National Institute of Mental Health; Amended Notice of Meeting, 9661 [05-3881]
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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
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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.
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[Federal Register Volume 70, Number 38 (Monday, February 28, 2005)]
[Notices]
[Page 9661]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3881]
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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.
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
