Proposed Collection; Comment Request, 44751-44753 [E8-17528]
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Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices
manufacturer, explain the reasons for
the delay, and discuss the time frame for
completing the review.
Third, the comment asked whether
‘‘the manufacturing facility is
approvable or to be re-inspected’’ if the
dispute is not resolved at the end of the
tier-two DR stage.
FDA Response—As described in the
guidance, it is FDA’s intention to
resolve through the DR process all
issues raised by the manufacturer. If
FDA agrees with the manufacturer, the
Form FDA 483 that prompted the
request for formal dispute resolution
would be revised or rescinded. If FDA
disagrees with the manufacturer’s
request, the issues raised in the Form
FDA 483 stand and FDA would expect
compliance with the applicable CGMP
requirements, which FDA may verify by
re-inspection.
Dated: July 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17577 Filed 7–30–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Data Collection; Comment
Request; Public Health Service; The
National Survey of Physician Attitudes
Regarding the Care of Cancer
Survivors (SPARCCS) (NCI)
SUMMARY: In compliance with the
provisions of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comments on
proposed data collection projects, the
National Institutes of Health (NIH),
National Cancer Institute (NCI) 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: The
National Survey of Physician Attitudes
Regarding the Care of Cancer Survivors
(SPARCCS); Type of Information
Collection Request: NEW; Need and Use
of Information Collection: The purpose
of SPARCCS is to identify the beliefs,
knowledge, attitudes, and practices of
primary care physicians and cancer
specialists regarding the components
described by the Institute of Medicine’s
(IOM) 2005 report that described the
essential components of cancer
survivorship care within a health care
delivery system. These data will inform
the process of standardization of
survivorship care practices; augment the
data collected in other cancer
survivorship studies such as the Cancer
Care Outcomes Research and
Surveillance Consortium (CanCORS),
and the Cancer Research Network; and
monitor the progress made toward
achieving NCI strategic goals of
improving the quality of cancer care
across the cancer control continuum.
Two questionnaires, one sent to primary
care physicians and one sent to medical
oncologists, will be administered by
mail to a randomly selected national
sample of 2,200 physicians. Study
participants will be 1,100 practicing
physicians who are family practitioners,
general internists, and obstetrician/
gynecologists and 1,100 medical
oncologists. Frequency of Response:
Once. Affected Public: Individuals and
Businesses. Type of Respondents:
Primary care and medical oncology
physicians practicing in a non-federal
facility. The annual reporting burden is
estimated at 903 hours as shown in
Table 1. The total burden hours is
estimated at 1,808 hours over the two
year field period of the study. There are
no capital, operating or maintenance
costs to report.
TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS
Number of
respondents
Survey
Receptionists .....................................
Family Practice .................................
General Internists ..............................
OB/GYNs ..........................................
Oncologists .......................................
Receptionists & Administrators .........
Screener ...........................................
PCP Instrument ................................
PCP Instrument ................................
PCP Instrument ................................
Oncology Instrument ........................
Follow-Up Phone Calls ....................
...........................................................
4,236
Average time
per response
(minutes/hour)
Annual burden
hours
1
1
1
1
1
4
5/60
20/60
20/60
20/60
20/60
5/60
169
83
83
17
183
368
........................
........................
903
Frequency of
response
2,033
250
250
50
550
1,103
Total ...........................................
jlentini on PROD1PC65 with NOTICES
Type of respondents
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(a) Whether the proposed collection of
information is necessary for the
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
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15:53 Jul 30, 2008
Jkt 214001
of automated collection techniques or
other forms of information technology.
FOR FURTHER INFORMATION CONTACT:
Send comments to Arnold Potosky,
PhD, Health Services and Economics,
Branch Applied Research Program,
Division of Cancer Control and
Population Sciences, National Cancer
Institute, 6130 Executive Blvd., EPN
Room 4005, Bethesda, MD 20892–7344
Telephone: (301) 496–5662; e-mail:
potoskya@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
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Dated: July 21, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office,
National Institutes of Health.
[FR Doc. E8–17505 Filed 7–30–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request
Evaluation of Risk Factors Associated
With Viral Infections in Chinese Donors:
a. Risk factors associated with HIV
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31JYN1
44752
Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices
b. Risk factors associated with Hepatitis
B virus (HBV) and Hepatitis C virus
(HCV)
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, the
National Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection: Title: Evaluation
of Risk Factors Associated with Viral
Infections in Chinese Donors: a. Risk
factors associated with Human
Immunodeficiency Virus (HIV), b. Risk
factors associated with Hepatitis B virus
(HBV) and Hepatitis C virus (HCV). This
collection will cover two protocols as
stated in the title. The first protocol will
aim to study risk factors associated with
HIV in Chinese donors and the second
protocol will study risk factors related
to HBV and HCV in Chinese donors.
Type of Information Collection Request:
NEW. Need and Use of Information
Collection: Understanding the risk
factors associated with HIV, HBV and
HCV infections in donors is essential for
developing donor behavioral screening
policies. Injection drug use, sexual
transmissions, transfusion history, and
medical injections are thought to be
major routes of transmission in China
but their relative importance in blood
donors is unknown.
In the U.S., risk factors have been
better characterized but, questions still
remain. Risk factors cannot be identified
in 33% and 40% of persons with acute
hepatitis B and C respectively, and risk
factors may differ between the U.S. and
China. This study will improve our
understanding of potential transfusion
transmitted viral risk factors that cannot
be optimally studied in the U.S. because
of their low prevalence. For example,
we may be able to assess whether
treatments commonly used in China,
such as acupuncture and medical
injections, are important routes of HBV
and HCV transmission.
The primary objectives of the
proposed study are to assess:
• The primary risk factors associated
with HIV, HBV and HCV.
• The relative importance of injection
drug use, heterosexual transmission,
family history, transfusion history,
history of previous whole blood or
plasma donation, male to male sex,
medical injections, acupuncture, and
tattoos as routes of transmission for HIV,
HBV and HCV.
• Other important routes of
transmission for these viruses such as
sex with an injection drug user, snorting
drugs, living with someone who has
HBV and HCV, living with someone
who injects drugs, sharing a toothbrush
or a razor, having been in jail,
occupational history, having surgery,
etc.
It is proposed to conduct a large,
multi blood center case-control study to
meet the study objectives. Cases for the
HIV protocol will be donors with
confirmed anti-HIV antibody reactivity.
Blood Centers will select a random
group of donors with negative infectious
disease test results as Controls for this
study. Controls will be enrolled with a
2:1 ratio to Cases and will be matched
to the Cases by blood center and
donation month. Blood Centers will
contact potential Controls by phone
and/or mail, inviting them to come back
to participate in this study. Cases and
Controls will be consented and
interviewed using the same Risk Factor
Questionnaire (RFQ) by Chinese-CDC
(C–CDC) or blood center staff, either at
the local C–CDC or blood center.
The second protocol assessing risk
factors related to HBV and HCV will
have three groups of donors: ‘‘HBV
Group’’: HBV (HBsAg) positive donors
either from prescreening (rapid testing)
or routine screening testing.
Confirmatory testing for HBV will be
done for these donors. ‘‘HCV Group’’:
HCV (anti-HCV) positive donors from
routine screening testing (blood centers
do not do prescreening rapid testing for
anti-HCV). Confirmatory testing for HCV
will be done for these donors. The third
group will be a ‘‘Control Group’’
including donors with negative results
for all prescreening and routine
screening tests. No additional testing is
done for these donors. On a monthly
basis, the blood centers will use the
confirmatory testing results for HBV and
HCV respectively, to generate a list of
cases. For that same month, the blood
center will generate a list of controls
(randomly selected and matched by
blood center and month of donation.)
The same control group will be used for
HBV and HCV cases. Donors in all three
groups will be mailed a Risk Factor
Survey study packet. The packet will
include a study information sheet
(discussing the purpose and nature of
this study), an informed consent
document explaining the voluntary
nature, the benefits and risks of this
study, a RFQ, a small monetary reward
for taking the survey and an envelope
with paid postage for the donor to mail
their completed questionnaire back to
the blood center.
Frequency of Response: Once.
Affected Public: Individuals. Type of
Respondents: Adult Blood Donors. The
annual reporting burden is as follows:
Estimated Number of Respondents:
3,920; Estimated Number of Responses
per Respondent: 1; Average Burden of
Hours per Response: 0.33; and
Estimated Total Annual Burden Hours
Requested: 1,293.5. The annualized cost
to respondents is estimated at: $1,940.25
(based on $1.50 per hour). According to
China’s National Bureau of Statistics in
2006, the average annual wage in China
is 21,001 Chinese Yuan (or $ 2,958 U.S.
dollars based on current exchange rate
of 1 U.S. dollar = 7.1). There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Estimated
number of
responses per
respondent
Estimated number of respondents
Average
burden hours
per response
Estimated total
annual burden
hours
requested
jlentini on PROD1PC65 with NOTICES
HIV Risk factor:
Case .....................................................................................................................................
Control ..................................................................................................................................
HBV and HCV Risk factor:
Case .....................................................................................................................................
Control ..................................................................................................................................
350
700
0.33
0.33
115.5
231
1,700
1,170
0.33
0.33
561
386
Total ...............................................................................................................................
3,920
0.33
1,293.5
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Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will 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 the assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information 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. George Nemo,
Project Officer, NHLBI, Two Rockledge
Center, Room 10142, 6701 Rockledge
Drive, MSC 7950, Bethesda, MD 20892–
7950, or call 301–435–0075, or e-mail
your request to nemog@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: July 23, 2008.
George Nemo,
Project Officer, NHLBI, National Institutes of
Health.
[FR Doc. E8–17528 Filed 7–30–08; 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.
jlentini on PROD1PC65 with NOTICES
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
VerDate Aug<31>2005
15:53 Jul 30, 2008
Jkt 214001
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.
Protein-tyrosine Phosphotase Inhibitors
as Inhibitors of Human Tyrosyl-DNA
Phosphodiesterase (Tdp1) and Methods
of Treating Disorders
Description of Technology: TyrosylDNA phosphodiesterase (Tdp1) is an
enzyme that repairs topoisomerase I
(Top1)-mediated DNA damage induced
by chemotherapeutic agents (such as
camptothecins) and ubiquitous DNA
lesions that interfere with transcription
and replication. Tdp1 is a relevant target
for anticancer therapies due to its role
in repairing Top1-mediated DNA
damage and DNA damage associated
with DNA strand breaks. Tdp1
inhibitors are expected to be effective in
cancer treatment when used in
combination with Top1 inhibitors.
The current invention is Me-3,4
dephostatin, and more generally
protein-tyrosine phosphatase inhibitors,
which is a Tdp1 inhibitor. Me-3,4
dephostatin could potentiate the
pharmacological action of Top1
inhibitors.
Applications and Modality
• It is anticipated that Tdp1
inhibitors in association with Top1
inhibitors can have selective activity
toward tumor tissues.
• Tdp1 inhibitors may exhibit
antitumor activity by themselves
because tumors have excess free
radicals.
Market
• An estimated 1,444,920 new cancer
diagnoses in the U.S. in 2007.
• 600,000 deaths caused by cancer in
the U.S. in 2006.
• Cancer is the second leading cause
of death in the U.S.
• Cancer drug market will likely
double to $50 billion in 2010 from $25
billion in 2006.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Yves Pommier (NCI) et al.
Relevant Publication: S Antony et al.
Novel high-throughput
electrochemiluminescent assay for
PO 00000
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Fmt 4703
Sfmt 4703
44753
identification of human tyrosyl-DNA
phosphodiesterase (Tdp1) inhibitors
and characterization for furamidine
(NSC 305831) as an inhibitor of Tdp1.
Nucleic Acid Res. 2007;35(13):4474–
4484.
Patent Status: U.S. Provisional
Application No. 61/042,706 filed 04 Apr
2008 (HHS Ref. No. E–121–2008/0–US–
01).
Licensing Status: Available for
exclusive and non-exclusive licensing.
Licensing Contact: Adaku
Nwachukwu, J.D.; 301–435–5560;
madua@mail.nih.gov.
Steroid Derivatives as Inhibitors of
Human Tyrosyl-DNA
Phosphodiesterase (Tdp1)
Description of Technology: TyrosylDNA phosphodiesterase (Tdp1) is an
enzyme that repairs topoisomerase I
(Top1)-mediated DNA damage induced
by chemotherapeutic agents and
ubiquitous DNA lesions that interfere
with transcription. The current
technology are steroid derivatives that
human inhibit Tdp1.
Currently, there are various types of
Top1 inhibitors used in chemotherapy,
e.g., camptothecin. However, Tdp1
inhibitors are expected to be effective in
combination therapy with Top1
inhibitors for the treatment of cancers.
Combining Tdp1 inhibitors with Top1
inhibitors would allow Tdp1 to
potentiate the antiproliferative activity
of Top1 inhibitors. In addition to Tdp1’s
effect on Top1, Tdp1 inhibitors can also
exhibit antitumor activity
independently, as tumors are shown to
have excess free radicals, and Tdp1
repairs DNA damage by oxygen radicals.
Applications and Modality: It is
anticipated that Tdp1 inhibitors in
association with Top1 inhibitors can
have selective activity toward tumor
tissues. Tdp1 inhibitors may exhibit
antitumor activity by themselves
because tumors have excess free
radicals.
Market: 600,000 deaths from cancer
related diseases were estimated in 2006.
In 2006, cancer drug sales were
estimated to be $25 billion.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Yves Pommier et al. (NCI).
Patent Status:
• U.S. Provisional Application No.
61/000,430 filed 24 Oct 2007 (HHS
Reference No. E–130–2007/1–US–01).
• PCT Application No. PCT/US2008/
004541 filed 05 Apr 2008, claiming
priority to 05 Apr 2007 (HHS Reference
No. E–130–2007/2–PCT–01).
Licensing Status: Available for
exclusive and non-exclusive licensing.
E:\FR\FM\31JYN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 148 (Thursday, July 31, 2008)]
[Notices]
[Pages 44751-44753]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17528]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request
Evaluation of Risk Factors Associated With Viral Infections in
Chinese Donors:
a. Risk factors associated with HIV
[[Page 44752]]
b. Risk factors associated with Hepatitis B virus (HBV) and Hepatitis C
virus (HCV)
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, the National Heart, Lung, and
Blood Institute (NHLBI), the National Institutes of Health (NIH), will
publish periodic summaries of proposed projects to the Office of
Management and Budget (OMB) for review and approval.
Proposed Collection: Title: Evaluation of Risk Factors Associated
with Viral Infections in Chinese Donors: a. Risk factors associated
with Human Immunodeficiency Virus (HIV), b. Risk factors associated
with Hepatitis B virus (HBV) and Hepatitis C virus (HCV). This
collection will cover two protocols as stated in the title. The first
protocol will aim to study risk factors associated with HIV in Chinese
donors and the second protocol will study risk factors related to HBV
and HCV in Chinese donors. Type of Information Collection Request: NEW.
Need and Use of Information Collection: Understanding the risk factors
associated with HIV, HBV and HCV infections in donors is essential for
developing donor behavioral screening policies. Injection drug use,
sexual transmissions, transfusion history, and medical injections are
thought to be major routes of transmission in China but their relative
importance in blood donors is unknown.
In the U.S., risk factors have been better characterized but,
questions still remain. Risk factors cannot be identified in 33% and
40% of persons with acute hepatitis B and C respectively, and risk
factors may differ between the U.S. and China. This study will improve
our understanding of potential transfusion transmitted viral risk
factors that cannot be optimally studied in the U.S. because of their
low prevalence. For example, we may be able to assess whether
treatments commonly used in China, such as acupuncture and medical
injections, are important routes of HBV and HCV transmission.
The primary objectives of the proposed study are to assess:
The primary risk factors associated with HIV, HBV and HCV.
The relative importance of injection drug use,
heterosexual transmission, family history, transfusion history, history
of previous whole blood or plasma donation, male to male sex, medical
injections, acupuncture, and tattoos as routes of transmission for HIV,
HBV and HCV.
Other important routes of transmission for these viruses
such as sex with an injection drug user, snorting drugs, living with
someone who has HBV and HCV, living with someone who injects drugs,
sharing a toothbrush or a razor, having been in jail, occupational
history, having surgery, etc.
It is proposed to conduct a large, multi blood center case-control
study to meet the study objectives. Cases for the HIV protocol will be
donors with confirmed anti-HIV antibody reactivity. Blood Centers will
select a random group of donors with negative infectious disease test
results as Controls for this study. Controls will be enrolled with a
2:1 ratio to Cases and will be matched to the Cases by blood center and
donation month. Blood Centers will contact potential Controls by phone
and/or mail, inviting them to come back to participate in this study.
Cases and Controls will be consented and interviewed using the same
Risk Factor Questionnaire (RFQ) by Chinese-CDC (C-CDC) or blood center
staff, either at the local C-CDC or blood center.
The second protocol assessing risk factors related to HBV and HCV
will have three groups of donors: ``HBV Group'': HBV (HBsAg) positive
donors either from prescreening (rapid testing) or routine screening
testing. Confirmatory testing for HBV will be done for these donors.
``HCV Group'': HCV (anti-HCV) positive donors from routine screening
testing (blood centers do not do prescreening rapid testing for anti-
HCV). Confirmatory testing for HCV will be done for these donors. The
third group will be a ``Control Group'' including donors with negative
results for all prescreening and routine screening tests. No additional
testing is done for these donors. On a monthly basis, the blood centers
will use the confirmatory testing results for HBV and HCV respectively,
to generate a list of cases. For that same month, the blood center will
generate a list of controls (randomly selected and matched by blood
center and month of donation.) The same control group will be used for
HBV and HCV cases. Donors in all three groups will be mailed a Risk
Factor Survey study packet. The packet will include a study information
sheet (discussing the purpose and nature of this study), an informed
consent document explaining the voluntary nature, the benefits and
risks of this study, a RFQ, a small monetary reward for taking the
survey and an envelope with paid postage for the donor to mail their
completed questionnaire back to the blood center.
Frequency of Response: Once. Affected Public: Individuals. Type of
Respondents: Adult Blood Donors. The annual reporting burden is as
follows: Estimated Number of Respondents: 3,920; Estimated Number of
Responses per Respondent: 1; Average Burden of Hours per Response:
0.33; and Estimated Total Annual Burden Hours Requested: 1,293.5. The
annualized cost to respondents is estimated at: $1,940.25 (based on
$1.50 per hour). According to China's National Bureau of Statistics in
2006, the average annual wage in China is 21,001 Chinese Yuan (or $
2,958 U.S. dollars based on current exchange rate of 1 U.S. dollar =
7.1). There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
number of Average total annual
Estimated number of respondents responses per burden hours burden hours
respondent per response requested
----------------------------------------------------------------------------------------------------------------
HIV Risk factor:
Case........................................................ 350 0.33 115.5
Control..................................................... 700 0.33 231
HBV and HCV Risk factor:
Case........................................................ 1,700 0.33 561
Control..................................................... 1,170 0.33 386
-----------------------------------------------
Total................................................... 3,920 0.33 1,293.5
----------------------------------------------------------------------------------------------------------------
[[Page 44753]]
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will 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 the assumptions used; (3) ways to enhance the quality, utility, and
clarity of the information 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. George Nemo, Project Officer, NHLBI, Two
Rockledge Center, Room 10142, 6701 Rockledge Drive, MSC 7950, Bethesda,
MD 20892-7950, or call 301-435-0075, or e-mail your request to
nemog@nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: July 23, 2008.
George Nemo,
Project Officer, NHLBI, National Institutes of Health.
[FR Doc. E8-17528 Filed 7-30-08; 8:45 am]
BILLING CODE 4140-01-P
