET-CAM)], and to compile a database
of in vivo data. ICCVAM and NICEATM are now finalizing these BRDs and
want to ensure the inclusion of all available data. NICEATM is
therefore issuing this second request for data generated using
standardized in vitro and in vivo test methods used to identify severe,
moderate, mild, or non-irritating substances. Test methods for
identifying severe (irreversible) ocular irritation/corrosion for which
data are sought include, but are not limited to: (1) The BCOP test; (2)
the IRE test; (3) the ICE test; and (4) the HET-CAM. In addition, high
quality data from standardized ocular irritancy test methods using
rabbits (e.g., EPA 1998; UN 2003) and in vivo data generated from
procedures/protocols that might alleviate or reduce pain and suffering
(e.g., topical and systemic analgesic) in test animals are requested.
These data will be used to evaluate the validation status of existing
in vitro test methods for ocular irritancy/corrosion and to develop a
list of substances with high quality in vivo data that can be
considered as reference chemicals for future validation studies. Data
from other in vitro methods used to assess reversible ocular irritation
effects or non-irritation are also requested.
Submission of Chemical and Protocol Information and Test Data
Data and other information submitted in response to this notice
should be sent to NICEATM [Dr. William S. Stokes, Director, NICEATM,
NIEHS, 79 T. W. Alexander Drive, P.O. Box 12233, MD EC-17, Research
Triangle Park, NC 27709, (phone) 919-541-2384, (fax) 919-541-0947,
iccvam@niehs.nih.gov] and received by March 30, 2005. Data and other
information received by this date will be compiled and added to the
database maintained by NICEATM and utilized where appropriate for the
final BRDs on the four methods listed above. Data received after this
date will also be considered and used where applicable for future
evaluation activities. All information submitted in response to this
notice will be made publicly available upon request to NICEATM.
When submitting data or information on protocols, 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 data to be
submitted as copies of pages from study notebooks and/or study reports,
if available. Each submission for a chemical 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 vitro test protocol used
Rabbit eye test protocol used
Human eye test protocol used
Individual animal/human or in vitro responses at each
observation time (i.e., raw data).
The extent to which the study complies with national/
international Good Laboratory Practice (GLP) guidelines
Date and testing organization
Those persons submitting data on chemicals tested for ocular
irritancy in rabbits are referred to the ICCVAM/NICEATM Web site
(https://iccvam.niehs.nih.gov/methods/eyeirrit.htm) for an example of
the type of experimental animal study information and data requested in
this notice.
[[Page 9662]]
In Vitro Ocular Irritancy Chemical Tests: BCOP, HET-CAM, ICE, and IRE
NICEATM is especially interested in data from four in vitro test
methods used to identify severe (irreversible) ocular irritation/
corrosion: BCOP, HET-CAM, ICE, and IRE. Because test methods for
identifying severe eye irritants/corrosives are of high priority,
NICEATM especially requests data on chemicals identified by these four
methods as severe irritants, although data on mildly irritating and
non-irritating substances are also welcome.
Other In Vitro Ocular Irritancy Methods
NICEATM also requests the submission of data and information for
standardized in vitro ocular irritancy methods, other than the four
identified above, and methods that might be used to identify non-
irritating and mild to moderate irritants. Detailed test method
protocols and other related information for these potential test
methods should be submitted along with the data.
In Vivo Test Methods for Ocular Irritancy
NICEATM requests the submission of high quality in vivo data that
might be used to identify appropriate reference chemicals for future
validation studies of in vitro ocular irritancy test methods. Data are
sought from studies conducted to comply with federal or other national/
international testing requirements, but may not be publicly available
because: (1) The data were submitted to regulatory authorities, but are
proprietary and cannot be released to the public by regulatory
authorities, or (2) there is no requirement to submit the data to
regulatory authorities. In addition to data from studies in animals,
NICEATM also welcomes the submission of data from human studies
including any human post-marketing or occupational exposure/
surveillance data that might be available.
Procedures for Reducing or Eliminating Pain and Suffering during In
Vivo Ocular Irritancy Testing
NICEATM requests the submission of information and data from in
vivo methods, procedures, and/or strategies that may reduce or
eliminate the pain and suffering associated with current in vivo eye
irritation methods, such as those using topical or systemic analgesics.
Background Information
In August 2003, the Scientific Advisory Committee on Alternative
Toxicological Methods (SACATM) unanimously recommended that NICEATM
focus efforts on test methods for ocular irritancy and possibly hold a
workshop and/or develop a background document on available methods. In
October 2003, the U.S. Environmental Protection Agency nominated the
following activities to ICCVAM: (1) Evaluate the validation status of
the four in vitro ocular toxicity test methods (BCOP, IRE, ICE, and
HET-CAM), (2) identify and develop in vivo ocular toxicity reference
data to support the validation of in vitro test methods, (3) explore
ways of alleviating pain and suffering from current in vivo ocular
toxicity testing, and (4) review the state of the science and the
availability of in vitro test methods for assessing mild or moderate
ocular irritants. ICCVAM endorsed the review of these methods as a high
priority and recommended that NICEATM develop Background Review
Documents for BCOP, IRE, ICE, and HET-CAM. NICEATM convened an
independent expert panel on January 11-12, 2005, to review the
validation status of these four methods and develop conclusions and
recommendations on standardized protocols and reference chemicals for
future testing and validation studies. Availability of the expert
panel's report will be announced in a future Federal Register notice.
Background Information on ICCVAM and NICEATM
ICCVAM is an interagency committee composed of representatives from
fifteen 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 (P.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 and provides scientific support
for the ICCVAM. 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.
References
EPA 1998. Health Effects Test Guidelines, OPPTS 870.2400, Acute Eye
Irritation, EPA 712-C-98-195. Available: https://www.epa.gov/opptsfrs/
OPPTS_Harmonized/870_Health_Effects_Test_Guidelines/Series/870-
2400.pdf.
UN 2003. Globally Harmonized System of Classification and Labelling
of Chemicals (GHS). [ST/SG/AC.10/30]. United Nations, New York and
Geneva. Available: https://www.unece.org/trans/danger/publi/ghs/
officialtext.html.
Dated: February 17, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-3831 Filed 2-25-05; 8:45 am]
BILLING CODE 4140-01-P
