Prospective Grant of Co-Exclusive License: The Development of Human Anti-CD22 Monoclonal Antibodies for the Treatment of Human Cancers and Autoimmune Disease, 41792-41793 [2012-17218]
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Federal Register / Vol. 77, No. 136 / Monday, July 16, 2012 / Notices
TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS—Continued
Type of respondents
Frequency of response
Average time per
response
(minutes/hour)
3,760 .................................
1.00
5/60
313
2,000 .................................
94,000 ...............................
1.00
1.00
5/60
15/60
167
23,500
...........................................
............................
............................
31,813
Number of respondents
Script for ASU Non-response.
HSQ ..................................
MUQ .................................
Total ............................
Survey instrument
...........................................
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) 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.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Christine D.
Berg, Chief, Early Detection Research
Group, National Cancer Institute, NIH,
EPN Building, Room 3100, 6130
Executive Boulevard, Bethesda, MD
20892, or call non-toll-free number 301–
496–8544 or email your request,
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Comments Due Date: Comments
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best assured of having their full effect if
received within 60 days of the date of
this publication.
srobinson on DSK4SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Dated: July 10, 2012.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2012–17237 Filed 7–13–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Co-Exclusive
License: The Development of Human
Anti-CD22 Monoclonal Antibodies for
the Treatment of Human Cancers and
Autoimmune Disease
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of a coexclusive license to practice the
inventions embodied in U.S. Patent
Application 61/042,239 entitled
‘‘Human Monoclonal Antibodies
Specific for CD22’’ [HHS Ref. E–080–
2008/0–US–01], PCT Application PCT/
US2009/124109 entitled ‘‘Human and
Improved Murine Monoclonal
Antibodies Against CD22’’ [HHS Ref. E–
080–2008/0–PCT–02], US patent
application 12/934,214 entitled ‘‘Human
Monoclonal Antibodies Specific for
CD22’’ [HHS Ref. E–080–2008/0–US–
03], and all related continuing and
foreign patents/patent applications for
the technology family, to Customized
Therapeutics. The patent rights in these
inventions have been assigned to and/or
exclusively licensed to the Government
of the United States of America.
The prospective co-exclusive licensed
territory may be worldwide, and the
field of use may be limited to:
SUMMARY:
The use of the m971 and m972 (SMB–002)
monoclonal antibodies as therapies for the
treatment of B cell cancers and autoimmune
disease. The Licensed Field of Use includes
the use of the antibodies in the form of an
immunoconjugate, including immunotoxins.
Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before July
31, 2012 will be considered.
DATES:
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16:32 Jul 13, 2012
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Annual burden
hours
Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated co-exclusive license
should be directed to: David A.
Lambertson, Ph.D., Senior Licensing
and Patenting Manager, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 435–4632; Facsimile:
(301) 402–0220; E-mail:
lambertsond@od.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention concerns monoclonal
antibodies against CD22 and methods of
using the antibodies for the treatment of
CD22-expressing cancers, including
hematological malignancies such as
hairy cell leukemia, chronic
lymphocytic leukemia and pediatric
acute lymphoblastic leukemia, and
autoimmune disease such as lupus and
Sjogren’s syndrome. The specific
antibodies covered by this technology
are designated m971 and m972 (SMB–
002; applicant designation).
CD22 is a cell surface antigen that is
preferentially expressed on certain types
of cancer cells, and is involved in the
modulation of the immune system. The
m971 and m972 antibodies can
selectively bind to diseased cells and
induce cell death while leaving healthy,
essential cells unharmed. This can
result in an effective therapeutic
strategy with fewer side effects due to
less non-specific killing of cells.
The prospective co-exclusive license
may be granted unless the NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR 404.7 within fifteen (15) days from
the date of this published notice.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated coexclusive license. Comments and
objections submitted to this notice will
not be made available for public
inspection and, to the extent permitted
by law, will not be released under the
ADDRESSES:
E:\FR\FM\16JYN1.SGM
16JYN1
Federal Register / Vol. 77, No. 136 / Monday, July 16, 2012 / Notices
Freedom of Information Act, 5 U.S.C.
552.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 11, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–17218 Filed 7–13–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
srobinson on DSK4SPTVN1PROD with NOTICES
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AIDS and
AIDS Related Research.
Date: August 2, 2012.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Robert Freund, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216,
MSC 7852, Bethesda, MD 20892, 301–435–
1050, freundr@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 10, 2012.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel
Services Research.
Date: July 20, 2012.
Time: 2 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Aileen Schulte, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6140, MSC 9608,
Bethesda, MD 20892–9608, 301–443–1225,
aschulte@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: July 10, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–17239 Filed 7–13–12; 8:45 am]
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Social
Science and Population Studies: Special
Topics.
Date: July 30, 2012.
Time: 3:30 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Valerie Durrant, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3148,
MSC 7770, Bethesda, MD 20892, (301) 827–
6390, durrantv@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 10, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–17213 Filed 7–13–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
BILLING CODE 4140–01–P
16:32 Jul 13, 2012
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
BILLING CODE 4140–01–P
[FR Doc. 2012–17214 Filed 7–13–12; 8:45 am]
VerDate Mar<15>2010
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Periodically, the Substance Abuse and
Mental Health Services Administration
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]]>Agencies
[Federal Register Volume 77, Number 136 (Monday, July 16, 2012)]
[Notices]
[Pages 41792-41793]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17218]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Co-Exclusive License: The Development of
Human Anti-CD22 Monoclonal Antibodies for the Treatment of Human
Cancers and Autoimmune Disease
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR Part 404.7(a)(1)(i), that the National Institutes of Health,
Department of Health and Human Services, is contemplating the grant of
a co-exclusive license to practice the inventions embodied in U.S.
Patent Application 61/042,239 entitled ``Human Monoclonal Antibodies
Specific for CD22'' [HHS Ref. E-080-2008/0-US-01], PCT Application PCT/
US2009/124109 entitled ``Human and Improved Murine Monoclonal
Antibodies Against CD22'' [HHS Ref. E-080-2008/0-PCT-02], US patent
application 12/934,214 entitled ``Human Monoclonal Antibodies Specific
for CD22'' [HHS Ref. E-080-2008/0-US-03], and all related continuing
and foreign patents/patent applications for the technology family, to
Customized Therapeutics. The patent rights in these inventions have
been assigned to and/or exclusively licensed to the Government of the
United States of America.
The prospective co-exclusive licensed territory may be worldwide,
and the field of use may be limited to:
The use of the m971 and m972 (SMB-002) monoclonal antibodies as
therapies for the treatment of B cell cancers and autoimmune
disease. The Licensed Field of Use includes the use of the
antibodies in the form of an immunoconjugate, including
immunotoxins.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before July
31, 2012 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated co-exclusive
license should be directed to: David A. Lambertson, Ph.D., Senior
Licensing and Patenting Manager, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301)
402-0220; E-mail: lambertsond@od.nih.gov.
SUPPLEMENTARY INFORMATION: This invention concerns monoclonal
antibodies against CD22 and methods of using the antibodies for the
treatment of CD22-expressing cancers, including hematological
malignancies such as hairy cell leukemia, chronic lymphocytic leukemia
and pediatric acute lymphoblastic leukemia, and autoimmune disease such
as lupus and Sjogren's syndrome. The specific antibodies covered by
this technology are designated m971 and m972 (SMB-002; applicant
designation).
CD22 is a cell surface antigen that is preferentially expressed on
certain types of cancer cells, and is involved in the modulation of the
immune system. The m971 and m972 antibodies can selectively bind to
diseased cells and induce cell death while leaving healthy, essential
cells unharmed. This can result in an effective therapeutic strategy
with fewer side effects due to less non-specific killing of cells.
The prospective co-exclusive license may be granted unless the NIH
receives written evidence and argument that establishes that the grant
of the license would not be consistent with the requirements of 35
U.S.C. 209 and 37 CFR 404.7 within fifteen (15) days from the date of
this published notice.
Complete applications for a license in the field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated co-exclusive license. Comments and objections
submitted to this notice will not be made available for public
inspection and, to the extent permitted by law, will not be released
under the
[[Page 41793]]
Freedom of Information Act, 5 U.S.C. 552.
Dated: July 11, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-17218 Filed 7-13-12; 8:45 am]
BILLING CODE 4140-01-P
