Proposed Collection; Comment Request; NIH Intramural Research, Training Program Application, 6505-6506 [06-1140]
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Federal Register / Vol. 71, No. 26 / Wednesday, February 8, 2006 / Notices
for the treatment of patients with locally
advanced metastatic non-small cell lung
cancer after prior chemotherapy.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
ALIMTA (U.S. Patent No. 5,344,932)
from Eli Lilly and Co., and the Patent
and Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated August 31, 2004, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of ALIMTA
represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
ALIMTA is 4,166 days. Of this time,
4,038 days occurred during the testing
phase of the regulatory review period,
while 128 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: September 10,
1992. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on September 10, 1992.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the act: September 30, 2003. The
applicant claims September 29, 2003, as
the date the new drug application
(NDA) for ALIMTA (NDA 21–462) was
initially submitted. However, FDA
records indicate that NDA 21–462 was
submitted on September 30, 2003.
3. The date the application was
approved: February 4, 2004. FDA has
verified the applicant’s claim that NDA
21–462 was approved on February 4,
2004.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,784 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect
may, submit to the Division of Dockets
Management (see ADDRESSES) written
comments and ask for a redetermination
by April 10, 2006, Furthermore, any
interested person may petition FDA, for
a determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by August 7, 2006. To meet its
burden, the petition must contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: January 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–1642 Filed 2–7–06; 8:45 am]
BILLING CODE 4160–01–S
Estimated
number of
respondents
Type of respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; NIH Intramural Research,
Training Program Application
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
Office of the Director, 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: NIH Intramural Research
Training Program Applications.
Type of Information Collection
Request: Revision/OMB No. 0925–0299;
February 28, 2006.
Need and Use of Information
Collection: The proposed information
collection activity is for the purpose of
collecting data related to the availability
of Training Fellowships in the NIH
Intramural Research Program. This
information must be submitted in order
to receive due consideration for a
fellowship and will be used to
determine the eligibility and quality of
potential awardees.
Frequency of Response: On occasion.
Affected Public: Individuals seeking
Intramural Training Opportunities and
references for these individuals.
Type of Respondents: Postdoctoral,
predoctoral, post-baccalaureate,
technical, clinical, and student IRTA
applicants. There are no capital costs,
operating costs, and/or maintenance
costs to report.
Estimated
number of
responses per
respondent
Average
burden hours
per
response
Estimated total
annual burden
hours
requested
rmajette on PROD1PC67 with NOTICES1
Postdoctoral .....................................................................................................
Predoctoral .......................................................................................................
Postbaccalaureate ...........................................................................................
Technical ..........................................................................................................
Clinical .............................................................................................................
Student .............................................................................................................
References for all categories ...........................................................................
1,000
175
2,090
175
300
7,000
31,395
3.00
1.00
1.00
1.00
1.00
1.00
1.00
1.00
1.00
1.00
1.00
1.00
1.00
0.33
3,000
175
2,090
175
300
7,000
10,360
Total ..........................................................................................................
42,135
1.0474665
0.5482378
23,100
Request for Comments
Written comments and/or suggestions
from the public and affected agencies
VerDate Aug<31>2005
15:26 Feb 07, 2006
Jkt 208001
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
PO 00000
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necessary for the proper performance of
the agency, including whether the
information will have practical utility;
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08FEN1
6506
Federal Register / Vol. 71, No. 26 / Wednesday, February 8, 2006 / Notices
(2) The accuracy of the agency’s
estimate of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Ways to enhance the quality, utility,
and the clarity of 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: Steve Alves, Web
site Programs Specialist, Office of
Intramural Training and Education, OD,
NIH, Building 2, Room 2W17, 2 Center
Drive MSC 0240, Bethesda, MD 20892–
0240, or call non-toll-free number (301)
402–1294, or e-mail your request,
including your address to:
alvess@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.
Dated: January 23, 2006.
Christine Major,
Acting Director, Office of Human Resources,
National Institutes of Health.
[FR Doc. 06–1140 Filed 2–7–06; 8:45 am]
BILLING CODE 4140–01–M
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.
rmajette on PROD1PC67 with NOTICES1
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
VerDate Aug<31>2005
15:26 Feb 07, 2006
Jkt 208001
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.
Oligodeoxyribonucleotides Comprising
O66-Benzylguanine and Their Use
Robert C. Moschel et al. (NCI)
U.S. Patent No. 6,060,458 issued 09 May
2000 (HHS Reference No. E–104–
1998/0–US–01).
Licensing Contact: George G. Pipia,
PhD.; 301/435–5560;
pipiag@mail.nih.gov.
Chemotherapy is a common treatment
for a variety of cancers.
Chemotherapeutic alkylating agents
represent a key category of commonly
used antineoplastic drugs. These drugs
are active against chronic leukemias,
non-Hodgkin lymphoma, Hodgkin
disease, multiple myeloma, lung, breast,
ovarian cancer, and certain other
cancers. The DNA repair protein, O6alkylguanine-DNA alkyltransferase
(AGT), is a primary source of tumor cell
resistance to the alkylating drugs that
alkylate the O6 position of guanine in
DNA. AGT therefore becomes the prime
target for modulation. Currently, AGT
inactivators are used as adjuvants to
enhance chemotherapy by the alkylating
drugs.
O6-Benzylguanine is the prototype
AGT inactivator in phase I, II and III
clinical trials as an adjuvant to improve
chemotherapy. Although O6benzylguanine is a promising AGT
inactivator, it is not an ideal drug. O6Benzylguanine is only sparingly soluble
in water, and it is not effective in
inactivating some mutant
alkyltransferase proteins that could
possibly be produced after repeated
chemotherapy cycles. The present
invention describes
oligodeoxyribonucleotides containing
O6-benzylguanine residues as another
class of AGT inactivators, and discusses
the advantages of their use in
comparison to O6-benzylguanine as the
free base. Oligodeoxyribonucleotides
containing O6-benzylguanine residues
are extremely water soluble and can
efficiently inactivate AGT at much
lower concentrations than O6benzylguanine. In addition, they are
effective in inactivating several mutant
alkyltransferase proteins that are highly
resistant to inactivation by O6benzylguanine. Furthermore,
positioning O6-benzylguanine near the
3′-or 5′-terminus of these
oligodeoxyribonucleotides improves
their resistance to degradation by
cellular nuclease proteins. Therefore,
oligodeoxyribonucleotides containing
PO 00000
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Sfmt 4703
multiple O6-benzylguanine residues
may be more effective chemotherapy
adjuvants than O6-benzylguanine.
The CCHC Zinc Fingers of the
Retroviral Nucleocapsid Protein
Comprises a New Target Useful in
Identification and Evaluation of AntiHIV Therapeutics
Louis E. Henderson et al. (NCI)
U.S. Patent No. 6,001,555 issued 14 Dec
1999 (HHS Reference No. E–174–
1993/1–US–01).
Licensing Contact: Sally H. Hu, PhD.,
M.B.A.; 301/435–5606;
hus@mail.nih.gov.
According to a recently released
report from the WHO, an estimated 40.3
million people worldwide are currently
living with HIV infection, and more
than three million people died of AIDSrelated illnesses in 2005. In response to
increased prevalence of HIV/AIDS, the
search for effective antiretroviral
therapy is intensive. The present
invention describes compounds that
may be useful for developing new types
of antiretroviral therapeutics for HIV
infection.
HIV–1 contains domains known as
‘‘CCHC zinc fingers’’ in the retroviral
nucleocapsid (NC) protein.
Nucleocapsid CCHC zinc fingers are
highly conserved throughout nearly all
retroviruses. They are sequences of 14
amino acids with four invariant
residues, Cys(X)2Cys(X)4His(X)4Cys,
which chelate zinc and perform
essential functions in viral infectivity.
HIV–1 NC has two CCHC zinc fingers,
both of which are necessary for
infectivity. Many compounds that
disrupt the CCHC zinc fingers also
inactivate HIV–1 by preventing the
initiation of reverse transcription and by
blocking production of infectious virus
from previously infected cells.
Compounds with this activity may be
useful for developing new types of
antiretroviral drugs. In addition,
compounds with this activity can be
useful for production of chemically
inactivated retroviral particles that lack
infectivity but retain structurally and
functionally intact envelope
glycoproteins. Such inactivated
particles may be useful both as in vitro
reagents in a variety of applications and
as immunogens for whole inactivated
virus vaccines.
The present invention concerns
antiretroviral compounds that disrupt
the CCHC zinc fingers and assays for
identifying such compounds. The
invariant nature of retroviral zinc
fingers also extends the usefulness of
these compounds to other retroviruses.
Thus these assays are also useful for
screening compounds effective against
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08FEN1
]]>Agencies
[Federal Register Volume 71, Number 26 (Wednesday, February 8, 2006)]
[Notices]
[Pages 6505-6506]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1140]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; NIH Intramural Research,
Training Program Application
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 Office of
the Director, 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: NIH Intramural Research Training Program Applications.
Type of Information Collection Request: Revision/OMB No. 0925-0299;
February 28, 2006.
Need and Use of Information Collection: The proposed information
collection activity is for the purpose of collecting data related to
the availability of Training Fellowships in the NIH Intramural Research
Program. This information must be submitted in order to receive due
consideration for a fellowship and will be used to determine the
eligibility and quality of potential awardees.
Frequency of Response: On occasion.
Affected Public: Individuals seeking Intramural Training
Opportunities and references for these individuals.
Type of Respondents: Postdoctoral, predoctoral, post-baccalaureate,
technical, clinical, and student IRTA applicants. There are no capital
costs, operating costs, and/or maintenance costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average total annual
Type of respondent number of responses per burden hours burden hours
respondents respondent per response requested
----------------------------------------------------------------------------------------------------------------
Postdoctoral.................................... 1,000 3.00 1.00 3,000
Predoctoral..................................... 175 1.00 1.00 175
Postbaccalaureate............................... 2,090 1.00 1.00 2,090
Technical....................................... 175 1.00 1.00 175
Clinical........................................ 300 1.00 1.00 300
Student......................................... 7,000 1.00 1.00 7,000
References for all categories................... 31,395 1.00 0.33 10,360
-----------------
Total....................................... 42,135 1.0474665 0.5482378 23,100
----------------------------------------------------------------------------------------------------------------
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
proper performance of the agency, including whether the information
will have practical utility;
[[Page 6506]]
(2) The accuracy of the agency's estimate of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) Ways to enhance the quality, utility, and the clarity of
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: Steve Alves, Web site Programs Specialist, Office
of Intramural Training and Education, OD, NIH, Building 2, Room 2W17, 2
Center Drive MSC 0240, Bethesda, MD 20892-0240, or call non-toll-free
number (301) 402-1294, or e-mail your request, including your address
to: alvess@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.
Dated: January 23, 2006.
Christine Major,
Acting Director, Office of Human Resources, National Institutes of
Health.
[FR Doc. 06-1140 Filed 2-7-06; 8:45 am]
BILLING CODE 4140-01-M
