Prospective Grant of Exclusive License: The Development of Human Therapeutics for the Treatment of Cancer, 41873-41874 [2010-17579]

Download as PDF jlentini on DSKJ8SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Notices materials be developed, or revised, after notice to the public, with a 60-day comment period, and in consultation with the ACCV, appropriate health care provider and parent organizations, and the Food and Drug Administration. The law also requires that the information contained in the materials be based on available data and information, be presented in understandable terms, and include: (1) A concise description of the benefits of the vaccine, (2) A concise description of the risks associated with the vaccine, (3) A statement of the availability of the National Vaccine Injury Compensation Program, and (4) Such other relevant information as may be determined by the Secretary. Instructions for use of the vaccine information materials and copies of the materials can be found on the CDC Web site at: https://www.cdc.gov/vaccines/ pubs/VIS/. In addition, single cameraready copies may be available from State health departments. The meeting described in this notice fulfills the legal requirements that the ACCV be consulted concerning the development or revision of vaccine information materials with respect to vaccines covered under the National Vaccine Injury Compensation Program. Public Comments: Persons interested in providing an oral presentation should submit a written request, along with a copy of their presentation to: Annie Herzog, DVIC, Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), Room 11C–26, 5600 Fishers Lane, Rockville, Maryland 20857 or e-mail: aherzog@ hrsa.gov. Requests should contain the name, address, telephone number, email address, and any business or professional affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The allocation of time may be adjusted to accommodate the level of expressed interest. DVIC will notify each presenter by e-mail, mail or telephone of their assigned presentation time. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may announce it at the time of the public comment period. Public participation and ability to comment will be limited to space and time as it permits. This meeting notice is being published less than the normally required 15-day timeframe due to the public health urgency of this agency business and in order to assure that completed vaccine information VerDate Mar<15>2010 16:24 Jul 16, 2010 Jkt 220001 materials will be available for distribution prior to the beginning of vaccination for the upcoming influenza season (41 CFR 102–3.150(b)). FOR FURTHER INFORMATION CONTACT: Anyone requiring information regarding the ACCV should contact Annie Herzog, DVIC, HSB, HRSA, Room 11C–26, 5600 Fishers Lane, Rockville, MD 20857; telephone (301) 443–6593 or e-mail: aherzog@hrsa.gov. Dated: July 12, 2010. Sahira Rafiullah, Director, Division of Policy and Information Coordination. [FR Doc. 2010–17437 Filed 7–14–10; 4:15 pm] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: The Development of Human Therapeutics for the Treatment of Cancer AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: This is a 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 an exclusive patent license to practice the inventions embodied in US Patent Application 61/ 241,620 entitled ‘‘Development of an Immunotoxin in Which All B–Cell Epitopes Have Been Removed and Which Has High Cytotoxic Activity’’ [HHS Ref. E–269–2009/0–US–01], US Patent Application 60/969,929 entitled ‘‘Deletions in Domain II of Pseudomonas Exotoxin A That Reduce Non-Specific Toxicity’’ [HHS Ref. E–292–2007/0–US– 01], US Patent Application 60/703,798 entitled ‘‘Mutated Pseudomonas Exotoxins with Reduced Antigenicity’’ [HHS Ref. E–262–2005/0–US–01], and all continuing applications and foreign counterparts, to MedImmune, LLC. This license may also include non-exclusive rights to US Patent Application 60/ 525,371 entitled ‘‘Mutated Anti-CD22 Antibodies and Immunoconjugates’’ [HHS Ref. E–046–2004/0–US–01], US Patent Application 60/325,360 entitled ‘‘Mutated Anti-CD22 Antibodies with Increased Affinity to CD22 Expressing Leukemia Cells’’ [HHS Ref. E–129–2001/ 0–US–01], US Patent Application 60/ 041,437 entitled ‘‘Recombinant Immunotoxins Targeted to CD22 Bearing Cells and Tumors’’ [HHS Ref. E– PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 41873 059–1997/0–US–01], US Patent 5,747,654 entitled ‘‘Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity’’ [HHS Ref. E–163–1993/0–US–01], PCT application PCT/US96/16327 entitled ‘‘Immunotoxin Containing A DisulfideStabilized Antibody Fragment’’ [HHS Ref. E–163–1993/2–PCT–01], and all continuing applications and foreign counterparts. 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 exclusive license territory may be worldwide, and the field of use may be limited to: The use of the HA22–LR, HA22–6X, HA22–8X, HA22–LR/6X and HA22–LR/8X immunotoxins for the treatment of CD22expressing hematological malignancies. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before August 3, 2010 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: 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: These inventions concern immunotoxins and methods of using the immunotoxins for the treatment of hematological malignancies such as hairy cell leukemia (HCL), chronic lymphocytic leukemia (CLL), acute lymphocytic leukemia (ALL) and non-Hodgkin’s lymphoma (NHL). Several specific immunotoxins are covered by this technology, including HA22–LR, HA22– 6X, HA22–8X, HA22–LR/6X and HA22– LR/8X. Each of these immunotoxins comprises (1) a toxin moiety that is a modified version of the Pseudomonas exotoxin A (‘‘PE’’) and (2) an antibody fragment domain that is capable of binding to the CD22 cell surface receptor. The PE moieties have been modified in various manners in order reduce the immunogenicity of the molecule. The modifications improve the therapeutic value of PE while maintaining its ability to trigger cell death. Since CD22 is preferentially expressed on several types of hematological cancer cells, the antiCD22 antibody binding fragment allows the immunotoxins to be targeted E:\FR\FM\19JYN1.SGM 19JYN1 41874 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Notices selectively to cancer cells so that only the cancer cells are killed. This results in an effective therapeutic strategy with fewer side effects due to less nonspecific killing of cells. 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 Part 404.7. The prospective 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 Part 404.7 within fifteen (15) days from the date of this published notice. 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: July 13, 2010. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2010–17579 Filed 7–16–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA–2007–0008] National Advisory Council Meeting Federal Emergency Management Agency, DHS. ACTION: Notice of the National Advisory Committee meeting. jlentini on DSKJ8SOYB1PROD with NOTICES AGENCY: SUMMARY: This notice announces the date, time, location, and agenda for the next meeting of the National Advisory Council (NAC). At the meeting, the subcommittees will report on their work since the February 10–11, 2010 meeting. This meeting will be open to the public. DATES: Meeting Dates: Wednesday, August 4, 2010, from approximately 10 a.m. MST to 5:45 p.m. MST and Thursday, August 5, 2010, 8:30 a.m. MST to 3:30 p.m. MST. A public comment period will take place on the afternoon of August 5, 2010, between approximately 2:30 p.m. MST and 3 p.m. MST. Comment Date: Persons wishing to make an oral presentation, or who are VerDate Mar<15>2010 16:24 Jul 16, 2010 Jkt 220001 unable to attend or speak at the meeting, may submit written comments. Written comments or requests to make oral presentations must be received by July 26, 2010. ADDRESSES: The meeting will be held at the Curtis Hotel, 1405 Curtis Street, Denver, CO 80202. Written comments and requests to make oral presentations at the meeting should be provided to the address listed in the FOR FURTHER INFORMATION CONTACT section and must be received by July 26, 2010. All submissions received must include the Docket ID FEMA–2007–0008 and may be submitted by any one of the following methods: Federal Rulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments on the Web site. E-mail: FEMA–RULES@dhs.gov. Include Docket ID FEMA–2007–0008 in the subject line of the message. Facsimile: (703) 483–2999. Mail: Office of Chief Counsel, Federal Emergency Management Agency (Room 835), 500 C Street, SW., Washington, DC 20472–3100. Hand Delivery/Courier: Office of Chief Counsel, Federal Emergency Management Agency (Room 835), 500 C Street, SW., Washington, DC 20472– 3100. Instructions: All submissions received must include the Docket ID FEMA– 2007–0008. Comments received also will be posted without alteration at https://www.regulations.gov, including any personal information provided. Docket: For access to the docket to read documents or comments received by the National Advisory Council, go to https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Alyson Price, Designated Federal Officer, Federal Emergency Management Agency (Room 832), 500 C Street, SW., Washington, DC 20472–3100, telephone 202–646–3746, fax 202–646–3930, and e-mail mailto: FEMA-NAC@dhs.gov. The NAC Web site is located at: https://www. fema.gov/about/nac/. SUPPLEMENTARY INFORMATION: Notice of this meeting is required under the Federal Advisory Committee Act (FACA), Public Law 92–463, as amended (5 U.S.C. App. 1 et seq.). The National Advisory Council (NAC) will meet for the purpose of reviewing the progress and/or potential recommendations of the following NAC subcommittees: Preparedness and Protection, Response and Recovery, Public Engagement and Mission Support, and Federal Insurance and Mitigation. The Council may receive updates on response, recovery, PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 preparedness, mitigation and Federal insurance issues, and on the Regional Advisory Councils. Public Attendance: The meeting is open to the public. Please note that the meeting may adjourn early if all business is finished. Persons with disabilities who require special assistance should advise the Designated Federal Officer of their anticipated special needs as early as possible. Members of the public who wish to make comments on Thursday, August 5, 2010 between 2:30 p.m. MST and 3 p.m. MST are requested to register in advance, and if the meeting is running ahead of schedule the public comment period may take place as early as 11 a.m. MST; therefore, all speakers must be present and seated by 10:45 a.m. MST. In order to allow as many people as possible to speak, speakers are requested to limit their remarks to 3 minutes. For those wishing to submit written comments, please follow the procedure noted above. In certain weather circumstances, a teleconference line for members of the public to call in may be set up. Dated: July 13, 2010. W. Craig Fugate, Administrator, Federal Emergency Management Agency. [FR Doc. 2010–17506 Filed 7–16–10; 8:45 am] BILLING CODE 9111–48–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5376–N–68] Quality Control for Rental Assistance Subsidy Determinations AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. Data are collected on a sample of households receiving HUD housing assistance subsidies. These households are interviewed and their incomes verified to determine if subsidies are correctly calculated. The study identifies the costs and types of errors. The results are used to target corrective actions and measure the impact of past corrective actions. DATES: Comments Due Date: August 18, 2010. E:\FR\FM\19JYN1.SGM 19JYN1

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[Federal Register Volume 75, Number 137 (Monday, July 19, 2010)]
[Notices]
[Pages 41873-41874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17579]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of Human 
Therapeutics for the Treatment of Cancer

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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

SUMMARY: This is a 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 
an exclusive patent license to practice the inventions embodied in US 
Patent Application 61/241,620 entitled ``Development of an Immunotoxin 
in Which All B-Cell Epitopes Have Been Removed and Which Has High 
Cytotoxic Activity'' [HHS Ref. E-269-2009/0-US-01], US Patent 
Application 60/969,929 entitled ``Deletions in Domain II of Pseudomonas 
Exotoxin A That Reduce Non-Specific Toxicity'' [HHS Ref. E-292-2007/0-
US-01], US Patent Application 60/703,798 entitled ``Mutated Pseudomonas 
Exotoxins with Reduced Antigenicity'' [HHS Ref. E-262-2005/0-US-01], 
and all continuing applications and foreign counterparts, to MedImmune, 
LLC. This license may also include non-exclusive rights to US Patent 
Application 60/525,371 entitled ``Mutated Anti-CD22 Antibodies and 
Immunoconjugates'' [HHS Ref. E-046-2004/0-US-01], US Patent Application 
60/325,360 entitled ``Mutated Anti-CD22 Antibodies with Increased 
Affinity to CD22 Expressing Leukemia Cells'' [HHS Ref. E-129-2001/0-US-
01], US Patent Application 60/041,437 entitled ``Recombinant 
Immunotoxins Targeted to CD22 Bearing Cells and Tumors'' [HHS Ref. E-
059-1997/0-US-01], US Patent 5,747,654 entitled ``Recombinant 
Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity'' 
[HHS Ref. E-163-1993/0-US-01], PCT application PCT/US96/16327 entitled 
``Immunotoxin Containing A Disulfide-Stabilized Antibody Fragment'' 
[HHS Ref. E-163-1993/2-PCT-01], and all continuing applications and 
foreign counterparts. 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 exclusive license territory may be worldwide, and 
the field of use may be limited to:

    The use of the HA22-LR, HA22-6X, HA22-8X, HA22-LR/6X and HA22-
LR/8X immunotoxins for the treatment of CD22-expressing 
hematological malignancies.


DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
August 3, 2010 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: 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: These inventions concern immunotoxins and 
methods of using the immunotoxins for the treatment of hematological 
malignancies such as hairy cell leukemia (HCL), chronic lymphocytic 
leukemia (CLL), acute lymphocytic leukemia (ALL) and non-Hodgkin's 
lymphoma (NHL). Several specific immunotoxins are covered by this 
technology, including HA22-LR, HA22-6X, HA22-8X, HA22-LR/6X and HA22-
LR/8X.
    Each of these immunotoxins comprises (1) a toxin moiety that is a 
modified version of the Pseudomonas exotoxin A (``PE'') and (2) an 
antibody fragment domain that is capable of binding to the CD22 cell 
surface receptor. The PE moieties have been modified in various manners 
in order reduce the immunogenicity of the molecule. The modifications 
improve the therapeutic value of PE while maintaining its ability to 
trigger cell death. Since CD22 is preferentially expressed on several 
types of hematological cancer cells, the anti-CD22 antibody binding 
fragment allows the immunotoxins to be targeted

[[Page 41874]]

selectively to cancer cells so that only the cancer cells are killed. 
This results in an effective therapeutic strategy with fewer side 
effects due to less non-specific killing of cells.
    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 Part 
404.7. The prospective 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 Part 404.7 within fifteen (15) days from the date 
of this published notice.
    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: July 13, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-17579 Filed 7-16-10; 8:45 am]
BILLING CODE 4140-01-P
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