Submission for OMB Review; Comment Request; Cancer Care for Uninsured Individuals: A Feasibility Study (NCI), 11122-11123 [E8-3836]
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11122
Federal Register / Vol. 73, No. 41 / Friday, February 29, 2008 / Notices
(minocycline hydrochloride) Capsules
EQ 75 mg base (NDA 050–649),
manufactured by Triax Pharmaceuticals,
Ltd. (Triax), was withdrawn from sale
for reasons of safety or effectiveness.
MINOCIN is a tetracycline-class
antibiotic medicine used to treat certain
infections caused by bacteria. MINOCIN
Capsules EQ 75 mg base was approved
on February 12, 2001. Our records show
that the 75 mg strength of this product
was marketed for a short period of time
in 2001. MINOCIN Capsules EQ 75 mg
base were discontinued in September
2001 and the drug product was moved
from the prescription drug product list
to the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
FDA has reviewed its records and,
under § 314.161, has determined that
MINOCIN Capsules EQ 75 mg base was
not withdrawn from sale for reasons of
safety or effectiveness. The petitioner
identified no data or other information
suggesting that MINOCIN Capsules EQ
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of safety or effectiveness. FDA has
independently evaluated relevant
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postmarketing adverse events and has
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list MINOCIN
(minocycline hydrochloride) Capsules
EQ 75 mg base in the ‘‘Discontinued
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Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to minocycline
hydrochloride capsules EQ 75 mg base
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other legal and regulatory requirements
for the approval of ANDAs are met. If
FDA determines that labeling for this
drug product should be revised to meet
current standards, the agency will
advise ANDA applicants to submit such
labeling.
Dated: February 21, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–3879 Filed 2–28–08; 8:45 am]
rwilkins on PROD1PC63 with NOTICES
BILLING CODE 4160–01–S
VerDate Aug<31>2005
19:22 Feb 28, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Cancer Care for
Uninsured Individuals: A Feasibility
Study (NCI)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on December 21, 2007 (Vol. 72,
No. 245, p. 72741 and allowed 60-days
for public comment. One public
comment was received that questioned
why the study was not funded by
University of Alabama (UAB) funds. A
response was made on February 8, 2008,
that indicated that UAB was funding
this study. 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: Cancer
Care For Uninsured Individuals: A
Feasibility Study. Type of Information
Collection Request: New. Need and Use
of Information Collection: The purpose
of this information collection is to
assess the feasibility of obtaining health
insurance information for participants
of the Prostate, Lung, Colon and Ovarian
(PLCO) Cancer Screening Trial
participants from health care providers
and self reports. The ultimate objective
is to compare the health care utilization
of insured and uninsured PLCO
participants. The PLCO data provides a
unique opportunity to study health care
seeking behavior after an abnormal
cancer screening test and the effect of
lack of health insurance. Participants
who had positive cancer screening tests
were referred to their doctors for followup care. No additional care was
provided by the trial. The study
collected detailed information on tests
received for diagnosis, clinical
presentation of disease, and cancer
treatment. Since the PLCO original data
collection had not recorded the health
insurance of participants at the time of
their screening, it is necessary to collect
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
it retrospectively. This feasibility study
will request information from 50
physicians and 150 participants. The
aims are to determine the:
(1) Total number of physicians to be
contacted to obtain insurance
information on all PLCO participants
who had a positive cancer screening
test;
(2) Percentage of physicians willing
and able to provide insurance
information;
(3) Percentage of participants with
and without insurance;
(4) Number of participants for whom
insurance status can be only determined
by self report;
(5) Percentage of PLCO participants
who accept to respond to the survey;
(6) Percentage of individuals who are
willing to provide information on
insurance status; and,
(7) Potential proportion of PLCO
participants without health insurance.
These results will be used to design
a study to examine the health care
behavior of insured and uninsured
PLCO participants. This is relevant to
understand the results of the PLCO
Cancer Screening Trial and other
screening trials currently being
conducted in the U.S. The success of
these trials is conditional on
participants’ access to care following a
recommendation for follow-up.
Uninsured individuals may be more
likely to join these trials than insured
ones in order to get free preventive care.
They may also be more likely to not
seek, or delay seeking, care after an
abnormal screening test even though
they are encouraged to get care and they
may be highly motivated to receive the
best care possible. It is relevant for other
decision makers to understand whether
uninsured persons are receiving
appropriate care after abnormal
screening results. The efforts to control
cancer disease and the loss of life
associated with it are concentrated on
population wide screening. These
endeavors may be compromised if a
significant proportion of the population
does not get appropriate follow-up after
screening or does not get the care
known to be effective for their disease.
Frequency of Response: One time.
Affected Public: Individuals and
households; businesses or other forprofit. Type of Respondents: Individuals
older than 55 who participated in the
PLCO Screening trial and physicians
who provided care for them. The annual
reporting burden is shown in the
following table.
E:\FR\FM\29FEN1.SGM
29FEN1
Federal Register / Vol. 73, No. 41 / Friday, February 29, 2008 / Notices
Number of
respondents
Type of respondents
Frequency of
response
150
1
Physicians office staff ........................................................................................
50
Totals ..........................................................................................................
rwilkins on PROD1PC63 with NOTICES
PLCO participants .............................................................................................
200
The annualized cost to respondents is
estimated at: $487.50. 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 should
address one or more of the following
points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) 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.
Direct Comments To OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the
Attention: NIH Desk Officer, Office of
Management and Budget, at
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
Maria Pisu, Division of Preventive
Medicine, University of Alabama at
Birmingham, MT 628, 1530 3rd Avenue
South, Birmingham, AL 35294–4410, or
call non-toll-free number (205) 975–
7366 or e-mail your request, including
your address to: mpisu@uab.edu
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
VerDate Aug<31>2005
19:22 Feb 28, 2008
Jkt 214001
Dated: February 20, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office,
National Institutes of Health.
[FR Doc. E8–3836 Filed 2–28–08; 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.
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 Pharmacophore for Isatin-bThiosemicarbazone Compounds With
MDR1-Inverse Activity
Description of Technology: One of the
major hindrances to successful cancer
chemotherapy is multi-drug resistance
(MDR), which is frequently caused by
the increased expression or activity of
ABC transporter proteins. Research has
generally been directed to overcoming
MDR during cancer therapy by
inhibiting the activity of ABC
transporters. However, compounds that
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Average
burden hours
per response
11123
Annual hour
burden
1
5 minutes
(0.083) ..........
20 minutes
(0.333)
12.5
16.7
........................
......................
29.2
inhibit ABC transporter activity often
elicit strong and undesirable sideeffects, restricting their usefulness in
therapy.
In an alternative approach to reducing
the debilitating effects of MDR in cancer
therapy, scientists at the National
Cancer Institute identified a family of
compounds whose antiproliferative
effects were actually enhanced in cells
with MDR. These compounds included
NSC 73306, a specific compound that
increased the chemosensitivity of cells
that overexpress ABC transporters
without inhibiting ABC transporter
activity. This invention concerns new
analogs of NSC 73306 with improved
selectivity and solubility, and the use of
the analogs as therapeutics.
Applications:
Treatment of cancers associated with
multi-drug resistance, either alone or in
combination with other therapeutics.
Development of a pharmacophore for
improved effectiveness in treating
cancers associated with multi-drug
resistance.
Advantages:
The agents capitalize on one of the
most common drawbacks to cancer
therapies (MDR) by using it as an
advantage to treating cancer.
Increased specificity allows these
analogs to be tailored to treating cancers
associated with the overexpression and
hyperactivity of particular ABC
transporters.
Increased solubility allows greater
access of the agent to tumor cells,
increasing therapeutic effectiveness of
the agents.
Benefits: Cancer is the second leading
cause of death in United States and it is
estimated that there will be
approximately 600,000 deaths caused by
cancer in 2007. Improving the quality of
life and duration of life of cancer
patients will depend on chemotherapies
with increased effectiveness and
reduced toxicity, thus this technology
can contribute significantly to a social
cause. Furthermore, small molecule
cancer therapy technologies have a
potential market of more than $2 billion.
Inventors: Matthew D. Hall et al.
(NCI).
E:\FR\FM\29FEN1.SGM
29FEN1
]]>Agencies
[Federal Register Volume 73, Number 41 (Friday, February 29, 2008)]
[Notices]
[Pages 11122-11123]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3836]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Cancer Care for
Uninsured Individuals: A Feasibility Study (NCI)
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the National Cancer Institute (NCI),
the National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request to review and approve the
information collection listed below. This proposed information
collection was previously published in the Federal Register on December
21, 2007 (Vol. 72, No. 245, p. 72741 and allowed 60-days for public
comment. One public comment was received that questioned why the study
was not funded by University of Alabama (UAB) funds. A response was
made on February 8, 2008, that indicated that UAB was funding this
study. 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: Cancer Care For Uninsured Individuals:
A Feasibility Study. Type of Information Collection Request: New. Need
and Use of Information Collection: The purpose of this information
collection is to assess the feasibility of obtaining health insurance
information for participants of the Prostate, Lung, Colon and Ovarian
(PLCO) Cancer Screening Trial participants from health care providers
and self reports. The ultimate objective is to compare the health care
utilization of insured and uninsured PLCO participants. The PLCO data
provides a unique opportunity to study health care seeking behavior
after an abnormal cancer screening test and the effect of lack of
health insurance. Participants who had positive cancer screening tests
were referred to their doctors for follow-up care. No additional care
was provided by the trial. The study collected detailed information on
tests received for diagnosis, clinical presentation of disease, and
cancer treatment. Since the PLCO original data collection had not
recorded the health insurance of participants at the time of their
screening, it is necessary to collect it retrospectively. This
feasibility study will request information from 50 physicians and 150
participants. The aims are to determine the:
(1) Total number of physicians to be contacted to obtain insurance
information on all PLCO participants who had a positive cancer
screening test;
(2) Percentage of physicians willing and able to provide insurance
information;
(3) Percentage of participants with and without insurance;
(4) Number of participants for whom insurance status can be only
determined by self report;
(5) Percentage of PLCO participants who accept to respond to the
survey;
(6) Percentage of individuals who are willing to provide
information on insurance status; and,
(7) Potential proportion of PLCO participants without health
insurance.
These results will be used to design a study to examine the health
care behavior of insured and uninsured PLCO participants. This is
relevant to understand the results of the PLCO Cancer Screening Trial
and other screening trials currently being conducted in the U.S. The
success of these trials is conditional on participants' access to care
following a recommendation for follow-up. Uninsured individuals may be
more likely to join these trials than insured ones in order to get free
preventive care. They may also be more likely to not seek, or delay
seeking, care after an abnormal screening test even though they are
encouraged to get care and they may be highly motivated to receive the
best care possible. It is relevant for other decision makers to
understand whether uninsured persons are receiving appropriate care
after abnormal screening results. The efforts to control cancer disease
and the loss of life associated with it are concentrated on population
wide screening. These endeavors may be compromised if a significant
proportion of the population does not get appropriate follow-up after
screening or does not get the care known to be effective for their
disease. Frequency of Response: One time. Affected Public: Individuals
and households; businesses or other for-profit. Type of Respondents:
Individuals older than 55 who participated in the PLCO Screening trial
and physicians who provided care for them. The annual reporting burden
is shown in the following table.
[[Page 11123]]
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average burden hours Annual hour
Type of respondents respondents response per response burden
----------------------------------------------------------------------------------------------------------------
PLCO participants.................... 150 1 5 minutes 12.5
(0.083)..................
Physicians office staff.............. 50 1 20 minutes 16.7
(0.333)..................
--------------------------------------------------------------------------
Totals........................... 200 .............. ......................... 29.2
----------------------------------------------------------------------------------------------------------------
The annualized cost to respondents is estimated at: $487.50. 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 should address one or more of the
following points: (1) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) 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.
Direct Comments To OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the Attention: NIH Desk Officer, Office of Management and
Budget, at OIRA_submission@omb.eop.gov or by fax to 202-395-6974. To
request more information on the proposed project or to obtain a copy of
the data collection plans and instruments, contact: Dr. Maria Pisu,
Division of Preventive Medicine, University of Alabama at Birmingham,
MT 628, 1530 3rd Avenue South, Birmingham, AL 35294-4410, or call non-
toll-free number (205) 975-7366 or e-mail your request, including your
address to: mpisu@uab.edu
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: February 20, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office, National Institutes of Health.
[FR Doc. E8-3836 Filed 2-28-08; 8:45 am]
BILLING CODE 4140-01-P
