Prospective Grant of Exclusive License: Methods of Using Deacetylase Inhibitors To Treat Dystrophies and Other Tissue Degeneration Disorders, 8099-8100 [E9-3809]

Download as PDF Federal Register / Vol. 74, No. 34 / Monday, February 23, 2009 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting jlentini on PROD1PC65 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. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel. Date: March 19, 2009. Time: 1 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: Democracy Plaza II, 6707 Democracy Blvd., Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Ruixia Zhou, PhD, Scientific Review Officer, 6707 Democracy Boulevard, Democracy Two Building, Suite 957, Bethesda, MD 20892, 301–496–4773, zhour@mail.nih.gov. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; Tissue Engineering/ Regenerative Medicine. Date: March 20, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, MD 20814. Contact Person: John K. Hayes, PhD, Scientific Review Officer, 6707 Democracy Boulevard, Democracy Two Building, Suite 959, Bethesda, MD 20892, 301–451–3398, hayesj@mail.nih.gov. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel. Date: March 20, 2009. Time: 1 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: Democracy Plaza II, 6707 Democracy Blvd., Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Ruixia Zhou, PhD, Scientific Review Officer, 6707 Democracy Boulevard, Democracy Two Building, Suite 957, Bethesda, MD 20892, 301–496–4773, zhour@mail.nih.gov. VerDate Nov<24>2008 16:31 Feb 20, 2009 Jkt 217001 Dated: February 13, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–3711 Filed 2–20–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Methods of Using Deacetylase Inhibitors To Treat Dystrophies and Other Tissue Degeneration Disorders AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: This 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. 60/335,705, filed October 18, 2001, now abandoned, entitled ‘‘Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration’’ [HHS Ref. No. E–353–2001/0–US–01]; U.S. Provisional Patent Application No. 60/ 343,854, filed October 25, 2001, now abandoned, entitled ‘‘Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation And Regeneration’’ [HHS Ref. No. E–353– 2001/1–US–01]; PCT Patent Application No. PCT/US02/33570, filed October 17, 2002, now abandoned, entitled ‘‘Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration’’ [HHS Ref. No. E–353–2001/2–PCT–01]; U.S. Patent Application No. 10/492,901, filed April 15, 2004, which issued as U.S. Patent No. 7,229,963, on June 12, 2007, entitled ‘‘Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration’’ [HHS Ref. No. E–353–2001/2–US–02]; and U.S. Patent Application No. 11/800,151, filed May 4, 2007, which published as 2008/0248994, on October 9, 2008, entitled ‘‘Methods of Using Deacetylase Inhibitors to Promote Cell Differentiation and Regeneration’’ [HHS Ref. No. E–353–2001/2–US–03] to ADVANCELL Advanced In Vitro Cell Technologies, S.A. which has an office in Barcelona, Spain. The patent rights in these inventions have been assigned to PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 8099 the United States of America and The Salk Institute for Biological Studies. The prospective exclusive license territory may be ‘‘worldwide’’, and the field of use may be limited to ‘‘the use of deacetylase inhibitors to treat dystrophies and other disorders involving tissue degeneration.’’ DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 21, 2009 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: Suryanarayana (Sury) Vepa, PhD, J.D., Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–5020; Facsimile: (301) 402– 0220; E-mail: vepas@mail.nih.gov. SUPPLEMENTARY INFORMATION: This technology relates to methods of enhancing progenitor cell differentiation, including enhancing myogenesis, neurogenesis and hematopoiesis, by contacting a progenitor cell with an effective amount of a deacetylase inhibitor (DI). The progenitor cell can be part of cell culture, such as a cell culture used for in vitro or in vivo analysis of progenitor cell differentiation, or can be part of an organism, such as a human or other mammal. Contacting the progenitor cell with a DI can lead to enhancement of expression of terminal cell-type specific genes in the progenitor cell, such as enhancing expression of muscle-specific genes in myoblasts, and can lead to skeletal muscle hypertrophy. Administering a DI to a subject also can provide some prophylactic or therapeutic effect for inhibiting, preventing, or treating conditions associated with a degeneration or loss of tissue. The DI can be administered to a subject as part of a pharmaceutical composition. 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, 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 E:\FR\FM\23FEN1.SGM 23FEN1 8100 Federal Register / Vol. 74, No. 34 / Monday, February 23, 2009 / Notices 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: February 10, 2009. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E9–3809 Filed 2–20–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form N–25, Extension of an Existing Information Collection Request; Comment Request jlentini on PROD1PC65 with NOTICES ACTION: 30-Day Notice of Information Collection Under Review: Form N–25, Request for Verification of Naturalization. OMB Control No. 1615– 0049. The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the Federal Register on November 20, 2008, at 73 FR 70361, allowing for a 60-day public comment period. USCIS did not receive any comments for this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until March 25, 2009. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), and to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), USCIS Desk Officer. Comments may be submitted to: USCIS, Chief, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, Suite 3008, Washington, DC 20529–2210. Comments may also be submitted to VerDate Nov<24>2008 16:31 Feb 20, 2009 Jkt 217001 DHS via facsimile to 202–272–8352 or via e-mail at rfs.regs@dhs.gov, and to the OMB USCIS Desk Officer via facsimile at 202–395–6974 or via e-mail at oira_submission@omb.eop.gov. When submitting comments by e-mail please make sure to add OMB Control Number 1615–0049 in the subject box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection (1) Type of Information Collection: Extension of an existing information collection. (2) Title of the Form/Collection: Request for Verification of Naturalization. (3) Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection: Form N–25. U.S. Citizenship and Immigration Services. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Not-for-Profit Institutions. This form will allow U.S. Citizenship and Immigration Services (USCIS) to obtain verification from the courts that a person claiming to be a naturalized citizen has, in fact, been naturalized. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 1,000 responses at 15 minutes (.25) per response. (6) An estimate of the total public burden (in hours) associated with the collection: 250 annual burden hours. If you have additional comments, suggestions, or need a copy of the proposed information collection PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 instrument with instructions, or additional information, please visit the USCIS Web site at: https:// www.regulations.gov/search/index.jsp. If additional information is required contact: USCIS, Regulatory Management Division, 111 Massachusetts Avenue, Suite 3008, Washington, DC 20529– 2210, (202) 272–8377. Dated: February 17, 2009. Stephen Tarragon, Deputy Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services. [FR Doc. E9–3796 Filed 2–20–09; 8:45 am] BILLING CODE 9111–97–P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Forms G–1041 and G– 1041A, Extension of a Currently Approved Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection Under Review: Forms G– 1041 and G–1041A, Historical Records Services Request; OMB Control No. 1615–0096. The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the Federal Register on November 14, 2008, at 73 FR 67537, allowing for a 60-day public comment period. USCIS did not receive any comments for this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until March 25, 2009. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), and to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), USCIS Desk Officer. Comments may be submitted to: USCIS, Chief, Regulatory Management Division, Clearance Office, E:\FR\FM\23FEN1.SGM 23FEN1

Agencies

[Federal Register Volume 74, Number 34 (Monday, February 23, 2009)]
[Notices]
[Pages 8099-8100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Methods of Using 
Deacetylase Inhibitors To Treat Dystrophies and Other Tissue 
Degeneration Disorders

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

ACTION: Notice.

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

SUMMARY: This 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. 60/335,705, filed October 18, 2001, now 
abandoned, entitled ``Methods of Using Deacetylase Inhibitors as Tools 
to Promote Cell Differentiation and Regeneration'' [HHS Ref. No. E-353-
2001/0-US-01]; U.S. Provisional Patent Application No. 60/343,854, 
filed October 25, 2001, now abandoned, entitled ``Methods of Using 
Deacetylase Inhibitors as Tools to Promote Cell Differentiation And 
Regeneration'' [HHS Ref. No. E-353-2001/1-US-01]; PCT Patent 
Application No. PCT/US02/33570, filed October 17, 2002, now abandoned, 
entitled ``Methods of Using Deacetylase Inhibitors as Tools to Promote 
Cell Differentiation and Regeneration'' [HHS Ref. No. E-353-2001/2-PCT-
01]; U.S. Patent Application No. 10/492,901, filed April 15, 2004, 
which issued as U.S. Patent No. 7,229,963, on June 12, 2007, entitled 
``Methods of Using Deacetylase Inhibitors as Tools to Promote Cell 
Differentiation and Regeneration'' [HHS Ref. No. E-353-2001/2-US-02]; 
and U.S. Patent Application No. 11/800,151, filed May 4, 2007, which 
published as 2008/0248994, on October 9, 2008, entitled ``Methods of 
Using Deacetylase Inhibitors to Promote Cell Differentiation and 
Regeneration'' [HHS Ref. No. E-353-2001/2-US-03] to ADVANCELL Advanced 
In Vitro Cell Technologies, S.A. which has an office in Barcelona, 
Spain. The patent rights in these inventions have been assigned to the 
United States of America and The Salk Institute for Biological Studies.
    The prospective exclusive license territory may be ``worldwide'', 
and the field of use may be limited to ``the use of deacetylase 
inhibitors to treat dystrophies and other disorders involving tissue 
degeneration.''

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
April 21, 2009 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: Suryanarayana (Sury) Vepa, PhD, J.D., 
Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-5020; Facsimile: (301) 
402-0220; E-mail: vepas@mail.nih.gov.

SUPPLEMENTARY INFORMATION: This technology relates to methods of 
enhancing progenitor cell differentiation, including enhancing 
myogenesis, neurogenesis and hematopoiesis, by contacting a progenitor 
cell with an effective amount of a deacetylase inhibitor (DI). The 
progenitor cell can be part of cell culture, such as a cell culture 
used for in vitro or in vivo analysis of progenitor cell 
differentiation, or can be part of an organism, such as a human or 
other mammal. Contacting the progenitor cell with a DI can lead to 
enhancement of expression of terminal cell-type specific genes in the 
progenitor cell, such as enhancing expression of muscle-specific genes 
in myoblasts, and can lead to skeletal muscle hypertrophy. 
Administering a DI to a subject also can provide some prophylactic or 
therapeutic effect for inhibiting, preventing, or treating conditions 
associated with a degeneration or loss of tissue. The DI can be 
administered to a subject as part of a pharmaceutical composition.
    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, 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

[[Page 8100]]

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: February 10, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-3809 Filed 2-20-09; 8:45 am]
BILLING CODE 4140-01-P

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