National Cancer Institute; Proposed Collection; Comment Requested; Study to Improve Thyroid Doses From Fallout Exposure in Kazakhstan-Follow-up, 2286-2287 [E7-625]
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Federal Register / Vol. 72, No. 11 / Thursday, January 18, 2007 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Proposed
Collection; Comment Requested;
Study to Improve Thyroid Doses From
Fallout Exposure in Kazakhstan—
Follow-up
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995
for opportunity for public comment on
proposed data collection projects,
National Cancer Institute (NCI), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: Study to improve thyroid doses
from fallout exposure in Kazakhstan—
Follow-up, Radiation Epidemiology
Branch, Division of Cancer
Epidemiology and Genetics, National
Cancer Institute (NCI). The proposed
work builds on an existing study
conducted 1998 of radiation exposure
and thyroid disease among individuals
in Kazakhstan exposed during
childhood to radioactive fallout from
nuclear tests conducted at the
Semipalatinsk Nuclear Test Site (SNTS)
between 1949 and 1962. The 1998 study
recruited 3000 participants who were 21
years of age or younger at fallout
exposure, from eight villages. Analyses
of preliminary dose estimates suggest
that internal and external exposures
independently and significantly
contributed to the dose response for
thyroid nodules. Type of Information
Collection Request: NEW.
This study population in Kazakhstan
is unique in several ways. This is only
the fourth major population in which
dose-response has been studied for
thyroid disease associated with
environmental releases of radioactive
materials. The conditions of fallout
exposure in Kazakhstan are directly
relevant to conditions following a
hypothetical nuclear accident or a
terrorist attack involving high levels of
local fallout. Among large study
populations with high exposure
following environmental releases of
radioactive materials, this population is
second in size only to those most
heavily exposed to radioactive materials
released during the 1986 Chornobyl
reactor accident. However, unlike the
Chornobyl population, the Kazakhstan
population was exposed to high levels
of radiation from external as well as
internal sources. This allows us to
evaluate the relative effectiveness of
internal and external radiation
exposures in terms of thyroid disease
risk within a single population. Need
and Use of Information Collection: NCI
proposes a small-scale field study to
acquire new data to improve our
estimates of internal and external
radiation dose and thereby refine the
dose-response estimates. Retrospective
information about factors influencing
radiation dose to the thyroid gland in
children of two distinct ethnic groups
(Kazakh and Russian) will be collected
using focus group interviews. These
new collected data will address key
weaknesses in the current dosimetry,
including milk and milk product
consumption, time typically spent
outdoors, radiation shielding provided
by dwellings and other buildings, and
seasonal practices of pasturing and
supplemental feeding of dairy animals
at the time of the nuclear tests. Since the
objective is to estimate group-specific
mean values (and ranges) and not to
collect individual data, focus groups are
better suited than conventional in-depth
individual interviews.
Focus group members for each village
will consist of two sets of participants
who (i) speak Russian or Kazakh and are
able to participate in a 2 hour focus
group session, and (ii) have verified
history of residence in the village at the
time of the nuclear tests will be
recruited for the study.
Frequency of Response: Once;
Affected Public: Individual and
household.
Type of Respondent: Women, Men age
65 or older
Estimated Number of Respondents:
128.
Estimated Number of Responses per
Respondent: 1.
Average Burden Hours per Response:
2.0. Annual Burden Hours Requested:
256.
• Women: In each village, three
groups of 8 women ages 65 years and
older who had children less than age 15
years or provided care to children in
this age group (i.e., younger siblings,
nieces and nephews) at the time of the
nuclear tests.
• Men: In each village, 8 men ages 65
and older who were engaged in farming
and care of dairy animals at the time of
the nuclear tests.
Since the main exposure years (time
of the tests) varies by village, specific
eligibility requirements will be applied
to each village. Verification of residence
history will be based on regional
records.
TABLE A.—TOTAL BURDEN ESTIMATES FOR DATA COLLECTION
Average burden per response
(in hours)
Number of respondents
Number of responses per
respondent
Focus Group ....................................................................................................
Male ..........................................................................................................
Female ......................................................................................................
128
32
96
1
1
1
2 hours
2 hours
2 hours
256
64
192
Total ...................................................................................................
........................
........................
........................
256
Form
pwalker on PROD1PC71 with NOTICES
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
Request for Comments
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
VerDate Aug<31>2005
17:52 Jan 17, 2007
Jkt 211001
proposed collection of information is
necessary for the proposed performance
of the functions of the agency, including
whether the information shall have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information
including the validity of the
methodology and assumptions used; (3)
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Total burden
(in hours)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
E:\FR\FM\18JAN1.SGM
18JAN1
Federal Register / Vol. 72, No. 11 / Thursday, January 18, 2007 / Notices
For Further Information Contact: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Charles Land,
Project Officer, National Cancer
Institute, EPS , 6120 Executive
Boulevard MSC 7238, Bethesda,
Maryland 20852, or call non-toll free
number 301–594–7165 or FAX your
request, including your address to 301–
402–0207.
Comments Due Date
Comments regarding this information
collection are best assured of having
their full effect if received within 60
days of this publication.
Dated: January 8, 2007.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E7–625 Filed 1–17–07; 8:45 am]
BILLING CODE 4140–01–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:
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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
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.
Novel Benztropine Analogs for
Treatment of Cocaine Abuse and Other
Mental Disorders
Description of Technology: Dopamine
is a neurotransmitter that exerts
important effects on locomotor activity,
VerDate Aug<31>2005
17:52 Jan 17, 2007
Jkt 211001
motivation and reward, and cognition.
The dopamine transporter (DAT) is
expressed on the plasma membrane of
dopamine synthesizing neurons, and is
responsible for clearing dopamine
released into the extra-cellular space,
thereby regulating neurotransmission.
The dopamine transporter plays a
significant role in neurotoxicity and
human diseases, such as Parkinson’s
disease, drug abuse (especially cocaine
addiction), Attention Deficit Disorder/
Attention Deficit Hyperactivity Disorder
(ADD/ADHD), and a number of other
CNS disorders. Therefore, the dopamine
transporter is a strong target for research
and the discovery of potential
therapeutics for the treatment of these
indications.
This invention discloses novel
benztropine analogs and methods of
using these analogs for treatment of
mental and conduct disorders such as
cocaine abuse, narcolepsy, ADHD,
obesity and nicotine abuse. The
disclosed analogs are highly selective
and potent inhibitors of DAT, but
without an apparent cocaine-like
behavioral profile. In addition to their
use as a treatment for cocaine abuse,
these compounds have also shown
efficacy in animal models of ADHD and
nicotine abuse, and have also been
shown to reduce food intake in animals.
They may also be useful medications for
other indications where dopaminerelated behavior is compromised, such
as alcohol addiction, tobacco addiction,
and Parkinson’s disease.
Applications: Drug leads for treatment
of cocaine abuse, ADHD, nicotine abuse,
obesity, and other dopamine-related
disorders; Imaging probes for dopamine
transporter binding sites.
Development Status: Pre-clinical data
are available.
Inventors: Amy H. Newman, Mu-fa
Zou, and Jonathan L. Katz (NIDA).
Patent Status: U.S. Provisional
Application No. 60/710,956 filed 24
Aug 2005 (HHS Reference No. E–234–
2005/0–US–01); PCT Application No.
PCT/US2006/33103 filed 24 Aug 2006
(HHS Reference No. E–234–2005/1–
PCT–01 and HHS Reference No. E–129–
2006/0).
Licensing Status: Available for
exclusive or nonexclusive licensing.
Licensing Contact: Tara Kirby, Ph.D.;
301/435–4426; tarak@mail.nih.gov.
Collaborative Research Opportunity:
The Medicinal Chemistry and
Psychobiology Sections, National
Institute on Drug Abuse-Intramural
Research Program, National Institutes of
Health, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
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2287
commercialize medications to treat
cocaine abuse and addiction. Please
contact John D. Hewes, Ph.D. at 301/
435–3121 or hewesj@mail.nih.gov for
more information.
Protein Arginine N-methyltransferase 2
(PRMT–2), a Modulator of NFKB, E2F1,
and STAT3 Activity
Description of Technology: Proteinarginine methyltransferases (PRMTs)
contain methyltransferase domains that
modify chromatin and regulate cellular
transcription through the posttranslational methylation of arginine
residues on the guanidine group of
target proteins. Members of this family
have roles in RNA processing,
transcriptional regulation, signal
transduction, and DNA repair. Until
recently, the functional significance of
one member of this family, PRMT–2,
was unknown.
Researchers at NHLBI, led by Dr.
Elizabeth Nabel, have elucidated the
role of PRMT–2. They have found that
PRMT–2 modulates the activity of
NFKB, E2F1, and STAT3. PRMT–2
inhibits NFKB dependent transcription,
and therefore PRMT–2 has a role in
modulating inflammation and the
immune response. Also, PRMT–2
proteins can repress E2F1
transcriptional activity and cause cell
cycle arrest, and thus may be used to
treat or prevent cancer. PRMT–2 also
methylates STAT3, and inhibition or
loss of PRMT–2 function causes
mammals to lose weight, eat less and
become more sensitive to insulin.
The invention describes methods of
modulating PRMT–2 activity or
expression in cells. These methods can
be used to inhibit the function of NF?B,
E2F1 and STAT3 for treatment of a
number of disorders, including
inflammation, cancer, and diabetes.
Applications: Target for treatment and
study of a number of disorders,
including:
Diabetes, obesity and metabolic
syndrome diseases; Inflammation and
immune response-related disorders;
Cancer.
Inventors: Elizabeth Nabel (NHLBI),
Hiroaki Iwasaki (NHLBI), Takanobu
Yoshimoto (NHLBI), and Gary Nabel
(NIAID).
Patent Status: U.S. Provisional
Application No. 60/466,751 filed 30
April 2003 (HHS Reference No. E–190–
2003/0–US–01); PCT Application No.
PCT2004/013375 filed 30 April 2004,
which published as WO 2004/098634
on 18 Nov 2004 (HHS Reference No. E–
190–2003/0–PCT–02); U.S. Application
No. 11/263,657 filed 31 Oct 2005, which
published as WO 2006/0239990 on 26
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18JAN1
]]>Agencies
[Federal Register Volume 72, Number 11 (Thursday, January 18, 2007)]
[Notices]
[Pages 2286-2287]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-625]
[[Page 2286]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Proposed Collection; Comment
Requested; Study to Improve Thyroid Doses From Fallout Exposure in
Kazakhstan--Follow-up
Summary: In compliance with the requirement of Section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity
for public comment on proposed data collection projects, National
Cancer Institute (NCI), the National Institutes of Health (NIH) will
publish periodic summaries of proposed projects to be submitted to the
Office of Management and Budget (OMB) for review and approval.
Proposed Collection
Title: Study to improve thyroid doses from fallout exposure in
Kazakhstan--Follow-up, Radiation Epidemiology Branch, Division of
Cancer Epidemiology and Genetics, National Cancer Institute (NCI). The
proposed work builds on an existing study conducted 1998 of radiation
exposure and thyroid disease among individuals in Kazakhstan exposed
during childhood to radioactive fallout from nuclear tests conducted at
the Semipalatinsk Nuclear Test Site (SNTS) between 1949 and 1962. The
1998 study recruited 3000 participants who were 21 years of age or
younger at fallout exposure, from eight villages. Analyses of
preliminary dose estimates suggest that internal and external exposures
independently and significantly contributed to the dose response for
thyroid nodules. Type of Information Collection Request: NEW.
This study population in Kazakhstan is unique in several ways. This
is only the fourth major population in which dose-response has been
studied for thyroid disease associated with environmental releases of
radioactive materials. The conditions of fallout exposure in Kazakhstan
are directly relevant to conditions following a hypothetical nuclear
accident or a terrorist attack involving high levels of local fallout.
Among large study populations with high exposure following
environmental releases of radioactive materials, this population is
second in size only to those most heavily exposed to radioactive
materials released during the 1986 Chornobyl reactor accident. However,
unlike the Chornobyl population, the Kazakhstan population was exposed
to high levels of radiation from external as well as internal sources.
This allows us to evaluate the relative effectiveness of internal and
external radiation exposures in terms of thyroid disease risk within a
single population. Need and Use of Information Collection: NCI proposes
a small-scale field study to acquire new data to improve our estimates
of internal and external radiation dose and thereby refine the dose-
response estimates. Retrospective information about factors influencing
radiation dose to the thyroid gland in children of two distinct ethnic
groups (Kazakh and Russian) will be collected using focus group
interviews. These new collected data will address key weaknesses in the
current dosimetry, including milk and milk product consumption, time
typically spent outdoors, radiation shielding provided by dwellings and
other buildings, and seasonal practices of pasturing and supplemental
feeding of dairy animals at the time of the nuclear tests. Since the
objective is to estimate group-specific mean values (and ranges) and
not to collect individual data, focus groups are better suited than
conventional in-depth individual interviews.
Focus group members for each village will consist of two sets of
participants who (i) speak Russian or Kazakh and are able to
participate in a 2 hour focus group session, and (ii) have verified
history of residence in the village at the time of the nuclear tests
will be recruited for the study.
Frequency of Response: Once;
Affected Public: Individual and household.
Type of Respondent: Women, Men age 65 or older
Estimated Number of Respondents: 128.
Estimated Number of Responses per Respondent: 1.
Average Burden Hours per Response: 2.0. Annual Burden Hours
Requested: 256.
Women: In each village, three groups of 8 women ages 65
years and older who had children less than age 15 years or provided
care to children in this age group (i.e., younger siblings, nieces and
nephews) at the time of the nuclear tests.
Men: In each village, 8 men ages 65 and older who were
engaged in farming and care of dairy animals at the time of the nuclear
tests.
Since the main exposure years (time of the tests) varies by
village, specific eligibility requirements will be applied to each
village. Verification of residence history will be based on regional
records.
Table A.--Total Burden Estimates for Data Collection
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Focus Group..................................... 128 1 2 hours 256
Male........................................ 32 1 2 hours 64
Female...................................... 96 1 2 hours 192
---------------------------------------------------------------
Total................................... .............. .............. .............. 256
----------------------------------------------------------------------------------------------------------------
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
Request for Comments
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
Whether the proposed collection of information is necessary for the
proposed performance of the functions of the agency, including whether
the information shall have practical utility; (2) The accuracy of the
agency's estimate of the burden of the proposed collection of
information including the validity of the methodology and assumptions
used; (3) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to minimize the burden of the
collection of information on those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
[[Page 2287]]
For Further Information Contact: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Charles Land, Project Officer, National Cancer
Institute, EPS , 6120 Executive Boulevard MSC 7238, Bethesda, Maryland
20852, or call non-toll free number 301-594-7165 or FAX your request,
including your address to 301-402-0207.
Comments Due Date
Comments regarding this information collection are best assured of
having their full effect if received within 60 days of this
publication.
Dated: January 8, 2007.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E7-625 Filed 1-17-07; 8:45 am]
BILLING CODE 4140-01-P
