Animal Drug User Fee Act; Public Meeting; Cancellation, 8860-8861 [06-1571]
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Federal Register / Vol. 71, No. 34 / Tuesday, February 21, 2006 / Notices
the halogenated gases (chloroform,
trichloroethylene, halothane,
methoxyflurane, fluroxene, and
enflurane) was established in 1977
[NIOSH 1977]. The halogenated
anesthetic agents, isoflurane, desflurane,
and sevoflurane, were subsequently
introduced and are not included in the
1977 NIOSH recommendation.
Isoflurane, desflurane, and sevoflurane
are commonly used for anesthesia in
modern hospitals; however, no
occupational exposure limits exist for
these agents. NIOSH is requesting: (1)
Comments and information relevant to
the evaluation of health risks associated
with occupational exposure to
isoflurane, desflurane, and sevoflurane,
(2) reports or other data that
demonstrate adverse health effects in
workers exposed to isoflurane,
desflurane, and sevoflurane, and (3)
information pertinent to establishing a
REL for isoflurane, desflurane, and
sevoflurane.
Comments should be
transmitted to the NIOSH Docket Office,
M/S C–34, Robert A. Taft Laboratories,
4676 Columbia Parkway, Cincinnati,
Ohio 45226, telephone 513/533–8303,
fax: 513/533–8285.
Comments may also be submitted
directly through the Web site (https://
www.cdc.gov/niosh/review/public/
Waste-Anesthetic-Gases/), by e-mail to
nioshdocket@cdc.gov, or by fax to 513/
533–8285. E-mail attachments should be
formatted as Microsoft Word. Comments
concerning this notice must be received
on or before April 18, 2006 and should
reference docket number NIOSH–064.
All information received in response
to this notice will be available for public
examination and copying at the NIOSH
Docket Office, Room 111, 4676
Columbia Parkway, Cincinnati, Ohio
45226.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Henryka Nagy, Ph.D., M/S C–32, Robert
A. Taft Laboratories, 4676 Columbia
Parkway, Cincinnati, Ohio 45226,
telephone 513/533–8369, e-mail
HUB1@cdc.gov.
During
patient anesthetization, small amounts
of anesthetic gases can escape from the
anesthetic delivery system and the
patient’s respiratory system. Waste
anesthetic gases may become a source of
harmful exposures for operating room
personnel.
Anesthesiologists, veterinarians,
dentists, anesthetic nurses, operating
room nurses, surgeons, operating room
technicians, and other operating room
personnel are at risk of exposure to
waste anesthetic gases. A concern about
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harm to the reproductive system, central
nervous system, liver, and kidneys
prompted NIOSH to develop RELs for
waste anesthetic gases [NIOSH 1977]. In
1977, the current NIOSH REL of 2 parts
per million (ppm) as a 60-minute ceiling
was established for the halogenated
gases chloroform, trichloroethylene,
halothane, methoxyflurane, fluroxene,
and enflurane [NIOSH 1977]. Isoflurane,
desflurane, and sevoflurane were
subsequently introduced and are not
included in the 1977 NIOSH
recommendation.
NIOSH has not yet developed RELs
for isoflurane, desflurane, and
sevoflurane. Furthermore, the
Occupational Safety and Health
Administration (OSHA) has no
permissible exposure limits (PELs) for
these agents. The Netherlands’ 1998
Dutch Expert Committee on
Occupational Standards (DECOS)
derived an occupational exposure limit
of 20 ppm for enflurane on the basis of
reproductive toxicologic data [DECOS
1998]. For isoflurane (an isomer of
enflurane), DECOS also recommended
an occupational exposure limit of 20
ppm on the basis of assumed structurerelated activity [DECOS 1998]. No
epidemiologic studies are available on
the health effects of the halogenated
agents, isoflurane, desflurane, and
sevoflurane.
NIOSH seeks to obtain materials,
including published and unpublished
reports and research findings, to
evaluate the possible health risks of
occupational exposure to these gases.
Examples of requested information
include, but are not limited to, the
following: (1) Identification of
industries or occupations in which
exposures to isoflurane, desflurane, or
sevoflurane may occur; (2) trends in
production and use of isoflurane,
desflurane, or sevoflurane over the past
10 years; (3) descriptions of procedures
with a potential for exposure to
isoflurane, desflurane, or sevoflurane;
(4) current occupational exposure
concentrations of isoflurane, desflurane,
or sevoflurane in various types of
occupational scenarios and, if available,
data to document these concentrations
(5) case reports or other health data that
demonstrate adverse health effects in
workers exposed to isoflurane,
desflurane, or sevoflurane, or animal
data (published or peer-reviewed data
are preferred); (6) descriptions of work
practices and engineering controls used
to reduce or prevent workplace
exposure; (7) educational materials for
worker safety or training on the safe
handling of these halogenated agents;
(8) data pertaining to the technical
feasibility of establishing a more
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protective REL for isoflurane,
desflurane, and sevoflurane.
NIOSH will use this information to
determine the need for developing
recommendations for reducing
occupational exposure to isoflurane,
desflurane, and sevoflurane.
References: DECOS [1998]. Enflurane,
isoflurane and cyclopropane: healthbased recommended occupational
exposure limits. Report of the Dutch
Expert Committee on Occupational
Standards, a committee of the Health
Council of the Netherlands.
NIOSH [1977]. Criteria for a
recommended standard * * *
occupational exposure to waste
anesthetic gases and vapors. Cincinnati,
OH: U.S. Department of Health,
Education, and Welfare, Public Health
Service, Center for Disease Control,
National Institute for Occupational
Safety and Health, DHEW (NIOSH)
Publication No. 77–140.
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: February 14, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 06–1542 Filed 2–17–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0488]
Animal Drug User Fee Act; Public
Meeting; Cancellation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is canceling the
meeting on the Animal Drug User Fee
Act scheduled for February 24, 2006.
This meeting was announced in the
Federal Register of December 28, 2005
(70 FR 76851). FDA will continue to
seek public comments relative to the
program’s overall performance and
reauthorization as directed by Congress.
FDA will publish another notice in the
Federal Register announcing any plans
for rescheduling the public meeting.
DATES: Written comments may be
submitted at any time.
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Federal Register / Vol. 71, No. 34 / Tuesday, February 21, 2006 / Notices
You may submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments tohttps://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments.
FOR FURTHER INFORMATION CONTACT:
Aleta Sindelar, Center for Veterinary
Medicine (HFV–3), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9004,
FAX: 240–276–9020, e-mail:
aleta.sindela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: If you
would like to submit written comments
to the docket regarding the Animal Drug
User Fee Act, please send your
comments to the Division of Dockets
Management (see ADDRESSES). Submit a
single copy of electronic comments or
two paper copies of any written
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
reviewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
ADDRESSES:
Dated: February 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–1571 Filed 2–15–06; 2:42 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Methodology for Large Scale
Manufacture of Stable DisulfideConjugated Antibody-Ribonuclease
David F. Nellis, Dianne L. Newton,
Susanna M. Rybak (NCI)
U.S. Provisional Application filed 30
Sep 2005 (HHS Reference No. E–218–
2005/0–US–01)
Licensing Contact: David A.
Lambertson; 301/435–4632;
lambertsond@mail.nih.gov
Large scale clinical production of
disulfide-conjugated antibody-RNase
therapeutics using previously reported
technologies usually results in an
unstable product that forms undesired
multimeric antibody/RNase species.
This invention describes improved
methods for the large scale manufacture
of stable disulfide-conjugated antibody
therapeutics. Antibody-RNase
conjugates produced by this method
were specific and highly active in vitro
in killing selected carcinoma, and also
showed in vivo activity in the treatment
of disseminated B-cell lymphoma.
These methods are broadly applicable to
disulfide-linked conjugation of
cytotoxic proteins. The claims for this
invention encompass methods for
preparing a protein for disulfide
conjugation with another molecule,
such as an RNase to an antibody.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
AGENCY:
Identification of Biomarkers by Serum
Protein Profiling
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Thomas Ried and Jens Habermann (NCI)
U.S. Provisional Application No. 60/
664,681 filed 22 Mar 2005 (HHS
Reference No. E–106–2005/0-US–01)
Licensing Contact: Thomas P. Clouse;
301/435–4076; clouset@mail.nih.gov
This invention describes serum
features that distinguish colorectal
carcinoma malignant patient samples
versus healthy samples using surfaceenhanced laser desorption ionization
time-of-flight (SELDI-TOF) mass
spectrometry. By comparing healthy
versus malignant samples, the
investigators were able to identify
thirteen (13) serum features that have
been validated using an independently
collected, blinded validation set of 55
sera samples. The features are
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National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
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8861
characterized by the mass to charge ratio
(m/z ratio). The investigators have
shown that SELDI-TOF based serum
marker protein profiling enables
minimally invasive detection of colon
cancer with 96.7 percent sensitivity and
100 percent specificity.
Colorectal cancer is the third most
common cancer and the third leading
cause of cancer-related mortality in the
United States. Current diagnostic
methods for colorectal cancer have a
large non-compliance rate because of
discomfort, e.g., sigmoidoscopy or
colonoscopy, or have a high rate of false
positive results, e.g., fecal occult blood
tests. The claimed invention has the
potential to be a widely used, easy-touse, and inexpensive diagnostic.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Novel Form of Interleukin–15, Fc–IL–
15, and Methods of Use
Morihiro Watanabe et al. (NCI)
U.S. Provisional Application No. 60/
670,862 filed 12 Apr 2005 (HHS
Reference No. E–296–2004/0–US–01)
Licensing Contact: Thomas P. Clouse,
J.D.; 301/435–4076;
clouset@mail.nih.gov
Interleukin–15 (IL–15) is a potent
cytokine that enhances host immune
system function by proliferating and
activating leukocytes. IL–15 increases
innate immunity and CD8 memory. The
investigators fused IL–15 with protein
Fc, a fragment of immunoglobulin. The
new fused moiety, Fc–IL–15, has a
longer half life in vivo than naturally
occurring IL–15 in a gene therapy
setting and has more potent anti-tumor
effects than IL–15 in some mouse tumor
models. The new moiety can serve as an
alternative to IL–15, particularly if long
term delivery is essential for a therapy.
The moiety can serve as a therapeutic
for both tumors and viral infections. The
moiety can include peptide linkers such
as, for example, a T cell inert sequence
or a non-immunogenic sequence.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
ELISA Assay of Serum Soluble CD22 To
Assess Tumor Burden/Relapse in
Subjects with Leukemia and
Lymphoma
Robert J. Kreitman et al. (NCI)
U.S. Patent Application No. 10/514,910
filed 16 Nov 2004 (HHS Reference No.
E–065–2002/0–US–03), with priority
to 20 May 2002
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]]>Agencies
[Federal Register Volume 71, Number 34 (Tuesday, February 21, 2006)]
[Notices]
[Pages 8860-8861]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1571]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0488]
Animal Drug User Fee Act; Public Meeting; Cancellation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is canceling the
meeting on the Animal Drug User Fee Act scheduled for February 24,
2006. This meeting was announced in the Federal Register of December
28, 2005 (70 FR 76851). FDA will continue to seek public comments
relative to the program's overall performance and reauthorization as
directed by Congress. FDA will publish another notice in the Federal
Register announcing any plans for rescheduling the public meeting.
DATES: Written comments may be submitted at any time.
[[Page 8861]]
ADDRESSES: You may submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments tohttps://
www.fda.gov/dockets/ecomments. Follow the instructions for submitting
comments.
FOR FURTHER INFORMATION CONTACT: Aleta Sindelar, Center for Veterinary
Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9004, FAX: 240-276-9020, e-mail:
aleta.sindela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: If you would like to submit written comments
to the docket regarding the Animal Drug User Fee Act, please send your
comments to the Division of Dockets Management (see ADDRESSES). Submit
a single copy of electronic comments or two paper copies of any written
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. Received comments may be reviewed in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-1571 Filed 2-15-06; 2:42 pm]
BILLING CODE 4160-01-S
