Prospective Grant of Exclusive License: Multi-Domain Amphipathic Helical Peptides for the Treatment of Cardiovascular Diseases, 4756-4757 [E9-1754]

Download as PDF 4756 Federal Register / Vol. 74, No. 16 / Tuesday, January 27, 2009 / Notices 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: Communication Disorders Review Committee. Date: February 11–13, 2009. Time: February 11, 2009, 8 p.m. to 10 p.m. Agenda: To review and evaluate grant applications. Place: Baltimore Marriott Waterfront, 700 Aliceanna Street, Baltimore, MD 21202. Time: February 12, 2009, 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Baltimore Marriott Waterfront, 700 Aliceanna Street, Baltimore, MD 21202. Time: February 13, 2009, 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Baltimore Marriott Waterfront, 700 Aliceanna Street, Baltimore, MD 21202. Contact Person: Shiguang Yang, DVM, PhD, Scientific Review Officer, 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: January 16, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–1665 Filed 1–26–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DATES: Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before March 30, 2009 will be considered. National Institutes of Health mstockstill on PROD1PC66 with NOTICES6 Prospective Grant of Exclusive License: Multi-Domain Amphipathic Helical Peptides for the Treatment of Cardiovascular Diseases 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 17:20 Jan 26, 2009 Jkt 217001 Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: Fatima Sayyid, M.H.P.M., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–4521; Facsimile: (301) 402– ADDRESSES: AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. VerDate Nov<24>2008 contemplating the grant of an exclusive license worldwide to practice the invention embodied in: United States Provisional Patent Application No. 60/ 619,392, filed October 15, 2004, entitled ‘‘Multi-Domain Amphipathic Helical Peptides and Methods of Their Use’’ (HHS Ref. No. E–114–2004/0–US–01), United States Patent Application Serial No. 11/577,259, filed April 13, 2007, entitled ‘‘Multi-Domain Amphipathic Helical Peptides and Methods of Their Use’’ (HHS Ref. No. E–114–2004/0–US– 07); Australian Patent Application Serial No. 2005295640, filed October 14, 2005, entitled ‘‘Multi-Domain Amphipathic Helical Peptides and Methods of Their Use’’ (HHS Ref. No. E– 114–2004/0–AU–03); Canadian Patent Application Serial No. 2584048, filed October 14, 2005, entitled ‘‘MultiDomain Amphipathic Helical Peptides and Methods of Their Use’’ (HHS Ref. No. E–114–2004/0–CA–04); European Patent Application Serial No. 05815961.7, filed October 14, 2005, entitled ‘‘Multi-Domain Amphipathic Helical Peptides and Methods of Their Use’’ (HHS Ref. No. E–114–2004/0–EP– 05); Japanese Patent Application Serial No. 2007–536912, filed October 14, 2005, entitled ‘‘Multi-Domain Amphipathic Helical Peptides and Methods of Their Use’’ (HHS Ref. No. E– 114–2004/0–JP–06) to KineMed, Inc., having a place of business in the State of California. The field of use may be limited to FDA or foreign regulatory body approved 5a peptide therapeutic for the prevention and treatment of cardiovascular diseases. The United States of America is the assignee of the patent rights in this invention. The territory may be worldwide. This announcement is the second notice to grant an exclusive license to this technology and supersedes any previous announcements including the Notice published in the Federal Register on Wednesday, May 11, 2005 (70 FR 24832). PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 0220; e-mail: Fatima.Sayyid@nih.hhs.gov. Clearance of excess cholesterol from cells by high density lipoproteins (HDL) is facilitated by the interaction of HDL apolipoprotein with cell surface binding sites or receptors such as ABCA1. ABCA1 is a member of the ATP binding cassette transporter family and is expressed by many cell types. Mutations in the ABCA1 transporter lead to diseases characterized by the accumulation of excess cellular cholesterol, low levels of HDL and an increased risk for cardiovascular disease. Research has demonstrated an inverse correlation between the occurrence of atherosclerotic events and levels of HDL and its most abundant protein constituent, apolipoprotein A–1 (apoA–1). ApoA–1 has been shown to promote lipid efflux from ABCA1 transfected cells. However, the nature of the interaction between apoA–1 and ABCA1 is not fully understood. Several other exchangeable type apolipoproteins have been shown to efflux lipid from ABCA1 transfected cells. Although the exchangeable type apolipoproteins do not share a similar primary amino acid sequence, they all contain amphipathic helices, a structural motif known to facilitate the interaction of proteins with lipids. Recently, it has been shown in both animal models and humans that intravenous administration of apoA–1 can reduce the size of atherosclerotic plaques. It has also been observed that synthetic peptide mimics of apoA–1 can promote efflux of excess cholesterol from cells. Therefore, synthetic mimics of apoA–1 can potentially also be used as therapeutic compounds in the prevention and treatment of atherosclerosis. Currently, there are a wide variety of treatments for dyslipidemia, which include, but are not limited to, pharmacologic regimens (mostly statins), partial ileal bypass surgery, portacaval shunt, liver transplantation, and removal of atherogenic lipoproteins by one of several apheresis procedures. The subject technology is related to peptides and peptide analogs with multiple amphipathic alpha-helical domains that promote lipid efflux from cells and it relates to methods for identifying non-cytotoxic peptides that promote lipid efflux from cells that are useful in the treatment and prevention of dyslipidemic and vascular disorders. Dyslipidemic and vascular disorders amenable to treatment with the isolated multi-domain peptides include, but are not limited to, hyperlipidemia, hyperlipoproteinemia, SUPPLEMENTARY INFORMATION: E:\FR\FM\27JAN1.SGM 27JAN1 Federal Register / Vol. 74, No. 16 / Tuesday, January 27, 2009 / Notices hypercholesterolemia, hypertriglyceridemia, HDL deficiency, apoA-I deficiency, coronary artery disease, atherosclerosis, thrombotic stroke, peripheral vascular disease, restenosis, acute coronary syndrome, and reperfusion myocardial injury. 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 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. 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: January 21, 2009. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E9–1754 Filed 1–26–09; 8:45 am] by accessing the SAMHSA Committee Web site, https://nac.samhsa.gov/ CSAPcouncil/index.aspx, or by contacting Ms. Haynes. The transcript for the open session will also be available on the SAMHSA Council Web site within three weeks after the meeting. Committee Name: Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention National Advisory Council. Date/Time/Type: February 10, 2009. From 1 p.m.–5 p.m.: Open. Place: Gaylord Convention Center, 201 Waterfront Street, National Harbor Room–4 & 5, National Harbor, MD 20745. Contact: Tia Haynes, Designated Federal Official, SAMHSA/CSAP National Advisory Council, 1 Choke Cherry Road, Room 4–1066, Rockville, MD 20857, Telephone: (240) 276–2436, FAX: (240) 276–2430, E-mail: tia.haynes@samhsa.hhs.gov. submit written reports of certain prescribed incidents. DATES: Send your comments by February 26, 2009. A comment to OMB is most effective if OMB receives it within 30 days of publication. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to oira_submission@omb.eop.gov or faxed to (202) 395–6974. FOR FURTHER INFORMATION CONTACT: Ginger LeMay, Office of Information Technology, TSA–11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 22202–4220; telephone (571) 227–3616; facsimile (571) 227–2907. SUPPLEMENTARY INFORMATION: Toian Vaughn, Committee Management Officer, Substance Abuse and Mental Health, Services Administration. [FR Doc. E9–1683 Filed 1–26–09; 8:45 am] Comments Invited BILLING CODE 4162–20–P BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY DEPARTMENT OF HEALTH AND HUMAN SERVICES Transportation Security Administration Extension of Agency Information Collection Activity Under OMB Review: Federal Flight Deck Officer Program Substance Abuse and Mental Health Services Administration mstockstill on PROD1PC66 with NOTICES6 Center for Substance Abuse Prevention; Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given of the meeting of the Center for Substance Abuse Prevention’s (CSAP) National Advisory Council on February 10, 2009. The meeting is open and will include discussion of the Center’s policy issues, and current administrative, legislative and program developments. Attendance by the public will be limited to space available. Public comments are welcome. Please communicate with the CSAP Council’s Designated Federal Official, Ms. Tia Haynes (see contact information below), to make arrangements to attend, comment or to request special accommodations for persons with disabilities. Substantive program information, a summary of the meeting, and a roster of Council members may be obtained as soon as possible after the meeting, either VerDate Nov<24>2008 17:20 Jan 26, 2009 Jkt 217001 4757 AGENCY: Transportation Security Administration, DHS. ACTION: 30-day notice. SUMMARY: This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), OMB control number 1652–0011, abstracted below to the Office of Management and Budget (OMB) for review and approval of an extension of the currently approved collection under the Paperwork Reduction Act. The ICR describes the nature of the information collection and its expected burden. TSA published a Federal Register notice, with a 60-day comment period soliciting comments, of the following collection of information on November 19, 2008, 73 FR 69670. The collection requires interested volunteers to fill out an application to determine their suitability for participating in the Federal Flight Deck Officer (FFDO) Program, and deputized FFDOs to PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The ICR documentation is available at www.reginfo.gov. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to— (1) Evaluate whether the proposed information requirement 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; (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 using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Information Collection Requirement Title: Federal Flight Deck Officer Program. Type of Request: Extension of a currently approved collection. OMB Control Number: 1652–0011. Forms(s): N/A. Affected Public: Volunteer pilots, flight engineers, and navigators. Abstract: The Federal Flight Deck Officer (FFDO) Program enables TSA to E:\FR\FM\27JAN1.SGM 27JAN1

Agencies

[Federal Register Volume 74, Number 16 (Tuesday, January 27, 2009)]
[Notices]
[Pages 4756-4757]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-1754]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Multi-Domain Amphipathic 
Helical Peptides for the Treatment of Cardiovascular Diseases

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 worldwide to practice the invention 
embodied in: United States Provisional Patent Application No. 60/
619,392, filed October 15, 2004, entitled ``Multi-Domain Amphipathic 
Helical Peptides and Methods of Their Use'' (HHS Ref. No. E-114-2004/0-
US-01), United States Patent Application Serial No. 11/577,259, filed 
April 13, 2007, entitled ``Multi-Domain Amphipathic Helical Peptides 
and Methods of Their Use'' (HHS Ref. No. E-114-2004/0-US-07); 
Australian Patent Application Serial No. 2005295640, filed October 14, 
2005, entitled ``Multi-Domain Amphipathic Helical Peptides and Methods 
of Their Use'' (HHS Ref. No. E-114-2004/0-AU-03); Canadian Patent 
Application Serial No. 2584048, filed October 14, 2005, entitled 
``Multi-Domain Amphipathic Helical Peptides and Methods of Their Use'' 
(HHS Ref. No. E-114-2004/0-CA-04); European Patent Application Serial 
No. 05815961.7, filed October 14, 2005, entitled ``Multi-Domain 
Amphipathic Helical Peptides and Methods of Their Use'' (HHS Ref. No. 
E-114-2004/0-EP-05); Japanese Patent Application Serial No. 2007-
536912, filed October 14, 2005, entitled ``Multi-Domain Amphipathic 
Helical Peptides and Methods of Their Use'' (HHS Ref. No. E-114-2004/0-
JP-06) to KineMed, Inc., having a place of business in the State of 
California. The field of use may be limited to FDA or foreign 
regulatory body approved 5a peptide therapeutic for the prevention and 
treatment of cardiovascular diseases. The United States of America is 
the assignee of the patent rights in this invention. The territory may 
be worldwide. This announcement is the second notice to grant an 
exclusive license to this technology and supersedes any previous 
announcements including the Notice published in the Federal Register on 
Wednesday, May 11, 2005 (70 FR 24832).

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
March 30, 2009 will be considered.

ADDRESSES: Requests for a copy of the patent applications, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Fatima Sayyid, M.H.P.M., Senior Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-4521; Facsimile: (301) 402-0220; e-mail: 
Fatima.Sayyid@nih.hhs.gov.

SUPPLEMENTARY INFORMATION: Clearance of excess cholesterol from cells 
by high density lipoproteins (HDL) is facilitated by the interaction of 
HDL apolipoprotein with cell surface binding sites or receptors such as 
ABCA1. ABCA1 is a member of the ATP binding cassette transporter family 
and is expressed by many cell types. Mutations in the ABCA1 transporter 
lead to diseases characterized by the accumulation of excess cellular 
cholesterol, low levels of HDL and an increased risk for cardiovascular 
disease. Research has demonstrated an inverse correlation between the 
occurrence of atherosclerotic events and levels of HDL and its most 
abundant protein constituent, apolipoprotein A-1 (apoA-1). ApoA-1 has 
been shown to promote lipid efflux from ABCA1 transfected cells. 
However, the nature of the interaction between apoA-1 and ABCA1 is not 
fully understood. Several other exchangeable type apolipoproteins have 
been shown to efflux lipid from ABCA1 transfected cells. Although the 
exchangeable type apolipoproteins do not share a similar primary amino 
acid sequence, they all contain amphipathic helices, a structural motif 
known to facilitate the interaction of proteins with lipids. Recently, 
it has been shown in both animal models and humans that intravenous 
administration of apoA-1 can reduce the size of atherosclerotic 
plaques. It has also been observed that synthetic peptide mimics of 
apoA-1 can promote efflux of excess cholesterol from cells. Therefore, 
synthetic mimics of apoA-1 can potentially also be used as therapeutic 
compounds in the prevention and treatment of atherosclerosis.
    Currently, there are a wide variety of treatments for dyslipidemia, 
which include, but are not limited to, pharmacologic regimens (mostly 
statins), partial ileal bypass surgery, portacaval shunt, liver 
transplantation, and removal of atherogenic lipoproteins by one of 
several apheresis procedures.
    The subject technology is related to peptides and peptide analogs 
with multiple amphipathic alpha-helical domains that promote lipid 
efflux from cells and it relates to methods for identifying non-
cytotoxic peptides that promote lipid efflux from cells that are useful 
in the treatment and prevention of dyslipidemic and vascular disorders. 
Dyslipidemic and vascular disorders amenable to treatment with the 
isolated multi-domain peptides include, but are not limited to, 
hyperlipidemia, hyperlipoproteinemia,

[[Page 4757]]

hypercholesterolemia, hypertriglyceridemia, HDL deficiency, apoA-I 
deficiency, coronary artery disease, atherosclerosis, thrombotic 
stroke, peripheral vascular disease, restenosis, acute coronary 
syndrome, and reperfusion myocardial injury.
    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 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.
    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: January 21, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E9-1754 Filed 1-26-09; 8:45 am]
BILLING CODE 4140-01-P
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