National Cancer Institute; Proposed Collection; Comment Requested; Study to Improve Thyroid Doses from Fallout Exposure in Kazakhstan, 30016-30017 [E7-10331]
Download as PDF
<![CDATA[
30016
Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices
Persons interested in attending any portion
of the meeting should contact Michele PrayGibson, Office of Rural Health Policy
(ORHP), Telephone (301) 443–0835. The
Committee meeting agenda will be posted on
ORHP’s Web site https://
www.ruralhealth.hrsa.gov.
Due to scheduling difficulties, this notice
will publish in the Federal Register less than
15 days before the date of the meeting.
Dated: May 24, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. 07–2683 Filed 5–25–07; 10:55 am]
BILLING CODE 4165–15–P
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
SUMMARY: In compliance with the
requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995
for opportunity for public comment on
proposed data collection projects, the
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 of the information
collection listed below. This proposed
information collection was previously
published in the Federal Register on
January 18, 2007, pages 2286–2287 and
allowed 60-days for public comment.
No public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Proposed Collection
Title: Study to improve thyroid doses
from fallout exposure in Kazakhstan,
Radiation Epidemiology Branch,
Division of Cancer Epidemiology and
Genetics, National Cancer Institute
(NCI). This is a dose reconstruction
effort. Additional data will be acquired
to improve on published estimates of
individual internal and external
radiation dose and better characterize
the underlying dose uncertainties for
individuals exposed as children to
radioactive fallout from nuclear tests
conducted at the Semipalatinsk Nuclear
Test Site (SNTS) in Kazakhstan during
the 1950s. Village residents near the test
site received high doses of internal and
external radiation to the thyroid gland
(up to 10 Gy for internal and 0.6 Gy for
external radiation) as a result of
multiple nuclear tests. Internal radiation
exposure occurred primarily through
consumption of milk and other dairy
products from animals grazing on
pastures contaminated with radioactive
iodine. The external dose received by
individuals was a function of the
exposure rate when the fallout was
deposited, shielding provided by
buildings and the number of hours
spent outdoors on a daily basis.
Collection from small focus groups of
persons who were young adults at the
time of the nuclear tests of specific
information about children’s milk
consumption and time spent indoors
and outdoors, shielding, and pasturing
and feeding of dairy animals for the
months following the nuclear tests will
allow dosimetrists to evaluate and
change, as appropriate, the current
assumptions and input values for the
parameters of the dose estimation
model. The new data will allow more
objective model assumptions and result
in a more informed characterization of
uncertainty.
Type of information collection
request: NEW. The Kazakhstan
population was exposed to high levels
of radiation from external as well as
internal sources, unlike the vast
majority of persons living downwind
from the Chernobyl accident who were
exposed only to radioactive isotopes of
ingested and inhaled iodine.
Availability of accurate dose estimates
will allow evaluation of the relative
biological effectiveness (RBE) of internal
vs. external radiation exposures in terms
of thyroid disease risk within a single
population. 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.
Need and Use of Information
Collection: NCI proposes a small-scale
field study to acquire new data to
improve published estimates of internal
and external radiation doses to
individuals exposed to fallout from
nuclear tests conducted at the SNTS
during 1949–1962. 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. New data
to be collected on 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 will enable dosimetrists to address
key weaknesses in the current dosimetry
models. 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 will be recruited from among
women and men who speak Russian or
Kazakh and have a verified history of
residence in the village at the time of
the nuclear tests. In each village, three
groups of 8 women, age 70 or older, who
had children or provided care to other
children (e.g., younger siblings, nieces
and nephews) who were under age 21
at the time of the nuclear tests will be
enrolled. In each village, 8 men, age 70
or older, who were engaged in farming
and the care of dairy animals at the time
of the nuclear tests will be enrolled.
Frequency of Response: Once.
Affected Public: Individual and
household. Type of Respondent: Women
and men, age 70 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:
85.3.
TABLE 1.—ESTIMATES OF ANNUALIZED HOUR BURDEN TO RESPONDENTS
Number of
respondents
sroberts on PROD1PC70 with NOTICES
Type of respondent
Frequency of
response
Average hours
per response
Total hours
(3 yr)
Annual hour
burden
Focus group
Kazakhstan villagers (adults) ≥70 yrs old) ..........................
VerDate Aug<31>2005
19:13 May 29, 2007
Jkt 211001
PO 00000
Frm 00075
128
Fmt 4703
Sfmt 4703
1
E:\FR\FM\30MYN1.SGM
1.9
30MYN1
243
81.1
30017
Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices
TABLE 1.—ESTIMATES OF ANNUALIZED HOUR BURDEN TO RESPONDENTS—Continued
Number of
respondents
Type of respondent
Frequency of
response
Average hours
per response
Total hours
(3 yr)
Annual hour
burden
Post-focus group evaluation
Kazakhstan villagers (adults ≥70 yrs old) ............................
128
1
0.1
13
4.3
Total ..............................................................................
128
1
2.0
256
85.3
There are no capital, operating or
maintenance costs to report.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request For Comments
National Institutes of Health
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.
Government-Owned Inventions;
Availability for Licensing
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Kiyohiko
Mabuchi, Principal Investigator,
National Cancer Institute, Executive
Plaza South, Room 7038, MSC 7238,
Bethesda, Maryland 20852, or call nontoll free number 301–594–7469 or FAX
your request, including your address to
301–402–0207.
FOR FURTHER INFORMATION CONTACT:
Comments Due Date
sroberts on PROD1PC70 with NOTICES
Comments regarding this information
collection are best assured of having
their full effect if received within 30
days of this publication.
Dated: May 21, 2007.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E7–10331 Filed 5–29–07; 8:45 am]
BILLING CODE 4140–01–P
VerDate Aug<31>2005
19:13 May 29, 2007
Jkt 211001
National Institutes of Health,
Public Health Service, HHS
ACTION: Notice.
AGENCY:
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.
A Fullerene-Based Anticoagulant
Description of Technology: This
technology relates to the use of
substituted or modified C60 fullerenes,
which are carbon-based molecular cages
that resemble soccer balls, for the
prevention or treatment of thrombosis,
peripheral arterial occlusion, and
catheter obstruction. Described are
compositions and methods for
administering such compounds at the
implantation site of an in-dwelling
device and methods of coating indwelling devices with such compounds.
Such devices include stents, stent grafts,
pacemakers, defibrillators, venous
valves, heart valves, sutures, catheters,
and drug delivery ports.
Applications: Non-invasive method of
preventing clot formation.
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
Market: Anticoagulation therapy
averages several billion dollars a year.
Further Research Required: Anticoagulant properties of C–60 derivatives
in vivo; Device coating and in vivo
efficacy; Safety evaluation of device, in
vivo models.
Inventors: Marina Dobrovolskaia et al.
(NCI)
Patent Status: PCT Application No.
PCT/US2006/041838 filed 25 Oct 2006
(HHS Reference No. E–140–2006/
0 PCT–01)
Licensing Status: Available for
licensing.
Licensing Contact: Fatima Sayyid,
M.H.P.M.; 301/435–4521;
sayyidf@mail.nih.gov
Aminoalkyl Substituted O6Benzylguanine Derivatives as
Inactivators of O6-Alkylguanine-DNA
Alkyltransferase and Adjuvants for
Chemotherapy
Description of Technology: This
present invention describes novel class
of compounds that inactivate the DNA
repair protein O6-alkylguanine-DNA
alkyltransferase (AGT). Inactivation of
this protein improves therapeutic
effectiveness of chemotherapy drugs
that modify O6-position of DNA guanine
residues.
These new compounds have several
advantages over the existing O6benzylguanine compounds in terms of
being more water soluble, being more
potent, and the compounds are more
readily formulated in water or
phosphate buffered saline solutions
than O6-benzylguanine compounds.
The existing O6-benzylguanine
compounds are currently in Phase II and
III clinical trials. The new aminoalkyl
substituted O6-benzylguanine
derivatives are currently in preclinical
trials.
Applications and Modality: New
compounds have potential to improve
chemotherapy treatment with anticancer
agents; New compounds are more water
soluble, more readily formulated and
more potent than existing O6benzylguanine compounds.
Market: 600,000 deaths from cancer
related diseases were estimated in 2006;
In 2006, cancer drug sales were
estimated to be $25 billion.
E:\FR\FM\30MYN1.SGM
30MYN1
]]>Agencies
[Federal Register Volume 72, Number 103 (Wednesday, May 30, 2007)]
[Notices]
[Pages 30016-30017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10331]
-----------------------------------------------------------------------
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
SUMMARY: In compliance with the requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995 for opportunity for public comment
on proposed data collection projects, the 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 of the information
collection listed below. This proposed information collection was
previously published in the Federal Register on January 18, 2007, pages
2286-2287 and allowed 60-days for public comment. No public comments
were received. The purpose of this notice is to allow an additional 30
days for public comment. The National Institutes of Health may not
conduct or sponsor, and the respondent is not required to respond to,
an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Proposed Collection
Title: Study to improve thyroid doses from fallout exposure in
Kazakhstan, Radiation Epidemiology Branch, Division of Cancer
Epidemiology and Genetics, National Cancer Institute (NCI). This is a
dose reconstruction effort. Additional data will be acquired to improve
on published estimates of individual internal and external radiation
dose and better characterize the underlying dose uncertainties for
individuals exposed as children to radioactive fallout from nuclear
tests conducted at the Semipalatinsk Nuclear Test Site (SNTS) in
Kazakhstan during the 1950s. Village residents near the test site
received high doses of internal and external radiation to the thyroid
gland (up to 10 Gy for internal and 0.6 Gy for external radiation) as a
result of multiple nuclear tests. Internal radiation exposure occurred
primarily through consumption of milk and other dairy products from
animals grazing on pastures contaminated with radioactive iodine. The
external dose received by individuals was a function of the exposure
rate when the fallout was deposited, shielding provided by buildings
and the number of hours spent outdoors on a daily basis. Collection
from small focus groups of persons who were young adults at the time of
the nuclear tests of specific information about children's milk
consumption and time spent indoors and outdoors, shielding, and
pasturing and feeding of dairy animals for the months following the
nuclear tests will allow dosimetrists to evaluate and change, as
appropriate, the current assumptions and input values for the
parameters of the dose estimation model. The new data will allow more
objective model assumptions and result in a more informed
characterization of uncertainty.
Type of information collection request: NEW. The Kazakhstan
population was exposed to high levels of radiation from external as
well as internal sources, unlike the vast majority of persons living
downwind from the Chernobyl accident who were exposed only to
radioactive isotopes of ingested and inhaled iodine. Availability of
accurate dose estimates will allow evaluation of the relative
biological effectiveness (RBE) of internal vs. external radiation
exposures in terms of thyroid disease risk within a single population.
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.
Need and Use of Information Collection: NCI proposes a small-scale
field study to acquire new data to improve published estimates of
internal and external radiation doses to individuals exposed to fallout
from nuclear tests conducted at the SNTS during 1949-1962.
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. New data to be
collected on 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 will enable
dosimetrists to address key weaknesses in the current dosimetry models.
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 will be recruited from among women and men who speak Russian or
Kazakh and have a verified history of residence in the village at the
time of the nuclear tests. In each village, three groups of 8 women,
age 70 or older, who had children or provided care to other children
(e.g., younger siblings, nieces and nephews) who were under age 21 at
the time of the nuclear tests will be enrolled. In each village, 8 men,
age 70 or older, who were engaged in farming and the care of dairy
animals at the time of the nuclear tests will be enrolled.
Frequency of Response: Once. Affected Public: Individual and
household. Type of Respondent: Women and men, age 70 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: 85.3.
Table 1.--Estimates of Annualized Hour Burden to Respondents
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average hours Total hours (3 Annual hour
Type of respondent respondents response per response yr) burden
----------------------------------------------------------------------------------------------------------------
Focus group
----------------------------------------------------------------------------------------------------------------
Kazakhstan villagers (adults) 128 1 1.9 243 81.1
>=70 yrs old)..................
----------------------------------------------------------------------------------------------------------------
[[Page 30017]]
Post-focus group evaluation
----------------------------------------------------------------------------------------------------------------
Kazakhstan villagers (adults 128 1 0.1 13 4.3
>=70 yrs old)..................
-------------------------------------------------------------------------------
Total....................... 128 1 2.0 256 85.3
----------------------------------------------------------------------------------------------------------------
There are no capital, 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.
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 Dr. Kiyohiko Mabuchi, Principal Investigator,
National Cancer Institute, Executive Plaza South, Room 7038, MSC 7238,
Bethesda, Maryland 20852, or call non-toll free number 301-594-7469 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 30 days of this
publication.
Dated: May 21, 2007.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E7-10331 Filed 5-29-07; 8:45 am]
BILLING CODE 4140-01-P
