Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Notice of Charter Renewal, 63839-63840 [2010-26114]
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Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices
relating to the safety of regulated
medical devices and radiation-emitting
products. FDA must conduct needed
research to ensure that such programs
have the highest likelihood of being
effective. Improving communications
about medical devices and radiationemitting products will involve many
research methods, including individual
indepth interviews, mall-intercept
interviews, focus groups, selfadministered surveys, gatekeeper
reviews, and omnibus telephone
surveys.
The information collected will serve
three major purposes. First, as formative
research it will provide critical
knowledge needed about target
audiences to develop messages and
campaigns about medical device and
radiation-emitting product use.
Knowledge of consumer and health care
professional decisionmaking processes
will provide the better understanding of
target audiences that FDA needs to
design effective communication
strategies, messages, and labels. These
communications will aim to improve
public understanding of the risks and
benefits of using medical devices and
radiation-emitting products by
providing users with a better context in
which to place risk information more
completely.
Second, as initial testing, it will allow
FDA to assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
their intended audiences. Testing
messages with a sample of the target
audience will allow FDA to refine
messages while still in the
developmental stage. Respondents will
be asked to give their reaction to the
messages in either individual or group
settings.
Third, as evaluative research, it will
allow FDA to ascertain the effectiveness
of the messages and the distribution
method of these messages in achieving
the objectives of the message campaign.
Evaluation of campaigns is a vital link
in continuous improvement of
communications at FDA.
Annually, FDA projects about 30
studies using a variety of research
methods and lasting an average of 0.17
hours each (varying from 0.08–1.5
hours). The operating and maintenance
costs include contractor expenses for
designing and conducting information
collection activities, specifically,
drawing samples, training interviewers,
collecting and analyzing information,
and reporting and disseminating
findings. FDA estimates the burden of
this collection of information based on
prior recent experience with the various
types of data collection methods
described earlier. FDA is requesting this
burden so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
In the Federal Register of July 13,
2010 (75 FR 39952), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment, however it was not related to
the collection of information.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of respondents
Annual frequency per response
Individual indepth interviews ..............................................
General public focus group interviews ..............................
Intercept interviews: Central location .................................
Intercept interviews: Telephone .........................................
Self-administered surveys ..................................................
Gatekeeper reviews ...........................................................
Omnibus surveys ...............................................................
360
144
600
10,000 2
2,400
400
2,400
1
1
1
1
1
1
1
360
144
600
10,000
2,400
400
2,400
.75
1.5
.25
.08
.25
.50
.17
Total (general public) ..................................................
Physician focus group interviews ......................................
16,304
144
1
16,304
144
1.5
Total (physician) .........................................................
144
........................
144
..........................
216
Total (overall) .......................................................
16,448
........................
16,448
..........................
2,860
Anticipated data collection methods
Total annual
responses
Hours per response
Total hours
270
216
150
800
600
200
408
2,644
216
1 There
2 Brief
are no capital costs or operating and maintenance costs associated with this collection of information.
interviews with callers to test message concepts and strategies following their call-in request to an FDA Center 1–800 number.
Dated: October 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–26119 Filed 10–15–10; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
BILLING CODE 4160–01–P
mstockstill on DSKH9S0YB1PROD with NOTICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel: Notice of Charter
Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel, Centers
for Disease Control and Prevention,
Department of Health and Human
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Services, has been renewed for a 2-year
period through September 18, 2012.
For information, contact Gladys G.
Lewellen, M.B.A, M.P.A., Designated
Federal Officer, Disease, Disability, and
Injury Prevention and Control Special
Emphasis Panel, Centers for Disease
Control and Prevention, Department of
Health and Human Services, 1600
Clifton Road, NE., Mailstop E11,
Atlanta, Georgia 30333, telephone (404)
498–1519 or fax (404) 498–1541.
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
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63840
Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: October 8, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–26114 Filed 10–15–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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
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.
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
Prevention and Treatment of Herpes
Virus Infection by Inhibition of the
JMJD2 Family of Histone Demethylases
Description of Invention: Investigators
at the NIH have discovered a potential
means for preventing or treating a
herpes virus infection by inhibiting the
activity of the host cell’s histone
demethylases. When herpesviruses
enter a cell, they are inactivated by
cellular defense mechanisms that wrap
the viral genome in repressive
chromatin structures. In order for viral
replication to progress, the host’s own
histone demethylases are recruited to
the viral genome to reverse this
repression. In a preceding invention, the
laboratory disclosed that viral
replication and reactivation can be
significantly reduced through inhibition
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of the histone demethylase LSD1 using
Mono-Amino Oxidase Inhibitors
(MAOIs); drugs that are in clinical use.
The current invention further discloses
that inhibition of a second set of histone
demethylases (JMJD2 family) using a
specific JMJD2 inhibitor,
dimethyloxaloylglycine (DMOG), also
results in significant repression of
herpes viral replication.
Either alone or in combination, small
molecule inhibition of LSD1 and the
JMJD2 family present novel approaches
for preventing herpes virus infection
and halting viral reactivation that can
lead to a disease that ranges from mild
core sores to herpesvirus keratitis and
life-threatening encephalitis.
Additionally, chromatin-mediated
repression of viral genomes and the
requirement to de-repress these
genomes for productive infection
appears to be general to herpesviruses.
Therefore, this treatment could also be
applicable to chicken pox, shingles,
CMV disease, mononucleosis, and
Kaposi’s sarcoma.
Applications: Prevention or treatment
of infection by herpes simplex virus and
other diseases caused by herpesviruses
(i.e. Epstein-Barr virus,
cytomegalovirus, varicella zoster, and
Kaposi’s sarcoma-associated
herpesvirus).
Advantage: Inhibition of histone
demethylases provides an alternative
pathway for repressing herpes virus
infection as compared to purine analog
antivirals. While purine analogs are the
most widely prescribed treatment for
herpes infection, drug resistance is
prevalent. Additionally, inhibition of
histone demethylases results in no
expression of viral gene products; in
contrast to DNA replication inhibitors.
Development Status:
• Early-stage development
• Pre-clinical data available for mice
• Further pre-clinical and clinical
development is needed
Market:
• Genital herpes can result from
infection with either HSV type 2 or type
1, mainly by HSV type 2 in the U.S.,
which typically causes more recurrent
and severe manifestations of the disease.
• According to the Centers for Disease
Control and Prevention, nationwide,
16.2%, or about one out of six, people
14 to 49 years of age have genital HSV–
2 infection.
• HSV keratitis is the most frequent
cause of corneal blindness in the United
States.
Inventors: Thomas Kristie et al.
(NIAID)
Publications: None related to this
invention available at this time.
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Patent Status: U.S. Provisional
Application No. 61/366,563 filed 22 Jul
2010 (HHS Reference No. E–184–2010/
0–US–01).
Related Technologies: ‘‘Use of MonoAmine Oxidase Inhibitors to Prevent
Herpes Virus Infections and
Reactivation from Latency’’—HHS
Reference No. E–275–2008/2–PCT–02.
Licensing Status: Available for
licensing.
Licensing Contacts:
• Eric W. Odom, PhD; 301–435–5009;
odome@mail.nih.gov.
• Susan O. Ano, PhD; 301–435–5515;
anos@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID Laboratory of Viral Diseases
is seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
prevention and treatment of viral
diseases. Please contact Thomas Kristie,
PhD at 301.496.3854 or
tkristie@niaid.nih.gov for more
information.
Treatment of Inflammatory Bowel
Disease (IBD) Using IL–13 Modulators
and Inhibitors
Description of Invention: Ulcerative
colitis (UC), a chronic inflammatory
disease of the colorectum, affects
approximately 400,000 people in the
United States. The cause of UC is not
known, although an abnormal
immunological response to bacterial
antigens in the gut microflora is thought
to be involved. Available for licensing
are broad claims covering (1) treatments
preventing the inflammatory response of
colitis by modulating IL–13 and Natural
Killer T cell (NKT) activity and (2)
methods for screening for therapeutic
compounds effective for colitis. NIH
scientists and their collaborators have
used a mouse model of experimental
colitis (oxazolone colitis, OC) to show
that IL–13, a Th2 cytokine, is a
significant pathologic factor in OC and
that neutralizing IL–13 in these animals
effectively prevents colitis.
Inflammation in this mouse model has
also been shown to be effectively
blocked by neutralizing IL–13 or by
inhibiting the activation of NK–T cells
through CD1.
Oxazolone colitis (OC) is a colitis
induced by intrarectal administration of
a relatively low dose of the haptenating
agent oxazolone subsequent to skin
sensitization with oxazolone. A highly
reproducible and chronic colonic
inflammation is obtained that is
histologically similar to human
ulcerative colitis. Studies show that
NKT cells, rather than conventional
CD4+T cells, mediate oxazolone colitis,
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[Federal Register Volume 75, Number 200 (Monday, October 18, 2010)]
[Notices]
[Pages 63839-63840]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26114]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel: Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act (Pub. L.
92-463) of October 6, 1972, that Disease, Disability, and Injury
Prevention and Control Special Emphasis Panel, Centers for Disease
Control and Prevention, Department of Health and Human Services, has
been renewed for a 2-year period through September 18, 2012.
For information, contact Gladys G. Lewellen, M.B.A, M.P.A.,
Designated Federal Officer, Disease, Disability, and Injury Prevention
and Control Special Emphasis Panel, Centers for Disease Control and
Prevention, Department of Health and Human Services, 1600 Clifton Road,
NE., Mailstop E11, Atlanta, Georgia 30333, telephone (404) 498-1519 or
fax (404) 498-1541.
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
[[Page 63840]]
management activities, for both CDC and the Agency for Toxic Substances
and Disease Registry.
Dated: October 8, 2010.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2010-26114 Filed 10-15-10; 8:45 am]
BILLING CODE 4163-18-P
