Prospective Grant of Exclusive License: Conjugate Vaccines Against B. anthracis, 53480-53481 [2011-21771]

Download as PDF 53480 Federal Register / Vol. 76, No. 166 / Friday, August 26, 2011 / Notices Name of Committee: Center for Scientific Review Special Emphasis Panel; Academic Research Enhancement Award (Parent 15). Date: September 8, 2011. Time: 11:30 a.m. to 1:30 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: Monica Basco, PhD, Scientific Review Officer,Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3220, MSC 7808, Bethesda, MD 20892, 301–496–7010, bascoma@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. 93.306, 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: August 19, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–21765 Filed 8–25–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Conjugate Vaccines Against B. anthracis (Anthrax) and Monoclonal Antibodies Against Anthrax National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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 (HHS), is contemplating the grant of an exclusive license to practice the following invention as embodied in the following patent applications: (1) E–146–2004/0, Purcell et al., ‘‘Monoclonal Antibodies That Neutralize Anthrax Protective Antigen (PA) Toxin’’, U.S. Patent Application Number 60/639,074, filed on December 22, 2004, PCT Application Number PCT/US2005/046/790, filed on December 21, 2005, and U.S. Patent Application Number 11/793,735, filed on December 8, 2009, (2) E–123–2007/ 0, Purcell et al., ‘‘Monoclonal Antibodies that Neutralize B. anthracis Protective Antigen (PA), Lethal Factor (LF) and Edema Factor (EF)’’, U.S. Patent Application Number 60/903,022, filed on February 23, 2007, PCT emcdonald on DSK2BSOYB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:37 Aug 25, 2011 Jkt 223001 Application Number PCT/US2008/ 054609, filed on February 21, 2008, and U.S. Patent Application Number 12/ 528,427, filed on August 24, 2009, and European Patent Application Number 08730415.0, filed on September 23, 2009, (3) E–125–2008/0, Purcell et al., ‘‘Monoclonal Antibodies That React With the Capsule of Bacillus anthracis’’, U.S. Patent Application Number 61/ 116,222, filed on November 19, 2008, PCT Application Number PCT/US2009/ 065198, filed on November 19, 2009, and U.S. Patent Application Number 13/ 130,044, filed on May 18, 2011, (4) E– 343–2002/0, Schneerson et al., ‘‘gammaPGA Conjugates for Eliciting Immune Responses Directed Against Bacillus anthracis and Other Bacilli’’, U.S. Patent Application Number 60/ 476,598, filed on June 5, 2003, PCT Application Number PCT/US2004/ 17736, filed on June 4, 2004, U.S. Patent Application Number 10/559,825, filed December 2, 2005, now U.S. Patent Number 7,803,386, European Patent Application Number 04754360.8, filed June 4, 2004, Canadian Patent Application Number 2,528,067, filed June 4, 2004, and Australian Patent Application Number 2004252091, filed June 4, 2004, now Australian Patent Number 2004252091, and (5) E–040– 2005/0, Schneerson et al., ‘‘Methods for Preparing Immunogenic Conjugates’’, U.S. Patent Application Number 11/ 005,851, filed on December 6, 2004, now U.S. Patent Number 7,625,736, PCT Application Number PCT/US2005/ 19678, filed June 3, 2005, European Patent Application Number 05758048.2, filed June 3, 2005, now European Patent Number 1765394 (rights were validated in Germany (Patent Number 602005015855), France (Patent Number 1765394), Great Britain (Patent Number 1765394), and Ireland (Patent Number 1765394)), Indian Patent Application Number 7703/DELNP/2006, filed June 3, 2005, Chinese Patent Application Number 200580018108.2, filed June 3, 2005, Australian Patent Application Number 2005249571, filed June 3, 2005, now Australian Patent Number 2005249571, Canadian Patent Application Number 2,568,364, filed June 3, 2005, and U.S. Patent Application Number 12/582,420, filed October 20, 2009, to Biologics Resources LLC, having a place of business in Boyds, Maryland, United States of America. The patent rights in these inventions have been assigned to the United States of America. Only written comments and/or application for a license which are received by the NIH Office of DATES: PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 Technology Transfer on or before September 26, 2011 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Peter Soukas, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; E-mail: ps193c@nih.gov; Telephone: (301) 435– 4646; Facsimile: (301) 402–0220. SUPPLEMENTARY INFORMATION: Anthrax, whether resulting from natural or bioterrorist-associated exposure, is a constant threat to human health. The lethality of anthrax is primarily the result of the effects of anthrax toxin, which has 3 components: a receptorbinding protein known as ‘‘protective antigen’’ (PA) and 2 catalytic proteins known as ‘‘lethal factor’’ (LF) and ‘‘edema factor’’ (EF). Although production of an efficient anthrax vaccine is an ultimate goal, the benefits of vaccination can be expected only if a large proportion of the population at risk is immunized. In contrast, passive administration of neutralizing human or chimpanzee monoclonal antibody to a subject at risk for anthrax or exposed to anthrax could provide immediate efficacy for emergency prophylaxis against or treatment of anthrax. The methods and compositions of these inventions provide a means for prevention and/or therapy of B. anthracis (anthrax) infection by immunization with conjugate vaccines against anthrax and/or passive immunization with monoclonal antibodies against B. anthracis. 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, 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 fields of use may be limited to (1) monoclonal antibodies against B. anthracis (anthrax) for use in humans and (2) B. anthracis conjugate vaccines for use in humans. 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 E:\FR\FM\26AUN1.SGM 26AUN1 Federal Register / Vol. 76, No. 166 / Friday, August 26, 2011 / Notices under the Freedom of Information Act, 5 U.S.C. 552. Dated: August 19, 2011. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2011–21771 Filed 8–25–11; 8:45 am] Federal Property Suitable as Facilities To Assist the Homeless Office of the Assistant Secretary for Community Planning and Development, HUD. AGENCY: Notice. This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless. SUMMARY: FOR FURTHER INFORMATION CONTACT: Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7262, Washington, DC 20410; telephone (202) 708–1234; TTY number for the hearing- and speechimpaired (202) 708–2565, (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800–927–7588. In accordance with the December 12, 1988 court order in National Coalition for the Homeless v. Veterans Administration, No. 88–2503–OG (D.D.C.), HUD publishes a Notice, on a weekly basis, identifying unutilized, underutilized, excess and surplus Federal buildings and real property that HUD has reviewed for suitability for use to assist the homeless. Today’s Notice is for the purpose of announcing that no additional properties have been determined suitable or unsuitable this week. SUPPLEMENTARY INFORMATION: emcdonald on DSK2BSOYB1PROD with NOTICES The Bureau of Ocean Energy Management, Regulation and Enforcement (BOEMRE) announces the availability of a Final Supplemental Environmental Impact Statement (SEIS) for Outer Continental Shelf (OCS) Oil and Gas Lease Sale 193, Chukchi Sea, Alaska (OCS EIS/EA BOEMRE 2011– 041). BOEMRE prepared this Final SEIS pursuant to: (1) The National Environmental Policy Act of 1969 (NEPA), as amended, 42 U.S.C. 4321 et seq., the Council on Environmental Quality (CEQ) regulations that implement the procedural provisions of NEPA (40 CFR parts 1500–1508); and (2) the July 21, 2010, remand order issued by the United States District Court for the District of Alaska. The Final SEIS augments the analysis of the Final EIS, Oil and Gas Lease Sale 193, Chukchi Sea Planning Area (OCS EIS/EA MMS 2007–026). BOEMRE will issue a NEPA Record of Decision after the 30-day period during which the Final SEIS is available. BOEMRE gives this notice of availability in accordance with Council on Environmental Quality regulations at 40 CFR 1506.6 (b). FOR FURTHER INFORMATION CONTACT: Ms. Sharon Warren or Mr. Mike Routhier, Bureau of Ocean Energy Management, Regulation and Enforcement, Alaska OCS Region, 3801 Centerpoint Drive, Suite 500, Anchorage, Alaska 99503– 5820. You may contact Ms. Warren or Mr. Routhier by telephone at 907–334– 5200. SUPPLEMENTARY INFORMATION: In May 2007, BOEMRE (formerly the Minerals Management Service (MMS)) published the Final EIS for Oil and Gas Lease Sale 193, Chukchi Sea (OCS EIS/EA MMS 2007–0026), which evaluated the potential effects of the proposed sale and three alternatives: a no action alternative, and two alternatives that incorporate deferral areas of varying size along the coastward edge of the proposed sale area. SUMMARY: [Docket No. FR–5477–N–34] Dated: August 18, 2011. Mark R. Johnston, Deputy Assistant Secretary for Special Needs. [FR Doc. 2011–21578 Filed 8–25–11; 8:45 am] BILLING CODE 4210–67–P 19:37 Aug 25, 2011 Outer Continental Shelf, Alaska OCS Region, Chukchi Sea Planning Area, Oil and Gas Lease Sale 193 Bureau of Ocean Energy Management, Regulation and Enforcement, Interior. ACTION: Notice of Availability of a Final Supplemental Environmental Impact Statement DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT VerDate Mar<15>2010 Bureau of Ocean Energy Management, Regulation and Enforcement AGENCY: BILLING CODE 4140–01–P ACTION: DEPARTMENT OF THE INTERIOR Jkt 223001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 53481 On January 31, 2008, plaintiffs filed a lawsuit challenging Chukchi Sea Oil and Gas Lease Sale 193, alleging violations of NEPA and the Endangered Species Act with the United States District Court for the District of Alaska (District Court) [Native Village of Point Hope et al., v. Salazar, No. 1:08–cv– 00004–RRB (D. Alaska)]. BOEMRE conducted the sale in February 2008. BOEMRE received high bids totaling approximately $2.6 billion and issued 487 leases. In July 2010, the District Court remanded the matter for further NEPA analysis in accordance with its order. The District Court amended this order in August 2010. The District Court directed BOEMRE to address three concerns: (1) Analyze the environmental impact of natural gas development; (2) determine whether missing information identified by BOEMRE in the Final EIS for Chukchi Sea Lease Sale 193 was essential or relevant under 40 CFR 1502.22; and (3) determine whether the cost of obtaining the missing information was exorbitant, or the means of doing so unknown. BOEMRE: (1) Completed Chukchi Sea Planning Area Oil and Gas Lease Sale 193 in the Chukchi Sea, Alaska, Draft Supplemental EIS (‘‘SEIS’’) OCS EIS/EA BOEMRE 2010–034 addressing each of these concerns; (2) published the Draft SEIS for public comment on October 15, 2010; and (3) provided a 45-day comment period. BOEMRE received over 150,000 comments on the Draft SEIS. Citing the Deepwater Horizon oil spill, many commenters requested an analysis of a potential blowout and oil spill during exploration. In response to those comments, BOEMRE determined it appropriate to provide analysis of a very large oil spill (‘‘VLOS’’) from a hypothetical exploration well blowout. BOEMRE prepared the Chukchi Sea Planning Area Oil and Gas Lease Sale 193 in the Chukchi Sea, Alaska, Revised Draft Supplemental SEIS OCS EIS/EA BOEMRE 2010–034 with the VLOS analysis and those issues under remand. On May 27, 2011, the Federal Register published a Notice of Availability of the Revised Draft SEIS for a 45-day public comment for BOEMRE and Notice of BOEMRE filing the Revised Draft EIS with the Environmental Protection Agency. The public comment period officially closed on July 11, 2011. During the Revised Draft SEIS public comment period, BOEMRE received over 360,000 comment letters and cards from Federal Agencies, state and local governments, Alaska Native tribes, interested groups, and members of the public. E:\FR\FM\26AUN1.SGM 26AUN1

Agencies

[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Notices]
[Pages 53480-53481]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21771]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Conjugate Vaccines 
Against B. anthracis (Anthrax) and Monoclonal Antibodies Against 
Anthrax

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 (HHS), is contemplating the 
grant of an exclusive license to practice the following invention as 
embodied in the following patent applications: (1) E-146-2004/0, 
Purcell et al., ``Monoclonal Antibodies That Neutralize Anthrax 
Protective Antigen (PA) Toxin'', U.S. Patent Application Number 60/
639,074, filed on December 22, 2004, PCT Application Number PCT/US2005/
046/790, filed on December 21, 2005, and U.S. Patent Application Number 
11/793,735, filed on December 8, 2009, (2) E-123-2007/0, Purcell et 
al., ``Monoclonal Antibodies that Neutralize B. anthracis Protective 
Antigen (PA), Lethal Factor (LF) and Edema Factor (EF)'', U.S. Patent 
Application Number 60/903,022, filed on February 23, 2007, PCT 
Application Number PCT/US2008/054609, filed on February 21, 2008, and 
U.S. Patent Application Number 12/528,427, filed on August 24, 2009, 
and European Patent Application Number 08730415.0, filed on September 
23, 2009, (3) E-125-2008/0, Purcell et al., ``Monoclonal Antibodies 
That React With the Capsule of Bacillus anthracis'', U.S. Patent 
Application Number 61/116,222, filed on November 19, 2008, PCT 
Application Number PCT/US2009/065198, filed on November 19, 2009, and 
U.S. Patent Application Number 13/130,044, filed on May 18, 2011, (4) 
E-343-2002/0, Schneerson et al., ``gammaPGA Conjugates for Eliciting 
Immune Responses Directed Against Bacillus anthracis and Other 
Bacilli'', U.S. Patent Application Number 60/476,598, filed on June 5, 
2003, PCT Application Number PCT/US2004/17736, filed on June 4, 2004, 
U.S. Patent Application Number 10/559,825, filed December 2, 2005, now 
U.S. Patent Number 7,803,386, European Patent Application Number 
04754360.8, filed June 4, 2004, Canadian Patent Application Number 
2,528,067, filed June 4, 2004, and Australian Patent Application Number 
2004252091, filed June 4, 2004, now Australian Patent Number 
2004252091, and (5) E-040-2005/0, Schneerson et al., ``Methods for 
Preparing Immunogenic Conjugates'', U.S. Patent Application Number 11/
005,851, filed on December 6, 2004, now U.S. Patent Number 7,625,736, 
PCT Application Number PCT/US2005/19678, filed June 3, 2005, European 
Patent Application Number 05758048.2, filed June 3, 2005, now European 
Patent Number 1765394 (rights were validated in Germany (Patent Number 
602005015855), France (Patent Number 1765394), Great Britain (Patent 
Number 1765394), and Ireland (Patent Number 1765394)), Indian Patent 
Application Number 7703/DELNP/2006, filed June 3, 2005, Chinese Patent 
Application Number 200580018108.2, filed June 3, 2005, Australian 
Patent Application Number 2005249571, filed June 3, 2005, now 
Australian Patent Number 2005249571, Canadian Patent Application Number 
2,568,364, filed June 3, 2005, and U.S. Patent Application Number 12/
582,420, filed October 20, 2009, to Biologics Resources LLC, having a 
place of business in Boyds, Maryland, United States of America. 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 
September 26, 2011 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Peter Soukas, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; E-mail: ps193c@nih.gov; Telephone: (301) 435-
4646; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: Anthrax, whether resulting from natural or 
bioterrorist-associated exposure, is a constant threat to human health. 
The lethality of anthrax is primarily the result of the effects of 
anthrax toxin, which has 3 components: a receptor-binding protein known 
as ``protective antigen'' (PA) and 2 catalytic proteins known as 
``lethal factor'' (LF) and ``edema factor'' (EF). Although production 
of an efficient anthrax vaccine is an ultimate goal, the benefits of 
vaccination can be expected only if a large proportion of the 
population at risk is immunized. In contrast, passive administration of 
neutralizing human or chimpanzee monoclonal antibody to a subject at 
risk for anthrax or exposed to anthrax could provide immediate efficacy 
for emergency prophylaxis against or treatment of anthrax.
    The methods and compositions of these inventions provide a means 
for prevention and/or therapy of B. anthracis (anthrax) infection by 
immunization with conjugate vaccines against anthrax and/or passive 
immunization with monoclonal antibodies against B. anthracis.
    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, 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 fields of use may be limited to (1) monoclonal antibodies 
against B. anthracis (anthrax) for use in humans and (2) B. anthracis 
conjugate vaccines for use in humans.
    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

[[Page 53481]]

under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: August 19, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-21771 Filed 8-25-11; 8:45 am]
BILLING CODE 4140-01-P
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