Prospective Grant of Exclusive License: Compositions and Method for Preventing Reactogenicity Associated with Administration of Immunogenic Live Rotavirus Compositions, 60510 [2011-25098]
Download as PDF
<![CDATA[
60510
Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices
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
Allergy and Infectious Diseases Special
Emphasis Panel; ‘‘Combined Multipurpose
Prevention Strategies for Sexual and
Reproductive Health’’.
Date: October 18, 2011.
Time: 12:30 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Jane K. Battles, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, Room 3147, Bethesda, MD
20892–7616, 301–451–2744,
battlesja@mail.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; ‘‘Combined Multipurpose
Prevention Strategies for Sexual and
Reproductive Health’’.
Date: October 31, 2011.
Time: 9 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Jane K. Battles, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, Room 3147, Bethesda, MD
20892–7616, 301–451–2744,
battlesja@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 23, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–25096 Filed 9–28–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSKG8SOYB1PROD with NOTICES
National Institutes of Health
Prospective Grant of Exclusive
License: Compositions and Method for
Preventing Reactogenicity Associated
with Administration of Immunogenic
Live Rotavirus Compositions
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
VerDate Mar<15>2010
15:29 Sep 28, 2011
Jkt 223001
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in U.S. Provisional Patent
Application No. 60/178,689, filed
January 28, 2000 [HHS Ref. No. E–088–
2000/0–US–01], now expired; PCT
Patent Application No. PCT/US01/
02686 [HHS Ref. No. E–088–2000/0–
PCT–02] filed January 26, 2001, which
published as WO/2001/54718 on August
2, 2001, now expired; U.S. Patent No.
7,431,931 [HHS Ref. No. E–088–2000/0–
US–06]; Australian Patent No. 784344
[HHS Ref. No. E–088–2000/0–AU–04];
German Patent No. 60141681.308 [HHS
Ref. No. E–088–2000/0–DE–08]; French
Patent No. 1251869 [HHS Ref. No. E–
088–2000/0–FR–09]; United Kingdom
Patent No. 1251869 [HHS Ref. No. E–
088–2000/0–GB–10]; and Canadian
Patent Application No. 2398428 [HHS
Ref. No. E–088–2000/0–CA–05], entitled
‘‘Compositions and Method for
Preventing Reactogenicity Associated
with Administration of Immunogenic
Live Rotavirus Compositions,’’ and all
continuing applications to International
Medica Foundation, having a place of
business in Rochester, Minnesota. The
patent rights in these inventions have
been assigned to the United States of
America.
The prospective exclusive license
territory may be ‘‘worldwide’’, and the
field of use may be limited to ‘‘rhesusbased rotavirus therapeutic and/or
prophylactic vaccines.’’
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
October 31, 2011 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Kevin W. Chang, 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) 435–5018; Facsimile: (301) 402–
0220; E-mail: changke@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
present invention provides
compositions for making a medicament
and methods for the administration of
vaccine compositions for protection
against human rotaviral disease without
significant reactogenicity. Human x
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
rhesus reassortant rotavirus
compositions were made which when
administered during the first 7 to about
10 days of life, provided a composition
which was non-reactogenic followed by
booster immunizations at 16 to 18
weeks or 14 to 20 weeks, up to 1 year
of age. The immune response induced
by the initial neonatal administration of
the live rotavirus vaccine composition
protects the infant from the
reactogenicity of the composition when
administered as a second vaccine dose
at or after 2 months of age.
Administration of the immunogenic
composition also is expected to ablate or
significantly diminish the increase in
the excess of intussusception observed 3
to 7 days following administration of
the initial dose of rotavirus vaccine at
about 2 to 4 months.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless
within thirty (30) days from the date of
this published notice, 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.
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 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 Freedom of Information Act,
5 U.S.C. 552.
Dated: September 22, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2011–25098 Filed 9–28–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2011–0076]
DHS Data Privacy and Integrity
Advisory Committee; Meeting
Privacy Office, DHS.
Notice.
AGENCY:
ACTION:
On Wednesday, September
21, 2011, the DHS Privacy Office
announced in the Federal Register at 76
FR 58524 that the Data Privacy and
SUMMARY:
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Page 60510]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Compositions and Method
for Preventing Reactogenicity Associated with Administration of
Immunogenic Live Rotavirus Compositions
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 404.7(a)(1)(i), that the National Institutes of Health, Department
of Health and Human Services, is contemplating the grant of an
exclusive patent license to practice the inventions embodied in U.S.
Provisional Patent Application No. 60/178,689, filed January 28, 2000
[HHS Ref. No. E-088-2000/0-US-01], now expired; PCT Patent Application
No. PCT/US01/02686 [HHS Ref. No. E-088-2000/0-PCT-02] filed January 26,
2001, which published as WO/2001/54718 on August 2, 2001, now expired;
U.S. Patent No. 7,431,931 [HHS Ref. No. E-088-2000/0-US-06]; Australian
Patent No. 784344 [HHS Ref. No. E-088-2000/0-AU-04]; German Patent No.
60141681.308 [HHS Ref. No. E-088-2000/0-DE-08]; French Patent No.
1251869 [HHS Ref. No. E-088-2000/0-FR-09]; United Kingdom Patent No.
1251869 [HHS Ref. No. E-088-2000/0-GB-10]; and Canadian Patent
Application No. 2398428 [HHS Ref. No. E-088-2000/0-CA-05], entitled
``Compositions and Method for Preventing Reactogenicity Associated with
Administration of Immunogenic Live Rotavirus Compositions,'' and all
continuing applications to International Medica Foundation, having a
place of business in Rochester, Minnesota. The patent rights in these
inventions have been assigned to the United States of America.
The prospective exclusive license territory may be ``worldwide'',
and the field of use may be limited to ``rhesus-based rotavirus
therapeutic and/or prophylactic vaccines.''
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
October 31, 2011 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Kevin W. Chang, 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) 435-5018; Facsimile: (301) 402-0220; E-
mail: changke@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The present invention provides compositions
for making a medicament and methods for the administration of vaccine
compositions for protection against human rotaviral disease without
significant reactogenicity. Human x rhesus reassortant rotavirus
compositions were made which when administered during the first 7 to
about 10 days of life, provided a composition which was non-reactogenic
followed by booster immunizations at 16 to 18 weeks or 14 to 20 weeks,
up to 1 year of age. The immune response induced by the initial
neonatal administration of the live rotavirus vaccine composition
protects the infant from the reactogenicity of the composition when
administered as a second vaccine dose at or after 2 months of age.
Administration of the immunogenic composition also is expected to
ablate or significantly diminish the increase in the excess of
intussusception observed 3 to 7 days following administration of the
initial dose of rotavirus vaccine at about 2 to 4 months.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
The prospective exclusive license may be granted unless within thirty
(30) days from the date of this published notice, 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.
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 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 Freedom of
Information Act, 5 U.S.C. 552.
Dated: September 22, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-25098 Filed 9-28-11; 8:45 am]
BILLING CODE 4140-01-P
