Prospective Grant of Exclusive License: Live, Attenuated Virus Vaccines Against RSV, PIV, and hMPV, 52058-52059 [E8-20650]

Download as PDF 52058 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: VerDate Aug<31>2005 17:59 Sep 05, 2008 Jkt 214001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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]


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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
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