Government-Owned Inventions; Availability for Licensing, 43992-43993 [2010-17446]

Download as PDF 43992 Federal Register / Vol. 75, No. 143 / Tuesday, July 27, 2010 / Notices TABLE 1.—ESTIMATED REPORTING BURDEN 21 U.S.C. Section 342 & 343/Section 1002(b) 2007 Amendments / Form FDA No. of Respondents Form FDA 3756 1 There Annual Frequency per Response 50 Total Annual Responses 10 500 Total Hours 20/60 167 are no capital costs or operating and maintenance costs associated with this collection of information. FDA estimates that each State will report (i.e., fill out the PETNet form to alert other PETNet members about a pet food-related incident) approximately 10 times per year. This estimate represents the maximum number of reports that FDA expects a State to submit in a year, and in many cases the number of reports submitted by a State will probably be far less. FDA believes that, given the form only has 11 items and most are drop down fields, 20 minutes is a sufficient amount of time to complete the form. State regulatory officials responsible for pet food already possess computer systems and have the internet access necessary to participate in PETNet, and thus there are no capital expenditures associated with the reporting. Regarding recordkeeping, State regulatory officials who report on PETNet receive the reportable information from consumers in their States in the course of their customary and regular duties. Further, these individuals already maintain records of such consumer complaints in the course of their duties which are sufficient for the purposes of reporting on PETNet. Therefore, FDA believes that the proposed collection of information does not have additional recordkeeping requirements. Dated: July 21, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–18303 Filed 7–26–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301/ 496–7057; fax: 301/402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. ADDRESSES: Therapeutics for the Treatment and Prevention of Atherosclerosis and Cardiovascular Disease Description of Invention: This technology consists of peptides and peptide-analogues that enhance clearance of excess cholesterol in cells and do not exhibit the cytotoxicity that has hampered development of similar potential therapeutics. Briefly, apolipoprotein A–1 (ApoA–1) promotes cholesterol efflux from cells and its concentration is inversely correlated with atherosclerotic events. The isolated peptidic component of ApoA–1 that acts within the cholesterol secretion pathway is therapeutic towards atherosclerosis but exhibits cytotoxic effects. In contrast, our inventors have derivatized that ApoA– 1 peptide which is both less cytotoxic and more active than the underivatized component in initial studies. This potential therapeutic is similar to high density lipoprotein (HDL) therapy and may complement statin-mediated reduction of pro-atherogenic lipoproteins. AGENCY: Potential Applications The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and • Treatment and prevention of atherosclerosis. • Treatment and prevention of cardiovascular disease, coronary artery disease, heart attack, stroke and inflammation. • Therapeutic or preventative coating for a heart or vascular implant. • Alternative to HDL therapy. National Institutes of Health, Public Health Service, HHS. ACTION: Notice. sroberts on DSKD5P82C1PROD with NOTICES Hours per Response SUMMARY: VerDate Mar<15>2010 16:30 Jul 26, 2010 Jkt 220001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 Potential Advantages • Enhanced cytotoxicity profile. • Enhanced hydrophilicity profile. • Complements statin-based therapies. • Oral delivery approaches in development. Development Status: Early stage with in vitro proof of concept data. Market: The CDC indicates that heart attacks account for 26% of deaths in the United States of which atherosclerosis is a significant contributing factor or cause. Global sales for cardiovascular therapeutics are expected to exceed $50b in 2010. Inventors: Amar A. Sethi (NHLBI) et al. Patent Status: U.S. Provisional Application No. 61/265,291 filed 30 Nov 2009 (HHS Reference No. E–047– 2009/0–US–01). Licensing Status: Available for licensing. Licensing Contact: Fatima Sayyid. M.H.P.M.; 301–435–4521; Fatima.Sayyid@nih.hhs.gov. Use of Immunosuppressive Agents for Treatment of Age-related Macular Degeneration (AMD) and Diabetic Retinopathy Description of Invention: AMD belongs to a group of disorders in which the immune system may play an important role. This invention discloses that patients with AMD gain additional therapeutic benefit from combination treatment of immunosuppressive agents and standard-of-care in comparison to standard-of-care alone. This invention slows the progression of choroidal neovascularization (CNV) and may have implications for related pathologies, including diabetic retinopathy. Clinical data from a small, randomized pilot clinical trial are available. Applications • A method of treatment for AMD. • A method of treatment for diabetic retinopathy. • A method of treatment for diseases associated with CNV. Advantages • Likely to be synergistic with existing therapeutics. • May enable repurposing of some exiting immunosuppressive agents. E:\FR\FM\27JYN1.SGM 27JYN1 Federal Register / Vol. 75, No. 143 / Tuesday, July 27, 2010 / Notices Development Status: In clinical trials. Market: An estimated three million individuals in the United States will have an advanced form of AMD by 2020 (Klein R et al. The epidemiology of agerelated macular degeneration. Am J Ophthalmol. 2004;137(3):486–95). Inventors: Robert B. Nussenblatt and Frederick L. Ferris (NEI). Publication: In preparation. Patent Status: U.S. Provisional Application No. 61/254,439 filed 23 Oct 2009 (HHS Reference No. E–198–2008/ 0–US–01). Licensing Status: Available for licensing. Licensing Contact: Norbert Pontzer, J.D., PhD; 301–435–5502; pontzern@mail.nih.gov. Collaborative Research Opportunity: The National Eye Institute, Laboratory of Immunology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the use of immunosuppressive agents in the treatment of age related macular degeneration. This is in light of new findings that immune mechanisms appear to be central to the expression of the clinical disease we know as AMD. Please contact Alan Hubbs, PhD at 301– 594–4263 or hubbsa@mail.nih.gov for more information. Dated: July 12, 2010. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2010–17446 Filed 7–26–10; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention sroberts on DSKD5P82C1PROD with NOTICES Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Patient Protection and Affordable Care Act (PPACA), Emerging Infections Program (EIP), Enhancing Epidemiology and Laboratory Capacity, Funding Opportunity Announcement CI10–003; Initial Review; Correction Correction: This notice was published in the Federal Register on July 7, 2010, Volume 75, Number 129, page 39033. The time and date should read as follows: Time and Date: 8 a.m.–5 p.m., September 8, 2010 (Closed). CONTACT PERSON FOR MORE INFORMATION: Gregory Anderson, M.S., M.P.H., VerDate Mar<15>2010 16:30 Jul 26, 2010 Jkt 220001 Scientific Review Officer, CDC, 1600 Clifton Road, NE., Mailstop E60, Atlanta, GA 30333, Telephone: (404) 498–2293. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: July 20, 2010. Michael J. Lanzilotta, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2010–18401 Filed 7–26–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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/or 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 grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council for Biomedical Imaging and Bioengineering, NACBIB September 2010. Date: September 13, 2010. Open: 9 a.m. to 1 p.m. Agenda: Report from the Institute Director, other Institute Staff and presentations of working group reports. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 43993 Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Independence Room (2nd Level), Bethesda, MD 20817. Closed: 1 p.m. to 3 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Independence Room (2nd Level), Bethesda, MD 20817. Contact Person: Anthony Demsey, PhD, Director, National Institute of Biomedical Imaging and Bioengineering, 6707 Democracy Boulevard, Room 241, Bethesda, MD 20892. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.nibib1.nih.gov/about/NACBIB/ NACBIB.htm, where an agenda and any additional information for the meeting will be posted when available. Dated: July 21, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–18385 Filed 7–26–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Service Administration Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). Dates and Times: August 19, 2010, 8:30 a.m. to 5 p.m., EST. August 20, 2010, 8:30 a.m. to 3 p.m., EST. Place: Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr, 1750 Rockville Pike, Rockville, Maryland 20852. Status: The meeting will be open to the public. Purpose: The Committee members will advance their efforts in the development of the Tenth Annual Report to the Secretary of the Department of Health and Human Services (the Secretary) and the Congress, focusing on the topic, Preparing the Interprofessional Workforce to Manage Health Behaviors. The Committee proposes to review concepts behind the initiation of a new degree program in Health Care Delivery Science established at Dartmouth University as it relates to managing health behaviors and ensuring a workforce that is prepared to address health behaviors in its education and E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 75, Number 143 (Tuesday, July 27, 2010)]
[Notices]
[Pages 43992-43993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17446]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

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

ACTION: Notice.

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

SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of Federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Therapeutics for the Treatment and Prevention of Atherosclerosis and 
Cardiovascular Disease

    Description of Invention: This technology consists of peptides and 
peptide-analogues that enhance clearance of excess cholesterol in cells 
and do not exhibit the cytotoxicity that has hampered development of 
similar potential therapeutics.
    Briefly, apolipoprotein A-1 (ApoA-1) promotes cholesterol efflux 
from cells and its concentration is inversely correlated with 
atherosclerotic events. The isolated peptidic component of ApoA-1 that 
acts within the cholesterol secretion pathway is therapeutic towards 
atherosclerosis but exhibits cytotoxic effects. In contrast, our 
inventors have derivatized that ApoA-1 peptide which is both less 
cytotoxic and more active than the underivatized component in initial 
studies. This potential therapeutic is similar to high density 
lipoprotein (HDL) therapy and may complement statin-mediated reduction 
of pro-atherogenic lipoproteins.

Potential Applications

     Treatment and prevention of atherosclerosis.
     Treatment and prevention of cardiovascular disease, 
coronary artery disease, heart attack, stroke and inflammation.
     Therapeutic or preventative coating for a heart or 
vascular implant.
     Alternative to HDL therapy.

Potential Advantages

     Enhanced cytotoxicity profile.
     Enhanced hydrophilicity profile.
     Complements statin-based therapies.
     Oral delivery approaches in development.
    Development Status: Early stage with in vitro proof of concept 
data.
    Market: The CDC indicates that heart attacks account for 26% of 
deaths in the United States of which atherosclerosis is a significant 
contributing factor or cause. Global sales for cardiovascular 
therapeutics are expected to exceed $50b in 2010.
    Inventors: Amar A. Sethi (NHLBI) et al.
    Patent Status: U.S. Provisional Application No. 61/265,291 filed 30 
Nov 2009 (HHS Reference No. E-047-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Fatima Sayyid. M.H.P.M.; 301-435-4521;
    Fatima.Sayyid@nih.hhs.gov.

Use of Immunosuppressive Agents for Treatment of Age-related Macular 
Degeneration (AMD) and Diabetic Retinopathy

    Description of Invention: AMD belongs to a group of disorders in 
which the immune system may play an important role. This invention 
discloses that patients with AMD gain additional therapeutic benefit 
from combination treatment of immunosuppressive agents and standard-of-
care in comparison to standard-of-care alone. This invention slows the 
progression of choroidal neovascularization (CNV) and may have 
implications for related pathologies, including diabetic retinopathy. 
Clinical data from a small, randomized pilot clinical trial are 
available.

Applications

     A method of treatment for AMD.
     A method of treatment for diabetic retinopathy.
     A method of treatment for diseases associated with CNV.

Advantages

     Likely to be synergistic with existing therapeutics.
     May enable repurposing of some exiting immunosuppressive 
agents.

[[Page 43993]]

    Development Status: In clinical trials.
    Market: An estimated three million individuals in the United States 
will have an advanced form of AMD by 2020 (Klein R et al. The 
epidemiology of age-related macular degeneration. Am J Ophthalmol. 
2004;137(3):486-95).
    Inventors: Robert B. Nussenblatt and Frederick L. Ferris (NEI).
    Publication: In preparation.
    Patent Status: U.S. Provisional Application No. 61/254,439 filed 23 
Oct 2009 (HHS Reference No. E-198-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Norbert Pontzer, J.D., PhD; 301-435-5502; 
pontzern@mail.nih.gov.
    Collaborative Research Opportunity: The National Eye Institute, 
Laboratory of Immunology, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the use of immunosuppressive agents 
in the treatment of age related macular degeneration. This is in light 
of new findings that immune mechanisms appear to be central to the 
expression of the clinical disease we know as AMD. Please contact Alan 
Hubbs, PhD at 301-594-4263 or hubbsa@mail.nih.gov for more information.

    Dated: July 12, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-17446 Filed 7-26-10; 8:45 am]
BILLING CODE 4140-01-M
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