Prospective Grant of Exclusive License: Live, Attenuated Virus Vaccines Against RSV, PIV, and hMPV, 52058-52059 [E8-20650]
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Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
National Institute on Deafness and
Other Communication Disorders;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; National Children’s
Study Repository, RFP: NIH–NICHD–NCS–
09–07.
Date: October 6, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Sathasiva B. Kandasamy,
PHD, Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health, and Human
Development, 6100 Executive Boulevard,
Room 5B01, Bethesda, MD 20892–9304, (301)
435–6680, skandasa@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: August 28, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–20647 Filed 9–5–08; 8:45 am]
Name of Committee: Communication
Disorders Review Committee.
Date: October 15–16, 2008.
Time: October 15, 2008, 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: One Washington Circle Hotel, One
Washington Circle, Washington, DC 20037.
Time: October 16, 2008, 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: One Washington Circle Hotel, One
Washington Circle, Washington, DC 20037.
Contact Person: Shiguang Yang, DVM,
PhD, Scientific Review Administrator,
Scientific Review Branch, Division of
Extramural Activities, NIDCD, NIH, 6120
Executive Blvd., Suite 400C, Bethesda, MD
20892, 301–435–1425,
yangshi@nidcd.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
Dated: August 29, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–20681 Filed 9–5–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Live, Attenuated Virus
Vaccines Against RSV, PIV, and hMPV
BILLING CODE 4140–01–P
mstockstill on PROD1PC66 with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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.
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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17:59 Sep 05, 2008
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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 (NIH), Department
of Health and Human Services, is
contemplating the grant of worldwide
exclusive license to practice the
invention embodied in:
RSV Technologies
(1) U.S. Patents 5,993,824 (issued
November 30, 1999) and associated
pending U.S. patent applications, serial
numbers 10/934,003 (filed September 2,
2004) and 10/722,000 (filed November
25, 2003) and associated foreign rights
from PCT applications PCT/US97/12269
(filed July 15, 1997) and PCT/US00/
08802 (filed March 31, 2000) (HHS
references E–142–1996/0,3,4);
(2) U.S. Patent 6,713,066 (issued
March 30, 2004) and associated pending
U.S. patent application, serial number
11/011,502 (filed December 13, 2004)
and associated foreign rights from PCT
application PCT/US00/18534 (HHS
reference E–194–1999/0);
(3) PCT application PCT/US00/09695
and associated foreign rights therefrom
(HHS reference E–040–1999/0);
(4) U.S. patent applications, serial
numbers 11/054,343 (filed February 9,
2001) and 11/033,055 (filed January 10,
2005), and associated foreign rights from
PCT application PCT/US01/20107 (HHS
reference E–225–2000/0).
PIV Technologies
(1) U.S. Patents 6,410,023 (issued June
25, 2002); 7,208,161 (issued April 24,
2007); 7,314,631 (issued January 1,
2008); 7,250,171 (issued July 31, 2007);
and pending U.S. patent application,
serial number 11/785,364 (filed April
17, 2007), and associated foreign rights
through PCT applications PCT/US98/
10551 (filed May 22, 1998) and PCT/
US00/18523 (filed July 6, 2000) (filed
December 8, 2000) (HHS references E–
089–1997/2,3,4,5,6,7);
(2) U.S. patent application, serial
number 10/667,141 (filed September 18,
2003) and associate foreign rights from
PCT/US03/29685 (filed September 18,
2003) (HHS reference E–092–2002/0);
(3) U.S. patent application (serial
number pending, filed January 10, 2006)
and associated foreign rights from PCT/
US2006/000666 (filed January 10, 2006)
(HHS reference E–295–2004/0);
(4) U.S. patent application, serial
number 10/302,547 (filed November 21,
2002) and associated foreign rights from
PCT/US02/37688 (filed November 21,
2002) (HHS reference E–280–2001/0).
hMPV Technology
(1) U.S. patent application, serial
number 10/789,400 (filed February 27,
E:\FR\FM\08SEN1.SGM
08SEN1
Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices
2004) and associated foreign rights from
PCT/US04/05881 (filed February 27,
2004) (HHS references E–093–2003/
0,1,2)
to MedImmune, LLC, having a place of
business in Gaithersburg, Maryland,
USA. The patent rights in these
inventions have been assigned to the
United States of America.
DATES: Only written comments and/or
application for a license which are
received by the NIH Office of
Technology Transfer on or before
November 7, 2008 will be considered.
ADDRESSES: Requests for a copy of the
patents and patent applications,
inquiries, comments and other materials
relating to the contemplated license
should be directed to: Michael
Shmilovich, Office of Technology
Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; e-mail:
shmilovm@mail.nih.gov; Telephone:
(301) 435–5019; Facsimile: (301) 402–
0220.
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 sixty (60) days from the date of
this published Notice, 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.
The above referenced technologies
describe development of live, attenuated
virus vaccines for respiratory syncytial
virus (RSV), subgroups A and B, human
parainfluenza, types 1, 2,3 (HPIV1,
HPIV2, and HPIV3), and human
metapneumovirus (hMPV).
The field of use in which NIH
contemplates granting an exclusive
license may be limited to the following
and excludes fields employing any
vectored vaccines and any humanbovine chimeras for RSV A, RSV B,
HPIV3, HPIV2, HPIVI, and hMPV:
Live attenuated virus vaccines for
intranasal administration to humans
against RSV subgroups A and B, HPIV1,
HPIV2, HPIV3, and hMPV based on the
following viruses (in bold) and their
corresponding attenuating mutations (in
bulleted italics):
Human RSV subgroups A or B or A/
B chimeras:
• rcp248/404/1030∆SH, including the
stabilized version of this virus;
• ∆NS1;
• ∆M2–2.
mstockstill on PROD1PC66 with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
17:59 Sep 05, 2008
Jkt 214001
HPIV3
• rcp45
HPIV2
• Mutations in C and L imported from
other viruses, e.g., HRSV, BPIV3, and
HPIV3, with or without stabilization by
codon substitution or deletion;
• L(∆1724);
• Viruses with P and V genes
separated
HPIV1
• Mutations in C and L imported from
other viruses, e.g., HRSV, BPIV3, and
HPIV3, with or without stabilization by
codon substitution or deletion;
• C(170);
• C(R84G) mutation;
• L(942stablized);
• Viruses with P and C genes
separated.
hMPV
• ∆G, alone or in combination with
∆SH;
• ∆M2–2;
• Avian-human chimera with avian P
ORF placed in hMPV backbone.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response 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: August 26, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–20650 Filed 9–5–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
Report on Carcinogens (RoC); Request
for Public Comments on the RoC
Expert Panel’s Recommendation on
Listing Status for Styrene in the 12th
RoC and the Scientific Justification for
the Recommendation
National Institute of
Environmental Health Sciences
(NIEHS); National Institutes of Health
(NIH).
ACTION: Request for comments.
AGENCY:
SUMMARY: The RoC Office invites public
comment on the recommendation from
an expert panel on the listing status for
styrene in the 12th RoC and the
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52059
scientific justification for the
recommendation. The recommendation
and scientific justification for styrene is
available electronically in Part B of the
Expert Panel Report (https://
ntp.niehs.nih.gov/go/29682, see Expert
Panel Report Part B) or in printed text
from the RoC Office (see FOR FURTHER
INFORMATION CONTACT below). The RoC
Office convened an eleven-member
expert panel of scientists from the
public and private sectors on July 21–
22, 2008. The panel was asked (1) to
apply the RoC listing criteria to the
relevant scientific evidence and make a
recommendation regarding listing status
(i.e., known to be a human carcinogen,
reasonably anticipated to be a human
carcinogen, or not to list) for styrene in
the 12th RoC and (2) to provide the
scientific justification for the
recommendation.
DATES: The Expert Panel Report (Part B)
for styrene will be available for public
comment by September 3, 2008. Written
comments should be submitted by
October 23, 2008.
ADDRESSES: Comments should be sent to
Dr. Ruth Lunn, Director, RoC Office
[NIEHS, P.O. Box 12233, MD EC–14,
Research Triangle Park, NC 27709, Fax:
919–541–0144, or lunn@niehs.nih.gov.
Courier address: Report on Carcinogens,
79 T.W. Alexander Drive, Building
4401, Room 3118, Research Triangle
Park, NC 27709].
FOR FURTHER INFORMATION CONTACT: Dr.
Ruth Lunn, RoC Office, 919–316–4637
lunn@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
Styrene is a flammable liquid used
worldwide in the manufacture of
polystyrene, which is used extensively
in the manufacture of plastic packaging,
thermal insulation in building
construction and refrigeration
equipment, and disposable cups and
containers. Styrene also is used in other
polymers and resins that are used to
manufacture boats, shower stalls, tires,
automotive parts, and many other
products. The general population is
exposed to styrene from inhalation of
indoor air; and outdoor air, tobacco
smoke, and ingestion of food.
Occupational exposure occurs mainly in
the reinforced plastics, styrenebutadiene rubber, and styrene monomer
and polymer industries.
As part of the RoC review process
(available at https://ntp.niehs.nih.gov/go/
15208), the NTP announced the
availability of the draft background
document for styrene (Federal Register:
May 20, 2008: Vol. 73, No. 98, pages
29139–29140), invited public comments
E:\FR\FM\08SEN1.SGM
08SEN1
Agencies
[Federal Register Volume 73, Number 174 (Monday, September 8, 2008)]
[Notices]
[Pages 52058-52059]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20650]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Live, Attenuated Virus
Vaccines Against RSV, PIV, and hMPV
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 (NIH),
Department of Health and Human Services, is contemplating the grant of
worldwide exclusive license to practice the invention embodied in:
RSV Technologies
(1) U.S. Patents 5,993,824 (issued November 30, 1999) and
associated pending U.S. patent applications, serial numbers 10/934,003
(filed September 2, 2004) and 10/722,000 (filed November 25, 2003) and
associated foreign rights from PCT applications PCT/US97/12269 (filed
July 15, 1997) and PCT/US00/08802 (filed March 31, 2000) (HHS
references E-142-1996/0,3,4);
(2) U.S. Patent 6,713,066 (issued March 30, 2004) and associated
pending U.S. patent application, serial number 11/011,502 (filed
December 13, 2004) and associated foreign rights from PCT application
PCT/US00/18534 (HHS reference E-194-1999/0);
(3) PCT application PCT/US00/09695 and associated foreign rights
therefrom (HHS reference E-040-1999/0);
(4) U.S. patent applications, serial numbers 11/054,343 (filed
February 9, 2001) and 11/033,055 (filed January 10, 2005), and
associated foreign rights from PCT application PCT/US01/20107 (HHS
reference E-225-2000/0).
PIV Technologies
(1) U.S. Patents 6,410,023 (issued June 25, 2002); 7,208,161
(issued April 24, 2007); 7,314,631 (issued January 1, 2008); 7,250,171
(issued July 31, 2007); and pending U.S. patent application, serial
number 11/785,364 (filed April 17, 2007), and associated foreign rights
through PCT applications PCT/US98/10551 (filed May 22, 1998) and PCT/
US00/18523 (filed July 6, 2000) (filed December 8, 2000) (HHS
references E-089-1997/2,3,4,5,6,7);
(2) U.S. patent application, serial number 10/667,141 (filed
September 18, 2003) and associate foreign rights from PCT/US03/29685
(filed September 18, 2003) (HHS reference E-092-2002/0);
(3) U.S. patent application (serial number pending, filed January
10, 2006) and associated foreign rights from PCT/US2006/000666 (filed
January 10, 2006) (HHS reference E-295-2004/0);
(4) U.S. patent application, serial number 10/302,547 (filed
November 21, 2002) and associated foreign rights from PCT/US02/37688
(filed November 21, 2002) (HHS reference E-280-2001/0).
hMPV Technology
(1) U.S. patent application, serial number 10/789,400 (filed
February 27,
[[Page 52059]]
2004) and associated foreign rights from PCT/US04/05881 (filed February
27, 2004) (HHS references E-093-2003/0,1,2)
to MedImmune, LLC, having a place of business in Gaithersburg,
Maryland, USA. The patent rights in these inventions have been assigned
to the United States of America.
DATES: Only written comments and/or application for a license which are
received by the NIH Office of Technology Transfer on or before November
7, 2008 will be considered.
ADDRESSES: Requests for a copy of the patents and patent applications,
inquiries, comments and other materials relating to the contemplated
license should be directed to: Michael Shmilovich, Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852-3804; e-mail: shmilovm@mail.nih.gov;
Telephone: (301) 435-5019; Facsimile: (301) 402-0220.
SUPPLEMENTARY INFORMATION: 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 sixty (60) days from the date of this published
Notice, 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.
The above referenced technologies describe development of live,
attenuated virus vaccines for respiratory syncytial virus (RSV),
subgroups A and B, human parainfluenza, types 1, 2,3 (HPIV1, HPIV2, and
HPIV3), and human metapneumovirus (hMPV).
The field of use in which NIH contemplates granting an exclusive
license may be limited to the following and excludes fields employing
any vectored vaccines and any human-bovine chimeras for RSV A, RSV B,
HPIV3, HPIV2, HPIVI, and hMPV:
Live attenuated virus vaccines for intranasal administration to
humans against RSV subgroups A and B, HPIV1, HPIV2, HPIV3, and hMPV
based on the following viruses (in bold) and their corresponding
attenuating mutations (in bulleted italics):
Human RSV subgroups A or B or A/B chimeras:
rcp248/404/1030[Delta]SH, including the stabilized version
of this virus;
[Delta]NS1;
[Delta]M2-2.
HPIV3
rcp45
HPIV2
Mutations in C and L imported from other viruses, e.g.,
HRSV, BPIV3, and HPIV3, with or without stabilization by codon
substitution or deletion;
L([Delta]1724);
Viruses with P and V genes separated
HPIV1
Mutations in C and L imported from other viruses, e.g.,
HRSV, BPIV3, and HPIV3, with or without stabilization by codon
substitution or deletion;
C(170);
C(R84G) mutation;
L(942stablized);
Viruses with P and C genes separated.
hMPV
[Delta]G, alone or in combination with [Delta]SH;
[Delta]M2-2;
Avian-human chimera with avian P ORF placed in hMPV
backbone.
Properly filed competing applications for a license filed in response
to this notice will be treated as objections to the contemplated
license. Comments and objections submitted in response 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: August 26, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-20650 Filed 9-5-08; 8:45 am]
BILLING CODE 4140-01-P